Draft IPR Petition 2014.12.04knobbemedical.com/wp-content/uploads/2014/12/... · TERUMO BCT, INC....

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD

TERUMO BCT, INC. Petitioner

v. NOBEL HOUSE GROUP PTY LTD.

Patent Owner U.S. Patent No. 8,777,921 Issue Date: July 15, 2014

Title: STERILE SAMPLING METHODS AND APPARATUS Inter Partes Review

Petition for Inter Partes Review for U.S. Patent No. 8,777,921 Under 35 U.S.C. §§ 311-319 and 37 C.F.R.§§ 42.1-.80, 42.100-.123

No. [To Be Assigned] Mail Stop “PATENT BOARD” Patent Trial and Appeal Board U.S. Patent and Trademark Office P.O. Box 1450 Alexandria, VA 22313-1450

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TABLE OF CONTENTS

TABLE OF AUTHORITIES ................................................................................ iii

TABLE OF EXHIBITS ........................................................................................... v

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

II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1) ...................... 1

A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ....................... 1

B. Related Matters Under 37 C.F.R. § 42.8(b)(2) ................................. 1

C. Standing ................................................................................................ 1

D. Counsel and Service Information Under 37 C.F.R. § 42.8(b)(3) .............................................................. 2

E. Power of Attorney ............................................................................... 2

F. Payment of Fees Under 37 C.F.R. § 42.103 ....................................... 2

III. CHALLENGE UNDER 37 C.F.R. § 42.104(b) AND STATEMENT OF PRECISE RELIEF REQUESTED ............................. 2

IV. PERSON OF ORDINARY SKILL IN THE ART ...................................... 3

V. STATE OF THE PLATELET SAMPLING ART ...................................... 4

VI. SUMMARY OF THE ‘921 PATENT .......................................................... 7

A. Brief Description of the ‘921 Patent .................................................. 7

B. Relevant Prosecution History of the ‘921 Patent ............................. 8

VII. CLAIM CONSTRUCTION FOR THE IPR ............................................. 13

VIII. APPLICATION OF PRIOR ART TO EACH CLAIM ........................... 18

A. U.S. Patent App. No. 10/711,707 (“Spray”) .................................... 18

B. The SSK Pamphlet ............................................................................ 20

C. U.S. Patent No. 6,328,726 (“Ishida”) ............................................... 21

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D. U.S. Patent No. 6,387,086 (“Mathias”) ........................................... 23

E. U.S. Patent No. 5,334,170 (“Moroski”) ............................................ 25

F. U.S. Patent No. 5,259,392 (“Schmitt”) ............................................. 27

IX. CLAIM CHARTS AND BASIS FOR INVALIDITY .............................. 27

A. First Basis For Invalidity – Spray and Spray in View of Ishida .................................................. 28

1. Anticipation – Spray (Claims 1-4 and 6-19) ......................... 28

2. Obviousness – Spray in View of Ishida (Claims 2, 3 and 5) ....................................................... 34

B. Second Basis For Invalidity – Obviousness in View of the SSK Pamphlet and Ishida (Claims 1-19) .................... 37

C. Third Basis For Invalidity – Mathias In View Of Moroski, Schmitt, And Ishida ........................................... 45

1. Obviousness – Mathias in View of Moroski (Claims 1-4, 6-12 and 14-18) ................................... 45

2. Mathias, Moroski, and Schmitt (Claims 13 and 19) ............ 54

3. Mathias, Moroski and Ishida (Claim 5) ................................ 56

X. CONCLUSION ............................................................................................ 57

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TABLE OF AUTHORITIES

Cases Bradford Co. v. Conteyor N. Am. Inc.,

603 F.3d 1262 (Fed. Cir. 2010) ............................................................................ 10 Environmental Designs, Ltd. v. Union Oil Co.,

713 F.2d 693, 696-97 (Fed. Cir. 1983) ................................................................... 4 In re GPAC Inc.,

57 F.3d 1573 (Fed. Cir. 1995) ................................................................................ 3 KSR Int’l Co. v. Teleflex, Inc.,

550 U.S. 398 (2007) .............................................................................................. 34 Lockwood v. Am. Airlines, Inc.,

107 F.3d 1565 (Fed. Cir. 1997) .............................................................................. 9

Statutes and Rules 35 U.S.C. § 120 .......................................................................................................... 9 35 U.S.C. § 314 ................................................................................................... 3, 57 37 C.F.R. § 42.10 ....................................................................................................... 2 37 C.F.R. § 42.100 ................................................................................................... 13 37 C.F.R. § 42.101 ..................................................................................................... 1 37 C.F.R. § 42.103 ..................................................................................................... 2 37 C.F.R. § 42.104 .................................................................................................1, 2 37 C.F.R. § 42.15 ....................................................................................................... 2 37 C.F.R. § 42.8 .....................................................................................................1, 2

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Other Authorities Merriam Webster’s Collegiate Dictionary (10th ed. 1995) ..................................... 16 MPEP § 2141.03 ........................................................................................................ 4

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TABLE OF EXHIBITS Exhibit Description

1001. U.S. Patent No. 8,777,921, Kashmirian et al.

1002. File Wrapper for U.S. Patent No. 8,777,921 obtained from United States Patent and Trademark Office PAIR website.

1003. U.S. Patent Application Publication No. 2011/013927 for U.S. Patent Application No. 12/857,918, Kashmirian et al.

1004. U.S. Patent No. 7,785,304, Kashmirian et al.

1005. ITL Corporation SampLock Sampling Kit (SSK) Brochure.

1006. Australian Provisional Application No. 2003906364.

1007. Declaration of Karl Leinsing, Curriculum Vitae, and Materials Relied Upon.

1008. American Red Cross website printout, http://www.redcross.org/about-us/history.

1009. Puget Sound Blood Center website printout, http://www.psbc.org/programs/platelets.htm.

1010. Red Cross website printout, http://www.redcross.org/news/article/Apheresis--A-Special-Kind-of-Blood-Donation.

1011. Mayo Clinic website printout, http://www.mayoclinic.org/diseases-conditions/thrombocytopenia/basics/causes/con-20027170.

1012. Article by Chiu et al., A Prospective Study of Symptomatic Bacteremia Following Platelet Transfusion and of its Management, Transfusion, Vol. 34 No. 11 (1994).

1013. Puget Sound Blood Center website printout, http://www.psbc.org/therapy/platelets.htm.

1014. Food and Drug Administration Guidance for Industry: Use of Sterile

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Connective Devices in Blood Bank Practices, November 2000.

1015. American Association of Blood Banks (“AABB”) 2005 Nationwide Blood Collection and Utilization Survey Report.

1016. Relevant Pages From AABB Standards for Blood Banks and Transfusion Services, (22nd ed. 2003).

1017. U.S. Patent No. 5,685,875, Hlavinka et al.

1018. Relevant Pages From Trima System Operator’s Manual 5.0 (2002).

1019. U.S. Patent Publication No. 2006/0074348 for U.S. Patent Application No. 10/711,707, Spray et al.

1020. U.S. Patent No. 6,328,726, Ishida et al.

1021. U.S. Patent No. 6,387,086, Mathias et al.

1022. U.S. Patent No. 5,334,170, Moroski.

1023. U.S. Patent No. 5,259,392, Schmitt.

1024. Relevant Pages From Merriam Webster’s Collegiate Dictionary, (10th ed. 1995).

1025. U.S. Patent No. 4,900,321, Kaufman et al.

1026. U.S. Patent No. 6,517,508, Utterberg et al.

1027. U.S. Patent No. 5,279,605, Karrasch et al.

1028. U.S. Patent No. 5,820,614, Erskine et al.

1029. U.S. Patent No. 5,330,464, Mathias et al.

1030. U.S. Patent No. 4,201,406, Dennehey et al.

1031. International Standard ISO 8536-5 Infusion equipment for medical use – Part 5: Burette type infusion sets (1992).

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I. INTRODUCTION

Terumo BCT, Inc. (“TBCT” or “Petitioner”) requests the Patent Trial and

Appeal Board institute an Inter Partes Review (“IPR”) of claims 1-19 of U.S.

Patent No. 8,777,921 (“the ‘921 Patent”), entitled “Sterile Sampling Methods and

Apparatus,” which is directed to an apparatus for sampling fluids, such as platelets

collected from a blood donor, to test the fluids for bacteria.

II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)

A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)

TBCT is the real party-in-interest, with corporate headquarters located at

10811 West Collins Avenue, Lakewood, Colorado, 80215.

B. Related Matters Under 37 C.F.R. § 42.8(b)(2)

TBCT is not aware of any other judicial or administrative matter that would

affect, or be affected by, a decision in this proceeding.

C. Standing

In accordance with 37 C.F.R. § 42.104(a), TBCT certifies that the ‘921

Patent is available for an IPR, that it has standing, and that it is not barred or

estopped from requesting this IPR. In accordance with 37 C.F.R. § 42.101(a),

TBCT has not filed a civil action challenging the validity of the ‘921 Patent. In

accordance with 37 C.F.R. § 42.101(b), TBCT states that it has not been served

with a complaint alleging infringement of the ‘921 Patent more than one year

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before the filing date of this Petition. In accordance with 37 C.F.R. § 42.104(b),

TBCT can challenge the claims of the ‘921 Patent on the grounds identified in this

Petition and requests cancellation of Claims 1-19 of the ‘921 Patent.

D. Counsel and Service Information Under 37 C.F.R. § 42.8(b)(3) Lead and Back-Up Counsel for TBCT are Robert R. Brunelli, Reg. No.

39,617, and Tadd Wilson, Reg. No. 54,544, respectively. Both Lead and Back-Up

Counsel are with, and correspondence and service copies of documents can be sent

to, Sheridan Ross P.C., 1560 Broadway, Suite 1200, Denver, Colorado 80202,

phone number 303.863.9700. TBCT also consents to electronic service by email at

[email protected] and [email protected].

E. Power of Attorney

Per 37 C.F.R. § 42.10(b), a power of attorney is filed herewith.

F. Payment of Fees Under 37 C.F.R. § 42.103

According to 37 C.F.R. §§ 42.103 and 42.15(a), TBCT provides payment of

the required fees herewith, and the United States Patent and Trademark Office

(“USPTO”) is authorized to charge any additional fees to Dep. Acct. No. 19-1970.

III. CHALLENGE UNDER 37 C.F.R. § 42.104(b) AND STATEMENT OF PRECISE RELIEF REQUESTED

TBCT respectfully requests an IPR be instituted on claims 1-19 of the ‘921

Patent on the grounds set forth in Table I, provided below, and included in this

Petition and requests cancellation of those claims as unpatentable.

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Table I

Claims of the ‘921 Patent

Grounds for Cancellation

Prior Art Citation

1-4 and 6-19 § 102 U.S. Patent App. No. 10/711,707 2, 3, and 5 § 103 U.S. Patent App. No. 10/711,707 and U.S. Patent

No. 6,328,726 1-19 § 103 Inventor disclosed SampLok Sampling Kit Non-

Patent Literature and U.S. Patent No. 6,328,726 1-4, 6-12 and

14-18 § 103 U.S. Patent No. 6,387,086 and U.S. Patent No.

5,334,170 13 and 19 § 103 U.S. Patent No. 6,387,086, U.S. Patent No.

5,334,170, and U.S. Patent No. 5,259,392 5 § 103 U.S. Patent No. 6,387,086, U.S. Patent No.

5,334,170, and U.S. Patent No. 6,328,726

An explanation of how the claims are statutorily unpatentable, including

relevance of the cited prior art and identification of where each element can be

found in the cited prior art, is provided in the form of text and detailed claim charts

provided below. This Petition, supported by the Declaration of Mr. Karl R.

Leinsing, MSME, PE (hereinafter “Leinsing Decl.” (Ex. 1007)), demonstrates that

there is a reasonable likelihood that TBCT will prevail with respect to at least one

challenged claim and that each of the challenged claims is unpatentable for the

reasons cited in this Petition. See 35 U.S.C. § 314(a).

IV. PERSON OF ORDINARY SKILL IN THE ART

An invalidity analysis is to be conducted from the standpoint of a person of

ordinary skill in the art, who is a hypothetical person who is presumed to know the

relevant art. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citations

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omitted). The USPTO considers several key factors in determining the level of

ordinary skill in the art: “(1) the educational level of the inventor; (2) type of

problems encountered in the art; (3) prior art solutions to those problems; (4)

rapidity with which innovations are made; (5) sophistication of the technology; and

(6) educational level of active workers in the field.” Environmental Designs, Ltd. v.

Union Oil Co., 713 F.2d 693, 696-97 (Fed. Cir. 1983) (citations omitted); MPEP

§ 2141.03(I).

TBCT submits that a person having ordinary skill in the relevant art would

be: a medical device designer with a Bachelor of Science degree in engineering,

such as mechanical, industrial, biomedical engineering, or an equivalent technical

degree with at least 5-7 years of experience in the field; or a person with an

advanced degree in bio-medical engineering, with fewer years of experience, but at

least some years of experience in the field; or a person who has worked in the field

for at least 15 years. (Ex. 1007, ¶¶ 13-17.)

V. STATE OF THE PLATELET SAMPLING ART

The blood banks of the American Red Cross and other organizations have

been collecting blood from donors for over 50 years. (Ex. 1007, ¶ 18.) These

blood banks sampled whole blood for bacteria and other contaminants for many

years. (Id., ¶ 25.) Apparatuses for whole blood sampling in 2003 and before

included many relatively simple devices which shared common elements, such as

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catheters, reservoirs (e.g., solution bags, burettes, or solution bottles), syringes,

VacutainerTM tubes, needles, biocompatible materials, flexible thermoplastic tubing,

vials, syringes, clamps, frangible devices, filters, connectors (including Luer

fittings), etc., which may withdraw fluid from either a donor or a collection pouch.

(Id.)

Whole blood, however was and still is, rarely used for medical purposes.

(Id., ¶ 18.) Rather, blood donations have been processed after collection so that

one or more blood components (e.g., red blood cells, plasma, platelets, etc.) could

be used for medical treatments. (Id., ¶¶ 18-20.) Various processes, such as

apheresis, have been routinely used to separate whole blood into components. (See

id., ¶ 19.) One or more of the separated components is then extracted, with the

remaining components often being returned to the donor. (Id.) Platelets have been

considered to be the most important of the various blood components, as the

platelets are difficult to obtain in large quantities and are valuable for many

medical treatments. (Id., ¶¶ 21-22.)

For sampling components of blood extracted through apheresis, more

complex bag sets than those used for whole blood were used well before 2003. (Id.,

¶ 27.) Such apheresis bag sets typically comprised needles, tubes, several blood

component bags, separation chambers (for mounting on a centrifuge), sterile

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connectors for coupling bags of fluid, clamps, frangible devices, filters, and other

components. (Id.)

In early 2003, the American Association of Blood Banks (“AABB”)

published the 22nd edition of the “Industry Standards for Blood Banks and

Transfusion Services,” which included the new standard 5.1.5.1 directed to

bacterial testing of platelets, which stated:

The blood bank or transfusion service shall have methods to limit and

detect bacterial contamination in all platelet components. Standard

5.6.2 applies.

(Id., ¶ 23; see also Ex. 1016.)

To comply with the standard, various manufacturers of apheresis equipment

were required to provide a means, device, apparatus, and/or procedure for the

blood banks to test bacteria within collected platelets. Because of the platelets’

intrinsic value, the industry was necessarily driven to provide for testing that would

be accurate, fast, and not wasteful. (Ex. 1007, ¶¶ 23-24.) The testing devices were

designed to extract an accurately measured sample of platelet rich plasma and

provide the sample to a sample tube. The sample tube could then be placed in a

test apparatus to test bacteria within the sample. Due to the availability of known

sampling devices and components of those devices, one skilled in the art had, at

that time, an array of known answers to address the AABB standard. (Id., ¶ 28.)

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VI. SUMMARY OF THE ‘921 PATENT

A. Brief Description of the ‘921 Patent

The ‘921 Patent claims an apparatus to facilitate sterile bacterial testing of a

liquid, such as red blood cells, plasma, or platelets, housed in a container. (Ex.

1001, Col. 1:16-20; Col. 2:12-20.) One of the example embodiments of the

apparatus is shown below:

(Id., Fig. 8.)

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The container 310 is connected, via tube 314, to a sight chamber 312,

formed from “a conventional medical syringe,” with a vent 320 (that contains a

filter) and an inlet located at the top of the chamber and a needle at an outlet 318.

(Id., Col. 4:64-5:9; Col. 2:52-59; Col. 6:14-20.) The needle may be surrounded by

a cup-like guard 316 and sample tubes can be inserted into the guard so that the

needle can pierce the septum enclosing the tube. (Id., Col. 2:52-56; Col. 5:10-15;

Col. 6:14-20.) As claimed, the apparatus must include a clamp 322 on, and a

frangible barrier 323 in, the inlet tube 314. (Id., Col. 9:16-35.) The combination

of the frangible barrier, the clamp, and the sight chamber vent allegedly establishes

patentability of claims 1-19 of the ‘921 Patent. (Ex. 1002 p. 8.)1

B. Relevant Prosecution History of the ‘921 Patent

The ‘921 Patent is a continuation application of U.S. Patent Application No.

12/857,918 (“the ‘918 Application”), which was filed on August 17, 2010 and is

now abandoned. (Ex. 1003.) The ‘918 Application is a continuation-in-part

application of U.S. Patent No. 7,785,304 (“the ‘304 Patent”), which was filed on

November 17, 2004. (Ex. 1004.) The ‘304 Patent claims priority to Australian

Provisional Application No. 2003906364 (“the ‘364 Application”), which was filed

on November 19, 2003. (Ex. 1006.) A timeline of the relevant dates is shown

below:

1 Page number references to Ex. 1002 are to page numbers of the exhibit document as filed.

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A continuation-in-part application, such as the ‘918 Application from which

the ‘921 Patent issued, is entitled to the filing date of a previously filed application

only if all the material in the claims is supported by the specification of the

previously filed application. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571-

72 (Fed. Cir. 1997) (stating that entitlement of the benefit of the filing date of an

10

earlier application under 35 U.S.C. § 120 only extends to that which is disclosed);

see also Bradford Co. v. Conteyor N. Am. Inc., 603 F.3d 1262, 1268-69 (Fed. Cir.

2010). The claims of the ‘921 Patent are not fully supported by the ‘364

Application or the ‘304 Patent. Rather, the claims are only supported by material

added into the ‘918 Application, filed August 17, 2010, meaning that the ‘921

Patent is entitled to a priority date of August 17, 2010. Specifically, the claim term

“frangible barrier” and the description of that term are first presented in text added

to the continuation-in-part ‘918 Application. (Ex. 1003, ¶¶ 43-52, seen in the ‘921

Pat. at Col. 8:16-9:8.) Thus, the critical date is August 17, 2009.

The ‘918 Application includes the same specification and figures as the ‘304

Patent, but also included FIG. 8, FIG. 9, and text describing those figures at ¶¶ 43-

52. The description of FIG. 8 and FIG. 9 is seen in Col. 8:16-9:8 of the ‘921

Patent, but is not included in the ‘304 Patent. The first mention of the term

“frangible barrier” and the description of that term are only found in the new

matter added to both the ‘918 Application and the ‘921 Patent, which relevantly

reads:

As supplied to the end user the tube clamp is preferably closed

and so blocks tube 314. Accordingly, until such time as the tube

clamp 322 is opened contamination cannot transfer from the sight

chamber 312 to the pouch 310. However, a frangible barrier 323 may

be provided in the tube 314 that initially closes the tube.

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. . .

With the tube clamp 322 or frangible barrier 323 closed the

fluid cannot transfer to the sight chamber.

. . .

The tube clamp 322 is opened or the frangible barrier 323

opened and fluid flows from the pouch to the sight chamber via tube

314.

(Ex. 1001, Col. 8:38-59.)

The prosecution history of the ‘921 Patent further demonstrates that August

17, 2010 is the earliest priority date. As filed, the ‘921 Patent originally claimed

an inlet tube comprising a “frangible,” not a “frangible barrier.” (Ex. 1002, pp.

210-19.) During the prosecution of the ‘921 Patent, the Examiner issued a Pre-

Interview First Office Action, rejecting claims 15, 22, 25, 28, 29, and 30 under 35

U.S.C. § 112, ¶ 2, because those claims “recite ‘a frangible’ without stating what

feature or entity is frangible. Thus, the scope of these claims is indeterminate and

indefinite.” (Id., pp. 81-84.) Applicants replied by amending claims 22 and 29 to

change the term “frangible” to “frangible barrier” and by cancelling other claims

reciting just a “frangible.” As support for the amendment, Applicants cited

paragraph 46 of the specification, which is part of the new matter added in the

continuation-in-part ‘918 Application. (Id., pp. 71-78.)

After receiving a Notice of Allowance, Applicants filed a Request for

Continued Examination and, for the first time, disclosed to the USPTO that the

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Inventors had distributed non-patent literature (“NPL”) in the United States before

the filing of the U.S. Application, referenced as items C2-C6 in the February 3,

2014 Information Disclosure Statement (“IDS”). (Id., pp. 33-37.) The NPL

included an advertising pamphlet which showed an illustration of a SampLok

Sampling Kit (“SSK Pamphlet”) that closely corresponds to FIG. 1 of the ‘921

Patent. The SSK Pamphlet was admitted, by the Inventors, to have been presented

to the public, and thus, is prior art to the claims, by at least November 4, 2003,

when the SSK pamphlet was provided to the public. (Id., p. 38; Ex. 1005.)

A telephonic interview was next conducted between the Examiner and

Applicants’ representative, during which information about the device shown in

the SSK Pamphlet and U.S. Patent No. 4,439,188 (“Dennehey”) were discussed:

The [device disclosed in the SSK Pamphlet, which was item C5] as

well as the Dennehey reference, which cites a frangible barrier and

was applied against the claims in the ‘918 application, were discussed

and the applicant’s representative proposed an amendment to

independent claims 6, 18 and 29 that would recite that the vent is in

the chamber wall. It was agreed that such an amendment eliminates

the issue prompting a 35 U.S.C. 112 rejection as discussed above and

also overcomes the Choksi reference cited in the 2/5/14 IDS. A further

amendment to claims 6 and 18 was discussed regarding the addition

of the frangible barrier already cited in claim 29. It was agreed that

this additional amendment would overcome the C5 NPL reference

cited in the IDS noted above. The applicant later submitted a write-up

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of the agreed claim language via e-mail . . . with authorization for the

examiner to make theese (sic) amendments to expedite prosecution.

(Ex. 1002, p. 19, emphasis added.)

Thus, Applicants constructively admitted , by adding a frangible barrier to

the claims, which was described in the new material in the ‘918 Application, that

frangible barrier was required to obtain patentability of claims in the ‘921 Patent.

The ‘921 Patent was subsequently allowed with the following corrected

Examiner’s statement of reasons for allowance:

Independent claims 6, 18 and 20 are amended to recite a vent in the

chamber wall. Such a vent in combination with a frangible barrier in

an inlet tube between the inlet tube’s proximal and distal ends is not

disclosed or suggested by the prior art of record. Claims 7, 9, 20, 21,

28 and 38-40 depend from one of claims 6, 18 and 29 are thus also

allowed.

(Id. p. 8.)

Since “frangible barrier” was only first disclosed upon the filing of the ‘918

Application and that structure was a reason all claims of the ‘921 Patent were

allowed, the ‘921 Patent is entitled only to the ‘918 Application’s filing date,

namely, August 17, 2010.

VII. CLAIM CONSTRUCTION FOR THE IPR

In an IPR, a claim term is given its “broadest reasonable construction in light

of the specification of the patent in which it appears.” 37 C.F.R. § 42.100(b). The

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claim terms requiring interpretation are italicized in the exemplary claim presented

below:

1. Apparatus for providing at least one sample of a liquid

contained in a pouch while mitigating the danger of contaminating the

liquid in the pouch, the apparatus comprising:

an inlet tube having proximal and distal ends, and comprising a

frangible barrier therein, between the proximal and distal ends, the

proximal end connected to an inlet of a sterile sight chamber, the

chamber comprising:

a vent in the chamber wall fitted with a bacterial filter

through which air can flow to and from the chamber; and

an outlet;

the inlet tube comprising a tube clamp thereon, wherein the

tube clamp is a sufficient distance from the distal end to permit a

sterile fluid connection to be established with the inlet tube at a point

distal to the tube clamp;

the tube clamp operable to regulate liquid flow through the inlet

tube to the chamber when the connection is established and operable

to block fluid flow in the absence of the connection; and

a sample port comprising a hollow body with a distal end and a

proximal end, wherein the distal end of the sample port is connected

to the outlet of the chamber, and the proximal end is opposite the

outlet.

(Ex. 1001, Claim 1, emphasis added.)

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For purposes of this Petition, TBCT sets forth the broadest reasonable

interpretation of the claim terms “frangible barrier,” “chamber,” and “bacterial

filter.” TBCT expressly reserves the right to present other interpretations and/or

constructions of any of the ‘921 Patent claim terms at a later time, for other reasons

or in a context where different claim construction standards may apply.

The specification of the ‘921 Patent describes a frangible barrier (i.e., a seal)

as impeding the flow of a fluid until broken. (Ex. 1001, Col. 8:48-49.) Once the

frangible barrier is broken, fluid can then pass. (Id., Col. 8:57-59.) Also important

here, the prosecution history shows that the term “frangible” is an adjective that

only modifies another term. This grammatical construction was acknowledged by

the Examiner during prosecution of the ‘921 Patent, where she rejected the claims

that only mentioned a “frangible,” as indeterminate and indefinite because the

“[c]laims recite ‘a frangible’ without stating what feature or entity is frangible.”

(Ex. 1002, p. 83 (emphasis added).)

Claim Term Proposed Construction

Frangible barrier A seal that impedes the flow of a fluid until

physically broken.

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Following the Examiner’s reasoning, the specification describes two distinct

frangible mechanisms. First, the specification of the ‘921 Patent describes a

“frangible connector,” stating:

In such applications the inlet tubes would be attached by the

manufacturer to the kits and it would not be necessary for the user to

make the initial connection. However, it may be preferred to employ a

frangible connector in the inlet tube to effect the initial connection

between the source of the sample liquid and the sterile sampling

apparatus of the present invention.

(Ex. 1001, Col. 3:58-67 (emphasis added).)

The Inventors show and describe a frangible connector in the ‘921 Patent in

figures 4 and 4A and the associated description, which shows and describes the use

of a blunt connector to break a frangible septum part to form an initial fluid

connection. (Id., Col. 2:35-51; Col. 4:20-25.) Second, the specification describes

a frangible barrier which impedes the flow of fluid until broken. (Id., Col. 8:48-

59.) Once the frangible barrier is broken, only then can fluid pass. (Id.) Thus, a

frangible barrier “seals” the tube until broken but does not make an initial

connection.

Not only does the specification describe a frangible connector in a different

way than a frangible barrier, but the plain and ordinary meanings of a connector

and a barrier are diametrically opposite. A “barrier” is “something material that

blocks passage or is intended to block passage.” (See Ex. 1024, Merriam

17

Webster’s Collegiate Dictionary p. 94 (10th ed. 1995).) In contrast, a “connector”

is defined as a device “to join or fasten together usually by something intervening.”

(Id., p. 244.) The claims of the ‘921 Patent recite a frangible barrier, not a

frangible connector. Because the specification does not support that a frangible

connector and a frangible barrier can have the same meaning, the broadest

reasonable interpretation in light of the specification is the interpretation proposed

above. (Ex. 1007, ¶¶ 29-43, 63.)

“Chamber” has multiple meanings. The specification of the ‘921 Patent

describes a chamber as being capable of and designed to hold a liquid. (Ex. 1001,

Col. 3:5-23.) The specification also describes that a chamber may be flexible (id.,

Col. 3:1-4) or semi-rigid (id., Col. 4:54-65). One skilled in the art would interpret

the term “chamber,” as used in the ‘921 Patent, as any container that can hold a

liquid. (Ex. 1007, ¶ 62.)


Chamber A container adapted to hold a liquid.


Bacterial filter A filter that maintains sterility.

18

To maintain system sterility, the specification of the ‘921 Patent describes

using a filter that prevents contaminants, such as bacteria, from entering the sight

chamber. For example, the specification describes connecting a sterile sight

chamber with a sampling pouch “in a sterile manner to allow fluid to flow into the

chamber while at the same time allowing air within the chamber to be displaced

through a bacterial filter to [the] atmosphere.” (Ex. 1001, Col. 2:15-20.) The

filter is thus described as any filter that allows air to flow out of or into the

chamber when liquid flows into or from the chamber and “block[s] passage of

airborne particles, including bacteria [from entering] into the chamber.” (Id., Col.

3:23-28.) One skilled in the art would thus interpret “bacterial filter” to mean any

filter that maintains sterility. (Ex. 1007, ¶ 64.)

VIII. APPLICATION OF PRIOR ART TO EACH CLAIM

The ‘921 Patent’s § 102(b) critical date is August 17, 2009. The references

relied upon by TBCT to invalidate claims 1-19 of the ‘921 Patent all qualify as

prior art as these references were published or issued before this critical date.

These references are:

A. U.S. Patent App. No. 10/711,707 (“Spray”)

Spray was not reviewed by the USPTO in granting the ‘921 Patent. Spray

teaches and describes every element of at least claims 1-4 and 6-19 of the ‘921

Patent as illustrated in more detail in the claim chart presented below in Section IX.

19

As seen in Figure 1 of Spray, reproduced below, the bacterial sampling

apparatus 10 comprises a component bag 12 that receives a biological fluid, such

as blood. (Ex. 1019, ¶ [0038].) As seen in the green box below (the colored boxes

were added to the figures for reviewability), the component bag 12 may have a

tube 14 that allows the blood to travel into and out of the bag 12. (Id., ¶ [0038].)

The device also includes a biologic fluid sampling apparatus having a fluid

sampler 32 [yellow box] connected to the bag 12 by tube 20, with a pinch clamp 42

placed on the tube, and a frangible pin 40 in the tube that prevents fluid from

flowing into a reservoir 34 until broken. (Id., ¶ [0039].) The tube connects to a

fluid access port of the reservoir 34 of the fluid sampler. (Id.) The reservoir 34,

which is formed of transparent biocompatible plastic, has a gauge 36 that allows

20

the level of the fluid in the reservoir 34 to be measured. (Id.) The reservoir 34

includes a vent, with a bacterial filter 44, that allows the venting of air when fluid

enters the reservoir 34. (Id., ¶ [0042].) As seen in the blue box, connected to the

end of the reservoir is a bottle adaptor 48, with a cap 54, that can accept tubes to

extract fluid from the reservoir for bacterial testing. (Id., ¶¶ [0040], [0043].)

B. The SSK Pamphlet

The SSK Pamphlet (Ex. 1005) was published and provided to the public by

November 4, 2003. (Ex. 1002, p. 38) Thus, the SSK Pamphlet is prior art to both

the ‘921 and the ‘304 Patents under 35 U.S.C. § 102(b). The SSK Pamphlet

teaches and describes every element of all claims of the ‘921 Patent except for a

frangible barrier. The figure shown in the SSK Pamphlet, reproduced below,

discloses a platelet transfer kit having a sampling chamber [yellow box 1] that may

be docked (i.e., connected) with a platelet pouch (not shown) by a tube [green box

2], having a pinch clamp. (Ex. 1007, ¶¶ 48, 49.)

21

Markings or graduations are shown on the site chamber, which allow for the

measurement of the present fluid. A filter with a cap is included on the sight

chamber above the graduations, which allows for the venting of air when platelets

enter or leave the chamber. As seen in the blue box 3, the sampling chamber is

shown as being connected by a Luer needle to a sampling adapter, with a cap. The

sampling adapter can accept tubes to which platelets can pass for bacterial testing.

C. U.S. Patent No. 6,328,726 (“Ishida”)

Ishida was issued on December 11, 2001, making it prior art to both the ‘921

and the ‘304 Patents under 35 U.S.C. § 102(b). (Ex. 1020.) Ishida was not

reviewed by the USPTO during the prosecution of the ‘921 Patent.

22

Ishida discloses a blood collecting apparatus 1 having a collecting bag 10

connected to a take-out port 71 (i.e., a sampling port) used to sample collected

blood, as Fig. 1 from Ishida reproduced below shows. Blood is collected into the

collecting bag 10 from a donor via tube 15. (Id., Col. 3:55-64.) There is a “Y”

branch portion 92, which is connected to a take-out port 71, by a tube 91. (Id.)

The take-out port 71 can include a vent with a cap 76. (Id., Col. 8:42-46; Col.

18:1-52.) The connecting tube is made from a flexible thermoplastic, and as seen

in the orange box, includes a breakable seal 93. (Id., Col. 5:26-30; Col. 6:65-7:18.)

The breakable seal 93 prohibits, until broken, fluid from flowing into the take-out

port. (Id., Col. 8:4-21.) Ishida also discloses use of a clamp 16 or 33 in line with

the tube 91. (Id., Col. 5:60-6:4.)

Fig. 8 of Ishida, reproduced below, describes in detail the above-noted

sealable air vent 51 [blue box below] for exhausting air from a blood collecting

apparatus and shows that the vent includes a vent cap 55 [dashed brown box] that

23

can open, partially open, or close the vent 51. (Id., Col. 18:1-52.) The air vent 51

includes a gas-permeable (ventalative) and blood-unpermeable filter 54. (Id., Col.

18:1-4.)

D. U.S. Patent No. 6,387,086 (“Mathias”)

Mathias was issued on May 14, 2002, making it prior art to the ‘921 and the

‘304 Patents under 35 U.S.C. § 102(b). (Ex. 1021.) Mathias was not reviewed by

the USPTO during prosecution of the ‘921 Patent, although family members of

Mathias were reviewed. Mathias discloses a disposable blood collection or

processing set that includes a sampling system.

24

Fig. 2A, reproduced above, shows a disposable processing set, which is suitable for

use in blood collection from a donor. (Id., Col. 4:33-40.) Blood is withdrawn

from the donor through a needle 12 and travels through tubing 14 and 15 to a

collection container 16. (Id.)

Fig. 3 of Mathias, reproduced below, shows a sampling device 18, which is

attached to the processing set. (Id., Col. 5:35-37.) A container 42 of the sampling

device 18 is attached at an inlet port 46 [yellow box] by a tubing segment 62 which

includes a frangible pin 64 that preserves the sterility of the blood flow path [green

box]. (Id., Col. 6:16-26.) A clamp 65 on the tubing segment allows for flow

control through the blood processing set. (Id., Col. 6:26-30.) A sampling port 68

[blue box] is then attached to the container 42. (Id., Col. 6:31-44.)

25

E. U.S. Patent No. 5,334,170 (“Moroski”)

Moroski issued on August 2, 1994, making it prior art to the ‘921 and the

‘304 Patents under 35 U.S.C. § 102(b). (Ex. 1022.) Moroski was not reviewed by

the USPTO during the prosecution of the ‘921 Patent. Moroski discloses a liquid

administration set having a clear chamber with graduation marks [dashed green

box shown in Fig. 2 below] for measuring an amount of contained liquid and

controlling the flow of that liquid by the opening of a vent [dark blue box shown in

Fig. 2 below] that may include a bacterial filter. (Id., Col. 6:10-18; Col. 4:36-48.)

26

Figure 2 from Moroski, reproduced above, shows a primary container 112

attached to an in-line burette 126 [yellow box] through an inlet 135 [red box]. (Id.,

Col. 3:59-61.) The primary container 112 is connected to the in-line burette 126

[yellow box] through tubing 116, 119, 124, 127. (Id., Col. 4:10-35.) The upper

wall 130 of the burette 126 connects to a vent-to-air member 132 and a filter

element 132(b) [dark blue box], with a slide clamp 134 located on the tubing. (Id.,

Col. 4:43-56.) The bottom wall 131 of the burette has a central outlet 136 [dashed

light blue box], which is connected to a tubing end through a Luer lock connector

136a, 137. (Id.)

27

F. U.S. Patent No. 5,259,392 (“Schmitt”)

Schmitt issued on November 9, 1993, making it prior art to the ‘921 and

‘304 Patents under 35 U.S.C. § 102(b). (Ex. 1023.) Schmitt was not reviewed by

the USPTO during the prosecution of the ‘921 Patent. Schmitt discloses a blood

sample device that protects a user from accidental needle sticks and includes a rear

end cap 56 that covers a double-ended needle 26. (Id., Col. 4:65-5:15.) Fig. 3 of

Schmitt, reproduced below, shows the tube cap 56 [dashed brown box] as being

fixed around a flange 46. (Id.)

IX. CLAIM CHARTS AND BASIS FOR INVALIDITY

All claims of the ‘921 Patent are invalid because they are anticipated or

obvious based upon one of three primary references, namely, Spray, the SSK

Pamphlet, or Mathias, either alone or in combination with at least Ishida, Schmitt,

28

and/or Moroski. TBCT provides the following claim charts and invalidity analysis,

which are not intended to be limiting.

A. First Basis For Invalidity – Spray and Spray in View of Ishida

1. Anticipation – Spray (Claims 1-4 and 6-19)

The blood sampling device of Spray anticipates claims 1-4 and 6-19 of the

‘921 Patent under 35 U.S.C. § 102(b) as it teaches all the elements of those claims.

For instance, Spray describes a bacterial sampling apparatus that comprises a

chamber (i.e., fluid sampler 32 with reservoir 34) connected to a pouch (i.e., bag

12) by an inlet tube (i.e., tube 20). (Ex. 1019, ¶ [0039].) The tube has a tube

clamp (i.e., pinch clamp 42), placed on the inlet tube, and a frangible barrier (i.e.,

frangible pin 40) in the inlet tube that prevents fluid flow. (Id.) The chamber,

which is formed of transparent biocompatible plastic, has graduations (i.e., gauge

36) that allow the level of the fluid in the reservoir to be measured. (Id.) The

chamber includes a vent with a bacterial filter 44 that allows the venting of air

when fluid enters the chamber. (Id., ¶ [0042].) Further, the chamber is connected

to a sample port (i.e., bottle adaptor 48), which includes a cap 54, and can accept

tubes to extract fluid from the chamber for bacterial testing. (Id., ¶¶ [0040],

[0043].) As such, Spray teaches the components of the bacterial sampling

apparatus claimed in the ‘921 Patent. (See also, Ex. 1007, ¶¶ 46-47; 68.)

29

Also, Spray inherently describes, to one skilled in the art, flexible,

thermoplastic tubing. First, the inlet tube 20 had to be flexible for the clamp 42 to

function. (Ex. 1007, ¶¶ 71-72). Second, Spray indicates that the tube 20 is a

thermoplastic. Indeed, Spray mentions that the apparatus can be formed from

different polymeric materials. (Ex. 1019, ¶ [0055].) A thermoplastic may be one

type of polymeric compound suggested by Spray. Regardless, the use of

thermoplastics was ubiquitous in the blood sampling industry. (Ex. 1007, Claim

Chart for Claim 2, p. 58; ¶¶ 71-72.) It would thus be an oddity for Spray to use

any other material besides a thermoplastic tubing.

Claims of ‘921 Patent Disclosure of Spray 1. Apparatus for providing at least one sample of a liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising:

Spray describes an apparatus for providing a sample of liquid contained in a pouch and is designed to mitigate the danger of contaminating the liquid in the pouch. (Spray, Fig. 1, item 10; ¶[0038].)

an inlet tube having proximal and distal ends, and comprising a frangible barrier therein, between the proximal and distal ends, the proximal end connected to an inlet of a sterile sight chamber, the chamber comprising:

Spray describes an inlet tube 26 with proximal and distal ends which extend between the component bag to an inlet of a sterile sight chamber 34 (i.e., reservoir). (Spray, Figs. 1& 2, items 26, 38, & 34; ¶[0039].) A frangible barrier 40 (i.e., frangible pin) is positioned between the proximal and distal ends of the inlet tube. (Spray, Figs. 1 & 2, items 26 & 40; ¶[0039].)

a vent in the chamber wall fitted with a bacterial filter through which air can flow to and from the chamber; and an outlet;

Spray describes the sight chamber 34 as including an air vent 44 with a bacterial filter located in the upper wall thereof. The sight chamber 34 also includes an outlet 62. Air can flow to and from the chamber through the vent. (Spray, Fig. 1,

30

item 44; ¶¶ [0039]; [0041]; [0042].) the inlet tube comprising a tube clamp thereon, wherein the tube clamp is a sufficient distance from the distal end to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp; the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection; and

Spray describes a tube clamp 42 (i.e., pinch clamp), which can control flow of a liquid into the chamber 34, located on the inlet tube 26. The tube clamp 42 is a sufficient distance away from the distal end of the tube to allow for a sterile connection to the pouch. (Spray, Fig. 1, item 42; ¶ [0039].) The tube clamp regulates fluid blocking flow when closed and allowing fluid flow when open. (Id. ¶ [0039].)

a sample port comprising a hollow body with a distal end and a proximal end, wherein the distal end of the sample port is connected to the outlet of the chamber, and the proximal end is opposite the outlet.

Spray describes a hollow sample port 48 (i.e., bottle adaptor) connected to the outlet. The proximal end outlet of the bottle adaptor is opposite the distal end connected to the reservoir. (Spray, Figs. 1, 2, 5, 6, 7A, 7B, & 10-14, item 48; ¶¶ [0040], [0043]-[0047].)

2. Apparatus according to claim 1, wherein the inlet tube comprises a flexible thermoplastic inlet tube.

Spray does not textually disclose that the inlet tube system is flexible or made of thermoplastic. However, the reference inherently discloses the tube is made of thermoplastic and is flexible, as discussed below, at pages 34-35.

3. Apparatus according to claim 2, wherein: the sight chamber is tubular and transparent and has an upper end and a lower end;

Spray describes a sight chamber 34 as a cylindrical container having upper and lower ends formed from transparent biocompatible plastic. (Spray, Fig. 3, item 34; ¶¶[0039], [0041].)

the inlet is located at the upper end, and the outlet is located at the lower end;

The inlet is at the upper end of the chamber 34 and the outlet 62 (i.e., fluid outlet port) is at the lower end. (Spray, Fig. 2, items 38 & 62; ¶¶[0039], [0041].)

the sample port is joined to the outlet in a rigid manner so that the sight chamber can be supported substantially upright by a user holding

Spray describes a flow control valve 46 that would rigidly join the reservoir 34 to the bottle adaptor (Spray, Fig. 3, item 46; ¶¶[0039], [0041]) so that the sight

31

the sample port in one hand while inserting a phial into the open end of the sample port with the other hand.

chamber can be supported substantially upright by a user holding the sample port in one hand while inserting a vial into the open end of the sample port with the other hand.

4. Apparatus for providing at least one sample of a liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising:

See Claim 1.

an inlet tube having proximal and distal ends, and comprising

See Claim 1.

a frangible barrier therein, between the proximal and distal ends,

See Claim 1.

the proximal end connected to an inlet of a sterile sight chamber,

See Claim 1.

the chamber comprising: a vent in the chamber wall fitted with a bacterial filter through which air can flow to and from the chamber; and

See Claim 1.

an outlet; See Claim 1. the inlet tube comprising a tube clamp thereon,

See Claim 1.

wherein the tube clamp is a sufficient distance from the distal end to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp; and

See Claim 1.

the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection wherein:

See Claim 1.

the sight chamber is tubular and transparent and has an upper end and a lower end;

Spray describes a sight chamber 34 that is a tubular container having upper and lower ends formed from transparent biocompatible plastic. (Spray, Fig. 3, item 34; ¶¶[0039], [0041].)

32

the inlet is located at the upper end, and the outlet is located at the lower end;

An inlet is at the upper end of the sight chamber 34 and the outlet 62 is at the lower end. (Spray, Fig. 2, items 34 & 62; ¶¶[0039], [0041].)

the vent is located at the upper end; An air vent 44 with a bacterial filter is located on the upper end of the sight chamber 34. (Spray, Fig. 1, item 44; ¶¶ [0039]; [0041]; [0042].)

the sight chamber is marked with graduations to indicate the volume of liquid therein, the uppermost of the graduations being below the inlet and vent.

The sight chamber 34 has graduations 36 to measure the level of fluid therein, where the uppermost graduation is below the inlet and vent 44. (Spray, Figs. 2 & 18, item 36; ¶[0039].)

6. Apparatus according to claim 1, wherein the chamber is transparent and rigid.

Spray describes chamber 34 as being a cylindrical container formed from transparent biocompatible plastic which maintains its cylindrical shape. (Spray, Fig. 3, item 34; ¶¶ [0039], [0041].)

7. Apparatus according to claim 1, wherein the inlet tube is attached to a platelet pouch of an aphaeresis kit.

Spray describes an inlet tube connected to a pouch 12, which is described as possibly being a platelet pouch of an apheresis kit. (See Spray, Fig. 1, item 12; ¶ [0038].)


See Claim 1.

an inlet tube having proximal and distal ends, and comprising a frangible barrier therein,

See Claim 1.

the proximal end connected to an inlet of a sterile sight chamber that is transparent,

The sight chamber 34 of Spray is described as being formed from transparent biocompatible plastic. (Spray, Fig. 3, item 34; ¶¶ [0039], [0041].)


See Claim 1.

33


See Claim 1.

wherein the tube clamp is a sufficient distance from the distal end to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp;

See Claim 1.

the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection; and

See Claim 1.

a cup-like sample port having an open end and a tubular peripheral wall connected to the outlet of the chamber in a rigid manner, wherein the open end is opposite the outlet.

Spray describes a hollow sample port 48 (i.e., bottle adaptor) that has a cup-like shape. The sample port 48 is rigidly connected to the outlet of the chamber 34. (See Spray, ¶¶ [0040], [0041].) The open end of the sample port is opposite the outlet. (Id., Figs. 1, 2, 5, 6, 7A, 7B, & 10-14, item 48; ¶¶ [0040], [0043]-[0047].)


The inlet tube of the fluid sampler 32 is connected to a pouch 12 that could be a platelet pouch of an apheresis kit. (Spray, Fig. 1, item 12; ¶ [0038].)

10. Apparatus according to claim 1, wherein the sample port has a cup-like shape.

The hollow sample port 48 has a cup-like shape. (Spray, Figs. 1, 5, 6, 7A, 7B, & 10-14, item 48; ¶¶ [0040]-[0041], [0043]-[0047].)

11. Apparatus according to claim 1, wherein the sample port comprises a hollow needle within the body of the sample port, the needle being attached to the distal end of the sample port body.

A hollow needle 50 is within the body of the sample port 48 and may be attached to the distal end of the sample port 34. (Spray, Figs. 1, 2, 7A, 7B, 12, & 17-19, item 50; ¶¶ [0040], [0045]-[0046], [0049]-[0051], [0053]-[0054].)

12. Apparatus according to claim 11, wherein the needle is sheathed.

Spray describes a sheathed needle 50. (Spray, Fig. 7A, item 135; ¶ [0045].)

34

13. Apparatus according to claim 1, wherein the sample port comprises a cap for closing the proximal end of the sample port.

Spray describes a sample port 48 that has a lid for closing the proximal end thereof. (Spray, Figs. 1, 7B, 10-12, & 16, item 188; ¶ [0048].)

14. Apparatus according to claim 4, wherein the chamber is rigid.

Spray describes the reservoir 34 is made of a rigid transparent biocompatible plastic. (Spray, Fig. 3, item 34; ¶¶[0039], [0041].)


Spray describes the inlet tube of the fluid sampler 32 connected to a pouch 12, which can be a pouch of an apheresis kit. (See Spray, Fig. 1, item 12; ¶ [0038].)


Spray describes chamber 34 as rigid and made of a transparent biocompatible plastic. (Spray, Fig. 3, item 34; ¶¶[0039], [0041].)


Spray describes a hollow needle 50 being within the sample port 48 and attached to the distal end of the sample port. (Spray, Figs. 1, 2, 7A, 7B, 12, & 17-19, item 50; ¶¶ [0040], [0045]-[0046], [0049]-[0051], [0053]-[0054].)


Spray describes a sheathed needle 50. (Spray, Fig. 7A, item 135; ¶ [0045].)


Spray describes a sample port 48 that has a cap for closing the proximal end thereof. (Spray, Figs. 1, 7B, 10-12, and 16, item 188; ¶ [0048].)

2. Obviousness – Spray in View of Ishida (Claims 2, 3 and 5)

Spray and Ishida have been described in detail above. Claims 2, 3 and 5 are

invalid as obvious under 35 U.S.C. § 103 because it would have been obvious for

one of ordinary skill in the art to combine the familiar elements of the blood

sampling device of Spray with the flexible thermoplastic inlet tube and vent/hinged

cap of Ishida to perform the functions those elements are known to perform in

35

order to yield what would be expected from such an arrangement. KSR Int’l Co. v.

Teleflex, Inc., 550 U.S. 398, 415-17 (2007).

A strong motivation existed in the industry to create a platelet sampling

device to comply with standard 5.1.5.1 of the AABB, which required blood banks

to “have methods to limit and detect bacterial contamination in all platelet

components.” (Ex. 1007, ¶¶ 69,72-75; Ex. 1016, Standards for Blood Banks and

Transfusion Services, 22nd Ed., AABB, Section 5.1.5.1.) The blood sampling

device of Spray accomplishes this requirement. Flexible thermoplastics were

preferred for tubes used in such applications to allow for the use of clamps and for

sealing of the tube when the sampling device was removed from the collection kit.

(Ex. 1020, Col. 6:65-7:18.) The vent cap 55 allowed for sealing the duct to the air

vent 51. (Id., Col. 18:23-32.)

With respect to Claim 2, flexible thermoplastic tubing is a common

component in blood collection and intravenous (IV) disposable sets. Indeed, Ishida

provides an explicit reference to flexible thermoplastic tubing. (Ex. 1020, Col.

6:65-7:18.) The tubing in Spray, should it not be found to already be made of

flexible thermoplastic tubing, could simply be replaced with the well-known

substitute of flexible thermoplastic tubing from Ishida. The configuration of the

fittings shown in Spray would have to be configured differently if the material was

not a flexible thermoplastic, such as using barbed-type connections. (Ex. 1007,

36

¶¶ 68-72; Claim Chart for Claim 2, p. 58) Thus, Spray also motivates the use of

thermoplastic tubing.

Claim 5 further requires the vent to have a hinged cap and be movable

between an open and closed position. Ishida shows and describes a vent 51, which

can be sealed by a hinged vent cap 55. (Ex. 1020, Fig. 8, items 51 & 55; Col.

17:65-18:32.) Vents with and without hinged closure systems were common for

blood sets as the closure systems helped to preserve the sterility of the blood sets.

(Ex. 1007, ¶¶ 73-75.) To provide a cap on the vent 44 in Spray, a hinged cap could

be adhered or mechanically fixed to the vent 44. (Id., ¶ 74.) The molds used to

form the air vent 44 could also be changed to mold a vent top with a hinged cap.

(Id.) All of these modifications are well within the skill in the art and were done

prior to the ‘921 Patent. (Id.)

Vents with hinged caps were used in these devices when sterile venting was

needed to be controlled. (Id., ¶ 75.) One skilled in the art would look at all blood

collection sets, including Ishida, and combined with his/her knowledge, would

easily see that hinged caps were commonly used on blood collection sets to control

the flow of air and allow for the control of fluid flow into and out of a chamber.

(Id.)

37

B. Second Basis For Invalidity – Obviousness in View of the SSK Pamphlet and Ishida (Claims 1-19)

The SSK Pamphlet discloses a platelet transfer kit having a sampling

chamber that may be docked with a platelet pouch by a tube, having a pinch clamp.

Although the SSK Pamphlet was considered by the USPTO in reviewing the ‘921

Patent, it was not combined with any other references in rejecting the claims. (Ex.

1002, p. 19.)

The SSK Pamphlet describes each and every element of every claim of the

‘921 Patent, except for a frangible barrier. The missing frangible barrier is shown

in Ishida, a reference which describes a sealing member 93 with a breakable

portion 933. (Ex. 1020, Figs. 1 & 2, item 93; Col. 4:29-31; Col. 5:26-31; Col. 8:4-

35.) It would have been obvious for one of ordinary skill in the art to combine the

familiar elements of a platelet sampling device of the SSK Pamphlet with the

breakable seal of Ishida to perform the functions those elements are known to

perform in order to yield what would be expected from such an arrangement. See

KSR, 550 U.S. at 415-417.

Claims of ‘921 Patent Disclosure of the SSK Pamphlet in View of Ishida


The SSK Pamphlet describes a “Bacterial Detection Ancillar[y]” to be attached to a pouch to obtain at least one sample from the liquid in the pouch and mitigates the danger of contamination of the liquid in the pouch. (Ex. 1005.)

38


The SSK Pamphlet describes an inlet tube with proximal and distal ends. (Id.)


Ishida describes a frangible barrier 93 (i.e., sealing member) that has a breakable portion 933. The breakable portion 933 is described as “a thin and frail breakable portion” that is broken to open the duct of the sealing member 93. (Ishida, Col. 8:16-20.) The frangible barrier 93 is located between the proximal and distal ends of an inlet tube. (Id., Figs. 1 & 2, item 93; Col. 4:29-31; Col. 5:26-31; Col. 8:4-35.)

the proximal end connected to an inlet of a sterile sight chamber

The SSK Pamphlet describes an inlet tube connected to a sight chamber (i.e., sterile sampling chamber). (Ex. 1005.)

the chamber comprising: a vent in the chamber wall fitted with a bacterial filter through which air can flow to and from the chamber; and an outlet;

The SSK Pamphlet describes the chamber that has a vent, with a bacterial filter located in the chamber wall that allows air to flow to and from the chamber. The chamber also has an outlet. (Ex. 1005.)

the inlet tube comprising a tube clamp thereon, wherein the tube clamp is a sufficient distance from the distal end to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp; the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection; and

The SSK Pamphlet describes a tube clamp, used to regulate liquid flow, located on the inlet tube at a distance from the distal end to permit a sterile fluid connection to a main pouch. (Ex. 1005.)

a sample port comprising a hollow body with a distal end and a proximal end, wherein the distal end of the sample port is

The SSK Pamphlet describes a sample port that has a proximal and distal end which is connected to an outlet of the chamber and where the proximal end is opposite the outlet.

39

connected to the outlet of the chamber, and the proximal end is opposite the outlet.

(Ex. 1005.)


The SSK Pamphlet discloses that the tube is sealed at manufacture and has a heat seal location for sterilely docking the device to a main fluid pouch. The SSK Pamphlet also shows use of a pinch clamp. The SSK Pamphlet thus inherently discloses to a skilled artisan the use of a flexible thermoplastic inlet tube. (Ex. 1005; and discussed below at pages 43-44.)

3. Apparatus according to claim 2, wherein: the sight chamber is tubular and transparent and has an upper end and a lower end; the inlet is located at the upper end, and the outlet is located at the lower end;

The SSK Pamphlet describes a sight chamber that is tubular and transparent with upper and lower ends. The inlet tube enters the inlet of the sight chamber at an upper end. The outlet is located at the lower end of the sight chamber. (Ex. 1005.)

the sample port is joined to the outlet in a rigid manner so that the sight chamber can be supported substantially upright by a user holding the sample port in one hand while inserting a phial into the open end of the sample port with the other hand.

A sample port (i.e., sampling adapter) is joined to the outlet of the chamber. The connection is shown as one with a Luer needle. A Luer connection is rigid and allows the chamber to be supported substantially upright by holding the sample port in one hand while inserting a phial (i.e., vial) into the open end of the sample port with the other hand. (Ex. 1005.)


See Claim 1.


See Claim 1.


See Claim 1.

40


See Claim 1.


See Claim 1.


See Claim 1.


See Claim 1.


See Claim 1.

the sight chamber is tubular and transparent and has an upper end and a lower end; the inlet is located at the upper end, and the outlet is located at the lower end; the vent is located at the upper end; the sight chamber is marked with graduations to indicate the volume of liquid therein, the uppermost of the graduations being below the inlet and vent.

The SSK Pamphlet describes a sight chamber that is tubular and transparent. The chamber has upper and lower ends. The inlet is located at the upper end and the outlet is located at the lower end. A vent with a filter is located at the upper end of the sampling chamber which is marked with graduations, where the uppermost graduation is shown below the inlet and the vent. (Ex. 1005.)

5. Apparatus according to claim The SSK Pamphlet describes a vent with a cap

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1, wherein the vent has an opening to the environment, and a hinged cap is mounted adjacent the opening, the cap movable between a closed position in which the cap blocks the opening and an open position in which the opening and positions therebetween in which the opening is partially blocked.

that can be opened and closed. The vent cap is hinged and can be moved between the open and closed position (shown in the open position), where the opening is open in the open position and closed in the closed position and partially blocked if between the open and closed position. (Ex. 1005.)


The SSK Pamphlet describes a chamber that is a transparent syringe, which is rigid. (Ex. 1005.)


The SSK Pamphlet describes the SSK sampling kit as a “Bacterial Detection Ancillar[y]” to a “[p]latelet transfer kit” that allows the ability to “streamline procedures with few steps to collect and transfer samples” with “[m]inimal platelet waste,” which teaches the required connection to a platelet pouch of an apheresis kit. (Ex. 1005.)


See Claim 1.


See Claim 1.

a frangible barrier therein, See Claim 1. the proximal end connected to an inlet of a sterile sight chamber that is transparent,

The SSK Pamphlet shows the proximal end of the tubing is connected to an inlet of a transparent sight chamber. (Ex. 1005.)


See Claim 1.

42


See Claim 1.


See Claim 1.


See Claim 1.


The SSK Pamphlet describes a sampling port that has a cup-like shape and an open end. The walls are tubular, and the port for samples is connected to the Luer needle. A Luer needle connection is rigid. The sample port opens opposite to the outlet of the chamber. (Ex. 1005.)



10. Apparatus according to claim 1, wherein the sample port has a cup-like shape.

The SSK Pamphlet describes a sample port with a cup-like shape. (Ex. 1005.)

11. Apparatus according to claim 1, wherein the sample port comprises a hollow needle within the body of the sample port, the needle being attached

The SSK Pamphlet describes a Luer needle within the sample port; the Luer needle is attached to the distal end of the sample port. (Ex. 1005.)

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to the distal end of the sample port body. 12. Apparatus according to claim 11, wherein the needle is sheathed.

The SSK Pamphlet describes a needle sheathed within the sampling adaptor. (Ex. 1005.)


The SSK Pamphlet describes a cap to close the proximal end of the sample port. (Ex. 1005.)


The SSK Pamphlet describes a chamber that appears to be a syringe body, which is rigid. (Ex. 1005.)




The SSK Pamphlet shows a chamber that is transparent; the chamber body appears to be made from a syringe, which is rigid. (Ex. 1005.)


The SSK Pamphlet describes a hollow needle within the sample port; the Luer needle is attached to the end of the sample port. (Ex. 1005.)


The SSK Pamphlet shows a needle sheathed within the sample port. (Ex. 1005.)


The SSK Pamphlet shows a cap to close the proximal end of the sample port. (Ex. 1005.)

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As explained above, there was a strong motivation in the industry to create a

platelet sampling device to comply with standard 5.1.5.1 of the AABB. That

standard required blood banks to “have methods to limit and detect bacterial

contamination in all platelet components.” (Ex. 1016.) Both the SSK Pamphlet

and Ishida are used for blood collection, and one skilled in the art would look to all

blood collection devices and combine parts as needed to make the system work

properly and as desired. (Ex. 1007, ¶ 77.)

The SSK Pamphlet is an accessory piece (or add-on piece) designed to be

placed in an apheresis blood collection set by a manufacturer or tester. (Id.,¶ 79.)

If attached to an apheresis set before a sample is taken, the tube is open and could

allow for the early, and undesired, extraction of platelets from the platelet pouch.

(See Id., ¶¶ 79-82.) Further, a clamp on an inlet tube could not be pre-clamped

because that would likely deform the tubing of the apheresis set during transport or

storage of the apheresis set. (Id., ¶ 81.) It is therefore desirable to have a seal that

can be broken in blood collection sets, so a clinician can control when the test set is

opened or accessed.

The heat seal in the SSK Pamphlet suggests the desirability of a seal by

showing the heat-sealed end that must be bypassed to have the SSK Pamphlet set

function and test platelets. (Id., ¶ 82.) The heat seal is one type of barrier, and

Ishida, being in the same family of blood collection as the SSK Pamphlet, teaches

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a second type of seal, a “frangible barrier,” that could be pre-positioned and used

in the test set of the SSK Pamphlet in place of the heat seal for the same functional

purpose. (Id.)

With respect to claims 1, 4 and 8, the frangible barrier 93 (i.e., breakable

seal) described in Ishida could easily be added to the device of the SSK Pamphlet.

When that SSK device is included as part of a collection kit, the breakable seal 93,

as described in Ishida, allows a user to “select the time at which a collected initial

flow of blood starts to flow toward . . . sampling port 71 . . .” (Ex. 1020; Col.

13:66-14:5.) The sealing member 93 of Ishida could be bonded at some point in

the tube shown in the SSK Pamphlet. (Ex. 1007, ¶ 78.)

C. Third Basis For Invalidity – Mathias In View Of Moroski, Schmitt, And Ishida

1. Obviousness – Mathias in View of

Moroski (Claims 1-4, 6-12 and 14-18) The combination of Mathias and Moroski teaches all the elements of claims

1-4, 6-12 and 14-18. (Ex. 1007, ¶ 83.) Mathias describes each and every

limitation of Claims 1-4, 6-12 and 14-18 of the ‘921 Patent, except for dispensing

multiple, known sample volumes through a vented sight chamber. Moroski

teaches such a sight chamber. Where each and every element of these claims can

be found in the two references is described in the claim chart below:

Claims of ‘921 Patent Disclosure of Mathias in View of Moroski 1. Apparatus for providing at Mathias shows and describes an apparatus that

46

least one sample of a liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising:

provides at least one sample of a liquid contained in a pouch, while mitigating the danger of contamination of that liquid. (Mathias, Figs. 2A & 3, item 18.)


Mathias describes an inlet tube with proximal and distal ends. A frangible barrier 64 (i.e., openable barrier) is located between the proximal and distal ends of the inlet tube. (Mathias, Col. 6:16-29.)


Mathias describes a frangible barrier. (Mathias, Fig. 3, items 62 & 64; Col. 6:16-29.)

the proximal end connected to an inlet of a sterile sight chamber

Mathias describes the proximal end of the inlet tube connected to the inlet of a sterile sight chamber 42 (i.e., sterile sampling container). (Mathias, Fig. 3, items 42 & 43; Col. 5:63 – 6:16.)


Moroski describes a sight chamber 126 (i.e., in-line burette) that has a vent in the upper wall that is fitted with a filter that allows air to flow into and from the chamber. (Moroski, Fig. 2, items 126, 132, 132b. Col. 3:57-4:56.) As Moroski teaches a system that must keep the fluid sterile, the filter would have to be a bacterial filter, as discussed below in the motivation to combine section after this claim chart. The chamber has an outlet. (Moroski, Fig. 2, item 131; Col. 4:49-56.)

an outlet; Moroski describes the chamber as having an outlet. (Moroski, Fig. 2, item 131; Col. 4:49-56.)

the inlet tube comprising a tube clamp thereon, wherein the tube clamp is a sufficient distance from the distal end to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp;

Mathias describes a tube clamp that is located on the inlet tube at a distance from the distal end of the tube and permits a sterile fluid connection at a point distal to the tube clamp. The tube clamp regulates flow by allowing flow and blocking flow through the inlet tube to the chamber. (Mathias, Fig. 3, item 65; Col. 6:26-29.)

47

the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection; and a sample port comprising a hollow body with a distal end and a proximal end, wherein the distal end of the sample port is connected to the outlet of the chamber, and the proximal end is opposite the outlet.

Mathias describes a sample port 68 (i.e., holder) that is hollow to accept sampling vials. The distal end of the sample port is connected to the outlet of the chamber 42. The proximal end is opposite the outlet. (Mathias, Fig. 3, item 68; Col. 6:30-51.)


Mathias describes tubes made from medical grade material such as polyvinyl chloride with a plasticizer, which is a thermoplastic, as discussed below in the motivation to combine section after this claim chart. (Mathias, Col. 5:63-6:1.)

3. Apparatus according to claim 2, wherein: the sight chamber is tubular and transparent and has an upper end and a lower end; the inlet is located at the upper end, and the outlet is located at the lower end;

Moroski describes a sight chamber 126 that is tubular and is transparent to allow for the measurement of fluid. The chamber has an upper end 130 (i.e., upper wall) with an inlet and a lower end 131 (i.e., bottom wall) with an outlet. (Moroski, Fig. 2, item 126; Col. 4:36-56.)

the sample port is joined to the outlet in a rigid manner so that the sight chamber can be supported substantially upright by a user holding the sample port in one hand while inserting a phial into the open end of the sample port with the other hand.

Mathias describes a sample port 68 (i.e., holder) joined to the sight chamber. (Mathias, Fig. 3 items 50 & 69; Col. 7:14-35.) The sample port is joined to the outlet in a rigid manner by bonding, so the chamber can be supported substantially upright by a user holding the sample port in one hand while inserting a vial into the open end of the sample port with the other hand. (Id.)

4. Apparatus for providing at least one sample of a liquid contained in a pouch while

See Claim 1.

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mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising: an inlet tube having proximal and distal ends, and comprising

See Claim 1.


See Claim 1.


See Claim 1.


See Claim 1.


See Claim 1.


See Claim 1.


See Claim 1.

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the sight chamber is tubular and transparent and has an upper end and a lower end; the inlet is located at the upper end, and the outlet is located at the lower end; the vent is located at the upper end; the sight chamber is marked with graduations to indicate the volume of liquid therein, the uppermost of the graduations being below the inlet and vent.

Moroski describes a sight chamber 126 that has an inlet, an outlet, and a vent. The inlet and vent are located at the upper end and the outlet is located at the lower end. The sight chamber is marked with graduations 129 (i.e., metering indicia) and is transparent to allow for the measurement of the fluid inside the chamber. The uppermost graduation is below the inlet and the vent. (Moroski, Fig. 2, items 126, 129, 132, & 132b; Col. 3:57-4:56.)


Moroski describes a chamber 126 that is cylindrical and is transparent to allow for the measurement of fluid within the chamber 126. To be functional, a burette is rigid, as discussed below in the motivation to combine section after this claim chart. (Moroski, Fig. 2, item 126; Col. 4:36-42.)


Mathias shows and describes a bag for collecting a blood component, such as platelets. (Mathias, Fig. 1, item 24; Col. 1:5-16; Col. 4:58-65.) The inlet tube to the sampling device 18 could be attached to a platelet pouch in a similar manner as sampling whole blood, as discussed below in the motivation to combine section after this claim chart.


See Claim 1.

an inlet tube having proximal and distal ends, and comprising a frangible barrier therein,

See Claim 1.

the proximal end connected to an See Claim 1.

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inlet of a sterile sight chamber that is transparent, the chamber comprising: a vent in the chamber wall fitted with a bacterial filter through which air can flow to and from the chamber; and

See Claim 1.


See Claim 1.


See Claim 1.


See Claim 1.


Mathias describes a sample port 68 with a cup-like shape having a tubular peripheral wall connected to the outlet 50 of a chamber in a rigid manner 69. The open end is opposite the outlet of the chamber. (Mathias, Fig. 3, items 50, 68 & 69; Col. 6:30-51.)


Mathias shows and describes a bag for collecting a blood component, such as platelets. (Mathias, Fig. 1, item 24; Col. 1:5-16; Col. 4:58-65.) The inlet tube to the sampling device 18 could be attached to a platelet pouch in a similar manner as sampling whole blood, discussed below in the motivation to combine section after this claim chart.

10. Apparatus according to Mathias describes a sample port 68 with a cup-

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claim 1, wherein the sample port has a cup-like shape.

like shape. (Mathias, Fig. 3, items 50, 68 and 69; Col. 6:30-51.)


Mathias describes a needle 74 (i.e., piercing member), such as a needle that is connected to the sample port body at the distal end. (Mathias, Fig. 3, items 74 & 76; Col. 6:52-65.)


Mathias describes a protective sheath 80 for a needle. (Mathias, Figs. 3 & 4, items 74 & 80; Col. 6:52-65.)


Moroski describes a chamber 126 (i.e., in-line burette). To be functional, a burette is rigid, as discussed below in the motivation to combine section after this claim chart. (Moroski, Fig. 2, item 126; Col. 4:36-42.)


Mathias describes a bag for collecting a blood component, such as platelets. (Mathias, Fig. 1, item 24; Col. 1:5-16; Col. 4:58-65.) The inlet tube to the sampling device could be attached to a platelet pouch in a similar manner as sampling whole blood, as discussed below in the motivation to combine section after this claim chart.


Moroski describes a chamber 126 (i.e., in-line burette) that is transparent to allow for the measurement of fluid within the chamber 126. (Moroski, Fig. 2, item 126; Col. 4:36-42.) To be functional, a burette is rigid, as discussed below in the motivation to combine section after this claim chart.


Mathias shows and describes a needle 74, which is connected to the sample port body 68 at the distal end. (Mathias, Fig. 3, items 74 and 76; Col. 6:52-65.) To draw a sample from the vial, the needle would have to be hollow, as discussed below in the motivation to combine section after this claim chart.

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Mathias describes a protective sheath 80 for a needle. (Mathias, Figs. 3 & 4, items 74 & 80; Col. 6:52-65.)

Claims 1-4, 6-12 and 14-18 require the claimed inlet tube to connect to or

include a sight chamber. Mathias shows and describes a container 42. (Ex. 1021,

Fig. 3, items 42 & 43; Col. 5:63-6:16.) However, the container 42 has a set

volume. Moroski teaches use of an in-line burette 126 that allows a technician to

measure an amount of fluid. (Ex. 1022, Fig. 2, item 126; Col. 3:57-4:56.) In

order to measure an amount of fluid, the burette has to be transparent and rigid.

(See Ex. 1007, Claim Chart for Claim 6 p. 84; ¶ 89.) To provide a more accurate

and flexible measurement, one skilled in the art would exchange the container 42,

described in Mathias, for the in-line burette described in Moroski. (Id., ¶ 88.)

The attachment of the in-line burette, of Moroski, would be similar to the

attachment of the Mathias container 42. The inlet side of the in-line burette, of

Moroski, could be bonded to the tube 62, of Mathias, with the openable barrier 64

placed within the tube 62. (Id., ¶ 85.) The outlet of the in-line burette of Moroski

includes a connector 136 that can mate, bond or be ultrasonically welded with the

distal end port 69 of the holder 68 of Mathias to form an integrated rigid system.

(Id.) Thus, a rigid connection could be formed between the outlet of the in-line

burette of Moroski and the holder of Mathias. (Id.)

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As explained previously, there existed a strong market force to create an

apparatus to test bacterial contamination of platelets after the AABB issued rule

5.1.5.1. One skilled in the art would necessarily look to Mathias to design a sterile

platelet extraction device because it involves the collection and testing of blood.

(Ex. 1007, ¶ 86.) Mathias discusses the ability to obtain a sample while preventing

contamination of the collected blood. (Id.) While Mathias teaches one skilled in

the art to provide a pre-determined volume-sized container 42, whole blood

samples typically did not need to be metered as they were not as valuable as

platelets. (Id.)

The amount of platelets needed for testing or that may be required in future,

improved testing methods was still to be determined in 2002/2003. (Ex. 1007,

¶ 87.) Indeed, AABB Rule 5.1.5.1 made no mention of what volume of platelets

needed to be tested. A technician or blood collection organization would want to

use a minimal amount of platelets for testing, but also wanted to be sure their

equipment would meet the to-be-determined standards. (Id.) Thus, to

accommodate new procedures, a container with a fixed volume would be a

hindrance. Rather, for accurate and flexible collection of test samples, one skilled

in the art would have been motivated to find a system that could measure different

amounts of platelets accurately. (Id., ¶¶ 87-88.)

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If one skilled in the art desires a more accurate means of measuring a

dispensed volume, then they would seek solutions known to provide that result.

(Ex. 1007, ¶ 88.) Moroski is an example of such a known solution that also

happens to measure a valuable liquid (i.e., a non-ionic contrast media) with a

device designed for the same purposes of preventing contamination and

maintaining sterility of the valuable liquid. (Ex. 1022, Col. 1:16-37; Col. 1:45-56;

Col. 2:39-50.) Thus, one skilled in the art would be motivated to choose the in-line

burette of Moroski to measure platelets (another valuable fluid) with accuracy and

flexibility. (Ex. 1007, ¶¶ 87-88.) Burettes, like the in-line burette shown and

described in Moroski, include vents with filters, are transparent, have graduations

for measuring the fluid within the burette, are cylindrical, and are rigid. (Id., ¶ 88.)

2. Mathias, Moroski, and Schmitt (Claims 13 and 19)

Schmitt describes the cap that is set forth in claims 13 and 19 of the ‘921

Patent. Schmitt shows and describes a tube rear end cap 56 that covers the end of

the tube 4 of a blood sample device. As seen in the claim chart below, Schmitt

shows and describes the further limitations of claims 13 and 19.

Claims of ‘921 Patent Mathias in View of Moroski and Schmitt 13. Apparatus according to claim 1, wherein the sample port comprises a cap for closing the proximal end of the sample port.

Schmitt describes a cap 56 (i.e., tube rear end cap) that can close the proximal end of a sampling port of a blood sampling device. (Schmitt, Fig. 3, item 56; Col. 4:65-5:17.)

19. Apparatus according to claim 18, wherein the sample port comprises a cap for closing

As discussed above, Schmitt shows and describes a cap 56 that can close the proximal end of a sampling port of a blood sampling

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the proximal end of the sample port.

device. (Schmitt, Fig. 3, item 56; Col. 4:65- 5:17.)

Claims 13 and 19 require the claimed sample port to include a closing cap

56. Mathias shows and describes a holder 68 for accepting sample vials. (Ex.

1029, Col. 6:45-7:35.) Mathias describes that the piercing end 74 may be enclosed

with a protective sheath 80. (Id.) However, the protective sheath may still be

pierced by the piercing member end 76. (Id.) Thus, the protective sheath 80

provides some protection to maintain sterility, but not protection of a phlebotomist.

Schmitt teaches a cap 56 for a blood collection device for added protection of the

phlebotomist. (Ex. 1023, Col. 3:35-42.) To combine Moroski with Mathias, the

cap 56 could be adhered or mechanically fixed to the holder 68. (Ex. 1007, ¶ 91.)

One skilled in the art could change how the holder 68, of Mathias, is formed. (Id.)

For example, the molds used to form the holder 68 could be changed to mold the

hinged cap 56 of Schmitt onto the end of the holder 68.

There is an on-going effort to protect medical personnel from accidental

wounding by contaminated needles, as described in Schmitt. (Ex. 1023, Col. 1:29-

52.) While the sheath 80 and holder 68 described in Mathias provide some

protection, medical professionals could still pierce themselves through the sheath.

As such, there is a strong motivation to place a rigid end cap, such as the cap 56 in

Schmitt, over the holder 68 in Mathias to further prevent accidental needle wounds

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to the medical professional collecting or processing the collected fluid, e.g.,

platelets. (Ex. 1007, ¶ 91.)

3. Mathias, Moroski and Ishida (Claim 5)

Claim 5 requires a hinged cap placed on the vent. Ishida describes a hinged

cap placed on the vent, as required by Claim 5. The cap in Ishida is movable to an

open and closed position, where the opening is closed when the cap is in the closed

position, and the opening is open in the open position. The opening is partially

open or partially blocked if the cap is moved in an intermediate position between

the open and closed position. (Ex. 1007, ¶ 92.)

Claim 5 is also invalid as obvious as the below chart shows:

Claims of ‘921 Patent Mathias in View of Moroski and Ishida 5. Apparatus according to claim 1, wherein the vent has an opening to the environment, and a hinged cap is mounted adjacent the opening, the cap movable between a closed position in which the cap blocks the opening and an open position in which the opening and positions therebetween in which the opening is partially blocked.

Ishida describes a vent 51 that has an opening to the environment, which can be sealed by a hinged cap 55 that is movable from a closed position and an open position. The cap 55 can block the opening. When the cap 55 is between the open and closed positions, the opening is partially blocked. (Ishida, Fig. 8, items 51 & 55; Col. 17:65-18:32.)

Vents with and without hinged closure systems were common for blood sets.

(Ex. 1007, ¶¶ 92-93.) To provide the Ishida cap on the vent-to-air member 132 in

Moroski, a hinged cap could be adhered or mechanically fixed to the filter element

132b. (Id., ¶ 92.) The molds used to form the filter element 132b could be

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changed to injection mold a vent top with a hinged cap, in which such injection

molding was done prior to the ‘921 Patent. (Id.) Vents with hinged caps were

used in these devices when venting needed to be controlled. (Id., ¶ 93.) Indeed,

Moroski includes a slide clamp 134 to control the air flow through the vent-to-air

member 132. (Ex. 1022, Col. 6:10-18.) The hinged cap of Ishida would be a

replacement for the slide clamp 134. (Ex. 1007, ¶ 93.)

One skilled in the art would look at all blood collection sets, including Ishida,

and combined with his/her knowledge, would easily see that hinged caps were

commonly used on blood collection sets as expected to control air flow and fluid

flow into and out of the container, i.e., the burette cylinder. (Id.) The cap provided

more control to the user. Hinged caps also added control of fluid flow and allowed

the vent to be closed for protection without the addition of another component and

cost, since the housing and cap could be molded as a single part. (Id.)

X. CONCLUSION

TBCT has demonstrated that it is reasonably likely to prevail regarding the

invalidity of at least one of claims 1-19 of the ‘921 Patent, as required by 35 U.S.C.

§ 314(a). Therefore, TBCT respectfully requests that this Petition to institute an

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Inter Partes review be granted and claims 1-19 of the ‘921 Patent be found

unpatentable.

Respectfully submitted, SHERIDAN ROSS P.C. Date: December 5, 2014. By: /ROBERT R. BRUNELLI/ Robert R. Brunelli (Reg. No. 39,617) Tadd F. Wilson (Reg. No. 54,544) 1560 Broadway, Suite 1200 Denver, Colorado 80202 Telephone: 303-863-9700 ATTORNEYS FOR PETITIONER TERUMO BCT, INC.

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CERTIFICATE OF SERVICE The undersigned hereby certifies that on December 5, 2014, I caused a true

and correct copy of the below listed materials:

Petition for Inter Partes Review of U.S. Patent No. 8,777,921

Exhibits Marked TBCT Ex. 1001 - TBCT Ex. 1031.

Terumo BCT, Inc. Power of Attorney

to be served via Express Mail on the following attorney of record listed on PAIR:

Weaver Austin Villeneuve & Sampson LLP P.O. Box 70250 Oakland, CA 94612-0250 The undersigned further certifies that on December 5, 2014, I caused a true

and correct courtesy copy of the above listed materials to be served via Express

Mail upon:

Mr. Marc N. Bernstein The Business Litigation Group, P.C. 555 Montgomery Street, Suite 1650 San Francisco, CA 94111 By: /ROBERT R. BRUNELLI/ Robert R. Brunelli (Reg. No. 39,617) Tadd F. Wilson (Reg. No. 54,544) 1560 Broadway, Suite 1200 Denver, Colorado 80202 Telephone: 303-863-9700 ATTORNEYS FOR PETITIONER TERUMO BCT, INC.

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