`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`ANCESTRY.COM DNA, LLC.
`Petitioner
`
`v.
`
`DNA GENOTEK, INC.
`Patent Owner
`
`
`
`Patent No. 8,221,381 B2
`
`_______________
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`Inter Partes Review No. IPR2016-00060
`____________________________________________________________
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`PATENT OWNER’S RESPONSE
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`sd-682683
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`IPR2016-00060
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`Docket No. 604140000012
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`TABLE OF CONTENTS
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`Page
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`I.
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`Introduction ..................................................................................................... 1
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`II.
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`The broadest reasonable interpretation of “[a] lid configured to
`removably engage [a] vial” does not include a lid that can attach to a
`vial and is merely capable of later removal .................................................... 3
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`III. Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan anticipates Claim 1 ..................................................................... 5
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`A. O’Donovan does not disclose “[a] lid configured to removably
`engage [a] vial” .................................................................................... 6
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`B.
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`Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan discloses a lid removably engaging a vial ...................... 10
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`IV. Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan in view of KCCL renders Claim 7 unpatentable ...................... 17
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`V.
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`Conclusion .................................................................................................... 22
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`CASES
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`TABLE OF AUTHORITIES
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`Page(s)
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`Aspex Eyewear v. Marchon Eyewear, 672 F.3d 1335 (Fed. Cir. 2012) ................ 4, 9
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`Continental Can v. Monsanto, 948 F.2d 1264 (Fed. Cir. 1991) .............................. 12
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`Elekta Instr. v. O.U.R. Sci. Int’l, 214 F.3d 1302 (Fed. Cir. 2000) ............................. 3
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`In re Giannelli, 739 F.3d 1375 (Fed. Cir. 2014) .................................................... 4, 9
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`In re Gordon, 733 F.2d 900 (Fed. Cir. 1984) .......................................................... 21
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`In re Man Machine Interface Tech., 2016 U.S. App. LEXIS 6993 (Fed. Cir.
`2016) ................................................................................................................. 4, 9
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`In re Robertson, 169 F.3d 743 (Fed. Cir. 1999) ...................................................... 12
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`In re Sponnoble, 405 F.2d 578 (CCPA 1969).......................................................... 21
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`Merck & Co. v. Teva Pharm., 395 F.3d 1364 (Fed. Cir. 2005) ................................. 3
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`Profectus Tech. v. Huawei Tech., Case Nos. 2015-1016, 2015-1018, and,
`2015-1019 (Fed. Cir. May 26, 2016) .................................................................. 10
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`Tec Air v. Denso Mfg. Michigan, 192 F.3d 1353 (Fed. Cir. 1999) .......................... 21
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`
`
`STATUTES
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`35 U.S.C. § 102(e)(2) ................................................................................................. 1
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`35 U.S.C. § 103 .......................................................................................................... 1
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`
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`OTHER AUTHORITIES
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`37 C.F.R. § 42.120 ..................................................................................................... 1
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`Patent Owner’s Exhibit List for Inter Partes Review of U.S. Patent
`No. 8,221,381 B2
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`Exhibit Description
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`Exhibit #
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`Screenshot from the PTO’s “Patent Application Information
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`Ex. 2001
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`Retrieval” for U.S. Patent No. 6,152,296,
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`http://portal.uspto.gov/pair/PublicPair accessed February 3, 2016.
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`Screenshot of http://www.uspto.gov/patent/contact-patents/patent-
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`Ex. 2002
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`technology-centers-management, accessed February 3, 2016.
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`Changes to Implement Miscellaneous Post Patent Provisions of the
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`Ex. 2003
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`Leahy-Smith American Invents Act, 1421 Off. Gaz. Pat. &
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`Trademark Office 1263 (December 29, 2015)
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`Transcript of Deposition of Terry Layton, Ph.D., May 25, 2016
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`Ex. 2004
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`Declaration of John Collins, Ph.D.
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`John M Collins, Ph.D. Resume
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`Ex. 2005
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`Ex. 2006
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`Petition for Inter Partes Review of U.S. Patent No. 8,221,381,
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`Ex. 2007
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`filed June 3, 2016
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`Declaration of Terry Layton, Ph.D. in Support of Petition for Inter
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`Ex. 2008
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`Partes Review of U.S. Patent No. 8,221,381, filed June 3, 2016
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`U.S. Patent No. 4,131,016
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`U.S. Patent No. 4,301,812
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`Ex. 2009
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`Ex. 2010
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`Exhibit Description
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`Exhibit #
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`ASTM D 1894-01, “Standard Test Method for Static and Kinetic
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`Ex. 2011
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`Coefficients of Friction of Plastic Film and Sheeting”
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`Patent Owner provides this Response under 37 C.F.R. § 42.120 and requests
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`relief through a determination that Petitioner has not shown by a preponderance of
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`the evidence that any instituted ground renders select claims of U.S. Patent
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`No. 8,122,381 B2 (“the ’381 Patent;” Ex. 1001) unpatentable.
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`I.
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`Introduction
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`The ’381 Patent claims an apparatus and method for releasing a substance
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`into a vial. A lid includes a reservoir with the substance and includes a membrane
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`to seal the substance in the reservoir. The vial includes a piercing member that
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`disrupts the membrane and thereby releases the substance into the vial. The lid and
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`vial are removably engaged and are sealed against leakage in the piercing position.
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`Petitioner proposed four grounds. (Resubmitted Petition (“RPet”), Table of
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`Contents.) The Board instituted inter partes review on two: (1) Claims 1, 2, 4, 5,
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`8, 11, 12, 15-17, 20, 41, 44, and 49 are allegedly anticipated under 35 U.S.C.
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`§ 102(e)(2) by U.S. Patent 7,645,424 (“O’Donovan”); and (2) Claims 1 and 7 are
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`allegedly unpatentable under 35 U.S.C. § 103(a) over O’Donovan in view of WO
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`98/03265 (“KCCL”). (Institution Decision (“Inst”), Page 22.) Patent Owner
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`submits that Petitioner has failed to prove by a preponderance of the evidence that
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`any of Claims 1, 2, 4, 5, 7, 8, 11, 12, 15-17, 20, 41, 44, and 49 are unpatentable.
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`For Ground 1, Petitioner fails to give “configured to” meaning in the
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`limitation “[a] lid configured to removably engage [a] vial,” thereby reading
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`“configured to” out of the claims and construing this limitation beyond its broadest
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`reasonable interpretation. Putting aside Petitioner’s failure to give “configured to”
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`meaning, Petitioner also fails to prove O’Donovan discloses a “releasably
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`engaged” lid.
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`For Ground 2, Petitioner has not shown by a preponderance of the evidence
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`that Claim 7 of the ’381 Patent is unpatentable over O’Donovan in view of KCCL.
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`Petitioner’s rationale is unclear. It is unclear whether Petitioner proposes replacing
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`O’Donovan’s friction fit connection with a threaded engagement, but if that is the
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`proposal then that change does not require changing the relative width of the ends
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`of O’Donovan’s vial. It is unclear whether Petitioner proposes replacing
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`O’Donovan’s vial with a different shaped vial, but if that is the proposal then that
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`change does not require changing the relative width of the ends of O’Donovan’s
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`vial. It is unclear whether Petitioner proposes substituting KCCL’s vial for
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`O’Donovan’s, but if that is the proposal then that change provides no structure to
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`pierce O’Donovan’s foil membrane and release O’Donovan’s buffer reagent.
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`For at least these reasons, Petitioner fails to prove by a preponderance of the
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`evidence that O’Donovan anticipates Claims 1, 2, 4, 5, 8, 11, 12, 15-17, 20, 41, 44,
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`and 49 and O’Donovan in view of KCCL renders Claim 7 unpatentable.
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`II. The broadest reasonable interpretation of “[a] lid configured to
`removably engage [a] vial” does not include a lid that can attach to a
`vial and is merely capable of later removal
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`Patent Owner submits that the broadest reasonable interpretation of “[a] lid
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`configured to removably engage [a] vial” is not met by a lid that can attach to a
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`vial and is merely capable of later removal. Petitioner’s unreasonably broad
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`construction of “[a] lid configured to removably engage [a] vial” is contradicted by
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`the claim language, the specification’s description of the invention’s purpose, and
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`Federal Circuit precedent analyzing the limitation “configured to.”
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`Claim 1 (and, through dependency, all challenged claims) includes the
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`limitation “[a] lid configured to removably engage [a] vial.” To give meaning to
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`the limitation “configured to,” this limitation must mean more than a “lid
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`removably engage[ing] a vial.” Otherwise, the term “configured to” would be
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`superfluous. Merck & Co. v. Teva Pharm., 395 F.3d 1364, 1372 (Fed. Cir. 2005)
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`(“A claim construction that gives meaning to all the terms of the claim is preferred
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`over one that does not do so.”); Elekta Instr. v. O.U.R. Sci. Int’l, 214 F.3d 1302,
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`1307 (Fed. Cir. 2000) (construing claim to avoid rendering a claim limitation
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`superfluous). Thus, “configured to” must be given meaning.
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`The ’381 Patent makes clear why the lid is configured to be removed from
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`the vial. The ’381 Patent’s systems are configured to store samples in a vial and
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`permit later access to the sample for “subsequent processing.” (See Ex. 2005, ¶ 22
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`(citing Ex. 1001, Col. 4:4-5).) If the lids were not configured for later release but
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`merely capable of later release, then an operator may not be able to access the
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`stored sample in the intended environment and/or procedure. (Ex. 2005, ¶ 22.) A
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`mere capability for release is insufficient to provide for subsequent processing.
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`(Id.)
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`The Federal Circuit consistently interprets “configured to” to be narrower
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`than “capable of.” In Aspex Eyewear v. Marchon Eyewear, the Federal Circuit
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`analyzed the term “adapted to” and noted it could be construed broadly as “capable
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`of” or narrowly as “configured to.” 672 F.3d 1335, 1349 (Fed. Cir. 2012) (“[T]he
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`phrase ‘adapted to’ is frequently used to mean ‘made to,’ ‘designed to,’ or
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`‘configured to,’ but it can also be used in a broader sense to mean ‘capable of’ or
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`‘suitable for.’”); see also In Re Man Machine Interface Tech., 2016 U.S. App.
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`LEXIS 6993, at Page 3 (Fed. Cir. 2016) (“We have noted that the phrase ‘adapted
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`to’ generally means ‘made to,’ ‘designed to,’ or ‘configured to,’ but it can also be
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`used more broadly to mean ‘capable of’ or ‘suitable for.’”); In Re Giannelli 739
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`F.3d 1375, 1379 (Fed. Cir. 2014).) In Aspex, the panel found “a narrower
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`definition, such as ‘configured to’” applied to the equivocal “adapted to.” 672
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`F.3d at 1349. The ’381 Patent is unequivocal; the claims require the lid to be
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`narrowly “configured to” removably engage a vial.
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`Petitioner fails to give “configured to” meaning. Petitioner offers an explicit
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`construction for “removably engage” (RPet, Page 10), but no explicit construction
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`for “configured to removably engage.” Petitioner argues O’Donovan discloses “[a]
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`lid configured to removably engage [a] vial” by applying Petitioner’s proposed
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`claim interpretation for “removably engage.” (Compare id. Page 10 (construing
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`“removably engaged” as “a lid that can be attached in various ways and can later
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`be removed”) with id. Page 22 (arguing O’Donovan meets “configured to
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`removably engage” because O’Donovan’s “[s]econd chamber 3 can attach and
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`remove to first chamber 2 via friction fit”).) Petitioner thus equates “removably
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`engage” with “configured to removably engage,” thereby impermissibly reading
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`“configured to” out of the claims.
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`In sum, “configured to” should be given meaning in the limitation “[a] lid
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`configured to removably engage [a] vial.”
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`III. Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan anticipates Claim 1
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`Petitioner bears the burden of proving by a preponderance of the evidence
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`that O’Donovan anticipates Claim 1. Petitioner fails to meet its burden.
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`First, O’Donovan does not disclose “[a] lid configured to removably engage
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`[a] vial.” Petitioner’s analysis is based upon an erroneous construction that reads
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`“configured to” out of the claim. When “configured to” is given meaning,
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`O’Donovan’s lid does not disclose “[a] lid configured to removably engage [a]
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`vial.”
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`Second, Petitioner fails to prove by a preponderance of the evidence that
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`O’Donovan discloses a lid “releasably engaged” to a vial. As an initial matter,
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`Petitioner’s interpretation of “releasably” is too broad under Federal Circuit
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`precedent. Additionally, Petitioner fails to show that O’Donovan discloses the
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`element even under Petitioner’s erroneous construction, either explicitly or
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`inherently.
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`A. O’Donovan does not disclose “[a] lid configured to removably
`engage [a] vial”
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`O’Donovan’s lid is not configured to removably engage O’Donovan’s vial.
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`O’Donovan uses a transparent chamber to enable “analys[is] by an optical
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`instrument at the point of care.” (Id., Col. 3:26-28.) O’Donovan has no need to
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`remove the lid from the vial because (1) analysis is performed by an optical
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`instrument through the transparent chamber (Figure 2 is edited and provided below
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`to demonstrate a sample within the transparent container) and (2) analysis is
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`performed at the point of care, so the closed vial can be discarded once the optical
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`analysis is complete. (See, e.g., Ex. 1007, Abstract, 2:39-40, 3:11-12, 3:41-43.)
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`There is no need to configure the lid for removal. (Ex. 2005, ¶ 31-32.)
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`Instead of discloses a lid that is configured to be removably engaged,
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`O’Donovan discloses the opposite: a lid configured to be non-removable. (Ex.
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`2005, ¶ 37.) When a user inserts O’Donovan’s vial into the lid, the top of the vial
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`and lid are flush and the gap between the lid and vial is very small (see relevant
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`portion of Figure 4, reproduced below). (Id.) This arrangement of structural
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`features prevents a user from removing the lid. (Id.)
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`When asked during cross-examination, Dr. Layton stated that a friction fit
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`could be designed for removal. (Ex. 2004, Page 31:7-11 (“THE WITNESS: If you
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`want it removed, you design it so it can be removed. If you don’t want it to be
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`removed, you design it so it can’t be removed.”); Page 128:4-19 (“Q.·Is it possible
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`to have a device where whether it’s still going to be removed or not [is] really
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`determined by the material being used? . . . A. The material is a possibility.
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`Dimensions are a big possibility. Dimensions are the most important one.”).)
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`Given the dimension’s importance in determining removability, the very small
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`space between the lid and vial clearly indicates that the lid and vial in
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`O’Donovan’s device are designed, or configured, to be non-removable.
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`In a declaration supporting Petitioner’s second IPR petition for the’381
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`Patent (Ex. 2007), Dr. Layton stated that a friction could be configured for
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`removal:
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`I would add that there is nothing in the nature of a friction fit that
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`itself requires that the two components, once engaged, create a flush
`end. For example, a stopper in a test tube is an example of a friction
`fit, and such stoppers are often inserted so that the top of the stopper
`extends beyond the opening of the test tube.
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`(Ex. 2008, ¶ 127.) Dr. Collin’s agrees that there is nothing in a friction fit
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`“requires that the two components, once engaged, create a flush end.” (Ex. 2005,
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`¶ 36-37.) However, O’Donovan is configured to have so that the two components
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`create a flush end and is thus configured to be non-removable. (Id.)
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`As noted above, Petitioner’s analysis of “[a] lid configured to removably
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`engage [a] vial” gives “configured to” no meaning. Petitioner argues that
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`O’Donovan’s “friction fit allows removal.” (RPet, Page 28) But “configured to” is
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`narrower than “capable of” or “suitable for” or “allowing” removal. Aspex, 672
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`F.3d at 1349; In Re Man Machine, 2016 U.S. App. LEXIS 6993, at 3; In Re
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`Giannelli, 739 F.3d at 1379. Petitioner also argues that O’Donovan’s “optional
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`cover” means O’Donovan must be “removable.” But, a “removable” lid is not
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`necessarily a “lid configured to removably engage” a vial because “removable”
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`encompasses lids merely capable of removal. Petitioner’s analysis fails to prove
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`by a preponderance of the evidence that O’Donovan discloses “[a] lid configured
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`to removably engage [a] vial.”
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`In sum, O’Donovan does not disclose “[a] lid configured to removably
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`engage [a] vial,” but instead discloses a lid configured not to be removably
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`engaged. Further, Petitioner’s analysis is fatally premised on an unreasonably
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`broad interpretation.
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`B.
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`Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan discloses a lid removably engaging a vial
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`As described above, Petitioner focuses its argument of “[a] lid configured to
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`removably engage [a] vial” on its construction of a lid “removably engaging” a vial
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`and thereby eliminates “configured to” from the claim. Even if “configured to”
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`were read out of “configured to removably engage,” Petitioner still fails to prove
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`by a preponderance of the evidence that O’Donovan discloses a lid removably
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`engaging a vial.
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`First, Petitioner’s proposed construction of “removably engage” (i.e., “a lid
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`that can be attached in various ways and can later be removed”) is impermissibly
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`met by a device without an “inherent feature” for lid removal. Second, even if
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`“removably engage” does not require an inherent feature for lid removal and is met
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`by a lid that merely can be later removed, Petitioner has failed to show that
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`O’Donovan explicitly or inherently discloses a lid that can be later removed.
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`Petitioner argues that “removably engage” means “a lid that can be attached
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`in various ways and can later be removed.” (RPet at Page 9-10.) Petitioner’s
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`construction fails to require an inherent feature for removal. The Federal Circuit
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`recently addressed a similar issue in Profectus Tech. v. Huawei Tech. In that case,
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`the disputed claim term was “mountable picture frame.” Case Nos. 2015-1016,
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`2015-1018, and, 2015-1019, Slip. Op. at 3 (Fed. Cir. May 26, 2016). The district
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`court construed the term to mean “having a feature for mounting;” the accused
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`infringer argued it meant “capable of being mounted.” Id., Slip. Op. at 5-6. The
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`Federal Circuit held the “term ‘mountable’ is a modifying word in . . . ‘mountable
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`picture frame’” and that broader words, “such as ‘capable of,’” were absent from
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`the claims. Id. at 9.
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`In the same way here, “removable” is a modifying word in “removably
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`engaged,” and Claim 1 does not describe the lid as broadly “capable of” removal.
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`In affirming that “mountable” must have “an inherent feature for mounting,” the
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`Federal Circuit in Profectus noted the specification’s consistent teaching of
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`inherent features for mounting. (Id. at 9-10.) In the same way, the ’381 Patent
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`consistently teaches an inherent feature for removing. For example, Figures 1-24
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`depict a threaded engagement between the lid and vial. Petitioner’s analysis of
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`“removably engaged” fails because it does not require an inherent feature for
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`removing.
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`There is no inherent feature in O’Donovan for removing the lid from the
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`vial. (Ex. 2005, ¶ 34.) There is no structure on the lid for a user to “apply [the
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`force] in reverse” because the lid is closed in the vial. (Id.) A user cannot access
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`the vial to push on the bottom of the lid. (Ex. 2005, ¶ 35.) Nor could a user pull
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`on the lid’s flat top end because there is nowhere to grip the flat top end. (Id.) As
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`Dr. Layton noted, dimensions are the most important feature for removability (Ex.
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`2005 (Page 128:4-19)); there is no evidence that O’Donovan’s dimensions provide
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`for removability. Thus, O’Donovan does not disclose an inherent feature for
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`removing the lid from the vial and thus does not disclose a lid “removably
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`engaged” to a vial. (Ex. 2005, ¶ 35.)
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`Assuming that Petitioner’s construction of “removably engage” is correct
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`and this term is met by a lid that merely can be later removed, Petitioner still fails
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`to prove O’Donovan explicitly or inherently discloses a lid that can later be
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`removed. Petitioner does not contend that O’Donovan explicitly discloses a lid for
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`later removal. Petitioner instead relies on two teachings in O’Donovan to prove
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`inherency: O’Donovan’s friction fit and O’Donovan’s optional cover.
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`“If the prior art reference does not expressly set forth a particular element of
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`the claim, that reference still may anticipate if that element is ‘inherent’ in its
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`disclosure.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). “To establish
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`inherency, the extrinsic evidence ‘must make clear that the missing descriptive
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`matter is necessarily present in the thing described in the reference, and that it
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`would be so recognized by persons of ordinary skill.’” Id. (citation omitted).
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`“Inherency, however, may not be established by probabilities or possibilities. The
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`mere fact that a certain thing may result from a given set of circumstances is not
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`sufficient.” Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1269
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`(Fed. Cir. 1991).
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`Petitioner argues that O’Donovan’s friction fit allows removal and relies on
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`Dr. Layton’s testimony to support its argument. (RPet at Page 28 (citing Ex. 1003,
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`¶¶ 111-112).) Dr. Layton opines that “a friction fit is known to be removable
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`because the same force used to form the friction fit can be applied in reverse to
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`remove the friction fit between the parts.” (Ex. 1003, ¶ 112.) Dr. Layton is
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`incorrect that the same force applied in reverse releases the fit. (Ex. 2005, ¶ 38.)
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`Considering O’Donovan in its entirety, the O’Donovan apparatus requires a
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`different force to remove the lid, if it is removable at all. (Id.)
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`When a user pushes on O’Donovan’s lid before the friction fit engages, there
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`is relative motion and the lid and vial are in dynamic friction. (Id. at ¶ 39.) The
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`friction fit engages at the level of the spikes because “[t]he spikes are located so
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`that there is just enough space for the rim of 11 of the chamber 3 to fit between the
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`spikes 20 and the wall of the socket 6 with a friction fit.” (Ex. 1007, Col. 2:63-66.)
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`Examine Figure 4 (reproduced in part below)—the spikes (and, hence, the friction
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`fit) only occupy a small lower portion of the opening in the chamber 3. (Id.)
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`To remove the lid after insertion requires more force because the lid is
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`initially at rest. (Ex. 2005, ¶ 40.) The lid will have to overcome the static friction
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`provided by the fiction fit. (Id.) As anyone who has pushed a stalled car knows,
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`the initial push to overcome static friction requires the most energy and, once the
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`car starts rolling, the car needs less force to maintain motion. In the same way,
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`removing O’Donovan’s lid would require more force when moving the lid from
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`rest. (Id.)
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`When cross-examined, Dr. Layton admitted that he could not say that a
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`friction fit necessarily leads to removable engagement. Dr. Layton was asked
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`whether “a friction fit always lead[s] to removable engagement?” (Ex. 2004, Page
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`134:11-13.) In response, Dr. Layton testified:
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`I don’t know the answer to that.· I would think I would have to do
`some heavy research, but I think in almost all cases a friction fit is
`removable. But there may be some cases where it isn’t, but in the vast
`majority of the instances that I’ve worked with and been involved
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`with, it’s removable. I can’t think of [one] right now, but there may
`be some.
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`(Id., Page 134:14-22.)
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`Turning now to the Petition and the Institution Decision’s reliance on
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`O’Donovan’s optional cover (RPet, Page 28; Inst, Pages 9-10), the optional cover
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`does not necessarily or inherently indicate that a lid is capable of removal.
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`Petitioner cites to Dr. Layton’s declaration to support its position. (RPet, Page 28
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`(citing Ex. 1003, ¶¶ 111-12).) However, Dr. Layton offers no opinion on the
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`optional cover in his declaration.
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`Moreover, Dr. Layton has since provided reasons for the optional cover, but
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`the reasons do not suggest that the lid can later be removed. In a declaration
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`supporting Petitioner’s second IPR petition for the’381 Patent (Ex. 2007),
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`Dr. Layton describes the reasons for the optional cover:
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`O’Donovan additionally teaches that further assurance against leakage
`may be desired, such as a “cover for covering the starter reagent
`chamber after it has been inserted into the socket ... [to] ensure that it
`is held in place in the socket.”
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`A POSITA would have credited the desire for additional assurance
`against leakage, whether contemplating use of a threaded engagement
`as in Birnboim or a friction fit engagement as in O’Donovan, to
`accommodate the possibility that a container portion might be
`defective or susceptible to leakage. A POSITA would particularly
`have credited the desire for additional assurance when the fluids
`contained within the vial were biological samples, such as “saliva,
`serum, plasma, blood, urine, mucus, gastric juices, pancreatic juices,
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`semen, products of lactation or menstruation, tears, or lymph,” as in
`Birnboim, or “blood,” as in O’Donovan, and thus were a potential
`source of infectious agents.
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`The motivation to include additional sealing means would have been
`particularly strong with friction fit embodiments, both for the reason
`articulated in O’Donovan (“[to] ensure that it is held in place in the
`socket,” and for the additional reason articulated in the ’381 patent in
`describing challenges presented by the friction fit used in its preferred
`pivoting partition embodiment (“there must be a high degree of
`precision for the manufacture of the components of the container.”
`The need for high precision manufacturing to prevent leakage would
`have provided additional motivation to include further sealing means
`for a friction fit embodiment.
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`(Ex. 2008, ¶¶ 161-63 (internal citations omitted).)
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`Thus, Dr. Layton provides an alternative reason (other than a removably
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`engaged lid and vial) for the optional cover: further assurance against leakage.
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`(Id.) Dr. Collins agrees with Dr. Layton’s analysis that a reason for the optional
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`cover is “further assurance against leakage.” (Ex. 2005, ¶ 42 (citing Ex. 2008,
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`¶¶ 161-63).) Dr. Collins also agrees with Dr. Layton that further assurance against
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`leakage is particularly important with friction fit embodiments, as in O’Donovan,
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`and where fluids contained within the vial are biological samples, as in
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`O’Donovan. (Ex. 2005, ¶ 40 (citing Ex. 2008, ¶¶ 161-63).)
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`Because there are alternative reasons for the optional cover, O’Donovan
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`does not necessarily disclose a lid that can be later removed. Because O’Donovan
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`does not necessarily disclose a removable lid, O’Donovan does not inherently
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`disclose a removable lid. Petitioner has failed to prove by a preponderance of the
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`evidence that O’Donovan explicitly or inherently discloses a removable lid.
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`In sum, Petitioner fails to prove by a preponderance of the evidence that
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`O’Donovan discloses a lid “releasably engaged” to a vial. Petitioner’s
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`interpretation of “releasably” is too broad under Federal Circuit precedent.
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`Further, Petitioner fails to show that O’Donovan discloses the element even under
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`its erroneous interpretation, either explicitly or inherently.
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`IV. Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan in view of KCCL renders Claim 7 unpatentable
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`Petitioner argues that one of ordinary skill in the art “would have understood
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`that a vial having uniform cross-section diameter could readily have been
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`substituted for the vial shown in O’Donovan simply by replacing the friction
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`socket with a threading engagement between the lid and vial.” (RPet, Page 32; see
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`also Layton Decl. at ¶ 148-152.) Petitioner argues that one of ordinary skill in the
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`art would have been motivated “to make [O’Donovan’s] reagent cuvette
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`compatible with other analytical devices.” (RPet, Page 32.) Petitioner also argues
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`that the substitution of KCCL’s vial for O’Donovan’s vial is a “simple
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`substitution.” (RPet, Page 32.)
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`Petitioner’s rationale is unclear. It is unclear whether Petitioner proposes
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`replacing O’Donovan’s friction fit connection with a threaded engagement,
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`whether Petitioner proposes replacing O’Donovan’s vial “to make the reagent
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`cuvette compatible with other analytical devices,” or whether Petitioner proposes
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`substituting KCCL’s vial for O’Donovan’s. None of these modifications render
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`Claim 7 obvious.
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`Assuming Petitioner proposes replacing O’Donovan’s friction fit connection
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`with a threaded engagement, the proposal does not require changing the relative
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`width of the ends of O’Donovan’s vial. The threaded engagement is on the outside
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`of the vial and thus would not have any impact on the interior of the vial. Thus,
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`this modification to O’Donovan would not result in a device that met Claim 7’s
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`“the width of said first end is equivalent to the width of said second end.”
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`Assuming Petitioner proposes replacing O’Donovan’s vial “to make the
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`reagent cuvette compatible with other analytical devices,” the proposal does not
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`require changing the relative width of the ends of O’Donovan’s vial. Even if one
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`of skill in the art were motivated to change the width of the bottom end of
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`O’Donovan’s vial, there is no need to change the relative width of the two ends. In
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`other words, one of skill in the art could make O’Donovan “compatible with other
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`analytical devices” without changing the relative widths of the ends. Thus, this
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`modification to O’Donovan would not result in a device that met Claim 7’s
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`limitation “the width of said first end is equivalent to the width of said second
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`end.”
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`Assuming Petitioner is proposing “a simple substitution” of KCCL’s vial for
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`O’Donovan’s vial, then one of skill in the art would not be motivated to make the
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`substation: the proposed combination provides no mechanism to pierce and tear
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`O’Donovan’s foil membrane. When one of skill in the art fully considers the
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`ramifications of Petitioner’s proposed combination, one of skill in the art would
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`not be motivated to modify O’Donovan as proposed. (Ex. 2005, ¶ 46.) Thus,
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`Petitioner has failed to prove that O’Donovan in view of KCCL renders 7 obvious.
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`Petitioner relied on Dr. Layton’s opinion in proposing the combination of
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`O’Donovan and KCCL. Specifically, Petitioner relies on Dr. Layton’s opinion to
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`support the conclusion that “POSITA would have been motivated to substitute the
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`vial of KCCL . . . for the cuvette of O’Donovan, to make the reagent cuvette
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`compatible with other analytical devices” (RPet, Page 32 (citing Ex. 1003,
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`¶ 148-52)) and to support the conclusion that “the substitution of elements would
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`have been merely a [s]imple substitution of one known element for another to
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`obtain predictable results.” (Id., Page 33 (citing Ex. 1003 ¶¶ 143-152)). Under
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`cross-examination, Dr. Layton testified that he was not substituting the vial of
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`KCCL for the cuvette of O’Donovan. (Ex. 2004, Page 159:25-160:4.)
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`O’Donovan Figure 4 (reproduced below) illustr