Filed: September 6, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________
`
`BEFORE THE PATENT AND TRIAL AND APPEAL BOARD
`
`_______________
`
`ANCESTRY.COM DNA, LLC,
`Petitioner
`
`v.
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`DNA GENOTEK INC.,
`Patent Owner
`
`_______________
`
`Case IPR2016-00060
`Patent 8,221,381 B2
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`_______________
`
`PETITIONER ANCESTRY.COM DNA, LLC’S
`REPLY TO PATENT OWNER’S RESPONSE
`
`
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`29584/95068/DOCS/4102491.5
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT AND TRIAL AND APPEAL BOARD
`
`_______________
`
`ANCESTRY.COM DNA, LLC,
`Petitioner
`
`v.
`
`DNA GENOTEK INC.,
`Patent Owner
`
`_______________
`
`Case IPR2016-00060
`Patent 8,221,381 B2
`
`_______________
`
`PETITIONER ANCESTRY.COM DNA, LLC’S
`REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`29584/95068/DOCS/4102491.5
`
`
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`Case No. IPR2016-00060
`Patent No. Patent 8,221,381 B2
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`I.
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`II.
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`III.
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`TABLE OF CONTENTS
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`UPDATED MANDATORY NOTICES .......................................................... 1
`
`A. Notice of Related Matters (37 C.F.R. § 42.8(b)(2)) .............................. 1
`
`INTRODUCTION ........................................................................................... 2
`
`PO HAS WAIVED ALLARGUMENTS NOT INCLUDED IN PATENT
`OWNER RESPONSE ...................................................................................... 3
`
`IV. PO NEWLY ARGUES IMPROPER CONSTRUCTION OF
`“CONFIGURED TO REMOVABLY ENGAGE” IN ADDRESSING
`ANTICIPATION BY O’DONOVAN (GROUND 1) ..................................... 4
`
`A.
`
`B.
`
`Prior PO Arguments Rely Upon a Much Broader Construction ........... 4
`
`Patent Owner’s New Claim Construction Improperly Reads in
`Unclaimed Limitations .......................................................................... 5
`
`1.
`
`2.
`
`3.
`
`PO Asks the Board to Read an Intended Use Requirement
`into Both the Prior Art and Claim 1 ............................................ 6
`
`PO Asks the Board to Read an “Inherent Feature”
`Requirement into Claim 1 ........................................................... 9
`
`PO’s Claim Construction is Inconsistent with Precedent ......... 11
`
`V. O’DONOVAN DISCLOSES A LID “CONFIGURED TO
`REMOVABLY ENGAGE” A VIAL ............................................................ 13
`
`A.
`
`Patent Owner’s Arguments Rely on Unsubstantiated and
`Unwarranted Assumptions .................................................................. 13
`
`1.
`
`2.
`
`PO Improperly Assumes a “Flush” Lid with “Very Small
`Gap” to Prevent User Removal ................................................. 13
`
`PO Relies on Incorrect Friction Coefficients ............................ 17
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`3.
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`4.
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`PO Arguments Regarding O’Donovan’s Cover are Based on
`a Logical Fallacy ....................................................................... 19
`
`PO Mistakenly Conflates Engagement of the Friction Fit
`with Engagement of the Lid ...................................................... 20
`
`VI. OBVIOUSNESS OVER O’DONOVAN IN VIEW OF KCCL (GROUND
`2) .................................................................................................................... 22
`
`A.
`
`B.
`
`C.
`
`PO Challenged No Limitations of Claims 1 and 7 over O’Donovan
`in view of KCCL ................................................................................. 22
`
`Patent Owner’s Arguments Regarding Combining O’Donovan and
`KCCL Misstate Petitioner ................................................................... 24
`
`Patent Owner’s Arguments Rely on a Mistaken Understanding of
`the Obviousness Standard Set Out in KSR Int'l Co. v. Teleflex Inc. ... 28
`
`VII. CONCLUSION .............................................................................................. 29
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`TABLE OF AUTHORITIES
`
`
`CASES
`DNA Genotek Inc. v. Spectrum Solutions L.L.C. and Spectrum DNA,
`Case No. 3:16-cv-01544-JLS-NLS (S.D. Cal.) ..................................................... 1
`
`DNA Genotek, Inc. v. Ancestry.com DNA LLC,
`Case No. 15-00355-SLR (D. Del.) ......................................................................... 1
`
`DNA Genotek, Inc. v. Spectrum DNA; Spectrum Solutions L.L.C., and Spectrum
`Packaging, LLC,
`Case No. 15-cv-00661-SLR (D. Del.) ................................................................... 1
`
`Ex parte Masham,
`2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) ..................................................... 8
`
`Ex parte Yutaka Imai,
`Appeal 2012-003246, Decision on Appeal at 4 (Sept. 30, 2014) ........................ 11
`
`In re Zletz,
`893 F.2d 319, 13 USPQ2d 1320 (Fed. Cir. 1989) ................................................. 9
`
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................. 28
`
`Merck & Co. v.Biocraft Laboratories, 874 F.2d 804 (Fed. Cir. 1989) ................... 14
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ............................................................................. 5
`
`Profectus Tech. v. Huawei Tech.,
`Case Nos. 2015-1016, 2015-1018, and, 2015-1019, Slip. Op. at 3 (Fed. Cir. May
`26, 2016) ................................................................................................... 9, 10, 11
`
`Riverbed Tech., Inc. v. Silver Peak Sys.,
`2013 U.S. Dist. LEXIS 102589 at 3 (D. Del., July 23, 2013) ............................. 11
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`SAP Am., Inc. v. Versata Dev. Group, Inc.,
`CBM2012-00001 (Paper 81) .................................................................................. 3
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`Tokai Corp. v. Easton Enterprises,
`632 F.3d 1358 (Fed. Cir. 2011) ............................................................................ 27
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`STATUTES
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`35 U.S.C. §301(d) ...................................................................................................... 5
`
`35 USC § 301(a)(2) .................................................................................................... 5
`
`REGULATIONS
`
`37 C.F.R. § 42.23 ....................................................................................................... 1
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`37 C.F.R. § 42.51(b)(1)(iii) ........................................................................................ 4
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`37 C.F.R. § 42.63(e) ................................................................................................... v
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`37 C.F.R. § 42.8(b)(2) ................................................................................................ 1
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`Exhibit
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`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`EXHIBIT LIST (37 C.F.R. § 42.63(e))
`
`Description
`
`U.S. Patent No. 8,221,381 to Muir, et al.
`
`File History of U.S. Patent No. 8,221,381
`
`Declaration of Terry N. Layton, Ph.D.
`
`Curriculum Vitae of Terry N. Layton, Ph.D.
`
`Plaintiff DNA Genotek Inc.’s Opening Brief in Support of Motion for
`Preliminary Injunction, DNA Genotek, Inc. v. Spectrum DNA; Spectrum
`Solutions L.L.C., and Spectrum Packaging, LLC, Case No. 15-cv-00661-
`SLR
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`Declaration of Juan C. Lasheras, Ph.D., DNA Genotek, Inc. v. Spectrum
`DNA; Spectrum Solutions L.L.C., and Spectrum Packaging, LLC, Case
`No. 15-cv-00661-SLR
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`U.S. Patent No. 7,645,424 to O’Donovan
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`PCT Patent Publication WO 2003/104251 to DNA Genotek, Inc. (ex-US
`designations) and Birnboim (US designation)
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`U.S. Patent No. 6,152,296 to Shih
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`PCT Patent Publication WO98/03265 (Japanese)
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`Certified English Translation of PCT Patent Publication WO98/03265
`and certification thereof
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`German Publication DE 199 50 884 A1 (German)
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`Certified English Translation of German Publication DE 199 50 884 A1
`and certification thereof
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`1014
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`U.S. Patent No. 6,228,323 to Asgharian, et al.
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`Exhibit
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`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`Description
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`The American Heritage Dictionary of the English Language, Fourth
`Edition (2000) (selected pages) (definitions of: “cor-ner”; “fastener”;
`“inert”; “reservoir”; “vial”)
`
`Defendants’ Brief in Opposition to DNA Genotek’s Motion for
`Preliminary Injunction, DNA Genotek, Inc. v. Spectrum DNA; Spectrum
`Solutions L.L.C., and Spectrum Packaging, LLC, Case No. 15-cv-00661-
`SLR (REDACTED, PUBLICLY AVAILABLE, VERSION)
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`Declaration of Terry Layton, Ph.D. in Support of Defendants’ Opposition
`to DNA Genotek’s Motion for Preliminary Injunction, DNA Genotek,
`Inc. v. Spectrum DNA; Spectrum Solutions L.L.C., and Spectrum
`Packaging, LLC, Case No. 15-cv-00661-SLR
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`U.S. provisional application no. 60/523,104, filed November 18, 2003 by
`O’Donovan
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`Chart, numerical designation of claim elements
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`Declaration of Michael J. Sacksteder in Support of Petitioner’s Motion
`for Pro Hac Vice Admission of Michael J. Sacksteder Pursuant to 37
`C.F.R. § 42.10(c)
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`Declaration of Melanie L. Mayer in Support of Petitioner’s Motion for
`Pro Hac Vice Admission of Melanie L. Mayer Pursuant to 37 C.F.R. §
`42.10(c)
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`NOT FILED, PREVIOUSLY SUBMITTED AS PAPER 5
`Resubmitted Petition for Inter Partes Review for US Patent 8,221,381
`(Paper 5)
`(Marked as Exhibit 1022 at the Deposition of John M. Collins, Ph.D. on
`August 24, 2016)
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`Exhibit
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`1023
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`1024
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`1025
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`1026
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`Description
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`NOT FILED, PREVIOUSLY SUBMITTED AS PAPER 19
`Institution Decision from The Patent Trial and Appeal Board (Paper 19)
`(Marked as Exhibit 1023 at the Deposition of John M. Collins, Ph.D. on
`August 24, 2016)
`
`Deposition of John M. Collins, Ph.D., August 24, 2016
`
`Excerpt from the Deposition of John Collins, Ph.D., November 13, 2015,
`DNA Genotek Inc. v. Spectrum DNA, et al., USDC – D. Del. Case No.
`15-CV-00661
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`Declaration of John M. Collins, Ph.D. in Support of Plaintiff’s Reply in
`Support of Motion for Preliminary Injunction, DNA Genotek Inc. v.
`Spectrum Solutions L.L.C., et al., USDC – S.D. Cal. Case No. 16-CV-
`01544 (Docket No. 51), filed August 19, 2016
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`1027
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`Biomek® User’s Manual, Beckman Coulter PN 719448, SAGIAN
`Control Number 100-00-00388, Revision AA, May 2000, select pages
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`The Board instituted Inter Partes Review on April 8, 2016. (Paper 19).
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`DNA Genotek Inc. (“PO”) filed its Response on June 22, 2016. (Paper 22).
`
`Ancestry.com DNA, LLC (“Petitioner”) submits this reply under 37 C.F.R. §
`
`42.23.
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`I.
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`UPDATED MANDATORY NOTICES
`A. Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`
`The ’381 patent is the subject of the following patent infringement lawsuits:
`
`(i) DNA Genotek, Inc. v. Ancestry.com DNA LLC, Case No. 15-00355-SLR (D.
`
`Del.) (the “Ancestry ’381 litigation”); and (ii) DNA Genotek, Inc. v. Spectrum
`
`DNA; Spectrum Solutions L.L.C., and Spectrum Packaging, LLC, Case No. 15-cv-
`
`00661-SLR (D. Del.) (the “Spectrum ’381 litigation”).
`
`U.S. Patent No. 9,207,164 issued from Application Serial No. 13/536,599
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`(“the ’599 application”), filed on 6/28/2013. The ‘599 application is a continuation
`
`of the ’381 patent. The ’164 patent is the subject of the following patent
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`infringement lawsuit: DNA Genotek Inc. v. Spectrum Solutions L.L.C. and
`
`Spectrum DNA, Case No. 3:16-cv-01544-JLS-NLS (S.D. Cal.) (the “Spectrum ‘164
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`litigation”).
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`The ’381 patent also is the subject of IPR2016-01152 (“second IPR”), filed
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`on June 3, 2016, which is not yet instituted.
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`The ’164 patent also is the subject of IPR2016-01467 (“third IPR”), filed on
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`July 21, 2016, which is not yet instituted.
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`II.
`
`INTRODUCTION
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`Patent Owner DNA Genotek Inc. (PO) has limited the issues the Board
`
`needs to consider by challenging only the limitation “configured to removably
`
`engage” for claim 1 in Ground 1 and the combining of references in Ground 2, and
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`has waived issues from POPR not maintained in POR. PO newly asks for a
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`narrowed construction of claim 1 that is inconsistent with its litigation position and
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`improperly reads in unclaimed limitations. PO’s arguments regarding Ground 1
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`rely upon unsubstantiated and unwarranted assumptions not supported by the
`
`factual record that lead to erroneous conclusions. PO’s Ground 2 arguments
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`misstate Petitioner’s combination motivations, and rely upon mischaracterizations
`
`of the role of the POSITA in the obviousness analysis. PO presents no legitimate
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`challenge to the Board’s reasoning from the Institution Decision.
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`III. PO HAS WAIVED ALLARGUMENTS NOT INCLUDED IN PATENT
`OWNER RESPONSE
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`The Patent Owner Response (POR) addresses only two main issues: For
`
`Ground 1, whether O’Donovan discloses “configured to removably engage” in
`
`limitation [1.6], and for Ground 2, whether sufficient motivation exists for
`
`combining O’Donovan and KCCL. Absent from POR is any argument addressing,
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`for Ground 1, any of the limitations of claim 1 besides “configured to removably
`
`engage,” and any of the additional limitations of dependent claims 2, 4, 5, 8, 11,
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`12, 15-17, 20, 41, 44, and 49. Also absent from POR is any argument addressing,
`
`for Ground 2, any limitations of claims 1 and 7, PO’s argument relying entirely on
`
`a challenge to the motivation to combine O’Donovan and KCCL.
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`PO did not identify or maintain several issues it had raised in its Patent
`
`Owner Preliminary Response (POPR) (Paper 16). In SAP Am., Inc. v. Versata
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`Dev. Group, Inc., CBM2012-00001 (Paper 81), the Board refused to consider a
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`PO’s arguments raised in the POPR that were not included in the POR, deeming
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`them to have been waived. Since PO in the present trial limits the issues raised in
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`the POR, any issues addressed solely in the POPR and not maintained in the POR
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`should likewise be deemed waived.
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`IV. PO NEWLY ARGUES IMPROPER CONSTRUCTION OF
`“CONFIGURED TO REMOVABLY ENGAGE” IN ADDRESSING
`ANTICIPATION BY O’DONOVAN (GROUND 1)
`A.
`
`Prior PO Arguments Rely Upon a Much Broader Construction
`
`POR newly offers a narrower construction of limitation [1.6]. This narrower
`
`construction runs contrary to prior assertions of scope made by PO and its expert in
`
`the Spectrum ’381 litigation. PO has not disclosed these positions as inconsistent
`
`with a position during concurrent litigation, as required by 37 C.F.R. §
`
`42.51(b)(1)(iii).
`
`According to Patent Owner’s litigation position on the scope of [1.6], a
`
`showing that a “lid is placed on the collection tube…and later removed” is
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`sufficient to show this limitation. See Petition at 9-10, citing Ex. 1006, ¶25.1
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`However, in the POR – in which the “broadest reasonable interpretation” (BRI)
`
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`1 Specifically, PO’s expert stated in litigation: “The next limitation of claim 1 is a
`
`lid configured to removably engage said vial. The Spectrum product meets this
`
`limitation. In operation, a user places the lid on the collection tube after filling the
`
`sample storage area with saliva. When the Spectrum Product arrives at the lab, the
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`lab staff removes the lid and assesses the sample.” Petition, Ex. 1006 at ¶25; see
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`also id., p. 100 (Exhibit E, claim chart: limitation [1.6]).
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`standard applies – PO argues that a lid that is placed and later removed is not
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`sufficient.
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`PO’s contrary litigation position is now indisputably ripe for consideration
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`by the Board. As admitted by PO in POPR, “35 USC § 301(a)(2) [] encourages
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`submission of Patent Owner claim constructions to prevent patentees from arguing
`
`broad interpretations under Phillips while simultaneously arguing narrow
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`constructions as the BRI,” and should be used when “determining the claim scope
`
`in a proceeding that has already been ordered or instituted.” POPR (Paper 16) at 5,
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`citing 35 U.S.C. § 301(a)(2), (d); POR, Ex. 2003 at 8. Despite advancing a
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`narrower position in this IPR than that relied upon in litigation, PO has not brought
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`such inconsistencies to the Board’s attention. Because PO considers these
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`positions about the scope of limitation [1.6] proper under the narrower litigation
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`standard set out in Phillips, PO cannot contend that such constructions fall outside
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`the scope of the limitation under the broader BRI.
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`B.
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`Patent Owner’s New Claim Construction Improperly Reads in
`Unclaimed Limitations
`
`Patent Owner’s focus on the words “configured to” in limitation [1.6] is
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`new. In the POPR, PO did not argue that these words had any special meaning.
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`Nor did PO do so in the litigation arguments discussed above. However, following
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`the Institution Decision, PO asks the Board to narrow the construction of this
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`limitation to read in requirements not recited in the claim. The opportunity for PO
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`to amend claim 1 has passed. If PO desired a narrower scope than it relied upon in
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`litigation, it should have amended claim 1 to reflect that scope.
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`1.
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`PO Asks the Board to Read an Intended Use Requirement into
`Both the Prior Art and Claim 1
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`PO’s expert, Dr. Collins, admitted in his direct testimony that he could not
`
`think of any two-piece assembly that cannot be separated in some way after being
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`attached. See Ex. 2005 at ¶21. But when questioned during his deposition about
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`whether the lid of the O’Donovan device could be removed, Dr. Collins refused to
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`answer outside the scope of the O’Donovan device’s intended use:
`
`Q.
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`I'm just saying, in a device that is built as O'Donovan teaches,
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`would it be possible to remove the lid?
`
`A.
`
`Q.
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`It shouldn't be, no. . . Within the context of the intended use. . . .
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`I didn't say anything about any context for intended use. I just
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`said, if you had a device that was built the way O'Donovan
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`teaches, could you remove the lid if you wanted to?. . .
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`A.
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`In what context? . . .
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`Q.
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`I'm talking about the device as a device, just as it exists. You
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`have this device, you have something inside that you want to
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`take out, regardless of whether that's in the context of the
`
`intended use or not, would it be possible to remove the lid?
`
`A.
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`If you take this device outside of it—completely outside of its
`
`intended use, and you bring it into a machine shop or
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`someplace with special equipment, sure, you can always find
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`some way of cutting the device or doing something to separate
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`the components of the device in a way it wasn't intended.
`
`Q.
`
`Paragraph 21 of your direct testimony, you say, “I can think of
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`no two-piece assembly (e.g., a ‘vial’ and a ‘lid’) that cannot be
`
`separated in some way after being attached”; correct?
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`A.
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`That's correct. . . .
`
`Q. And so that includes the lid and vial in O'Donovan; correct?
`
`A.
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`That's absolutely correct when done outside of context of how
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`this device intended to be used.
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`Exhibit 1024 at 59:14-61:23 (objections omitted).
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`The Board held in Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. &
`
`Inter. 1987), that a claim containing a “recitation with respect to the manner in
`
`which a claimed apparatus is intended to be employed does not differentiate the
`
`claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all
`
`the structural limitations of the claim. In Masham, the claim recited “means for
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`mixing…. said mixing means being stationary and completely submerged in the
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`developer material.” The claim was rejected over a reference that taught all
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`structural limitations of the claim, even though the prior art reference’s mixer was
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`only partially submerged in the developer material. The Board held that the
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`amount of submersion – the intended use – was immaterial to the structure of the
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`mixer, and thus the claim was properly rejected. Similarly, because O’Donovan
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`discloses all structural limitations of claim 1, PO’s focus on “intended use” is
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`immaterial to the analysis here.
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`Paralleling the effort to read a limiting “intended use” into the prior art, PO
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`also argues for the unclaimed intended use of the ’381 vial to be read into claim 1.
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`PO argues that “[t]he ’381 Patent makes clear why the lid is configured to be
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`removed from the vial…. A mere capability for release is insufficient to provide
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`for subsequent processing.” POR at 3-4 (emphasis added).
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`First, this argument is nonsensical. If it is capable of being released, then the
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`release would provide access for the subsequent processing. More importantly, the
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`“subsequent processing” that PO relies upon is not recited in claim 1. Since this
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`limitation is not claimed, it is improper to import it from the specification. See In
`
`re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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`2.
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`PO Asks the Board to Read an “Inherent Feature” Requirement
`into Claim 1
`
`In the POR, PO newly offers a narrower construction of the limitation of
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`“configured to removably engage” in [1.6], as meaning that the lid must have an
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`“inherent feature” for removal. For this new argument, PO relies on Profectus
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`Tech. v. Huawei Tech., Case Nos. 2015-1016, 2015-1018, and, 2015-1019, Slip.
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`Op. at 3 (Fed. Cir. May 26, 2016). See POR at 10-12. PO relies on Profectus to
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`support its position that the term “configured to” preceding “removably engage”
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`means something narrower than just “removably engage.”
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`In particular, PO alleges that the court in Profectus “held the “term
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`‘mountable’ [] a modifying word in….‘mountable picture frame’” and that broader
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`words, “such as ‘capable of,’” were absent from the claims.” POR at 11. Based on
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`Profectus, PO argues that “configured to be removably engaged” means that the lid
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`has an “inherent feature” for removal, since “mountable” was held to mean having
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`a feature for mounting.
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`Dr. Collins appeared to have relied on Patent Owner’s alleged “inherent
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`feature” requirement when rendering his opinion.
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`Q. Why did you discuss whether there is an inherent feature
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`disclosed for lid removal in O’Donovan?
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`A.
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`Because the patent would need to teach that there's some way to
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`be able to remove it, so there needs to be some feature which is
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`inherent, or in quotes, an “inherent feature.”
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`Q. Why do you believe that?
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`A.
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`Q.
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`A.
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`It's my understanding.
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`Based on what?
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`Based on my discussion with counsel and my understanding as
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`an engineer reading patents.
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`Ex. 1024 at 82:18-83:3 (objections removed).
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`However, PO selectively quotes Profectus and mischaracterizes its holding.
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`Specifically, PO omits portion of the paragraph that addresses the very words at
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`issue here: “configured to.” The relevant sentence reads in full:
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`“Absent from the claims are words that embrace broader meaning, such as
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`“capable of,” “adapted to,” or “configured to.” Profectus at 9 (emphasis added).
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`Thus, in context, Profectus includes among the “broadening terms” the
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`identical term used in claim 1 – “configured to.” The court concluded that
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`inclusion of “configured to” along with “modifying words” broadens these words
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`rather than narrowing them.
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`Since Profectus distinguished claims that have “words that embrace broader
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`meaning, such as …configured to,” PO’s argument that an “inherent feature” is
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`required to meet this limitation is erroneous, since it only applies when “configured
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`to” or other broadening terms are absent. Dr. Collins’s opinions based on this
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`spurious “inherent feature” requirement likewise should be accorded no weight.
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`3.
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`PO’s Claim Construction is Inconsistent with Precedent
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`PO misstates the role of design in the case law regarding the term
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`“configured to.” Precedent holds that if a prior art system is designed to be capable
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`of performing the function recited with the “configured to” language, the claim
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`limitation is met. See, e.g., Riverbed Tech., Inc. v. Silver Peak Sys., 2013 U.S.
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`Dist. LEXIS 102589 at *3 (D. Del., July 23, 2013); see also Ex parte Yutaka Imai,
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`Appeal 2012-003246, Decision on Appeal at 4 (Sept. 30, 2014). Thus, the
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`limitation of ’381 claim 1 is met if the O’Donovan lid is designed in a way that is
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`capable of removable engagement.
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`If PO’s position is that the intended use of the O’Donovan device at the
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`point of care is somehow meaningful to the Board’s assessment of anticipation,
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`O’Donovan’s affirmative selection of a friction fit plus a cover for use at point of
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`care, rather than selection of a more permanent closure, also must be accorded
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`meaning. If O’Donovan’s selection of a friction fit plus a cover was indeed a
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`design choice, that choice was an affirmative choice against permanence. Thus,
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`PO’s contention that the intended use at point of care necessarily implies that
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`O’Donovan intended its lid not to be removable is directly contradicted by
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`O’Donovan’s having selected an impermanent closure for such use.
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` Moreover, PO’s argument is directly contradicted by the teachings of
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`O’Donovan’s specification that the optional cover is “to ensure” that the lid was
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`held in place. If the lid was not intended to be removable, there would be no need
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`for an optional component to prevent it from being removed.
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`V. O’DONOVAN DISCLOSES A LID “CONFIGURED TO
`REMOVABLY ENGAGE” A VIAL
`A.
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`Patent Owner’s Arguments Rely on Unsubstantiated and Unwarranted
`Assumptions
`
`1.
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`PO Improperly Assumes a “Flush” Lid with “Very Small Gap”
`to Prevent User Removal
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`According to PO, “[w]hen a user inserts O’Donovan’s lid into the vial, the
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`top of the vial and lid are flush and the gap between the lid and vial is very small
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`(see relevant portion of Figure 4, reproduced below). This arrangement of
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`structural features prevents a user from removing the lid.” POR at 7; Ex. 2005 at
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`33. But this argument relies on incorrect assumptions.
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`First, PO relies upon O’Donovan’s to argue that the lid is “flush” with the
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`vial once inserted into the socket. See POR at 7 (referring to FIG. 4); Ex. 2005 at
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`¶33 (FIG. 4), ¶37. However, nowhere does O’Donovan use the word “flush,” or
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`otherwise describe requiring that the lid be flush with the socket when fully
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`inserted. Indeed, O’Donovan does not limit the size of the lid to require it to be
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`flush with the socket once inserted. Dr. Collins admitted that this is the case:
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`“Q. The text does not say that the lid has to be flush with the top of the vial;
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`correct? A. I don't believe it says those words, no.” Ex. 1024 at 85:14-16.
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`Patent Owner’s reliance on the lid being “flush” with the socket is based
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`entirely on the figures, which show only one embodiment. In Merck & Co.
`
`v.Biocraft Laboratories, 874 F.2d 804 (Fed. Cir. 1989), the court held that a
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`reference may be relied upon for all that it would have reasonably suggested to one
`
`having ordinary skill the art, including nonpreferred embodiments. Thus, Patent
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`Owner’s efforts to limit O’Donovan to an embodiment disclosed in the figures is
`
`erroneous.
`
`Second, PO asserts that “the gap between the lid and vial is very small,”
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`again relying on FIG. 4. See POR at 7. But when questioned about this assertion,
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`Dr. Collins admitted he performed no calculations to measure the gap:
`
`Q. You didn’t do anything to calculate what that gap was?
`
`A.
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`It’s a schematic, so no, I don’t need to. I can look at the relative
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`dimensions.
`
`Q.
`
`The answer is you did not do anything to attempt to calculate
`
`the size of the gap; correct?
`
`A.
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`I approximated it.
`
`Q. You eyeballed it?
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`A.
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`I eyeballed it, yeah, absolutely. It's small.
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`Ex. 1024, at 88:7-17.
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`PO’s reliance on its expert’s “eyeball” (non-)measurement is insufficient to
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`support the asserted conclusion.
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`In order for the “flush” and “very small gap” assertions to support PO’s
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`thesis that O’Donovan discloses an “arrangement of structural features [that]
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`prevent[] a user from removing the lid” (POR at 7; Ex. 2005 at ¶33), PO further
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`appears to assume without support that removal must be by hand:
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`Q. What makes you say it’s not accessible?
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`A.
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`Just looking at the design.
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`Q. Why specifically do you think it’s not accessible to be pulled
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`out?
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`A.
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`There’s nothing to grab. There’s no way to get a hold of it and
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`pull it out with my fingers.
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`Ex. 1024 at 65:11-16.
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`But nowhere does the claim recite that the lid needs to be removable “by a
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`user,” i.e., by hand. Dr. Collins agreed to this later in his deposition:
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`Q.
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`In the ’381 patent, is there any requirement for removing the lid
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`A.
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`Q.
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`by hand?
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`I don’t believe so, no.
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`Is it possible to -- would it be possible to practice the
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`“configured to removably engage” limitation with a lid that is
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`designed to be removed by a tool or a machine?
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`A. Well, the ’381 patent describes the fact that once the sample is
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`collected and it’s sealed by the user, it’s shipped to a
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`laboratory—or it’s shipped to a facility where there’s a
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`laboratory that will basically get direct access. So it needs to
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`remove the cap. And robotic tools could be used to unscrew
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`them so you can get direct access to the fluid.
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`Ex. 1024 at 70:14-71:2.
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`Indeed, the ’381 patent specification says, “Desirably vial 500 is suitable for
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`use with robotic DNA purification systems (e.g., the Beckman BioMek™ FX).”
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`The Beckman BioMek FX machine described therein allows for placement and
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`removal of lids by the machine. See Biomek® FX User’s Manual, Ex. 1027 at 3.
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`Thus, whether O’Donovan’s lid makes it difficult for a user to remove the lid by
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`hand is irrelevant, since the claim does not require removal by a user or by hand.
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`2.
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`PO Relies on Incorrect Friction Coefficients
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`POR questions Petitioner’s expert testimony that the friction fit of
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`O’Donovan allows the same force applied in reverse to remove the lid. See POR at
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`13-14. For support, PO relies on the testimony of Dr. Collins and a reference
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`entitled “Standard Test Method for Static and Kinetic Coefficients of Friction of
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`Plastic Film and Sheeting” (POR, Ex. 2011), to show the differences in coefficients
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`of friction between static and dynamic friction. See Ex. 2005 at ¶40, citing Ex.
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`2011 at Table 2. In Dr. Collins’ opinion, dynamic friction applies when the lid of
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`O’Donovan is being inserted because the lid is in motion before the friction fit
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`engages “at the level of the spikes.” Ex. 2005 at ¶39. Removal, according to Dr.
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`Collins, is from a stationary position, and thus static friction applies. Collins thus
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`argues that the forces are not the same, on the basis that static friction is greater
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`than dynamic friction, citing Ex. 2011.
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`But parts of the evidence on which Dr. Collins relies contradict his opinion.
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`In the example from Ex. 2011 shown in Dr. Collins’ declaration (Table 2), static
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`friction is shown as being up to 1/3rd higher than dynamic friction, at 38°C
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`(~100.4° F). But Ex. 2011 also includes Table 1, which shows the frictions at
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`23°C (~73.4°F), which Dr. Collins agreed was approximately room temperature.
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`See Ex. 2011, Table 1; see also Ex. 1024 at 80. Dr.
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