UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
`
`EXCELSIOR MEDICAL CORPORATION,
`
`Petitioner,
`
`V.
`
`BECTON, DICKINSON AND COMPANY,
`
`Patent Owner
`
`Patent No. 8,740,864
`Issued: June 3, 2014
`Title: PATIENT FLUID LINE ACCESS VAL VE ANTIMICROBIAL
`CAP/CLEANER
`
`Trial No.: Unassigned
`
`PETITION FOR INTER PARTES REVIEW
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R § 42.100 ET SEQ.
`
`Mail Stop PA TENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`2099993.1
`
`BAXTER EXHIBIT 1005
`Page 1 of 194
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`

`

`TABLE OF CONTENTS
`
`EXHIBIT LIST . . . .. . .. .. . . . . . . . . .. . . . . . . . . . .. .. . . .. . . .. .... .. .. . . .. . .. . . .. .
`
`Page iii
`
`Page I
`INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . .. . . . . . .. . . . . . . . . . . . . . . . . . .
`I.
`II. MANDATORY NOTICES.......................................
`Page I
`Page I
`A.
`Real Party-In-Interest . . . . . . . . . .. .. . . . . . . . . . . . .. . . . . . . . .. ...
`Page 1
`B.
`Related Matters . .. . . .. .. .. .. .. . .. . .. . .. . .. .. . . . . . . . .. .. . . . ..
`Page 2
`C.
`Lead and Back-Up Counsel...............................
`Page 2
`D.
`Power of Attorney . . . . . . . . . . .. .. . .. . .. .. .. .. .. .. .. . . . . ... .. .
`Page 2
`E.
`Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`PETITION FEE . . . . . . . . . . . . .. . . . . . . . . . . .. .. .. . .. . . . .. .. .. . . . . . . .. ..
`III.
`Page 2
`IV. GROUNDS FOR STANDING..................................
`Page 3
`Page 3
`V.
`RELIEF REQUESTED............................................
`Page 3
`A.
`Statement of Precise Relief Requested . .. .. .. . .. .. . . . . . .
`Page 3
`B.
`Full Statement of Reasons for the Relief Requested....
`VI. CLAIMS CHALLENGE AND SPECIFIC GROUNDS AND ART ... Page 3
`A.
`Claim IO (pending claim 79)................................. Page 4
`B.
`Claim 11 (pending claim 80)..............................
`Page 4
`C.
`Claim 12 (pending claim 81 ) ................................. Page 4
`D.
`Claim 13 (pending claim 82) ................................. Page 4
`E.
`Claim 14 (pending claim 83) ................................. Page 4
`F.
`Claim 10 (pending claim 79) ................................. Page 4
`G.
`Claim 11 (pending claim 80)..............................
`Page 4
`H.
`Claim 12 (pending claim 81)....... . . . . . . . . . . . . . . . . . . . . . . . . . . Page 4
`I.
`Claim 13 (pending claim 82)................................. Page 4
`Claim 14 (pending claim 83) ................................. Page 4
`J.
`VII. THE '864 PATENT.................................................. Page 5
`. A.
`Overview of the '864 Patent . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . Page 5
`B.
`The Prior Art .. .. . . .. .. .. . . .. .. . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . .. Page 9
`1. White..................................................
`Page 9
`2.
`Gcnatcmpo ............................................... Page 10
`3.
`Harding.................................................. Page 12
`4.
`Paradis.................................................. Page 13
`5.
`Busch..................................................
`Page 13
`6. Mcnyhay .................................................. Page 14
`Summary of the Prosecution of the '864 Patent.......... Page 15
`C.
`VIII. DETAILED EXPLANATION OF GROUNDS FOR INV ALIDITY .. Pagc 18
`A.
`Claim Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 18
`
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`Ordinary Skill in Art. .................................... .
`B.
`The Obviousness Framework .......................... .
`C.
`Claim 10 ......................................................... ..
`D.
`Claim 11 .......................................................... .
`E.
`Claiml2 .......................................................... .
`F.
`Claim 13 .......................................................... .
`G.
`Claim 14 .......................................................... .
`H.
`Claim Chart ...................................................... .
`I.
`Clai1n 10 .......................................................... .
`J.
`Claim I I .......................................................... .
`K.
`Claim 12 ......................................................... ..
`L.
`Claim 13 .......................................................... .
`M.
`Claim 14 .......................................................... .
`N.
`0.
`Claim Chart ...................................................... .
`IX. CONCLUSION ...................................................... .
`
`Page 18
`Page 19
`Page 20
`Page 24
`Page 25
`Page 26
`Page 27
`Page 27
`Page 33
`Page 37
`Page 37
`Page 38
`Page 38
`Page 39
`Page 44
`
`11
`
`BAXTER EXHIBIT 1005
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`List of Exhibits
`Petitioner
`Exhibit
`Exhibit No.
`
`Ex. 1001
`Ex. 1002
`
`Ex. 1003
`
`Ex. 1004
`Ex. 1005
`Ex. 1006
`Ex. 1007
`Ex. 1008
`Ex. 1009
`Ex. 1010
`Ex. 1011
`Ex. 1012
`Ex. 1013
`Ex. 1014
`Ex. 1015
`Ex. 1016
`Ex. 1017
`Ex. 1018
`Ex. 1019
`Ex. 1020
`Ex. 1021
`Ex. 1022
`Ex. 1023
`Ex. 1024
`Ex. 1025
`Ex. 1026
`Ex. 1027
`Ex. 1028
`Ex. 1029
`Ex. I 030
`
`Issue Notification for U.S. Patent No. 8,740,864
`U.S. Patent Publication 2007/0112333 to Hoang for "Patient
`Fluid Line Access Valve Antimicrobial Cap/Cleaner"
`U.S. Divisional Patent No. 8,491,546 to Hoang for "Patient
`Fluid Linc Access Valve Antimicrobial Cap/Cleaner
`Requirement for Restriction/Election mailed July 29, 2009
`Restriction Response filed August 24, 2009
`Non-Final (First) office action mailed November 25, 2009
`"Amendment A" filed February 19, 2010
`Final (Second) office action mailed June 11, 20 I 0
`"Amendment B" filed November 12, 2010
`Non-final (Third) office action mailed April 10, 2012
`Applicant Initiated Interview Summary May 30, 2012
`"Amendment C" filed June 28, 2012
`Final (Fourth) office action mailed September 25, 20 I 2
`Applicant Initiated Interview Summary January 23, 2013
`"Amendment D" filed January 24, 2013
`... -
`Applicant Initiated Interview Summary August 15, 2013
`Non-final (Fifth) office action mailed AU!:,'1.!St 15, 2013
`"Amendment E" filed November 14, 2013
`Examiner Initiated Interview Summary January 21, 2014
`Applicant Initiated Interview Summary April 7, 2014
`WHITE, U.S. Patent No. 5,242,425
`HARDING 2003, U.S. Patent Publication No. 2003/009853
`HARDING 2008, U.S. Patent Publication No. 2008/0027399
`GENA TEMPO, U.S. Patent No. 4,440,207
`PARADIS, U.S. Patent No. 6,117,114
`BUSCH, U.S. Patent Publication No. 2004/0004019
`LAKE, U.S. Patent Publication No. 2004/0258560
`PELUSO, U.S. Patent No. 4,624,664
`MENYHA Y, U.S. Patent No. 5,554,135
`LYNN, U.S. Patent Publication No. 2002/0193752
`
`· · " - - · - - - -
`
`111
`
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`Ex. 1031
`Ex. 1032
`Ex. 1033
`Ex. 1034
`Ex. 1035
`Ex. 1036
`Ex. 1037
`
`35 U.S.C. 103(a) as effective prior to March 16, 2013
`KSR Int'! v. Teleflex Inc., 550 U.S. 398 (2007)
`Philips v. A WH Corp., 415 F.3d 1303 (Fed. Cir. 2005)
`Graham v. John Deere, 381 U.S. 1 (1966)
`In re Bigio, 381 F.3d 1320 (Fed. Cir. 2004)
`Okajima v. Bourdeau, 261 f.3d 1350 (Fed. Cir. 2001)
`Declaration of Terry Layton, Ph.D.
`
`IV
`
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`

`

`I.
`
`INTRODUCTION
`
`Petitioner seeks inter partes review of claims 10 to 14 of U.S. Patent No.
`
`8,740,864 (the "'864 patent"), which issued on June 3, 2014, to Becton, Dickinson
`
`and Company ("Patent Owner"). Petitioner relies on new prior art -- U.S.
`
`Publication No. 2003/0109853 to Harding, et al. (Ex. l 022) -- that was not before
`
`the examiner during the prosecution of the '864 patent.
`
`In addition, Petitioner
`
`shows that the examiner did not fully appreciate the disclosures of the primary
`
`references during prosecution, including U.S. Patent No. 5,242,425 to White (Ex.
`
`1021 ), and U.S. Patent No. 4,440,207 to Genatempo (Ex. 1024).
`
`II. MANDA TORY NOTICES
`
`A.
`
`Real Party-In-Interest
`
`Petitioner Excelsior Medical Corporation is the real party-in-interest.
`
`B.
`
`Related Matters
`
`Petitioner is filing, concurrent with this petition, a declaratory judgment
`
`action m the District of New Jersey against Patent Owner and its exclusive
`
`licensee, Ivera Medical Corporation, entitled Excelsior Medical Corporation v.
`
`Becton. Dickinson and Company, et al.
`
`There are no other judicial or
`
`administrative matters that would affect, or be affected by, a decision in this
`
`proceeding.
`
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`C.
`
`Lead and Back-Up Counsel
`
`Petitioner is represented by Michael L. Kenaga (Reg. No. 34,639) as lead
`
`counsel, and Scan S. Swidler (Reg. No. 49,033) as back-up counsel. The addresses
`
`for both are:
`
`IpHorgan Ltd.
`195 Arlington Heights Road
`Suite 125
`Buffalo Grove, II 60089-1768
`(PH) 847-808-5500
`patentmail@iphorgan.net
`
`D.
`
`Power of Attorney
`
`Petitioner submits herewith a power of attorney in favor of the lead and
`
`back-up counsel identified above.
`
`E.
`
`Service Information
`
`The service information for Petitioner required under §42.8(b )( 4 )(i-v) is set
`
`out above under the designation of lead and back-up counsel. Electronic service is
`
`approved and preferred.
`
`III. PETITION FEE
`
`The undersigned authorizes the Office to charge $23,000.00 to Deposit
`
`Account No. 50-3993 in payment of the fee required under §42. l 5(a)(l) for filing a
`
`request for inter partes review, and under §42. l 5(a)(2) for inter partes review
`
`post-institution. Petitioner submits that the fees required by §42. l 5(a)(3) and
`
`2
`
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`§42. l 5(a)( 4) are not applicable because this Petition seeks review of only five
`
`claims.
`
`IV. GROUNDS FOR STANDING
`
`As required under §42.104(a), Petitioner certifies that the '864 patent is
`
`available for inter partes review and that Petitioner is not barred or estopped from
`
`requesting such review on the grounds identified in this Petition.
`
`V.
`
`RELIEF REQUESTED
`
`A.
`
`Statement of Precise Relief Requested
`
`As required by §42.22(a)(l) and §42.104(b), Petitioner asks the Board to
`
`initiate inter partes review on challenged claims 10 to 14 of the '864 patent on all
`
`grounds of unpatentability asserted against each claim, and to cancel claims IO to
`
`14.
`
`B.
`
`Full Statement of Reasons for the Relief Requested
`
`Petitioner provides a full statement of the reasons for the relief requested,
`
`including a detailed explanation of the significance of the material facts and
`
`governing law, below.
`
`VI. CLAIMS CHALLENGED ON THE
`BASIS OF SPECIFIC PRIOR ART
`
`As required by §42.22(a)( I -2) and §42.104(b )( 1-2), Petitioner challenges the
`
`claims in issue as obvious under 35 U.S.C. 103(a) (pre-AIA) on the basis of the
`
`following prior art combinations:
`
`3
`
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`A.
`
`Claim IO -- White (Ex. 1021) in view of Harding (Ex. 1022) and
`
`Genatempo (Ex. 1024).
`
`B.
`
`Claim 11
`
`-- White (Ex. I 021) in view of Harding (Ex. I 022),
`
`Genatempo (Ex. 1024), and Paradis (Ex. 1025).
`
`C.
`
`Claim 12 -- White (Ex. I 021) in view of Harding (Ex. 1022) and
`
`Genatempo (Ex. 1024).
`
`D.
`
`Claim 13 -- White (Ex. 1021) in view of Harding (Ex. 1022),
`
`Gena tempo (Ex. 1024 ), and Busch (Ex. I 026).
`
`E.
`
`Claim 14 -- White (Ex. I 021) in view of Harding (Ex. 1022),
`
`Genatempo (Ex. 1024 ), and Busch (Ex. 1026).
`
`F.
`
`G.
`
`Claim 10 -- Menyhay (Ex. I 029) in view of Genatempo (Ex. I 024).
`
`Claim 11 -- Menyhay (Ex. I 029) in view of Genatempo (Ex. I 024),
`
`and Paradis (Ex. I 025).
`
`H.
`
`Claim 12 -- Menyhay (Ex. I 029) in view of Genatempo (Ex. I 024).
`
`I.
`
`Claim 13 -- Menyhay (Ex. 1029) in view of Genatempo (Ex. 1024),
`
`and Busch (Ex. 1026).
`
`J.
`
`Claim 14 -- Menyhay (Ex. 1029) in view ofGenatempo (Ex. 1024).
`
`4
`
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`VII. THE '864 PATENT
`
`A. Overview of the '864 Patent
`
`The '864 patent issued on June 3, 2014, from an application, serial no.
`
`11/281, 711, filed on November 17, 2005.
`
`The '864 patent is directed to an antimicrobial cap for a patient fluid line
`
`( catheter) access valve that is left in a patient's body during an extended treatment
`
`regimen. The access valve contains a septum into which a male luer (or needle) is
`
`inserted to administer medicine or other liquids to a patient through a catheter. The
`
`disinfecting cap is placed over the access valve when the patient is not being
`
`treated to prevent bacterial contamination of the access valve that could cause
`
`infections and other maladies. (Sec Abstract, and the sixth paragraph of the
`
`Detailed Description).
`
`Claims IO to 14 provide:
`
`10. A device for maintaining a patient fluid line access valve having an access
`
`portion with an end face that includes a septum and external threads on the access
`
`portion proximate the septum, the device comprising:
`
`a housing for covering the access po1iion of the patient fluid line access
`
`valve, the housing having an open end, a closed end, and a cavity, the housing
`
`5
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`including a thread on an inner wall of the cavity for engaging the external threads
`
`on the access portion of the patient fluid line access valve;
`
`a wet pad impregnated with a cleaning solution prior to attachment of the
`
`housing to the access portion of the patient fluid line access valve, the wet pad
`
`being positioned within the cavity for contacting the end face to disinfect the end
`
`face and at least a portion of the external threads of the access portion of the
`
`patient fluid line access valve when the housing is positioned over and covers the
`
`access portion; and
`
`a lid over the open end of the housing to seal the cavity with the wet pad
`
`within the cavity and provide a moisture barrier, the lid being removable to expose
`
`the wet pad and allow insertion of the access portion of the patient fluid line access
`
`valve into the cavity so that the end face of the access portion contacts the wet pad.
`
`11.
`
`The device of claim 10, wherein the inner cavity comprises an inner
`
`circumference and the thread comprises a length that is less than the inner
`
`circumference.
`
`12.
`
`The device of claim 10, wherein the cleaning solution comprises an
`
`antimicrobial agent.
`
`13.
`
`The device of claim 12, wherein the antimicrobial agent comprises at least
`
`one of chlorhexidine gluconate and chlorhexidine diacetate.
`
`6
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`14. The device of claim 12, wherein the cleaning solution is an alcohol-based
`
`cleaning solution.
`
`Hence, the preamble of claim IO calls for a protective cap for an "access
`
`portion" of an access valve with "an end face that includes a septum and external
`
`threads ... proximate the septum." The access portion, septum, and threads of the
`
`access valve of claim 10 are illustrated below in the partial reproduction of Figure
`
`I (and described in the associated text) of the '864 patent as items A6 (septum), A4
`
`(thread), and AIO (access portion).
`
`A6
`
`M
`
`7.
`
`The subsequent limitations of claim 10 require:
`
`(i) a cap 78 with threads 18 on the inner wall of the cavity of the cap
`
`to engage the external threads [A4] of the access portion [AlO] of the access
`
`valve [A];
`
`7
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`FIG. 10B
`
`78\._
`
`18
`
`78a
`
`80
`
`(ii) a "wet pad [80] impregnated with a cleaning solution" in the
`
`cavity "for contacting the end face [of the septum A6 of fig. l] ... and at least
`
`a portion of the external threads [A4] of the access portion" of the access
`
`valve; and
`
`(iii) a removable lid 78A over the open end of the cap to protect the
`
`wet pad until the lid is removed and the cap is attached to access valve "so
`
`that the end face of the access portion contacts the wet pad."
`
`8.
`
`Dependent claim 11 calls for the cavity of the cap to have an
`
`inner circumference 82 with a thread 18 that comprises a length that is less than the
`
`inner circumference. Dependent claim 12 specifies that the cleaning solution of
`
`claim IO is an antimicrobial agent. Dependent claim 13, in turn, requires the
`
`antimicrobial agent of claim 12 to be at least one of chlorhexidine gluconate and
`
`chlorhexidine diacetate. Lastly, dependent claim 14 calls for the cleaning solution
`
`of claim IO to be an alcohol-based cleaning solution.
`
`8
`
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`B.
`
`The Prior Art
`
`1.
`
`The White Patent
`
`United States Patent No. 5,242,425 to White, et al. (Ex. I 021, "White" or the
`
`"White patent") issued in 1993. White shows that the use of catheter access valves
`
`long pre-dates the 2005 filing of the Hoang patent application, and that it has been
`
`well known for almost as long that patients run a high risk of infection if an access
`
`valve is not properly maintained to prevent contamination by bacteria. (Ex. I 021,
`
`col. 2,
`
`lines 27-34).
`
`The White patent discloses an answer
`
`to
`
`the
`
`contamination/infection problem in the form of a cap, containing a sponge with a
`
`disinfecting solution, that is placed over a catheter access valve when it is not
`
`being used to treat a patient.
`
`More specifically, as shown in Figure 7 and described in the associated text
`
`of the White patent, an outer protective cap 78 contains a sponge 80 saturated
`
`with an antiseptic. The cap 78 has internal threads 76 at the open, distal end. The
`
`protective cap fits on a catheter coupler (or access) assembly 70, 82 with a self(cid:173)
`
`sealing septum 84, injection cap 82, and external shoulder threads 74 to receive the
`
`internal threads 76 of the protective cap 78.
`
`9
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`

`78
`
`{¼
`
`82
`
`7~
`74
`
`70
`
`72
`
`/8
`
`FJ.9. 7
`
`The protective cap 78 is spaced from the injection cap 82 "to permit
`
`antiseptic to bathe the exterior surfaces of distal member 70, proximal member 82,
`
`and self-sealing septum 84" when the cap is placed on the access valve assembly
`
`70. (Ex. 1021, col. 7, lines 29-32).
`
`White also diseloses in another embodiment in Figs. 1-6 an outer protective
`
`cap 64 having a sponge 68 saturated with an antiseptic material. The cap 64 does
`
`not inelude threads but rather snap-fits onto a catheter coupler I 0, 32 having a
`
`septum 54.
`
`2.
`
`The Genatempo Patent
`
`United States Patent No. 4,440,207 to Genatempo, et al. (Ex. I 024,
`
`"Genatempo" or the "Genatempo patent"), issued in 1984. As seen in Figs. I and 3
`
`shown below, Genatempo also discloses a protective cap 10 containing absorbent
`
`IO
`
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`material 24 saturated with antiseptic liquid that is placed in contact with a
`
`connector 32 attached to medical tubing 34, such as a catheter, to prevent
`
`contamination of the connector 32 before or between uses. (See Ex. 1024, col. 2,
`
`lines 66-68 and col. 3, lines 22, 23, 32-35, 40 and 41 ).
`
`FIG. I
`
`FIG. 3
`
`A removable, peel-back, lid 20 covers the open end of the cap 10 to prevent loss of
`
`the antiseptic liquid prior to use.
`
`In addition, the internal wall of the cap has
`
`threads 38 to engage the external threads 42 of a connector 32. As shown in Figure
`
`3 and described in the specification of the Genatempo patent, when the cap is
`
`placed on a connector "an antibacterial effect" is provided to the connector "as well
`
`as threads 42 through migration of the antiseptic." (Ex. 1024, col. 3, lines 43-45).
`
`11
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`3.
`
`The Harding Publication
`
`U.S. Publication No. 2003/0109853 to Harding, et al. (Ex. 1022, "Harding"
`
`or the "Harding publication"), was published on June 12, 2003. The Patent Owner
`
`was the assignee of Harding at the time of filing and publication, but did not
`
`disclose the Harding publication or its subject matter to the examiner during
`
`prosecution of the '864 patent.
`
`Harding discloses a catheter access valve that is remarkably similar, if not
`
`identical, to the access valve depicted in Figure 1 of the '864, as illustrated by, for
`
`example, the access valves of Figure 4 of Harding and part of Figure 1 of the '864
`
`patent:
`
`FIG. 4
`
`10~
`
`21
`
`·1'
`
`-----~-
`
`----- ·····---
`
`12
`
`16
`
`A6
`
`M
`
`FIG. 4 of HARDING
`
`PART OF FIG. I OF '864 PATENT
`
`The Harding access valve IO includes a top portion 12 that contains a
`
`septum 20 and has exterior luer threads 14 adjacent the septum "that allow another
`
`12
`
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`medical device having a male luer lock to be connected to the top of proximal
`
`portion 12." (Ex. I 022, paragraph [0073 ]).
`
`4.
`
`The Paradis Patent
`
`U. S. Patent No. 6,117,114 to Paradis (Ex. 1025, the "Paradis patent"),
`
`issued in 2000, teaches a valve having threading of a length that is less than the
`
`circumference of cylindrical connector (see partial luer threads 43 on cylindrical
`
`cap 40 in Fig. 4a).
`
`40 ~
`
`4C
`
`42
`Fig. 4A
`
`5.
`
`The Busch Patent
`
`U. S. Publication No. 2004/0004019 to Busch, was published on January 8,
`
`2004 (Ex. I 026, "Busch" or the "Busch publication"). It discloses "a presoaked
`
`preparation swab, sponge, applicator, or the like" that is saturated with antiseptic
`
`liquid and used to prevent contamination. The cleaning solution may be
`
`"[b ]etadine or another antiseptic solution ( e.g. alcohols, idophors, chlorhexadine,
`
`chlorhexadine gluconate with isopropyl alcohol, etc.)." (Ex. I 026, paragraph
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`[0026]).
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`6.
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`The Menyhay Patent
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`U.S. Patent No. 5,554,135 to Mcnyhay issued September 10, 1996. (Ex.
`
`I 029). It discloses in Fig. 2 (reproduced below) an external injector port 19, with
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`an access portion having external threads 17, and an end face having a septum 18.
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`A catheter 25 extends from the port 19. A cover IO is shown having an open end
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`and a closed end, forming a cavity (Fig. 2). An internal wall of the cover I 0
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`includes internal threads 15. The closed end includes an inwardly pointed
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`projection 13. The cover 10 receives the breakable capsule 11 and sponge 12. The
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`breakable capsule 11 includes an antiseptic, bactericidal and virucidal solution
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`consisting ofpovidonc iodine and isopropyl alcohol. Ex. I 029, col. 6, lines 44-58.
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`9
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`10
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`"
`
`"
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`Fig. 2 ofMcnyhay
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`14
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`C.
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`Summary of Prosecution of the '864 Patent
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`Although the application for the '864 was filed in 2005, the first office action
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`did not occur until July 2009 when the examiner issued a restriction requirement
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`because the original application claims covered a combination cleaner and cap 10
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`(see, e.g., Figures 1-4, 6-9) as well as the independent, standalone disinfecting cap
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`78 of Figure 1 OB. See Restriction mailed July 29, 2009 (Ex. I 004). The patent
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`owner elected to proceed with the cap alone. 1
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`The examiner issued five substantive rejections of claims proposed by the
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`Patent Owner throughout prosecution of the '864 application in view of, among
`
`other references, White, Genatempo, Paradis, and Busch. Finally, in the fifth
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`office action on the merits of August 15, 2013 (Ex. I 017), the examiner indicated
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`that, upon curing an antecedent basis rejection, new dependent application claim
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`71 would be allowable because it provided that the internal threads of the cap
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`"receive[] the external threads thereby causing the interface to advance into the
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`inner cavity such that the septum contacts the wet pad."
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`The examiner otherwise rejected application claim 79 (now issued claim I 0)
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`in the fifth office action as obvious because White disclosed all the features of
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`The Patent Owner filed a divisional application covering the combination
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`cleaner and cap, which issued as U.S. Patent No. 8,491,546 on July 23, 2013 (Ex.
`
`1003).
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`claim 79 except for a lid, and that Genatempo disclosed the lid m1ssmg from
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`White. Dependent application claims 80
`
`to 83 were rejected
`
`in
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`light of
`
`combinations of White, Genatempo, Paradis, and Busch.
`
`In response to the fifth office action, the Patent Owner cancelled application
`
`claim 71 and amended independent application claims 69 and 84 (now, issued
`
`claims l and 15) to require rotation of the internal threads of the cap with the
`
`external threads of the access valve to cause the wet pad to come into contact with
`
`the septum.
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`However, the Patent Owner did not amend claim 79 to include such a
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`rotational limitation. Instead, claim 79 was simply amended to require that the wet
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`pad "disinfect[] the end face and a portion of the external threads" of the access
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`valve.
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`With a minor, irrelevant change, the examiner allowed application claims
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`69, 70, and 72 to 88, as so amended, on January 21, 2014.
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`In his reasons for
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`allowance, the examiner cited the rotational limitations added to application claims
`
`69 and 84:
`
`The prior art does not disclose or render obvious the combination as
`claimed specifically including housing have a wet pad positioned
`within a cavity having an internal thread, where the wet pad contacts
`the end face of an externally threaded patient fluid line access valve
`when the housing is positioned over and covers the access valve and
`rotational movement of the threads relative to another causes the end
`face to advance into the cavity resulting in the end face contacts the
`wet pad such that both the end face and at least a portion of the
`
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`external threads of the access valve are disinfected 111 combination
`with the other elements of the claims.
`
`See Examiner's Statement of Reasons for Allowance (Ex. IO 19, pages 7 and
`8).
`
`Forgetting about White, the examiner wrongly determined that Genatempo
`
`was the closest prior art, finding that "Genatempo fails to teach or suggest an
`
`access valve having an end face that contacts the wet pad and is advanced into the
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`cavity via the engagement of the threads. Rather, in Gcnatempo, by the time the
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`respective threads are engaged, the end face has past [sic] the wet pad and is no
`
`longer in contact." That is a correct description of Genatcmpo as its Figure 3
`
`shows that the end face near reference arrow 42 is located in cavity 30 below the
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`wet pad 24.
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`In a subsequent interview initiated by the Patent Owner on April I, 2014, the
`
`examiner acknowledged that application claim 79 does not require rotational
`
`movement of the cap and that it is enough that the housing wet pad engage the
`
`access portion. The examiner again noted Genatempo docs not teach or suggest
`
`that the end face of a septum comes into contact with a pad as discussed above.
`
`Sec Applicant Initiated Interview Summary, (Ex. I 020, p.4). White was not
`
`discussed. (Ex. I 020, p. 2).
`
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`VIII. DETAILED EXPLANATION OF GROUNDS FOR INVALIDITY
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`A.
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`Claim Construction
`
`As required by §42.22(a)(2) and §42.104(b)(3), Petitioner submits that the
`
`claim terms of issued claims 10-14 are to be given their broadest reasonable
`
`interpretation, as understood by one of ordinary skill in the art and consistent with
`
`the disclosure.
`
`B.
`
`Ordinary Skill in the Art
`
`Petitioner submits that the relevant person of ordinary skill in the art
`
`includes one skilled in the art of patient fluid line access valve antimicrobial caps.
`
`Examples of such persons skilled in the art prior to the filing date of November 17,
`
`2005 of the underlying application, may be inferred from the following prior art.
`
`Patent Publication No.
`WHITE, U.S. Patent No. 5,242, 425
`HARDING 2003, U.S. Patent Publication No.
`2003/009853
`HARDING 2008, U.S. Patent Publication No.
`2008/0027399
`GENA TEMPO, U.S. Patent No. 4,440,207
`PARADIS, U.S. Patent No. 6,117,114
`BUSCH, U.S. Patent Publication No. 2004/0004019
`LAKE, U.S. Patent Publication No. 2004/0258560
`PELUSO, U.S. Patent No. 4,624,664
`MENYHA Y, U.S. Patent No. 5,554,135
`
`Exhibit No.
`Ex. 1021
`Ex. 1022
`
`Ex. 1023
`
`Ex. 1024
`Ex. 1025
`Ex. 1026
`Ex. 1027
`Ex. 1028
`Ex. 1029
`
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`C.
`
`The Obviousness Framework
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`An invention that would have been obvious to a person having ordinaiy skill
`
`in the relevant art is not patentable. 35 U.S.C. § I 03(a) (pre-AIA). (Ex. I 031, p. I)
`
`As established in Graham v. John Deere Co., 383 U.S. I,_ (1966), obviousness is
`
`a question of law that is resolved, in part relevant here, in light of following factual
`
`inquiries: (i) the scope and content of the prior art; (ii) the level of ordinary skill in
`
`the art; and (iii) the differences between the between the claimed invention and the
`
`prior art. Based on those factual inquiries, the focus in determining obviousness is
`
`on what a person of ordinary skill in the relevant art would have known at the time
`
`of the invention and on what that person would have been able to do with that
`
`knowledge. M.P.E.P. § 214l(II).
`
`The scope and content of the prior art has been detailed above. The cited
`
`references are plainly relevant as they are from the same field of endeavor as the
`
`claimed inventions and are pertinent to the problem confronting the inventor. In re
`
`Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). (Ex. 1035).
`
`Petitioner submits that the level of skill of the hypothetical person of
`
`ordinary skill in the art may be inferred from the prior art of record. Okajima v.
`
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). (Ex. 1036). Alternatively,
`
`petitioner's expert, Dr. Teny Layton, opines that a person of ordinary skill would
`
`have a bachelor's degree in biomechanical or mechanical engineering and a
`
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`minimum of two to three years of work experience in the development and design
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`of medical devices that connect to catheters or tubes where bacterial contamination
`
`may be an issue. Layton Dec., il 20.
`
`Petitioner discusses immediately below the differences between the prior art
`
`and the subject matter of claims 10 to 14, giving the claims "the broadest
`
`reasonable interpretation consistent with the specification." Phillips v. A WH
`
`Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005). (Ex. 1033).
`
`D.
`
`Claim 10 Is Obvious in View of White, Harding, and Genatempo
`
`Several substantial limitations of claim 10 of the '864 patent are disclosed by
`
`the White patent. Both White and claim 10 describe a disinfecting cap for an
`
`indwelling catheter access valve.
`
`(Ex. I 021, col. 2, lines 53-61 ). Each cap
`
`contains a sponge that is saturated with an aseptic solution, and each cap has
`
`internal threads for mating with the external threads of a catheter access valve.
`
`(Ex. 1021, col. 7, lines 26-29). Upon positioning the caps of White and claim 10 on
`
`an access valve, the sponges in both caps come into contact with a septum and
`
`disperse aseptic solutions that bathe the septum and the surrounding structure of
`
`the access valve to prevent bacterial contamination. (Ex. 1021, col. 7, lines 29-32).
`
`Layton Dec. Ex. 1037, il 22.
`
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`White and claim 10 differ in only three minor respects: namely, as to the
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`location of the external threads of the access valve of White; whether the aseptic
`
`solution of White disinfects a portion of the external threads; and the absence of an
`
`express teaching of a peel-able lid on White's protective cap. The solution to these
`
`differences would have been readily obvious to a person of ordinary skill, given his
`
`or her's presumed knowledge of the teachings of the prior art Harding publication
`
`and Genatempo patent, as well as the inherent properties of the White cap.
`
`First, White may not meet the limitation of the preamble of claim 10,
`
`requiring that the external threads of the access valve be "proximate" the septum,
`
`because the external threads 74 of the access valve of White arc near the shoulder
`
`of the valve. (Ex. 1021, col. 7, lines 23-25).
`
`However, one of ordinary skill in the art would have known that the Harding
`
`publication discloses an access valve with external threads near the septum that is
`
`very similar, if not identical, to the access valve of the '864 patent and claim 1 0.
`
`Layton Dec. Ex. 1037, ~ 23. Hence, charged with the task of designing a
`
`disinfecting cap for an access valve with threads near the septum, it would have
`
`been an utterly predictable and simple matter for a person of ordinary skill to
`
`relocate the internal threads of the White cap away from the opening so that, when
`
`placed on access valve with external threads near a septum as disclosed in Harding,
`
`the sponge of the White cap would make contact with the septum to cause the
`