Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 1 of 24
`Case 1:17-cv-12194—RGS Document 55-1 Filed 06/28/19 Page 1 of 24
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`EXHIBIT 1
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`EXHIBIT 1
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`Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 2 of 24
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`Trials@uspto.gov
`571-272-7822
`
`
`Paper No. 12
`Date: May 14, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FOUNDATION MEDICINE, INC.,
`Petitioner,
`
`v.
`
`CARIS MPI, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00166
`Patent 9,292,660 B2
`____________
`
`
`
`
`Before CHRISTOPHER G. PAULRAJ, JACQUELINE T. HARLOW, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`

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`Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 3 of 24
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`IPR2019-00166
`Patent 9,292,660 B2
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`I.
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`INTRODUCTION
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`Foundation Medicine, Inc. (“Petitioner”) filed a Petition (Paper 3,
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`“Pet.”), requesting institution of an inter partes review of claims 1–16, 18,
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`22, and 23 of U.S. Patent No. 9,292,660 B2 (Ex. 1001, “the ’660 patent”).
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`Caris MPI, Inc. (“Patent Owner”) timely filed a Preliminary Response
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`(Paper 7, “Prelim. Resp.”). Pursuant to our authorization (Paper 8),
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`Petitioner filed a Reply to Patent Owner’s Response (Paper 9, “Reply”) and
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`Patent Owner filed a Sur-Reply to Petitioner’s Reply (Paper 10, “Sur-
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`Reply”).
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`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.” Upon consideration of the arguments and
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`evidence presented in the Petition, Preliminary Response, Reply, and Sur-
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`Reply and for the reasons explained below, we determine there is a
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`reasonable likelihood that Petitioner would prevail in showing the
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`unpatentability of at least one challenged claim. Thus, we institute an inter
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`partes review of claims 1–16, 18, 22, and 23 of the ’660 patent based on the
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`grounds set forth in the Petition.
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`A. Related Proceedings
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`Patent Owner has asserted the ’660 patent against Petitioner in a
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`copending litigation in the United States District Court for the District of
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`Massachusetts: Civil Action No: 1:17-cv-12194-MLW. Pet. 2; Paper 5.
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`Along with the current Petition, Petitioner has filed another Petition
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`challenging claims 17, 19–21, and 24 of the ’660 patent. See IPR2019-
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`2
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`IPR2019-00166
`Patent 9,292,660 B2
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`00203. The following proceedings, before the Board, also involve the same
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`parties and other related patents: IPR2019-00164 (U.S. Patent No. 8,880,350
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`B2), IPR2019-00165 (U.S. Patent No. 9,092,392 B2), IPR2019-00170 (U.S.
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`Patent No. 9,372,193 B2), and IPR2019-00171 (U.S. Patent No. 9,383,365
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`B2).
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`B. The ’660 Patent (Ex. 1001)
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`The ’660 patent issued on March 22, 2016 to Von Hoff et al., and
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`claims priority as a continuation of an application filed February 12, 2010
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`and as a continuation-in-part of an application filed May 18, 2007, as well as
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`to a provisional application filed May 18, 2006. The ’660 patent relates
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`generally to “methods and system for molecular profiling, using the results
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`from molecular profiling to identify treatments for individuals.” Ex. 1001,
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`2:31–33. According to the patent, treatment therapies or regimens have been
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`selected according to what particular disease a patient has been diagnosed
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`with, although some regimens have been determined using molecular
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`profiling and clinical characterization of a patient. Id. at 1:29–48. The
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`patent discloses that molecular profiling analysis can provide more informed
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`and effective personalized treatment options, which can result in improved
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`patient care and enhanced treatment outcomes. Id. at 2:21–24.
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`The ’660 patent discloses a method of identifying a candidate
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`treatment for a subject that includes, among other things, analyzing a sample
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`from the subject. Id. at 2:36–46. The patent discloses that the analysis (i.e.,
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`molecular profiling) can be performed by “any known means for detecting a
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`molecule in a biological sample.” Id. at 8:43–44. The types of analysis
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`include: immunohistochemistry (IHC) analysis to determine an IHC
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`3
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`expression profile for at least five proteins, a microarray analysis to
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`determine a microarray expression profile of at least ten genes, a fluorescent
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`in-situ hybridization (FISH) analysis to determine a FISH mutation profile
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`on at least one gene, and DNA sequencing to determine a sequencing
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`mutation profile of at least one gene. Id. at 2:36–44, 8:44–62.
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`According to the ’660 patent, the results for the analysis are compared
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`against a “rules database.” Id. at 2:46–49. The ’660 patent discloses that the
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`rules can be generated from abstracts of peer reviewed clinical oncology
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`literature, expert opinions, and clinical citations that have been assessed for
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`relevance. Id. at 51:23–32, 57:20–23. For instance, the rules database can
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`indicate which treatment has a known biological activity against cancer cells
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`that overexpress or underexpress one or more proteins in the IHC expression
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`profile, overexpress or underexpress one or more genes in the microarray
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`expression profile, have no mutations or one or more mutations of the genes
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`included in the FISH mutation profile, and have no mutations or one or more
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`mutations of the genes included in the sequencing mutation profile. Id. at
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`2:49–58.
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`A candidate treatment is identified if the comparison step indicates a
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`biological activity against the cancer for the treatment and the comparison
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`step does not contraindicate the treatment for treating the cancer. Id. at
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`2:58–61. Such a comparison may be conducted by using a database that
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`maps treatments and molecular profiling results. Id. at 53:35–36. Such
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`maps may be created, for example, by reviewing literature for links between
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`biological agents and therapeutic agents. Id. at 53:46–49. In a particular
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`example, a rules database may show that overexpression of the ADA gene or
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`protein indicates pentostatin as a possible treatment whereas
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`4
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`underexpression of the ADA gene or protein indicates resistance to
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`cytarabine and that the latter is not an optimal treatment. Id. at 54:63–67.
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`The ’660 patent further discloses a system that uses molecular
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`profiling of a patient’s biological specimen to determine individualized
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`medical intervention. Id. at 143:56–59. The system includes, among other
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`things, an application program stored in a memory that is accessible by a
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`processor, internal databases, and external databases. Id. at 143:59–65. The
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`internal databases can include information about the patient biological
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`sample, patient test results from molecular profiling, clinical data, and study
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`protocols. Id. at 144:10–14. The external databases can include drug
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`libraries, gene libraries, disease libraries, and public and private databases.
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`Id. at 144:14–18.
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`C. Illustrative Claim
`
`Petitioner challenges claims 1–16, 18, 22, and 23 of the ’660 patent.
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`Independent claim 1 is illustrative, and is reproduced below:
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`1. A system for generating a report identifying a therapeutic
`agent for an individual with lung cancer comprising:
`a. at least one device configured to assay a plurality of
`molecular targets in a biological sample from the individual
`with lung cancer to determine molecular profile test values for
`the plurality of molecular targets, wherein the plurality of
`molecular targets comprises PTEN, CTNNBl, cKIT, BRAF and
`PIK3CA;
`b. at least one computer database comprising:
`i. a reference value for each of the plurality of
`molecular targets;
`ii. a listing of available therapeutic agents for the
`plurality of molecular targets;
`c. a computer-readable program code comprising
`instructions to input the molecular profile test values and to
`compare each of the molecular profile test values with a
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`
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`5
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`IPR2019-00166
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`corresponding reference value from the at least one computer
`database in (b)(i);
`d. a computer-readable program code comprising
`instructions to access the at least one computer database in
`(b)(ii) and to identify at least one therapeutic agent if present in
`the at least one computer database for each of the plurality of
`molecular targets wherein said comparison to the reference
`values in (c) indicates a likely benefit of the at least one
`therapeutic agent; and
`e. a computer-readable program code comprising
`instructions to generate a report that comprises a listing of the
`members of the plurality of molecular targets for which the
`comparison to the reference value indicated a likely benefit of
`the at least one therapeutic agent in (d) and the at least one
`therapeutic agent identified in (d).
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`D. The Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of the ’660 patent based on the
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`following grounds:
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`Reference(s)
`
`Basis
`
`Claim(s) challenged
`
`Von Hoff,1 Bibikova,2 and
`Illumina3
`
`§ 103(a)
`
`1–16, 18, 22, and 23
`
`Petitioner further relies upon the declaration of Paul Spellman, Ph.D.
`
`(Ex. 1002).
`
`
`1 Von Hoff et al., US 2008/0014146 A1, published Jan. 17, 2008 (Ex. 1074)
`(“Von Hoff”).
`2 Marina Bibikova et al., Gene Expression Profiles in Formalin-Fixed,
`Paraffin-Embedded Tissues Obtained with a Novel Assay for Microarray
`Analysis, 50 Clinical Chemistry 2384 (2004) (Ex. 1047) (“Bibikova”).
`3 Illumina® Gene Expression Profiling, Technical Bulletin, RNA Profiling
`with the DASL® Assay (2005) (Ex. 1005) (“Illumina”).
`
`
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`6
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`Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 8 of 24
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`II. ANALYSIS
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`A. Level of Skill in the Art
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`Petitioner contends that a person of ordinary skill in the art (“skilled
`
`artisan” or “POSA”) for the ’660 patent “would have had a Ph.D. in
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`genetics, molecular biology, bioinformatics, or a related field, and at least
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`five years of research experience in an academic or industry setting,
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`including at least two to three years of research experience in the field of
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`cancer genomics.” Pet. 16 (citing Ex. 1002 ¶ 31). Patent Owner does not
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`address the requisite level of skill in its Preliminary Response.
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`On this record, we adopt Petitioner’s definition of the level of
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`ordinary skill in the art as it is undisputed at this time and consistent with the
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`evidence of record. We further take into account the level of skill in the art
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`reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d
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`1350, 1355 (Fed. Cir. 2001).
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`B. Claim Construction
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`Based on the filing date of the Petition (November 6, 2018), the Board
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`interprets claim terms in the ’660 patent according to the broadest reasonable
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`construction in light of the specification of the patent in which they appear.
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`37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`
`2142–46 (2016).4 Under the broadest reasonable construction standard,
`
`
`4 On October 11, 2018, the USPTO revised its rules to harmonize the
`Board’s claim construction standard for interpreting claims in trial
`proceedings before the Patent Trial and Appeal Board with the standard used
`in federal district court. CHANGES TO THE CLAIM CONSTRUCTION STANDARD
`FOR INTERPRETING CLAIMS IN TRIAL PROCEEDINGS BEFORE THE PATENT
`TRIAL AND APPEAL BOARD, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (to be
`codified at 37 C.F.R. pt. 42). This rule change, however, applies to petitions
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`
`
`7
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`claim terms are generally given their ordinary and customary meaning, as
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`would be understood by one of ordinary skill in the art at the time of the
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`invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
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`2007). “Absent claim language carrying a narrow meaning, the PTO should
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`only limit the claim based on the specification . . . when [it] expressly
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`disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed.
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`Cir. 2004). “Although an inventor is indeed free to define the specific terms
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`used to describe his or her invention, this must be done with reasonable
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`clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480
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`(Fed. Cir. 1994).
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`Petitioner does not propose any constructions for claim terms in the
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`claim construction section of the Petition. Pet. 16–17. However, in its
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`analysis for element (d) of claim 1, Petitioner contends that “the broadest
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`reasonable interpretation of ‘likely benefit of the at least one therapeutic
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`agent’ is any therapeutic agent with potential efficacy.” Pet. 35 (citing Ex.
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`1002 ¶ 177). Additionally, Petitioner contends that “a POSA would
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`understand claim element (d) to not require a therapeutic agent for any
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`particular molecular target because claim element (d) only requires ‘at least
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`one therapeutic agent’ from the ‘listing of available therapeutic agents for
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`the plurality of molecular targets.’” Id. (citing Ex. 1002 ¶ 178.). Petitioner
`
`points out that the specification indicates “there are no ‘recommended
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`agents’ at all for two of the gene targets in the claimed panel, PIK3CA, and
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`CTNNB1,” and “[f]urther, for BRAF, no recommended agents are listed,
`
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`filed on or after November 13, 2018, and, therefore, does not apply to this
`proceeding. Id.
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`8
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`except when mutational analysis indicates that BRAF is not mutated, ‘wild
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`type genotype.’” Id. (citing Ex. 1001, Table 2; Ex. 1002 ¶ 178).
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`Because the claim language of element (d) is open-ended due to the
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`term “comprises,” Petitioner contends that it would be understood “to mean
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`the claimed system has the computer-implemented capacity to access test
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`and reference values in a database and to cross-reference molecular targets
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`exhibiting a change in test and reference values with a therapeutic agent
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`database that includes information associating agents with some, but not
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`necessarily all, molecular targets in the plurality.” Id. at 36 (citing Ex. 1002
`
`¶ 178).
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`Patent Owner does not address the foregoing arguments in its
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`Preliminary Response, nor does it propose any of its own claim
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`constructions for other claim terms. Prelim. Resp. 14–15.
`
`Petitioner’s interpretation of claim element (d) “to not require a
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`therapeutic agent for any particular molecular target” oversimplifies the
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`plain language of the claims, which includes a requirement “to identify at
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`least one therapeutic agent if present in the at least one computer database
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`for each of the plurality of molecular targets.” That is, the claim language,
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`on its face, appears to require the system to be capable of identifying a
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`therapeutic agent correlating to each of the five molecular targets recited in
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`the claims (PTEN, CTNNBl, cKIT, BRAF and PIK3CA) as long as such a
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`therapeutic agent is present in the relevant computer database. Nonetheless,
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`as it is undisputed at this stage, we will accept Petitioner’s proposed
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`interpretation of claim element (d) in our analysis as to whether there is a
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`reasonable likelihood that Petitioner would prevail with respect to at least
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`9
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`Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 11 of 24
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`one challenged claim.5 We request the parties to further address this claim
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`construction issue in their post-institution briefs.
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`C. Priority Date
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`The ’660 patent is a continuation of Application No. 12/658,770 (“the
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`’770 application”), filed February 12, 2010, which in turn is a continuation-
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`in-part of a series of applications dating back to May 18, 2007. Ex. 1001,
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`(63). Among this chain of priority applications, Petitioner contends that the
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`first possible support for “CTNNB1,” a molecular target recited in claim 1,
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`is found in the ’770 application, which recites “BETA-CATENIN” (an
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`alternate name for CTNNB1) as part of a long list of “[g]enes and gene
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`products.” Pet. 18; see Ex. 1079, 44:14–46:45 (U.S. Patent No. 8,768,629
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`issued from the ’770 application). That same disclosure is found in the ’660
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`patent. Ex. 1001, 45:5–47:44. Because the challenged claims all require
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`CTNNB1 to be included on any panel to be assayed, Petitioner contends that
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`none of those claims can have a priority date earlier than February 12, 2010.
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`Id. at 18–19 (citing Ex. 1002 ¶¶ 106–107). Patent Owner does not dispute
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`these assertions in the Preliminary Response. See Prelim. Resp. 12
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`(acknowledging priority chain for the ’660 patent, but not addressing
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`Petitioner’s arguments regarding priority).
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`Based on the record at this stage of the proceeding, Petitioner has
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`made a sufficient showing that the claims of the ’660 patent are not entitled
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`to a priority date earlier than February 12, 2010. To the extent Patent Owner
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`contends that the challenged claims are entitled to an earlier filing date, it
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`5 In this regard we note Petitioner’s currently unrebutted assertion, discussed
`infra, that “there were already therapeutic agent(s) with potential efficacy
`associated with each recited gene prior to February 12, 2010.” Pet. 36 n.8.
`
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`10
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`has the burden of producing evidence in support of that contention. See
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`Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir.
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`2008) (holding that patent owner has the “burden of going forward with
`
`evidence either that the prior art does not actually anticipate, or, as was
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`attempted in this case, that it is not prior art because the asserted claim is
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`entitled to the benefit of a filing date prior to the alleged prior art”).
`
`D. Patentability Analysis
`
`1. Prior Art
`
`Petitioner relies primarily upon the following prior art teachings in its
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`challenge.
`
`a. Von Hoff (Ex. 1074)
`
`Von Hoff is a U.S. patent application published January 17, 2008.
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`Von Hoff is listed as an inventor of the ’660 patent. Ex. 1001, (72).
`
`Petitioner acknowledges that the ’660 patent is a continuation-in-part
`
`of U.S. Application No. 11/750,721, filed on May 18, 2007, which published
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`as the Von Hoff reference. Pet. 19. Petitioner argues Von Hoff nonetheless
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`qualifies as prior art under 35 U.S.C. § 102(b) because, as discussed above,
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`the claims of the ’660 patent are not entitled to a priority date earlier than
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`February 12, 2010. Id. at 19–20. Petitioner also contends Von Hoff lists
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`only two inventors of the ’660 patent and thus is prior art by “another” under
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`§ 102(a). Id. at 20 (citing Ex. 1002 ¶ 115). Patent Owner does not dispute
`
`these assertions in its Preliminary Response.
`
`Von Hoff describes a system and method for determining
`
`individualized medical intervention for a particular disease state.
`
`Ex. 1074 ¶ 8. Figure 2 of Von Hoff is reproduced below.
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`
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`11
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`Id., Fig. 2. Figure 2 of Von Hoff is a flowchart of “a method for
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`determining individualized medical intervention for a particular disease state
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`that utilizes molecular profiling of a patient’s biological specimen that is
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`non-disease specific.” Id. ¶ 17.
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`Von Hoff discloses performing at least one test for at least one target
`
`from a biological sample of a patient (i.e., step 52 in Figure 2). Id. ¶ 53.
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`The target may be one or more genes, one or more gene expressed proteins,
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`one or more molecular mechanisms, and/or combinations thereof. Id. Von
`
`Hoff teaches that the test can include IHC analysis, micro array analysis, and
`
`other molecular tests. Id. The gene can be, among others, PTEN and KIT,
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`and the gene expressed protein can be, among others, c-kit. Id. ¶¶ 9–10.
`
`Von Hoff’s method further includes determining whether one or more
`
`targets exhibit a change in expression compared to a normal reference for
`
`the particular target (i.e., step 60 in Fig. 2). Id. ¶ 55. Subsequently, a non-
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`disease specific agent that interacts with each target having a changed
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`expression is identified (i.e., step 70 in Fig. 2). Id. ¶ 56, Table 1. The agent
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`may be a therapeutic drug or compound capable of interacting with the
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`sample target that has exhibited a change in expression. Id. Von Hoff
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`discloses that identification of the drug therapy may be conducted via an
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`automated review of an extensive literature database and/or database
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`generated from clinical trials. Id. ¶¶ 8, 52. Such a database may have stored
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`data, such as patient data, biological sample data, prior treatment and
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`protocol data, patient clinical data, molecular profiling data of biological
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`samples, data on therapeutic drug agents and/or investigative drugs, a gene
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`library, a disease library, a drug library, and other types of data stored within
`
`the database. Id. ¶¶ 24, 59.
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`Von Hoff further teaches that a patient profile report can be provided
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`that includes test results for various targets and any proposed therapies based
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`on the results (i.e., step 80 in Fig. 2). Id. ¶ 57.
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`b. Bibikova (Ex. 1047)
`
`Bibikova is an article entitled “Gene Expression Profiles in Formalin-
`
`Fixed, Paraffin-Embedded Tissues Obtained with a Novel Assay For
`
`Microarray Analysis” that appears to have been published in the journal
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`Clinical Chemistry in 2004 (vol. 5, no. 12). Ex. 1047, 2384. Specifically,
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`Bibikova teaches the use of the cDNA-mediated annealing, selection,
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`extension, and ligation (DASL) assay developed at Illumina, Inc. as a gene
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`expression method. Id. Bibikova discloses that 16 formalin-fixed, paraffin-
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`embedded (FFPE) tissue samples of four types (i.e., prostrate, colon, breast,
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`and lung) from both nondiseased and cancer tissues were profiled. Id.
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`Bibikova states that the DASL assay provided highly reproducible intensity
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`measurements for the FFPE samples and the results showed “increased
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`expression of tumor- and stroma-specific markers,” which demonstrated the
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`feasibility of using heterogeneous FFPE tissues for biomarker discovery. Id.
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`at 2384–85.
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`c. Illumina (Ex. 1005)
`
`Illumina appears to be a technical bulletin prepared by Illumina, Inc.
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`regarding RNA profiling with the DASL assay. Ex. 1005. Illumina teaches
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`that microarray analysis of gene expression has proven to be a remarkable
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`tool but has faced challenges because high quality, cryopreserved RNA
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`samples are limited in availability and must be collected over the course of a
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`disease and FFPE tissue samples provide RNA of poor integrity. Id. at 1,
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`Introduction. In view of this, Illumina discloses a gene expression assay for
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`microarrays capable of using partially degraded RNA. Id. Specifically,
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`Illumina discloses its DASL assay can monitor RNA expression of up to
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`1536 sequence targets derived from RNA in FFPE samples. Id. The cancer
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`panel for the DASL assay is a pool of selected probe groups that targets 502
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`genes from ten publicly available gene lists. Id. at 4, The DASL Cancer
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`Panel. The cancer panel genes include, among others, BRAF, CTNNB1,
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`KIT, KRAS2, PIK3CA, and PTEN. Id. at Table 1. Illumina discloses the
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`Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 16 of 24
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`DASL can assay RNA from normal samples and from cancer tissues. Id. at
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`7–8.
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`Patent Owner contends that Petitioner failed to establish Illumina
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`qualifies as a printed publication. Prelim. Resp. 15–25. At the institution
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`stage, the Board has required the petitioner to make a “threshold showing”
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`that any reference relied upon was publicly accessible prior to the effective
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`filing date of the challenged patent. See, e.g., Frontier Therapeutics, LLC v.
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`Medac Gesellschaft Fur Klinische Spezialpraparate MBH, IPR2016-00649,
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`slip op. at 22 (PTAB Sept. 1, 2016) (Paper 10) (denying trial institution upon
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`finding that petitioner failed to make a threshold showing that an alleged
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`“printed package insert” was a printed publication); Instradent USA, Inc. v.
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`Nobel Biocare Servs. AG, IPR2015-01786, slip op. at 16–17 (PTAB Feb.
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`19, 2016) (Paper 14) (finding that deposition testimony from the challenged
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`patent’s co-inventor stating that hundreds of copies of a catalog may have
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`been printed and distributed to customers was sufficient to make a threshold
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`showing of public accessibility; granting trial institution).
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`Here, we are persuaded that Petitioner has made the requisite
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`threshold showing that Illumina is a prior art printed publication for
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`purposes of institution. As noted by Petitioner, the Illumina reference itself
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`bears indicia that it was likely published, including a publication date
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`(November 16, 2005) and a publication number (470-2005-003). See Pet.
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`24; Reply 1–2. Moreover, Illumina is identified as a “technical bulletin,”
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`akin to a product catalog, which “is the type of document intended for public
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`dissemination, and it bears no designations, such as ‘draft’ or ‘confidential,’
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`that might suggest that it was not intended for public distribution.” See
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`Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1377 (Fed.
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`Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 17 of 24
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`Cir. 2018). In addition to the dates and markings on the document itself,
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`Petitioner has pointed to the declaration of the Internet Archive’s Office
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`Manager, Christopher Butler, attesting that the Illumina publication was
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`archived by the Wayback Machine on December 27, 2005, and thereby
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`confirming that it was publicly available. Ex. 1024, 5; Reply 4–5.
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`Patent Owner argues that the Butler declaration and attached
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`Wayback Machine printouts are insufficient to establish public accessibility
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`of the Illumina reference because Petitioner fails to mention Exhibit 1024
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`anywhere in its Petition outside the exhibit list, and this evidence should
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`therefore not be considered in our institution analysis. Prelim. Resp. 18. We
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`are not persuaded by this argument because, although the Petition itself does
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`not discuss Exhibit 1024, any need to rely upon that evidence to support a
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`showing of public accessibility only became apparent after Patent Owner
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`raised the issue in its Preliminary Response. Moreover, we gave the parties
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`a sufficient opportunity to address the Butler declaration evidence in the
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`additional briefing (both a Reply and Sur-Reply) that we authorized. Paper
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`8. We have considered the arguments presented in those briefs in
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`determining whether Petitioner has made a sufficient showing for institution.
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`Patent Owner further argues that, even if the Butler declaration were
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`considered, it fails to show that the Illumina reference was available to
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`persons of skill at the relevant time as there is no showing that the skilled
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`artisan could have searched for and found the reference on the web without
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`already having the exact URL where it was published. Prelim. Resp. 19.
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`Patent Owner further contends that there is no indication that the product
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`page shown on the archived webpage (Ex. 1024, 4) linked directly to the
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`version of the Illumina reference appearing in the affidavit (id. at 6–13).
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`Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 18 of 24
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`Prelim. Resp. 20. Patent Owner also contends that the Petition fails to meet
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`the standard set forth in Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331,
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`1349–50 (Fed. Cir. 2016) for showing public accessibility of webpages,
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`which according to Patent Owner may be shown through (1) evidence that
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`the reference was viewed or downloaded, (2) any testimony evidence that
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`one of ordinary skill in the art would have been independently aware of the
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`webpage, or (3) any evidence that a query of a search engine before the
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`critical date, using any combination of search words, would have led to the
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`reference appearing in the search results. Sur-Reply 1–2.
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`We do not interpret Federal Circuit precedent as suggesting that only
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`certain types of evidence may be used to show public accessibility of a
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`webpage. To the contrary, whether a reference is a “printed publication” is a
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`“case-by-case inquiry into the facts and circumstances surrounding the
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`reference’s disclosure to members of the public.” Jazz Pharm., Inc. v.
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`Amneal Pharm., LLC, 895 F.3d 1347, 1359 (Fed. Cir. 2018) (citing In re
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`Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). In Jazz
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`Pharmaceuticals, the Federal Circuit made clear that “neither indexing nor
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`searchability” was required to determine that an online document was
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`publicly accessible. Id. at 1359. Here, we find on the current record that the
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`relevant public, including those skilled in the art, would have been generally
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`aware that Illumina, Inc. offered research tools used for gene expression
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`assays. See Ex. 1047, 2384 (Bibikova describing Illumina’s DASL assay).
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`That would seem to provide enough of a reason for anyone interested in the
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`DASL assay to look at Illumina’s website, where technical bulletins such as
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`the Illumina reference could be accessed.
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`Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 19 of 24
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`We find Patent Owner’s arguments largely go to the question of
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`whether Petitioner has met its ultimate burden of proving that the Illumina
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`reference was publicly accessible. However, we need not answer that
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`question at this stage. Rather, based on the present record, we find that
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`Petitioner has made a sufficient threshold showing that the Illumina
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`reference qualifies as a prior art printed publication for purposes of
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`institution. To the extent Patent Owner continues to challenge the printed
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`publication status of the Illumina reference after institution, the parties may
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`further develop the record on this issue, and we will make our determination
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`as to whether Petitioner has satisfied its burden of proving public
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`accessibility in our final written decision.
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`2. Obviousness of Claim 1–16, 18, 22, and 23 Based on Von
`Hoff, Bibikova, and Illumina
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`Petitioner contends that claims 1–16, 18, 22, and 23 are rendered
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`obvious by the combined teachings of Von Hoff, Bibikova, and Illumina.
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`Pet. 26–38. In determining whether Petitioner has shown a reasonable
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`likelihood of prevailing, we focus our analysis on independent claim 1.
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`The preamble of claim 1 recites “[a] system for generating a report
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`identifying a therapeutic agent for an individual with lung cancer
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`comprising:.” Ex. 1001, 164:39–40. Petitioner contends that the recitations
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`of the preamble are taught because Von Hoff discloses a system that
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`determines medical intervention for a disease state, particularly cancer, by
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`providing a patient profile report and identifying a proposed drug therapy,
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`and further because Bibikova discloses profiling lung cancer tissue samples.
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`Pet. 26–27 (citing Ex. 1074 Abstract, ¶ 11, Fig. 2; Ex. 1047, 2384, 2386).
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`Case 1:17-cv-12194-RGS Document 55-1 Filed 06/28/19 Page 20 of 24
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`Claim 1 further recites: “a. at least one device configured to assay a
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`plurality of molecular