Trials@uspto.gov
`571.272.7822
`
`Paper 19
`Entered: April 8, 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 IPR2016-00060
`Patent 8,221,381 B2
`____________
`
`
`
`
`
`Before WILLIAM V. SAINDON, HYUN J. JUNG, and
`MICHELLE N. WORMMEESTER, Administrative Patent Judges.
`
`WORMMEESTER, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`571.272.7822
`
`Paper 19
`Entered: April 8, 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 IPR2016-00060
`Patent 8,221,381 B2
`____________
`
`
`
`
`
`Before WILLIAM V. SAINDON, HYUN J. JUNG, and
`MICHELLE N. WORMMEESTER, Administrative Patent Judges.
`
`WORMMEESTER, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`IPR2016-00060
`Patent 8,221,381 B2
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`Ancestry.com DNA, LLC (“Petitioner”) filed a Resubmitted Petition
`(Paper 5, “Pet.”) requesting inter partes review of claims 1–20, 39–41, 43–
`47, and 49 of U.S. Patent No. 8,221,381 B1 (Ex. 1001, “the ’381 patent”).
`DNA Genotek Inc. (“Patent Owner”) filed a Preliminary Response (Paper
`16, “Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314(a), which
`provides that 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 institute an inter partes review as to claims 1, 2, 4, 5, 7, 8, 11, 12, 15–17,
`20, 41, 44, and 49 of the ’381 patent.
`
`
`I. BACKGROUND
`A. Related Proceedings
`The parties identify two cases involving the ’381 patent: (1) DNA
`Genotek, Inc. v. Ancestry.com DNA LLC, Case No. 15-00355-SLR (D. Del.);
`and (2) DNA Genotek, Inc. v. Spectrum DNA, Case No. 15-cv-00661-SLR.
`Pet. 2; Paper 7, 2.
`
`
`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
`store or ship diagnostic compositions before combining them with biological
`samples. Id. at 1:30–32. The ’381 patent addresses this need, describing a
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`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.
`
`
`
`
`
`As shown in Figure 3, the piercing member 6 is shaped like a trapezoid. In
`particular, the piercing member 6 includes a cutting edge 32 with a first
`pointed end 30 at a first corner of the trapezoid and a second end at a second
`corner of the trapezoid where the cutting edge 32 intersects a side wall 34.
`Id. at 6:33–37.
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`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.
`Because the vial is removable, it “is suitable for subsequent
`processing of samples and/or for use in robotic systems.” Id. at 4:3–5.
`
`
`C. Illustrative Claim
`Independent claim 1 of the ’381 patent 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
`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,
`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
`
`b)
`
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`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.
`
`
`
`O’Donovan and KCCL2
`Shih3 and KCCL
`Shih and Birnboim4
`
`§ 103
`§ 103
`§ 103
`
`D. Asserted Grounds of Unpatentability
`Petitioner challenges claims 1–20, 39–41, 43–47, and 49 of the ’381
`patent on the following grounds. Pet. 3, 18–58.
`Reference(s)
`Basis
`Claims Challenged
`O’Donovan1
`§ 102
`1, 2, 4, 5, 8, 11, 12, 15–17, 20,
`41, 44, and 49
`1, 7, and 14
`1, 2, 4, 5, 11–13, and 15–19
`3, 6, 8–10, 20, 39–41, 43–47,
`and 49
`
`
`
`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); In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268, 1278–79 (Fed. Cir. 2015), cert. granted sub nom. Cuozzo
`Speed Techs. LLC v. Lee, 136 S. Ct. 890 (mem.) (2016). Under this
`standard, claim terms are given their ordinary and customary meaning, as
`would be understood by one of ordinary skill in the art in the context of the
`
`
`1 O’Donovan, U.S. Patent No. 7,645,424 B2, issued Jan. 12, 2010
`(Ex. 1007).
`2 Okauchi, International Publication No. WO98/03265, published
`Jan. 29, 1998 [English translation] (Ex. 1010).
`3 Shih, U.S. Patent No. 6,152,296, issued Nov. 28, 2000 (Ex. 1009).
`4 Birnboim, International Publication No. WO03/104251 A2, published
`Dec. 18, 2003.
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`entire disclosure. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). On the other hand, a “claim term will not receive its
`ordinary meaning if the patentee acted as his own lexicographer” 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, and Patent Owner responds. See Pet. 5–18; Prelim. Resp. 4–10.
`For purposes of this Decision, we conclude that no term requires
`interpretation at this time.
`
`
`II. DISCUSSION
`A. Anticipation by O’Donovan
`Petitioner contends that O’Donovan anticipates claims 1, 2, 4, 5, 8,
`11, 12, 15–17, 20, 41, 44, and 495 of the ’381 patent, relying on the
`supporting testimony of Terry N. Layton, Ph.D. Pet. 10–21 (citing Ex.
`1003). We are persuaded that Petitioner has established a reasonable
`likelihood of prevailing on its asserted ground for the reasons explained
`below.
`
`
`1. 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
`
`
`5 Petitioner identifies claims 1, 2, 4, 5, 8, 11, 12, 15–17, 20, 41, 44, and 49 in
`its summary of the asserted grounds on page 4 of the Petition, but omits
`claims 11 and 12 in the heading on page 18 of the Petition. Given the
`substance of Petitioner’s arguments, we presume the latter to be a
`typographical error.
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`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-
`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.
`O’Donovan teaches that the cuvette may include a cover for covering
`the starter reagent chamber after it has been inserted into the socket in order
`to ensure that the chamber is held in place in the socket. Id. at 3:52–55.
`
`
`2. Analysis
`Petitioner contends that O’Donovan discloses each and every element
`of claim 1. See Pet. 21–29. For example, Petitioner points to disclosures in
`O’Donovan as corresponding to certain elements in this claim:
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`Disclosure in O’Donovan
`Element in Claim 1
`cuvette 1
`“container system”
`starter reagent
`“substance”
`inspection chamber 2
`“vial”
`sample
`“sample”
`spike 20
`“piercing member”
`starter reagent chamber 3
`“lid”
`foil membrane
`“pierceable membrane”
`See id. On the record at this stage of the proceeding, we are persuaded by
`Petitioner’s contentions in this regard. For example, Petitioner directs us to
`where O’Donovan teaches that the cuvette (container system) comprises the
`starter reagent chamber (lid) and the inspection chamber (vial), where the
`inspection chamber has a socket with spikes (piercing member). Pet. 21
`(citing Ex. 1007, 2:40–43), 22 (citing Ex. 1007, 3:12–20, Figs. 1, 3, 4).
`Petitioner also directs us to where O’Donovan teaches injecting a starter
`reagent (substance) into the starter reagent chamber, which is sealed with a
`foil membrane (pierceable membrane); adding a sample, such as blood, to
`the inspection chamber; and then inserting the starter reagent chamber into
`the socket of the inspection chamber, where the foil membrane is broken by
`the spikes. See id. at 21 (citing Ex. 1007, 3:4–5), 22 (citing Ex. 1007, 3:12–
`20). Once the foil membrane is broken, the starter reagent drops from within
`the starter reagent chamber into the inspection chamber, and the chambers
`effectively form a single chamber, with a friction fit between the starter
`reagent chamber and the socket of the inspection chamber. See id. at 23
`(citing Ex. 1007, 3:20–24, 28–30).
`In its Preliminary Response, Patent Owner argues that O’Donovan
`does not disclose three limitations recited in claim 1: (1) “a lid configured to
`removably engage said vial,” (2) “the chamber is sealed against leakage to
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`the outside of the container system in the piercing position,” and (3) “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.” Prelim. Resp. 11–21. Based on the
`current record, we are not persuaded by Patent Owner’s arguments.
`Regarding the “removably engage” limitation, Patent Owner contends
`that “a person of skill in the art would not understand O’Donovan’s lid to be
`configured for removal.” Id. at 12. As Petitioner points out, however,
`O’Donovan teaches providing the socket of the inspection chamber with “a
`cover for covering the starter reagent chamber after it has been inserted into
`the socket,” which “would ensure that it is held in place in the socket.” Pet.
`28; Ex. 1007, 3:52–55 (cited at Pet. 22). The fact that the cover would
`ensure that the starter reagent chamber (lid) is held in place in the socket of
`the inspection chamber (vial) implies that the starter reagent chamber is
`removable from the socket. Accordingly, based on the record before us, we
`are persuaded that O’Donovan discloses the “removably engage” limitation.
`Regarding the “sealed against leakage” limitation, Petitioner argues
`that the friction fit between the starter reagent chamber and the inspection
`chamber prevents leakage to the outside of the cuvette, “especially when the
`optional cover and seal are engaged.” Pet. 23, 28–29. In support of its
`argument, Petitioner directs us to where O’Donovan teaches that the friction
`fit allows for the chambers to form a single chamber. Id. at 23 (citing Ex.
`1007, 3:28–30, Figs. 3, 4). Petitioner also relies on Dr. Layton’s testimony
`that “the container system prevents leakage because it is friction fit between
`parts that are closely matched in shape.” Id. (citing Ex. 1003 ¶ 115).
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`Patent Owner acknowledges that the chambers in O’Donovan form a
`single chamber, but contends that a chamber is not necessarily sealed.
`Prelim. Resp. 18–19. As to Dr. Layton’s testimony, Patent Owner further
`contends that “O’Donovan does not say the parts are closely matched in
`shape.” Prelim. Resp. 19.
`As Patent Owner points out, however, O’Donovan explicitly teaches
`that “there is just enough space for the rim 11 of the chamber 3 to fit
`between the spikes 20 and the wall of the socket 6 with a friction fit.”
`Prelim. Resp. 20 (quoting Ex. 1007, 2:63–67) (emphasis added). We further
`note that Figures 3 and 4 also appear to show that the rim of the starter
`reagent chamber and the wall of the socket match in shape. See Ex. 1007,
`Figs. 3, 4. Accordingly, based on the record before us, we are persuaded
`that Petitioner has shown sufficiently that O’Donovan discloses the “sealed
`against leakage” limitation.
`Patent Owner further contends that “[i]t is unclear which embodiment
`Petitioner relies on as anticipating claim 1” because “Petitioner argues that
`the option of using an additional cover and seal means that O’Donovan’s
`embodiment without the optional cover is ‘removably engaged,’ whereas the
`embodiment with the optional cover is ‘sealed.’” Prelim. Resp. 19 (internal
`citations omitted). As discussed above, however, the fact that the optional
`cover would ensure that the starter reagent chamber is held in place in the
`socket of the inspection chamber implies that the starter reagent chamber is
`removable from the socket, whether or not the optional cover is used.
`Further, as discussed above, the cited portions of O’Donovan imply that the
`chambers form a seal where there is a friction fit between the rim of the
`starter reagent chamber and the wall of the socket, whether or not the
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`optional cover is used. Accordingly, based on the record before us, we are
`unpersuaded by Patent Owner’s contention in this regard.
`Finally, regarding the recited piercing member, Petitioner directs us to
`Figure 3 of O’Donovan, which illustrates a spike (piercing member). Pet.
`22. Petitioner also relies on Dr. Layton’s testimony explaining how the
`different portions of the spike in O’Donovan satisfy the recited elements of
`the piercing member in claim 1. Id. (citing Ex. 1003 ¶ 108). In response,
`Patent Owner contends that “O’Donovan only describes ‘spikes’ as doing
`the cutting,” not “what Dr. Layton labels as the ‘edge.’” Prelim. Resp. 21.
`We note, however, that O’Donovan teaches that the foil membrane “is both
`pierced and torn by the spikes” when the starter reagent chamber is pressed
`down into the inspection chamber. Ex. 1007, 3:17–23 (cited at Pet. 23).
`Given this teaching, we understand that the portion of the spike that Dr.
`Layton labels as the “first pointed corner” pierces the foil membrane, and the
`portion of the spike that Dr. Layton labels as the “first cutting edge” tears the
`foil membrane. See Ex. 1003 ¶ 108. Accordingly, based on the record
`before us, we are persuaded that O’Donovan discloses the recited piercing
`member.
`In view of the foregoing, we conclude that Petitioner has established a
`reasonable likelihood of prevailing on its assertion that O’Donovan
`anticipates claim 1. Having reviewed Petitioner’s arguments (see Pet. 24–
`27, 29) asserting that O’Donovan anticipates dependent claims 2, 4, 5, 8, 11,
`12, 15–17, 20, 41, 44, and 49, we also conclude that Petitioner has
`established a reasonable likelihood of prevailing on its assertion that
`O’Donovan anticipates these claims.
`
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`B. Obviousness over O’Donovan and KCCL
`Petitioner argues that claims 1, 7, and 14 of the ’381 patent would
`have been obvious over O’Donovan and KCCL. See Pet. 29–37. For the
`reasons explained below, we are persuaded that Petitioner has established a
`reasonable likelihood of prevailing on its asserted ground as to claims 1 and
`7, but not as to claim 14.
`
`
`1. KCCL
`KCCL describes a reagent vessel for water quality analysis. Ex. 1011,
`Abstract. The vessel comprises a main vessel body and a cap body that may
`be screwed onto the main vessel body. Id. at 7. The drawings in KCCL
`show the main vessel body having a cylindrical shape. Id. at Figs. 1, 4, 7.
`The cap body includes a film vessel that contains a reagent and a cutter
`blade edge located below the film vessel. Id. at 7–8, Fig. 1.
`In use, test water is poured into the vessel main body. Id. at 9. The
`cap body is then screwed onto the vessel main body. Id. As the cap body is
`tightened, the cutter blade edge breaks the film vessel, allowing for the
`reagent to leak into the vessel main body and mix with the test water. Id. at
`9–10. The reagent vessel is then placed into an automatic measurement
`device so that the test water may be analyzed. Id. at 11.
`
`
`2. Claims 1 and 7
`Petitioner contends that, “[a]s discussed above in Ground 1,
`O’Donovan anticipates ‘381 claim 1.” Pet. 31. For example, Petitioner
`contends that O’Donovan teaches the recited vial, which includes first and
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`second ends. Id. at 34. For the reasons given above, we are persuaded that
`O’Donovan discloses the limitations recited in claim 1.
`Claim 7 further limits the vial in claim 1, reciting that “the width of
`said first end is equivalent to the width of said second end.” For this
`limitation, Petitioner relies on KCCL. In particular, Petitioner directs us to
`where KCCL illustrates a cylindrical main vessel body (vial). See id. at 32,
`36–37 (citing Ex. 1011, Figs. 1, 4, 7). As Petitioner acknowledges, the
`widths of the ends of the main vessel body in KCCL appear to be “near
`equivalen[t]. Id. at 32; Ex. 1011, Figs. 1, 4, 7. We note, however, that the
`’381 patent similarly describes the widths of the ends of the vial as
`“approximately equivalent.” Ex. 1001, 6:62–63. Based on the current
`record, we are persuaded that Petitioner has shown sufficiently that KCCL
`teaches the recited limitation.
`In addition to demonstrating that each of the components is known,
`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) (cited by KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398, 418 (2007)). In that regard, Petitioner contends that a person
`of ordinary skill in the art “would have been motivated to substitute the vial
`of KCCL, with its near equivalence in cross-sectional diameter at the open
`and closed ends of the vial . . . , for the cuvette of O’Donovan, to make the
`reagent cuvette compatible with other analytical devices.” Pet. 32.
`According to Petitioner, this would have been a “[s]imple substitution of one
`known element for another to obtain predictable results.” Id. at 33.
`Petitioner supports its contention with Dr. Layton’s testimony that “[a]
`person of ordinary skill in the art would have understood that the exact shape
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`of the vial is not critical to functioning of O’Donovan’s reagent cuvette, so
`long as (i) the cuvette could be used in an analytical instrument — and many
`such instruments accommodate cylindrical vials.” Id. at 32, 36 (citing Ex.
`1003 ¶ 152). On this record, we are satisfied with Petitioner’s articulated
`reasoning (see Pet. 32), which is supported by a rational underpinning. See
`Kahn, 441 F.3d at 988.
`In view of the foregoing, we determine that Petitioner has established
`a reasonable likelihood of prevailing on its assertion that claims 1 and 7
`would have been obvious over O’Donovan and KCCL. See Ormco Corp. v.
`Align Tech., Inc., 498 F.3d 1307, 1319 (Fed. Cir. 2007) (finding that
`independent claims would have been obvious because dependent claims
`were found to have been obvious).
`
`
`3. Claim 14
`Claim 14 recites “said side wall [of the piercing member] further
`includes a second cutting edge.” For this limitation, Petitioner relies on
`KCCL. In particular, Petitioner directs us to where KCCL describes a
`crescent moon-shaped cutter blade edge and a crown-shaped cutter blade
`edge. Pet. 37 (citing Ex. 1011 at 6, Figs. 3, 5). According to Petitioner,
`each of these cutter blade edges in KCCL has “at least two cutting edges.”
`Id.
`
`It is not sufficient, however, for Petitioner to demonstrate that each of
`the components is known. See KSR, 550 U.S. at 418. Petitioner must also
`provide “some articulated reasoning with some rational underpinning to
`support the legal conclusion of obviousness.” Kahn, 441 F.3d at 988. In
`that regard, Petitioner contends that “a POSITA would have been motivated
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`to substitute the piercing members of KCCL having a second cutting edge
`for the piercing members of O’Donovan in order to improve the piercing
`member’s ability to pierce the membrane, and thereby ensure that the
`substance in the lid is completely and reliably released into the vial.” Pet.
`32–33. Petitioner supports its contention with testimony of Dr. Layton. See
`id. at 33 (citing Ex. 1003 ¶ 149), 37 (citing Ex. 1003 ¶¶ 156–160).
`Based on the current record, we are not persuaded that Petitioner has
`provided adequately articulated reasoning with some rational underpinning
`to support the legal conclusion of obviousness. See Kahn, 441 F.3d at 988.
`First, Petitioner proposes substituting the cutter blade edge in KCCL for the
`spike in O’Donovan. Petitioner does not, however, explain sufficiently how
`the cutter blade edge in KCCL satisfies the recited piercing member, which
`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,” where “said side wall includes a second cutting
`edge.” Although the cutter blade edge in KCCL may comprise first and
`second cutting edges (see Pet. 37), Petitioner does not show that the cutter
`blade edge further comprises other features of the recited piercing member.
`Second, Petitioner does not explain sufficiently why one of ordinary
`skill in the art would have considered it obvious to combine or modify
`elements of O’Donovan with the identified elements of KCCL, or why one
`of ordinary skill in the art would have considered it obvious to modify the
`teachings of O’Donovan in view of the teachings of KCCL to arrive at the
`claimed invention. For example, we note that O’Donovan teaches that “[t]he
`foil material of this membrane is both pierced and torn by the spikes 20 so
`that the full quantity of starter reagent drops into the inspection part 5.” Ex.
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`1007, 3:22–24 (cited at Pet. 23) (emphasis added). Neither Petitioner nor
`Dr. Layton explains sufficiently why a person of ordinary skill in the art
`would have considered it obvious to replace the spike in O’Donovan with
`the cutter blade edge in KCCL, when the spike in O’Donovan already
`pierces the foil membrane such that the full quantity of the starter reagent is
`released into the inspection part (vial).
`In view of the foregoing, we determine that Petitioner has not
`established a reasonable likelihood of prevailing on its assertion that claim
`14 would have been obvious over O’Donovan and KCCL.
`
`
`4. Claim 1: Obviousness over O’Donovan
`With respect to claim 1, Petitioner appears to argue alternatively that
`the claim “would have been obvious over O’Donovan, even without reliance
`on a second prior art reference.” Pet. 31 (emphasis added). In support of
`this argument, Petitioner contends that “[a]ny element or limitation that the
`Board finds absent from O’Donovan would have been obvious to a person of
`ordinary skill in the art.” Id. at 32.
`As discussed above, it is not sufficient for Petitioner to demonstrate
`that each of the components is known. See KSR, 550 U.S. at 418. Petitioner
`must also provide “some articulated reasoning with some rational
`underpinning to support the legal conclusion of obviousness.” Kahn, 441
`F.3d at 988. Neither Petitioner nor Dr. Layton, however, explains
`sufficiently why one of ordinary skill in the art would have considered it
`obvious to combine elements of O’Donovan with the teachings of any other
`patent or printed publication, or why one of ordinary skill in the art would
`have considered it obvious to modify the system of O’Donovan based on
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`any other teachings to arrive at the claimed invention. On this record, we
`are not persuaded that Petitioner has provided adequately articulated
`reasoning with some rational underpinning to support the legal conclusion of
`obviousness. See id. at 988.
`In view of the foregoing, we determine that Petitioner has not
`established a reasonable likelihood of prevailing on its assertion that claim 1
`would have been obvious over O’Donovan alone.
`
`
`C. Obviousness over Shih and KCCL
`Petitioner argues that claims 1, 2, 4, 5, 11–13, and 15–19 of the ’381
`patent would have been obvious over Shih and KCCL. See Pet. 37–50. We
`are not persuaded that Petitioner has established a reasonable likelihood of
`prevailing on its asserted ground for the reasons explained below.
`
`
`1. Shih
`Shih describes “an additive holder for a PET bottle which enables an
`additive such as sugar, cream milk, or the like to mix with a drink in a PET
`bottle as desired.” Ex. 1009, 1:33–36. The additive holder comprises a
`closed cylindrical container with a handle at the top end and an open tubular
`member with a toothed neck at the bottom end. Id. at 2:22–24, 35–36. An
`additive is inside the container. Id. at 2:60–61. The tubular member is fitted
`in the mouth of the PET bottle, and the container is fitted inside the tubular
`member, with the handle extending from the top of the tubular member. Id.
`at 2:32–33, 37–39.
`When a user is ready to mix the additive in the container with the
`drink in the PET bottle, the user depresses the handle. Id. at 2:59–63. As a
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`result, the toothed neck of the tubular member pierces the bottom of the
`container, allowing for the additive to drop into the PET bottle. Id. at 2:62–
`66. The amount of additive added to the drink may be controlled by the
`depressing force on the handle. Id. at 2:66–3:2.
`
`
`2. Analysis
`Petitioner argues that “Shih and KCCL disclose or suggest each and
`every limitation of claims 1, 2, 4, 5, 11–13, and 15–19 of the ’381” patent.
`Pet. 39. In support of this argument, Petitioner directs us to disclosures in
`both Shih and KCCL, which Petitioner contends teach the limitations recited
`in the claims. See Pet. 41–50. Petitioner also relies on testimony of Dr.
`Layton. See id.
`As noted above, Petitioner must provide “some articulated reasoning
`with some rational underpinning to support the legal conclusion of
`obviousness” in addition to demonstrating that each of the components is
`known. See KSR, 550 U.S. at 418; Kahn, 441 F.3d at 988. In that regard,
`Petitioner contends that one of ordinary skill in the art would have been
`motivated to combine Shih and KCCL to arrive at the claimed invention
`“because both references are directed to container systems for releasably
`storing a substance,” and because both references are similarly classified.
`Pet. 39–40. Petitioner also contends that, “in each case,” combining Shih
`and KCCL would have involved a “[s]imple substitution of one known
`element for another to obtain predictable results.” Id. at 40. According to
`Petitioner, no “extra-ordinary skill is required to combine Shih and KCCL,
`and the improvement would have been obvious.” Id. at 41. This is not
`sufficient for explaining why one of ordinary skill in the art would combine
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`elements of Shih and elements of KCCL, or why one of ordinary skill in the
`art would modify the teachings of Shih in view of the teachings of KCCL to
`arrive at the claimed invention.
`For example, Petitioner proposes a substitution for each combination
`of elements. See Pet. 40. As an initial matter, Petitioner does not specify the
`elements from Shih and KCCL that would have been obvious to combine.
`We note that Petitioner contends that Shih and KCCL teach several of the
`same limitations recited in the claims. See Pet. 41–50. Petitioner does not,
`however, explain sufficiently why a person of ordinary skill in the art would
`have considered it obvious to replace a particular element in Shih that
`satisfies a recited limitation with a particular element in KCCL that also
`satisfies the recited limitation, when Shih already teaches an element that
`satisfies the recited limitation. On this record, we are not persuaded that
`Petitioner has provided adequately articulated reasoning with some rational
`underpinning to support the legal conclusion of obviousness. See Kahn, 441
`F.3d at 988.
`In view of the foregoing, we determine that Petitioner has not
`established a reasonable likelihood of prevailing on its assertion that claims
`1, 2, 4, 5, 11–13, and 15–19 would have been obvious over Shih and KCCL.
`
`
`D. Obviousness over Shih and Birnboim
`Petitioner argues that claims 3, 6, 8–10, 20, 39–41, 43–47, and 49 of
`the ’381 patent would have been obvious over Shih and Birnboim. See Pet.
`50–58. We are not persuaded that Petitioner has established a reasonable
`likelihood of prevailing on its asserted ground for the reasons explained
`below.
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`
`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 broken, and
`the composition and the sample become mixed together. Id. at 24:20–23.
`
`
`2. Analysis
`Petitioner argues that “[t]he portions of claims 3, 6, 8–10, 20, 39–41,
`43–47, and 49 that are not disclosed in Shih are . . . disclosed in Birnboim.”
`Pet. 52. In support of this argument, Pet
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