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  • Illumina, Inc. v. Natera, Inc.No claims unpatentable
    PTAB · Dec 11, 2020 · IPR2019-01201 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1–27 were not shown unpatentable: the single-cell Dhallan theories lacked a reasonable expectation of success, and Rabinowitz was not established as prior art.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable

      “In sum, Petitioner’s evidence in the Petition establishes that single cells were used for genetic analysis, amplification techniques were known, and SNP arrays could be used to analyze chromosome imbalances. Petitioner’s evidence, however, does not persuasively address the interplay between the amount of DNA in a single cell and the amount of DNA or amplified DNA needed to carry out the claimed method using a SNP 22 genotyping array and Dhallan’s aneuploidy analysis. This is important because Patent Owner cites evidence demonstrating that at the relevant time, “various researchers had determined that very low amounts of DNA could not be reliably used for SNP genotyping arrays (even with intervening amplification).” PO Resp. 47.” slip op. at 22

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “On this record, we agree with Patent Owner and Dr. Quackenbush that the ’406 application and ’741 provisional together demonstrate to persons of 23 The ’741 provisional is incorporated by reference into the ’406 application. Ex. 1026, 1:5–13. 48 ordinary skill that the inventors understood pyrosequencing could be used for high-throughput sequencing, if expensive machines were purchased. In other words, the ’741 provisional gives context to the statement in the ’406 application, and we agree with Dr. Quackenbush that “‘[s]uitability’, as the provisional makes clear to a person of ordinary skill in the art, is a cost issue, rather than a technical one.” Ex. 2012 (Quackenbush Decl.) ¶ 277; see also id. ¶¶ 276–80 (opining on disclosures in the ’741 provisional).” slip op. at 48

    • ExcludeMotion to exclude, deniedDenied

      “As to Dr. Quackenbush’s qualifications, although Petitioner characterizes his expertise as relating to statistics, the record reflects that he also has adequate experience in the fields of genetics and biotechnology. For example, he is Professor of Computational Biology and Bioinformatics, the Chair of the Department of Biostatistics, and the Director of the Health Data Science Center at the Harvard TH Chan School of Public Health. Ex. 2013, 1. He has almost three decades of experience in research and teaching in the fields of genetics and biotechnology (id. at 1–8, 12), has published hundreds of articles in these fields (id. at 13–52), was the Editor-in-Chief of the journal Genomics for over a decade (id. at 8), and has served as a peer reviewer, or on the editorial board, of a dozen other publications relating to genetics and biotechnology (id. at 7–8). Paper 49, 2. Given that experience in genetics and biotechnology, we find that Dr. Quackenbush has sufficient 54 specialized knowledge, experience, and education in the techniques of the ’592 Patent and prior art, such as DNA amplification, genotyping, and analysis of genetic data, for his testimony to be helpful to us. Moreover, even if Dr. Quackenbush did not personally work in fetal diagnostics at the relevant time, there is no requirement that a declarant must actually be a person of ordinary skill in the art to present testimony as to what such a person would have understood at the time of the invention. See, e.g., SEB S.A., 594 F.3d at 1373 (stating there is no requirement of a perfect match between an expert’s experience and the field of the art in question, provided the expert has “sufficient relevant technical experience” to testify). The remaining arguments raised in Petitioner’s motion relate to the sufficiency, rather than admissibility, of evidence. Such arguments are improperly advanced in a motion to exclude. See TPG 79 (stating that a motion to exclude may not be used to challenge the sufficiency of the evidence to prove a particular fact); see also Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“[T]he Board, sitting as a non-jury tribunal, is well-positioned to determine and assign appropriate weight to the evidence presented in this trial.”). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00010, Paper 59 at 40 (PTAB February 24, 2014). Rather than excluding evidence that is allegedly 55 confusing, misleading, or incorrect, we simply give it the appropriate weight in our analysis.” slip op. at 54

    • Strike new argumentNew argument disregardedDecided for patent owner

      “success arguments focus solely on Dhallan’s single cell disclosure, while “ignor[ing] Dhallan’s disclosure that its methodology can be performed using 2–32 cells, which also falls within the claims.” Reply 18 (citing, e.g., Pet. 13–14). Patent Owner responds that this is an improper attempt to change the thrust of the obviousness theory presented in the Petition. Sur-reply 16–17. We agree with Patent Owner. Although the Petition references portions of Dhallan that address using sources of DNA other than a single cell (see, e.g., Pet. 13–14, citing Ex. 1002 ¶¶ 44, 74), this is by way of background only, falling within a section titled “Introduction to Dhallan.” See Pet. 11. Petitioner’s detailed obviousness arguments for claim 1 are limited to use of DNA from a single cell, and do not extend to DNA from multiple cells.15 See, e.g., id. at 19–20 (arguing that, because Dhallan’s preferred embodiment is one embryo cell, Dhallan teaches the claimed limitation reciting “wherein the small amount of genetic material from the individual is from fifty or fewer of the individual’s 15 As noted above, claim 1 recites several possible sources for the claimed “small amount of genetic data.” See supra n.9. Here we focus on Petitioner’s unpatentability arguments based on option [i], but note that Petitioner’s unpatentability arguments under options [ii] and [iii] also did not extend to use of DNA from multiple cells. See, e.g., Pet. 20 (cross-referencing arguments for claims 4, 5, and 17); id. at 34 (for claim 4, arguing option [ii] based on “a single human cell”); id. at 35 (for claim 5, arguing option [iii] based on “extracellular fetal DNA from maternal blood”); id. at 42 (for claim 17, arguing option [iii] based on a “single fetal cell”). 30 cells”); id. at 29 (“A POSA would have been motivated to use a single cell as the source of genetic material . . . .”); id. at 31 (“A POSA would have reasonably expected success in using Dhallan’s methodology, for example as described in Example 14, on one embryonic cell.”). Accordingly, we agree with Patent Owner that Petitioner is impermissibly attempting to change the thrust of its obviousness theory on reply. Sur-reply 16–17. We will not consider Petitioner’s belated attempt to argue a reasonable expectation of success in using more than a single cell in the claimed method. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the . . . patent owner response.”).” slip op. at 30

    Patent outcomesUS 8,682,592 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 8,682,592
  • PTAB · Dec 2, 2020 · IPR2020-00511 · APJ Bart A Gerstenblith · IPR · Rehearing

    The Board denied DivX’s rehearing request, leaving the institution decision in place because the rule remained effective and Dr. McDaniel’s testimony was supported on the record.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. ANALYSIS A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c).” slip op. at 2

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “assertions regarding Dr. McDaniel’s testimony. Dr. McDaniel testified that (a) Chen teaches video data streams, (b) “[a]s was widely known in the art, for example as disclosed by Grab-333,[1] a [person of ordinary skill in the art] would have understood that video data streams were comprised of a series of video frames,” and (c) a person of ordinary skill in the art “would have understood that Chen teaches a plurality of frames of video are encrypted using at least one scrambling key/control word.” Ex. 1003 ¶ 112;” slip op. at 3

    None
    Patents in suitUS 9,184,920
  • Eis GmbH v. Novoluto GmbHRehearing granted
    PTAB · Sep 25, 2020 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Rehearing

    Granted EIS GMBH’s rehearing request and instituted IPR of claims 1–3, 5, 7, 8, 11, 14, 15, 17–21, and 23–26 on all asserted grounds.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “We conclude from a review of Fang and Taylor that they are not substantially the same art nor is Petitioner making substantially the same argument as was presented the Office during prosecution of the ’061 Patent based on Fang. We find that the way in which Fang and Taylor work appear to be materially different. Fang appears to apply only suction to the skin whereas Taylor, with the sealingly connected suction cup, appears to apply a cyclical vacuum that Dr. Prisco testifies meets the claim limitations requiring generation of a pattern of negative and positive pressures, modulated with respect to a reference pressure. Ex. 1002 ¶¶ 62–64, 75. Thus Taylor appears to teach the claim element Patent Owner argued during prosecution was missing from Fang. Also, in applying factors (b) and (d) of Becton, Dickinson, because of such differences noted above, we find that Taylor is not cumulative of Fang, which was considered and applied by the Office during prosecution of the ’061 Patent. 4. Conclusion Thus, we find that Taylor and Fang are not substantially the same art, nor were substantially the same arguments based on these references presented in the Petition and during prosecution of the ’061 Patent, respectively. As discussed above, because Petitioner primarily relies on Taylor in all four grounds for teaching the modulation of positive and negative pressures with respect to a reference pressure as required by all of the challenged claims, we also find that, overall, the same or substantially the same art was not previously presented to the Office nor were the same or substantially the same arguments previously presented to the Office. Therefore, we do not need to reach the application of the remaining Becton, Dickenson factors relating to whether the Petitioner has demonstrated a material error by the Office. Thus, we decline to exercise our discretion under § 325(d) to deny institution of an inter partes review here.” slip op. at 12

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
    Patents in suitUS 9,849,061
  • PTAB · Jun 30, 2020 · IPR2019-01517 · APJ Jennifer Meyer Chagnon · IPR · Rehearing

    The Board denied rehearing, leaving institution denied because Petitioner did not show a reasonable likelihood that claims 21–28 and 31 were obvious over Voyksner, Watson, and Rainbow.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “The party challenging a decision in a request for rehearing bears the burden of showing the decision should be modified. 37 C.F.R. § 42.71(d). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” Id. Upon a request for rehearing, the decision on a petition will be reviewed for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be indicated if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004). III. ANALYSIS” slip op. at 2

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “precursor of 25-hydroxvitamin D2 having a molecule weight of 412.7 g/mol.” Id. (citing Pet. 27; Ex. 1002 ¶ 57). Petitioner’s arguments explain what a skilled artisan could have done, i.e., select an appropriate precursor ion. However, as discussed in the Decision, the Petition, even when considered along with Dr. Fitzgerald’s testimony, “does not describe specifically why one of ordinary skill in the art would have selected the specific precursor ion” (Dec. 19), when as discussed above, multiple precursors are possible.5 See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”).” slip op. at 7

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

      “prior art teaches determining the presence or amount of 25-hydroxyvitamin D2 in a sample. However, as discussed in the Decision, claim 21 “requires more than merely determining the presence or amount of 25-hydroxyvitamin D2 in a sample.” Id. at 18. Petitioner does not argue that our interpretation of the plain meaning of claim 21 is incorrect or that we should disregard the step of generating “protonated and dehydrated precursor ion of said 25-hydroxyvitamin D2 with a mass to charge ratio (m/z) of 395.30±0.5.” See id. Accordingly, we are not persuaded that we overlooked Petitioner’s arguments. Further, we agree with Patent Owner that the Petition lacks sufficient explanation of why a person of ordinary skill in the art “would have chosen to [specifically] investigate 25-hydroxyvitamin D2 using Voyksner’s methods in the first place, particularly since Voyksner only discusses ‘dihydroxyvitamin D3’ for the purposes of evaluating the orientation of certain mass spectrometry equipment.” Opp. 5 (citing Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362–63 (Fed. Cir. 2016) (noting that it is error to accept general knowledge in the art without evidence on the record for limitations that are “not evidently and indisputably within the common knowledge of those skilled in the art”) (emphasis in original)).” slip op. at 9

    § 103 obviousness
    Patents in suitUS 7,972,867
  • Eis GmbH v. Novoluto GmbHRehearing granted
    PTAB · Jun 17, 2020 · IPR2019-01302 · APJ John E Schneider · IPR · Rehearing

    Granted rehearing and instituted inter partes review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Guan, Lee, and Hovland.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “An abuse of discretion occurs if the decision (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision.” Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015). With this in mind, we address the arguments presented by Petitioner in turn.” slip op. at 3

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “Request for Rehearing and conclude there are genuine issues of material fact about the teachings of Guan that warrant institution and resolution at trial.” slip op. at 2

    • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

      “Patent Owner contends that Guan is non-analogous art in that it is not related to stimulation of the clitoris. Prelim. Resp. 59. Patent Owner also contends that there is no motivation to combine the teachings of Lee and Guan. Id. at 60–63. Patent Owner argues that one skilled in the art would not consider using the indirect stimulator of Guan in the dildo of Lee as it would require a modification of Lee beyond a simple substitution of elements. Id.” slip op. at 5

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

      “Petitioner has also provided a reasonable motivation to combine the teachings of Lee and Guan. Lee comprises a dildo with an extension which directly stimulates the clitoris, a body part. Ex. 1006, Fig. 1; Ex. 1002, ¶¶ 72, 134–137. Guan discloses an apparatus, which indirectly stimulates a body part. Ex. 1007, 3; Ex. 1002 ¶ 137. Given the teaching in the art of the problems with direct stimulation versus indirect stimulation, we agree on this record with Dr. Prisco that one skilled in the art would have had a reason to substitute the indirect stimulation device of Guan for the direct intensive and is best decided on a full record. Cf. Monark Knitting Mach, Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 886 (Fed. Cir. 1998) (determining that issues of fact concerning secondary considerations precluded grant of summary judgment) reasonable expectation of success. Ex. 1002 ¶¶ 132–137.” slip op. at 6

    § 103 obviousness
    Patents in suitUS 9,937,097
  • PTAB · Jun 10, 2020 · IPR2019-00406 · APJ Avelyn M Ross · IPR · Institution

    The Board denied institution of IPR on all challenged claims, exercising § 314(a) discretion because the parallel district court case was advanced, overlapping, and likely to conclude first.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied

      “waive a jury demand, a trial “will happen sooner if it is scheduled as a bench trial than it will as a jury trial.” Id. at 14:20–24. According to the Court, the parties should expect trial to occur within a year. See id. at 17:21–23 (“What I’m telling you is that you will get reached in sooner than a year, in all likelihood.”). Both parties withdrew their request for a jury demand. See Ex. 3006. Were we to institute inter partes review, a final written decision in this proceeding would issue in June 2021—leaving a year before resolution of this proceeding. Given the Western District of Texas’ emphasis that the parallel litigation should proceed as if still set for June 22, 2020, and its expectation of holding a bench trial within a year, this factor weighs strongly in favor of discretionary denial in this case.” slip op. at 10

    Discretionary denial
    Patents in suitUS 6,596,296
  • PTAB · Apr 14, 2020 · PGR2019-00002 · APJ John E Schneider · PGR · Final written decision

    Claims 1–29 are unpatentable: claims 1–17 and 19–28 for lack of enablement and obviousness; claims 18 and 29 for obviousness.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Dr. Braun, Petitioner’s proffered expert, defines a person of ordinary skill in the art as having an advanced degree or its substantial equivalent in the biological sciences, including specifically in the fields of immunology, microbiology and the microbiome, and oncology, coupled with research experience in those fields. Ex. 1002 ¶ 40. Patent Owner does not contest Petitioner’s definition of a person of ordinary skill in the art. See generally, PO Resp. We determine that Petitioner’s description of the level of ordinary skill in the art is supported by the current record. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “interprets claim terms in an unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b) (2018);3 Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to trial proceeding before the USPTO.). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of 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)).” slip op. at 9

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “We have considered the arguments presented by the parties and the evidence of record and conclude that the unpredictability of the art weighs in favor of finding non-enablement with respect to CPIs in general. While we agree with Patent Owner that CPIs can be effective in treating some cancers, the Specification and the evidence of record show that all of the effective CPIs are antibodies. For example, all of the CPIs listed in the chart of page 10 of Patent Owner’s Response are antibodies. Tr. 39. We find nothing in the record, other than attorney argument that one skilled in the art would know how to make of use other CPIs, such as an interfering nucleic acid molecule, in the claimed method. For example, as Petitioner points out, Patent Owner’s expert did not consider CPIs other than antibodies, in reaching his conclusions regarding enablement. Pet. Reply, 4; Ex. 1042, 19–29. The record also does not support the contention that one skilled in the art could predict the action of non-antibody CPIs based on the action of an antibody CPI. The art and the Specification identify one non-antibody CPI, and the Fe region of human IgG. Ex. 1001, col. 5, ll. 20–23; Ex. 2034, 206. At the time the ’302 patent was filed, studies of this potential CPI indicated that it acted differently than antibody CPIs and that efficacy was lacking compared to other CPIs. Id. This evidence supports Petitioner’s contention that the use of CPIs, especially non-antibody CPIs, was unpredictable at the time the ’302 patent was filed. We also agree with Petitioner that the selection of Bifidobacterium was unpredictable. The evidence of record supports Petitioner’s contention that the immunostimulatory activity of Bifidobacterium varies from strain to strain, even within the same species. Pet. 44–45. O’Mahony teaches that Bifidobacterium longum strain AH1714 is immunosuppressive while another stain of B. longum exhibits immunostimulatory activity. Ex. 1017 ¶¶ 103– 109. Similarly, Lopez evaluated 12 strains of four different species of Bifidobacterium and concluded that the properties exhibited by Bifidobacterium varied among the strains. Ex. 1038, Abstr. Patent Owner’s arguments regarding the credibility of O’Mahony and Lopez are unpersuasive. Patent Owner made specific representations to the Examiner on several occasions that strain AH1714 disclosed in O’Mahony was immunosuppressive to support Patent Owner’s argument that one would not combine an immunosuppressive agent with an immunostimulatory agent. See, e.g. Ex. 1014, 8–9. Patent Owner suggests that it was not asserting that the statements in O’Mahony were accurate, but merely argues that those statements would have led away from making the combination proposed by the Examiner. PO Sur-Reply 10. This argument fails in its logic. If one skilled in the art upon reading O’Mahony would have recognized the alleged errors in O’Mahony’s teachings and disregarded them as Patent Owner now combination advanced by the Examiner in prosecution as Patent Owner argued. With respect to Lopez, Lopez states unambiguously that the immune effects of Bifidobacteria are species and strain specific. Petitioner has advanced evidence that those skilled in the art accepted these conclusions, citing Lopez in subsequent articles. Pet. Reply 10–11 (citing Ex. 1044). Moreover, the present inventors found Lopez to be sufficiently credible to incorporate the teachings of Lopez in their entirety into the instant Specification of the ’302 patent. Ex. 1001, col. 37, l. 62–col. 38, l. 4.” slip op. at 23

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledEnabledMixed

      “evidence of record and conclude that applying the all the Wands factors, Petitioner has demonstrated by a preponderance of the evidence that claims 1–17 and 19–28 are not enabled. In reviewing the evidence of record, we find that the nature of the invention that involves very broad claims, the high level of skill required in such an unpredictable art, and the dearth of working examples and lack of specific guidance on the full range of CPIs and cancers challenged claims are not enabled. Because claims 18 and 29 require known CPIs, however, we find that Petitioner has failed to show that these claims are not enabled.” slip op. at 26

    Patent outcomesUS 9,855,302 unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 9,855,302
  • PTAB · Apr 3, 2020 · IPR2019-00840 · APJ Bart A Gerstenblith · IPR · Rehearing

    The Board denied Microsoft’s rehearing request, leaving institution denied because it did not show error in the Board’s § 325(d) analysis.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “decision should be modified. 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c).” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for patent owner

      “Petitioner did not argue, in the Petition, that FIPA97 was released as individual parts. Petitioner’s Rehearing Request (page 8) cites to the Petition at page 20 and Exhibit 1054. Page 20 of the Petition, however, contains Petitioner’s argument that FIPA97 was made publicly available as a single document, as discussed above. It does not include any argument or suggestion that FIPA97 was released as individual parts. Additionally, Exhibit 1054 is not cited on page 20 of the Petition in the discussion of FIPA97 nor does it appear that Exhibit 1054 was cited anywhere in the Petition. Thus, because Petitioner did not argue, in the Petition, that FIPA97 was released as individual parts, we could not have overlooked that argument. Petitioner’s contention of error in our determination that FIPA97 was involved during examination of the ’128 patent application is premised upon finding that FIPA97 existed as individual parts. Because Petitioner fails to demonstrate that we overlooked an argument that was not made, we are not persuaded of error.” slip op. at 4

    Discretionary denial
    Patents in suitUS 7,036,128
  • PTAB · Apr 3, 2020 · IPR2019-00838 · APJ Bart A Gerstenblith · IPR · Rehearing

    The Board denied Microsoft’s rehearing request, leaving institution denied under § 325(d) because Microsoft did not show the Board overlooked arguments made in the petition.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. ANALYSIS A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c).” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner

      “and the prior art relied upon in Petitioner’s challenges to the ’128 patent, Petitioner did not address 35 U.S.C. § 325(d) in the Petition (Paper 1). Instead, Petitioner made two critical representations—(1) that the Examiner of the ’128 patent “did not have FIPA97 before him, or any other FIPA reference for that matter” (Pet. 1) and (2) that despite there being seven “Parts” to FIPA97, “FIPA97 was made publicly available as a single document” and was “developed and published as a single, integrated work.” Pet. 20 (citing Ex. 1055 (FIPA97 Table of Contents for Parts 1–7)); Ex. 1026, 5 (Foundation for Intelligent Physical Agents, “Resolution of Munich meeting”). In the Petition (Paper 1), Petitioner never contended that FIPA97 was published or available as separate and distinct parts, such that access to one part might not mean access to each other part. Rather, Petitioner’s sole statement regarding separate parts was that it filed FIPA97 as seven separate exhibits “due to its size and numbering schedule.” Id. at 20. Accordingly, on the record presented, we agreed with Petitioner’s representation and we found that FIPA97 (Exs. 1006–1012) constitutes a single document, which we then found was involved during examination of the ’128 patent application. Inst. Dec. 15.” slip op. at 3

    Discretionary denial
    Patents in suitUS 7,036,128
  • PTAB · Apr 3, 2020 · IPR2019-00839 · APJ Bart A Gerstenblith · IPR · Rehearing

    The Board denied Microsoft's rehearing request, leaving institution denied under § 325(d) because it did not show the Board overlooked arguments about FIPA97 or misweighed the Becton factors.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. ANALYSIS A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c).” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner

      “and the prior art relied upon in Petitioner’s challenges to the ’128 patent, Petitioner did not address 35 U.S.C. § 325(d) in the Petition (Paper 1). Instead, Petitioner made two critical representations—(1) that the Examiner of the ’128 patent “did not have FIPA97 before him, or any other FIPA reference for that matter” (Pet. 1) and (2) that despite there being seven “Parts” to FIPA97, “FIPA97 was made publicly available as a single document” and was “developed and published as a single, integrated work.” Pet. 20 (citing Ex. 1055 (FIPA97 Table of Contents for Parts 1–7)); Ex. 1026, 5 (Foundation for Intelligent Physical Agents, “Resolution of Munich meeting”). In the Petition (Paper 1), Petitioner never contended that FIPA97 was published or available as separate and distinct parts, such that access to one part might not mean access to each other part. Rather, Petitioner’s sole statement regarding separate parts was that it filed FIPA97 as seven separate exhibits “due to its size and numbering schedule.” Id. at 20. Accordingly, on the record presented, we agreed with Petitioner’s representation and we found that FIPA97 (Exs. 1006–1012) constitutes a single document, which we then found was involved during examination of the ’128 patent application. Inst. Dec. 15.” slip op. at 3

    Discretionary denial
    Patents in suitUS 7,036,128
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