Trials@uspto.gov
`571.272.7822
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` Paper No. 10
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` Entered: August 20, 2019
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`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 B2
`____________
`
`
`Before TINA E. HULSE, JOHN E. SCHNEIDER, KRISTI L. R. SAWERT,
`Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`
`I. INTRODUCTION
`
`Foundation Medicine, Inc. (“Petitioner”) filed a Petition requesting an
`
`inter partes review of claims 1–11, 13, and 15–26 of U.S. Patent No.
`
`9,902,992 B2 (Ex. 1001, “the ’992 patent”) in IPR2019-00636. IPR2019-
`
`00636, Paper 2 (“Pet.”). Petitioner filed a second Petition requesting an
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`inter partes review of claims 11, 12, 14, and 27–33 of the ’992 patent in
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`IPR2019-00637. IPR2019-00637, Paper 2 (“IPR637 Pet.”). Guardant
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`Health, Inc. (“Patent Owner”) filed a corrected Preliminary Response to
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`each Petition. IPR2019-00636, Paper 7 (“Prelim. Resp.”); IPR2019-00637,
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`Paper 7 (“IPR637 Prelim. Resp.”).
`
`We have authority under 35 U.S.C. § 314, which provides that an
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`inter partes review may not be instituted “unless . . . there is a reasonable
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`likelihood that the petitioner would prevail with respect to at least 1 of the
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`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
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`the argument and evidence presented in each Petition, we determine that
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`Petitioner has not established a reasonable likelihood that it would prevail in
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`showing the unpatentability of at least one claim challenged in the Petitions.
`
`Accordingly, we decline to institute an inter partes review of any claim of
`
`the ’992 patent on any ground.1
`
`
`
`1 The Petitions both challenge the ’992 patent, in which claim 1 is the only
`independent claim. Because both Petitions turn on the same issue regarding
`claim 1, we exercise our discretion and issue a single decision to be entered
`in both proceedings. 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.
`
`2
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`A.
`
`Related Proceedings
`
`The parties identify two district court cases where Patent Owner has
`
`asserted the ’992 patent against Petitioner and Personal Genome
`
`Diagnostics, Inc. respectively: Guardant Health, Inc. v. Foundation
`
`Medicine, Inc., Case No. 17-cv-1616 (D. Del.) and Guardant Health, Inc. v.
`
`Personal Genome Diagnostics, Inc., Case No. 17-cv-1623 (D. Del.). Pet.
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`70; Paper 3, 2.
`
`Petitioner filed two petitions for inter partes review of the ’992
`
`patent: IPR2019-00636 and IPR2019-00637. Petitioner has also filed other
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`petitions for inter partes review of related patents: U.S. Patent No.
`
`9,598,731 (IPR2019-00130), U.S. Patent No. 9,834,822 (IPR2019-00652
`
`and IPR2019-00653), and U.S. Patent No. 9,840,743 (IPR2019-00634).
`
`Paper 3, 2–3.
`
`Petitioner also identifies related patents and patent applications in the
`
`’992 patent family. Pet. 71.
`
`B.
`
`The ’992 Patent
`
`Genetic testing is useful for a number of diagnostic methods.
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`Ex. 1001, 1:35–36. Disorders that are caused by rare genetic mutations
`
`(e.g., sequence variations) or changes in epigenetic markers, such as cancer
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`and partial or complete aneuploidy, may be detected or more accurately
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`characterized with DNA sequence information. Id. at 1:36–40.
`
`Early detection and monitoring of genetic diseases is often useful and
`
`needed in the successful treatment or management of a disease. Id. at 1:41–
`
`43. According to the ’992 patent, one approach may include monitoring a
`
`sample derived from cell-free nucleic acids, which are polynucleotides that
`
`can be found in different types of bodily fluids. Id. at 1:43–46. Cell-free
`
`3
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`DNA (“cfDNA”) “has been known in the art for decades, and may contain
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`genetic aberrations associated with a particular disease.” Id. at 1:51–53.
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`The ’992 patent states that “there is a need in the art for improved
`
`methods and systems for using cell free DNA to detect and monitor disease.”
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`Id. at 1:55–57. Accordingly, the ’992 patent relates to a system and method
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`for the detection of rare mutations (e.g., single or multiple nucleotide
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`variations) and copy number variations in cell-free polynucleotides.
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`Ex. 1001, 30:15–18.
`
`C.
`
`Illustrative Claim
`
`Petitioner challenges claims 1–11, 13, and 15–26 of the ’992
`
`patent in IPR2019-00636, and claims 11, 12, 14, and 27–33 of the
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`’992 patent in IPR2019-00637. Claim 1, the only independent claim
`
`of the ’992 patent, is illustrative and is reproduced below:
`
`1. A method for detecting genetic aberrations in cell-free
`DNA (“cfDNA”) molecules from a subject, comprising:
`
`a) providing cfDNA molecules obtained from a bodily
`sample of the subject;
`
`b) attaching tags comprising barcodes having a plurality of
`different barcode sequences to the cfDNA molecules to
`tag at least 20% of the cfDNA molecules, which
`attaching comprises ligating adaptors comprising the
`barcodes to both ends of the cfDNA molecules, wherein
`ligating comprises using more than 10x molar excess of
`the adaptors as compared to the cfDNA molecules,
`thereby generating tagged parent polynucleotides;
`
`c) amplifying the tagged parent polynucleotides to produce
`amplified tagged progeny polynucleotides;
`
`d) sequencing the amplified tagged progeny polynucleotides
`to produce a plurality of sequence reads from each of the
`tagged parent polynucleotides, wherein each sequence
`read of the plurality of sequence reads comprises a
`
`4
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`barcode sequence and a sequence derived from a cfDNA
`molecule of the cfDNA molecules;
`
`(e) mapping sequence reads of the plurality of sequence
`reads to one or more reference sequences from a human
`genome;
`
`f) grouping the sequence reads mapped in e) into families
`based at least on barcode sequences of the sequence
`reads, each of the families comprising sequence reads
`comprising the same barcode sequence, whereby each of
`the families comprises sequence reads amplified from the
`same tagged parent polynucleotide;
`
`g) at each of a plurality of genetic loci in the one or more
`reference sequences, collapsing sequence reads in each
`family to yield a base call for each family at the genetic
`locus; and
`
`h) detecting, at one or more genetic loci, a plurality of
`genetic aberrations, wherein the plurality of genetic
`aberrations comprises two or more different members
`selected from the group of members consisting of a
`single base substitution, a copy number variation (CNV),
`an insertion or deletion (indel), and a gene fusion.
`
`Ex. 1001, 64:2–41.
`
`5
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`D.
`
`The Asserted Grounds of Unpatentability
`
`In IPR2019-00636, Petitioner challenges the patentability of claims 1–
`
`11, 13, and 15–26 of the ’992 patent as obvious over Schmitt2 and Fan3 or
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`Forshew4.
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`In IPR2019-00637, Petitioner challenges the patentability of
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`dependent claims 11, 12, 14, and 27–33 of the ’992 patent on the following
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`grounds:
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`References
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`Basis
`
`Claim(s) challenged
`
`Schmitt and Fan or Forshew
`
`§ 103
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`27–33
`
`Schmitt, Fan or Forshew, and
`Kucera5
`Schmitt, Forshew, and
`Schwarzenbach6
`
`§ 103
`
`§ 103
`
`11 and 12
`
`14
`
`Petitioner also relies on the Declaration of Stacey Gabriel, Ph.D.
`
`(“Gabriel Decl.,” Ex. 1002).
`
`
`
`2 Schmitt et al., US 9,752,188 B2, issued Sept. 5, 2017 (“Schmitt,”
`Ex. 1011).
`3 Fan et al., Noninvasive Diagnosis of Fetal Aneuploidy by Shotgun
`Sequencing DNA from Maternal Blood, 105 PNAS 16266–71 (2008) (“Fan,”
`Ex. 1048).
`4 Forshew et al., Noninvasive Identification and Monitoring of Cancer
`Mutations by Targeted Deep Sequencing of Plasma DNA, 4 SCI. TRANSL.
`MED. 136ra68 (2012) (“Forshew,” Ex. 1004).
`5 Kucera et al., US 8,697,408 B2, issued Apr. 15, 2014 (“Kucera,”
`Ex. 1071).
`6 Schwarzenbach et al., Cell-free Nucleic Acids as Biomarkers in Cancer
`Patients, 11 Nature 426– 37 (2011) (“Schwarzenbach,” Ex. 1054).
`
`6
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`II. ANALYSIS
`
`A.
`
`Person of Ordinary Skill in the Art
`
`Petitioner asserts that a person of ordinary skill in the art at the time of
`
`the invention would have had a Ph.D. in genetics, molecular biology,
`
`bioinformatics, or a related field, and at least five years of research in an
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`academic or industry setting, including at least two to three years of research
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`experience in the field of cancer genomics. Pet. 17 (citing Ex. 1002 ¶ 66).
`
`Patent Owner does not offer a proposed definition of the level of ordinary
`
`skill in the art at this stage of the proceeding. See Prelim. Resp.
`
`At this stage of the proceeding, and absent opposition from Patent
`
`Owner, we adopt Petitioner’s definition of the level of ordinary skill in the
`
`art because it is consistent with the level of skill reflected in the asserted
`
`prior art references. Accordingly, the prior art itself is sufficient to
`
`demonstrate the level of skill in the art at the time of the invention. See
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`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that
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`specific findings regarding ordinary skill level are not required “where the
`
`prior art itself reflects an appropriate level and a need for testimony is not
`
`shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755
`
`F.2d 158, 163 (Fed. Cir. 1985))).
`
`B.
`
`Claim Construction
`
`Where, as here, a Petition is filed on or after November 13, 2018, the
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`Board applies the same claim construction standard that would be used to
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`construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R.
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`§ 100(b) (2019); see Changes to the Claim Construction Standard for
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`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal
`
`Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018).
`
`7
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`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`Under that standard, claim terms “are generally given their ordinary
`
`and customary meaning” as understood by a person of ordinary skill in the
`
`art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303,
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`1312–13 (Fed. Cir. 2005) (en banc). “In determining the meaning of the
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`disputed claim limitation, we look principally to the intrinsic evidence of
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`record, examining the claim language itself, the written description, and the
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`prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic
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`Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips,
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`415 F.3d at 1312–17). Extrinsic evidence is “less significant than the
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`intrinsic record in determining ‘the legally operative meaning of claim
`
`language.’” Phillips, 415 F.3d at 1317.
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`The Board will consider any prior claim construction determination in
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`a civil action or proceeding before the International Trade Commission that
`
`is timely made of record in the inter partes review proceeding. 37 C.F.R.
`
`§ 42.100(b). The Board will also consider statements regarding claim
`
`construction made by Patent Owner and Petitioner in other proceedings, if
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`the statements are timely made of record. Trial Practice Guide July 2019
`
`Update, 17.
`
`The Petition sets forth proposed constructions for a number of terms.
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`Pet. 18–19. Patent Owner asserts that Petitioner’s proposed constructions
`
`are unnecessary and the claims should be given their plain and ordinary
`
`meaning. Prelim. Resp. 4. For example, Patent Owner notes that certain
`
`terms, such as “non-uniquely tagged,” do not appear in any of the challenged
`
`claims of the respective Petitions. Id.
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`Patent Owner also notes that Petitioner’s proposed construction for
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`“parent polynucleotide” differs from this proceeding compared to IPR2019-
`
`00130, where Patent Owner contends Petitioner offered at least four
`
`8
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`different constructions for the term, as it appeared in the context of a similar
`
`specification in U.S. Patent No. 9,598,731. Prelim. Resp. 5.
`
`Having considered the parties’ respective arguments, we determine
`
`that it is unnecessary to expressly construe any claim terms for purposes of
`
`rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d
`
`1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the
`
`extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v.
`
`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
`
`C. Obviousness over Schmitt and Other Cited References
`
`Petitioner asserts that claims 1–11, 13, and 15–26 are unpatentable as
`
`obvious over Schmitt and Fan or Forshew in IPR2019-00636. Pet. 29–67.
`
`Petitioner also challenges claims 11, 12, 14, and 27–33—which all depend
`
`from claim 1—as obvious over Schmitt and other cited references in
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`IPR2019-00637. IPR637 Pet. 31–65. Based on the current record of both
`
`proceedings, we determine that Petitioner has not established a reasonable
`
`likelihood that it would prevail in showing any of the challenged claims are
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`unpatentable as obvious over Schmitt and the cited references.
`
`1.
`
`Schmitt (Ex. 1011)
`
`Schmitt relates to a method called Duplex Consensus Sequencing
`
`(“DCS”) that, according to Schmitt, greatly reduces sequencing errors by
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`independently tagging and sequencing each of the two strands of a DNA
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`duplex. Ex. 1011, Abstract. Because the two strands of DNA are
`
`complementary, true mutations can be found at the same position on both
`
`strands, as opposed to on a single strand if PCR or sequencing errors occur.
`
`Id.
`
`According to Schmitt’s DCS method, sheared double-stranded DNA
`
`that has been end-repaired and T-tailed is combined with A-tailed single
`
`9
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`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`molecule identifier (SMI) adaptors and ligated. Id. at 3:44–47. In one
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`embodiment, every adaptor contains a unique, double-stranded,
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`complementary n-mer random tag on each end, such that every DNA
`
`fragment becomes labeled with two distinct SMI sequences. Id. at 3:47–53.
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`The labeled DNA fragments are amplified by PCR, resulting in two types of
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`PCR products, each with a distinct SMI sequence. Id. at 3:53–60.
`
`For error correction through DCS, sequence reads sharing a unique set
`
`of SMI tags are grouped into paired families, each pair reflecting one
`
`double-stranded DNA fragment. Id. at 4:4–10. Mutations present in only
`
`one or a few family members, or mutations occurring in only one of the two
`
`strands represent sequencing mistakes or PCR-introduced errors. Id. at
`
`4:10–18. True mutations are present on both strands and appear in all
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`members of a family pair. Id. at 4:18–20.
`
`2.
`
`Fan (Ex. 1048)
`
`Fan relates to a method for diagnosing fetal aneuploidy by directly
`
`sequencing cell-free DNA from the plasma of pregnant women with high-
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`throughput shotgun sequencing technology. Ex. 1048, Abstract. In doing
`
`so, Fan was able to measure the over- and underrepresentation of
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`chromosomes from an aneuploidy fetus. Id.
`
`3.
`
`Forshew (Ex. 1004)
`
`Forshew relates to a method for identifying cancer mutations present
`
`in cell-free DNA using tagged-amplicon deep sequencing (TAm-Seq).
`
`Ex. 1004, Abstract. Tagged amplicon deep sequencing allows amplification
`
`and deep sequencing of genomic regions spanning thousands of bases. Id. at
`
`1. Forshew applied the technique to both abundant and rare mutations in
`
`circulating DNA from blood plasma of ovarian and breast cancer patients.
`
`Id. at 1–2.
`
`10
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`4.
`
`Analysis
`
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`
`differences between the claimed subject matter and the prior art are such that
`
`the subject matter, as a whole, would have been obvious at the time the
`
`invention was made to a person having ordinary skill in the art to which the
`
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`
`(2007). The question of obviousness is resolved on the basis of underlying
`
`factual determinations, including: (1) the scope and content of the prior art;
`
`(2) any differences between the claimed subject matter and the prior art;
`
`(3) the level of skill in the art; and (4) objective evidence of nonobviousness.
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`Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`“[A] patent composed of several elements is not proved obvious
`
`merely by demonstrating that each of its elements was, independently,
`
`known in the prior art.” KSR, 550 U.S. at 418. “[I]t can be important to
`
`identify a reason that would have prompted a person of ordinary skill in the
`
`relevant field to combine the elements in the way the claimed new invention
`
`does.” Id. Moreover, a person of ordinary skill in the art must have had a
`
`reasonable expectation of success of doing so. PAR Pharm., Inc. v. TWi
`
`Pharms., Inc., 773 F.3d 1186, 1193 (Fed. Cir. 2014).
`
`Claim 1 recites a method for detecting genetic aberrations in cfDNA,
`
`including the step of “attaching tags comprising barcodes having a plurality
`
`of different barcode sequences to the cfDNA molecules to tag at least 20%
`
`of the cfDNA molecules.” Ex. 1001, 64:2–8. Petitioner asserts that it “relies
`
`upon Schmitt for disclosure of virtually all of the claimed limitations [and]
`
`relies upon Fan or Forshew only for disclosure relating to testing DNA from
`
`cfDNA samples.” Pet. 29. Petitioner admits that “Schmitt does not
`
`explicitly recite tagging ‘at least 20%’ of the cfDNA molecules by ligation.”
`
`11
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`Pet. 39. But Petitioner argues that Schmitt teaches using “state of the art
`
`ligation techniques, which a [person of ordinary skill in the art] would have
`
`understood to result in at least a 10-20% yield of tagged DNA fragments.”
`
`Id. For example, Petitioner argues that Schmitt teaches the use of blunt-end
`
`ligation and TA ligation. Id. (citing Ex. 1011, 7:58–62, 15:5–20; Ex. 1012,
`
`21). According to Petitioner, a person of ordinary skill in the art would have
`
`known that the blunt-end technique “was capable of generating a 10-20%
`
`final library yield” (id., citing Ex. 1061, 2, 7; Ex. 1002 ¶ 131), and that TA
`
`ligation “was likely to result in a higher yield of tagged fragments” (id.,
`
`citing Ex. 1062, 1006; Ex. 1002 ¶ 131). Moreover, because Schmitt states
`
`that the efficiency of adaptor ligation is “comparable to those seen with
`
`standard library preparation methods,” Petitioner argues, a person of
`
`ordinary skill in the art would have understood the method of Schmitt would
`
`achieve a 10–20% or higher yield. Id. at 40 (citing Ex. 1011, 22:43–56;
`
`Ex. 1012 ¶ 65; Ex. 1002 ¶ 132).
`
`Petitioner also argues that a person of ordinary skill in the art would
`
`have understood that ligation efficiency could be improved using various
`
`techniques known in the art as of September 4, 2012. Id. As an example,
`
`Petitioner asserts that it was known that ligation efficiency could be
`
`improved by using ultrapure commercial ligases, and that by September 4,
`
`2012, kits were available that would improve ligation efficiency. Id. at 40–
`
`41 (citing Ex. 1062, 1006–07; Ex. 1063, 1, 3, Fig. 2; Ex. 1002 ¶ 134). Thus,
`
`Petitioner contends that a person of ordinary skill in the art would have
`
`understood Schmitt “to teach directly a method wherein at least 10-20% of
`
`DNA molecules were tagged” and that it would have been obvious that “a
`
`ligation yield wherein 20% or more molecules are tagged could be achieved
`
`using methods known in the art.” Id. at 41.
`
`12
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`In response, Patent Owner argues the Petition fails to establish
`
`Schmitt necessarily teaches tagging “at least 20%” of the cfDNA molecules
`
`by ligation. Prelim. Resp. 9. Patent Owner asserts that neither Schmitt nor
`
`any of the other references cited by Petitioner apply their methods to
`
`cfDNA, as required by the claim. Id. Thus, according to Patent Owner,
`
`Petitioner has not established that Schmitt, alone or in combination with any
`
`other reference, teaches this limitation. Id. Furthermore, Patent Owner
`
`argues that none of the references cited by Petitioner establish that Schmitt
`
`necessarily uses blunt-end ligation to tag at least 20% of any DNA
`
`molecules, as Petitioner has not established that they use the same blunt-end
`
`ligation methods. Id. at 10–11. Finally, in response to Petitioner’s argument
`
`that a person of ordinary skill in the art would have known that ligation
`
`efficiency could be improved using various known techniques, Patent Owner
`
`argues that Petitioner does not explain why a person of ordinary skill in the
`
`art would have been motivated to improve Schmitt’s method, how the
`
`modification could have been carried out, or whether success would have
`
`been reasonably expected. Id. at 11–12.
`
`Having considered the parties’ arguments and evidence, we determine
`
`that Patent Owner has the better position. Petitioner admits that Schmitt
`
`does not expressly teach tagging “at least 20% of the cfDNA molecules.”
`
`Pet. 39. Thus, although not stated as such, Petitioner argues Schmitt
`
`inherently teaches the limitation. To establish that a prior art reference
`
`inherently teaches a claim limitation, however, Petitioner must show that
`
`“the limitation at issue necessarily must be present, or [is] the natural result
`
`of the combination of elements explicitly disclosed by the prior art.” Par
`
`Pharm., 773 F.3d at 1196. We find Petitioner has not made that showing.
`
`13
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`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`Petitioner repeatedly argues that a person of ordinary skill in the art
`
`would have known that the ligation methods taught by Schmitt would result
`
`in “at least 10-20% yield” of tagged DNA fragments. Pet. 39–41. On its
`
`face, Petitioner’s inherency argument fails. The claim requires tagging of
`
`“at least 20% of the cfDNA molecules.” Ex. 1001, 64:6–8. Thus,
`
`Petitioner’s argument that Schmitt’s blunt-end ligation method would result
`
`in at least 10-20% yield does not necessarily teach “at least 20%” yield, as
`
`required by the claim. See Pet. 39; Ex. 1002 ¶ 131 (“As of September 2012,
`
`it was known in the art that the blunt-end ligation technique was capable of
`
`generating a 10-20% final library yield.”). Similarly, Petitioner’s assertion
`
`that TA ligation was “likely to result in a higher yield of tagged fragments”
`
`than blunt-end ligation does not necessarily teach “at least 20%” yield,
`
`either. See Pet. 39 (emphasis added); Ex. 1002 ¶ 131. We find Petitioner’s
`
`argument to be speculative, which cannot establish inherency. Endo
`
`Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir.
`
`2018) (“[I]nherency may not be established by probabilities or possibilities.”
`
`(quotation omitted)). That the ligation methods taught by Schmitt may result
`
`in at least 20% yield is not sufficient. Id. (“The mere fact that a certain thing
`
`may result from a given set of circumstances is not sufficient.”).
`
`To the extent Petitioner also argues that tagging “at least 20% of the
`
`cfDNA molecules” would have been obvious because ligation efficiency
`
`“could be improved using a variety of techniques,” we are not persuaded.
`
`See Pet. 40; Ex. 1002 ¶ 133. “[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.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir.
`
`2015). Petitioner and its declarant, Dr. Gabriel, simply assert that kits were
`
`14
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`available in September 2012 that could improve ligation efficiency. Pet. 40–
`
`41; Ex. 1002 ¶ 134. We agree with Patent Owner, however, that 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.
`
`Prelim. Resp. 11–12. Thus, we are not persuaded that Petitioner has shown
`
`sufficiently that a person of ordinary skill in the art would have had a reason
`
`to modify the method of Schmitt to tag “at least 20%” of the DNA
`
`molecules.
`
`Accordingly, on this record, we find Petitioner has not shown
`
`sufficiently that Schmitt inherently teaches tagging “at least 20% of the
`
`cfDNA molecules,” as required by claim 1, or that that limitation would
`
`have been obvious over Schmitt. As such, we determine Petitioner has not
`
`shown a reasonable likelihood of prevailing on its assertion that claim 1 (or
`
`any of the other challenged claims depending from claim 1) of the ’992
`
`patent is unpatentable as obvious over Schmitt and the other cited prior art.
`
`III. CONCLUSION
`
`We conclude that Petitioner has not established a reasonable
`
`likelihood of prevailing on its assertions that claims 1–33 of the ’992 patent
`
`are unpatentable as obvious.
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that the Petition in IPR2019-00636 and the Petition in
`
`IPR2019-00637 are denied as to all challenged claims of the ’992 patent and
`
`no trial is instituted.
`
`
`
`
`
`15
`
`

`

`IPR2019-00636; IPR2019-00637
`Patent 9,902,992 B2
`
`
`PETITIONER:
`Rolando Medina
`Eric Marandett
`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
`
`
`
`16
`
`