Facsimile (703) 836-2021 [email protected] UNITED ... · Katelyn J. Bernier, Esq. BUCHANAN...

Filed on behalf of Petitioner 3Shape Medical A/S By: Erin M. Dunston, Esq. Aaron L. J. Pereira, Esq. Katelyn J. Bernier, Esq. BUCHANAN INGERSOLL & ROONEY PC 1737 King Street, Suite 500 Alexandria, Virginia 22314-2727 Telephone (703) 836-6620 Facsimile (703) 836-2021 [email protected] [email protected] [email protected]

UNITED STATES PATENT AND TRADEMARK OFFICE __________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

__________________

3SHAPE MEDICAL A/S Petitioner

v.

SIRONA DENTAL SYSTEMS GMBH Patent Owner

__________________

Case No.: To be assigned

Patent 6,319,006 __________________

PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,319,006 (CLAIMS 1-10) UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 et seq.

Petition for Inter Partes Review of U.S. Patent No. 6,319,606

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TABLE OF CONTENTS

I. INTRODUCTION ........................................................................................... 1

II. MANDATORY NOTICES PURSUANT TO 37 C.F.R. § 42.8 ..................... 1

A. Real Party-In-Interest ............................................................................ 1

B. Related Matters ...................................................................................... 1

C. Lead and Backup Counsel ..................................................................... 2

D. Service Information ............................................................................... 3

III. PAYMENT OF FEES ..................................................................................... 3

IV. REQUIREMENTS UNDER 37 C.F.R. § 42.104 ............................................ 4

A. Grounds for Standing ............................................................................ 4

B. Identification of Challenge and Precise Relief Requested .................... 5

1. Claims for Which Inter Partes Review is Requested ................. 5

2. Specific Patents and Printed Publications and Statutory Grounds on Which the Challenge is Based ................................ 5

3. Evidence Relied Upon to Support the Challenge ....................... 6

4. How the Challenged Claims Are to Be Construed ..................... 6

V. THE ’006 PATENT AND THE PRIOR ART RELIED UPON ..................... 7

A. The ʼ006 Patent ..................................................................................... 7

B. Critical Date and Prosecution History of the ʼ006 Patent ..................... 9

C. One of Ordinary Skill in the Art............................................................ 9

D. The Art Relied Upon in Petitioner’s Four Grounds ............................ 10

1. U.S. Patent No. 5,562,448 to Mushabac ................................... 11

2. U.S. Patent No. 5,725,376 to Poirier ........................................ 12


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3. German Patent Application Publication No. 195 10 294 A1 to Bannuscher ...................................................................... 13

4. U.S. Patent No. 5,372,502 to Massen et al. .............................. 15

5. Verstreken ................................................................................. 15

6. U.S. Patent No. 5,842,858 to Truppe ........................................ 16

7. Weese ........................................................................................ 17

VI. PETITIONERS HAVE A REASONABLE LIKELIHOOD OF PREVAILING ............................................................................................... 17

A. Claim Charts Setting Forth Where Every Element of Claims 1-5, 9, and 10 is Found in the Cited Prior Art ........................................ 18

B. Explanation of Why Claims 1-5, 9, and 10 Are Anticipated and/or Rendered Obvious by Mushabac or Poirier ............................. 36

1. Mushabac .................................................................................. 36

a. Claim 1 ............................................................................ 37

b. Claim 2 ............................................................................ 40

c. Claim 3 ............................................................................ 41

d. Claims 4 and 5 ................................................................ 42

e. Claims 9 and 10 .............................................................. 43

2. Poirier ........................................................................................ 44

a. Claim 1 ............................................................................ 44

b. Claim 2 ............................................................................ 47

c. Claim 3 ............................................................................ 47

d. Claims 4 and 5 ................................................................ 48

e. Claims 9 and 10 .............................................................. 49


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C. Explanation of Why Claims 1-5 Would Have Been Obvious Over Bannuscher in View of Massen. ................................................. 50

1. Claim 1 ...................................................................................... 51

2. Claim 2 ...................................................................................... 53

3. Claim 3 ...................................................................................... 53

4. Claims 4 and 5 ........................................................................... 54

D. Explanation of Why Claims 6-8 Would Have Been Obvious Over Poirier, Mushabac, or Bannuscher and Massen in View of Verstreken, Truppe, or Weese. ............................................................ 54

VII. CONCLUSION .............................................................................................. 60

APPENDIX 1 - LIST OF EXHIBITS


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TABLE OF AUTHORITIES

Cases Page(s)

Acromed Corp. v. Sofamor Danek Group, Inc., 253 F.3d 1371 (Fed. Cir. 2001) ............................................................... 18

InTOUCH Techs., Inc. v. VGo Commc’ns, Inc., 751 F.3d 1327 (Fed. Cir. 2014) ............................................................... 18

KSR Int’l Co. v. Teleflex Inc, 550 U.S. 398 (2007)........................................................................... 43, 60

Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561 (Fed. Cir. 1987) ............................................................... 10

Rolls-Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010) ................................................................. 9

In re Venner, 262 F.2d 91 (C.C.P.A. 1958) ................................................................... 52

Statutes

35 U.S.C. § 102(b) ............................................................................................... 5

35 U.S.C. § 103(a) ........................................................................................... 5, 6

35 U.S.C. §§ 311-319 .......................................................................................... 1

35 U.S.C. § 318(a) ............................................................................................... 4


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Rules

37 C.F.R. § 42.8 ................................................................................................... 1

37 C.F.R. § 42.8(b)(1) .......................................................................................... 1

37 C.F.R. § 42.8(b)(2) .......................................................................................... 1

37 C.F.R. § 42.8(b)(3) .......................................................................................... 2

37 C.F.R. § 42.10(a) ............................................................................................. 2

37 C.F.R. § 42.10(b) ............................................................................................ 3

37 C.F.R. § 42.15(a)(1) ........................................................................................ 3

37 C.F.R. § 42.15(a)(2) ........................................................................................ 3

37 C.F.R. § 42.100 ............................................................................................... 1

37 C.F.R. § 42.100(b) .......................................................................................... 6

37 C.F.R. § 42.102(a)(2) ...................................................................................... 4

37 C.F.R. § 42.104 ............................................................................................... 4

37 C.F.R. § 42.104(a) ........................................................................................... 4

37 C.F.R. § 42.104(b) .......................................................................................... 5

37 C.F.R. § 42.104(b)(3) ...................................................................................... 6


1

I. INTRODUCTION

Because the subject matter of Claims 1-10 (“the Challenged Claims”) of

U.S. Patent No. 6,319,006, issued on November 20, 2001, to Franz Scherer and

Joachim Pfeiffer (“the ’006 Patent”) (Ex. 1001) would have been anticipated

and/or obvious under 35 U.S.C. §§ 102 and 103 to one of ordinary skill in the art,

3SHAPE MEDICAL A/S (“Petitioner”) respectfully requests institution of an inter

partes review of the Challenged Claims in accordance with 35 U.S.C. §§ 311-319

and 37 C.F.R. § 42.100 et seq.

II. MANDATORY NOTICES PURSUANT TO 37 C.F.R. § 42.8

A. Real Party-In-Interest

Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner certifies that 3SHAPE

MEDICAL A/S is a real party-in-interest. Petitioner also certifies that 3SHAPE,

INC. and BIOLASE, INC. are real parties-in-interest. Petitioner further certifies

that, in an abundance of caution, 3SHAPE A/S is a real party-in-interest.

B. Related Matters

Pursuant to 37 C.F.R. § 42.8(b)(2), the following is a list of judicial and

administrative matters that would affect, or be affected by, a decision in this

proceeding. Items 3-7 are hereinafter referred to as “the District Court Litigation.”

1. Anatomage, Inc. v. Sirona Dental Systems GmbH, Case No.

IPR2015-01057, Petition for Inter Partes Review of U.S. Patent No. 6,319,006,

filed on April 15, 2015 (instituted on October 20, 2015) (pending);


2

2. Institut Straumann AG v. Sirona Dental Systems GmbH, Case

No. IPR2015-1190, Petition for Inter Partes Review of U.S. Patent No. 6,319,006,

filed on May 11, 2015 (instituted on November 16, 2015) (pending);

3. Sirona Dental Systems GmbH v. 3Shape A/S, Civil Action No.

1-15-cv-00278 (D. Del.), Complaint filed March 30, 2015 (pending);

4. Sirona Dental Systems GmbH v. Dentsply IH Inc., Civil Action

No. 1-14-cv-00538 (D. Del.), Complaint filed April 24, 2014 (pending);

5. Sirona Dental Systems GmbH v. OnDemand3D Technology

Inc., Civil Action No. 1-14-cv-00539 (D. Del.), Complaint filed April 24, 2014

(Consent Judgment and Order of Dismissal entered on May 18, 2015);

6. Sirona Dental Systems GmbH v. Anatomage, Inc., Civil Action

No. 1-14-cv-00540, Complaint filed April 24, 2014 (pending); and

7. Sirona Dental Systems GmbH v. Dental Wings Inc., Civil

Action No. 1-14-cv-00460, Complaint filed April 11, 2014 (pending).

C. Lead and Backup Counsel

Pursuant to 37 C.F.R. §§ 42.8(b)(3) and 42.10(a), Petitioner hereby

identifies its lead and backup counsel as follows:


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Lead Counsel for Petitioner: Erin M. Dunston, Esq. Registration No. 51,147 BUCHANAN INGERSOLL & ROONEY PC 1737 King Street, Suite 500 Alexandria, Virginia 22314 Main Telephone (703) 836-6620 Direct Telephone (703) 838-6645 Main Facsimile (703) 836-2021 [email protected]

Backup Counsel for Petitioner: Aaron L. J. Pereira, Esq. Registration No. 71,839 BUCHANAN INGERSOLL & ROONEY PC 1290 Avenue of the Americas, 30th Floor New York, New York 10104 Main Telephone (212) 440-4400 Direct Telephone (212) 440-4468 Main Facsimile (212) 440-4401 [email protected]

Backup Counsel for Petitioner: Katelyn J. Bernier Registration No. 72,986 BUCHANAN INGERSOLL & ROONEY PC 1737 King Street, Suite 500 Alexandria, Virginia 22314 Main Telephone (703) 836-6620 Direct Telephone (703) 299-6925 Main Facsimile (703) 836-2021 [email protected]

Powers of Attorney are being filed concurrently herewith in accordance with

37 C.F.R. § 42.10(b).

D. Service Information

Papers concerning this matter should be served by EXPRESS MAIL, hand-

delivery, or electronic mail at lead counsel’s address as listed above.

III. PAYMENT OF FEES

The undersigned authorizes the Office to charge the inter partes request fee

of $9,000 as required by 37 C.F.R. § 42.15(a)(1) and the inter partes post-

institution fee of $14,000 as required by 37 C.F.R. § 42.15(a)(2) for the filing of

this Petition for Inter Partes Review, to Deposit Account No. 02-4800. The


4

undersigned further authorizes the payment for any additional fees, or credit for

any overpayment, to Deposit Account No. 02-4800.

IV. REQUIREMENTS UNDER 37 C.F.R. § 42.104

A. Grounds for Standing

Pursuant to 37 C.F.R. § 42.104(a), Petitioner hereby certifies that the ’006

Patent is available for inter partes review in accordance with 37 C.F.R.

§ 42.102(a)(2), and that the Petitioner is not barred or estopped from requesting

inter partes review challenging the claims of the ’006 Patent on the grounds

identified in this Petition.

This Petition is being filed within one year from the date on which the

Petitioner and each of the other named interested parties was first served with a

complaint by Sirona Dental Systems GmbH in the District Court litigation, in

which Petitioner is accused of infringing the ’006 Patent.

Neither Petitioner nor any privy of Petitioner nor any of the real parties in

interest has received a final written decision under 35 U.S.C. § 318(a) regarding

any claim of the ’006 Patent on any ground that was raised or could have been

raised by Petitioner or its privies in any inter partes review, post grant review, or

covered business method patent review.


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B. Identification of Challenge and Precise Relief Requested

Pursuant to 37 C.F.R. § 42.104(b), Petitioner challenges Claims 1-10 of the

’006 Patent and requests that these claims be found unpatentable over the prior art

for the reasons given herein.

1. Claims for Which Inter Partes Review is Requested

Petitioner requests inter partes review of Claims 1-10 of the ’006 Patent.

2. Specific Patents and Printed Publications and Statutory Grounds on Which the Challenge is Based

Each patent and printed publication used as part of a ground for invalidation

of one or more claims of the ’006 Patent is prior art to the ’006 Patent under 35

U.S.C. § 102(b).

Ground 1: Claims 1-5, 9, and 10 are unpatentable because they are

anticipated under 35 U.S.C. § 102(b) by, or would have been obvious under 35

U.S.C. § 103(a) in view of, U.S. Patent No. 5,562,448 (“Mushabac”) (Ex. 1006).

Ground 2: Claims 1-5, 9, and 10 are unpatentable because they are

anticipated under 35 U.S.C. § 102(b) by, or would have been obvious under 35

U.S.C. § 103(a) in view of, U.S. Patent No. 5,725,376 (“Poirier”) (Ex. 1005).

Ground 3: Claims 1-5 are unpatentable because they would have been

obvious under 35 U.S.C. § 103(a) over German Patent Application Publication DE

195 10 294 (Ex. 1007), whose verified English translation is Ex. 1008

(“Bannuscher”), in view of U.S. Patent No. 5,372,502 (“Massen”) (Ex. 1009).


6

Ground 4: Claims 6-8 are unpatentable because they would have been

obvious under 35 U.S.C. § 103(a) over Poirier, Mushabac, or Bannuscher in view

of Kris Verstreken et al., An Image-Guided Planning System for Endosseous Oral

Implants, 17(5) IEEE TRANS. ON MED. IMAGING (Oct. 1998) (“Verstreken”)

(Ex. 1010), U.S. Patent No. 5,842,858 (“Truppe”) (Ex. 1011), or Jürgen Weese et

al., An Approach to 2D/3D Registration of a Vertebra in 2D X-ray Fluoroscopies

with 3D CT Images, in 1205 LECTURE NOTES IN COMPUTER SCIENCE, CVRMED-

MRCAS’97 119 (Jocelyne Troccaz et al. eds. 1997) (“Weese”) (Ex. 1015).

3. Evidence Relied Upon to Support the Challenge

Petitioner relies upon the prior art patents, patent applications, and printed

publications cited herein and set forth in the Exhibit List, including the Declaration

of Dr. Scott D. Ganz (Ex. 1004), including the claim charts and the documents

cited therein. See Ex. 1004, ¶¶ 1-44, 163-165.

4. How the Challenged Claims Are to Be Construed

The terms of the Challenged Claims are to be given their broadest

reasonable interpretation in light of the specification of the ’006 Patent, as

understood by one of ordinary skill in the art. See 37 C.F.R. § 42.100(b); see also

In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278 (Fed. Cir. 2015). Pursuant

to 37 C.F.R. § 42.104(b)(3), Petitioner has relied upon the ordinary meaning for

most claim terms but construes the following term. See Ex. 1004, ¶¶ 40, 67.


7

The broadest reasonable interpretation of the term “pseudo-X-ray picture”

solely for purposes of this requested inter partes review is “a representation of

measured data records of the three-dimensional optical measuring that can be

superimposed with an X-ray picture.” See Ex. 1004, ¶¶ 67-69.

V. THE ’006 PATENT AND THE PRIOR ART RELIED UPON

To understand Petitioner’s four grounds of unpatentability for the

Challenged Claims, Petitioner offers the following summary of the ’006 Patent, its

prosecution history, and the prior art relied upon. See Ex. 1004, ¶¶ 57-62.

A. The ʼ006 Patent

The ’006 Patent is titled “Method for Producing a Drill Assistance Device

for a Tooth Implant.” Ex. 1001, Title. The Challenged Claims, which include one

independent claim (Claim 1), carry out the method using five steps: (1) taking an

X-ray of the jaw into which the implant will be placed, (2) carrying out three-

dimensional (“3-D”) optical measuring of the visible surfaces of the jaw and of the

teeth, (3) correlating the measured data records from the X-ray and optical

measuring, (4) determining the optimal bore hole for the implant based on the X-

ray, and (5) determining a pilot hole in a drill template based on the X-ray and

optical measuring. See id., col. 5, ll. 2-18; see also Ex. 1004, ¶ 60. In

summarizing the invention, the ’006 Patent explains that it seeks to “provide a drill

assistance device that will allow the exact drilling of a pilot hole for a tooth


8

implant in relation to the teeth that still remain in the jaw.” See Ex. 1001, col. 2, ll.

5-10; see also Ex. 1004, ¶¶ 59-63.

The ’006 Patent sought to remedy a difficulty encountered when placing

dental implants. The ’006 Patent explains that prior methods relied upon “an

imprint that is taken from the jaw bone.” See Ex. 1001, col. 1, ll. 28-30; see also

Ex. 1004, ¶¶ 57-58. The ’006 Patent also explains that drill templates sought “to

allow the placement of an exactly positioned bore hole” planned using X-rays, but

suggested that it was “difficult . . . to determine the position of a pilot hole exactly

during the drilling process because the information that is contained in the X-ray

cannot be exactly transferred to the optical images which the physician sees while

drilling.” See Ex. 1001, col. 1, ll. 28-39; see also Ex. 1004, ¶ 59. The ’006 Patent

also states that while “implants are planned and manufactured very exactly and

precise to the last detail,” the implants’ “positioning in the jaw area [was] effected

to date on the basis of individual experience, which can vary considerably among

different dentists” and can lead to “unsatisfactory” results. See Ex. 1001, col. 1, ll.

39-47; see also Ex. 1004, ¶ 59.

According to the ’006 Patent, the Challenged Claims remedy these problems

by interconnecting an X-ray and the “actual optical proportions inside the patient’s

mouth . . . by linking the two images in such a way that a drill assistance device in

[the] form of a drill template can be made available which contains the pilot hole


9

that is necessary for fastening the implant in its optimal position, based on the

location of the neighboring teeth.” See Ex. 1001, col. 2, ll. 33-44; see also

Ex. 1004, ¶ 61.

Yet, the remedy provided by the ’006 Patent was nothing new. See Ex.

1004, ¶¶ 45-56, 71-72. Long before the ’006 Patent, dental implant practitioners

had been gathering and correlating X-ray and 3-D data in an effort to best place

bore holes and pilot holes in drill templates. See Ex. 1004, ¶¶ 49-50, 71.

Examples of these prior disclosures are detailed below.

B. Critical Date and Prosecution History of the ʼ006 Patent

The ’006 Patent issued on November 20, 2001, from U.S. Patent Application

Serial. No. 09/699,363 (“the ʼ363 Application”) filed on October 31, 2000. See Ex.

1002, p. 1. The ’006 Patent claims priority to a published German application, DE

199 52 962, filed on November 3, 1999. See Ex. 1001, Cover, field (30); see also

Ex. 1002, pp. 6, 9, 24, 30, 50; see also Ex. 1004, ¶ 70.

The prosecution history of the ’006 Patent reveals that little occurred. See

Ex. 1002.

C. One of Ordinary Skill in the Art

It is through the lenses of one of ordinary skill in the art, prior to the

purported invention of the Challenged Claims, that the Challenged Claims and

relied-upon art must be viewed. See, e.g., Rolls-Royce, PLC v. United Techs.


10

Corp., 603 F.3d 1325, 1338 (Fed. Cir. 2010); see also Panduit Corp. v. Dennison

Mfg. Co., 810 F.2d 1561, 1566 (Fed. Cir. 1987). For purposes of this Petition, one

of ordinary skill in the art is one with a D.M.D. (Doctor of Medicine in Dentistry

or Doctor of Dental Medicine) or D.D.S. (Doctor of Dental Surgery) and at least

several years of experience with 3-D technology used in dental implant treatment,

planning, and surgery. Alternatively, one of ordinary skill in the art may be one

with a computer engineering degree, or a trained dental laboratory technician with

substantial experience with 3-D technology and software applications used in

dental implant treatment, planning, and surgery. See Ex. 1004, ¶¶ 63-66.

D. The Art Relied Upon in Petitioner’s Four Grounds

While the ’006 Patent purports to offer something new to the public, such is

not the case. See Ex. 1004, ¶ 47-48. Methods to assist dental practitioners in

safely and precisely placing dental implants, including how to place bores in an

exact manner, were well-known by the time the ʼ363 Application was filed. See

Ex. 1004, ¶¶ 48-56, 71. Each of Mushabac, Poirier, and Bannuscher, the primary

art relied upon, clearly shows steps for developing drill templates from X-rays and

3-D scanning technologies. See Ex. 1004, ¶¶ 71-72, 74-84. All of the prior art

used in Petitioner’s four grounds encourage the use of computer-assisted implant

planning in the manner set forth in the Challenged Claims. See Ex. 1004, ¶ 71.


11

Put differently, the Challenged Claims offer nothing then new and non-obvious.

See Ex. 1004, ¶¶ 71-72, 163.

1. U.S. Patent No. 5,562,448 to Mushabac

Mushabac, which issued on October 8, 1996, is very similar to the content of

the Challenged Claims, teaching methods “for facilitating dental diagnosis and

treatment.” See Ex. 1006, col. 1, ll. 13-14; see also Ex. 1004, ¶ 74.

Like the Challenged Claims, Mushabac seeks to precisely place the implant,

explaining that its method “is especially useful in boring through hard or soft

tissues and preparing a site for anchoring a dental implant in a jaw of a patient.

. . . . The optimal position and the optimal orientation of the drilling or material

removal tool are adapted to produce a desired position and a desired orientation of

the blade or anchor for the implant.” See Ex. 1006, col. 3, ll. 57-66; see also Ex.

1004, ¶ 75. Again, like the Challenged Claims, the optimal implant positioning is

achieved by correlating “X-ray data and the surface data . . . to produce a

composite image showing both internal and external structure in the precise

geometric relationships they have to each other in the patient’s mouth.” See Ex.

1006, col. 4, ll. 8-13; see also Ex. 1004, ¶ 75.

Like the Challenged Claims, Mushabac states that an “object of the present

invention is to provide an improved method for positioning and orientation (sic) an

implant blade. Yet another object of the present invention is to provide an


12

improved method for monitoring the formation, in a patient’s jaw bone, of a bore

for a dental implant.” See Ex. 1006, col. 3, ll. 29-34; see also Ex. 1004, ¶ 76.

As explained in Ground 1, Mushabac teaches every element of Claims 1-5,

9, and 10 of the ’006 Patent. See Ex. 1004, ¶¶ 72, 77.

2. U.S. Patent No. 5,725,376 to Poirier

Poirier, which issued on March 10, 1998, is also strikingly similar to the

content of the Challenged Claims. See Ex. 1004, ¶ 78. Poirier was not cited in the

Information Disclosure Statement filed in the ʼ363 Application nor by the

Examiner, but its purported foreign counterpart, International Patent Application

Publication No. WO 99/32045 (Ex. 1014), was. See Ex. 1002, pp. 47-48; see also

Ex. 1001, Cover, field (56), col. 1, l. 11.

Poirier, like the ’006 Patent, clearly identifies the industry-wide problem

sought to be remedied:

In the known prior art, the oral surgeon typically has difficulty

deciding on a drill axis for the implants since the ideal position for

the implants should be decided with knowledge of the jawbone

structure into which the jawbone is to be inserted, knowledge of

the position within the jawbone structure of the nerve tissue, the

gum surface and the required position of the false teeth or dentures

to be supported by the dental implant.


13

See Ex. 1005, col. 1, ll. 32-39; see also Ex. 1004, ¶ 79. Poirier’s mission, like that

of the ’006 Patent, is to provide “a method of manufacturing of a dental implant

drill guide.” See Ex. 1005, col. 1, ll. 9-10; see also Ex. 1004, ¶ 79.

Just as is done in the Challenged Claims, Poirier achieves its mission by

choosing “[d]ental implant drill holes . . . by creating a computer model giving

jawbone structural details, gum surface shape information and proposed teeth or

dental prosthesis shape information.” See Ex. 1005, Abstract; see also Ex. 1004,

¶ 80. Poirier, like the ’006 Patent, focuses on bore placement, stating: “The

computer model shows the bone structure, gum surface and teeth images properly

referenced to one another so that implant drill hole positions can be selected taking

into consideration proper positioning within the bone as well as proper positioning

with respect to the dental prosthesis.” See Ex. 1005, Abstract; see also Ex. 1004,

¶ 80. As explained in Ground 2, Poirier teaches every element of Claims 1-5, 9,

and 10 of the ’006 Patent. See Ex. 1004, ¶¶ 72, 81.

3. German Patent Application Publication No. 195 10 294 A1 to Bannuscher

Bannuscher, which published on October 2, 1996, is directed to methods

“for preparing a surgical template for dental implant surgery for installation of

implants in the upper and/or lower jaw.” See Ex. 1008, p. 2; see also Ex. 1004,

¶ 82. Bannuscher identifies the problem as a lack of uniformity in the planning of

the implant, therapy, and surgical process, stating: “the oral surgeon, the dentist


14

and the dental technician, each had to develop constructions and processing

techniques using their own experience. . . . If, according to the prior art, implant-

supported structures are created, the practitioner is forced to rely on his practical

experience and on his ‘static feeling.’” See Ex. 1008, p. 2; see also Ex. 1004, ¶ 82.

Like the Challenged Claims, Bannuscher’s “key concept” is combining “X-

ray diagnostics and the model or oral situation of the patient.” See Ex. 1008, p. 8;

see also Ex. 1004, ¶ 83. Bannuscher prepares “a surgical template for dental

implant surgery” by digitally entering “into a computer” “and relative to the

patient’s skull”

a three-dimensional model geometric model of the mouth and jaw

area and an X-ray image of the same . . . . An optimized implant

position is compared with the existing vertical bone. According to

a comparison between the optimized implant position and the

existing vertical bone, reference points are defined in the

radiograph. . . . Angular and anatomical conditions essential for

surgery are dimensioned, evaluated and represented by real values.

The real values are transferred to the surgical template.

See Ex. 1008, p. 2; see also Ex. 1004, ¶ 83. Bannuscher explains that the “main

advantage of the inventive process lies in combining all the important information

and parameters for implant surgery planning.” See Ex. 1008, p. 9; see also Ex.

1004, ¶ 83. As explained in Ground 3, Bannuscher in combination with Massen

teaches every element of Claims 1-5 of the ’006 Patent. See Ex. 1004, ¶¶ 72, 84.


15

4. U.S. Patent No. 5,372,502 to Massen et al.

Massen, which issued on December 13, 1994, is similar to the Challenged

Claims in that it provides more precision when placing dental implants. See Ex.

1004, ¶ 85. Massen is directed to an “optical oral or mouth probe which is utilized

for the three-dimensional measurement or surveying of teeth.” See Ex. 1009,

Abstract; see also Ex. 1004, ¶ 85. Massen explains that “direct optical three-

dimensional surveying or measuring of teeth in the oral cavity of a patient

facilitates the obtainment of the digital construction data necessary for the

computer-controlled manufacture of tooth replacements without having to make

any impression of the teeth.” See Ex. 1009, col. 1, ll. 19-24; see also Ex. 1004,

¶ 85. Massen’s optical probe includes a charge-coupled image sensor that “is a

device in which electrical charges are introduced when light from a scene is

focused on the surface of the device.” See Ex. 1009, col. 5, ll. 46-49; see also Ex.

1004, ¶ 85. As explained in Ground 3, Bannuscher in combination with Massen

teaches every element of Claims 1-5 of the ’006 Patent. See Ex. 1004, ¶¶ 72, 86.

5. Verstreken

As explained in Ground 4, Mushabac, Poirier, or Bannuscher and Massen in

combination with Verstreken teaches every element of Claims 6-8 of the ’006

Patent. See Ex. 1004, ¶¶ 73, 88.


16

Verstreken is an article that was accessible to the public, as evidenced by the

date stamp on Exhibit 1010 showing receipt by January 11, 1999. Verstreken

teaches a preoperative planning system for oral implant surgery that combines 2-D

CT images of the jaw with 3-D surface rendered models of the bone and CAD

implant models using a double scanning technique. See Ex. 1010, p. 846; Ex.

1004, ¶ 87. The two scans are aligned using the markers to provide a composite

image that depicts both the external and internal structures of the patient’s jaw and

teeth. See Ex. 1010, p. 846; Ex. 1004, ¶ 87.

6. U.S. Patent No. 5,842,858 to Truppe


combination with Truppe teaches every element of Claims 6-8 of the ’006 Patent.

See Ex. 1004, ¶¶ 73, 90.

Truppe, which issued on December 1, 1998, is similar to Mushabac, Poirier,

Bannuscher, and the Challenged Claims in that it seeks to provide more precision

in the planning of dental implant positioning. See Ex. 1011, cover page; Ex. 1004,

¶ 89. Truppe relates to a method of representing a patient’s jaw using a

combination of 2-D and 3-D images. See Ex. 1011, Abstract; Ex. 1004, ¶ 89.

Truppe provides that an optical image of the patient’s jaw is superimposed over at

least one X-ray picture of the patient’s jaw. See Ex. 1011, col. 2, ll. 41-43 and col.

19-20; Ex. 1004, ¶ 89. Truppe explains that marking points are used in both the X-


17

ray image and the 3-D optical image to facilitate the alignment of the images. See

Ex. 1011, col. 2, ll. 41-47; Ex. 1004, ¶ 89. Accordingly, Truppe’s method makes

clear that “it is possible to position the data set such that the structures of the data

set will always match.” See Ex. 1011, col. 3, ll. 19-36; Ex. 1004, ¶ 89.

7. Weese


combination with Weese teaches every element of Claims 6 and 7 of the ’006

Patent. See Ex. 1004, ¶¶ 73, 93.

Weese is an article that was publicly presented in Grenoble, France in March

1997 and accessible to the public, as evidenced by the date stamp on Exhibit 1015

showing receipt by October 7, 1998. Weese teaches a voxel-based method for

2D/3D registration of an intra-operatively acquired X-ray fluoroscopy with 3D CT

images for use during an operation for navigation. See Ex. 1004, ¶ 91. Weese

provides that pseudo projections, using a small part of the CT image, are computed

and the resulting template is compared to the X-ray projection. See Ex. 1015, p.

119; Ex. 1004, ¶¶ 91-92. Weese describes correlating X-ray and 3D CT images to

“support the placement of pedicle screws in spine surgery.” See Ex. 1015,

Abstract, p. 119; Ex. 1004, ¶ 92.

VI. PETITIONERS HAVE A REASONABLE LIKELIHOOD OF PREVAILING

Petitioners have a reasonable likelihood of prevailing because Claims 1-5, 9,


18

and 10 are anticipated by Mushabac or Poirier, and all of the Challenged Claims

are obvious in view of the listed prior art. See Ex. 1004, ¶¶ 72, 73, 94-163.

Anticipation under 35 U.S.C. § 102 requires that the asserted art contain

each element of a properly-construed claim under consideration, either literally or

inherently. See, e.g., Acromed Corp. v. Sofamor Danek Group, Inc., 253 F.3d

1371, 1383 (Fed. Cir. 2001).

“Obviousness is a question of law based on underlying factual findings:

(1) the scope and content of the prior art; (2) the differences between the claims

and the prior art; (3) the level of ordinary skill in the art; and (4) objective indicia

of nonobviousness.” InTOUCH Techs., Inc. v. VGo Commc’ns, Inc., 751 F.3d

1327, 1347 (Fed. Cir. 2014). The scope and content of the prior art relevant to this

Petition are set forth below for each statutory ground of rejection upon which this

Petition is based. The differences between the prior art and the invention claimed

in the ’006 Patent are also addressed below. One of ordinary skill in this art would

be able to read and understand the ’006 Patent and, using that skill and knowledge,

would have been able to create (or be able to specify completely) the system or

method of the challenged claims.

A. Claim Charts Setting Forth Where Every Element of Claims 1-5, 9, and 10 is Found in the Cited Prior Art

The following claim charts support the four grounds of unpatentability and

highlight the overlapping nature of the cited art. See Ex. 1004, ¶ 72.


19

’006 Patent Claims

Exemplary Disclosure from Mushabac (Ex. 1006)

1. Method for producing a drill assistance device for a tooth implant in a person’s jaw, comprising the following process steps:

Mushabac discloses a method for producing a drill assistance device for a tooth implant in a person’s jaw. Mushabac discloses “a method for use in forming a preparation in a patient’s jaw” that is “especially useful in boring through hard or soft tissues and preparing a site for anchoring a dental implant in a jaw of a patient.” Mushabac further explains that “the preparation comprises a bored structured form that has been in the jaw bone for receiving a form or blade for the implant.” Ex. 1006, col. 3, ll. 42-66; Ex. 1004, pp. 28-29. Mushabac discloses a block of acrylic material 606 that is provided with a hole “matching the bore 560 to be formed in the patient’s jaw bone 608. The hole in block 606 can then be used as a template to guide, limit or control the motions of an implant drill during an actual operation on a patient’s jaw bone 558.” Ex. 1006, col. 27, ll. 3-11, Fig. 28; Ex. 1004, p. 29.

taking an x-ray picture of the jaw and compiling a corresponding measured data record,

Mushabac discloses taking an X-ray picture of the jaw and compiling a corresponding measured data record. Mushabac’s method for use in forming a preparation in a patient’s jaw includes “(a) generating electrically encoded data specifying pre-existing dental structure” which “comprises a first step of generating digitized surface data and a second step of generating digitized X-ray data.” Ex. 1006, col. 3, ll. 44-46, col. 4, ll. 3-6, Fig. 1; Ex. 1004, p. 29. Mushabac discloses a “computerized interactive system” wherein “computer 24 may receive from a third data generating device or assembly 28 digitized input signals relating to internal structures of the tooth being scanned. Specifically, data generating device 28 may take the form of an


20

X-ray device such as used in current extra-oral or intra-oral radiology or other methodologies and basically comprises a source 30 of X-ray radiation and a detector 32 for receiving the X-ray radiation after it passes through a tooth and converting the incident radiation into a digital data stream.” Ex. 1006, col. 10, ll. 36-55, Fig. 1; Ex. 1004, pp. 29-30.

carrying out a three-dimensional optical measuring of the visible surfaces of the jaw and of the teeth and compiling a corresponding measured data record,

Mushabac discloses carrying out a three-dimensional optical measuring of the visible surfaces of the jaw and of the teeth and compiling a corresponding measured data record Mushabac discloses “(a) generating electrically encoded data specifying pre-existing dental structure” which “comprises a first step of generating digitized surface data.” Ex. 1006, col. 3, ll. 44-46; col. 4, ll. 3-6, Fig. 1; Ex. 1004, p. 30. Mushabac discloses that the “digitized surface data may include . . . video surface data and/or contour data generated with the aid of a probe.” Ex. 1006, col. 4, ll. 8-10; Ex. 1004, p. 30. Mushabac discloses a “second data generating device or assembly 26 [that] is operatively connected to computer 24 for transmitting thereto digitized signals containing information pertaining to a curvilinear contour on the surface of the three-dimensional surface of the tooth.” Ex.


21

1006, col. 10, ll. 42-46; Ex. 1004, pp. 30-31. Mushabac also discloses a “data generating device 22” that with an opto-electrical transducer and a “grid projection assembly 46.” The opto-electrical transducer “generates and transmits to computer 24 a digitized video signal containing information used by computer 24 to calculate the dimensions of the subject tooth and to display the tooth’s structure in a three-dimensional graphic representation on monitor 34.” Ex. 1006, col. 12, ll. 46-60, Fig. 2; Ex. 1004, p. 31.

Mushabac discloses that “[u]pon the transmission to computer 24 of sufficient data from surface data generating device 22 and contour data generating device 26 (FIG. 1), computer displays partial or complete graphic representations on monitor 34 of the subject tooth or teeth. The graphic representations include the visible three-dimensional surfaces of each such tooth.” Ex. 1006, col. 16, ll. 5-10, Figs. 1-2; Ex. 1004, p. 31. Mushabac provides that “probe member 52 (FIG. 1) is used to digitize the surface of the jaw bone 558.” Ex. 1006, col. 24, ll. 53-56, Fig. 1; Ex. 1004, p. 31.

correlating the measured data records from the x-ray picture and from the measured data

Mushabac discloses correlating the measured data records from the X-ray picture and from the measured data records of the three-dimensional optical measuring Mushabac discloses “digitized signals containing information pertaining to a curvilinear contour on the surface of the three-dimensional surface of the tooth” and “digitized input signals


22

records of the three-dimensional optical measuring,

relating to internal structures of the tooth being scanned” transmitted to computer 24. Ex. 1006, col. 10, ll. 42-49; Ex. 1004, p. 32. Mushabac discloses that opto-electrical transducer “48 generates and transmits to computer 24 a digitized video signal containing information used by computer 24 to calculate the dimensions of the subject tooth and to display the tooth’s structure in a three-dimensional graphic representation.” Ex. 1006, col. 12, ll. 54-60; Ex. 1004, p. 32. Mushabac discloses that the “X-ray data and the surface data are correlated to produce a composite image showing both internal and external structures in the precise geometric relationships they have to each other in the patient’s mouth” and the correlation is done to optimize implant placement. Ex. 1006, col. 4, ll. 10-13, 37-39; Ex. 1004, p. 32. Mushabac further discloses an electronic chart that “presents internal structural features and external structural features together, showing the geometric and dimensional relationships among the various structures.” Ex. 1006, col. 6, ll. 1-4; Ex. 1004, p. 32.

determinating the optimal bore hole for the implant, based on the x-ray picture, and

Mushabac discloses determinating the optimal bore hole for the implant, based on the X-ray picture. Mushabac discloses “an improved method for monitoring the formation, in a patient’s jaw bone, of a bore for a dental implant.” Ex. 1006, col. 3, ll. 32-34; Ex. 1004, p. 33. Mushabac discloses “three views of an optimal position and orientation 556 of a drill (not separately enumerated) for cutting into a patient’s mandible 558 (or any body structure) a bore 560 for receiving an anchor or blade (not shown) of an implant.” Ex. 1006, col. 24, ll. 36-40, Fig. 25; Ex. 1004, p. 33.


23

Mushabac discloses that the “exact placement of bore 560” is determined “by [the] computer 24” “in accordance with (a) surface data as to molars 566 and front teeth 568, (b) surface data as to opposing teeth (bite information . . . ), (c) the dimensions and shape of jaw bone 558, and (d) the location of internal bone structures.” Ex. 1006, col. 24, ll. 66 to col. 25, ll. 6, Fig. 25; Ex. 1004, p. 33. Mushabac discloses that the locations of the internal bone structures are obtainable by X-ray: “[d]ata as to internal structures (e.g., blood vessel canals) of jaw bone 558 may be obtained via X-ray data generating device or assembly 28 (FIG. 1).” Ex. 1006, col. 25, ll. 14-16, Fig. 1; Ex. 1004, p. 33.

determinating a pilot hole in a drill template relative to surfaces of the neighboring teeth based on the x-ray picture and optical measurement.

Mushabac discloses determinating a pilot hole in a drill template relative to surfaces of the neighboring teeth based on the X-ray picture and optical measurement. Mushabac discloses a block of acrylic material 606 that is provided with a hole “matching the bore 560 to be formed in the patient’s jaw bone 608. The hole in block 606 can then be used as a template to guide, limit or control the motions of an implant drill during an actual operation on a patient’s jaw bone 558.” Ex. 1006, col. 27, ll. 3-11, Fig. 28; Ex. 1004, p. 34. Mushabac discloses that the “exact placement of bore 560” is determined “by [the] computer 24” “in accordance with (a) surface data as to molars 566 and front teeth 568, (b) surface data as to opposing teeth (bite information . . . ), (c) the dimensions and shape of jaw bone 558, and (d) the location of internal bone structures.” Ex. 1006, col. 24, ll. 66 to col. 25, ll. 6, Fig. 25; Ex. 1004, p. 34.


24

Mushabac further discloses a practice run of an “implant drilling operation” where the “drill 604 cuts a bore into a block of acrylic material 606 which has been fastened to the patient’s jaw.” Ex. 1006, col. 26, ll. 62 to col. 27, ll. 5; Ex. 1004, p. 34.

2. The method according to claim 1, wherein the x-ray picture is one of a panoramic tomography image, a tomosynthetic image or a computer tomography image.

See Claim 1. Mushabac discloses the X-ray picture is one of a panoramic tomography image, a tomosynthetic image or a computer tomography image. Mushabac discloses that “[d]ata fed to computer 24 via X-ray generating device or assembly 28 may comprise two or more views of the same tooth from different angles. In that event, computer 24 can use a stereophotogrammetric triangulation program to determine the three-dimensional shapes and dimensions of structures internal to the subject tooth.” Ex. 1006, col. 27, ll. 65 to col. 28, ll. 3; Ex. 1004, p. 34.

3. The method according to claim 1, wherein the three-dimensional, measured, visible surfaces are the occlusal surfaces of neighboring teeth located on the jaw.

See Claim 1. Mushabac discloses that the three-dimensional, measured, visible surfaces are the occlusal surfaces of neighboring teeth located on the jaw. Mushabac discloses that “[u]pon the transmission to computer 24 of sufficient data from surface data generating device 22 and contour data generating device 26 (FIG. 1), computer displays partial or complete graphic representations on monitor 34 of the subject tooth or teeth. The graphic representations include the visible three-dimensional surfaces of each such tooth.” Ex. 1006, col. 16, ll. 5-10, Figs. 1-2; Ex. 1004, p. 35. “Fig. 25 [of Mushabac] shows . . . a third screen portion 572 [which] is a top plan view of molars 566, front teeth 568, and bone 558.” Ex. 1006, col. 24, ll. 35-50; Ex. 1004, p. 35.

4. The method according to claim 1, wherein the correlation of the measured

See Claim 1. Mushabac discloses that the correlation of the measured data records from the X-ray picture and from the three-dimensional optical image is carried out by the provision of markers attached to the teeth.


25

data records from the x-ray picture and from the three-dimensional optical image is carried out by the provision of markers attached to the teeth.

Mushabac discloses that the “electrically encoded coordinate reference data for enabling the coordination of the X-ray data and surface data may be produced in part by attaching an X-ray opaque reference element to a dental surface in the patient’s mouth. The position of the X-ray opaque reference element is then automatically recorded as part of the X-ray data and is additionally incorporated into the surface or contour data, whereby the two kinds of data (external and internal) may be correlated to produce an integral composite image.” Ex. 1006, col. 6, ll. 23-31; Ex. 1004, p. 35.

5. The method according to claim 4, wherein the marker comprises a ball shaped body.

See Claim 4. Mushabac also discloses that the marker comprises a ball shaped body. Mushabac discloses that “[a]lthough FIG. 29 shows T-shaped reference elements, it is to be understood that numerous other shapes may be used.” Ex. 1006, col. 27, ll. 56-57, Fig. 29; Ex. 1004, p. 36.

Mushabac discloses that the “[s]tylus 148 [of Fig. 9] is formed at a distal end with three prongs 152, 154 and 156 each having a respective sphere 158, 160 and 162 at its free end. Spheres 158, 160 and 162 may have different sizes for facilitating the measurement of anatomical distances by computer 24.” Ex. 1006, col. 14, ll. 4-12, Fig. 9; Ex. 1004, p. 36.

9. The method according to claim 1, wherein the drill assistance

See Claim 1.


26

device is ground out from a dimension-stable material, and said material represents the form of occlusal surfaces of neighboring teeth as a negative with respect to an implant position.

Mushabac discloses that the drill assistance device is ground out from a dimension-stable material, and said material represents the form of occlusal surfaces of neighboring teeth as a negative with respect to an implant position. Mushabac discloses a block of acrylic material 606 that is provided with a hole “matching the bore 560 to be formed in the patient’s jaw bone 608. The hole in block 606 can then be used as a template to guide, limit or control the motions of an implant drill during an actual operation on a patient’s jaw bone 558.” Ex. 1006, col. 27, ll. 3-11, Fig. 28; Ex. 1004, p. 37. Mushabac discloses “[d]uring motions of virtual instrument 600 towards jaw bone 558, as if an actual operation were being performed, drill 604 cuts a bore into a block of acrylic material 606 which has been fastened to the patient’s jaw.” Ex. 1006, col. 26, l. 62 to col. 27, ll. 5, Fig. 28; Ex. 1004, p. 37.

10. The method according to claim 9, wherein the drill assistance device contains a bore hole position that serves as a guide for the drill.

See Claim 9. Mushabac discloses the drill assistance device contains a bore hole position that serves as a guide for the drill. Mushabac discloses a block of acrylic material 606 that is provided with a hole “matching the bore 560 to be formed in the patient’s jaw bone 608. The hole in block 606 can then be used as a template to guide, limit or control the motions of an implant drill during an actual operation on a patient’s jaw bone 558.” Ex. 1006, col. 27, ll. 3-11, Fig. 28; Ex. 1004, p. 37.

’006 Patent

Claims Exemplary Disclosure

from Poirier (Ex. 1005) 1. Method for producing a drill assistance device for a tooth implant in a person’s jaw,

Poirier discloses a method for producing a drill assistance device for a tooth implant in a person’s jaw. Poirier discloses “a method of manufacturing a dental implant drill guide or drill template which will result in a precise and accurate drill guide for selected drill holes.” Ex. 1005, col. 2, ll. 9-12; Ex. 1004, pp. 37-38. Poirier states that “the dental surgeon


27

comprising the following process steps:

will select the position for each implant drill hole, . . . to position the implant in the optimum location within the jawbone.” Ex. 1005, col. 3, ll. 33-36; Ex. 1004, p. 38.


Poirier discloses taking an X-ray picture of the jaw and compiling a corresponding measured data record. Poirier discloses that a “medical image of the jawbone and tissue structure is obtained by using X-ray imaging . . . to produce a three-dimensional computer graphics model which has a reference to the gum surface or some other fixed reference with respect to the patent’s jawbone .” Ex. 1005, col. 3, ll. 12-17; Ex. 1004, p. 38. Poirier states that “[a]s shown in FIG. 4, the result of the radiographic scanning is to obtain a three-dimensional computer graphics model 29 of the patient’s lower jaw.” Ex. 1005, col. 5, ll. 63-65, Fig. 4; Ex. 1004, p. 38.


Poirier discloses carrying out a three-dimensional optical measuring of the visible surfaces of the jaw and of the teeth and compiling a corresponding measured data record. Poirier discloses “imaging a jawbone and tissue structure with reference to a gum surface to produce a three-dimensional computer graphics model.” Ex. 1005, col. 2, ll. 35-37; Ex. 1004, p. 38. Poirier explains that “imaging of the gum surface can be carried out by using laser camera imaging techniques known in the art.” Ex. 1005, col. 3, ll. 58-60; Ex. 1004, p. 39. Poirier explains that the “gum surface image data” is used to “build up” the “3-D computer model 29.” Ex. 1005, col. 6, ll. 19-22, Fig. 5; Ex. 1004, p. 39.

correlating the measured data records from the x-ray picture and from the measured data records of the three-dimensional optical

Poirier discloses correlating the measured data records from the X-ray picture and from the measured data records of the three-dimensional optical measuring. Poirier discloses “imaging the patient’s dentures or teeth, and possibly gum structure, in addition to the jawbone and tissue structure, in such a way that all images are referenced with respect to one another to be integrated into the same three-dimensional computer graphics model.” Ex. 1005, col. 3, ll. 42-46; Ex. 1004, p. 39.


28

measuring,

Poirier also states that “the 3-D computer model 29 is built up using the radiographic 3-D imaging data as well as referenced gum surface image data and referenced denture image data.” Ex. 1005, col. 6, ll. 19-22, Fig. 5; Ex. 1004, p. 39.


Poirier discloses determining the optimal bore hole for the implant, based on the X-ray picture. Poirier provides that “[i]t is a first object of the present invention to provide a method of manufacturing a dental implant drill guide or drill template which will result in a precise and accurate drill guide for selected drill holes.” Ex. 1005, col. 2, ll. 9-12; Ex. 1004, p. 39. Poirier discloses “selecting at least one implant drill hole position for at least one dental implant using the [three-dimensional computer graphics model], the position being specified in three dimensions, including a hole termination point and orientation, and being referenced to the gum surface reference.” Ex. 1005, col. 2, ll. 37-42; Ex. 1004, p. 39. Poirier discloses that a “medical image of the jawbone and tissue structure is obtained by using X-ray imaging . . . to produce a three-dimensional computer graphics model which has a reference to the gum surface or some other fixed reference with respect to the patent’s jawbone .” Ex. 1005, col. 3, ll. 12-17; Ex. 1004, p. 40. Poirier further provides that “the oral surgeon may select the optimum position for dental implants using the three-dimensional computer graphics model.” Ex. 1005, col. 3, ll. 21-23; Ex. 1004, p. 40.

determinating a pilot hole in a drill template relative to surfaces of the neighboring teeth based on the x-ray

Poirier discloses determinating a pilot hole in a drill template relative to surfaces of the neighboring teeth based on the X-ray picture and optical measurement. Poirier discloses “providing fixed drill guide sockets in the template body for each one of the drill hole positions or position selected using the computer graphics model.” Ex. 1005, col. 3, ll. 26-29; Ex. 1004, p. 40.


29

picture and optical measurement.

Poirier discloses “imaging the patient’s dentures or teeth, and possibly gum structure, in addition to the jawbone and tissue structure, in such a way that all images are referenced with respect to one another to be integrated into the same three-dimensional computer graphics model.” Ex. 1005, col. 3, ll. 42-46; Ex. 1004, p. 40.


See Claim 1. Poirier further discloses that the X-ray picture may be one of a panoramic tomography image, a tomosynthetic image or a computer tomography image. Poirier states that “it may be convenient for the purposes of selecting the drill hole axis to use a two-dimensional representation of the jawbone and tissue structure, the two-dimensional view being displayed with a user controlled slice angle.” Ex. 1005, col. 3, ll. 29-33; Ex. 1004, p. 40. Poirier states that for “ease of selection of the drill axis 31, namely the position in space of the end point and the angular orientation of the drill axis 31, it may be possible to present slices of the computer model 29 to the dental surgeon or technician which would make it easier to select the parameters.” Ex. 1005, col. 6, ll. 6-10, Fig. 6; Ex. 1004, p. 41.


See Claim 1. Poirier also discloses that the three-dimensional, measured, visible surfaces are the occlusal surfaces of neighboring teeth located on the jaw. Poirier discloses “imaging the patient’s dentures or teeth, and possibly gum structure, in addition to the jawbone and tissue structure, in such a way that all images are referenced with respect to one another to be integrated into the same three-dimensional computer graphics model.” Ex. 1005, col. 3, ll. 42-46; Ex. 1004, p. 41.

4. The method according to claim 1,

See Claim 1. Poirier also discloses that the correlation of the measured data


30

wherein the correlation of the measured data records from the x-ray picture and from the three-dimensional optical image is carried out by the provision of markers attached to the teeth.

records from the X-ray picture and from the three-dimensional optical image is carried out by the provision of markers attached to the teeth. Poirier discloses “[r]adio-opaque reference spheres 28 . . . bonded to the [scanner] guide 27 with one sphere on each side at the rear and one in the front. . . . the spheres are shown near the lower jaw surface since it is the lower jaw that is to be imaged.” Ex. 1005, col. 5, ll. 46-50, Fig. 2; Ex. 1004, p. 41. Poirier further discloses that “[i]mages of the reference spheres 28 appear as 33 and provide a reference to a coordinate axes 32.” Ex. 1005, col. 5, ll. 63-67, Fig. 3; Ex. 1004, pp. 41-42.


See Claim 4. Poirier also discloses that the marker comprises a ball shaped body. Poirier discloses “[r]adio-opaque reference spheres 28.” Ex. 1005, col. 5, ll. 46, Fig. 3; Ex. 1004, p. 42.

9. The method according to claim 1, wherein the drill assistance device is ground out from a

See Claim 1. Poirier also discloses the drill assistance device is ground out from a dimension-stable material, and said material represents the form of occlusal surfaces of neighboring teeth as a negative with respect to an implant position. Poirier discloses that it is “possible to prepare the drill template


31

dimension-stable material, and said material represents the form of occlusal surfaces of neighboring teeth as a negative with respect to an implant position.

body and provide it with the drill guide sockets using the CNC device.” Ex. 1005, col. 3, ll. 48-50; Ex. 1004, p. 42. Poirier discloses in “FIG. 12 . . . a perspective view of the drill guide according to the preferred embodiment.” Ex. 1005, col. 5, ll. 12-13, Fig. 12; Ex. 1004, pp. 42-43.

10. The method according to claim 9, wherein the drill assistance device contains a bore hole position that serves as a guide for the drill.

See Claim 9. Poirier also discloses the drill assistance device contains a bore hole position that serves as a guide for the drill. Poirier discloses “providing fixed drill guide sockets in the template body for each one of the drill hole positions or position selected using the computer graphics model.” Ex. 1005, col. 3, ll. 26-29; Ex. 1004, p. 43. Poirier further discloses that the “drill guide tubes 66 may be removed and reinserted into the drill guide sockets 68 in order to change the internal diameter of the drill guide tubes as is required during surgery since the implant drill hole is started with a very small diameter drill bit and subsequently larger drill bits are used until the full size implant drill hole is obtained. As shown in FIG. 13, the drill used in surgery is provided with a collar 69 for abutting against the upper surface of the guide tube 66 in such a way that the distance between the bottom of the collar 69 and the end of the drill bit 71 is fixed as required.” Ex. 1005, col. 7, ll. 11-20, Fig. 12; Ex. 1004, p. 43. Poirier further states that “the oral surgeon screws in an implant 72 into the hole made using drill guide 61. This can be done with the drill guide remaining in place, the implants being inserted through the sockets 68.” Ex. 1005, col. 7, ll. 40-44, Fig. 14; Ex. 1004, p. 43.


32

’006 Patent Claims

Exemplary Disclosure From Bannuscher (Ex. 1008) and Massen (1009)

1. Method for producing a drill assistance device for a tooth implant in a person’s jaw, comprising the following process steps:

Bannuscher discloses a method for producing a drill assistance device for a tooth implant in a person’s jaw. Bannuscher discloses a “method for preparing a surgical template for a dental implant surgery for installation of implants in the upper and/or lower jaw.” Ex. 1008, p. 2; Ex. 1004, p. 44.


Bannuscher discloses taking an X-ray picture of the jaw and compiling a corresponding measured data record. Bannuscher discloses “making a surgical template for dental implant surgery for installation of implants in the upper and/or lower jaw, in which a three-dimensional geometric model of the mouth and jaw area and an X-ray image of the same are entered, digitally and relative to the patient’s skull, into a computer, the basic statics of both the upper and lower jaws are recorded.” Ex. 1008, p. 5; Ex. 1004, p. 44.


Bannuscher in combination with Massen discloses carrying out a three-dimensional optical measuring of the visible surfaces of the jaw and of the teeth and compiling a corresponding measured data record. Bannuscher discloses that the “key concept of the present invention is to combine the X-ray diagnostics and the model or oral situation of the patient. After the general medical implant-specific evaluation of the patient’s oral situation . . . the corresponding impressions of the patient’s oral situation made by the dentist are cast and molded once by the dental technician. The plaster models thus obtained are transferred by means of a registration image of the patient’s head in a three-dimensional relation into a skull-related simulation device.” Ex. 1008, pp. 8-9; Ex. 1004, p. 44. Massen teaches “an optical three-dimensional measuring probe for the surveying of the three-dimensional geometry of teeth in


33

the oral cavity of a patient.” Ex. 1009, col. 3, ll. 22-25; Ex. 1004, p. 45. Massen’s optical “measuring probe includes a highly resoluting two-dimensionally point-by-point freely-programmable projection unit, an image memory for storing a digitalized projection pattern, an image computer having a microprocessor for the pixel-wise control of the projection unit utilizing a digital pixel image stored in the image memory, the digital pixel image being projected through an endoscopic probe onto the tooth surface which is to be surveyed, a charge-coupled image sensor for converting a distorted image reflected off the tooth surface upon which said digital image is projected into a form suitable for processing by said microprocessor, and said microprocessor comprising a program which calculates a topographic representation of the teeth in the oral cavity based upon a comparison between said distorted image and said digital pixel image.” Ex. 1009, col. 3, ll. 25-41; Ex. 1004, p. 45. Massen provides an “optical three-dimensional measuring probe [that] is utilized to generate a three-dimensional image of a single tooth or a group of teeth within the oral cavity of a patient.” Ex. 1009, col. 4, ll. 14-17; Ex. 1004, p. 45. Massen further teaches that the “direct optical three-dimensional surveying or measuring of teeth in the oral cavity of a patient facilitates the obtainment of the digital constructional data necessary for the computer-controlled manufacture of tooth replacements without having to make any impression of the teeth.” Ex. 1009, col. 1, ll. 19-24; Ex. 1004, p. 45.

correlating the measured data records from the x-ray picture and from the measured data records of the three-dimensional optical measuring,

Bannuscher discloses correlating the measured data records from the X-ray picture and from the measured data records of the three-dimensional optical measuring. Bannuscher discloses that the “key concept of the present invention is to combine the X-ray diagnostics and the model or oral situation of the patient.” Ex. 1008, pp. 8-9; Ex. 1004, p. 46. Bannuscher states that the plaster models “are transferred by means of a registration image of the patient’s head in a three-dimensional relation into a skull-related simulation device. At the same time an X-ray image of the patient in the form of an orthopantomogram is made. The three-dimensional plaster models and the X-ray image are now entered, relative to the


34

patient’s skull, into a computer by digital transmission. . . . an immediate comparison is made between the optimal tooth position and the existing vertical bone, i.e., the bone cavities of the surgical field of the implant. . . . the positions of the reference points are defined in the radiograph. These reference points are also the setting for a transverse sectional X-ray image acquisition.” Ex. 1008, p. 9; Ex. 1004, p. 46. Massen provides an “optical three-dimensional measuring probe [that] is utilized to generate a three-dimensional image of a single tooth or a group of teeth within the oral cavity of a patient.” Ex. 1009, col. 4, ll. 14-17; Ex. 1004, p. 46.


Bannuscher discloses determinating the optimal bore hole for the implant, based on the X-ray picture. Bannuscher discloses that “[a]n optimized implant position is compared with the existing vertical bone. According to a comparison between the optimized implant position and the existing vertical bone, reference points are defined in the radiograph. A transverse sectional X-ray image considering the reference points is entered, digitally and relative to the patient’s skull, into the computer. Angular and anatomical conditions essential for surgery are dimensioned, evaluated and represented by real values. The real values are transferred to the surgical template.” Ex. 1008, p. 2; Ex. 1004, pp. 46-47.

determinating a pilot hole in a drill template relative to surfaces of the neighboring teeth based on the x-ray picture and optical measurement.

Bannuscher discloses determinating a pilot hole in a drill template relative to surfaces of the neighboring teeth based on the X-ray picture and optical measurement. Bannuscher discloses that “any angle, determined by the combination of the three-dimensional geometric model and the X-ray image of the mouth and jaw area of the patient, can be made on a surgical template arranged on the three-dimensional geometric model. After the holes in the surgical template are made with regard to their open areas and their bore hole angles, the surgical template is removed from the device . . . and may then be used during the operation in the mouth of the patient.” Ex. 1008, p. 10; Ex. 1004, p. 47.


35


See Claim 1. Bannuscher discloses that the X-ray picture is one of a panoramic tomography image, a tomosynthetic image or a computer tomography image. Bannuscher discloses that “an X-ray panoramic image is produced.” Ex. 1008, p. 4; Ex. 1004, p. 47. Bannuscher states: “an X-ray image of the patient in the form of an orthopantomogram is made.” Ex. 1008, p. 9; Ex. 1004, p. 47. Bannuscher also states that the “transverse tomographic X-ray image is also digitized and now complements the overall planning in three-dimensional planes.” Ex. 1008, p. 9; Ex. 1004, p. 47.


See Claim 1. Bannuscher discloses that the three-dimensional, measured, visible surfaces are the occlusal surfaces of neighboring teeth located on the jaw. Bannuscher discloses that the “basic statics of both the upper and lower jaws is recorded. Regions intended for replacement supporting zones are labeled and transferred to the X-ray image. An optimized implant position is compared with the existing vertical bone.” Ex. 1008, p. 2; Ex. 1004, pp. 47-48. Bannuscher further provides that “[f]or the functional layout of the implantological-prosthetic planning, the entire occlusion structure can be recorded and all necessary parameters can be connected to each other.” Ex. 1008, p. 7; Ex. 1004, p. 48. Massen uses a “programmable projection unit 10 . . . to generate the particular pattern which is to be projected onto the surface of the single tooth or group of teeth.” Ex. 1009, col. 4, ll. 43-47, Fig. 1; Ex. 1004, p. 48.

4. The method according to claim 1, wherein the correlation of the measured data records

See Claim 1. Bannuscher discloses the correlation of the measured data records from the X-ray picture and from the three-dimensional optical image is carried out by the provision of markers attached to the teeth.


36

from the x-ray picture and from the three-dimensional optical image is carried out by the provision of markers attached to the teeth.

Bannuscher provides that the “three-dimensional plaster models and the X-ray image are now entered, relative to the patient’s skull, into a computer by digital transmission. . . . an immediate comparison is made between the optimal tooth position and the existing vertical bone.” Ex. 1008, p. 9; Ex. 1004, p. 48. Bannuscher further discloses that “[m]etal beads with a defined diameter are cemented in the planned implant region. Using this radiographic guide, an X-ray panoramic image is produced, which then makes it possible to determine the available vertical bone or the bone height.” Ex. 1008, p. 4; Ex. 1004, p. 48.


See Claim 4. Bannuscher discloses that the marker comprises a ball shaped body. Bannuscher discloses “[m]etal beads with a defined diameter are cemented in the planned implant region.” Ex. 1008, p. 4; Ex. 1004, p. 49.

B. Explanation of Why Claims 1-5, 9, and 10 Are Anticipated and/or

Rendered Obvious by Mushabac or Poirier

Claims 1-5, 9, and 10 are unpatentable because they are anticipated by each

of Mushabac and Poirier. At a minimum, either Mushabac or Poirier render

obvious Claims 1-5, 9, and 10. See Ex. 1004, ¶¶ 72, 94-134.

1. Mushabac

Mushabac anticipates Claims 1-5, 9, and 10 of the ʼ006 Patent because

Mushabac discloses each and every element of those claims, as set forth in the

foregoing claim charts, or at least renders them obvious. See Ex. 1004, ¶¶ 74-77.


37

a. Claim 1

Each of the five elements of Claim 1 – taking an X-ray and collecting data,

measuring visible surfaces in 3-D and collecting data, correlating the X-ray and 3-

D data, using the X-ray to determine a bore hole in the patient’s jaw, and

determining a pilot hole in a drill template – are found in Mushabac. See Ex. 1004,

¶¶ 94-95.

Mushabac discloses a method for use in forming a preparation in a patient’s

jaw. See Ex. 1004, ¶ 96. The method is one that is “especially useful in boring

through hard or soft tissues and preparing a site for anchoring a dental implant in a

jaw of a patient.” See Ex. 1004, ¶ 96. The preparation is a “bored structured form

that has been in the jaw bone for receiving a form or blade for the implant.” See

Ex. 1004, ¶ 96. Figure 28, shown below, depicts a block of acrylic material with a

hole, which matches the bore to be formed in the patient’s jaw bone. See Ex. 1004,

¶ 96. That hole is used “as a template to guide, limit or control the motions of an

implant drill during an actual operation on the patient’s jaw bone.” See Ex. 1004,

¶ 96. Like Claim 1, Mushabac’s method produces a drill assistance device for a

tooth implant in a person’s jaw. See Ex. 1004, ¶ 96.

The steps in Mushabac’s method track those of Claim 1. See Ex. 1004, ¶ 97.

Mushabac’s method generates electrically-encoded data reflecting the existing

dental structure by generating digitized surface data and digitized X-ray data. See


38

Ex. 1004, ¶ 97. The incident radiation of the X-ray is converted into a digital data

stream fed to the computer (24), i.e., the corresponding X-ray “measured data

record” of Claim 1. See Ex. 1004, ¶ 97.

Annotated Figure 1 of Mushabac (Exhibit 1006)

As for Claim 1’s 3-D optical measuring of the visible surfaces of the jaw and

teeth and compiling a corresponding measured data record, Mushabac does this by

generating “digitized surface data,” which includes “video surface data and/or

contour data generated with the aid of a probe.” See Ex. 1004, ¶ 98. Figure 1 of

Mushabac (above) shows the computerized interactive system, including data

generating device (26) to transmit digitized signals containing information

pertaining to the 3-D surface of the tooth to the computer (24). See Ex. 1004, ¶ 98.

The computer displays graphic 3-D representations of the patient’s teeth, which


39

correspond to Claim 1’s compiled “measured data record.” See Ex. 1004, ¶ 99.

Mushabac also stipulates that surface information concerning a patient’s teeth and

jaw is also digitized. See Ex. 1004, ¶ 100.

Like Claim 1, Mushabac correlates the two measured data records, i.e., that

of the X-ray picture of the jaw and of the 3-D visible surfaces of the jaw and teeth.

See Ex. 1004, ¶¶ 101, 103. Mushabac’s correlation produces a composite image

showing both internal and external structures in the precise geometric relationships

they have to each other in the patient’s mouth. See Ex. 1004, ¶ 101.

Mushabac uses the X-ray picture to decide where the bore hole (560) should

be located. See Ex. 1004, ¶ 104. Mushabac uses the correlated data in the

computer (24) and a block of acrylic, fastened to the patient’s jaw, to form a hole

(606) in the block that matches the bore hole. See Ex. 1004, ¶¶ 102, 105. Thus,

the hole in the block corresponds to Claim 1’s “pilot hole in a drill template.” See

Ex. 1004, ¶ 102.


40

Because the hole in the block is set to match the bore (560) in the patient’s

jaw bone, the location of the hole is necessarily determined in the same manner as

the bore. See Ex. 1004, ¶ 106. Thus, the exact placement of the hole in the block

(606) is determined by the computer (24) in accordance with: (1) surface data as to

molars (566) and front teeth (568), (2) surface data as to opposing teeth (bite

information), (3) the dimensions and shape of jaw bone (558), and (4) the location

of internal bone structures. See Ex. 1004, ¶ 106.

Mushabac’s practice run of the implant drilling operation performed with a

virtual instrument (600) further shows how each and every element of Claim 1 is

disclosed. See Ex. 1004, ¶ 107. As set forth above in Figure 25, the computer

monitor shows the optimal and actual orientations of the dental instrument, such as

a drill, relative to the patient’s dentitious surfaces. See Ex. 1004, ¶ 107.

b. Claim 2

Claim 2 builds upon Claim 1, but requires that the X-ray picture is one of a

“panoramic tomography image, a tomosynthetic image or a computer tomography

image.” See Ex. 1001, col. 5, ll. 19-21; see also Ex. 1004, ¶ 108. Mushabac

discloses at least a computer tomography image.

Computer tomography (“CT”) has an accepted meaning of “radiography in

which a three-dimensional image of a body structure is constructed by computer

from a series of plane cross-sectional images made along an axis.” See Ex. 1004,


41

¶ 109. Mushabac explains that the data fed to the computer via an X-ray data

generating device “may comprise two or more views of the same tooth from

different angles.” See Ex. 1004, ¶ 109. The computer then uses a

stereophotogrammetric triangulation program to determine the 3-D shapes and

dimensions of the structures internal to the subject tooth. See Ex. 1004, ¶ 109.

Using multiple images taken from different angles is the same as an image

acquired by CT.

c. Claim 3

Claim 3 builds upon Claim 1, but requires that “the three-dimensional,

measured, visible surfaces are the occlusal surfaces of neighboring teeth located on

the jaw.” See Ex. 1001, col. 5, ll. 22-24; see also Ex. 1004, ¶ 110. Mushabac

discloses these occlusal surfaces. See Ex. 1004, ¶ 110.

The plain meaning of the term “occlusal surface” is “the surface of the teeth

that comes in contact with those of the opposite jaw during occlusion.” See Ex.

1004, ¶ 111. Mushabac makes clear that its data generating device (26) transmits

digitized signals containing information pertaining to the three-dimensional surface

of the tooth to the computer. See Ex. 1004, ¶ 111. Mushabac’s opto-electrical

transducer (48) also generates and transmits a digitized video signal containing

information to display the tooth structure in a 3-D graphic representation to the

computer (24), which then displays partial or complete graphic representations of


42

the subject teeth. See Ex. 1004, ¶ 111. Mushabac states that these “graphic

representations include the visible three-dimensional surfaces of each such tooth,

as well as invisible base line data.” See Ex. 1004, ¶ 111.

Figure 25 of Mushabac depicts third screen portion (572), which shows a top

plan view of molars (566), front teeth (568), and bone (558). See Ex. 1004, ¶ 112.

Thus, the visible 3-D surfaces of each tooth necessarily include the occlusal

surfaces of neighboring teeth located on the jaw. See Ex. 1004, ¶ 112.

d. Claims 4 and 5

Claim 4, which builds upon Claim 1, requires that the method’s correlation

occur using “markers attached to the teeth” and Claim 5, which builds upon Claim

4, requires that the markers comprise “a ball shaped body.” See Ex. 1001, col. 5, l.

25-col. 6, l. 4; see also Ex. 1004, ¶ 113. Such markers are clearly depicted in

Mushabac, as evidenced by Figures 9 and 29. See Ex. 1004, ¶ 113.

Mushabac explains that the “electrically encoded coordinate reference data

for enabling the coordinate of the X-ray data and surface data may be produced in

part by attaching an X-ray opaque reference element to a dental surface in the

patient’s mouth” which “is then automatically recorded as part of the X-ray data

and is additionally incorporated into the surface or contour data, whereby the two

kinds of data (external and internal) may be correlated to produce an integral

composite image.” See Ex. 1004, ¶ 114. While Figure 29 depicts these opaque


43

reference elements, i.e., markers, having a T shape, Mushabac makes clear that

“numerous other shapes may be used.” See Ex. 1004, ¶ 114. One of ordinary skill

in the art would have readily appreciated the ball-shaped bodies of the reference

stylus of Figure 9 could have replaced the T-shaped markers of Figure 29 and

would have expected no substantive change in function due to the substitution. See

Ex. 1004, ¶ 114; see also KSR Int’l Co. v. Teleflex Inc, 550 U.S. 398, 415-421

(2007).

e. Claims 9 and 10

Claim 9 builds upon Claim 1 but requires that the drill assistance device is

ground out from a dimension-stable material, which represents the form of occlusal

surfaces of neighboring teeth as a negative with respect to an implant position. See

Ex. 1001, col. 6, ll. 17-21; see also Ex. 1004, ¶ 115. Claim 10 builds upon Claim 9

and adds that the drill assistance device contains a bore hole position that serves as

a guide for the drill. See Ex. 1001, col. 6, ll. 22-24; see also Ex. 1004, ¶ 115.

Mushabac’s disclosure of the acrylic block shown as element 606 in Figure

28, satisfies the requirements of both Claim 9 and Claim 10. See Ex. 1004, ¶ 116.

The block is a drill assistance device, and the acrylic material from which it is

made is dimension-stable. See Ex. 1004, ¶ 116. The hole in the block aligns with

the bore to be formed in a patient’s jaw, and represents “the form of occlusal

surfaces of the neighboring teeth as a negative” such that the block could be


44

secured in place in the patient’s jaw. See Ex. 1004, ¶ 116. Mushabac even states

that the “hole in block 606 can then be used as a template to guide, limit or control

the motions of an implant drill during an actual operation on the patient’s jaw bone

558.” See Ex. 1006, col. 27, ll. 8-11 (italics added); see also 1004, ¶ 116.

2. Poirier

Poirier anticipates Claims 1-5, 9, and 10 of the ʼ006 Patent because Poirier

discloses each and every element of those claims, as set forth in the foregoing

claim charts, or at least renders them obvious. See Ex. 1004, ¶¶ 72, 78-81, 117-

134.

a. Claim 1

Like Mushabac, Poirier discloses all five elements of Claim 1. See supra

pp. 37-40; Ex. 1004, ¶ 118. Poirier discloses a method of manufacturing a dental

implant drill guide or drill template which will result in a precise and accurate drill

guide for selected drill holes. See Ex. 1004, ¶ 119. Poirier explains that the dental

surgeon will select the position for each implant drill hole “to position the implant

in the optimum location within the jawbone” and that selection of the drill axes for

the drill holes is made in view of “the relative position of the gum surface and the

relative position of the dentures or teeth.” See Ex. 1004, ¶ 119.

Poirier’s method tracks Claim 1’s taking of an X-ray picture of the jaw and

carrying out a 3-D optical measurement of the visible surfaces of the jaw and teeth


45

and compiling the corresponding measured data records by (a) imaging a jawbone

and tissue structure with reference to a gum surface to produce a 3-D computer

graphics model, and (b) selecting at least one implant drill hole position for at least

one dental implant using the model, the position being specified in three

dimensions, including a hole termination point and orientation, and being

referenced to the gum surface. See Ex. 1004, ¶ 120. Poirier makes clear that

imaging of the jaw surface is done by radiographic scanning to obtain a 3-D

computer graphics model. See Ex. 1004, ¶ 121.

With regard to Claim 1’s correlation step, Poirier explains that the 3-D

computer graphics model is prepared as a composite of images of the jawbone and

images of the tissue structure. See Ex. 1004, ¶ 122. Poirier states that it is

preferable to display, in addition to the 3-D computer graphics model of the

jawbone and tissue structure, the patient’s dentures in the proper spatial

relationship with respect to the jawbone and tissue structure. See Ex. 1004, ¶ 122.

Poirier notes that doing so requires imaging the patient’s dentures or teeth and gum

structure, in addition to the jawbone and tissue structure, so that all images are

referenced with respect to one another to be integrated into the same 3-D computer

graphics model. See Ex. 1004, ¶ 122. The integration of the radiographic 3-D

imaging data, referenced gum surface image data, and referenced denture image


46

data to form computer graphics model, i.e., Claim 1’s correlation step, is depicted

in Figure 5 of Poirier. See Ex. 1004, ¶ 122.

Poirier then uses the X-ray picture to determine the optimal bore hole for the

implant. See Ex. 1004, ¶ 123. Poirier explains that that oral surgeon selects “the

optimum position for dental implants using the three-dimensional computer

graphics model of the jawbone and tissue structure.” See Ex. 1005, col. 3, ll. 21-

24; see also Ex. 1004, ¶ 123. Moreover, Poirier discloses that the drill axes for the

drill holes are selected with knowledge of the relative positions of the gum surface

and the dentures or teeth. See Ex. 1005, col. 6, ll. 16-19; see also Ex. 1004, ¶ 123.

As for the final step of Claim 1, determining a pilot hole in the drill

template, Poirier expressly provides that “[s]election of the drill hole positions

using the computer graphics model is transferred to a . . . device for the purposes of

providing fixed drill guide sockets in the template body for each one of the drill

hole positions or position selected using the computer graphics model.” See Ex.

1005, col. 3, ll. 21-28; see also Ex. 1004, ¶ 124. Poirier explains that it is

preferable to display, in addition to the 3-D computer graphics model of the

jawbone and tissue structure, the patient’s dentures in the proper spatial

relationship with respect to the jawbone and tissue structure, which requires

“imaging the patient’s dentures or teeth, and possibly gum structure, in addition to

the jawbone and tissue structure, in such a way that all images are referenced with


47

respect to one another to be integrated into the same three-dimensional computer

graphics model.” See Ex. 1005, col. 3, ll. 38-46, Fig. 5; see also Ex. 1004, ¶ 124.

A finished drill guide body having a plurality of drill guide sockets is shown in

Figure 12 of Poirier (as set forth in the claim chart above). See Ex. 1004, ¶ 125.

b. Claim 2

Poirier discloses at least a CT image, which has an ordinary meaning of

“radiography in which a three-dimensional image of a body structure is constructed

by computer from a series of plane cross-sectional images made along an axis.”

See Ex. 1001, col. 5, ll. 19-21; see also Ex. 1004, ¶ 126. Poirier explains that it

may be convenient to use a 2-D representation of the jawbone and tissue structure,

wherein the 2-D view is displayed with a user-controlled slice angle. See Ex. 1004,

¶ 127. Accordingly, those slices of the 2-D representation of the jawbone and

tissue structure represent multiple images taken from differing angles, i.e., images

acquired by computer tomography. See Ex. 1004, ¶ 127.

c. Claim 3

Poirier discloses these occlusal surfaces. See Ex. 1001, col. 5, ll. 22-24; see

also Ex. 1004, ¶ 128. The plain meaning of the term “occlusal surface” is “the

surface of the teeth that comes in contact with those of the opposite jaw during

occlusion.” See Ex. 1004, ¶ 129. Poirier makes clear that laser camera imaging

techniques are used to image dentures or teeth to be placed over the gum surface


48

and that gum surface image data is used with the radiographic 3-D imaging data to

form the 3-D computer model. See Ex. 1004, ¶ 129. Poirier explains

it is preferred to display . . . the patient’s dentures in the proper

spatial relationship with respect to the jawbone and tissue

structure [which] requires imaging the patient’s dentures or teeth,

and possibly gum structure, in addition to the jawbone and tissue

structure, in such a way that all images are referenced with respect

to one another to be integrated into the same three-dimensional

computer graphics model.

See Ex. 1005, col. 3, ll. 38-46 (emphases added); see Ex. 1004, ¶ 129. Thus, the

visible 3-D surfaces of the patient’s teeth as imaged by Poirier necessarily include

the occlusal surfaces of neighboring teeth located on the jaw. See Ex. 1004, ¶ 129.

d. Claims 4 and 5

Such markers are clearly disclosed in Poirier, which are described as

“[r]adio-opaque reference spheres 28 having a known diameter” and which are

used to “provide a reference to a coordinate axes.” See Ex. 1001, col. 5, l. 25-col.

6, l. 4; Ex. 1005, col. 5, ll. 46-50, 63-67, Figures 2 and 3 (as set forth in the claim

chart above); see also Ex. 1004, ¶ 130. The spheres serve as reference guides

which facilitate the alignment of the 2-D and 3-D data to form the composite

image. See Ex. 1004, ¶ 130. Without the markers, the dentist or dental technician

would not know how to precisely align the 2-D X-ray image with the 3-D optical

image. See Ex. 1004, ¶ 130. Even if Poirier does not explicitly state that the


49

reference spheres are “attached to the teeth,” it would have been obvious to one of

ordinary skill in the art at the time of the invention to attach Poirier’s reference

spheres to the patient’s teeth to provide a reference indicator in both the 2-D and 3-

D images to facilitate the subsequent alignment of both sets of data into a single

composite image. See Ex. 1004; ¶ 130.

e. Claims 9 and 10

Poirier discloses the additional requirements of Claims 9 and 10. See Ex.

1004, ¶ 131. In terms of Claim 9, Poirier characterizes Figure 12 as a “view of the

drill guide according to the preferred embodiment.” See Ex. 1001, col. 6, ll. 17-24;

Ex. 1005, col. 5, ll. 12-13, Figure 12; see also Ex. 1004, ¶ 132. Poirier explains

that it is possible “to prepare the drill template body and provide it with the drill

guide sockets using the CNC device.” See Ex. 1005, col. 3, ll. 48-50; see also Ex.

1004, ¶ 132. A CNC device is simply a computerized numerical control device

and is very well-known for use in milling. See Ex. 1004, ¶ 132. Milling is

generally described as the act or process of grinding and a well-known subtractive

manufacturing technique. See Ex. 1004, ¶ 132. Poirier explains that the CNC drill

is “programmed to convert the hole position and orientation data as referenced to

the frame of reference of the computer model to the reference frame of the CNC

drill so that the drill holes may be prepared in the physical model.” See Ex. 1005,

col. 6, ll. 54-58; see also Ex. 1004, ¶ 132. That is, Poirier’s drill guide is a


50

dimension-stable material that is made using a CNC device that grinds out material

representing occlusal surfaces of neighboring teeth as a negative with respect to the

implant position. See Ex. 1004, ¶ 132.

As for Claim 10, Poirier’s drill assistance device includes a bore hole

position that serves as a guide for the drill. See Ex. 1004, ¶ 133. Poirier provides

that “[s]election of the drill hole positions using a computer graphics model is

transferred to a CNC device for the purposes of providing fixed drill guide sockets

in the template body for each one of the drill hole positions or position selected

using the computer graphics model.” See Ex. 1005, col. 3, ll. 26-29; see also Ex.

1004, ¶ 133. Poirier further states that “the oral surgeon screws in an implant . . .

into the hole made using drill guide” which can be done “with the drill guide

remaining in place, the implants being inserted through the sockets.” See Ex. 1005,

col. 7, ll. 40-44, Figure 14; see also Ex. 1004, ¶ 134.

C. Explanation of Why Claims 1-5 Would Have Been Obvious Over Bannuscher in View of Massen.

Claims 1-5 are unpatentable because they would have been obvious over

Bannuscher in view of Massen. See Ex. 1004, ¶¶ 72, 82-86, 135-145.


51

1. Claim 1

Bannuscher is directed to a method for preparing a surgical template for

dental implant surgery for installation of implants in the upper and/or lower jaw.

See Ex. 1004, ¶ 136. Bannuscher’s method includes taking an X-ray image of the

mouth and jaw area as well as creating a 3-D geometric model thereof. See Ex.

1004, ¶ 136. The “key concept” of Bannuscher is combining the two to make the

template. See Ex. 1004, ¶ 136. Because the X-ray image of the mouth and jaw

area is input into a computer, the digital data of the X-ray image thus corresponds

to Claim 1’s “measured data record.” See Ex. 1004, ¶ 136.

Bannuscher describes determining the optimized implant position based on a

comparison with the existing vertical bone. See Ex. 1004, ¶ 137. Once the basic

structure of both the upper and the lower jaws is recorded from the 3-D model and

the X-ray thereof is entered into the computer, reference points are defined in the

radiograph “[a]ccording to a comparison between the optimized implant position

and the existing vertical bone.” See Ex. 1008, p. 2; see also Ex. 1004, ¶ 137. A

transverse sectional X-ray image considering those reference points is entered into

the computer and “[a]ngular and anatomical conditions essential for surgery are

dimensioned, evaluated and represented by real values,” which are “transferred to

the surgical template.” See Ex. 1008, p. 2; see also Ex. 1004, ¶ 137.


52

Bannuscher expressly states that any angle determined by the “key”

combination of the X-ray and 3-D model data can be made on a surgical template

arranged on the 3-D model. See Ex. 1004, ¶ 138. Further, Bannuscher provides

that once the bore holes in the surgical template are made, the template is removed

and may be used in the operation in the patient’s mouth. See Ex. 1004, ¶ 138.

While Bannuscher describes a 3-D geometric model of the mouth and jaw

area derived from impressions that are made into plaster models which “are

transferred by means of a registration image of the patient’s head in a three-

dimensional relation into a skull-related simulation device,” Bannuscher does not

explicitly describe the 3-D model as being carried out by a 3-D optical measuring.

See Ex. 1008, p. 9; see also Ex. 1004, ¶ 139.

One of ordinary skill in the art, with the hope of creating the most accurate

drill assistance device for tooth implant procedures, would have looked to Massen

at least because it removed a manual step from Bannuscher (having to create the 3-

D physical model) and replaced it with an highly-precise automated method. See

Ex. 1004, ¶ 140; see also In re Venner, 262 F.2d 91, 95 (C.C.P.A. 1958) (“it is

well-settled that it is not ‘invention’ to broadly provide a mechanical or automatic

means to replace manual activity which has accomplished the same result”).

Massen’s optical probe is used to generate a 3-D image of a single tooth or a group

of teeth within the oral cavity of a patient. See Ex. 1004, ¶ 141. In operation, a


53

surveying procedure is repeated a number of times wherein a pattern projected

against the tooth or teeth is always varied. See Ex. 1004, ¶ 141. Consequently, the

distorted pattern which is captured by the measuring probe will also vary, but each

iteration provides refinement of the topography of the tooth or teeth. See Ex. 1004,

¶ 141. Because Bannuscher and Massen are both concerned with providing 3-D

models of a patient’s mouth and jaw, one of ordinary skill would have expected

reasonable success when utilizing Massen’s optical measurement probe in lieu of

Bannuscher’s dental impressions and plaster mold.

2. Claim 2

The orthopantomogram disclosed in Bannuscher is a panoramic radiograph,

which has a plain meaning of a rotational panoramic dental X-ray that allows the

dentist to view the upper and lower jaws. See Ex. 1004, ¶ 143. Bannuscher

discloses that X-ray panoramic images are known to determine available vertical

bone or the bone height. See Ex. 1008, p. 9; see also Ex. 1004, ¶¶ 142, 143.

3. Claim 3

Bannuscher discloses occlusal surfaces of the neighboring teeth. See Ex.

1001, col. 5, ll. 22-24; Ex. 1004, ¶ 144. Because Bannuscher describes imaging

the structures of both the upper and lower jaws, Bannuscher necessarily discloses

or at the very least suggests measuring the occlusal surfaces of the neighboring

teeth located on the jaw. See Ex. 1004, ¶ 144. Additionally, Massen describes


54

generating a 3-D image of a single tooth or a group of teeth within the oral cavity

of a patient. See Ex. 1004, ¶ 144. As shown in at least Figure 1 of Massen, the

optical probe is oriented to image a top view of the teeth, which would necessarily

include the occlusal surfaces thereof. See Ex. 1004, ¶ 144.

4. Claims 4 and 5

Correlation via markers attached to the teeth are clearly disclosed in

Bannuscher, which explains that “[m]etal beads with a defined diameter are

cemented in the planned implant region” as a radiographic guide. See Ex. 1001,

col. 5, l. 25-col. 6, l. 4; Ex 1008, p. 4; see also Ex. 1004, ¶ 145.

D. Explanation of Why Claims 6-8 Would Have Been Obvious Over Poirier, Mushabac, or Bannuscher and Massen in View of Verstreken, Truppe, or Weese.

Claims 6-8 are unpatentable because they would have been obvious over

Poirier, Mushabac, or Bannuscher and Massen in view of Verstreken, Truppe, or

Weese. See Ex. 1004, ¶¶ 73, 146-162. The Ganz Declaration sets forth claim

charts wherein each and every element of Claims 6-8 in the cited art is identified.

See Ex. 1004, ¶ 73; pp. 49-78.

Claims 6-8 require the creation and use of a “pseudo-X-ray picture” − a term

with no accepted meaning in the art. See Ex. 1004, ¶ 148. Claim 6 requires

conversion of the measured data record of the 3-D optical measuring into a pseudo-

X-ray, reducing 3-D data to 2-D data and superimposing the pseudo-X-ray data


55

onto the X-ray. See Ex. 1001, col. 6, ll. 5-9; see also Ex. 1004, ¶ 149. Verstreken

provides this element. Verstreken teaches a double-scan technique: a CT scan is

taken of the prosthesis surface with markers, then, a scan is taken of the patient,

also with markers, to facilitate alignment of the first and second scans. See Ex.

1010, p.845-846; Ex. 1004, ¶ 149. “The markers are visible in both sets and so

allow the transformation between the two sets to be computed . . . the scan of the

prosthesis can be realigned with the scan of the patient, and both can be inspected

together.” See Ex. 1010, p. 846; Ex. 1004, ¶ 149.

Claim 7 requires that the X-ray picture and the pseudo-X-ray picture are

superimposed from several directions, and Claim 8 requires that when doing so the

X-ray picture comprises at least two panoramic images showing the longitudinal

and transverse sections of the jaw. See Ex. 1001, col. 6, ll. 10-16; see also Ex.

1004, ¶ 150. Verstreken provides these aspects. Verstreken teaches the

superimposition of the 2-D reslices of the axial CT slices with the 3-D surface

rendered models of the bone and CAD implant models. See Ex. 1010, Abstract;

Ex. 1004, ¶ 150. In Figure 7, Verstreken depicts the superimposed bone surface

model of the maxilla, noting that it would not have been possible to reconstruct the

same with the 2-D images alone. See Ex. 1010, p. 846; see also Ex. 1004, ¶ 150.

Verstreken also explains that the 2-D/3-D composite image provides the ability “to

show reslices along every direction,” thus providing better visualization of the


56

teeth. See Ex. 1010, p. 849; Ex. 1004, ¶ 150. The availability of the reslices to be

viewed along every direction thus indicates that the X-ray picture and the pseudo-

X-ray picture are superimposed from several directions.


image of a patient’s jaw and teeth, would have looked to Verstreken at least

because its double scanning technique facilitates the visualization of risk for

anatomical structures, sinus perforation, and fenestrations that would not have been

visible using solely 2-D data. See Ex. 1010, p. 851; Ex. 1004, ¶ 151. Because

Poirier, Mushabac, Bannuscher, and Verstreken are all concerned with providing

2-D/3-D composite images of a patient’s mouth and jaw, one of ordinary skill

would have expected reasonable success in applying Verstreken’s double scanning

technique to Poirier, Mushabac, or Bannuscher’s jaw and teeth modeling methods.

Verstreken also teaches oral image reformatting software with resulting

images that includes “axial slices, an overview axial slice with the curve,

panoramic images along the curve, and reslices orthogonal to it.” See Ex. 1010, p.

843; Ex. 1004, ¶ 152. Cross-sectional images or slices of the image are taken to

provide interactive multiplanar reslices. See Ex. 1010, p. 844; Ex. 1004, ¶ 152. By

using this technique, the implants are visible on every reslice they intersect, but not

those which they do not intersect. See Ex. 1010, p. 849; Ex. 1004, ¶ 150.


57

Alternatively, Truppe provides the aforementioned elements of claims 6-8.

Truppe teaches generating a superposition of a 3-D optical image of the jaw over at

least one X-ray image, based in carrying out a number of coordinate transformation

between the 3-D image and the 2-D X-ray image. See Ex. 1011, col. 3, ll. 19-36;

Ex. 1004, ¶ 153. 3-D structures are inserted “into the data set of the [X-ray]

picture, and that the picture is represented in the positionally correct association

with the optical image.” See Ex. 1011, col. 4, ll. 33-37; Ex. 1004, ¶ 153.

Truppe further describes using marking points in the X-ray image as well as

with the 3-D optical image to align the image together. See Ex. 1011, col. 2, ll. 41-

46; Ex. 1004, ¶ 154. Truppe explains that by carrying out the coordinate

transformations, “it is possible to position the data set such that the structures of

the data set always still match.” See Ex. 1011, col. 3, ll. 19-36; Ex. 1004, ¶ 154. In

this regard, the multiple coordinate transformation constitute the superimposed 2-D

and 3-D data from several directions.


image of a patient’s jaw and teeth, would have looked to Truppe at least because

its method of representing a patient’s jaw incorporates 2-D and 3-D imaging

techniques to very vivid represent the relationship between a patient’s actual jaw

and a surgical planning model of the same. See Ex. 1011, col. 3, ll. 55-58; Ex.

1004, ¶ 155. Because Poirier, Mushabac, Bannuscher, and Truppe are all


58

concerned with providing 2-D/3-D composite images of a patient’s mouth and jaw,

one of ordinary skill would have expected reasonable success when applying

Truppe’s 2-D/3-D composite data modeling technique to any one of Poirier,

Mushabac, or Bannuscher’s jaw and teeth modeling methods. See Ex. 1004, ¶ 155.

Claim 8 requires that the X-ray picture comprises at least two panoramic

images showing the longitudinal and transverse sections of the jaw. Truppe

provides that “at least one picture” of the jaw of the person be taken with an

imaging process such as an X-ray. See Ex. 1011, col. 2, ll. 41-43; Ex. 1004, ¶ 156.

Even though Truppe does not explicitly state that at least two X-ray images are

taken, it suggests that more than one picture can be employed. At the very least, it

would have been obvious to one of ordinary skill in the art at the time of the

invention of the ’006 Patent to use at least two X-ray pictures for the benefit of

viewing the jaw from different angles because one of ordinary skill would have

been familiar with acquiring cross-sectional images or slices of an image via CT.

The cross-sectional images or slices of an image, the thickness of which are

defined by the imaging device at the time of scan acquisition, provide relevant

bone thickness information that would be beneficial in planning the location of an

implant. Thus, it would have been obvious to one of skill in the art at the time of

the invention to have used at least two individual images as the x-ray picture in

order to more precisely plan the location of a dental implant. See Ex. 1004, ¶ 156.


59

Further, Weese provides the aforementioned elements of claims 6 and 7.

See Ex. 1004, ¶¶ 158-159. Weese provides that pseudo projections are computed

using a small part of the CT image covering the vertebra only. See Ex. 1015, p.

120; Ex. 1004, ¶ 160. Weese discloses that the pseudo projections are “calculated

by integrating the gray-values inside the segmented volume along the ray from the

x-ray source to a pixel in the projection plane” taking into account absorption

coefficients. See Ex. 1015, p. 122; Ex. 1004, ¶ 160.

It would have been obvious to one of skill in the art at the time of the

invention to have converted the measured data records of the three-dimensional

measurements of any one of Poirier, Mushabac, or Bannuscher and Massen into a

pseudo-x-ray picture as taught by Weese. See Ex. 1004, ¶ 161. Poirier, Mushabac,

Bannuscher, Massen, and Weese are all directed to similar problems, mainly

combining two sets of image data to aid in the process of planning a surgical

procedure for an implant. One of ordinary skill in the art would have recognized

that there are a finite number of ways of correlating a three-dimensional image of a

patient’s jaw with an x-ray image of the same. Accordingly, one of ordinary skill

would have been motivated at the time of the invention to employ Weese’s pseudo-

x-ray in combination with any one of Poirier, Mushabac, or Bannuscher and

Massen as a simple matter of applying a known technique to a method ready for


60

improvement, to obtain predictable results. See KSR Int’l Co. v. Teleflex Inc, 550

U.S. 398, 415-421 (2007); Ex. 1004, ¶ 161.

Claim 7 requires that the X-ray picture and the pseudo-X-ray picture are

superimposed from several directions. See Ex. 1001, col. 6, ll. 10-12; Ex. 1004,

¶ 162. Weese provides these aspects. Weese teaches computing pseudo

projections by using a small part of the CT image covering the vertebra only. See

Ex. 1015, p.120; Ex. 1004, ¶ 162. Figure 1 of Weese illustrates the location and

orientation of the CT image with respect to the x-ray device, with the images being

correlating the x-, y-, and z-directions. That is, Weese teaches superimposing the

X-ray picture and the pseudo-X-ray picture from several directions.

VII. CONCLUSION

For at least the reasons given above, Claims 1-10 of the ’006 Patent are

unpatentable due to anticipation and/or obviousness.

Respectfully submitted,

Date: January 20, 2016 By: /Erin M. Dunston/ Erin M. Dunston, Esq. Registration No. 51,147 BUCHANAN INGERSOLL & ROONEY PC 1737 King Street, Suite 500 Alexandria, Virginia 22314 Main Telephone (703) 836-6620 Main Facsimile (703) 836-2021 [email protected] Counsel for Petitioner


A-1

APPENDIX 1 - LIST OF EXHIBITS

EXHIBIT DESCRIPTION

1001 U.S. Patent No. 6,319,006, issued on November 20, 2001 (“the ’006 Patent”) to Scherer et al.

1002 Prosecution History of the ’006 Patent, i.e., U.S. Patent Application Serial No. 09/699,363

1003 Curriculum vitae of Dr. Scott D. Ganz

1004 Declaration of Dr. Scott D. Ganz

1005 U.S. Patent No. 5,725,376, issued on March 10, 1998, to Poirier (“Poirier”)

1006 U.S. Patent No. 5,562,448, issued on October 8, 1996, to Mushabac (“Mushabac”)

1007 German Patent Application Publication No. DE 195 10 294 A1, published on October 2, 1996, to Bannuscher

1008 Verified English translation of German Patent Application Publication No. DE 195 10 294 A1 (“Bannuscher”)

1009 U.S. Patent No. 5,372,502, issued on December 13, 1994, to Massen et al. (“Massen”)

1010 Kris Verstreken et al., An Image-Guided Planning System for Endosseous Oral Implants, 17(5) IEEE TRANS. ON MED. IMAGING (Oct. 1998) (“Verstreken”)

1011 U.S. Patent No. 5,842,858, issued on December 1, 1998, to Truppe (“Truppe”)

1012 Kris Verstreken et al., Computer-Assisted Planning of Oral Implant Surgery: A Three-Dimensional Approach, 11(6) INT J ORAL

MAXILLOFACIAL IMPLANTS (1996) (“Verstreken 1996”)


A-2

EXHIBIT DESCRIPTION

1013 S.D. Ganz, The Triangle of Bone – A Formula for Successful Implant Placement and Restoration, 5(5) THE IMPLANT SOCIETY, INC. (1995)

1014 International Patent Application Publication No. WO 99/32045 to Poirier

1015 Jürgen Weese et al., An Approach to 2D/3D Registration of a Vertebra in 2D X-ray Fluoroscopies with 3D CT Images, in 1205 LECTURE NOTES IN COMPUTER SCIENCE, CVRMED-MRCAS’97 119 (Jocelyne Troccaz et al. eds. 1997)


CERTIFICATE OF SERVICE

I hereby certify that a true and correct copy of the foregoing PETITION

FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,319,006 (CLAIMS

1-10) UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 is being served via

overnight UPS this 20th day of January, 2016 on the Patent Owner at the

correspondence address of record as follows:

Dykema Gossett PLLC Franklin Square, Third Floor West 1300 I Street, NW Washington, DC 20005

A courtesy copy is being served via overnight UPS to:

John G. Day Andrew Colin Mayo Lauren E. Maguire ASHBY & GEDDES 500 Delaware Avenue, 8th Floor Wilmington, DE 19899

John D. Carlin Josh Calabro Sean M. McCarthy Michael P. Sandonato FITZPATRICK CELLA HARPER & SCINTO 1290 Avenue of the Americas New York, NY 10104-3800

Date: January 20, 2016 /Erin M. Dunston/ Erin M. Dunston, Esq. Registration No. 51,147 BUCHANAN INGERSOLL & ROONEY PC 1737 King Street, Suite 500 Alexandria, Virginia 22314 Main Telephone (703) 836-6620 Main Facsimile (703) 836-2021 [email protected] Counsel for Petitioner

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