UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ANCESTRY.COM DNA, LLC.
`Petitioner
`
`v.
`
`DNA GENOTEK, INC.
`Patent Owner
`
`
`
`Patent No. 8,221,381 B2
`
`_______________
`
`Inter Partes Review No. IPR2016-00060
`____________________________________________________________
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`PATENT OWNER’S PRELIMINARY RESPONSE
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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.
`
`Introduction ..................................................................................................... 1
`
`II.
`
`The Board should reject Petitioner’s proposed claim constructions .............. 4
`
`A.
`
`B.
`
`C.
`
`Petitioner asks the Board to adopt Patent Owner’s “claim
`constructions” from the Spectrum litigation, but Section 301(d)
`prohibits the Board from considering Patent Owner’s federal
`court statements when deciding to institute ......................................... 5
`
`The Board should reject Petitioner’s construction of “vial”
`because it has no volumetric limit ........................................................ 8
`
`Petitioner’s myriad claim constructions are unnecessary for the
`Board to resolve Petitioner’s reasonable likelihood of prevailing ....... 9
`
`III. Petitioner fails to establish a reasonable likelihood of invalidating any
`claim as anticipated by O’Donovan.............................................................. 10
`
`A.
`
`B.
`
`C.
`
`Petitioner fails to show that O’Donovan teaches a lid
`“removably engaged” with a vial ....................................................... 11
`
`Petitioner fails to show that O’Donovan teaches a “chamber
`sealed against leakage to the outside of the container system in
`the piercing position” ......................................................................... 18
`
`Petitioner fails to show that O’Donovan teaches a “piercing
`member” ............................................................................................. 20
`
`IV. Petitioner fails to establish a reasonable likelihood of invalidating any
`claim as obvious over O’Donovan in view of KCCL .................................. 21
`
`A.
`
`B.
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`Petitioner fails to ascertain the differences between the claimed
`invention and O’Donovan or KCCL .................................................. 22
`
`Petitioner offers no reason or motivation to combine
`O’Donovan and KCCL ....................................................................... 25
`
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`TABLE OF CONTENTS
`(continued)
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`Page
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`V.
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`Petitioner fails to establish a reasonable likelihood of invalidating any
`claim as obvious over Shih in view of KCCL .............................................. 27
`
`A.
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`Shih does not teach a lid comprising a reservoir or pierceable
`member for holding the substance ..................................................... 28
`
`B.
`
`Shih teaches a drinking bottle, not a vial ........................................... 33
`
`C.
`
`Petitioner does not articulate the required Section 103(a)
`analysis of Shih and KCCL ................................................................ 36
`
`VI. Petitioner fails to establish a reasonable likelihood of invalidating any
`claims as obvious over Shih in view of Birnboim ........................................ 41
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`VII. Conclusion .................................................................................................... 44
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`ii
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`IPR2016-00060
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`Docket No. 604140000012
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`CASES
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`TABLE OF AUTHORITIES
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`Page(s)
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`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) .......................................................................... 26
`
`Graham v. John Deere Co,
`383 U.S. 1 (1966) .......................................................................................... 23, 36
`
`Hakim v. Cannon Avent Group, PLC,
`479 F.3d 1313 (Fed. Cir. 2007) ...................................................................... 9, 10
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ............................................................................ 41
`
`In re Mlot-Fijalkowski,
`676 F.2d 666 (CCPA 1982) .......................................................................... 38, 43
`
`In re Robertson,
`169 F.3d 743 (Fed. Cir. 1999) ............................................................................ 11
`
`InTouch Techs., Inc. v. VGO Commc’ns., Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) .............................................................. 25, 26, 37
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ................................................................................ 23, 25, 39
`
`McGinley v. Franklin Sports,
`262 F.2d 1339 (Fed. Cir. 2001) .......................................................................... 41
`
`Schering Corp. v. Geneva Pharms., Inc.,
`339 F.3d 1373 (Fed. Cir. 2003) .................................................................... 13, 19
`
`Verdegaal Bros. v. Union Oil Co. of California,
`814 F.2d 628 (Fed. Cir. 1987) ............................................................................ 11
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999) ............................................................................ 10
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`IPR2016-00060
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`STATUTES
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`Docket No. 604140000012
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`35 U.S.C.
`§ 301(a)(2) ........................................................................................................ 4, 5
`§ 301(d) ......................................................................................................... 4, 5, 6
`
`35 USC
`§ 102(e)(2) ...................................................................................................... 1, 10
`§ 103(a) (“Section 103(a)”) .........................................................................passim
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`OTHER AUTHORITIES
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`37 C.F.R. § 42.23 ....................................................................................................... 1
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`IPR2016-00060
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`Docket No. 604140000012
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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
`
`technology-centers-management, accessed February 3, 2016.
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`Changes to Implement Miscellaneous Post Patent Provisions of the
`
`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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`IPR2016-00060
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`Docket No. 604140000012
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`Patent Owner provides this Preliminary Response under 37 C.F.R. § 42.23
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`and requests relief through denial of institution of inter partes review of all
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`challenged claims of U.S. Patent No. 8,122,381 B2 (“the ’381 Patent”; Ex. 1001).
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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 offers four grounds: (1) Claims 1, 2, 4, 5, 8, 15-17, 20, 41, 44,
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`and 49 are anticipated under 35 USC § 102(e)(2) by U.S. Patent 7,645,424
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`(“O’Donovan”); (2) Claims 1, 7, and 14 are unpatentable under 35 USC § 103(a)
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`(“Section 103(a)”) over O’Donovan in view of WO 98/03265 (“KCCL”);
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`(3) Claims 1, 2, 4, 5, 11-13, and 15-19 are unpatentable under Section 103(a) as
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`obvious over U.S. Pat. No. 6,152,296 (“Shih”) in view of KCCL; and (4) Claims 3,
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`6, 8-10, 20, 39-41, 43-47, and 49 are unpatentable under Section 103(a) over Shih
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`in view of WO 2003/104251 (“Birnboim”). (Resubmitted Petition (“RPet”), Table
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`of Contents.) Petitioner fails to show a reasonable likelihood of prevailing on any
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`ground.
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`Docket No. 604140000012
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`Petitioner offers claim constructions for each and every limitation in the
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`challenged claims. The Board need not construe these limitations to resolve the
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`issues presented in the Resubmitted Petition. In addition, the Board can dismiss
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`Petitioner’s claim constructions because Petitioner impermissibly relies on Patent
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`Owner’s statements during federal court litigation. Finally, Petitioner construes
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`“vial” so that the meaning is internally inconsistent, a result of Petitioner’s
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`unexplained deviation from the dictionary definition presented in the Petition.
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`Petitioner’s anticipation analysis under O’Donovan fails because Petitioner
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`has not shown that O’Donovan teaches, explicitly or inherently, a “releasably
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`engaged” lid and vial, a sealed lid and vial in the piercing position, and the claimed
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`piercing members. Petitioner cannot provide explicit teachings in O’Donovan for
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`these limitations, and does not provide arguments that the claim limitations
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`necessarily flow from O’Donovan teachings.
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`Petitioner’s obviousness analysis does not try to resolve the O’Donovan
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`deficiencies. Instead, Petitioner argues that all limitations of claim 1 are taught in
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`both O’Donovan and KCCL. This is a theme in Petitioner’s obviousness
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`analysis—the Resubmitted Petition does not ascertain the differences between the
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`claimed invention and the prior art.
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`Petitioner’s analysis of O’Donovan and KCCL also suffers from another
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`failure that runs through the Resubmitted Petition—Petitioner does not offer a
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`Docket No. 604140000012
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`sufficient reason or motivation for one of skill in the art to combine the references.
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`Petitioner argues that one of skill in the art would be motivated to combine the
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`references merely because they are in the same or related classification. Petitioner
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`also concludes that the combination of O’Donovan and KCCL would be simple
`
`substitution with the same improvements, but fails to identify what elements would
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`be substituted and fails to identify the improvements.
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`Petitioner’s analysis of Shih in view of KCCL and Birnboim suffers from
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`the same flaws—the Resubmitted Petition fails to ascertain the differences between
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`the claimed invention and the prior art, and fails to provide an adequate reason or
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`motivation to combine the references.
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`Petitioner’s analysis of Shih in view of KCCL and Birnboim suffers from
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`the additional flaw that Shih does not teach many of the claimed features.
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`Petitioner argues that Shih’s drinking bottle is a “vial,” but Petitioner later
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`contradicts itself by admitting that Shih does not teach the “implied dimensional
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`limitations” of a vial. Petitioner argues that Shih’s drinking bottle teaches a
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`reservoir and pierceable member for holding the substance, but both are included
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`in the drinking bottle—not the lid, as required by the claims.
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`Patent Owner respectfully requests denial of institution of all challenged
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`claims of the ’381 Patent because Petitioner has failed to show a reasonable
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`likelihood of prevailing on any challenged claim.
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`Docket No. 604140000012
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`II. The Board should reject Petitioner’s proposed claim constructions
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`Petitioner asks the Board to rely on Patent Owner’s alleged claim
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`construction arguments under 35 U.S.C. Section 301(a)(2). But that section is
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`limited by 35 U.S.C. Section 301(d), which prohibits the Board from relying on
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`patent owners’ litigation statements before the Board institutes review. Because
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`the Board has not instituted review here, the Board cannot consider Patent Owner’s
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`statements in the Spectrum litigation1. Thus, the Board should reject Petitioner’s
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`claim constructions that are premised on Patent Owner’s statements.
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`The Board should reject Petitioner’s construction of “vial.” Petitioner
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`recognizes the plain meaning of vial as being a “small container,” but inexplicably
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`asserts that a vial has no size requirements. Indeed, Petitioner’s construction is
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`inconsistent with its own analysis of Shih, in which Petitioner argues that Shih
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`does not meet “the implied, but undefined, dimensional limitations of ‘vial.’”
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`These “implied dimensional limitations” are ignored in Petitioner’s construction.
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`Finally, Petitioner asks the Board to construe over 30 claim limitations, but
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`Petitioner does not, and cannot, provide a reason why the Board should embark on
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`an all-inclusive claim construction. The Board can ignore all of these proposed
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`1 DNA Genotek, Inc. v. Spectrum DNA; Spectrum Solutions L.L.C.; and Spectrum
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`Packaging, L.L.C., Case No. 15-cv-00661-SLR (D. Del., filed July 30, 2015).
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`Docket No. 604140000012
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`constructions and still resolve Petitioner’s likelihood to prevail on the challenged
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`claims.
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`A.
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`Petitioner asks the Board to adopt Patent Owner’s “claim
`constructions” from the Spectrum litigation, but Section 301(d)
`prohibits the Board from considering Patent Owner’s federal
`court statements when deciding to institute
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`Petitioner admits that its claim constructions are based on Patent Owner’s
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`statements in the Spectrum litigation:
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`Petitioner further submits these interpretations under the authority of
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`35 USC § 301(a)(2), which encourages submission of Patent Owner
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`claim constructions
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`to prevent patentees from arguing broad
`
`interpretations under Phillips while simultaneously arguing narrow
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`constructions as the BRI.
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`(RPet, Page 6 (citing Legislative History of 35 USC § 301, Fed. Reg. 48698).)
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`Petitioner justifies its reliance on 35 USC § 301(a)(2) (“Section 301(a)(2)”)
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`and urges the Board to consider Patent Owner’s statements. However, Section
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`301(a)(2) is limited by 35 USC § 301(d) (“Section 301(d)”):
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`A written statement . . . shall not be considered by the Office for any
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`purpose other than to determine the proper meaning of a patent claim
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`in a proceeding that is ordered or instituted pursuant to section 304,
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`314, or 324.
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`Docket No. 604140000012
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`The Patent and Trademark Office (“the Office”) recently clarified the
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`meaning of Section 301(d), foreclosing the use of “patent owner claim scope
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`statements” in institution decisions:
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`Comment 4: Several comments suggested that properly submitted
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`patent owner claim scope statements should be considered when the
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`Office is deciding whether to order or institute a post-patent
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`proceeding.
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`Response: Use of a patent owner claim scope statement is governed
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`by statute. New 35 U.S.C. 301(d) . . . prohibits the use of the
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`statement for any purpose other than determining the claim scope in a
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`proceeding that has already been ordered or instituted. Therefore, the
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`Office may not, and will not, consider such statements when the Office
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`is deciding whether to order or institute a post-patent proceeding.
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`(Ex. 2003, Page 8) (emphasis added).)
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`The Board should ignore Petitioner’s proposed interpretations of the
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`following claim limitations because Petitioner impermissibly asks the Board to
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`consider Patent Owner’s statements in “deciding whether to order or institute a
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`post-patent proceeding:”
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`• “a piercing member” (RPet, Pages 7-8 (relying on Ex. 1006));
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`• “a pointed corner” (RPet, Pages 8-9 (relying on Ex. 1006));
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`• “wherein, when said system is closed by removable engagement of
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`said vial with said lid, said vial and said lid are movable to a piercing
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`IPR2016-00060
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`Docket No. 604140000012
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`position in which the piercing member disrupts the pierceable
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`membrane to allow fluid communication between said reservoir and
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`said chamber” (RPet, Pages 10-11 (relying on Ex. 1006)); and
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`• “wherein said pierceable membrane is inert” (RPet, Pages 11-12
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`(relying on Ex. 1006)). 2
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`2 Petitioner characterizes Patents Owner’s statements as (1) “proposed claim
`
`construction offered by the Patent Owner” or (2) “Petitioner’s understanding of
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`Patent Owner’s claim construction.” (RPet, Pages 5-6 (emphasis in original).)
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`With respect to (1), Patent Owner did not propose claim construction arguments in
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`the related Spectrum litigation. With respect to (2), Petitioner’s “understanding” of
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`Patent Owner’s “non-explicit” claim construction is irrelevant. Moreover,
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`Petitioner frequently mischaracterizes Patent Owner’s statements. (See, e.g., RPet,
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`Pages 10-11 (“[T]he claim construction position advanced by the Patent Owner in
`
`the Spectrum litigation is . . . attachment of the lid itself causes piercing of the
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`membrane.”) (citing Ex. 1006, ¶ 28) and Ex. 1006, ¶ 28 (“When the Spectrum
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`Product lid is placed on the collection tube, the piercing member wedges in the
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`collection tube and is then pushed up through the lid to the foil membrane (an
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`“inert” membrane), causing the stabilizing fluid to flow through the pierced
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`membrane and into the sample storage area.”).)
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`Docket No. 604140000012
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`Petitioner also asks the Board to rely on Dr. Layton’s opinion in deciding
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`whether to institute inter partes review. However, Dr. Layton states that he was
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`“informed by counsel and [understood] that the broadest reasonable interpretation
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`should be broad enough to include claim construction positions previously
`
`advanced by the Patent Owner in the Spectrum litigation.” (Ex. 1003, ¶ 30; see
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`also ¶¶ 40, 46, 55, 60, and 185 (relying on Patent Owner’s statements in the
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`Spectrum litigation for many constructions).) The Board should also reject
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`Dr. Layton’s supporting opinion for the claim constructions listed in this section
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`because if the Board relies on Dr. Layton’s opinion it will indirectly rely on Patent
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`Owner’s statements during litigation.
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`B.
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`The Board should reject Petitioner’s construction of “vial”
`because it has no volumetric limit
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`Petitioner argues that “the BRI of ‘vial’ is a small closed or closable vessel,
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`with no definitive size or shape requirements.” (RPet, Page 7.) The Board should
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`reject Petitioner’s construction of “vial” because it expands the plain meaning to
`
`eliminate any size limitation.
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`Petitioner relies on the American Heritage Dictionary to support its
`
`construction. (RPet, Page 7 (citing Ex. 2015, p. 8).) However, the dictionary does
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`not support a container with a volume of any size. The American Heritage
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`Dictionary’s entry for the noun “vial” is, in its entirety, “[a] small container,
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`Docket No. 604140000012
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`usually with a closure, used especially for liquids;” the dictionary does not include
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`“no . . . size requirements.” (Ex. 1015, p. 8.)
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`Petitioner tacks on “no definite size . . . requirements” to the dictionary
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`definition, but the addition renders Petitioner’s construction internally inconsistent.
`
`Petitioner argues that “vial” is a small container, but also argues that a vial has no
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`size requirements. Petitioner’s construction is inconsistent; “small” is a size
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`requirement. A vial cannot both be “small” and have no size requirements.
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`Petitioner’s invalidity arguments illustrate the implicit sizing of a vial. In
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`discussing Shih, Petitioner argues that “[w]ith the exception of the implied, but
`
`undefined, dimensional limitations of ‘vial,’ Shih discloses [1.P]-[1.10].” (RPet,
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`Page 51 (emphasis added).) Thus, Petitioner acknowledges “vial” includes
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`implicit dimensional limitations. These “implied dimensional limitations of a vial”
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`allow one of skill in the art to distinguish a non-vial container based on its size.
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`Petitioner’s proposed construction ignores these “implied dimensional limitations.”
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`The Board should reject Petitioner’s inconsistent claim construction of vial
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`because it inexplicably deviates from plain meaning.
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`C.
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`Petitioner’s myriad claim constructions are unnecessary for the
`Board to resolve Petitioner’s reasonable likelihood of prevailing
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`Petitioner asks the Board to construe almost every claim limitation in the
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`’381 Patent. (RPet, Pages 5-18.) The Board should only construe those limitations
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`necessary to resolve the issues presented by the Petition. Hakim v. Cannon Avent
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`Group, PLC, 479 F.3d 1313, 1318-1319 (Fed. Cir. 2007) (“When there is no
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`dispute as to the meaning of a term that could affect the disputed issues of the
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`litigation, ‘construction’ may not be necessary.”); see also Vivid Techs., Inc. v. Am.
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`Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that only those
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`terms that are in controversy need to be construed, and only to the extent necessary
`
`to resolve the controversy). Petitioner provides no justification for a
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`comprehensive construction of every claim limitation. As explained in the
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`following sections, none of the constructions is necessary to resolve the issues
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`presented by Petitioner.
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`III. Petitioner fails to establish a reasonable likelihood of invalidating any
`claims as anticipated by O’Donovan
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`Petitioner argues that Claims 1, 2, 4, 5, 8, 15-17, 20, 41, 44, and 49 are
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`anticipated under 35 USC § 102(e)(2) by O’Donovan. (RPet, Pages 18-29.)
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`Petitioner supports its argument with testimony from Dr. Layton’s declaration.
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`(Ex. 1003.) Petitioner fails to establish a reasonable likelihood of invalidating any
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`claims as anticipated by O’Donovan.
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`As explained above, Petitioner’s claim constructions impermissibly rely on
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`statements made in federal court and ignore plain meaning. For at least the reason
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`that Petitioner’s analysis of O’Donovan is premised on an incorrect claim
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`construction analysis, Petitioner fails to carry its burden of showing a reasonable
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`likelihood of prevailing on any challenged claims with O’Donovan.
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`In addition, Petitioner fails to carry its burden because Petitioner does not
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`show that O’Donovan teaches a “lid configured to removably engage said vial,” a
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`“chamber sealed against leakage to the outside of the container system,” and a
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`“piercing member.”
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`A.
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`Petitioner fails to show O’Donovan teaches a lid “removably
`engaged” with a vial
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`Independent claim 1 requires that the “lid is configured to removably engage
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`said vial.” Petitioner argues that O’Donovan teaches this limitation because
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`“[s]econd chamber 3 can attach and remove to first chamber 2 via friction fit.”
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`(RPet, Page 22.) Petitioner supports its argument with testimony from Dr. Layton.
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`(Ex. 1003, ¶¶ 111-112.)
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`“A claim is anticipated only if each and every element as set forth in the
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`claim is found, either expressly or inherently described, in a single prior art
`
`reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631
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`(Fed. Cir. 1987). Petitioner cannot and does not point to an explicit teaching in
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`O’Donovan for a lid that is “removably engaged,” and instead offers only possible
`
`interpretations of O’Donovan’s embodiments. “Inherency, however, may not be
`
`established by probabilities or possibilities. The mere fact that a certain thing may
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`result from a given set of circumstances is not sufficient.” In re Robertson, 169
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`F.3d 743, 745 (Fed. Cir. 1999) (citations omitted). Petitioner grounds its analysis
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`in possibilities.
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`Docket No. 604140000012
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`Petitioner does not explain how O’Donovan’s first and second chamber can
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`be removed “via friction fit.” Petitioner appears to argue that if a lid and vial can
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`be engaged, then they also can be removed. (See also RPet, 9-10 (arguing that “the
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`particular means used to removably engage the lid to the vial is not important.”).)
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`But this conflates “engaged” with “removably engaged” and thus reads
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`“removably” out of “removably engaged.”
`
`The ’381 Patent explains “removably engaged” and why it is important: “in
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`one example of the present invention, the container system includes a removable
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`vial which is suitable for subsequent processing of samples and/or for use with
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`robotic systems.” (Ex. 1001, Col. 4:2-5.) Petitioner does not explain how
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`O’Donovan’s lid can be removed for further processing of a sample.
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`Further, a person of skill in the art would not understand O’Donovan’s lid to
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`be configured for removal. First, O’Donovan has no need for a removable lid.
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`O’Donovan teaches a “transparent” chamber. (Ex. 1007, Col. 2:43-44.) Using a
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`transparent chamber, O’Donovan teaches “analys[is] by an optical instrument at
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`the point of care.” (Id., Col. 3:26-28.) O’Donovan has no need to remove the lid
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`from the vial because (1) analysis is performed by an optical instrument through
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`the transparent chamber (Figure 2 is edited and provided below to demonstrate a
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`sample within the transparent container) and (2) analysis is performed at the point
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`IPR2016-00060
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`Docket No. 604140000012
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`of care, not at a later time, so once the optical analysis is complete, the closed vial
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`can be discarded.
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`Second, O’Donovan’s system does not suggest that a user could remove the
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`lid from the vial, either by hand or otherwise. When a user inserts O’Donovan’s
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`vial into the lid, the top of the vial and lid are flush and the gap between the lid and
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`vial is very small (see relevant portion of Figure 4, reproduced below).
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`O’Donovan does not teach the lid is removably engaged and Petitioner does not
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`argue that O’Donovan’s lid is necessarily removably engaged. Schering Corp.
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`v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“Moreover, a prior
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`art reference may anticipate without disclosing a feature of the claimed invention if
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`that missing characteristic is necessarily present, or inherent, in the single
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`anticipating reference.”) (emphasis added).
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`(Ex. 2007, Figure 4.)
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`Petitioner argues that “[i]f chamber 3 were not removable, the provision of
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`an optional cover . . ., or “fastener” . . . , would make no sense.” (RPet, Page 28.)
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`Petitioner does not explain why an optional cover or fastener means O’Donovan’s
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`lid is necessarily removably engaged from the vial. Petitioner cites to Dr. Layton’s
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`declaration to support its position (id. (citing Ex. 1003, ¶¶ 111-12)); Dr. Layton
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`offers no opinion on the optional cover and fastener.
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`Moreover, there are other possibilities for the optional cover that “make
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`sense.” For example, some percentages of lids may be defective. In that scenario,
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`a redundant safeguard against losing liquid or against tampering would be
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`advantageous. Indeed, the “alternative embodiments” indicate O’Donovan’s goal
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`is to make the vial and lid more secure and tamper-evident, not that the lid itself is
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`“removably engaged.”
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`Dr. Layton’s declaration does not improve Petitioner’s likelihood of
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`prevailing. First, 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.” Dr. Layton is incorrect that the same
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`force applied in reverse releases the fit. Considering O’Donovan in its entirety, the
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`O’Donovan apparatus requires a different force to remove the lid, if it were
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`removable at all.
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`When a user pushes on O’Donovan’s lid before the friction fit engages,
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`nothing opposes the applied force. The friction fit engages at the level of the
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`spikes because “[t[he spikes are located so that there is just enough space for the
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`rim of 11 of the chamber 3 to fit between the spikes 20 and the wall of the socket 6
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`with a friction fit.” (Ex. 1007, Col. 2:63-66.) Examine Figure 4 (reproduced in
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`part above)—the spikes (and, hence, the friction fit) only occupy a small lower
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`portion of the opening in the chamber 3. Thus, the applied force accelerates the lid
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`relative to the vial and the lid gains momentum until the friction fit. When the lid
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`engages the friction fit, the lid’s momentum and the continued force applied by the
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`user allow the lid to overcome the friction fit.
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`To remove the lid after insertion requires more force because the lid is
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`initially at rest. First, a user will need more force because there is no momentum
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`from a resting position to assist in the lid’s movement. Second, the lid will have to
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`overcome the static friction provided by the fiction fit. As anyone who has pushed
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`a stalled car knows, the initial push to overcome static friction requires the most
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`energy and, once the car starts rolling, the car needs less force to maintain motion.
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`In the same way, removing O’Donovan’s lid would require more force when
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`moving the lid from rest.
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`Dr. Layton’s conclusion is wrong for an additional reason. Dr. Layton
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`argues that “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.” In reality, a user could not apply a
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`removal force in the same way as the insertion force. Figures 1 and 2 of
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`O’Donovan are edited and colored below to demonstrate its operation.
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`On insertion, a user pushes in on the lid. On removal, there is no structure
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`on the lid for a user to “apply [the force] in reverse” because the lid is closed in the
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`vial. A user cannot access the vial to push on the bottom of the lid. Nor could a
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`user pull on the lid’s flat top end because there is nowhere to grip the flat top end.
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`Removing O’Donovan’s lid is akin to removing the cork from a wine bottle; there
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`is no structure for one’s fingers to grab the cork/lid.
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`Neither Petitioner’s conclusory analysis nor Dr. Layton’s incomplete
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`analysis of “releasably engaged” shows that Petitioner has a reasonable likelihood
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`of prevailing on any challenged claims from O’Donovan. Petitioner fails to show
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`that O’Donovan explicitly or inherently teaches a “removably engaged” lid.
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`Moreover, when O’Donovan is considered in its entirety, one of skill in the art
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`would not consider O’Donovan’s lid and vial to be removably engaged. The
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`Board should deny institution over O’Donovan for at least this reason.
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`B.
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`Petitioner fails to show that O’Donovan teaches a “chamber
`sealed against leakage to the outside of the container system in the
`piercing position”
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`Independent claim 1 requires “wherein the chamber is sealed against leakage
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`to the outside of the container system in the piercing position.” Petitioner argues
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`that O’Donovan explicitly teaches this limitation because O’Donovan states “[t]he
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`combination of the chambers 2 and 3 are effectively a single chamber . . .
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`especially when the optional cover and seal are engaged, and is inherent in the
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`intended use.” (RPet, Pages 23, 28-29.) Petitioner supports its argument with
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`testimony from Dr. Layton. (Ex. 1003 ¶¶ 114-115.)
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`As an initial matter, Petitioner mislabels O’Donovan’s description; there is
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`no “explicit teaching” of a chamber “sealed to the outside of the container.”
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`O’Donovan merely teaches that two chambers can be joined together to a single
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`chamber—there is no mention of the single chamber preventing leakage to the
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`outside. Petitioner reads a feature into “single chamber” that is not necessarily
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`there, namely that the single chamber is a sealed chamber. A chamber may not be
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`sealed. For example, neither of chambers 2 and 3 is sealed. Petitioner deals in
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`possibilities, not the necessity required for inherency.
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`Moreover, Petitioner’s argument for the “sealed” limitation is inconsistent
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`with its argument for the “removably engaged” limitation. Petitioner argues that
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`the option of using an additional cover and seal means that O’Donovan’s
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`embodiment without the optional cover is “removably engaged” (RPet, Pages 28),
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`whereas the embodiment with the optional cover is “sealed” (RPet, Page 28-29). It
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