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  • PTAB · Jan 15, 2025 · IPR2024-01108 · APJ Kevin W Cherry · IPR · Institution

    The Board instituted IPR on claims 1, 2, 5–8, 10–15, 17, 18, 20, and 21 under § 103 and granted BRP’s motion to join the Foil Boarding IPR.

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

      “At this stage of the proceeding and based on our preliminary review, we find Petitioner has demonstrated a reasonable likelihood of showing the unpatentability of the Challenged Claims for the same reasons discussed in our Decision on Institution in the Foil Boarding IPR. Granting the Petition and joining Petitioner to the Foil Boarding IPR will provide us with the opportunity to more fully consider Patent Owner’s arguments—first raised in response to the petition in the Foil Boarding IPR—in the context in which they were first raised. Those common arguments will be fully considered in the Foil Boarding IPR, with the benefit of a complete record.8 Accordingly, for the reasons discussed above, we are persuaded Petitioner has demonstrated a reasonable likelihood of showing the unpatentability of the Challenged Claims of the ’044 patent. We therefore grant the Petition, and institute inter partes review of the Challenged Claims.” slip op. at 6

    • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

      “challenges the same claims on the same grounds using the same prior art, Kyocera factor (2) favors joinder. See Kyocera, IPR2013-00004, Paper 15 at 4. Indeed, the Board “routinely grants motions for joinder where the party seeking joinder introduces identical arguments and the same grounds raised in the existing proceeding.” Samsung Elecs. Co. v. Raytheon Co., IPR2016- 00962, Paper 12 at 9 (PTAB Aug. 24, 2016). Moreover, because the issues to be decided are the same and Petitioner avers that it will take an “understudy” role to Foil Boarding in the Foil Boarding IPR by consolidating all filings, refraining from advancing new arguments, binding itself to any discovery agreements, and limiting its deposition time to the time already allotted, Kyocera factors (3) and (4) also favor joinder. See Mot. 4–6; Kyocera, IPR2013-00004, Paper 15 at 4. For the reasons explained above, we find that joining Petitioner to the Foil Boarding IPR is appropriate under the present circumstances. We, therefore, grant Petitioner’s Motion.” slip op. at 8

    None
    Patents in suitUS 9,359,044
  • PTAB · Jan 15, 2025 · IPR2024-01107 · APJ Kevin W Cherry · IPR · Institution

    The Board instituted IPR on claims 1, 2, 4, 5, 7–11, 13, and 15 under § 103 and granted BRP’s motion to join IPR2024-00085.

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

      “At this stage of the proceeding and based on our preliminary review, we find Petitioner has demonstrated a reasonable likelihood of showing the unpatentability of the Challenged Claims for the same reasons discussed in our Decision on Institution in the Foil Boarding IPR. Granting the Petition and joining Petitioner to the Foil Boarding IPR will provide us with the opportunity to more fully consider Patent Owner’s arguments—first raised in response to the petition in the Foil Boarding IPR—in the context in which they were first raised. Those common arguments will be fully considered in the Foil Boarding IPR, with the benefit of a complete record.8 Accordingly, for the reasons discussed above, we are persuaded Petitioner has demonstrated a reasonable likelihood of showing the unpatentability of the Challenged Claims of the ’659 patent. We therefore grant the Petition, and institute inter partes review of the Challenged Claims.” slip op. at 6

    • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

      “Patent Owner does not oppose Petitioner’s Motion. We are persuaded by Petitioner’s arguments. Because the Petition challenges the same claims on the same grounds using the same prior art, Kyocera factor (2) favors joinder. See Kyocera, IPR2013-00004, Paper 15 at 4. Indeed, the Board “routinely grants motions for joinder where the party seeking joinder introduces identical arguments and the same grounds raised in the existing proceeding.” Samsung Elecs. Co. v. Raytheon Co., IPR2016- 00962, Paper 12 at 9 (PTAB Aug. 24, 2016). Moreover, because the issues to be decided are the same and Petitioner avers that it will take an “understudy” role to Foil Boarding in the Foil Boarding IPR by consolidating all filings, refraining from advancing new arguments, binding itself to any discovery agreements, and limiting its deposition time to the time already allotted, Kyocera factors (3) and (4) also favor joinder. See Mot. 4–6; Kyocera, IPR2013-00004, Paper 15 at 4. For the reasons explained above, we find that joining Petitioner to the Foil Boarding IPR is appropriate under the present circumstances. We, therefore, grant Petitioner’s Motion.” slip op. at 8

    None
    Patents in suitUS 9,586,659
  • PTAB · Dec 17, 2024 · IPR2024-00999 · APJ Michael L Woods · IPR · Institution

    The Board denied joinder and denied institution on all challenged claims and grounds because the petition was time-barred under § 315(b).

    RulingsInstitution decision
    • PTAB / AIA Trials › §315(b) time barInstitution denied time barDenied

      “Whether we institute review depends on whether we grant Petitioner’s Motion for Joinder. If granted, the one-year bar does not apply. See 35 U.S.C. § 315(b). If denied, the Petition is time-barred. See id.” slip op. at 6

    • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied

      “As in Code200 I, Petitioner provides no explanation as to why it did not file a petition seeking inter partes review of the ’659 patent within the one-year window. See generally Mot.; see also Opp. 2 (“Petitioner offers no explanation for why it waited over three years to seek to challenge the patent through IPR proceedings.”). Furthermore, Petitioner provides no explanation as to why joinder would be fair or otherwise in the interests of justice. See generally Mot.; see also Opp. 2 (“Petitioner offers no explanation for how joinder would be fair to, and not otherwise prejudice, Patent Owner.”). Accordingly, Petitioner has failed to establish that it is entitled to the requested relief under our Rules. See 37 C.F.R. §§ 42.1, 42.20(c). For the forgoing reasons, we exercise our discretion to deny Petitioner’s Motion for Joinder.” slip op. at 13

    Discretionary denial
    Patents in suitUS 9,586,659
  • PTAB · Dec 17, 2024 · IPR2024-00998 · APJ Michael L Woods · IPR · Institution

    The Board denied joinder and denied institution on all challenged claims because the petition was time-barred under § 315(b).

    RulingsInstitution decision
    • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied

      “establish that it is entitled to the requested relief.” See 37 C.F.R. § 42.20(c). Regarding joinder, the relevant statute provides that: If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314. 35 U.S.C. § 315(c).” slip op. at 5

    • PTAB / AIA Trials › §315(b) time barInstitution denied time barInstitution denied

      “This statute further provides that the petition for inter partes review must be filed no later than “1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.” 35 U.S.C. § 315(b); see also 37 C.F.R. § 42.101(b). This one-year time bar, however, “shall not apply to a request for joinder.” 35 U.S.C. § 315(b); see also 37 C.F.R. § 42.122(b).” slip op. at 5

    Discretionary denial
    Patents in suitUS 9,359,044
  • PTAB · Nov 27, 2024 · IPR2023-00918 · APJ Robert J Silverman · IPR · Final written decision

    Claims 1–29 are unpatentable: claims 1–27 under the Adharapurapu (Alcatel) and Kerr obviousness ground, and claims 28–29 under the Adharapurapu (Alcatel) anticipation ground.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Our Institution Decision addressed the matter of the appropriate level of ordinary skill, in view of the Petition and the Preliminary Response, as follows: The parties’ descriptions of the level of ordinary skill at the time of the invention do not appear to differ in any material way that would affect this Decision. However, at this stage of the proceeding, it is unclear whether it would be proper to require Patent Owner’s proposed requirement of “three years of experience working with digital advertising and geofencing.” Prelim. Resp. 10–11. Accordingly, for the purposes of this [Institution] Decision, we adopt Petitioner’s description of the relevant level of skill in the art, because it appears to be consistent with the level of skill reflected in the ’620 patent and asserted prior art. Inst. Dec. 16. Patent Owner’s Response endorses the determination presented in the Institution Decision. PO Resp. 2. Petitioner does not address our initial determination in its Reply. See generally Pet. Reply. Accordingly, consistent with our Institution Decision, in this Final Written Decision, we employ Petitioner’s description of the relevant level of skill in the art. C. Claim Interpretation” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed

      “The Specification of the ’620 patent supports the understanding that a “consumer” is “a user or person,” per Patent Owner’s proposal (PO Resp. 11). See Ex. 1001, 8:36–38 (“The AdDrop™ may require the consumer to be one of the first few people to input an answer to a question to win the promotion.”) However, Patent Owner’s further proposed requirement — i.e., that a “consumer” be someone “to whom an advertisement may be sent” — would cloud, rather than clarify, the term’s meaning. PO Resp. 11 (emphasis added). For instance, under Patent Owner’s construction, it is not clear if “consumers” require access to the cellular network or Internet in order to be sent advertisements. Further, Patent Owner’s proposed construction would not assist in resolving any issue in this proceeding, contrary to our ambition to construe claim terms “only to the extent necessary to resolve the controversy.” Vivid Techs., 200 F.3d at 803. Moreover, the role of the term “consumer,” in the ’620 patent’s claims, is based upon the relationship of the “consumer” to particular actions and instrumentalities, e.g., associated “media content,” “profile data,” or a “device.” See, e.g., Ex. 1001, 37:57, 66–67, 38:15. In view of the foregoing, we do not adopt Patent Owner’s proposed construction that requires a “consumer” to be a person “to whom an advertisement may be sent.” See PO Resp. 11 (emphasis added). D. Prior Art References” slip op. at 15

    • Strike new argumentNew argument disregardedDecided for petitioner

      “As an initial matter, such a new argument that is introduced in a Sur- reply is improper. See 37 C.F.R. § 42.23(b) (“A sur-reply may only respond to arguments raised in the corresponding reply.”); Consolidated Trial Practice Guide10 74 (Nov. 2019) (“While replies and sur-replies can help crystalize issues for decision, a reply or sur-reply that raises a new issue or belatedly presents evidence may not be considered. The Board is not required to attempt to sort proper from improper portions of the reply or surreply.”); Hulu, LLC v. SITO Mobile R&D IP, LLC, IPR2021-00158, Paper 34 at 55 (PTAB Apr. 15, 2022). In addition, Patent Owner’s new “geolocation” argument is founded on attorney argument, without adequate support in record evidence, and is contradicted by the unchallenged testimony of Dr. Goldberg. See Ex. 2002 ¶¶ 29–66 (discussing terrestrial location technologies), 175–195 (discussing the disclosure of “geolocation” features in the Adharapurapu (Alcatel) reference).” slip op. at 22

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

      “Yet, Patent Owner does not address Petitioner’s stated reasons (quoted above) for combining teachings of Adharapurapu (Alcatel) and Kerr, regarding the “registering asset data” features of limitation 1(a) (including its subparts) — reasons that are supported by the unchallenged testimony of Dr. Goldberg. See Pet. 50–51 (citing Ex. 1002 ¶¶ 196–197). Still further, Patent Owner does not address Petitioner’s other reasons for combining teachings of Adharapurapu (Alcatel) and Kerr, concerning the recited “content interaction layer” and “consumer tracking layer” features of limitation 1(b) (including its subparts): , POSITA would have found it obvious to incorporate Kerr’s user content interaction features into Alcatel to provide user subjective information/feedback for improving the accuracy, reducing noise, and enhancing efficiency in tailored communications. Pet. 43–44. Petitioner’s discussion of these reasons for combining the references’ teachings is supported by additional unrebutted testimony of Dr. Goldberg. Ex. 1002 ¶ 180. Having considered the parties’ arguments and the evidence of record (including the unchallenged testimony of Dr. Goldberg), we determine that Petitioner has sufficiently shown that the combination of Adharapurapu (Alcatel) and Kerr teach or suggest limitation 1(a) (including all subparts).” slip op. at 23

    Patent outcomesUS 10,621,620 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,621,620
  • PTAB · Nov 27, 2024 · IPR2023-00919 · APJ Michael L Woods · IPR · Final written decision

    Claims 1–23 are unpatentable: claims 13–19 were anticipated by Felt, and claims 1–23 would have been obvious over Adharapurapu and Felt.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedDenied

      “Accordingly, we deny Petitioner’s motion to exclude in its entirety. IV. PATENT OWNER’s MOTION TO EXCLUDE Patent Owner moves to exclude Exhibits 1002 and 1009—the” slip op. at 84

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

      “Accordingly, the Petition fails to establish that Felt satisfies” slip op. at 34

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable

      “uncontroverted testimony of Dr. Goldberg, and the reasoning to combine the references, Petitioner has shown by a preponderance of the evidence that claims 1–23 would have been obvious over the combination of Adharapurapu and Felt (Ground 6). Petitioner has also shown, by a preponderance of the evidence, that Felt anticipates claims 13–19 (Ground 1), renders obvious claims 13–19 (Ground 2), and that claims 1–19 would have been obvious over Felt in view of Creemer or Scofield (Ground 4).” slip op. at 86

    Patent outcomesUS 10,692,108 unpatentable
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,692,108
  • PTAB · Oct 3, 2024 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Institution

    The Board instituted IPR of claims 1–30 on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–30 of the ’462 patent is unpatentable.” slip op. at 2

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

      “Design, Eligibility). At this point in the proceeding, we interpret the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients. The record is devoid of evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition to exclude the same treatment of other patients, such as the treatment of control patients not having the condition.” slip op. at 22

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

      “5002). Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. See Ex. 1003 ¶¶ 124, 130, 132, 136. Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. Pet. 42–43 (citing Ex. 1003, ¶ 136). Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were actively treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. Pet. 43 (citing Ex. 1016; Ex. 1017; Ex. 1003 ¶¶ 131–132). According to Petitioner, these other references would have “independently urged” those of ordinary skill in the art to treat MSI-H cancer with PD-1 inhibitors or other immunotherapy, such as pembrolizumab, and would have given them a reasonable expectation of success. Pet. 44–45. Petitioner cites, along with other references, Pernot, which states “[colorectal cancers] associated with MSI could lead to a more intense immune response, but also to specific immunoregulatory phenomena, making them good candidates for immunotherapy.” (Ex. 1006,3 3741; see Pet. 43.) Petitioner also cites Champiat, which states that” slip op. at 25

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that one of ordinary skill in the art relevant to the ’462 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. Pet. 11 (citing Neugut Decl., Ex. 1003 ¶ 19). Petitioner argues further that the ordinarily skilled artisan would have had experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. Id. Patent Owner, having not entered a response, does not dispute Petitioner’s proposal about the POSA’s qualifications on this record.. For this Decision, we adopt and apply Petitioner’s proposal above, which is supported by Dr. Neugut’s testimony and does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8

    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,643,462
  • PTAB · Sep 27, 2024 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR of claims 1–28 on all six asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–28 of the ’187 patent are unpatentable.” slip op. at 2

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

      “Anticipation is a question of fact, as is the question of what a prior art reference teaches. In re NTP, Inc., 654 F.3d 1279, 1297 (Fed. Cir. 2011). “Because the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates a claim is assessed from the skilled artisan’s perspective. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching that every claim element was disclosed in that single reference.” (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))).” slip op. at 9

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted

      “The obviousness inquiry also typically requires an analysis of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). A petitioner cannot prove obviousness with “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Rather, a petitioner must articulate a sufficient reason why a person of ordinary skill in the art would have combined the prior art references. In re NuVasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016).” slip op. at 10

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

      “Petitioner argues that we need not construe any terms of the challenged claims to resolve the issues presented in the Petition. Pet. 11. We determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,629,187
  • PTAB · Sep 27, 2024 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1–36 because the Petition showed a reasonable likelihood of prevailing on at least one challenged claim across the asserted grounds.

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving the unpatentability of at least one of claims 1–36 of the ’287 patent.” slip op. at 2

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

      “summarized above, we are persuaded by Petitioner that the MSI-H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); Ex. 1003, ¶¶ 58–62. We are also persuaded that Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated with pembrolizumab. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.3 Accordingly, we are persuaded by Petitioner that, on this record, the MSI-H Study Record discloses each element of claim 1. In view of the above, we determine that Petitioner has sufficiently shown a reasonable likelihood of establishing that the MSI-H Study Record anticipates claim 1. Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing.” slip op. at 16

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

      “not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating a human patient having colorectal cancer that is microsatellite instability high or DNA mismatch repair deficient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. Ex. 1006, 3741; Ex. 1003 ¶ 136. Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with pembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD-1 inhibitor (Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (Ex. 1032, e27817-5). Pet. 44 (citing Ex. 1003 ¶ 49). Thus, based on the current record, we determine that Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art. Accordingly, in view of the above, we are persuaded that there is a reasonable likelihood that Petitioner will prevail with respect to at least one claim challenged under Ground 2 in the Petition.” slip op. at 21

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention would be a medical doctor or a professional in a related field with at least five years of experience with treating cancer. . . . The POSA would also have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and a pathologist with comparable experience. . . . The inherent anticipation and obviousness grounds discussed herein would not change due to a modestly lesser or greater level of experience. Pet. 11–12 (citing Ex. 1003 ¶ 19). For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7

    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,649,287
  • PTAB · Sep 27, 2024 · IPR2024-00650 · APJ Deborah Katz · IPR · Institution

    The Board instituted IPR of claims 1–38 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that 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). We determine whether to institute an inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2

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

      “determined to be microsatellite instability high or DNA mismatch repair deficient were placed into a study arm and then treated with pembrolizumab. (See Ex. 1005, Ex. 1003 ¶¶ 60–73.) Because treatment of the patients was performed only after MSI-H status was determined, the MSI-H Study Record teaches treating the patients “in response to” determining their MSI- H status.” slip op. at 15

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted

      “have been expected, Petitioner cites to Brown as teaching that PD-1 inhibitors are inherently more effective when treating tumors comprised of cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1034, 747).) Petitioner argues further that Duval teaches that MSI-H cancers have cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1087, 5002).) Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. (See Ex. 1003 ¶¶ 124, 130, 132; see Pet. 41.) Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. (See Pet. 41 (citing Ex. 1003 ¶ 130).) Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were successfully treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. (See Pet. 42 (citing Ex. 1003 ¶¶ 131, 132).)” slip op. at 18

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that one of ordinary skill in the art relevant to the ’219 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. (See Pet. 11 (citing Neugut Decl., Ex. 1003 ¶19).) Petitioner argues further that the ordinarily skilled artisan would have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. (See id.) Dr. Neugut’s testimony supports Petitioner’s arguments regarding the level of skill that an ordinarily skilled artisan in the relevant field would have. (See Ex. 1003 ¶ 19.) Accordingly, in the analysis below, and in the absence of argument by Patent Owner to the contrary, we apply the level of skill set forth by Petitioner and refer to Dr. Neugut’s testimony of what one of ordinary skill in the art would have understood at the time the application that became the ’491 patent was filed, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,634,491

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