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
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ANCESTRY.COM DNA, LLC,
`Petitioner
`
`v.
`
`DNA GENOTEK INC.,
`Patent Owner.
`
`
`
`i
`
`Inter Partes Review No. IPR2016-00060
`Patent 8,221,381 B2
`_____________
`
`RESUBMITTED PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT 8,221,381
`(assigned filing date October 20, 2015)
`
`DNA Genotek, Inc. Exhibit 2001 Page 1
`
`

`
`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`TABLE OF CONTENTS
`
`
`
`Page
`
`INTRODUCTION .......................................................................................... 1
`I.
`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)) ...... 2
`D.
`Service of Information (37 CFR § 42.8(b)(4)) ..................................... 2
`III. GROUNDS FOR STANDING (37 CFR § 42.104(A)) .................................. 3
`IV. THRESHOLD FOR REVIEW ....................................................................... 3
`V.
`IDENTIFICATION OF CHALLENGE (37 CFR § 42.104(B)) .................... 3
`A.
`Effective filing date of the challenged claims ...................................... 3
`B.
`Technical background .......................................................................... 4
`C.
`Claim Construction (37 CFR § 42.104(b)(3)) ...................................... 5
`D. Ground 1: Claims 1, 2, 4, 5, 8, 15-17, 20, 41, 44, and 49 are
`anticipated under 35 USC § 102(e)(2) by U.S. Patent 7,645,424. ..... 18
`Ground 2: Claims 1, 7, and 14 are unpatentable under 35 USC
`§ 103(a) over U.S. Patent No. 7,645,424 in view of WO 98/03265. . 29
`Ground 3: Claims 1, 2, 4, 5, 11-13, and 15-19 are unpatentable under
`35 USC § 103(a) as obvious over U.S. Pat. No. 6,152,296 in view of
`WO 98/03265. .................................................................................... 37
`G. Ground 4: Claims 3, 6, 8-10, 20, 39-41, 43-47, and 49 are
`unpatentable under 35 USC § 103(a) over Shih in view of
`WO 2003/104251 (“Birnboim”). ....................................................... 50
`VI. THE ASSERTED GROUNDS ARE NON-CUMULATIVE AND NON-
`REDUNDANT ............................................................................................. 58
`
`E.
`
`F.
`
`
`
`-ii-
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`DNA Genotek, Inc. Exhibit 2001 Page 2
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`VII. CONCLUSION ............................................................................................. 60
`
`
`
`-iii-
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`DNA Genotek, Inc. Exhibit 2001 Page 3
`
`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`CASES
`In re Cuozzo Speed Techs., LLC,
`778 F.3d 1271 (Fed. Cir. 2015) ............................................................................ 5
`
`In re Trans Texas Holdings Corp.,
`498 F.3d 1290 (Fed. Cir. 2007) ............................................................................ 5
`
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ................................................................................ 33, 40, 41
`
`NuVasive v. Warsaw Orthopedic,
`IPR2013-00395 ................................................................................................... 59
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ........................................................................ 5, 6
`
`SAP America Inc. v. Versata Dev. Group Inc.,
`CBM2012-00001 .................................................................................................. 5
`
`Titanium Metals Corp.v. Banner,
`778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) .................................................. 29
`
`STATUTES
`
`35 USC § 102(b) ....................................................................... 30, 37, 38, 50, 59, 60
`
`35 USC § 102(e) ...................................................................................................... 59
`
`35 USC § 102(e)(2) ................................................................................ 18, 19, 21, 30
`
`35 USC § 103(a) ................................................................................ 3, 29, 30, 37, 50
`
`35 USC § 111 ........................................................................................................... 18
`
`35 USC § 112(6) ...................................................................................................... 15
`
`35 USC § 120 ........................................................................................................... 18
`
`iv
`
`DNA Genotek, Inc. Exhibit 2001 Page 4
`
`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`TABLE OF AUTHORITIES
`(continued)
`
`
`35 USC § 154 ........................................................................................................... 19
`
`35 USC § 301 ............................................................................................................. 6
`
`35 USC § 301(a)(2) .................................................................................................... 6
`
`35 USC § 311 ........................................................................................................... 60
`
`35 USC §§ 311-319.................................................................................................... 1
`
`35 USC § 314(a) ........................................................................................................ 3
`
`35 USC § 365(c) ...................................................................................................... 18
`
`35 USC § 371 ............................................................................................................. 4
`
`OTHER AUTHORITIES
`
`37 CFR §§ 42.1-42.80 & 42.100-42.123 ................................................................... 1
`
`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) ................................................................................................... 2
`
`37 CFR § 42.8(b)(4) ................................................................................................... 2
`
`37 CFR § 42.63(e) ............................................................................................. vii-viii
`
`37 CFR § 42.100(b) ................................................................................................... 5
`
`37 CFR § 42.101 ...................................................................................................... 60
`
`37 CFR § 42.104(a) .................................................................................................... 3
`
`37 CFR § 42.104(B) ................................................................................................... 3
`
`37 CFR § 42.104(b)(3) ............................................................................................... 5
`
`
`
`-v-
`
`DNA Genotek, Inc. Exhibit 2001 Page 5
`
`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`TABLE OF AUTHORITIES
`(continued)
`
`
`MPEP § 2131.03(I) .................................................................................................. 29
`
`MPEP § 2141 III.(D) .......................................................................................... 33, 40
`
`
`
`
`
`-vi-
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`DNA Genotek, Inc. Exhibit 2001 Page 6
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`EXHIBIT LIST (37 CFR § 42.63(e))
`
`Exhibit
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`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
`
`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
`
`PCT Patent Publication WO 2003/104251 to DNA Genotek,
`Inc. (ex-US designations) and Birnboim (US designation)
`
`U.S. Patent No. 6,152,296 to Shih
`
`PCT Patent Publication WO98/03265 (Japanese)
`
`Certified English Translation of PCT Patent Publication
`WO98/03265 and certification thereof
`
`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.
`
`vii
`
`DNA Genotek, Inc. Exhibit 2001 Page 7
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`Exhibit
`
`Description
`
`1015
`
`1016
`
`1017
`
`The American Heritage Dictionary of the English Language,
`Fourth Edition (2000) (selected pages) (definitions of: “corner”;
`“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)
`
`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
`
`1018
`
`U.S. provisional application no. 60/523,104, filed November
`18, 2003 by O’Donovan
`
`1019
`
`Chart, numerical designation of claim elements
`
`
`
`-viii-
`
`DNA Genotek, Inc. Exhibit 2001 Page 8
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`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 1-20, 39-41, 43-
`
`47, and 49 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 Peti-
`
`tion 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 (DE) (“AncestryDNA”) (“Petitioner”), and the following corporate en-
`
`tities that have the ability to influence Petitioner’s actions in this proceeding: An-
`
`cestry.com Operations Inc. (Delaware; 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: AncestryHealth.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 International DNA
`
`Company (IE); Ancestry International Health Unlimited Company (IE). Pursuant
`-1-
`
`
`
`DNA Genotek, Inc. Exhibit 2001 Page 9
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`to an indemnification agreement, Petitioner has assumed and 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.); and (ii) DNA Genotek, Inc. v. Spectrum DNA; Spectrum Solutions
`
`L.L.C., and Spectrum Packaging, LLC, Case No. 15-cv-00661-SLR (the “Spectrum
`
`litigation”).
`
`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 of Information (37 CFR § 42.8(b)(4))
`Service of any documents via hand-delivery may be made at the postal mail-
`
`ing 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.
`
`
`
`
`
`-2-
`
`DNA Genotek, Inc. Exhibit 2001 Page 10
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`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.
`
`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 of the elements of claims 1-20, 39-41, 43-47, and 49 of the
`
`’381 patent are taught or suggested by the prior art. Claims 1, 2, 4, 5, 8, 11-12, 15-
`
`17, 20, 41, 44, and 49 are fully anticipated; the other claims challenged in this Peti-
`
`tion would have been obvious over the asserted prior art combinations. For those
`
`Grounds asserted under 35 USC § 103(a), the motivation to combine is provided.
`
`As set forth in Section VI of this Petition, each of the four asserted Grounds is non-
`
`redundant and has particular, 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 11/24/2008. The ’767 application is a National Phase Entry
`-3-
`
`
`
`DNA Genotek, Inc. Exhibit 2001 Page 11
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
`
`under 35 USC § 371 of International Application No. PCT/CA2006/002009, filed
`
`December 11, 2006, which claimed priority to U.S. provisional Application Serial
`
`No. 60/748,977, filed 12/9/2005. See Ex. 1002, p. 186. Thus, the effective filing
`
`date of the challenged claims is no earlier than 12/9/2005. The ‘381 patent is sub-
`
`ject to the pre-AIA provisions of the Patent Statute; all statutory references in this
`
`Petition are to the applicable pre-AIA provision.
`
`B. Technical background
`As stated in the Background section of the ’381 patent specification, “[i]t is
`
`often desirable 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. This market need exists across a wide variety of dis-
`
`ciplines. Ex. 1003 ¶ 22. Given the ubiquity of the need, a “variety of containers”
`
`had been developed prior to the ‘381 patent’s earliest claimed filing date “for hold-
`
`ing substances separately in such a manner that a user may open a closure to com-
`
`bine the substances.” Ex. 1001, 1:44-46. Routinely, this need was met by releasa-
`
`bly storing the substance within the container’s lid. See generally, Ex. 1013; Ex.
`
`1014. See also Ex. 1003 ¶¶ 22-26.
`
`The ’381 patent, drawn to a “[c]ontainer system for releasably storing a sub-
`
`stance” (Ex. 1001, Title), employs this standard approach to “holding substances
`
`separately in such a manner that a user may open a closure to combine the sub-
`
`
`
`-4-
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`DNA Genotek, Inc. Exhibit 2001 Page 12
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`stances.” Ex. 1001, 1:44-46. See also Ex. 1001, 2:17-29; Ex. 1003 ¶ 27.
`
`C. Claim Construction (37 CFR § 42.104(b)(3))
`The terms in the challenged claims are to be given their broadest reasonable
`
`interpretation (“BRI”), as understood by one of ordinary skill in the art and
`
`consistent with the disclosure. See 37 CFR § 42.100(b); see also In re Cuozzo
`
`Speed Techs., LLC, 778 F.3d 1271, 1278 (Fed. Cir. 2015).
`
`The BRI of certain claim terms advanced in this Petition may differ from the
`
`construction that those same terms may receive following claim construction
`
`proceedings in district court. See, e.g., SAP America Inc. v. Versata Dev. Group
`
`Inc., CBM2012-00001, Paper 70 at 7-15 (PTAB 2013); In re Trans Texas Holdings
`
`Corp., 498 F.3d 1290, 1297 (Fed. Cir. 2007). Thus the claim constructions
`
`presented in this Petition, including where Petitioner does not propose an express
`
`construction, do not necessarily reflect the claim constructions that Petitioner
`
`believes should be adopted by a district court under Phillips v. AWH Corp., 415
`
`F.3d 1303 (Fed. Cir. 2005).
`
`However, unless otherwise stated, Petitioner’s proposed BRI, and Grounds
`
`based thereon, affirmatively includes (1) the proposed claim construction offered
`
`by the Patent Owner in the Spectrum litigation, or (2) for terms where Patent
`
`Owner has not explicitly offered a claim construction, Petitioner’s understanding
`
`of Patent Owner’s claim construction based upon infringement arguments made in
`
`
`
`-5-
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`DNA Genotek, Inc. Exhibit 2001 Page 13
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`Patent Owner’s motion for preliminary injunction in the Spectrum litigation. See
`
`Ex. 1005; Ex. 1006. Because Patent Owner considers these constructions proper
`
`under the Phillips standard, Patent Owner cannot contend that such constructions
`
`fall outside the scope of the BRI. Petitioner further submits these interpretations
`
`under the authority of 35 USC § 301(a)(2), which encourages submission of Patent
`
`Owner claim constructions to prevent patentees from arguing broad interpretations
`
`under Phillips while simultaneously arguing narrow constructions as the BRI.1
`
`Petitioner does not concede that any claim interpretation impliedly or
`
`expressly proposed by Patent Owner is appropriate for the district court litigation,
`
`where a different legal standard applies to the construction of the asserted claim
`
`terms. Petitioner does not believe that many of the Patent Owner’s implied or
`
`express proposed interpretations are appropriate under Phillips.
`
`For convenience and clarity of reference, Petitioner has assigned numerical
`
`designations to claim elements and limitation. See Exhibit 1019.
`
`1
` The legislative history of 35 USC § 301 indicates that this section was in-
`
`tended to “allow the Office to identify inconsistent statements made about claim
`
`scope-for example, cases where a patent owner successfully advocated a claim
`
`scope in district court that is broader than the ‘broadest reasonable construction’
`
`that he now urges in an inter partes review.” Fed. Reg. 48698, citing 157 Cong.
`
`Rec. S1375 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl).
`
`
`
`-6-
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`DNA Genotek, Inc. Exhibit 2001 Page 14
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`Limitation [1.1] recites “a vial,” which is not defined in the specification of
`
`the ’381 patent. The plain meaning is “[a] small container, usually with a closure,
`
`used especially for liquids.” Ex. 1015, p. 8 (original page 1915). The specification
`
`describes some embodiments that accommodate about 1-4 ml of sample and 1-16
`
`ml of sample (Ex. 1001, 6:10-13), as reflected in ‘381 claims 9 and 10; however,
`
`the ’381 patent specification imposes no absolute constraints on size or shape.
`
`Thus, the BRI of “vial” is a small closed or closable vessel, with no definitive size
`
`or shape requirements. See also Ex. 1003 ¶ 33.
`
`The BRI of limitation [1.2] is its plain meaning: an end that is sufficiently
`
`open as to be able to receive a sample. See Ex. 1001, 2:52; 10:25-27. See also Ex.
`
`1003 ¶ 34.
`
`The BRI of the phrase “second end comprising a sample storage chamber”
`
`of limitation [1.3] is that the vial has an interior portion that can store a received
`
`sample. See also Ex. 1003 ¶ 35.
`
`Recitation in limitation [1.4] of comprising a piercing member means hav-
`
`ing at least one piercing member. Ex. 1003 ¶ 36.
`
`The piercing member may be an integral part of the vial, as Dr. Layton
`
`argued in his litigation declaration. See Ex. 1017 ¶¶ 21-23; see also Ex. 1003 ¶¶
`
`36-39. However, in Inter Partes Review, the BRI of this limitation should be
`
`broad enough to include claim construction positions previously advanced by the
`
`
`
`-7-
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`DNA Genotek, Inc. Exhibit 2001 Page 15
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`Patent Owner in related litigation, which was that “a vial comprising … a piercing
`
`member” includes a piercing member first “located in the … lid,” which then
`
`“becomes wedged in the top of the collection tube, completing the claimed ‘vial.’”
`
`Ex. 1006 ¶ 21. Thus, limitation [1.4] should be interpreted as a vial that includes at
`
`least one piercing member as an integrated, but not necessarily integral,
`
`component. See Ex. 1001, 2:17-21, 32-38; 6:14-23; FIGS. 10 and 23. See also Ex.
`
`1003 ¶¶ 36-41.
`
`
`
`Limitation [1.5] recites “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.” FIG. 3
`
`(shown annotated below) shows a “first pointed corner” 30, “first cutting edge” 32,
`
`and “side wall” 34. See, e.g., Ex. 1001, 6:33-38. The “second corner”, which is
`
`undesignated in FIG. 3, is identified in the annotation below, as is the “first pointed
`
`corner” 30.
`
`
`
`Piercing member 6 is described as “first cutting edge 33 [sic; 32] having
`
`pointed end 30 at one corner.” See Ex. 1001, 6:33-37; 8:32-37. In other words, the
`-8-
`
`
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`DNA Genotek, Inc. Exhibit 2001 Page 16
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`first corner comes to a point at the end. The ʼ381 patent uses the word “pointed”
`
`consistent with its plain and ordinary meaning. See Ex. 1015, p. 6 (original p.
`
`1355); Ex. 1003 ¶ 45. However, the claim construction position advanced by the
`
`Patent Owner in the Spectrum litigation is different, i.e., that a “pointed corner”
`
`also includes a squared off corner. See Ex. 1017 ¶¶ 37-39. See also Ex. 1017 ¶ 24
`
`(citing Ex 1006 ¶ 20); Ex. 1001, 9:59-65. Thus, the BRI of “pointed corner”
`
`requires merely that first pointed corner 30 be capable of performing the required
`
`function, which is disrupting the pierceable membrane. See also Ex. 1003 ¶¶ 42-
`
`47.
`
`
`
`Thus, in view of the above constructions, the BRI of element “a)” of claim 1
`
`(limitations [1.1]-[1.5]) is a small closed or closable vessel sufficiently open at one
`
`end so as to be able to receive a sample, with an interior portion that can store the
`
`sample, and at least one piercing member as an integrated, but not necessarily
`
`integral, component, in which the first corner is capable of disrupting the
`
`pierceable membrane. See also Ex. 1003 ¶¶ 33-48.
`
`The term “removably engage” in limitation [1.6] is not defined in the ’381
`
`specification, and thus the plain meaning should apply. Per the specification of
`
`’381, the particular means used to removably engage the lid to the vial is not
`
`important, as long as the lid and vial are moveable to a piercing position. See Ex.
`
`1001, 5:7-15. This plain meaning also includes the Patent Owner’s litigation
`
`
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`-9-
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`DNA Genotek, Inc. Exhibit 2001 Page 17
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`

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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`construction. See Ex. 1006 ¶ 26. Thus, the BRI of this term is a lid that can be
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`attached in various ways and can later be removed. See also Ex. 1003 ¶¶ 49-50.
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`The BRI of limitation [1.7] is a receptacle or chamber for storing a liquid,
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`solid, semi-solid, gas, or mixtures thereof. Ex. 1015, p. 7 (original page 1483). See
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`also Ex. 1003 ¶ 51.
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`The BRI of this limitation [1.8], is a physical barrier that can be pierced,
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`including barriers made of foil or clear material. See Ex. 1001, 4:34-36; Ex. 1006 ¶
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`27. See also Ex. 1003 ¶ 52.
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`Thus, in view of the above constructions, the BRI of element “b)” of claim 1
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`([1.6]-[1.8]) is a lid that can be attached in various ways and later removed, the lid
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`including a receptacle or chamber for storing a liquid, solid, semi-solid, gas, or
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`mixtures thereof, and a physical barrier that can be pierced, including barriers
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`made of foil or clear plastic. See also Ex. 1003 ¶¶ 49-53.
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`Limitation [1.9] recites “wherein, when said system is closed by removable
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`engagement of said vial with said lid, said vial and said lid are movable to a
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`piercing position in which the piercing member disrupts the pierceable membrane
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`to allow fluid communication between said reservoir and said chamber.” In the
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`specification of the ’381 patent, in some embodiments the initial “removable
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`engagement” of the vial with the lid occurs first, and the movement to the piercing
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`position occurs thereafter. See Ex. 1001, 6:45-49. However, the claim construction
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`position advanced by the Patent Owner in the Spectrum litigation is different,
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`which is that attachment of the lid itself causes piercing of the membrane. See Ex.
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`1006 ¶28. Thus, the BRI of limitation [1.9] is that when the lid is engaged with the
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`vial, the vial and lid are either moved to, or are movable to, a piercing position in
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`which the piercing member disrupts the pierceable membrane, releasing the stored
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`substance from the reservoir. See also Ex. 1003 ¶¶ 54-55.
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`The BRI of limitation [1.10] is the plain meaning, which is that the chamber
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`is sufficiently sealed against leakage to enable the intended use of the container
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`system. See also Ex. 1003 ¶ 56.
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`The BRI of element [2.1] is that at least a portion of the perimeter of the
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`reservoir is formed by a wall located within the lid. The wall has a sealing surface
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`for sealingly attaching the pierceable membrane. See also Ex. 1003 ¶ 58.
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`The BRI of element [3.1] is the plain meaning, that the reservoir in the lid
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`has a volume sufficient to retain about 1 ml to about 4 ml of the substance. There is
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`no upper volumetric limit. See also Ex. 1003 ¶ 59.
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`Element [4.1] recites “wherein said pierceable membrane is inert.” The term
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`“inert,” as used in the specification of the ’381 patent, means “inert with respect to
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`the intended use.” See Ex. 1001, 5:4-5; Ex. 1015 p. 5 (original p. 896). In the
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`Patent Owner’s construction in the Spectrum litigation, an inert membrane includes
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`a foil membrane. See Ex. 1006 ¶28. Thus the BRI of “inert” should include foil
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`membranes. See also Ex. 1003 ¶ 60.
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`The BRI of element [5.1] is its plain meaning. See also Ex. 1003 ¶ 61.
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`Element [6.1] recites “wherein said pierceable membrane is sealingly
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`attached to said sealing surface by an adhesive, a heat-sealing treatment, a fastener,
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`or any combinations thereof.” Each of these terms should be interpreted according
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`to its plain meaning. See, e.g., Ex. 1015, p. 4 (original p. 643). The seal thereby
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`effected should be sufficient to retain the substance in the reservoir for reasonable
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`periods prior to use of the container system. See also Ex. 1003 ¶ 62.
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`Element [7.1] recites that “the width of said first end [of the vial] is
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`equivalent to the width of said second end [of the vial].” A reasonable
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`interpretation is that “width” refers to the internal diameter of a representative
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`cross-section taken at right angles to the axis running from lid to “second end.” See
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`also Ex. 1003 ¶ 63.
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`The BRI of element [8.1] is the plain meaning, which is that the first open
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`end has a discernibly greater internal diameter than the internal diameter of a
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`representative cross-section of the storage chamber taken at right angles to the axis
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`running from lid to “second end.” The ’381 specification states that in one
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`embodiment, “the first open end of vial 1 is generally wider than the second end of
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`vial 1. In this example, the generally wider first open end facilitates sample
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`collection by, for example, acting similar to a funnel.” Ex. 1001, 5:64-67. See also
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`Patent No. 8,221,381 — Petition for Inter Partes Review
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`Ex. 1003 ¶ 64.
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`The BRI of elements [9.1] and [10.1] is the plain meaning, at least 16 ml in
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`volume and at least 4 ml in volume, respectively; no upper size limits are imposed.
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`See also Ex. 1003 ¶¶ 65-66.
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`The BRI of the term “base surface” in limitation [11.1] is any surface that is
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`oriented so that it can oppose the force of the lid movement during engagement.
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`The ’381 specification does not define a specific and singular “base surface” of the
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`chamber, and in fact shows different locations of the piercing members in the two
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`principal embodiments shown in the figures. See Ex. 1011, FIGS. 10 and 9
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`compared with FIGS. 23 and 24 (shown below). See also Ex. 1003 ¶¶ 67-68.
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`The BRI of element [12.1] is its plain meaning, that the piercing members
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`extend perpendicularly from the base surface, with some reasonable variance from
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`an exact right angle. See, e.g., Ex. 1001, FIGS. 9, 10, 23, and 24. See also Ex. 1003
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`¶ 69.
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`The BRI of element [13.1] is a plain meaning that is an alternative to [12.1],
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`that the angle of the piercing member is outside the reasonable variance from an
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`exact right angle between the piercing member and base surface permitted in claim
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`12. See also Ex. 1003 ¶ 70.
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`Limitation [14.1] recites that the “side wall” of the piercing member “further
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`includes a second cutting edge.” The ’381 specification describes a second cutting
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`edge in conjunction with FIG. 10, copied below: “Optionally, side wall 34 also
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`includes cutting edge 33, which extends from cutting edge 32.” Ex. 1001, 6:37-38.
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`Thus, the BRI is that second cutting edge 33 is sufficiently sharp as to be capable
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`of piercing the pierceable membrane. See also Ex. 1003 ¶¶ 71-72.
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`Elements [15.1], [16.1], and [17.1] should be given their plain meaning,
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`that the vial includes at least two members ([15.1], [17.1]) or at least three
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`
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`members ([16.1]). See also Ex. 1003 ¶ 73.
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`Element [18.1] recites “sealing means for…,” which creates a presumption
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`that the element falls under 35 USC § 112(6), and that the “means” are therefore to
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`be interpreted to cover the corresponding structure(s) described in the
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`specification. The BRI of claim 18 does not require that the seal prevent long-term
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`leakage, nor prevent leakage in all spatial orientations; all that is required is some
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`discernible amount of sealing against leakage to the outside of the container system
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`once closed. See Ex. 1001, 6:39-7:5; FIG. 9 (shown below). See also Ex. 1003
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`¶ 75.
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`
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`Although Ex. 1001, 6:39-7:5 is the only portion of the ‘381 specification that
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`explicitly states that it is describing “means for sealing attachment of lid 1 to