Patent No. 8,221,381 — Petition for Inter Partes Review
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ANCESTRY.COM DNA, LLC,
`Petitioner
`
`v.
`
`DNA GENOTEK INC.,
`Patent Owner.
`
`
`
`Inter Partes Review No. IPR_____________
`Patent 8,221,381 B2
`_____________
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT 8,221,381
`
`
`
`
`
`
`
`
`Filed on behalf of Ancestry.com DNA, LLC
`
`By: Daniel M. Becker, Reg. No. 38,376
`
`Jennifer R. Bush, Reg. No. 50,784
`
`Fenwick & West LLP
`
`801 California Street
`
`Mountain View, CA 94041
`
`Tel: (650) 988-8500
`
`Fax: (650) 938-5200
`
`

`
`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`INTRODUCTION .......................................................................................... 1
`II. MANDATORY NOTICES (37 CFR § 42.8(a)(1)) ........................................ 1
`A.
`Real Party-In-Interest (37 CFR § 42.8(b)(1)) ...................................... 1
`B.
`Notice of Related Matters (37 CFR § 42.8(b)(2)) ................................ 2
`C.
`Designation of Lead and Backup Counsel (37 CFR § 42.8(b)(3)) ...... 3
`D.
`Service Information (37 CFR § 42.8(b)(4)) ......................................... 3
`III. GROUNDS FOR STANDING (37 CFR § 42.104(a)) ................................... 3
`IV. THRESHOLD FOR REVIEW ....................................................................... 4
`V.
`IDENTIFICATION OF CHALLENGE (37 CFR § 42.104(b)) ..................... 4
`A.
`Effective filing date of the challenged claims ...................................... 4
`B.
`Technical Background .......................................................................... 5
`C.
`Claim Construction (37 CFR § 42.104(b)(3)) .................................... 14
`D. Ground 1: Claims 3, 6, 9, 10, 39, 40, 43, and 45-47 would have been
`obvious under 35 USC § 103(a) over WO 2003/104251(Birnboim) in
`view of U.S. Patent No. 7,645,424 (O’Donovan). ............................. 26
`Ground 2: Claims 18 and 19 would have been obvious under 35 USC
`§ 103(a) over WO 2003/104251(Birnboim) in view of U.S. Patent No.
`7,645,424 (O’Donovan), further in view of US Pre-grant Publication
`No. 2003/0089627 A1 (Chelles). ....................................................... 51
`Ground 3: Claims 13 and 14 would have been obvious under 35 USC
`§ 103(a) over WO 2003/104251(Birnboim) in view of U.S. Patent No.
`7,645,424 (O’Donovan), further in view of WO 2005/023667
`(Clarkson). .......................................................................................... 60
`1. Claim 14 ..................................................................................... 61
`
`E.
`
`F.
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`
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`2. Claim 13 ..................................................................................... 67
`
`3.
`
`Further evidence ......................................................................... 69
`
`VI. THE ASSERTED GROUNDS ARE NON-CUMULATIVE AND NON-
`REDUNDANT ............................................................................................. 73
`VII. CONCLUSION ............................................................................................. 75
`
`
`
`ii
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Apple Inc. v. VirnetX,
`IPR2013-00348, Paper 14, 2013 WL 8595302 (PTAB Dec. 13, 2013) ................ 4
`
`Askeladden LLC v. Sean I. McGhie and Brian K. Buchheit,
`IPR2015-00137, Paper 31 (Institution Decision) ................................................ 37
`
`DNA Genotek, Inc. v. Ancestry.com DNA LLC,
`Case No. 15-00355-SLR (D. Del.) .....................................................................2, 3
`
`DNA Genotek, Inc. v. Spectrum DNA; Spectrum Solutions L.L.C.,
`and Spectrum Packaging, LLC,
`Case No. 15-cv-00661-SLR (D. Del.) ...................................................... 2, 17, 34
`
`In re Cuozzo Speed Techs., LLC, 778 F.3d 1268, (Fed. Cir. 2015),
`cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890 (mem.)
`(2016) ................................................................................................................... 15
`
`In re Ngai,
`367 F.3d 1336 (Fed. Cir. 2004) ............................................................................ 50
`
`In re Paulsen,
`30 F.3d 1475 (Fed. Cir. 1994) .............................................................................. 15
`
`In re Petering,
`301 F.2d 676 (CCPA 1962) ................................................................................. 45
`
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) ............................................................................ 15
`
`King Pharm. Research and Dev., Inc. v. Eon Labs., Inc.,
`616 F.3d 1267 (Fed. Cir. 2010) ............................................................................ 50
`
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ................................................................................ 37, 57, 66
`
`iii
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`TABLE OF AUTHORITIES
`(continued)
`
`
`Motorola Mobility LLC v. Arnouse,
`IPR2013-00010, Paper 20, 2013 WL 2023657 (PTAB Jan. 30, 2013) ................. 4
`
`Titanium Metals Corp.v. Banner,
`778 F.2d 775 (Fed. Cir. 1985) .............................................................................. 45
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999) .............................................................................. 15
`
`STATUTES
`
`35 USC § 102 ............................................................................................................. 2
`
`35 USC § 102(a) ...................................................................................................... 63
`
`35 USC § 102(b) ............................................................................................... 26, 55
`
`35 USC § 102(e)(2) ........................................................................................... 30, 63
`
`35 USC § 103 ............................................................................................................. 2
`
`35 USC § 103(a) ................................................................................... 26, 35, 51, 60
`
`35 USC § 111 ........................................................................................................... 29
`
`35 USC § 112(6) ............................................................................................... 23, 52
`
`35 USC § 120 ........................................................................................................... 29
`
`35 USC § 154 ........................................................................................................... 30
`
`35 USC § 311 ........................................................................................................... 75
`
`35 USC § 314(a) ........................................................................................................ 4
`
`35 USC § 315(b) ........................................................................................................ 3
`
`35 USC § 315(e)(1) .................................................................................................... 4
`
`35 USC § 365(c) ...................................................................................................... 29
`
`iv
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`TABLE OF AUTHORITIES
`(continued)
`
`
`35 USC § 371 ............................................................................................................. 4
`
`35 USC §§ 311-319.................................................................................................... 1
`
`OTHER AUTHORITIES
`
`37 CFR § 42.100(b) ................................................................................................. 15
`
`37 CFR § 42.101 ...................................................................................................... 75
`
`37 CFR § 42.104(A) ................................................................................................... 3
`
`37 CFR § 42.104(b) ................................................................................................... 4
`
`37 CFR § 42.104(b)(3) ............................................................................................. 14
`
`37 CFR § 42.63(e) .............................................................................................. vi, vii
`
`37 CFR § 42.8(A)(1) ................................................................................................. 1
`
`37 CFR § 42.8(b)(1) ................................................................................................... 1
`
`37 CFR § 42.8(b)(2) ................................................................................................... 2
`
`37 CFR § 42.8(b)(3) ................................................................................................... 3
`
`37 CFR § 42.8(b)(4) ................................................................................................... 3
`
`37 CFR §§ 42.100-42.123 .......................................................................................... 1
`
`37 CFR §§ 42.1-42.80 ................................................................................................ 1
`
`Ancestry.com DNA, LLC v. DNA Genotek, Inc.
`IPR2016-00060 (PTAB Oct. 20, 2015) ....................................................... passim
`
`MPEP § 2131.03 [R-07.2015] ................................................................................. 45
`
`MPEP § 2141 III.(D) ................................................................................... 37, 57, 66
`
`
`
`v
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`
`EXHIBIT LIST
`(37 CFR § 42.63(e))
`
`Description
`
`Exhibit
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`U.S. Patent No. 8,221,381 to Muir, et al. (“the ‘381 patent”)
`
`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
`
`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
`
`U.S. Patent No. 7,645,424 to O’Donovan (“O’Donovan”)
`
`PCT Patent Publication WO 2003/104251 to DNA Genotek,
`Inc. (ex-US designations) and Birnboim (US designation)
`(“Birnboim”)
`
`U.S. Patent No. 6,152,296 to Shih (“Shih”)
`
`PCT Patent Publication WO98/03265 (Japanese) (“KCCL”)
`
`Certified English Translation of PCT Patent Publication
`WO98/03265 and certification thereof (“KCCL”)
`
`German Publication DE 199 50 884 A1 (German)
`
`Certified English Translation of German Publication DE 199 50
`884 A1 and certification thereof
`
`1014
`
`U.S. Patent No. 6,228,323 to Asgharian, et al. (“Asgharian”)
`
`vi
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`
`
`EXHIBIT LIST
`(continued)
`
`
`Exhibit
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`Description
`
`The American Heritage Dictionary of the English Language,
`Fourth Edition (2000) (selected pages) (definitions of: “corner”;
`“fastener”; “inert”; “pointed”; “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)
`
`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
`
`U.S. provisional application no. 60/523,104, filed Novem-
`ber 19, 2003 by O’Donovan
`
`Chart, numerical designation of ‘381 claim elements
`
`U.S. Pre-Grant publication no. 2003/0089627 A1 (“Chelles”)
`
`PCT Publication no. WO 2005/023667 A1 to Clarkson (“Clark-
`son”)
`
`Proof of Service, case 1:15-cv-00355-SLR, United States Dis-
`trict Court for the District of Delaware (docket 5) (see page 2)
`(Service date: June 4, 2015)
`
`Pending claims, U.S. Pat. Application no. 12/338,873 (“Birn-
`boim ‘873 application”)
`
`vii
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`Exhibit
`
`Description
`
`1024
`
`1025
`
`Abstract of title, U.S. Pat. Application no. 12/338,873 (“Birn-
`boim ‘873 application”)
`
`Deposition of John Collins, Ph.D., November 13, 2015, DNA
`Genotek, Inc. v. Spectrum DNA; Spectrum Solutions L.L.C.,
`and Spectrum Packaging, LLC, Case No. 15-cv-00661-SLR
`(D. Del.) (transcript pages 1, 140-141)
`
`viii
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`INTRODUCTION
`
`I.
`
`In accordance with 35 USC §§ 311-319 and 37 CFR §§ 42.1-42.80 &
`
`42.100-42.123, Petitioner requests Inter Partes Review of claims 3, 6, 9, 10, 13, 14,
`
`18, 19, 39, 40, 43, and 45-47 of United States Patent No. 8,221,381 to Muir, et al.,
`
`titled “Container System for Releasably Storing a Substance” (the “’381 patent”)
`
`(Exhibit 1001,“Ex. 1001”), owned by DNA Genotek, Inc. (“Genotek” or “Patent
`
`Owner”). This Petition demonstrates that there is a reasonable likelihood that the
`
`petitioner will prevail on at least one of the challenged claims. The challenged
`
`claims of the ’381 patent should be canceled as unpatentable.
`
`II. MANDATORY NOTICES (37 CFR § 42.8(a)(1))
`A. Real Party-In-Interest (37 CFR § 42.8(b)(1))
`The real party-in-interest for this Petition is the Petitioner, Ancestry.com
`
`DNA, LLC (Delaware; “DE”) (“AncestryDNA”) (“Petitioner”), and the following
`
`corporate entities that have the ability to influence Petitioner’s actions in this pro-
`
`ceeding: Ancestry.com Operations Inc. (DE); Ancestry.com Inc. (DE); Ancestry
`
`US Holdings Inc. (DE); Ancestry.com LLC (DE); Ancestry.com Holdings LLC
`
`(DE). The following Ancestry entities are also being included: Ancestry-
`
`Health.com LLC (DE); Ancestry International DNA LLC (DE); Ancelux 3 S.à.r.l.
`
`(LU); Ancestry International LLC (DE); Anvilire (IE); Ancelux 4 S.à.r.l. (LU);
`
`Ancestry Ireland DNA LLC (DE); Ancestry Ireland Health LLC (DE); Ancestry
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`1
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`International DNA Company (IE); Ancestry International Health Unlimited Com-
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`pany (IE). Pursuant to an indemnification agreement, Petitioner has assumed and
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`controls the defense of Spectrum DNA, Spectrum Solutions LLC, and Spectrum
`
`Packaging, LLC (collectively, the “Spectrum defendants”) in the Spectrum
`
`litigation described below. The Spectrum defendants do not exercise control over
`
`this Petition and are not real parties-in-interest with respect to the instant Petition.
`
`B. Notice of Related Matters (37 CFR § 42.8(b)(2))
`The ’381 patent is presently 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 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 litigation”).
`
`The ‘381 patent is presently the subject of IPR2016-00060 (“first IPR”), in
`
`which the PTAB has instituted trial on two grounds:
`
`(i) Anticipation under pre-AIA § 102 of claims 1, 2, 4, 5, 8, 11, 12, 15-17,
`
`20, 41, 44, and 49 by O’Donovan, U.S. Pat. No. 7,645,424 (Ex. 1007
`
`hereto); and
`
`(ii) Obviousness under pre-AIA § 103 of claims 1 and 7 over O’Donovan
`
`in view of WO 98/03265 (“KCCL”) (Exs. 1010 and 1011 hereto).
`
`2
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`In the first IPR, the PTAB declined to institute trial on the claims challenged in the
`
`present Petition on two grounds different from the grounds advanced herein.
`
`C. Designation of Lead and Backup Counsel (37 CFR § 42.8(b)(3))
`Petitioner designates Daniel M. Becker (Reg. No. 38,376) as its lead counsel
`
`and Jennifer R. Bush (Reg. No. 50,784) as its back-up counsel.
`
`D. Service Information (37 CFR § 42.8(b)(4))
`Service of any documents may be made via hand-delivery or Federal Ex-
`
`press to the postal mailing address of Fenwick & West LLP, 801 California Street,
`
`Mountain View, CA 94041 (Tel: (650) 988-8500 and Fax: (650) 988-5200), with
`
`courtesy copies to the email address DBecker-PTAB@fenwick.com. Petitioner
`
`consents to electronic service to the email address DBecker-PTAB@fenwick.com.
`
`III. GROUNDS FOR STANDING (37 CFR § 42.104(a))
`Petitioner certifies pursuant to Rule 42.104(a) that the ’381 patent is
`
`available for Inter Partes Review and that Petitioner is not barred or estopped from
`
`requesting an Inter Partes Review challenging the validity of the above-referenced
`
`claims of the ’381 patent on the grounds identified in the Petition.
`
`The Complaint in the Ancestry litigation was served on Petitioner on
`
`June 4, 2015. See Proof of Service, Exhibit 1022 (“Ex. 1022”), at page 2.
`
`Accordingly, the present Petition, filed less than one year after that service date, is
`
`not barred under AIA 35 USC § 315(b). Motorola Mobility LLC v. Arnouse,
`
`3
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`IPR2013-00010, Paper 20, 2013 WL 2023657 (PTAB Jan. 30, 2013). See also,
`
`Apple Inc. v. VirnetX, IPR2013-00348, Paper 14, 2013 WL 8595302 (PTAB Dec.
`
`13, 2013). The PTAB has not yet issued a final written decision in the first IPR.
`
`Accordingly, the present Petition is not estopped under AIA 35 USC § 315(e)(1).
`
`IV. THRESHOLD FOR REVIEW
`A petition for Inter Partes Review must demonstrate “a reasonable likeli-
`
`hood that the petitioner would prevail with respect to at least one of the claims
`
`challenged in the petition.” 35 USC § 314(a). This Petition meets this threshold. As
`
`discussed in detail herein and in the accompanying Declaration of Terry N. Layton,
`
`Ph.D. (Ex. 1003), all limitations of claims 3, 6, 9, 10, 13, 14, 18, 19, 39, 40, 43,
`
`and 45-47 of the ’381 patent are taught or suggested by the prior art, and the chal-
`
`lenged claims would have been obvious over the asserted prior art combinations.
`
`The motivation to combine the references is provided. As set forth in Section VI
`
`of this Petition, each of the three asserted Grounds is non-redundant and has par-
`
`ticular, unique, relevance.
`
`V.
`
`IDENTIFICATION OF CHALLENGE (37 CFR § 42.104(b))
`A. Effective filing date of the challenged claims
`The ’381 patent issued from Application Serial No. 12/096,767 (“the ’767
`
`application”), filed on November 24, 2008. The ’767 application is a National
`
`Phase Entry under 35 USC § 371 of International Application No.
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`4
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`PCT/CA2006/002009, filed December 11, 2006, which claimed priority to U.S.
`
`provisional Application Serial No. 60/748,977, filed December 9, 2005. See Ex.
`
`1002, p. 186. Thus, the effective filing date of the challenged claims is no earlier
`
`than December 9, 2005. The ’381 patent is subject to the pre-AIA provisions of the
`
`Patent Statute; unless otherwise noted, all statutory references in this Petition are to
`
`the applicable pre-AIA provision.
`
`B. Technical Background
`The ‘381 patent is drawn to a “container system for releasably storing a sub-
`
`stance.” Ex. 1001, Title. “According to one embodiment ..., the container system
`
`... is suitable for releasably storing a composition intended to stabilize, preserve, or
`
`facilitate the recovery of nucleic acid from a biological sample,” Ex. 1001,
`
`10:18-22, such as saliva, Ex. 1001, 10:55. “The combination of the composition to
`
`stabilize, preserve, or facilitate the recovery of nucleic acid and saliva may then be
`
`used in standard nucleic acid testing reactions....” Ex. 1001, 11:43-46. This em-
`
`bodiment of the ‘381 container system is known colloquially in the art as a “spit
`
`kit.” Ex. 1003, ¶ 9.
`
`The ‘381 container system is an explicit improvement over Patent Owner’s
`
`prior spit kit, described in WO 2003/104251, “Compositions and methods for ob-
`
`taining nucleic acids from sputum” (“Birnboim”; Ex. 1008). As described in the
`
`background section of the ’381 patent, the Birnboim container system “has a first
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`region for collecting a biological sample, a second region containing a composition
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`for preserving a nucleic acid, and a barrier between the first region and the second
`
`region, which … maintains the sample and composition separate.” Ex. 1001, 1:54-
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`59. See also Ex. 1003 ¶¶ 24, 97. The device further includes “means for disturbing
`
`the integrity of the barrier such that the composition is capable of contacting the
`
`biological sample.” Ex. 1008, 9:22-24. “[T]he means for closing the container may
`
`be coupled to the disestablishment of the barrier….” Ex. 1008, 24:8-9.
`
`In an embodiment of the Birnboim spit kit discussed at greater length below
`
`in Petitioner’s Ground 1, “the barrier may be a septum … that would separate the
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`composition from the fluid until the septum … is pierced …” (Ex.1008, 23:29-31)
`
`or “punctured” (Ex. 1008, 9:11). See also Ex. 1003 ¶¶ 25, 27, 98, 109.
`
`In the preferred embodiment of Birnboim, however, the barrier is not a sep-
`
`tum. As described in the ’381 patent’s background section, the “exemplified barri-
`
`er of WO 2003/104251 is a pivoting partition.” Ex. 1001, 1:59-60 (emphasis add-
`
`ed). In this preferred embodiment, illustrated in Birnboim FIGS. 10 and 11, repro-
`
`duced below,
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`6
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`
`
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` FIG. 10
`
`
`
`FIG. 11
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`“[a]ttachment of a lid to the container forces the barrier to pivot from its original
`
`closed position spanning the container and thereby separating the first region and
`
`the second region, to an open position in which both regions are exposed to each
`
`other and contact between the composition contained in one region space and the
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`biological sample contained in the other region is allowed.” Ex. 1001, 1:60-66.
`
`As explained in the ’381 patent background section, “[a] drawback of this
`
`container is that it includes multiple parts..., which increases the cost of manufac-
`
`ture of the container. Additionally, because the disk is held in place by friction fit,
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`there must be a high degree of precision for the manufacture of the components of
`
`the container.” Ex. 1001, 1:66-2:4. Accordingly, prior to the effective date of the
`
`’381 patent, “[t]here remain[ed] a need for an improved container system for re-
`
`leasably and reliably storing a substance.” Ex. 1001, 2:5-6. See also Ex. 1003
`
`¶¶ 25, 28, 108.
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`7
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`The need “to store a substance, such as a liquid, solid, gas, mixtures thereof,
`
`or the like, in a container prior to mixing the contents of the container with another
`
`material,” Ex. 1001, 1:19-21, is not a need unique to Patent Owner, nor a need
`
`unique to spit kits. This need has long existed across a wide variety of disciplines.
`
`Ex. 1003 ¶¶ 29, 110. Given the ubiquity of the need, a “variety of containers” had
`
`been developed prior to the ’381 patent’s earliest claimed filing date “for holding
`
`substances separately in such a manner that a user may open a closure to combine
`
`the substances.” Ex. 1001, 1:44-46.
`
`Routinely, these prior art containers met the need by storing the substance
`
`within the container’s lid, with the contents released from the lid by attachment of
`
`the lid to the body of the container—optionally with a further advancement of the
`
`lid, or of lid components, toward the container body:
`
`Chelles (Ex. 1020), FIG. 2
`
`
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`8
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`Asgharian (Ex. 1014), FIGS. 5 and 6
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`
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`
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`Shih (Ex. 1009), FIG. 5 (excerpt)
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`9
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`
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`DE 199 50 884 A1 (Exs. 1012, 1013), FIGS. 1, 4, 5
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`10
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`KCCL (Exs. 1010, 1011), FIG. 1
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`See generally, Exs. 1020; 1014; 1009; 1012; 1013; 1010; 1011. See also Ex. 1003
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`¶¶ 30-36.
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`The ’381 Patent Owner employed this routine configuration to solve the ad-
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`mitted drawbacks and deficiencies of the earlier Birnboim spit kit.
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`The ’381 patent is drawn to a “[c]ontainer system for releasably storing a
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`substance” (Ex. 1001, Title). Claim 1 is drawn to the container system, and recites
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`(formatting added):
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`1. A container system for releasably storing a substance, comprising:
`a) a vial comprising
` a first open end for receiving a sample,
` a second end comprising a sample storage chamber and
` a piercing member,
`wherein said piercing member comprises a side wall, a
`first cutting edge extending from a first pointed corner to
`a second corner that defines the intersection between said
`cutting edge and said side wall; and
`b) a lid configured to removably engage said vial, said lid comprising
` a reservoir for holding the substance, and
` a pierceable membrane sealing the substance within said reser-
`voir,
`wherein, when said system is closed by removable engagement of said
`vial with said lid, said vial and said lid are movable to a piercing
`position in which the piercing member disrupts the pierceable
`membrane to allow fluid communication between said reservoir
`and said chamber,
`wherein the chamber is sealed against leakage to the outside of
`the container system in the piercing position.
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`Claims 2-20, 39-40, and 49 depend directly or indirectly from claim 1.
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`Claims 41 and 43-45 are drawn to a method of using the container system of
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`claim 1, and claim 46 is drawn to a kit comprising the container system of claim 1
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`and instructions for its use.
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`One embodiment of the ’381 container system is shown in ’381 FIG. 23 (top
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`perspective view of vial; the lid is not shown), FIG. 24 (side view of vial and cap
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`prior to assembly, identifying pierceable membrane 160 and piercing member 6),
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`and FIG. 22 (top perspective view of vial and cap after assembly):
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`A second embodiment is shown in ’381 FIG. 10 (top perspective view of vial and
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`lid prior to assembly), FIG. 9 (side cross-sectional view of vial and lid after
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`assembly), and FIG. 4 (top perspective view of vial and lid after assembly):
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`In a third embodiment, the piercing member is integrated into a separate funnel.
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`That embodiment corresponds to independent claim 21, which is not challenged in
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`this Petition, and is not shown above.
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`It is no surprise that the Patent Owner, in seeking a remedy to the admitted
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`deficiencies of Birnboim’s preferred embodiment, would have chosen this art-
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`recognized routine approach for “releasably storing a composition intended to
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`stabilize, preserve, or facilitate the recovery of nucleic acid from a biological
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`sample,” Ex. 1001, 10:18-22—as discussed in detail below, it was not only the
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`obvious choice, but as the PTAB has already recognized in its Decision instituting
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`the first IPR, it was a solution that was fully anticipated by O’Donovan.
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`C. Claim Construction (37 CFR § 42.104(b)(3))
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`The terms in the challenged claims are to be given their broadest reasonable
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`interpretation (“BRI”) as understood by one of ordinary skill in the art and
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`consistent with the disclosure. See 37 CFR § 42.100(b); see also In re Cuozzo
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`Speed Techs., LLC, 778 F.3d 1268, 1275–79 (Fed. Cir. 2015), cert. granted sub
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`nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890 (mem.) (2016). Under that
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`standard, claim terms are given their ordinary and customary meaning, as would be
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`understood by one of ordinary skill in the art in the context of the entire disclosure.
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`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special
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`definition for a claim term must be set forth in the specification with reasonable
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`clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
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`1994).
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`Only those terms that are in controversy need be construed, and only to the
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`extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g,
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`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In the Decision instituting the first IPR,
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`the panel found “that no term requires interpretation at this time.” First IPR, Pa-
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`per 19, p. 6. In light of that guidance, Petitioner advances interpretations of only a
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`subset of claim terms that Petitioner believes may be relevant to the present IPR;
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`the broadest reasonable interpretations of certain other claim terms are discussed in
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`the accompanying Declaration, should such evidence become necessary after insti-
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`tution. See Ex. 1003, ¶¶ 42-92.
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`For convenience and clarity of reference, Petitioner has assigned numerical
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`designations to claim limitations. See Exhibit 1019.
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`Limitation [1.5] recites “wherein said piercing member comprises a side
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`wall, [and] a first cutting edge extending from a first pointed corner to a second
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`corner that defines the intersection between said cutting edge and said side wall.”
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`FIG. 3 of the ’381 patent (shown annotated below) shows a “first pointed
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`corner” 30, “first cutting edge” 32, and “side wall” 34. See, e.g., Ex. 1001, 6:33-38.
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`The “second corner,” which is undesignated in FIG. 3, is identified in the
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`annotation below, as is the “first pointed corner” 30.
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`Piercing member 6 is described as “first cutting edge 33 [sic; 32] having
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`pointed end 30 at one corner....” See Ex. 1001, 6:34-35; 8:33-34. In other words,
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`the first corner comes to a point at the end. The ʼ381 patent uses the word
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`“pointed” consistent with its plain and ordinary meaning. See Ex. 1015, p. 6 (origi-
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`nal p. 1355). However, the claim construction position implied by the Patent
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`Owner in the Spectrum litigation is different, i.e., that a “pointed corner” also
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`includes a squared off corner. See Ex. 1017 ¶ 24 (citing Ex. 1006 ¶ 20); Ex. 1017
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`¶ 39. See also Ex. 1001, 9:59-65. Because the Patent Owner cannot contend that
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`the construction it advanced in district court is unreasonable, that construction can-
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`not fall outside the broadest reasonable interpretation, and the BRI of “pointed
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`corner” requires merely that first pointed corner 30 be capable of performing the
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`required function, which is disrupting the pierceable membrane.1 See also Ex. 1003
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`¶¶ 58-59, 121.
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`The Board’s use of Patent Owner’s statements is limited by 35 USC
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`1
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`§ 301(d). Thus, these comments are included herein merely to aid in claim con-
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`struction during the proceeding, and to avoid any possible inconsistencies between
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`the Patent Owner claim construction in this IPR and that implied in the Spectrum
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`litigation, which constructions Patent Owner cannot contend fall outside the scope
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`of the BRI per 35 USC § 301(a)(2), which seeks to prevent patentees from arguing
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`broad interpretations under Phillips while simultaneously arguing narrow construc-
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`tions as the BRI.
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`The term “removably engage” in limitation [1.6] is not defined in the ’381
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`specification, and thus the plain meaning should apply. Per the specification of the
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`’381 patent, the particular means used to removably engage the lid to the vial is not
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`important, as long as the lid and vial are moveable to a piercing position. See Ex.
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`1001, 5:7-15. This plain meaning also includes the Patent Owner’s implied
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`litigation construction. See Ex. 1006 ¶ 26. Thus, the BRI of this term is a lid that
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`can be attached in various ways and can later be removed. See also Ex. 1003 ¶¶ 61,
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`64.
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`The BRI of limitation [1.10], “wherein the chamber is sealed against leakage
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`to the outside of the con