Trials@uspto.gov
`571.272.7822
`
`Paper 11
`Entered: November 23, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ANCESTRY.COM DNA, LLC,
`Petitioner,
`
`v.
`
`DNA GENOTEK INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01152
`Patent 8,221,381 B2
`____________
`
`
`
`
`
`Before WILLIAM V. SAINDON, HYUN J. JUNG, and
`MICHELLE N. WORMMEESTER, Administrative Patent Judges.
`
`WORMMEESTER, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`571.272.7822
`
`Paper 11
`Entered: November 23, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ANCESTRY.COM DNA, LLC,
`Petitioner,
`
`v.
`
`DNA GENOTEK INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01152
`Patent 8,221,381 B2
`____________
`
`
`
`
`
`Before WILLIAM V. SAINDON, HYUN J. JUNG, and
`MICHELLE N. WORMMEESTER, Administrative Patent Judges.
`
`WORMMEESTER, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`IPR2016-01152
`Patent 8,221,381 B2
`
`
`Ancestry.com DNA, LLC (“Petitioner”) filed a Petition (Paper 1,
`“Pet.”) requesting inter partes review of claims 3, 6, 9, 10, 13, 14, 18, 19,
`39, 40, 43, and 45–47 of U.S. Patent No. 8,221,381 B2 (Ex. 1001, “the ’381
`patent”). DNA Genotek Inc. (“Patent Owner”) filed a Preliminary Response
`(Paper 6, “Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314 and
`37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), an inter partes review may
`not be instituted “unless . . . there is a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” For the reasons that follow, we deny institution of an inter
`partes review.
`
`
`I. BACKGROUND
`A. Related Proceedings
`The parties identify three cases involving the ’381 patent: (1) DNA
`Genotek, Inc. v. Ancestry.com DNA LLC, Case No. 15-00355-SLR (D. Del.);
`(2) DNA Genotek, Inc. v. Spectrum DNA, Case No. 15-cv-00661-SLR (D.
`Del.); and (3) DNA Genotek, Inc. v. Spectrum DNA, Case No. 16-cv-1544-
`MMA-NLS (S.D. Cal.). Pet. 2; Paper 5, 2.
`The parties also identify the following petition for inter partes review
`involving the ’381 patent: IPR2016-00060. Pet. 2; Paper 5, 3.
`
`
`B. The ’381 Patent
`The ’381 patent is titled “Container System for Releasably Storing a
`Substance.” According to the ’381 patent, there is often a need to store a
`substance in a container before mixing the substance with another substance.
`Ex. 1001, 1:19–21. For example, there is a need in certain applications to
`
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`IPR2016-01152
`Patent 8,221,381 B2
`
`store or ship diagnostic compositions before combining them with biological
`samples. Id. at 1:30–32. The ’381 patent addresses this need, describing a
`container system that releasably and reliably stores a substance. Id. at 2:5–6,
`15–16.
`The container system of the ’381 patent comprises a vial and a lid that
`may be screwed onto the vial. Id. at 4:6–7, 5:7–10. The lid defines a
`reservoir for holding a substance, such as a nucleic acid preservative. Id. at
`4:27–31, 5:17–18. A pierceable membrane that attaches to the lid serves as
`a physical barrier to releasably store the substance within the reservoir. Id.
`at 4:34–36.
`The vial comprises a chamber for receiving a sample, such as saliva.
`Id. at 5:53–55. The vial also comprises at least one piercing member, which
`extends from a base surface within the vial. Id. at 6:14–23. Figure 3, which
`is reproduced below, illustrates a piercing member.
`
`
`
`Figure 3 is a perspective view of the interior of the vial. Id. at 3:3–4. As
`shown in the figure, piercing member 6 is shaped like a trapezoid. In
`particular, piercing member 6 includes cutting edge 32 with first pointed end
`
`
`
`3
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`IPR2016-01152
`Patent 8,221,381 B2
`
`30 at a first corner of the trapezoid and a second end at a second corner of
`the trapezoid where cutting edge 32 intersects side wall 34. Id. at 6:33–37.
`When a user begins to screw (or twist) the lid onto the vial, the lid and
`vial are moved to a piercing position. Id. at 7:12–13. At the piercing
`position, the first pointed end of the piercing member pierces the pierceable
`membrane. Id. at 7:18–20. As the user continues to twist the lid, the cutting
`edge of the piercing member moves through the pierceable membrane,
`creating an opening in the membrane that allows for the substance stored in
`the lid to enter the vial and mix with the sample stored in the vial. Id. at
`7:21–24, 11:37–39. With the lid on, the vial is sealed against leakage of its
`contents. Id. at 7:1–9.
`
`
`C. Illustrative Claim
`Petitioner challenges claims 3, 6, 9, 10, 13, 14, 18, 19, 39, 40, 43, and
`45–47, each of which depends from independent claim 1. We resolve issues
`raised by Petitioner’s challenges based on claim 1, as we will explain in our
`discussion section below. Claim 1 recites:
`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
`reservoir,
`
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`IPR2016-01152
`Patent 8,221,381 B2
`
`
`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.
`
`
`
`D. Asserted Grounds of Unpatentability
`Petitioner challenges claims 3, 6, 9, 10, 13, 14, 18, 19, 39, 40, 43, and
`45–47 of the ’381 patent on the following grounds. Pet. 26–72.
`References
`Basis
`Claims Challenged
`Birnboim1 and O’Donovan2
`§ 103
`3, 6, 9, 10, 39, 40, 43, and 45–47
`Birnboim, O’Donovan,
`§ 103
`18 and 19
`Chelles3
`Birnboim, O’Donovan, and
`Clarkson4
`In support of its arguments, Petitioner proffers the Declaration of Dr. Terry
`N. Layton, Ph.D. (Ex. 1003). See id.
`
`
`§ 103
`
`13 and 14
`
`E. Claim Construction
`We construe claims in an unexpired patent by applying the broadest
`reasonable interpretation in light of the specification of the patent in which
`they appear. See 37 C.F.R. § 42.100(b); Cuozzo Speed Techs. LLC v. Lee,
`
`1 Birnboim, Int’l Publ’n No. WO 03/104251 A2, published Dec. 18, 2003
`(Ex. 1008).
`2 O’Donovan, U.S. Patent No. 7,645,424 B2, issued Jan. 12, 2010
`(Ex. 1007).
`3 Chelles, U.S. Publ’n No. US 2003/0089627 A1, published May 15, 2003
`(Ex. 1020).
`4 Clarkson, Int’l Publ’n No. WO 2005/023667 A1, published Mar. 17, 2005
`(Ex. 1021).
`
`5
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`IPR2016-01152
`Patent 8,221,381 B2
`
`136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest
`reasonable interpretation standard). Under this standard, claim terms
`generally are given their ordinary and customary meaning, as would be
`understood by one of ordinary skill in the art in the context of the entire
`disclosure. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). A “claim term will not receive its ordinary meaning if the patentee
`acted as his own lexicographer,” however, and clearly set forth a definition
`of the claim term in the specification. CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359, 1366 (Fed. Cir. 2002).
`Petitioner provides proposed interpretations for various limitations of
`the claims. See Pet. 16–26. Patent Owner responds. Prelim. Resp. 6. For
`purposes of this Decision, we conclude that no term requires express
`interpretation at this time to resolve any controversy in this proceeding. See
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999) (“only those terms need be construed that are in controversy, and only
`to the extent necessary to resolve the controversy”).
`
`
`II. DISCUSSION
`A. Obviousness over Birnboim and O’Donovan
`Petitioner argues that claims 3, 6, 9, 10, 39, 40, 43, and 45–47 of the
`’381 patent would have been obvious over Birnboim and O’Donovan under
`35 U.S.C. § 103. Pet. 26–51. For the reasons explained below, we are not
`persuaded that Petitioner has demonstrated a reasonable likelihood of
`prevailing on its asserted ground.
`
`
`6
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`IPR2016-01152
`Patent 8,221,381 B2
`
`
`1. Birnboim
`Birnboim describes “a novel collection device useful for collecting a
`biological sample from a subject, and subsequently mixing the collected
`sample with a composition intended to stabilize, preserve, or facilitate the
`recovery of components of the sample.” Ex. 1008, 22:23–26. The
`collection device comprises a container and a cap that may be screwed onto
`the container. Id. at 24:11–15, Fig. 10. The container includes a plunger
`and a sealing disc. Id. at 24:11–13, 17–18, Figs. 10, 11. The sealing disc
`divides the container into two regions, a first region above the disc and a
`second region below the disc. Id. at Fig. 11. A biological sample is added
`to the first region of the container, while a nucleic acid-preserving
`composition is added to the second region of the container. Id. at 11:15,
`24:12–13, 22–23, Fig. 11.
`When the cap is screwed onto the container, the plunger is forced
`downward and, in turn, causes the sealing disc to pivot. Id. at 24:15–20. As
`a result, the barrier between the two regions of the container is removed, and
`the composition and the sample become mixed together. Id. at 24:20–23.
`
`
`2. O’Donovan
`O’Donovan describes a reagent cuvette for sample analysis. Ex.
`1007, 1:9–10. The cuvette comprises a starter reagent chamber and an
`inspection chamber. Id. at 2:39–43, 3:36 (“inspection chamber”), 3:53
`(“starter reagent chamber”). The starter reagent chamber contains a starter
`reagent that is sealed inside the chamber with a foil membrane. Id. at 3:1–5.
`The inspection chamber includes an inspection part with a square cross-
`
`7
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`IPR2016-01152
`Patent 8,221,381 B2
`
`section and a socket for receiving the starter reagent chamber. Id. at 2:46–
`49. There are four spikes at the base of the socket. Id. at 2:60–63.
`In use, a sample (such as blood) is added to the inspection chamber.
`Id. at 3:11–13. The starter reagent chamber is then inserted into the socket.
`Id. at 3:17–19. As the starter reagent chamber is pressed down, the spikes in
`the socket pierce and tear the foil membrane such that all of the starter
`reagent drops into the inspection part of the inspection chamber. Id. at 3:17–
`24. The combined chambers effectively form a single chamber, where there
`is a friction fit between the starter reagent chamber and the socket of the
`inspection chamber. Id. at 3:28–30. The inspection part is finally placed
`into an optical inspection instrument for analysis of the sample/reagent
`mixture. Id. at 3:30–32.
`
`
`3. Analysis
`Each of claims 3, 6, 9, 10, 39, 40, 43, and 45–47 depends from claim
`1, and, therefore, includes all the limitations of claim 1. With respect to
`claim 1, Petitioner relies primarily on Birnboim. See Pet. 29 (“Birnboim
`discloses all elements of ’381 claim 1 except [1.5], which limits the shape of
`the piercing member, and the positioning of reservoir [1.7] within lid
`[1.6].”). Petitioner additionally relies on O’Donovan for certain of the
`limitations recited in claim 1, including a “lid comprising a reservoir for
`holding the substance.” Id. at 29, 41. In particular, Petitioner identifies
`O’Donovan’s chamber 3 as a “lid,” and points out that “O’Donovan
`discloses that starter reagent is injected into the chamber 3.” Id. at 41.
`It is not sufficient, however, for Petitioner to demonstrate that each of
`the claim elements is known. See KSR Int’l Co. v. Teleflex Inc., 550 U.S.
`
`8
`
`
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`IPR2016-01152
`Patent 8,221,381 B2
`
`398, 418 (2007). Petitioner must also provide “some articulated reasoning
`with some rational underpinning to support the legal conclusion of
`obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). In that
`regard, Petitioner directs us to where Birnboim describes a container with a
`barrier, which may be a septum that separates a composition from a fluid
`until the septum is pierced or punctured. Pet. 36 (citing Ex. 1008, 9:11,
`23:29–31). Petitioner also directs us to where Birnboim teaches that “the
`means for closing the container may be coupled to the disestablishment of
`the barrier.” Id. (citing Ex. 1008, 24:8–9). According to Petitioner,
`however, “Birnboim does not disclose how, in such embodiment, the ‘means
`for closing the container may be coupled to the disestablishment of the
`barrier.’” Id. Thus, Petitioner argues, a POSITA would have looked to
`analogous art “for a solution that would complete” Birnboim’s embodiment,
`and would have “recognized [O’Donovan] as providing a particularly
`relevant solution to the identified problem because, like Birnboim,
`O’Donovan is explicitly directed to a container system for use in analyzing
`biological samples.” Id. at 36–37 (citing Ex. 1003 ¶ 111).
`We are unpersuaded by Petitioner’s argument. As Patent Owner
`points out, Petitioner does not explain sufficiently why one of ordinary skill
`in the art would have considered combining the container of Birnboim with
`certain features of the container of O’Donovan to arrive at the claimed
`invention. Prelim. Resp. 35. The mere fact that both Birnboim and
`O’Donovan are in the same field of endeavor falls short of an adequate
`rationale. The same field of endeavor analysis is merely the jumping-off
`point in reaching the determination of whether a claimed invention is
`obvious. See K-TEC, Inc. v. Vita-Mix Corp., 696 F.3d 1364, 1375 (Fed. Cir.
`
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`IPR2016-01152
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`
`2012) (to qualify as prior art in an obviousness analysis, references must be
`analogous art—either from the same field of endeavor, or reasonably
`pertinent to the problem with which the inventor is involved).
`Petitioner further argues that combining the teachings of Birnboim
`and O’Donovan “would have required no more than ‘[a]pplying a known
`technique to a known device (method, or product) ready for improvement to
`yield predictable results,’” noting that “‘[a] person with ordinary skill in the
`art is a person of ordinary creativity, not an automaton, and in many cases
`. . . will be able to fit the teachings of multiple patents together like pieces of
`a puzzle.’” Pet. 37 (citing Ex. 1003 ¶ 112). We also are unpersuaded by this
`argument. Petitioner’s conclusory statements are nothing more than a
`restatement of basic tests identified by the Supreme Court for determining
`whether an invention would have been obvious. See KSR, 550 U.S. at 417
`(“whether the improvement is more than the predictable use of prior art
`elements according to their established functions”); id. (whether “the
`claimed subject matter may involve more than . . . the mere application of a
`known technique to a piece of prior art ready for the improvement”); see
`also id. at 421 (“A person of ordinary skill is also a person of ordinary
`creativity, not an automaton.”). General principles on what may constitute a
`supporting rationale cannot substitute for specific application of those
`principles to the facts. Petitioner does not provide a persuasive, fact-based
`analysis to support the proposed combination of Birnboim and O’Donovan.
`Notably, it is not clear which features of O’Donovan’s container are to be
`incorporated into Birnboim’s container, or how, or why.
`In view of the foregoing, we are not persuaded that Petitioner has
`provided adequately articulated reasoning with some rational underpinning
`
`10
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`IPR2016-01152
`Patent 8,221,381 B2
`
`to support the legal conclusion of obviousness with respect to claim 1. See
`Kahn, 441 F.3d at 988. As each of claims 3, 6, 9, 10, 39, 40, 43, and 45–47
`depends from claim 1, we determine, based on the record before us, that
`Petitioner has not demonstrated a reasonable likelihood of prevailing in
`showing that these dependent claims would have been obvious over
`Birnboim and O’Donovan.
`
`
`B. Obviousness over Birnboim, O’Donovan, and Chelles
`Petitioner argues that claims 18 and 19 of the ’381 patent would have
`been obvious over Birnboim, O’Donovan, and Chelles. Pet. 51–60. Claims
`18 and 19 depend from claim 1. Petitioner’s arguments and evidence
`regarding these dependent claims do not remedy the deficiencies discussed
`above with respect to claim 1 in relation to Birnboim and O’Donovan. See
`Pet. 58–60 (relying on Chelles only for claims 18 and 19); see also id. at 58
`(for claim 1, referring to “Reasons Birnboim and O’Donovan Render
`Obvious Claim 1 above under Ground 1,” which is based on Birnboim and
`O’Donovan). On this record, and for the reasons discussed above, we
`determine that Petitioner has not demonstrated a reasonable likelihood of
`prevailing on its assertion that claims 18 and 19 would have been obvious
`over Birnboim, O’Donovan, and Chelles.
`
`
`C. Obviousness over Birnboim, O’Donovan, and Clarkson
`Petitioner argues that claims 13 and 14 of the ’381 patent would have
`been obvious over Birnboim, O’Donovan, and Clarkson. Pet. 60–72.
`Claims 13 and 14 depend from claim 1. Petitioner’s arguments and evidence
`regarding these dependent claims do not remedy the deficiencies discussed
`
`11
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`IPR2016-01152
`Patent 8,221,381 B2
`
`above with respect to claim 1 in relation to Birnboim and O’Donovan. See
`Pet. 70–72 (relying on Clarkson only for claims 13 and 14); see also id. at 70
`(for claim 1, referring to “Ground 1 re claim 1,” where Ground 1 is based on
`Birnboim and O’Donovan). On this record, and for the reasons discussed
`above, we determine that Petitioner has not demonstrated a reasonable
`likelihood of prevailing on its assertion that claims 13 and 14 would have
`been obvious over Birnboim, O’Donovan, and Clarkson.
`
`
`III. CONCLUSION
`For the foregoing reasons, we are not persuaded that Petitioner has
`demonstrated a reasonable likelihood that it would prevail on any of the
`asserted grounds as to any of the challenged claims of the ’381 patent.
`
`
`IV. ORDER
`For the reasons given, it is
`ORDERED that the Petition is denied as to all challenged claims, and
`no trial is instituted.
`
`
`
`
`
`12
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`
`IPR2016-01152
`Patent 8,221,381 B2
`
`PETITIONER:
`Daniel Becker
`DBecker-PTAB@fenwick.com
`Jennifer Bush
`Jbush-ptab@fenwick.com
`
`PATENT OWNER:
`Brian Kramer
`bmkramer@mofo.com
`Peng Chen
`pchen@mofo.com
`Desmond O'Sullivan
`dosullivan@mofo.com
`
`13
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