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`Case 1:17-cv-12194—RGS Document 55-3 Filed 06/28/19 Page 1 of 33
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`Case 1:17-cv-12194-RGS Document 55-3 Filed 06/28/19 Page 2 of 33
`Trials@uspto.gov
`Paper No. 12
`Date: May 30, 2019
`571-272-7822
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`FOUNDATION MEDICINE, INC.,
`Petitioner,
`
`v.
`
`CARIS MPI, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00164
`Patent 8,880,350 B2
`____________
`
`
`Before CHRISTOPHER G. PAULRAJ, JACQUELINE T. HARLOW, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`SAWERT, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`IPR2019-00164
`Patent 8,880,350 B2
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`I.
`
`INTRODUCTION
`Foundation Medicine, Inc. (“Petitioner”) filed a Petition (Paper 3,
`“Pet.”), requesting institution of an inter partes review of claims 1–14 of
`U.S. Patent No. 8,880,350 B2 (Ex. 1001, “the ’350 patent”). Caris MPI, Inc.
`(“Patent Owner”) timely filed a Preliminary Response (Paper 7,
`“Prelim. Resp.”). On our authorization (Paper 8), Petitioner filed a Reply to
`Patent Owner’s Preliminary Response (Paper 9, “Reply”) and Patent Owner
`filed a Sur-Reply to Petitioner’s Reply (Paper 10, “Sur-Reply”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an
`inter partes review “unless . . . there is a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” 35 U.S.C. § 314(a). On April 24, 2018, the Supreme Court
`held that a decision to institute under 35 U.S.C. § 314(b) may not institute
`review on fewer than all claims challenged in the petition. SAS Inst., Inc. v.
`Iancu, 138 S. Ct. 1348, 1355–56 (2018). Also, in accordance with USPTO
`Guidance, “if the PTAB institutes a trial, the PTAB will institute on all
`challenges raised in the petition.” See Guidance on the Impact of SAS on
`AIA Trial Proceedings (April 26, 2018) (available at
`https://www.uspto.gov/patents-application-process/patent-trial-and-
`appealboard/trials/guidance-impact-sas-aia-trial).
`Applying those standards, and upon consideration of the information
`presented in the Petition, Preliminary Response, Reply, and Sur-Reply, we
`determine that Petitioner has demonstrated a reasonable likelihood of
`success in proving that at least one claim of the ’350 patent is unpatentable.
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`Accordingly, we institute an inter partes review of all challenged claims (1–
`14) of the ’350 patent, based on all grounds raised in the Petition.
`
`II. BACKGROUND
`A. Related Proceedings
`The ’350 patent is the subject of a co-pending litigation in the United
`States District Court for the District of Massachusetts captioned Civil Action
`No: 1:17-cv-12194-MLW. Pet. 2; Paper 4, 2. The following proceedings,
`before the Board, also involve the same parties: IPR2019-00165 (U.S.
`Patent No. 9,092,392 B2), IPR2019-00166 (U.S. Patent No. 9,292,660 B2),
`IPR2019-00170 (U.S. Patent No. 9,372,193 B2), IPR2019-00171 (U.S.
`Patent No. 9,383,365 B2), and IPR2019-00203 (U.S. Patent No. 9,292,660
`B2). Trials were instituted in IPR2019-00166 and IPR2019-00203 on May
`14, 2019. See IPR2019-00166 (Paper 12); IPR2019-00203 (Paper 12).
`B. The ’350 patent
`The ’350 patent, titled “System and Method for Determining
`Individualized Medical Intervention for a Disease State,” issued on
`November 4, 2014. Ex. 1001, (54), (45). The ’350 patent relates to a
`“system and method for determining individualized medical intervention for
`a particular disease state,” such as cancer, that “includes the molecular
`profiling of a biological sample from the patient.” Id. at Abstract.
`According to the ’350 patent, “[a]lthough the molecular mechanisms
`behind various disease states have been the subject of studies for years, the
`specific application of a diseased individual’s molecular profile in
`determining treatment regimens and therapies . . . has been disease specific
`and not widely pursued.” Id. at 1:42–46. The ’350 patent states that this
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`approach “presents a risk that an effective treatment regimen may be
`overlooked for a particular individual” because some treatment regimens
`traditionally administered for one particular disease state also may be
`effective in treating a different disease state. Id. at 1:55–62. Thus, the ’350
`patent states, “there is a need for a system and method for determining an
`individualized medical intervention” for a patient that can identify
`“additional targets” or “molecular mechanisms, genes, gene expressed
`proteins and/or combinations of such.” Id. at 2:18–23, 28–29. The ’350
`patent states that this approach would provide patients “with a viable
`therapeutic alternative to those treatment regimens which currently exist.”
`Id. at 2:24–27.
`Figure 2 of the ’350 patent, reproduced below, provides an overview
`of an exemplary method for determining individualized medical intervention
`that utilizes a patient’s molecular profile. Id. at 5:1–4, 13:7–12.
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`In step 52, at least one test is performed for at least one molecular
`
`target (e.g., one or more genes, proteins, and/or molecular mechanisms)
`from a patient’s biological sample. Id. at 13:15–21. Tests that may be
`performed include immunohistochemistry (IHC) analysis 54, microarray
`analysis 56, and/or any other known molecular tests 58. Id. at 13:21–31.
`The ’350 patent states that IHC analysis may be performed for such proteins
`as c-kit, EGFR, MLH1, and PDGFR. Id. at 2:64–3:2. Microarray analysis
`may be performed for such genes as ESR1, PDGFRA, PTEN, and TOP1.
`Id. at 3:3–20.
`In step 60, “a determination is made as to whether one or more of the
`targets that were tested for in step 52 exhibit a change in expression
`compared to a normal reference for that particular target.” Id. at 13:40–43.
`A change in expression may be observed via differential staining 64, the
`amount of overexpression or underexpression 66, and/or “by an absence of
`one or more genes, gene expressed proteins, molecular mechanisms, or other
`molecular findings.” Id. at 43–63.
`Next, “at least one non-disease specific agent is identified that
`interacts with each target having a changed expression in step 70.” Id. at
`13:64–67. The ’350 patent states that a “non-disease specific agent” “is a
`therapeutic drug or compound not previously associated with treating the
`patients diagnosed disease that is capable of interacting with the target from
`the patient’s biological sample that has exhibited a change in expression.”
`Id. at 14:1–5.
`Finally, in step 80, “a patient profile report may be provided which
`includes the patient’s test results for various targets and any proposed
`therapies based on those results.” Id. at 14:21–24. The ’350 patent discloses
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`a computerized system for generating the report, which includes, among
`other things, an application program stored in a memory that is accessible by
`a processor, internal databases, and external databases. Id. at 12:47–55. The
`internal databases can include information about the patient biological
`sample, patient test results from molecular profiling, clinical data, and study
`protocols. Id. at 12:65–13:2. The external databases can include drug
`libraries, gene libraries, disease libraries, and public databases such as
`GenBank. Id. at 13:2–6.
`The ’350 patent states that the processor comprises instructions for
`assessing a patient’s molecular profile, determining whether at least one
`molecular target exhibits a change in expression “compared to a normal
`reference,” and accessing a drug therapy database to identify drug therapies.
`Id. at 4:1–21. The ’350 patent states that a drug therapy may be identified
`“from an automated review of an extensive literature base and/or an
`automated review of data generated from clinical trials.” Id. at 4:42–46.
`C. Illustrative Claim
`Of the challenged claims, claim 1 is independent and illustrative of the
`claimed subject matter. Claim 1 recites:
`1. A system for generating a report identifying at least one
`therapeutic agent for an individual with a cancer comprising:
`
`a. at least one device configured to assay a plurality of
`molecular targets in a biological sample to determine
`individualized molecular profile test values for the
`plurality of molecular targets, wherein the molecular
`targets comprise EGFR, KIT, TOP1, MLH1, PTEN,
`PDGFRA and ESR1; and
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`b. at least one computer database comprising:
`i. a reference value for the plurality of molecular
`targets; and
`ii. a listing of available therapeutic agents for said
`plurality of molecular targets;
`
`
`c. a computer-readable program code comprising instructions to
`input the individualized molecular profile test values and
`to compare said test values with a corresponding
`reference value in (b)(i);
`
`
`d. a computer-readable program code comprising instructions to
`access the at least one computer database and to identify
`at least one therapeutic agent from the listing of available
`therapeutic agents for the plurality of molecular targets
`wherein said comparison to said reference 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 molecular
`targets wherein said comparison to said reference
`indicated a likely benefit of the at least one therapeutic
`agent in (d) along with the at least one therapeutic agent
`identified in (d).
`Id. at 16:64–17:27.
`D. The Prior Art
`Petitioner advances the following references as prior art on which it
`relies for the asserted grounds challenging the claims of the ’350 patent:
`1. Mou-Ying Fu Lu and Rong Yu, WO 03/017038 A2 (Feb. 27, 2003)
`(“Lu,” Ex. 1004);
`
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`2. Illumina® Gene Expression Profiling, Technical Bulletin, RNA
`Profiling with the DASL® Assay (2005) (“Illumina,” Ex. 1005);
`
`3. Patrick J. Muraca, U.S. Patent Application Publication
`No. 2002/0150966 A1 (Oct. 17, 2002) (“Muraca,” Ex. 1006); and
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`4. Amy L. McDoniels-Silvers et al., Differential Expression of
`Critical Cellular Genes in Human Lung Adenocarcinomas and
`Squamous Cell Carcinomas in Comparison to Normal Lung
`Tissues, 4(2) NEOPLASIA 141–50 (2002) (“McDoniels-Silvers,”
`Ex. 1007).
`E. Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of the ’350 patent’s claims on
`the following three grounds:
`References
`Lu and Illumina
`
`Basis
`§ 103(a)
`
`Claims challenged
`1–14
`
`Lu, Illumina, and Muraca
`
`§ 103(a)
`
`2 and 3
`
`Lu, Illumina, and McDoniels-
`Silvers
`Pet. 3–4. Petitioner also relies on the Declaration of Paul T. Spellman, Ph.D.
`(Ex. 1002). Id. at 4.
`
`7, 11, and 12
`
`§ 103(a)
`
`III. ANALYSIS
`We organize our analysis into four sections. First, we address the
`level of ordinary skill in the art. Second, we address claim construction.
`Third, we provide an overview of the asserted references. And fourth,
`taking account of the information presented, we consider whether the
`grounds asserted in the Petition meet the threshold showing for instituting an
`inter partes review under 35 U.S.C. § 314(a).
`A. Level of Ordinary Skill in the Art
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art. Petitioner contends,
`
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`and Dr. Spellman testifies, that as of May 18, 2006—the earliest filing date
`in the priority chain for the ’350 patent—a person of ordinary skill in the art
`“would have had a Ph.D. in genetics, molecular biology, bioinformatics, or a
`related field, and at least five years of research experience in an academic or
`industry setting, including at least two to three years of research experience
`in the field of cancer genomics.” Pet. 16 (citing Ex. 1002 ¶ 32). Patent
`Owner does not address the requisite level of skill in its Preliminary
`Response.
`We adopt Petitioner’s definition for our analysis in this decision,
`because it is consistent with the level of ordinary skill reflected in the prior
`art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
`2001). Further, based on the information presented at this stage of the
`proceeding, we consider Petitioner’s declarant, Dr. Spellman, qualified to
`opine about the perspective of an ordinary artisan at the time of the
`invention. See Ex. 1002 ¶¶ 4–15.
`B. Claim Interpretation
`Based on the filing date of the Petition (November 6, 2018), the Board
`interprets claim terms in the ’350 patent according to the broadest reasonable
`construction in light of the specification of the patent in which they appear.
`See 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct.
`2131, 2144–46 (2016) (upholding the use of the broadest reasonable
`interpretation standard).1
`
`1 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. See Changes to the Claim Construction Standard for
`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal
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`Under that standard, we presume that a claim term carries its
`“ordinary and customary meaning,” which “is the meaning that the term
`would have to a person of ordinary skill in the art in question” at the time of
`the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007); see also TriVascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir.
`2016) (“Under a broadest reasonable interpretation, words of the claim must
`be given their plain meaning, unless such meaning is inconsistent with the
`specification and prosecution history.”).
`Petitioner does not propose any constructions for claim terms.
`Pet. 16–17. In its analysis for element (d) of claim 1, however, Petitioner
`contends that “the broadest reasonable interpretation of ‘likely benefit of the
`at least one therapeutic agent’ is any therapeutic agent with potential
`efficacy.” Pet. 34 (citing Ex. 1002 ¶ 141). Petitioner further contends that
`an ordinarily skilled artisan “would understand claim element (d) not to
`require a therapeutic agent for any particular molecular target because claim
`element (d) only recites ‘at least one therapeutic agent’ from the ‘listing of
`available therapeutic agents for the plurality of molecular targets.’” Id. at
`34–35 (citing Ex. 1002 ¶ 142).
`Additionally, Petitioner contends that “plurality of molecular targets”
`in element (d) is open-ended because the claim recites “comprises,” and
`thus, the skilled artisan would understand “element (d) to mean the claimed
`system has the computer-implemented capacity to access test and reference
`values in a database and to cross-reference molecular targets exhibiting a
`
`
`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 filed on or after
`November 13, 2018, and, therefore, does not apply to this proceeding. Id.
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`difference in test and reference values with a therapeutic agent database that
`includes information associating agents with one or more molecular targets.”
`Id. at 35 (citing Ex. 1002 ¶ 142 n.8).
`Patent Owner does not address the foregoing arguments in its
`Preliminary Response, nor does it propose any of its own interpretations for
`other claim terms. Prelim. Resp. 14–15.
`Because the broadest reasonable interpretation of claim element (d) is
`undisputed at this stage, we accept Petitioner’s proposed interpretation in our
`analysis as to whether there is a reasonable likelihood that Petitioner would
`prevail with respect to at least one challenged claim.2 We request the parties
`to further address this claim interpretation issue in their post-institution
`briefs.
`We determine that we need not expressly interpret any other claim
`term for this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that
`are in controversy, and only to the extent necessary to resolve the
`controversy.”).
`
`C. Asserted References
`Before turning to Petitioner’s asserted grounds of unpatentability, we
`provide a brief summary of the asserted references.
`
`
`2 In this regard, we note Petitioner’s currently unrebutted assertion
`that “there were already therapeutic agent(s) with potential efficacy
`associated with each recited gene prior to May 18, 2006.” Pet. 35, n.5.
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`1. Lu
`Lu teaches a “computerized decision support system for selecting the
`optimum treatment for human cancer.” Ex. 1004, (54). The system predicts
`“which of one or more drugs suitable to treat a cancerous condition in a
`patient are the optimum drug(s)” “based upon the particular patient’s
`genotype.” Id. at (57). According to Lu, the system comprises:
`a PCR kit and/or a gene chip designed to detect multiple genes,
`expressions and/or mutations associated with a particular cancer
`using a sample of the patient’s tissue or blood; a detector for
`accepting receipt of the gene chip toward analyzing the patient’s
`genotype; a database describing the correlation of patient
`genotypes and the efficacy and toxicity of various anti-cancer
`drugs used in treating patients with a particular cancerous
`condition; and a computerized decision support system operably
`connected to the detector for correlating the output of the detector
`to the database.
`Id. ¶ 18.
`
`Lu teaches that the detector outputs genetic data into a “bioinformatic
`software package” that compares the genetic data with “a database of data
`toward providing the physician with a recommendation into plain English in
`order to assist doctors to select the most effective medicine with the least
`amount of side effects for patients.” Id. ¶ 42. Lu teaches that the software
`may be “customized for a single disease or multiple diseases.” Id.
`In a preferred embodiment, the system detects the breast cancer genes
`ER Alpha, Her2, ErbB1, BRAC1, and BRAC2. Id. ¶ 22. For example, the
`system detects upregulation or downregulation of the expression of those
`genes, or mutations in those genes. Id. ¶¶ 51, 53. Depending on the results,
`the system provides an output that recommends or discourages the use of
`certain drug(s) for cancer therapy. Id. ¶¶ 52, 54.
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`2. Illumina
`Illumina is a technical bulletin prepared by Illumina, Inc. Ex. 1005.
`Illumina teaches that “[m]icroarray analysis of gene expression has proven
`to be a remarkable tool,” but has faced challenges because of the lack of
`high-quality and/or poor integrity RNA. Id. at 1 (Introduction). Illumina
`discloses a “gene expression assay for microarrays that is capable of
`utilizing partially degraded RNA.” Id.
`Specifically, Illumina discloses the “cDNA-mediated Annealing,
`Selection, extension and Litigation (DASL) Assay,” which “can monitor
`RNA expression of up to 1536 sequence targets.” Id. According to
`Illumina, “the DASL Assay offers researchers the opportunity to analyze
`hundreds to thousands of RNA transcripts derived from previously collected,
`preserved samples.” Id.
`Illumina discloses a particular DASL assay—the “DASL Cancer
`Panel”—that “is a pool of selected probe groups that targets 502 genes from
`ten publicly available gene lists.” Id. at 4 (“The DASL Cancer Panel”).
`Illumina teaches that the “[g]enes were chosen based on the frequency of
`appearance on these lists and the frequency of literature citations of these
`genes in association with cancer.” Id. The DASL Cancer Panel includes,
`among others, the genes EGFR, KIT, TOP1, MLH1, PTEN, PDGFRA and
`ESR1. Id. at Table 1.
`Illumina further teaches that the DASL assay can be used to analyze
`differential expression profiles, and provides an example comparing the
`expression of RNA from both normal prostate tissue and a prostate cancer
`cell line. Id. at 5. Illumina states that “expression analysis using degraded
`RNA will properly reflect biological differences using intact RNA.” Id. at 6.
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`Illumina also teaches the DASL assay can be used to study differences in
`expression in clinical samples, to “report[] biologically relevant results.” Id.
`at 7 (“Application to Clinical Samples”).
`Finally, Illumina discloses that the DASL assay provides for high-
`throughput expression profiling, because it allows for the analysis of 16 or
`96 samples simultaneously. Id. at 8 (“Summary”).
`3. Muraca
`Muraca discloses a “system for accessing, organizing, and displaying
`tissue information.” Ex. 1006 ¶ 1. The system “correlate[s] molecular
`profiling data obtained from tissue microarrays with patient information in a
`specimen-linked database.” Id. The specimen-linked database “is a
`repository of information including . . . information relating to phenotype,
`genotype, pathology, and expression of biomolecules in tissues, and
`including information relating to the medical history of the individuals who
`are the sources of tissues being analyzed,” such as demographic and
`epidemiologic information. Id. ¶ 9.
`Muraca teaches that, in one embodiment, the “system provides
`information relating to diagnosis, prognosis, or likelihood of recurrence of a
`disease.” Id. ¶ 22. Specifically, a user inputs a patient’s biological
`characteristic(s), such as gene or protein expression, into the system, which
`then “retrieves information from the specimen-linked database about the
`disease state associated with the particular expression pattern identified by
`the user.” Id.
`Muraca also teaches embodiments in which the system identifies drug
`biological targets for drug therapy and potential drugs, provides information
`
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`relating to clinical trials, and suggests treatment options for a particular
`disease diagnosis or prognosis. Id. ¶ 23.
`4. McDoniels-Silvers
`McDoniels-Silvers presents a study of the differential expression of
`certain genes in human lung adenocarcinomas and squamous cell
`carcinomas compared to normal lung tissues. Ex. 1007, Abstract.
`McDoniels-Silvers examined the expression of 588 genes using a human
`cDNA expression array. Id. McDoniels-Silvers obtained tumor tissue
`samples from cancer patients, and compared the results to normal tissues.
`Id. at 142. McDoniels-Silvers found that 45 of those genes “were
`differentially expressed by at least two-fold in tumor tissues compared to
`corresponding normal tissues.” Id. at 141. McDoniels-Silvers teaches that
`“[t]hese gene expression changes may directly contribute to the initiation or
`progression of human lung cancer or may be secondary effects of the
`tumorigenesis process,” but “[r]egardless, many of these differences may be
`useful in the diagnosis and/or treatment of” lung cancers. Id.
`D. Illumina as a “Printed Publication”
`Before turning to Petitioner’s asserted grounds of unpatentability, we
`address Patent Owner’s threshold argument that Petitioner has failed to
`establish that Illumina qualifies as a printed publication. Prelim. Resp. 18–
`28. Under 35 U.S.C. § 311(b), a petitioner in an inter partes review may
`challenge the claims of a patent only on “prior art consisting of patents or
`printed publications.”
`At the institution stage, the Board has required the petitioner to make
`a “threshold showing” that any reference relied upon was publicly accessible
`prior to the effective filing date of the challenged patent. See, e.g., Frontier
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`Therapeutics, LLC v. Medac Gesellschaft Für Klinische Spezialpräparate
`mbH, IPR2016-00649, slip op. at 22 (PTAB Sept. 1, 2016) (Paper 10)
`(denying trial institution upon finding that petitioner failed to make a
`threshold showing that an alleged “printed package insert” was a printed
`publication); Instradent USA, Inc. v. Nobel Biocare Servs. AG, IPR2015-
`01786, slip op. at 16–17 (PTAB Feb. 19, 2016) (Paper 14) (finding that
`deposition testimony from the challenged patent’s co-inventor stating that
`hundreds of copies of a catalog may have been printed and distributed to
`customers was sufficient to make a threshold showing of public
`accessibility; granting trial institution).
`Here, we are persuaded that Petitioner has made the requisite
`threshold showing that Illumina is a prior art printed publication for
`purposes of institution. As noted by Petitioner, the Illumina reference itself
`bears indicia that it was likely published, including a publication date
`(November 16, 2005) and a publication number (470-2005-003). See
`Pet. 20; Reply 3–5. Moreover, Illumina is identified as a “technical
`bulletin,” akin to a product catalog, which “is the type of document intended
`for public dissemination, and it bears no designations, such as ‘draft’ or
`‘confidential,’ that might suggest that it was not intended for public
`distribution.” See Nobel Biocare Servs. AG v. Instradent USA, Inc., 903
`F.3d 1365, 1377 (Fed. Cir. 2018). In addition to the dates and markings on
`the document itself, Petitioner has pointed to the declaration of the Internet
`Archive’s Office Manager, Christopher Butler, attesting that the Illumina
`publication was archived by the Wayback Machine on December 27, 2005,
`and thereby confirming that it was publicly available. Ex. 1024, 5; Pet. 20;
`Reply 2–3.
`
`
`
`16
`
`
`
`Case 1:17-cv-12194-RGS Document 55-3 Filed 06/28/19 Page 18 of 33
`IPR2019-00164
`Patent 8,880,350 B2
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`
`Patent Owner argues that the Butler declaration and attached
`Wayback Machine printouts are insufficient to establish the public
`accessibility of the Illumina reference because “Petitioner fails to mention
`[the Butler declaration] anywhere in its Petition outside the exhibit list,” and
`this evidence should therefore not be considered in our institution analysis.
`Prelim. Resp. 21. We are not persuaded by this argument. As an initial
`matter, we observe that Petitioner cited to Exhibit 1024 in its Petition as the
`“Affidavit of Christopher Butler,” immediately after stating that “Illumina is
`prior art under § 102(a).” Pet. 20. Moreover, we gave the parties a
`sufficient opportunity to address the Butler declaration in additional briefing
`(both a Reply and Sur-Reply). Paper 8. We have considered the arguments
`presented in those briefs in determining whether Petitioner has made a
`sufficient showing for institution.
`Patent Owner further argues that, even if the Butler declaration were
`considered, it fails to show that the Illumina reference was available to
`persons of skill at the relevant time, because there is no showing that the
`skilled artisan could have searched for, and found, the reference on the
`Internet without already having the exact URL where it was published.
`Prelim. Resp. 21–23. Patent Owner contends that there is no indication that
`the product page shown on the archived webpage (Ex. 1024, 4) linked
`directly to the version of the Illumina reference appearing in the Butler
`declaration (id. at 6–13). Prelim. Resp. 23. Patent Owner also contends that
`the Petition fails to meet the standard set forth in Blue Calypso, LLC v.
`Groupon, Inc., 815 F.3d 1331, 1349–50 (Fed. Cir. 2016). Sur-Reply 1.
`We do not interpret Federal Circuit precedent as suggesting that only
`certain types of evidence may be used to show public accessibility of a
`
`
`
`17
`
`
`
`Case 1:17-cv-12194-RGS Document 55-3 Filed 06/28/19 Page 19 of 33
`IPR2019-00164
`Patent 8,880,350 B2
`
`webpage. To the contrary, whether a reference is a “printed publication” is a
`“case-by-case inquiry into the facts and circumstances surrounding the
`reference’s disclosure to members of the public.” Jazz Pharm., Inc. v.
`Amneal Pharm., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018) (citing In re
`Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). In Jazz
`Pharmaceuticals, the Federal Circuit made clear that “neither indexing nor
`searchability” was required to determine that an online document was
`publicly accessible. Id. at 1359. Here, we find on the current record that the
`relevant public, including those skilled in the art, would have been generally
`aware that Illumina, Inc., offered research tools used for gene expression
`assays. See Ex. 1047, 2384 (describing Illumina’s DASL assay). That
`would seem to provide enough of a reason for anyone interested in the
`DASL assay to look at Illumina’s website, where technical bulletins such as
`the Illumina reference could be accessed.
`We find Patent Owner’s remaining arguments largely go to the
`question of whether Petitioner has met its ultimate burden of proving that the
`Illumina reference was publicly accessible. But we need not answer that
`question at this stage. Rather, based on the present record, we find that
`Petitioner has made a sufficient threshold showing that Illumina qualifies as
`a prior art printed publication for institution. To the extent Patent Owner
`continues to challenge the printed publication status of Illumina after
`institution, the parties may further develop the record on this issue. We will
`make our determination as to whether Petitioner has satisfied its burden of
`proving public accessibility in our final written decision based on the entire
`record.
`
`
`
`18
`
`
`
`Case 1:17-cv-12194-RGS Document 55-3 Filed 06/28/19 Page 20 of 33
`IPR2019-00164
`Patent 8,880,350 B2
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`
`E. Asserted Ground of Unpatentability Based on Lu in View of
`Illumina
`Petitioner contends that claims 1–14 are unpatentable as obvious over
`Lu and Illumina. Pet. 23–58. Specifically, Petitioner argues that the
`combination of Lu and Illumina teaches or suggests each limitation of those
`claims. Id. at 23–48. Relying on the Declaration of Dr. Spellman, Petitioner
`also argues that a person of ordinary skill in the art would have been
`motivated to combine the references, and would have had a reasonable
`expectation of success. Id. at 48–58 (citing Ex. 1002 ¶¶ 113–24, 68, 147,
`183–87). Patent Owner opposes. Prelim. Resp. 17–35.
`A 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 of the invention to a
`person having ordinary skill in the art. 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 t
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