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  • PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

    Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.

    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 10

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner

      “Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24

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

      “the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30

    Patent outcomesUS 11,643,462 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,643,462
  • PTAB · Nov 5, 2025 · IPR2024-00133 · APJ Scott B Howard · IPR · Final written decision

    Claims 1–10 are unpatentable as obvious over Sturman and Ho; the Board found the Ho/Jiau/Choi grounds, with and without Ellis, insufficient.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “We see very little difference between the parties’ respective proposals. We adopt Patent Owner’s marginally more specific proposal as it better reflects the ’089 patent. Additionally, because we would reach the same conclusions under Petitioner’s proposal, we agree with Patent Owner that this does not affect our analysis.” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

      “Consistent with Phillips, we begin with the “ordinary and customary meaning” of the words of the claims. Phillips, 415. F.3d at 1312–13 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). The parties agree that the ordinary and customary meaning of the phrase “background object” is consistent with the dictionary definition and means an object that is “not in the foreground.” Tr. 8:10–16; PO Resp. 8–9; Ex. 2008 (AMERICAN HERITAGE DICTIONARY 2006); see also Ex. 2009 (“the scenery or ground behind something,” “the part of a painting representing what lies behind objects in the foreground”) (MERRIAM- WEBSTER DICTIONARY 2007); Ex. 2010 (“the part of a picture or pattern that is behind the main people or things in it” (MACMILLIAN ENGLISH DICTIONARY 2007); Ex. 2011 (“the ground or parts, as of a scene, situated in the rear (opposed to foreground)”) (RANDOM HOUSE WEBSTER’S COLLEGE DICTIONARY 2005). Having determined the ordinary and customary meaning, we need only look to see if there is some reason—such as the applicant acting as a lexicographer or the ordinary and customary meaning being improperly subjective—why the ordinary and customary meaning is not controlling.” slip op. at 15

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

      “We do not find that the prosecution history demonstrates that the applicant acted as a lexicographer by “clearly set forth a definition of the disputed claim term,” or “clearly express[ing] an intent to define the term” as required by Thorner, 669 F.3d at 1365. Instead, the language in the prosecution history is consistent with the ordinary and customary meaning. That is, the applicant focuses on the location of the object relative to the area of game play, i.e., the foreground. For example, the applicant distinguishes Chu’s object as not being “background objects” because they “are featured in the forefront of [the] game play as primary objects to be manipulated or used during game play (see Chu at ¶¶ [0063]–[0065]).” Ex. 1002, 85 (emphasis added).12 The applicant continued by arguing that Chu’s objects “exist in the background, outside of the primary focus of game play and as unexpectedly interactive components, and are not themselves needed or required in order to play the game.” Id. If anything, this demonstrates an intent of the applicant to use the customary and ordinary meaning—not in the foreground—and not act as a lexicographer.” slip op. at 17

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “We do not agree with Patent Owner’s argument. Under our rules, “[e]xpert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). We have reviewed Dr. Zagal’s testimony on this subject (see Ex. 1003 ¶¶ 156–160, 163, 166, 172, 177–178) and find that it complies with our requirements. Specifically, Dr. Zagal provides his opinion and identifies specific evidence in the record that supports it. We do not find MarkForged, a nonprecedential decision, persuasive. Although MarkForged cites 37 C.F.R. § 42.65(a) as support for the proposition that expert testimony “is entitled to little to no weight [if] it merely parrots the Petition,” the rule is silent on that point. Patent Owner has not directed us to any rule or precedential decision that says that non- 17 The decision was affirmed by the Director. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 12 (PTAB Aug. 24, 2022). conclusory testimony which cites underlying factual support, such as Dr. Zagal gives in this proceeding, is entitled to no weight.” slip op. at 49

    Patent outcomesUS 8,688,089 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,688,089
  • PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “Pet. 12 (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. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8

    • 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. 11–12; 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” slip op. at 7

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

      “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 ’975 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 inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (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 Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. 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. Id. at 20–22. 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. Id. at 21. 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 23. 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).” slip op. at 24

    Patent outcomesUS 11,325,975 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,325,975
  • PTAB · 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 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,934,356
  • PTAB · Oct 14, 2025 · IPR2024-00422 · APJ Scott B Howard · IPR · Final written decision

    The Board held claims 1–152 unpatentable based on the asserted obviousness grounds and struck Section II of Petitioner’s reply claim-construction brief.

    RulingsFinal written decision
    • BurdenFwd all claims unpatentableUnpatentable

      “Decision issues pursuant to 35 U.S.C. § 318(a). For the reasons that follow, we determine that Petitioner has shown by a preponderance of the evidence that the challenged claims are unpatentable.” slip op. at 2

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

      “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

    • Strike new argumentGranted

      “FURTHER ORDERED that Section II of Petitioner’s Reply Claim Construction Brief is stricken from the record; and” slip op. at 80

    Patent outcomesUS 7,861,260 unpatentable
    Claim constructioncites Phillips · KSR · Graham
    Patents in suitUS 7,861,260
  • PTAB · Oct 14, 2025 · IPR2025-00128 · APJ Scott B Howard · IPR · Final written decision

    The Board held claims 1–152 unpatentable based on obviousness grounds and struck Section II of Petitioner’s Reply Claim Construction Brief.

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

      “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

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

      “d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a preponderance of the evidence that the subject matter of claim 1 would have been obvious over Baig, Costa, and Zwicky. 5. Analysis of Claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137– 145, 147, 148, 151, and 152 Petitioner argues that the combination of Baig, Costa, and Zwicky teaches the limitations recited in claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137–145, 147, 148, 151, and 152 and that a person having ordinary skill in the art would have combined the teachings with a reasonable expectation of success. Pet. 28–60; 422Pet. 29–51. Petitioner’s arguments are supported by citations to the prior art and the testimony of Mr. Lett. See Pet. 28–60; 422Pet. 29–51. We have reviewed Petitioner’s arguments and evidence, agree with them, and, therefore, adopt Petitioner’s arguments and evidence as our own. Patent Owner does not separately address those claims. See PO Resp.; 422PO Resp. Instead, Patent Owner only relies on the arguments discussed above for claim 1. See PO Resp. 13–16; 422PO Resp. 13–16. For the same reason as discussed above in Section II.D.4(b), we do not agree with Patent Owner’s arguments regarding the reason to combine the references. Accordingly, Petitioner has shown by a preponderance of the evidence” slip op. at 50

    • Strike new argumentNew argument disregardedGranted

      “F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74

    Patent outcomesUS 7,861,260 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,861,260
  • PTAB · Oct 14, 2025 · IPR2024-00421 · APJ Scott B Howard · IPR · Final written decision

    The Board held claims 1–152 unpatentable over the asserted prior art and struck Section II of Petitioner’s reply claim construction brief.

    RulingsFinal written decision
    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a” slip op. at 50

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

      “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

    • Strike new argumentGranted

      “F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74

    Patent outcomesUS 7,861,260 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,861,260
  • PTAB · Oct 1, 2025 · IPR2024-00943 · APJ Scott B Howard · IPR · Final written decision

    Claims 2–23, 26, 41–60, 63, 64, 91–152, and 155–171 are unpatentable; Rao anticipates some claims, and the stated Rao combinations render the remaining claims obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that a person having ordinary skill in the art “would have at least a bachelor’s degree in computer science, computer engineering, or a similar field, and approximately two years of industry or academic experience in a field related to computer software development and/or computer networking.” Pet. 2 (citing Ex. 1015 ¶¶ 50–52). Petitioner further argues that “[w]ork experience can substitute for education, and additional education can substitute for work experience.” Id. at 2–3 (citing Ex. 1015 ¶¶ 50–52). Because Petitioner’s proposed level of ordinary skill in the art is consistent with the field of the invention of the ’541 patent and not disputed by Patent Owner (see PO Resp.), we adopt Petitioner’s formulation of the person having ordinary skill in the art.” slip op. at 12

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

      “Petitioner states “[n]o terms require construction to resolve this Petition.” Pet. 3. Patent Owner does not propose any claim constructions. See PO Resp. For the purposes of this Decision, we need not expressly construe any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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))).” slip op. at 13

    • Expert testimonyPetitioner expert creditedDecided for petitioner
    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

      “preponderance of the evidence that claim 3 was anticipated by Rao.” slip op. at 25

    Patent outcomesUS 8,589,541 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,589,541
  • PTAB · Oct 1, 2025 · IPR2024-00942 · APJ Scott B Howard · IPR · Final written decision

    Claims 2–23, 26, 41–60, 63, 64, 91–152, and 155–171 are unpatentable; Rao anticipates some claims, and Rao-based combinations render the others obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that a person having ordinary skill in the art “would have at least a bachelor’s degree in computer science, computer engineering, or a similar field, and approximately two years of industry or academic experience in a field related to computer software development and/or computer networking.” Pet. 2 (citing Ex. 1015 ¶¶ 50–52). Petitioner further argues that “[w]ork experience can substitute for education, and additional education can substitute for work experience.” Id. at 2–3 (citing Ex. 1015 ¶¶ 50–52). Because Petitioner’s proposed level of ordinary skill in the art is consistent with the field of the invention of the ’541 patent and not disputed by Patent Owner (see PO Resp.), we adopt Petitioner’s formulation of the person having ordinary skill in the art.” slip op. at 12

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

      “Petitioner states “[n]o terms require construction to resolve this Petition.” Pet. 3. Patent Owner does not propose any claim constructions. See PO Resp. For the purposes of this Decision, we need not expressly construe any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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))).” slip op. at 13

    • Expert testimonyOther

      “157, and 171 are anticipated by Rao. Pet. 1, 19–39, 42. Petitioner’s arguments are supported by citations to the prior art and the testimony of Dr. Wolfe. See id. We have reviewed Petitioner’s arguments and evidence, agree with them, and, therefore, adopt Petitioner’s arguments and evidence as our own.” slip op. at 26

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

      “anticipated by Rao. Pet. 1, 30–31, 33–42. We have reviewed Petitioner’s arguments for each of those dependent claims. See Pet. 30–31, 33–42. For each of those dependent claims, the Petition appears to only argue a theory of obvious. That is, the Petition never states that the additional limitation is disclosed by Rao. See id. For example, claim 26 depends from claim 1 and further recites “wherein the policy is based on a background service class.” Ex. 1001, 112:49–52. We reproduce Petitioner’s arguments directed to claim 26 below: Rao’s policies 520 may “define prioritization” for network packets “based on whether an application is running in the foreground or the background.” [Ex. 1002] ¶ 182; id. ¶¶ 38–43, 180, 182, 188–89, 193, Figs. 5A, 5B. Each packet “may be placed and arranged in a priority order respective to all other . . . packets to provide a packet by packet prioritization across all applications 338a-338n and . . . network packets.” Id. ¶ 191. It would have been obvious to determine and apply a policy assigning a specific priority to packets associated with background applications, supra [1e]-[1f], and Rao thus discloses or renders obvious assigning a priority to network communications based on whether they are characterized as background services (class of services associated with application(s) running in the background of client 105), EX-1015 ¶¶195-96; supra [1e], [1f]. Pet. 33–34. Although the Petition sets forth why the claim limitation would have been obvious, there is no discussion as to how the additional limitation of claim 26—policy based on background class—is disclosed in Rao. See id. Similar arguments are presented for the other claims. See Pet. 30–31, 35–42. Because the Petition does not sufficiently show how the additional limitations recited in claims 20, 26, 58, 64, 165, and 169 were disclosed by Rao, Petitioner has not shown by a preponderance of the evidence that claims 20, 26, 58, 64, 165, and 169 were anticipated by Rao.” slip op. at 28

    Patent outcomesUS 8,589,541 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,589,541
  • PTAB · 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 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,629,187
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