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
`____________________________________________________________
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`sd-682683
`
`
`_______________
`
`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
`____________________________________________________________
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`sd-682683
`
`
`
`IPR2016-00060
`
`
`Docket No. 604140000012
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`Introduction ..................................................................................................... 1
`
`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 .................................................... 3
`
`III. Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan anticipates Claim 1 ..................................................................... 5
`
`A. O’Donovan does not disclose “[a] lid configured to removably
`engage [a] vial” .................................................................................... 6
`
`B.
`
`Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan discloses a lid removably engaging a vial ...................... 10
`
`IV. Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan in view of KCCL renders Claim 7 unpatentable ...................... 17
`
`V.
`
`Conclusion .................................................................................................... 22
`
`
`
`sd-682683
`
`i
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Aspex Eyewear v. Marchon Eyewear, 672 F.3d 1335 (Fed. Cir. 2012) ................ 4, 9
`
`Continental Can v. Monsanto, 948 F.2d 1264 (Fed. Cir. 1991) .............................. 12
`
`Elekta Instr. v. O.U.R. Sci. Int’l, 214 F.3d 1302 (Fed. Cir. 2000) ............................. 3
`
`In re Giannelli, 739 F.3d 1375 (Fed. Cir. 2014) .................................................... 4, 9
`
`In re Gordon, 733 F.2d 900 (Fed. Cir. 1984) .......................................................... 21
`
`In re Man Machine Interface Tech., 2016 U.S. App. LEXIS 6993 (Fed. Cir.
`2016) ................................................................................................................. 4, 9
`
`In re Robertson, 169 F.3d 743 (Fed. Cir. 1999) ...................................................... 12
`
`In re Sponnoble, 405 F.2d 578 (CCPA 1969).......................................................... 21
`
`Merck & Co. v. Teva Pharm., 395 F.3d 1364 (Fed. Cir. 2005) ................................. 3
`
`Profectus Tech. v. Huawei Tech., Case Nos. 2015-1016, 2015-1018, and,
`2015-1019 (Fed. Cir. May 26, 2016) .................................................................. 10
`
`Tec Air v. Denso Mfg. Michigan, 192 F.3d 1353 (Fed. Cir. 1999) .......................... 21
`
`
`
`STATUTES
`
`35 U.S.C. § 102(e)(2) ................................................................................................. 1
`
`35 U.S.C. § 103 .......................................................................................................... 1
`
`
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.120 ..................................................................................................... 1
`
`
`
`sd-682683
`
`ii
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`Patent Owner’s Exhibit List for Inter Partes Review of U.S. Patent
`No. 8,221,381 B2
`
`Exhibit Description
`
`Exhibit #
`
`Screenshot from the PTO’s “Patent Application Information
`
`Ex. 2001
`
`Retrieval” for U.S. Patent No. 6,152,296,
`
`http://portal.uspto.gov/pair/PublicPair accessed February 3, 2016.
`
`Screenshot of http://www.uspto.gov/patent/contact-patents/patent-
`
`Ex. 2002
`
`technology-centers-management, accessed February 3, 2016.
`
`Changes to Implement Miscellaneous Post Patent Provisions of the
`
`Ex. 2003
`
`Leahy-Smith American Invents Act, 1421 Off. Gaz. Pat. &
`
`Trademark Office 1263 (December 29, 2015)
`
`Transcript of Deposition of Terry Layton, Ph.D., May 25, 2016
`
`Ex. 2004
`
`Declaration of John Collins, Ph.D.
`
`John M Collins, Ph.D. Resume
`
`Ex. 2005
`
`Ex. 2006
`
`Petition for Inter Partes Review of U.S. Patent No. 8,221,381,
`
`Ex. 2007
`
`filed June 3, 2016
`
`Declaration of Terry Layton, Ph.D. in Support of Petition for Inter
`
`Ex. 2008
`
`Partes Review of U.S. Patent No. 8,221,381, filed June 3, 2016
`
`U.S. Patent No. 4,131,016
`
`U.S. Patent No. 4,301,812
`
`Ex. 2009
`
`Ex. 2010
`
`sd-682683
`
`iii
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`Exhibit Description
`
`Exhibit #
`
`ASTM D 1894-01, “Standard Test Method for Static and Kinetic
`
`Ex. 2011
`
`Coefficients of Friction of Plastic Film and Sheeting”
`
`
`
`sd-682683
`
`iv
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`Patent Owner provides this Response under 37 C.F.R. § 42.120 and requests
`
`relief through a determination that Petitioner has not shown by a preponderance of
`
`the evidence that any instituted ground renders select claims of U.S. Patent
`
`No. 8,122,381 B2 (“the ’381 Patent;” Ex. 1001) unpatentable.
`
`I.
`
`Introduction
`
`The ’381 Patent claims an apparatus and method for releasing a substance
`
`into a vial. A lid includes a reservoir with the substance and includes a membrane
`
`to seal the substance in the reservoir. The vial includes a piercing member that
`
`disrupts the membrane and thereby releases the substance into the vial. The lid and
`
`vial are removably engaged and are sealed against leakage in the piercing position.
`
`Petitioner proposed four grounds. (Resubmitted Petition (“RPet”), Table of
`
`Contents.) The Board instituted inter partes review on two: (1) Claims 1, 2, 4, 5,
`
`8, 11, 12, 15-17, 20, 41, 44, and 49 are allegedly anticipated under 35 U.S.C.
`
`§ 102(e)(2) by U.S. Patent 7,645,424 (“O’Donovan”); and (2) Claims 1 and 7 are
`
`allegedly unpatentable under 35 U.S.C. § 103(a) over O’Donovan in view of WO
`
`98/03265 (“KCCL”). (Institution Decision (“Inst”), Page 22.) Patent Owner
`
`submits that Petitioner has failed to prove by a preponderance of the evidence that
`
`any of Claims 1, 2, 4, 5, 7, 8, 11, 12, 15-17, 20, 41, 44, and 49 are unpatentable.
`
`For Ground 1, Petitioner fails to give “configured to” meaning in the
`
`limitation “[a] lid configured to removably engage [a] vial,” thereby reading
`
`sd-682683
`
`1
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`“configured to” out of the claims and construing this limitation beyond its broadest
`
`reasonable interpretation. Putting aside Petitioner’s failure to give “configured to”
`
`meaning, Petitioner also fails to prove O’Donovan discloses a “releasably
`
`engaged” lid.
`
`For Ground 2, Petitioner has not shown by a preponderance of the evidence
`
`that Claim 7 of the ’381 Patent is unpatentable over O’Donovan in view of KCCL.
`
`Petitioner’s rationale is unclear. It is unclear whether Petitioner proposes replacing
`
`O’Donovan’s friction fit connection with a threaded engagement, but if that is the
`
`proposal then that change does not require changing the relative width of the ends
`
`of O’Donovan’s vial. It is unclear whether Petitioner proposes replacing
`
`O’Donovan’s vial with a different shaped vial, but if that is the proposal then that
`
`change does not require changing the relative width of the ends of O’Donovan’s
`
`vial. It is unclear whether Petitioner proposes substituting KCCL’s vial for
`
`O’Donovan’s, but if that is the proposal then that change provides no structure to
`
`pierce O’Donovan’s foil membrane and release O’Donovan’s buffer reagent.
`
`For at least these reasons, Petitioner fails to prove by a preponderance of the
`
`evidence that O’Donovan anticipates Claims 1, 2, 4, 5, 8, 11, 12, 15-17, 20, 41, 44,
`
`and 49 and O’Donovan in view of KCCL renders Claim 7 unpatentable.
`
`sd-682683
`
`2
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`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
`
`Patent Owner submits that the broadest reasonable interpretation of “[a] lid
`
`configured to removably engage [a] vial” is not met by a lid that can attach to a
`
`vial and is merely capable of later removal. Petitioner’s unreasonably broad
`
`construction of “[a] lid configured to removably engage [a] vial” is contradicted by
`
`the claim language, the specification’s description of the invention’s purpose, and
`
`Federal Circuit precedent analyzing the limitation “configured to.”
`
`Claim 1 (and, through dependency, all challenged claims) includes the
`
`limitation “[a] lid configured to removably engage [a] vial.” To give meaning to
`
`the limitation “configured to,” this limitation must mean more than a “lid
`
`removably engage[ing] a vial.” Otherwise, the term “configured to” would be
`
`superfluous. Merck & Co. v. Teva Pharm., 395 F.3d 1364, 1372 (Fed. Cir. 2005)
`
`(“A claim construction that gives meaning to all the terms of the claim is preferred
`
`over one that does not do so.”); Elekta Instr. v. O.U.R. Sci. Int’l, 214 F.3d 1302,
`
`1307 (Fed. Cir. 2000) (construing claim to avoid rendering a claim limitation
`
`superfluous). Thus, “configured to” must be given meaning.
`
`The ’381 Patent makes clear why the lid is configured to be removed from
`
`the vial. The ’381 Patent’s systems are configured to store samples in a vial and
`
`permit later access to the sample for “subsequent processing.” (See Ex. 2005, ¶ 22
`
`sd-682683
`
`3
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`(citing Ex. 1001, Col. 4:4-5).) If the lids were not configured for later release but
`
`merely capable of later release, then an operator may not be able to access the
`
`stored sample in the intended environment and/or procedure. (Ex. 2005, ¶ 22.) A
`
`mere capability for release is insufficient to provide for subsequent processing.
`
`(Id.)
`
`The Federal Circuit consistently interprets “configured to” to be narrower
`
`than “capable of.” In Aspex Eyewear v. Marchon Eyewear, the Federal Circuit
`
`analyzed the term “adapted to” and noted it could be construed broadly as “capable
`
`of” or narrowly as “configured to.” 672 F.3d 1335, 1349 (Fed. Cir. 2012) (“[T]he
`
`phrase ‘adapted to’ is frequently used to mean ‘made to,’ ‘designed to,’ or
`
`‘configured to,’ but it can also be used in a broader sense to mean ‘capable of’ or
`
`‘suitable for.’”); see also In Re Man Machine Interface Tech., 2016 U.S. App.
`
`LEXIS 6993, at Page 3 (Fed. Cir. 2016) (“We have noted that the phrase ‘adapted
`
`to’ generally means ‘made to,’ ‘designed to,’ or ‘configured to,’ but it can also be
`
`used more broadly to mean ‘capable of’ or ‘suitable for.’”); In Re Giannelli 739
`
`F.3d 1375, 1379 (Fed. Cir. 2014).) In Aspex, the panel found “a narrower
`
`definition, such as ‘configured to’” applied to the equivocal “adapted to.” 672
`
`F.3d at 1349. The ’381 Patent is unequivocal; the claims require the lid to be
`
`narrowly “configured to” removably engage a vial.
`
`sd-682683
`
`4
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`Petitioner fails to give “configured to” meaning. Petitioner offers an explicit
`
`construction for “removably engage” (RPet, Page 10), but no explicit construction
`
`for “configured to removably engage.” Petitioner argues O’Donovan discloses “[a]
`
`lid configured to removably engage [a] vial” by applying Petitioner’s proposed
`
`claim interpretation for “removably engage.” (Compare id. Page 10 (construing
`
`“removably engaged” as “a lid that can be attached in various ways and can later
`
`be removed”) with id. Page 22 (arguing O’Donovan meets “configured to
`
`removably engage” because O’Donovan’s “[s]econd chamber 3 can attach and
`
`remove to first chamber 2 via friction fit”).) Petitioner thus equates “removably
`
`engage” with “configured to removably engage,” thereby impermissibly reading
`
`“configured to” out of the claims.
`
`In sum, “configured to” should be given meaning in the limitation “[a] lid
`
`configured to removably engage [a] vial.”
`
`III. Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan anticipates Claim 1
`
`Petitioner bears the burden of proving by a preponderance of the evidence
`
`that O’Donovan anticipates Claim 1. Petitioner fails to meet its burden.
`
`First, O’Donovan does not disclose “[a] lid configured to removably engage
`
`[a] vial.” Petitioner’s analysis is based upon an erroneous construction that reads
`
`“configured to” out of the claim. When “configured to” is given meaning,
`
`sd-682683
`
`5
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`O’Donovan’s lid does not disclose “[a] lid configured to removably engage [a]
`
`vial.”
`
`Second, Petitioner fails to prove by a preponderance of the evidence that
`
`O’Donovan discloses a lid “releasably engaged” to a vial. As an initial matter,
`
`Petitioner’s interpretation of “releasably” is too broad under Federal Circuit
`
`precedent. Additionally, Petitioner fails to show that O’Donovan discloses the
`
`element even under Petitioner’s erroneous construction, either explicitly or
`
`inherently.
`
`A. O’Donovan does not disclose “[a] lid configured to removably
`engage [a] vial”
`
`O’Donovan’s lid is not configured to removably engage O’Donovan’s vial.
`
`O’Donovan uses a transparent chamber to enable “analys[is] by an optical
`
`instrument at the point of care.” (Id., Col. 3:26-28.) O’Donovan has no need to
`
`remove the lid from the vial because (1) analysis is performed by an optical
`
`instrument through the transparent chamber (Figure 2 is edited and provided below
`
`to demonstrate a sample within the transparent container) and (2) analysis is
`
`performed at the point of care, so the closed vial can be discarded once the optical
`
`analysis is complete. (See, e.g., Ex. 1007, Abstract, 2:39-40, 3:11-12, 3:41-43.)
`
`There is no need to configure the lid for removal. (Ex. 2005, ¶ 31-32.)
`
`sd-682683
`
`6
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`
`
`Instead of discloses a lid that is configured to be removably engaged,
`
`O’Donovan discloses the opposite: a lid configured to be non-removable. (Ex.
`
`2005, ¶ 37.) When a user inserts O’Donovan’s vial into the lid, the top of the vial
`
`and lid are flush and the gap between the lid and vial is very small (see relevant
`
`portion of Figure 4, reproduced below). (Id.) This arrangement of structural
`
`features prevents a user from removing the lid. (Id.)
`
`sd-682683
`
`7
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`
`
`When asked during cross-examination, Dr. Layton stated that a friction fit
`
`could be designed for removal. (Ex. 2004, Page 31:7-11 (“THE WITNESS: If you
`
`want it removed, you design it so it can be removed. If you don’t want it to be
`
`removed, you design it so it can’t be removed.”); Page 128:4-19 (“Q.·Is it possible
`
`to have a device where whether it’s still going to be removed or not [is] really
`
`determined by the material being used? . . . A. The material is a possibility.
`
`Dimensions are a big possibility. Dimensions are the most important one.”).)
`
`Given the dimension’s importance in determining removability, the very small
`
`space between the lid and vial clearly indicates that the lid and vial in
`
`O’Donovan’s device are designed, or configured, to be non-removable.
`
`In a declaration supporting Petitioner’s second IPR petition for the’381
`
`Patent (Ex. 2007), Dr. Layton stated that a friction could be configured for
`
`removal:
`
`I would add that there is nothing in the nature of a friction fit that
`
`sd-682683
`
`8
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`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.
`
`(Ex. 2008, ¶ 127.) Dr. Collin’s agrees that there is nothing in a friction fit
`
`“requires that the two components, once engaged, create a flush end.” (Ex. 2005,
`
`¶ 36-37.) However, O’Donovan is configured to have so that the two components
`
`create a flush end and is thus configured to be non-removable. (Id.)
`
`As noted above, Petitioner’s analysis of “[a] lid configured to removably
`
`engage [a] vial” gives “configured to” no meaning. Petitioner argues that
`
`O’Donovan’s “friction fit allows removal.” (RPet, Page 28) But “configured to” is
`
`narrower than “capable of” or “suitable for” or “allowing” removal. Aspex, 672
`
`F.3d at 1349; In Re Man Machine, 2016 U.S. App. LEXIS 6993, at 3; In Re
`
`Giannelli, 739 F.3d at 1379. Petitioner also argues that O’Donovan’s “optional
`
`cover” means O’Donovan must be “removable.” But, a “removable” lid is not
`
`necessarily a “lid configured to removably engage” a vial because “removable”
`
`encompasses lids merely capable of removal. Petitioner’s analysis fails to prove
`
`by a preponderance of the evidence that O’Donovan discloses “[a] lid configured
`
`to removably engage [a] vial.”
`
`In sum, O’Donovan does not disclose “[a] lid configured to removably
`
`engage [a] vial,” but instead discloses a lid configured not to be removably
`
`sd-682683
`
`9
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`engaged. Further, Petitioner’s analysis is fatally premised on an unreasonably
`
`broad interpretation.
`
`B.
`
`Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan discloses a lid removably engaging a vial
`
`As described above, Petitioner focuses its argument of “[a] lid configured to
`
`removably engage [a] vial” on its construction of a lid “removably engaging” a vial
`
`and thereby eliminates “configured to” from the claim. Even if “configured to”
`
`were read out of “configured to removably engage,” Petitioner still fails to prove
`
`by a preponderance of the evidence that O’Donovan discloses a lid removably
`
`engaging a vial.
`
`First, Petitioner’s proposed construction of “removably engage” (i.e., “a lid
`
`that can be attached in various ways and can later be removed”) is impermissibly
`
`met by a device without an “inherent feature” for lid removal. Second, even if
`
`“removably engage” does not require an inherent feature for lid removal and is met
`
`by a lid that merely can be later removed, Petitioner has failed to show that
`
`O’Donovan explicitly or inherently discloses a lid that can be later removed.
`
`Petitioner argues that “removably engage” means “a lid that can be attached
`
`in various ways and can later be removed.” (RPet at Page 9-10.) Petitioner’s
`
`construction fails to require an inherent feature for removal. The Federal Circuit
`
`recently addressed a similar issue in Profectus Tech. v. Huawei Tech. In that case,
`
`the disputed claim term was “mountable picture frame.” Case Nos. 2015-1016,
`
`sd-682683
`
`10
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`2015-1018, and, 2015-1019, Slip. Op. at 3 (Fed. Cir. May 26, 2016). The district
`
`court construed the term to mean “having a feature for mounting;” the accused
`
`infringer argued it meant “capable of being mounted.” Id., Slip. Op. at 5-6. The
`
`Federal Circuit held the “term ‘mountable’ is a modifying word in . . . ‘mountable
`
`picture frame’” and that broader words, “such as ‘capable of,’” were absent from
`
`the claims. Id. at 9.
`
`In the same way here, “removable” is a modifying word in “removably
`
`engaged,” and Claim 1 does not describe the lid as broadly “capable of” removal.
`
`In affirming that “mountable” must have “an inherent feature for mounting,” the
`
`Federal Circuit in Profectus noted the specification’s consistent teaching of
`
`inherent features for mounting. (Id. at 9-10.) In the same way, the ’381 Patent
`
`consistently teaches an inherent feature for removing. For example, Figures 1-24
`
`depict a threaded engagement between the lid and vial. Petitioner’s analysis of
`
`“removably engaged” fails because it does not require an inherent feature for
`
`removing.
`
`There is no inherent feature in O’Donovan for removing the lid from the
`
`vial. (Ex. 2005, ¶ 34.) There is no structure on the lid for a user to “apply [the
`
`force] in reverse” because the lid is closed in the vial. (Id.) A user cannot access
`
`the vial to push on the bottom of the lid. (Ex. 2005, ¶ 35.) Nor could a user pull
`
`on the lid’s flat top end because there is nowhere to grip the flat top end. (Id.) As
`
`sd-682683
`
`11
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`Dr. Layton noted, dimensions are the most important feature for removability (Ex.
`
`2005 (Page 128:4-19)); there is no evidence that O’Donovan’s dimensions provide
`
`for removability. Thus, O’Donovan does not disclose an inherent feature for
`
`removing the lid from the vial and thus does not disclose a lid “removably
`
`engaged” to a vial. (Ex. 2005, ¶ 35.)
`
`Assuming that Petitioner’s construction of “removably engage” is correct
`
`and this term is met by a lid that merely can be later removed, Petitioner still fails
`
`to prove O’Donovan explicitly or inherently discloses a lid that can later be
`
`removed. Petitioner does not contend that O’Donovan explicitly discloses a lid for
`
`later removal. Petitioner instead relies on two teachings in O’Donovan to prove
`
`inherency: O’Donovan’s friction fit and O’Donovan’s optional cover.
`
`“If the prior art reference does not expressly set forth a particular element of
`
`the claim, that reference still may anticipate if that element is ‘inherent’ in its
`
`disclosure.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). “To establish
`
`inherency, the extrinsic evidence ‘must make clear that the missing descriptive
`
`matter is necessarily present in the thing described in the reference, and that it
`
`would be so recognized by persons of ordinary skill.’” Id. (citation omitted).
`
`“Inherency, however, may not be established by probabilities or possibilities. The
`
`mere fact that a certain thing may result from a given set of circumstances is not
`
`sd-682683
`
`12
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`sufficient.” Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1269
`
`(Fed. Cir. 1991).
`
`Petitioner argues that O’Donovan’s friction fit allows removal and relies on
`
`Dr. Layton’s testimony to support its argument. (RPet at Page 28 (citing Ex. 1003,
`
`¶¶ 111-112).) Dr. Layton opines that “a friction fit is known to be removable
`
`because the same force used to form the friction fit can be applied in reverse to
`
`remove the friction fit between the parts.” (Ex. 1003, ¶ 112.) Dr. Layton is
`
`incorrect that the same force applied in reverse releases the fit. (Ex. 2005, ¶ 38.)
`
`Considering O’Donovan in its entirety, the O’Donovan apparatus requires a
`
`different force to remove the lid, if it is removable at all. (Id.)
`
`When a user pushes on O’Donovan’s lid before the friction fit engages, there
`
`is relative motion and the lid and vial are in dynamic friction. (Id. at ¶ 39.) The
`
`friction fit engages at the level of the spikes because “[t]he spikes are located so
`
`that there is just enough space for the rim of 11 of the chamber 3 to fit between the
`
`spikes 20 and the wall of the socket 6 with a friction fit.” (Ex. 1007, Col. 2:63-66.)
`
`Examine Figure 4 (reproduced in part below)—the spikes (and, hence, the friction
`
`fit) only occupy a small lower portion of the opening in the chamber 3. (Id.)
`
`sd-682683
`
`13
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`
`
`To remove the lid after insertion requires more force because the lid is
`
`initially at rest. (Ex. 2005, ¶ 40.) The lid will have to overcome the static friction
`
`provided by the fiction fit. (Id.) As anyone who has pushed a stalled car knows,
`
`the initial push to overcome static friction requires the most energy and, once the
`
`car starts rolling, the car needs less force to maintain motion. In the same way,
`
`removing O’Donovan’s lid would require more force when moving the lid from
`
`rest. (Id.)
`
`When cross-examined, Dr. Layton admitted that he could not say that a
`
`friction fit necessarily leads to removable engagement. Dr. Layton was asked
`
`whether “a friction fit always lead[s] to removable engagement?” (Ex. 2004, Page
`
`134:11-13.) In response, Dr. Layton testified:
`
`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
`
`sd-682683
`
`14
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`with, it’s removable. I can’t think of [one] right now, but there may
`be some.
`
`(Id., Page 134:14-22.)
`
`Turning now to the Petition and the Institution Decision’s reliance on
`
`O’Donovan’s optional cover (RPet, Page 28; Inst, Pages 9-10), the optional cover
`
`does not necessarily or inherently indicate that a lid is capable of removal.
`
`Petitioner cites to Dr. Layton’s declaration to support its position. (RPet, Page 28
`
`(citing Ex. 1003, ¶¶ 111-12).) However, Dr. Layton offers no opinion on the
`
`optional cover in his declaration.
`
`Moreover, Dr. Layton has since provided reasons for the optional cover, but
`
`the reasons do not suggest that the lid can later be removed. In a declaration
`
`supporting Petitioner’s second IPR petition for the’381 Patent (Ex. 2007),
`
`Dr. Layton describes the reasons for the optional cover:
`
`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.”
`
`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,
`
`sd-682683
`
`15
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`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.
`
`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.
`
`(Ex. 2008, ¶¶ 161-63 (internal citations omitted).)
`
`Thus, Dr. Layton provides an alternative reason (other than a removably
`
`engaged lid and vial) for the optional cover: further assurance against leakage.
`
`(Id.) Dr. Collins agrees with Dr. Layton’s analysis that a reason for the optional
`
`cover is “further assurance against leakage.” (Ex. 2005, ¶ 42 (citing Ex. 2008,
`
`¶¶ 161-63).) Dr. Collins also agrees with Dr. Layton that further assurance against
`
`leakage is particularly important with friction fit embodiments, as in O’Donovan,
`
`and where fluids contained within the vial are biological samples, as in
`
`O’Donovan. (Ex. 2005, ¶ 40 (citing Ex. 2008, ¶¶ 161-63).)
`
`Because there are alternative reasons for the optional cover, O’Donovan
`
`does not necessarily disclose a lid that can be later removed. Because O’Donovan
`
`does not necessarily disclose a removable lid, O’Donovan does not inherently
`
`sd-682683
`
`16
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`disclose a removable lid. Petitioner has failed to prove by a preponderance of the
`
`evidence that O’Donovan explicitly or inherently discloses a removable lid.
`
`In sum, Petitioner fails to prove by a preponderance of the evidence that
`
`O’Donovan discloses a lid “releasably engaged” to a vial. Petitioner’s
`
`interpretation of “releasably” is too broad under Federal Circuit precedent.
`
`Further, Petitioner fails to show that O’Donovan discloses the element even under
`
`its erroneous interpretation, either explicitly or inherently.
`
`IV. Petitioner fails to prove by a preponderance of the evidence that
`O’Donovan in view of KCCL renders Claim 7 unpatentable
`
`Petitioner argues that one of ordinary skill in the art “would have understood
`
`that a vial having uniform cross-section diameter could readily have been
`
`substituted for the vial shown in O’Donovan simply by replacing the friction
`
`socket with a threading engagement between the lid and vial.” (RPet, Page 32; see
`
`also Layton Decl. at ¶ 148-152.) Petitioner argues that one of ordinary skill in the
`
`art would have been motivated “to make [O’Donovan’s] reagent cuvette
`
`compatible with other analytical devices.” (RPet, Page 32.) Petitioner also argues
`
`that the substitution of KCCL’s vial for O’Donovan’s vial is a “simple
`
`substitution.” (RPet, Page 32.)
`
`Petitioner’s rationale is unclear. It is unclear whether Petitioner proposes
`
`replacing O’Donovan’s friction fit connection with a threaded engagement,
`
`whether Petitioner proposes replacing O’Donovan’s vial “to make the reagent
`
`sd-682683
`
`17
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`cuvette compatible with other analytical devices,” or whether Petitioner proposes
`
`substituting KCCL’s vial for O’Donovan’s. None of these modifications render
`
`Claim 7 obvious.
`
`Assuming Petitioner proposes replacing O’Donovan’s friction fit connection
`
`with a threaded engagement, the proposal does not require changing the relative
`
`width of the ends of O’Donovan’s vial. The threaded engagement is on the outside
`
`of the vial and thus would not have any impact on the interior of the vial. Thus,
`
`this modification to O’Donovan would not result in a device that met Claim 7’s
`
`“the width of said first end is equivalent to the width of said second end.”
`
`Assuming Petitioner proposes replacing O’Donovan’s vial “to make the
`
`reagent cuvette compatible with other analytical devices,” the proposal does not
`
`require changing the relative width of the ends of O’Donovan’s vial. Even if one
`
`of skill in the art were motivated to change the width of the bottom end of
`
`O’Donovan’s vial, there is no need to change the relative width of the two ends. In
`
`other words, one of skill in the art could make O’Donovan “compatible with other
`
`analytical devices” without changing the relative widths of the ends. Thus, this
`
`modification to O’Donovan would not result in a device that met Claim 7’s
`
`limitation “the width of said first end is equivalent to the width of said second
`
`end.”
`
`sd-682683
`
`18
`
`
`
`IPR2016-00060
`
`Docket No. 604140000012
`
`Assuming Petitioner is proposing “a simple substitution” of KCCL’s vial for
`
`O’Donovan’s vial, then one of skill in the art would not be motivated to make the
`
`substation: the proposed combination provides no mechanism to pierce and tear
`
`O’Donovan’s foil membrane. When one of skill in the art fully considers the
`
`ramifications of Petitioner’s proposed combination, one of skill in the art would
`
`not be motivated to modify O’Donovan as proposed. (Ex. 2005, ¶ 46.) Thus,
`
`Petitioner has failed to prove that O’Donovan in view of KCCL renders 7 obvious.
`
`Petitioner relied on Dr. Layton’s opinion in proposing the combination of
`
`O’Donovan and KCCL. Specifically, Petitioner relies on Dr. Layton’s opinion to
`
`support the conclusion that “POSITA would have been motivated to substitute the
`
`vial of KCCL . . . for the cuvette of O’Donovan, to make the reagent cuvette
`
`compatible with other analytical devices” (RPet, Page 32 (citing Ex. 1003,
`
`¶ 148-52)) and to support the conclusion that “the substitution of elements would
`
`have been merely a [s]imple substitution of one known element for another to
`
`obtain predictable results.” (Id., Page 33 (citing Ex. 1003 ¶¶ 143-152)). Under
`
`cross-examination, Dr. Layton testified that he was not substituting the vial of
`
`KCCL for the cuvette of O’Donovan. (Ex. 2004, Page 159:25-160:4.)
`
`O’Donovan Figure 4 (reproduced below) illustr
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
