- Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.
RulingsFinal written decision- BurdenUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
- Skill levelSkill level board ownDecided for petitioner
“Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’356 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
Patent outcomesUS 10,934,356 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,934,356 - PTAB · Oct 16, 2025 · IPR2025-00711 · APJ Linda E Horner · IPR · Institution
The Board instituted IPR on claims 1, 2, 4–7, 9, 11–13, 15, 19, 23, 24, and 29 based on a reasonable likelihood of success on the § 103 challenges.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition and the preliminary response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that Petitioner has shown a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we grant the Petition and institute an inter partes review of claims 1, 2, 4–7, 9, 11‒13, 15, 19, 23, 24, and 29 of the ’164 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Cir. 2012). “The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (alteration in original) (quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner argues that it is not necessary for us to provide an express construction for any claim term because the Petition “establishes the prior art meets each claim limitation under any reasonable construction.” Pet. 13. Patent Owner similarly submits that we “need not construe any terms at this stage, because under any reasonable construction of the claim terms, the prior art fails to disclose or suggest the claimed features.” Prelim. Resp. 9. At this stage of the proceeding, we do not need to expressly construe any claim terms to determine whether Petitioner showed a reasonable likelihood of prevailing as to its challenge of at least one challenged claim.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Kelly discloses that game processor 12 implements the functions of game unit 10 during a game process and includes several input and output functions (Ex. 1005, 9:15–18), including: The game processor controls the game apparatus by receiving inputs from a player, from other game apparatuses, from a server (described below), from a progressive bonus apparatus, and from other sources. The game processor also controls output signals to update the game process when appropriate. In addition, the game processor controls the redemption system of the present invention by calculating when prizes are awarded, calculating and updating prize lists and prize costs, and other functions, as described below. Ex. 1005, 9:18–27. As to the redemption system, Kelly discloses prize table 480 that is displayed to the operator. Ex. 1005, 34:64–65, Fig. 9a. In one embodiment, the operator can adjust prize characteristics for the game unit and any linked game units. Id. at 35:1–2. Kelly also discloses an alternative embodiment, however, in which selection of a specific prize from the table 480 can be based on random and/or statistical determination. Id. at 36:48–49. In this alternative embodiment, “random determination of whether a particular prize is to be awarded is also modified by statistical information to create a ‘best fit’ of prizes awarded according to the operator’s desired odds.” Id. at 36:63–66. awarded every 8,000 games, so if it is randomly determined that a third video console is to be awarded within, for example, the 3000th game, then a different prize, e.g., the next most valuable prize, can be awarded so that the desired odds are better met. Id. at 37:1–9. Thus, we find Petitioner has set forth sufficient evidence to show a reasonable likelihood that Kelly’s game processor can modify the variable parameters of the prizing structure to meet the mandated parameters of the desired odds, as called for in limitation [1.c.v].” slip op. at 23
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artOther
“To remove Walker as prior art under §§ 102(a) and 102(e), Patent Owner must show either it reduced the invention to practice prior to Walker’s effective date, or that it invented prior to Walker’s effective date. In the case of the latter, Patent Owner must demonstrate conception prior to May 1, 2003, and reasonably continuous diligence throughout the entire critical period, which begins just prior to the Walker’s effective date and ends on the date of the invention’s actual or constructive reduction to practice. Patent Owner provides evidence purporting to show that it conceived of the invention prior to May 1, 2003. Patent Owner has not asserted that this evidence demonstrates actual reduction to practice, nor do we have sufficient evidence at this stage to make that determination. Further, Patent Owner’s earliest possible constructive reduction to practice (September 1, 2004) does not pre-date Walker’s effective date. Thus, at this stage, Patent Owner would need to show it invented prior to Walker’s effective date through evidence of conception and reasonable diligence to remove Walker as prior art. At this stage of the proceeding, without Patent Owner’s evidence of diligence, Patent Owner has not provided sufficient evidence to show that Petitioner fails to show a reasonable likelihood of prevailing in establishing that Walker is prior art. This issue of whether Walker is prior art to the ’164 patent will benefit from further development of the record during the trial proceeding.” slip op. at 31
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,335,164 - PTAB · Oct 16, 2025 · IPR2025-00712 · APJ James A Tartal · IPR · Institution
The Board instituted inter partes review of claims 1, 3–9, 13, 17, 18, 23, 25, 26, 28, and 29 on all asserted grounds, finding a reasonable likelihood of prevailing on claim 1 over Walker.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2025). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . 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). Upon institution of inter partes review, the review proceeds “on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). Based on our consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review as to the Challenged Claims of the ’279 patent on all grounds asserted in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedOther
“application filed November 12, 2021, that asserts the benefit of a series of applications, the earliest of which was filed September 2, 2003. Ex. 1001, codes (22), (45), (60). Petitioner asserts that the Challenged Claims of the ’279 patent “are entitled to an effective filing date of no earlier than September 2, 2003,” consistent with the date of the earliest application identified by the ’279 patent.9 See Pet. 6. For purposes of our analysis on the current record, in this Decision we apply September 2, 2003, as the priority date of the Challenged Claims.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“independent claim 1. Pet. 32–63. Petitioner relies on the testimony of Mr. Crevelt in support of its contentions with respect to claim 1. Ex. 1003 ¶¶ 234–286. Further, according to Petitioner, “[n]o findings regarding motivation to combine or reasonable expectation of success are necessary with a single reference ground,” but Walker “teaches that the features of the embodiments are options that can be combined.” Pet. 42 n.6 (citing Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1372–73 (Fed. Cir. 2019). At this stage, Patent Owner does not contest Petitioner’s proffered assertions about the” slip op. at 20
§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,393,279 - PTAB · Oct 16, 2025 · IPR2025-00708 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 1, 3–5, 12, 13, 18–20, 22, 24–26, 29, 42, 44–47, and 50 are unpatentable over Walker and Schneier.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2025). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . 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). Upon institution of inter partes review, the review proceeds “on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). Based on our consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review as to the Challenged Claims of the ’336 patent on all grounds asserted in the Petition.” slip op. at 2
- Skill levelSkill level board ownOther
“B. Level of Ordinary Skill in the Art At this stage of the proceeding, there is no evidentiary dispute about the level of ordinary skill in the art.8 Based on the testimony of Mr. Crevelt, we determine that a person of ordinary skill in the art would have had at least a bachelor’s degree in computer science or computer engineering, with at least three years of experience in game development. Pet. 14 (citing Ex. 1003 ¶¶ 62–65). Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Id. We determine that the level of ordinary skill in the art 7 Petitioner states that it is not aware of secondary considerations that affect the obviousness arguments it presents. Pet. 66. Patent Owner has not offered objective evidence of nonobviousness at this stage of the proceeding. 8 Patent Owner “disagrees with the proposed level of skill” but asserts that “under any level of skill a [person of ordinary skill in the art] would not understand the asserted Grounds to raise any unpatentability issues.” Prelim. Resp. 8. Thus, Patent Owner does not present evidence or arguments in its Preliminary Response related to the level of ordinary skill in the art. competence reflected in the ’336 patent Specification and the asserted prior art references, based on our review of the limited record.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“standard as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.100(b). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; see also Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012). “The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (alteration in original) (quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner argues that it is not necessary for us to provide an express construction for any claim term because the Petition “establishes the prior art meets each claim limitation under any reasonable construction.” Pet. 14–15. Patent Owner similarly submits that we “need not construe any terms at this stage, because under any reasonable construction of the claim terms, the prior art fails to disclose or suggest the claimed features.” Prelim. Resp. 8. At this stage of the proceeding, we do not need to expressly construe any claim terms to determine whether Petitioner showed a reasonable likelihood of prevailing as to its challenge of at least one challenged claim.” slip op. at 12
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedOther
“an application filed September 20, 2010, that asserts the benefit of an application filed September 2, 2003. Ex. 1001, codes (22), (45), (54), (62). Petitioner asserts that the Challenged Claims of the ’336 patent “are entitled to an effective filing date of no earlier than September 2, 2003,” consistent with the date of the earliest application identified by the ’336 patent.9 See Pet. 7. For purposes of our analysis on the current record, in this Decision we apply September 2, 2003, as the priority date of the Challenged Claims. Walker was filed on May 1, 2003, and refers back to a provisional application filed on May 6, 2002, but Walker was not published until January 1, 2004. Ex. 1006, codes (22), (43), (60). Thus, Petitioner fails to show on the current record how, under pre–AIA 35 U.S.C. § 102(a), Walker discloses an invention that was described in a printed publication in this country before the invention thereof by the Patent Owner, because Walker was published after the applied priority date of the Challenged Claims of the’336 patent.” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,529,336 - PTAB · Oct 8, 2025 · IPR2025-00629 · APJ Scott C Moore · IPR · Institution
The Board instituted IPR of claims 1–20 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Beard and Laufer.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We may institute an inter partes review when “the information presented in the petition . . . 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). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of one or more claims of the ’711 Patent. We, therefore, institute inter partes review of claims 1–20 on the grounds identified in the Petition. B.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that one of ordinary skill in the art would have had the following qualifications: [E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace or avionics fields, or (2) at least four years of experience in any of the above industries. 1 The Leahy-Smith America Invents Act (“AIA”) included revisions to 35 U.S.C. §§ 102 and 103 that became effective on March 16, 2013. Because the applications from which the ’711 Patent claims priority were all filed after this date, the post-AIA version of §103 applies. See Ex. 1001, codes (60), (63). 2 U.S. Patent No. 9,769,387 B1, iss. Sept. 19, 2017 (Ex. 1009). 3 U.S. Patent App. Pub. No. 2017/0059692 A1, pub. Mar. 2, 2017 (Ex. 1010). 4 U.S. Patent App. Pub. No. 2012/0106800 A1, pub. May 3, 2012 (Ex. 1021). 5 U.S. Patent App. Pub. No. 2017/0161911 A1, pub. June 8, 2017 (Ex. 1007). 6 U.S. Patent App. Pub. No. 2013/0301905 A1, pub. Nov. 14, 2013 (Ex. 1024). 7 U.S. Patent App. Pub. No. 2012/0004844 A1, pub. Jan. 5, 2012 (Ex. 1025). 8 PCT App. Pub. No. WO 2017/123477 A1, pub. July 20, 2017 (Ex. 1022). 9 U.S. Patent App. Pub. No. 2017/0160751 A1, pub. June 8, 2017 (Ex. 1005). Pet. 8 (citing Ex. 1003 ¶¶ 50–54). Patent Owner does not presently dispute Petitioner’s proposed formulation. See generally Prelim. Resp. For purposes of this Decision, we adopt and apply Petitioner’s formulation regarding the level of ordinary skill in the art because it is (1) consistent with the ’711 Patent and the asserted prior art; and (2) it is supported by the testimony of Dr. Singhose. B.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“But the Detecting Limitations of claims 1, 19, and 20, merely require that a target be “detected.” The Detecting Limitations do not require that target detection be performed “aboard the reference UAV,” and claim 19 does not recite or require “machine learning.” Moreover, the Specification makes clear that the claims should not be limited to aspects of the disclosed embodiments, as Patent Owner proposes to do here. See, e.g., Ex. 1001, 2:56–59 (“The invention is described in connection with such embodiments, but the invention is not limited to any embodiment. The scope of the invention is limited only by the claims . . . .”) Patent Owner additionally fails to cite any lexicographic definition or clear and unambiguous disclaimer of claim scope sufficient to limit the claims in the manner it proposes. We, thus, are not persuaded that the Detecting Limitations require “applying aboard the reference UAV a machine learning model to the capture image for: (i) identifying a target in the captured image.”” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Priority Date of the Challenged Claims Petitioner contends that claims 1–20 of the ’711 Patent “should not have priority to the October 9, 2016 filing date of U.S. provisional [patent] application 62/405,972 due to a lack of written description support.” Pet. 3. Petitioner thus “assumes” a priority date of October 1, 2017 (the filing date of U.S. Provisional Patent Application No. 62/556,449) for purposes of this proceeding. Id. at n.2; see also Ex. 1003, code (60). Patent Owner does not presently dispute Petitioner’s contention that the ’711 Patent is not entitled to a priority date earlier than October 1, 2017. See generally Prelim. Resp. For purposes of this decision, we accept Petitioner’s undisputed contention that the ’711 Patent is not entitled to a priority date prior to 10 Any determination, no matter how designated in this Institution Decision (except our ultimate decision to institute), is preliminary and non-binding. Our Final Written Decision, based on a fully developed record of arguments and evidence, will state our binding determinations, findings, and conclusions. If a party disagrees with this preliminary construction, or any other determination set forth in this Institution Decision, that party should present its arguments at trial. The parties are reminded that any arguments not made during trial will be considered waived. Patent Owner is further reminded that arguments in the Preliminary Response are not preserved and will be considered waived at trial unless those arguments are re-raised in the Patent Owner Response. The parties are additionally reminded that arguments raised in subsequent briefing must be set forth in full in the briefs themselves, and may not be incorporated by reference from prior filings such as the Preliminary Response. See 37 C.F.R. § 42.6(a)(3). October 1, 2017.11 Accordingly, Petitioner has made a sufficient showing that all of the cited references qualify as prior art. See Pet. 4–6. D.” slip op. at 11
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,514,711 - PTAB · Oct 8, 2025 · IPR2025-00525 · APJ Scott C Moore · IPR · Institution
The Board instituted review of claim 21 on all asserted grounds after finding a reasonable likelihood it is obvious over Beard.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the petition . . . 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). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of claim 21, the sole challenged claim. We, therefore, institute inter partes review of claim 21 on the grounds asserted in the Petition. B.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“[E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace, avionics, telecommunications, or electronic device manufacturing industry, or (2) at least four years of industry experience in any of the above industries. Pet. 21 (citing Ex. 1003 ¶ 47). Patent Owner does not presently dispute Petitioner’s proposed formulation. See generally Prelim. Resp. For 3 U.S. Patent App. Pub. No. US 2016/0253907 A1, published Sept. 1, 2016 (Ex. 1010). 4 PCT Pub. No. WO 2016/078093 A1, published May 26, 2016 (Ex. 1011). 5 PCT Pub. No. WO 2016/154949 A1, published Oct. 6, 2016 (Ex. 1012). 6 U.S. Pat. App. Pub. No. US 2016/0127890 A1, published May 5, 2016 (Ex. 1013). 7 PCT Pub. No. WO 2015/043123 A1, published Apr. 2, 2015 (Ex. 1014). purposes of this Decision, we adopt and apply Petitioner’s formulation regarding the level of ordinary skill in the art because it is (1) consistent with the ’959 Patent and the asserted prior art; and (2) it is supported by the testimony of Dr. Chowdhary. B.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“But before describing the embodiments cited by Patent Owner, the Specification plainly states: “Any terms not expressly defined herein have their conventional meaning as commonly understood by those having skill in the relevant art(s).” Ex. 1001, 4:64–67. Thus, the Specification itself cautions against construing the claim terms such as “secure identifier” as limited to the scope of the disclosed embodiments. Here, Patent Owner has not cited any express definition of “secure identifier,” or identified any explicit disclaimer of claim scope that might justify narrowing the scope of this claim term to specific embodiments disclosed in the Specification. In the absence of such a definition or disclaimer, we are not persuaded that the scope of the claim term “secure identifier” should be limited to specific aspects of the preferred embodiments cited by Patent Owner. See Prelim. Resp. 7–14. On this record, and at this stage of the proceeding, we decline to adopt Patent Owner’s proposed construction and preliminarily construe “secure identifier” as “a credential that can be used to securely verify the identity of a device, such as an airborne object or ground-based transmitter.”8” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“’071 Application lack adequate written description support for the “secure identifier” claim limitation. For a patent claim to be entitled to the priority date of an earlier-filed application, the earlier application must provide complete written description support for the claim as required by 35 U.S.C. § 112(a). L.A. Biomedical Rsch. Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“L.A. Biomed”). To satisfy this requirement, the written description must “reasonably convey” to a person of ordinary skill in the art that the inventor had possession on the claimed priority date of each limitation of the later-claimed subject matter. L.A. Biomed, 849 F.3d at 1057. It is not enough that an earlier application’s disclosure “renders the later-claimed invention obvious;” as “the disclosure must describe the claimed invention with all its limitations.” L.A. Biomed, 849 F.3d at 1057. On this record, we agree with Petitioner that the ’153 Provisional and ’071 Application lack adequate written description support for the “secure identifier” limitation of claim 21. We have preliminarily construed “secure identifier” as “a credential that can be used to securely verify the identity of a device, such as an airborne object or ground-based transmitter.” See supra § II.B. As discussed above, the Specification of the ’959 Patent does not use the term “secure identifier,” but the Specification contains extensive discussion of the need for an identification credential that is secure (e.g., difficult for a bad actor to clone or impersonate). See, e.g., Ex. 1001, 1:56– 65 (discussing the need for a system that is difficult to “clone”), 10:20–49 (discussing the need “trust” between a drone and ground-based equipment, and the need for a way to verifying the drone’s credentials), 11:5–12:62 (disclosing the use of encryption and a rotating SSID to generate a secure identifier for a drone). None of the portions of the Specification cited above is present in the ’153 Provisional or the ’071 Application. See generally Ex. 1006, 1007. The ’153 Provisional and ’071 Application discuss the need for identifiers for low-altitude aircraft (see, e.g., Ex. 1006, 2; Ex. 1007, 9), but there is no discussion of any need for an identification credential to be secure or resistant to cloning or impersonation. See generally Ex. 1006, 1007. The ’153 Provisional and ’071 Application do not disclose the use of encryption, SSIDs (much less rotating SSIDs), or any other technologies for the purpose of verifying the authenticity of an identification credential. See generally id. Based on our review of the ’153 Provisional and ’071 Application, we preliminarily conclude that neither of these applications would have reasonably conveyed to a person of ordinary skill in the art that the inventor then had possession of the concept of the “secure identifier” that was later claimed in the ’959 Patent.” slip op. at 12
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · GrahamPatents in suitUS 10,713,959 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 23, 2025 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–28 are unpatentable: claims 1, 2, 4–7, 9–12, 14–17, and 19–28 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 9
- Skill levelSkill level board ownOther
“In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Inst. Dec. 7. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such cancers and the associated conditions and immunotherapy.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“holding is limited to anticipation of a claimed genus through disclosure of individual species, whereas the facts of this case involve the disclosure of a genus. PO Resp. 14. Because the facts before us, including the testimony of Patent Owner’s witness, indicate that one of ordinary skill in the art would have immediately understood that the third arm of the study described in the MSR includes patients with cancers recited in claim 1, including endometrial, gastric, and small-bowel cancers, we are persuaded that one of ordinary skill in the art would have understood that the MSR discloses species that fall within the scope of claim 1. Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 63; Ex. 1005, 4. We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1.6” slip op. at 29
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Regarding the dependent claims that Petitioner challenges only on obviousness grounds (claims 3, 8, 13, 18), Patent Owner must show a nexus between the claimed methods and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner does not direct us to evidence of a nexus to limitations recited in the dependent claims, for example to claims 3 and 13, which recite testing a biological sample that is a bodily fluid, claims 8 and 18, which recite testing that comprises assessing one or more markers selected from the group consisting of BAT-25, BAT-26, MONO-27, NR-21 and NR-24. Even if there is a nexus to the Patent Owner’s evidence of secondary considerations, the evidence addresses the methods of independent claims 1 and 11, not the limitations of the claims Petitioner challenges as being obvious. PO Resp. 55–83. Patent Owner directs us only to evidence regarding treating patients determined to have certain MSI-H cancers with pembrolizumab, which we determine to be anticipated by the MSR. Id. at 58. When evidence of a “secondary consideration is exclusively related to a single feature that is in the prior art,” our reviewing court has held the evidence is of no relevance to the obviousness inquiry. See Yita LLC v. MacNeil IP LLC, 69 F.4th 1356, 1363–65 (Fed. Cir. 2023), cert. denied, 144 S. Ct. 499 (2023) (distinguishing WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330–31 (Fed. Cir. 2016)); see also Ethicon Endo-Surgery, Inc. v. Covidien LP, 812 F.3d 1023, 1034 (Fed. Cir. 2016) (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”). In Yita, the prior art taught close-conformance of a floor tray with the walls of a vehicle foot well, which one of ordinary skill in the art would have had reason to use in combination with other prior-art teachings to arrive at the claimed invention. See Yita, 69 F.4th at 1359–61. The court held that because the asserted evidence of secondary consideration related exclusively to close-conformity, the evidence was not persuasive of non-obviousness, even though the claimed floor tray was coextensive with the product that produced the evidence. See id. at 1364–65 (“The coextensiveness inquiry bears only on the presumption of nexus; it does not decide the overall nexus question.”). Because Patent Owner directs us only to evidence that the methods recited in claims 1 and 11 produced evidence of secondary considerations, we are not persuaded that this evidence is persuasive of the non-obviousness of the specific methods recited in the dependent claims. For example, Patent Owner fails to direct us to evidence that a method of treating MSI-H colorectal cancer in a patient “wherein the biological sample is a body fluid from the patient,” as recited in claim 3, or “wherein the at least one marker comprises BAT-25, BAT-26, MONO-27, NR-21 or NR-24,” as recited in claim 8, demonstrated unexpected results or commercial success. Accordingly, having considered the evidence of record as a whole, we determine that Petitioner has demonstrated by a preponderance of the evidence that the methods of claims 3, 8, 13, and 18 would have been obvious. We are not persuaded to the contrary by Patent Owner’s arguments or evidence of second secondary considerations.” slip op. at 47
Patent outcomesUS 11,629,187 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,629,187 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 23, 2025 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–36 are unpatentable: claims 1–2, 4–8, 11–12, 14–18, and 21–36 as anticipated, and claims 3, 9, 10, 13, 19, and 20 as obvious.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The ’287 patent claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. See Ex. 1001, 24:42–52; Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Dec. 7– 8. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such cancers and the associated conditions and immunotherapy.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). We credit Dr. Neugut’s and Dr. Oberstein’s testimony about what one of ordinary skill in the art would have understood after reviewing the MSR. slip op. at 34
Patent outcomesUS 11,649,287 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,649,287 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 19, 2025 · IPR2024-00650 · APJ Deborah Katz · IPR · Final written decision
Claims 1–38 are unpatentable: claims 1, 2, 4–7, 11–17, 19–22, and 26–38 are anticipated by the MSR; the remaining claims are obvious over the MSR and cited references.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would be a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. (See Pet. 11 (citing Ex. 1003 ¶ 19).) To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. (See PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 91–99).) Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’491 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:36–52, 26:24–41, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’491 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. C. Claim Construction” slip op. at 8
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Dr. Lonberg, Patent Owner’s witness, does not dispute any of Dr. Neugut’s or Dr. Oberstein’s testimony, but asserts only that Dr. Neugut’s testimony relies only on what was generally done, not on what is expressly disclosed in the MSR. (See Ex. 2072 ¶¶ 105–107.) On cross-examination, Dr. Lonberg agreed with Dr. Oberstein that patients who had received prior cancer therapy were not excluded from the study described in the MSR. (See Ex. 1245, 57:5–58:2, 40:5–14, 49:2–12.) Thus, after considering the evidence cited by each party, we find Dr. Neugut’s and Dr. Oberstein’s testimony to be the most directly relevant and persuasive about what one of ordinary skill in the art would have understood from the MSR itself. We are also persuaded by the lack of a specific contradiction regarding the understanding of one of ordinarily skill in the art by Dr. Lonberg. Even if some patients who had been previously treated with specific drugs were excluded from the study described in the MSR, we are persuaded that one of ordinary skill in the art would have understood the MSR as including other patients who have been treated with a prior cancer therapy drug. We are persuaded that Petitioner has met its burden of proving whether a skilled artisan would reasonably understand or infer that the limitations of claims 13, 28, 32, and 36 were disclosed in the MSR. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSR, not what it inherently discloses. (Contra PO Resp. 19–22.)” slip op. at 38
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Patent Owner argues that the “in response to” limitation of claim 1 describes administering the claimed treatment only to patients determined to have an MSI-H tumor. (See PO Resp. 6.) But neither claim 1 nor claim 16 includes a limitation excluding the treatment of any patient, such as specifically excluding treatment of any patient who has a tumor that is not MSI-H or dMMR. Neither claim 1 nor claim 16 recites any language differentiating between patients or identifying a patient population to be excluded from treatment. Instead, claims 1 and 16 provide that if the colorectal cancer patient is tested and the cancer is determined to be MSI-H or dMMR, the patient is treated with a therapeutically effective amount of pembrolizumab. We note that the methods of claims 1 and 16 use the open-ended transitional phrase “comprising” that is generally interpreted to not exclude additional, unrecited elements. See Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language that means that the named elements are essential, but that other elements may be added and still form a construct within the scope of the claim.”). The use of the open-ended transitional phrase “comprising” in claims 1 and 16 further suggests to us that any additional steps taken in conjunction with expressly recited method steps, such as the treatment of patients who are not MSI-H or dMMR, are not excluded from the scope of the claim.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“discloses species that fall within the scope of claim 1. (See Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 67; Ex. 1005, 4.) We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1. d) Element [1.3]: “thereby determining that the patient’s cancer is” slip op. at 26
Patent outcomesUS 11,634,491 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 18, 2025 · IPR2024-00625 · APJ Deborah Katz · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–4 and 6–8 are anticipated by MSR, and claim 5 is obvious over MSR with the additional marker-testing teachings of Chapelle.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). Although Patent Owner argues that a missing element cannot be filled by what an ordinarily skilled artisan would have envisioned, Petitioner’s argument is based on what one of ordinary skill in the art would have understood from what the MSR expressly teaches. (See Pet. 20 (“Indeed, prior art concerning the MSI-H Study indicates that the physicians understood postings on clinicaltrials.gov indicated that patients had ‘metastatic tumors.’ (EX1049, 444; see also EX1050, S4; EX1003, ¶62.)”).) Unlike the facts of Nidec, where a missing signal could have been envisioned but was not present, we are persuaded by the evidence Petitioner presents that those of ordinary skill in the art understood the MSR express disclosure to include patients with unresectable or metastatic tumors because references referring to the study underlying the MSR discuss the inclusion of patients with metastatic tumors in the study. Even if Dr. Neugut’s reasoning that the reference to “measurable” disease in the MSR would have indicated patients having metastatic cancer is flawed, we are persuaded by Petitioner’s evidence of publications referring to the MSR as a study of metastatic colorectal cancer, and we are further persuaded that one of ordinary skill in the art would have understood the MSR to disclose treating patients having metastatic colorectal cancer with pembrolizumab. (See Ex. 1049, 444, Ex. 1050, S4.) Patent Owner does not address this evidence. Instead, Patent Owner acknowledges that “the MSR discloses treating cancer patients that could be within the claimed subset,” but argues that the MSR does not inherently anticipate results later obtained by treating only patients within the claimed subset. (See Pet. Sur- Reply 5–6.) We are persuaded, though, that Petitioner’s challenge is based on what one of ordinary skill in the art would have understood from the MSR (that patients who had an unresectable or metastatic tumor were selected), not on what is inherent to the disclosure of the MSR. We are persuaded that one of ordinary skill in the art at the time would have understood the MSR to teach selecting a patient “who has an unresectable or metastatic,” as required in claim 1. c) Element 1.2: “microsatellite instability-high (MSI-H) or mismatch slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Patent Owner argues further that the MSR discloses an experimental use that does not qualify as prior art. (See PO Resp. 16–23.) Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. (See id. at 16 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998).) According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). (See PO Resp. 17–23.) For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. (See PO Resp. 18–20.) Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. (See id. at 19–20.) Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” (Id. at 21.) In City of Elizabeth, the Supreme Court was concerned that “[i]t is sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024). After considering the parties’ arguments and evidence, we are” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“In order to show that objective evidence renders the method of claim 5 non-obvious, Patent Owner must show a nexus between the subject matter recited in claim 5 and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner argues that there is a nexus between the development and commercialization of pembrolizumab and the patented method of treatment recited in the challenged claims, citing, inter alia, the package insert for Keytruda® (pembrolizumab), but Patent Owner does not direct us to evidence of a nexus to MSI-H or MMR deficient tumors that exhibit instability in the microsatellite markers recited in claim 5 and the unexpected results, commercial success, or other objective measures of non-obviousness flowing from these additional limitations. (See PO Resp. 50–63 (citing Ex. 2129, Ex. 2072 ¶ 190, Ex. 2090 ¶¶ 82–92).) Patent Owner directs us only to evidence regarding determining MSI-H status and then using Keytruda® to treat MSI-H cancer patients, which we determine to be anticipated by the MSR. (See PO Resp. 60.) When evidence of a “secondary consideration [] is exclusively related” slip op. at 34
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“(Ex. 1001, 26:19–28.) In Grounds 3 and 5, Petitioner argues, relying on Dr. Neugut’s testimony, that Chapelle teaches standard methods of testing whether a tumor is MSI-H, including determining whether the patient’s tumor exhibits instability in a microsatellite marker, such as BAT-25 or BAT-26. (See Pet. 42 (citing Ex. 1007, 3380, 3383; Ex. 1003 ¶ 107).) For example, Chapelle states that “‘a standard test’ using a ‘[p]anel consisting of … BAT26, BAT25’ has ‘stood the test of time.’” (Ex. 1007 at 3382.) Dr. Neugut testifies that one of ordinary skill in the art would have been motivated to treat a patient with an unresectable or metastatic MSI-H dMMR tumor, wherein the tumor exhibits instability in the BAT-25 and BAT-26 microsatellite marker, and would have expected success in doing so, in light of the teachings of Chapelle. (See Ex. 1003 ¶¶ 105–108.) We find that the record as recounted above supports Petitioner’s challenges of claim 5 in Grounds 3 and 5.” slip op. at 31
Patent outcomesUS 11,339,219 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,339,219
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.