Trials@uspto.gov
`571-272-7822
`
` Paper No. 14
`
` Entered: December 20, 2019
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FOUNDATION MEDICINE, INC.,
`Petitioner,
`
`v.
`
`GUARDANT HEALTH, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00636
`Case IPR2019-00637
`Patent 9,902,992 B21
`____________
`
`
`Before TINA E. HULSE, JOHN E. SCHNEIDER, KRISTI L. R. SAWERT,
`Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request on Rehearing of Decision Denying Institution
`37 C.F.R. § 42.71(d)
`
`
`
`1 The Petitions in both proceedings challenged the ’992 patent, in which
`claim 1 is the only independent claim. Because both Petitions turned on the
`same issue regarding claim 1, we exercised our discretion and issued a single
`Decision Denying Institution in both proceedings. Petitioner has filed a
`single Rehearing Request in both proceedings. We, therefore, enter a single
`Decision on the Rehearing Request. For the sake of convenience, and unless
`stated otherwise, paper and exhibit numbers refer to those filed in IPR2019-
`00636. Similar papers and exhibits were filed in IPR2019-00637.
`
`
`
`571-272-7822
`
` Paper No. 14
`
` Entered: December 20, 2019
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FOUNDATION MEDICINE, INC.,
`Petitioner,
`
`v.
`
`GUARDANT HEALTH, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00636
`Case IPR2019-00637
`Patent 9,902,992 B21
`____________
`
`
`Before TINA E. HULSE, JOHN E. SCHNEIDER, KRISTI L. R. SAWERT,
`Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request on Rehearing of Decision Denying Institution
`37 C.F.R. § 42.71(d)
`
`
`
`1 The Petitions in both proceedings challenged the ’992 patent, in which
`claim 1 is the only independent claim. Because both Petitions turned on the
`same issue regarding claim 1, we exercised our discretion and issued a single
`Decision Denying Institution in both proceedings. Petitioner has filed a
`single Rehearing Request in both proceedings. We, therefore, enter a single
`Decision on the Rehearing Request. For the sake of convenience, and unless
`stated otherwise, paper and exhibit numbers refer to those filed in IPR2019-
`00636. Similar papers and exhibits were filed in IPR2019-00637.
`
`
`
`
`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
` INTRODUCTION
`Foundation Medicine, Inc. (“Petitioner”) filed a Request for
`Rehearing (Paper 11, “Reh’g Req.”) of our Decisions Denying Institution of
`Inter Partes Review, holding that Petitioner had failed to establish a
`reasonable likelihood that it would prevail in showing that claims 1–33 of
`U.S. Patent No. 9,902,992 B2 (Ex. 1001, “the ’992 patent”) are
`unpatentable. Specifically, in IPR2019-00636, we denied institution as to
`claims 1–11, 13, and 15–26 of the ’992 patent. IPR2019-00636, Paper 10
`(“Dec.”). And in IPR2019-00637, we denied institution as to claims 11, 12,
`14, and 27–33 of the ’992 patent. IPR2019-00637, Paper 10.
`Petitioner requests a rehearing of our decision, arguing that we
`(1) misapprehended Petitioner’s obviousness argument and improperly
`required Petitioner to meet an inherency standard; and (2) overlooked
`Petitioner’s express identification of motivation to improve ligation
`efficiency. Reh’q Req. 3–12.
`For the reasons stated below, Petitioner’s request is denied.
` STANDARD OF REVIEW
`The party requesting rehearing has the burden to show that the
`decision should be modified. Under 37 C.F.R. § 42.71(d), the request for
`rehearing must identify, specifically, all matters the party believes the Board
`misapprehended or overlooked, and the place where each matter was
`previously addressed in a motion, an opposition, or a reply. When rehearing
`a decision on a petition, we review the decision for an abuse of discretion.
`37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based
`on an erroneous interpretation of law, if a factual finding is not supported by
`substantial evidence, or if an unreasonable judgment is made in weighing
`relevant factors. In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir. 2000).
`
`2
`
`
`
`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
` ANALYSIS
`Petitioner argues that we erroneously applied an inherency standard to
`Petitioner’s argument that a person of ordinary skill in the art would have
`understood Schmitt2 to teach tagging “at least 20% of the cfDNA
`molecules,” as required by the claims. Reh’g Req. 3 (citing Pet. 39–41).
`According to Petitioner, we erred because “the absence of an express
`disclosure of a claim limitation by a prior art reference in an obviousness
`analysis does not necessarily result in reliance on an inherency theory.” Id.
`at 5. Petitioner asserts that it never made an inherency argument and that we
`were led to erroneously apply an inherency standard because of Patent
`Owner’s mischaracterization of its obviousness argument. Id. Petitioner
`asserts that we overlooked the evidence in the Petition that demonstrated a
`person of ordinary skill in the art, with knowledge of the state of the art,
`would have understood Schmitt to teach a 10–20% or higher ligation
`efficiency. Id. at 6–9.
`We are not persuaded that we misapprehended or overlooked
`Petitioner’s argument. It is Petitioner’s burden to demonstrate that all
`claimed limitations are disclosed in the prior art, either alone or in
`combination with other prior art. See PAR Pharm., Inc. v. TWI Pharms.,
`Inc., 773 F.3d 1186, 1194 (Fed. Cir. 2014). The claims require tagging “at
`least 20% of the cfDNA molecules.” Petitioner admits that “Schmitt does
`not explicitly recite tagging ‘at least 20%’ of the cfDNA molecules by
`ligation.” Pet. 39. Petitioner argues, however, that Schmitt teaches “using
`state of the art ligation techniques, which a [person of ordinary skill in the
`
`
`2 Schmitt et al., US 9,752,188 B2, issued Sept. 5, 2017 (“Schmitt,”
`Ex. 1011).
`
`3
`
`
`
`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`art] would have understood to result in at least a 10–20% yield of tagged
`DNA fragments.” Id. To support its argument, Petitioner relies on various
`prior art references and the testimony of its expert, which largely parrots the
`language in the Petition. Compare Ex. 1002 ¶¶ 131–135 with Pet. 39–41.
`In our Decision, we considered and addressed Petitioner’s arguments.
`In the Petition, Petitioner admits that Schmitt does not explicitly teach the
`“at least 20%” claim limitation. Pet. 39. Petitioner now asserts that it did
`not argue Schmitt inherently teaches the claim limitation. Rather, Petitioner
`argues that “the Petition provided sufficient evidence that a [person of
`ordinary skill in the art], with knowledge of the state of the art, would
`understand the method of Schmitt to achieve a 10–20% or higher ligation
`efficiency.” Reh’g Req. 9. Even if Petitioner did not expressly make an
`inherency argument, it was not erroneous to explain why Schmitt does not
`inherently teach the claim limitation, as argued by Patent Owner. Prelim.
`Resp. 9–11. The Decision establishes that even if a person of ordinary skill
`in the art would have understood that the ligation techniques in Schmitt
`would result in a 10–20% yield of tagged DNA fragments, that
`understanding does not teach a yield of “at least 20%,” either expressly or
`inherently. Dec. 13–14.
`Our analysis, however, did not stop there. Once we found that
`Schmitt does not expressly or inherently teach “at least 20%” ligation
`efficiency, we then addressed Petitioner’s argument that the claim limitation
`would have been obvious. Id. at 14–15. Thus, contrary to Petitioner’s
`assertion, we did not “hold Petitioner to the inherency standard” without
`considering its obviousness argument. See Reh’g Req. 3–9. We considered
`Petitioner’s obviousness arguments and evidence, but we were not
`persuaded that Petitioner had met its burden to institute trial. Id.
`
`4
`
`
`
`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`Petitioner argues that we overlooked its express identification of
`motivation to improve ligation efficiency. Id. at 10–12. Specifically,
`Petitioner asserts that it explained that “[t]he relevance of ligation efficiency
`was well-known to the [person of ordinary skill in the art], which was to
`improve the sequencing library’s diversity or representation of the genome
`by optimizing one or more steps of sample preparation.” Id. at 10 (quoting
`Pet. 39). Petitioner contends that this statement sufficiently explains why a
`person of ordinary skill in the art would have been motivated to improve
`ligation efficiency according to techniques known in the art. Id.
`We did not overlook Petitioner’s evidence or argument of improving
`ligation efficiency. Indeed, we expressly acknowledged it. See Dec. 14
`(noting Petitioner’s argument that “tagging ‘at least 20% of the cfDNA
`molecules’ would have been obvious because ligation efficiency ‘could be
`improved using a variety of techniques’”). After reviewing Petitioner’s
`evidence and argument, however, we were not persuaded that it was
`sufficient. Id. Even if the relevance of ligation efficiency was well known
`to a person of ordinary skill in the art for the reasons stated by Petitioner, the
`Petition still fails to provide a specific motivation to modify Schmitt. As
`explained in the Decision, “even if techniques were known that could have
`improved ligation efficiency, Petitioner has not shown sufficiently why a
`person of ordinary skill in the art would have modified Schmitt to tag ‘at
`least 20%’ of the DNA molecules.” Dec. 15; see also Belden Inc. v. Berk-
`Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns
`whether a skilled artisan not only could have made but would have been
`motivated to make the combinations or modifications of prior art to arrive at
`the claimed invention.”). That is, Petitioner’s motivation is “generic and
`bears no relation to any specific combination of prior art elements.”
`
`5
`
`
`
`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`ActiveVideo Networks, Inc. v. Verizon Comm’cns, Inc., 694 F.3d 1312, 1328
`(Fed. Cir. 2012). As the Federal Circuit has explained, “knowledge of a
`problem and motivation to solve it are entirely different from motivation to
`combine particular references to reach the particular claimed method.”
`Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 (Fed. Cir. 2008).
`It is not until its Rehearing Request that Petitioner specifically ties its
`ligation efficiency argument to Schmitt. Reh’g Req. 11. Specifically,
`Petitioner asserts that “[b]ecause it would have been desirable to improve the
`sequencing library’s diversity or representation of the genome, a [person of
`ordinary skill in the art] trying to detect genetic aberrations with the DCS
`method of Schmitt would have been motivated to modify the method of
`Schmitt to optimize sample preparation, e.g., improve ligation efficiency,
`based on the techniques known in the art.” Id. As evidenced by the lack of
`citation, Petitioner did not make this argument in its Petition. We, therefore,
`do not consider it on rehearing, as a request for rehearing is not an
`opportunity to present new arguments or evidence that could have been
`presented in the petition.
`
` CONCLUSION
`For the foregoing reasons, Petitioner has not demonstrated that we
`abused our discretion by misapprehending or overlooking any evidence or
`argument in its Petitions.
`
` ORDER
`
`Accordingly, it is hereby:
`ORDERED that Petitioner’s Rehearing Requests in IPR2019-00636
`and in IPR2019-00637 are denied.
`
`
`
`
`6
`
`
`
`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`PETITIONER:
`
`Rolando Medina
`Eric Maradett
`Stephanie L. Schonewald
`CHOATE, HALL & STEWART LLP
`rmedina@choate.com
`emarandett@choate.com
`sschonewald@choate.com
`
`PATENT OWNER:
`
`Michael T. Rosato
`Steven W. Parmelee
`Sonja R. Gerrard
`WILSON SONSINI GOODRICH & ROSATI
`mrosato@wsgr.com
`sparmelee@wsgr.com
`sgerrard@wsgr.com
`
`
`
`7
`
`
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