• Arashi Vision (U.S.) LLC (D/B/A Insta360) v. Gopro, IncNo claims unpatentable
  PTAB · Nov 25, 2025 · IPR2024-01165 · APJ William V Saindon · IPR · Final written decision

  Claims 1–21 were not shown unpatentable because Zhou does not teach the claimed low-light high-pass or stickiness parameter limitations.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “4. Conclusion for the Prior Art Analysis In sum, we find that Zhou does not disclose the low-light high-pass parameter or the stickiness parameter. Petitioner’s grounds for both independent claims 1 and 16 rely on Zhou for teaching a low-light high-pass parameter or a stickiness parameter. Pet. 23–28, 64. Because we find Zhou does not teach these limitations, all of Petitioner’s grounds fall for this reason. III. CONCLUSION For the reasons given above, we determine that Petitioner has not established by a preponderance of the evidence that any claim of the ’840 patent would have been obvious in view of the prior art cited.” slip op. at 18

  • Skill levelSkill level petitioner adoptedOther

    “A person of ordinary skill in the art (POSITA) in the field of the ’840 patent would have a bachelor’s degree in engineering or computer science, or equivalent field, and two years of experience working on image or video processing, or digital cameras. Alternatively, a POSITA would have four years of experience working on image or video processing, or digital cameras. An advanced graduate degree in the disciplines cited above may make up for the work experience indicated above. Pet. 6 (citing Ex. 1002 ¶ 32). Patent Owner applies the same standard. PO Resp. 26–27. We use this agreed-upon standard for purposes of this Decision.” slip op. at 7

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “We review this testimony based on the strength of the underlying factual basis. 37 C.F.R. § 42.65(a); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value . . ..”). Here, the underlying factual basis is not very strong for either witness. That said, we find that Dr. Foroosh’s testimony is more logically sound and consistent with the ’840 patent disclosure. Based on our reading of the specification, we find a clear indication that “stickiness” has to do with the past. In order to control “the extent by which preceding portion(s) . . . impacts determination of the smoothed trajectory” (emphasis added), one must control the degree by which the past frames impact determination. And to control the degree of the past’s influence, one must, as a consequence, favor the past over the future. That is, the frame of reference of the stickiness parameter is the past. The specification could have used a time-agnostic term, like a “nearness” or “adjacency” parameter, but it did not. Thus, the fact that “stickiness” is used in conjunction with “preceding” indicates that it deals with a preference for preceding frames. On this basis, we find Dr. Katsaggelos’s testimony less persuasive than Dr. Foroosh’s.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “That said, we do not construe a stickiness parameter as prohibiting consideration of future frames. Instead, we determine that the stickiness parameter’s value determines the impact of the preceding portions, versus the following portions. The ’840 patent recognizes this, when it says that a stickiness parameter value of “1,” representing a “lazy” stabilizer that maximally favors the past, would not override a violation of the margin constraint based on the look-ahead (i.e., would not allow the viewing window to fall out of bounds in the event of large future motion). See Ex. 1001, 22:26–30; see also id. at 12:61–13:29 (acknowledging that favoring the past may lead to a conflict with the viewing window determination), 15:39–60 (adjusting the viewing window to ensure it does not violate a margin constraint). Thus, while a past-favoring parameter by necessity favors the past over the future, it does not prohibit consideration of the future. In view of the above, we construe the claimed “stickiness parameter” as a parameter that controls the extent by which preceding portions of the trajectory impacts determination of the smoothed trajectory, with an understanding that in order to favor preceding portions, to some extent, the parameter must relatively disfavor following portions.” slip op. at 10

  Patent outcomesUS 10,958,840 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,958,840
• Arashi Vision (U.S.) LLC (D/B/A Insta360) v. Gopro, IncNo claims unpatentable
  PTAB · Nov 25, 2025 · IPR2024-01164 · APJ William V Saindon · IPR · Final written decision

  Claims 1–21 were not shown unpatentable because Shi does not disclose the claimed low-light high-pass parameter required by the asserted obviousness grounds.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “Given the teachings of the specification, we agree with Patent Owner that a low-light high-pass parameter is a parameter of a smoothing function that favors high frequencies (high pass) when exposure times are long (low light). See Tr. 42:10–18 (Patent Owner’s counsel stating that “high-pass” means “there’s a bias or preference for high frequencies”); Ex. 2020, 93:23– 94:15 (Petitioner’s declarant, Dr. Katsaggelos, agreeing that a high-pass system attenuates the low frequency of a signal). Although we acknowledge Petitioner’s position that the specification provides other ways or considerations in implementing a smoothing function, based on our above analysis of the specification, we find that the specification describes the lowlight high-pass parameter as a specific component of a smoothing function. See, e.g., Ex. 1001, 21:17–25 (setting out several parameters besides the low-light high-pass parameter used in trajectory smoothing).” slip op. at 10

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “position and a real device position. Id. at 18:27–40. In other words, the blur is addressed by analyzing the image to identify motion and then shifting the image. Shi, however, does not disclose how its parameter is based on low light (or the long exposure times indicative of low light). In its Petition, Petitioner asserts that a person of ordinary skill in the art would understand that “blurs can be caused by low light conditions.” Pet. 28 (citing Ex. 1003 ¶ 111). Although this is true, that does not mean that Shi’s blurs are identified by a parameter that considers low light. As we just described, Shi identifies the blur by quantifying the amount of motion of the points in an image, not by identifying low light. This is simply a different way to determine the presence of motion blur. In Shi, blur is measured, whereas in the ’840 patent, it is inferred based on low-light conditions (e.g., by observing the exposure time). See, e.g., Ex. 1007, 18:7– 26; Ex. 1001, 19:12–26. In its Reply, Petitioner does not point to any further disclosures. Accordingly, we find that Shi does not disclose the “low-light” aspect of the claimed low-light high-pass parameter. This is sufficient to determine that Petitioner’s ground does not meet all claim limitations. Similarly, we find that Shi does not disclose the “high-pass” aspect of the parameter. Shi’s blur compensation uses a spherical interpolation to modify the image. Ex. 1007, 18:27–40. The low-light high-pass parameter, as we have construed the term, allows more high frequencies. To allow more high frequencies, this necessarily means either allowing fewer low frequencies, or allowing more high frequences as opposed to some counterfactual situation in which fewer high frequencies were going to be allowed. See Ex. 2020, 94:23–95:15; Ex. 2022. We are directed to no persuasive evidence from Petitioner that Shi’s spherical interpolation favors high frequencies over low frequencies. Accord Ex. 2018 ¶ 107 (Patent Owner’s expert stating that Shi’s spherical interpolation “reintroduce[es] both high- and low-frequency motion”). Even if Shi allows the viewing window to track the camera position “consistent with the natural blur in the image” (Ex. 1007, 17:63–67), we are not provided with sufficient evidence to conclude by a preponderance of the evidence that providing a similar visual goal as a high-pass parameter (Ex. 1001, 22:16–18, “the output motion may include high frequencies that mask motion blur”) is the same as having a high-pass parameter. Again, merely preserving high frequencies is not the same as having a “high-pass parameter” because, as construed, a “high-pass parameter” also involves some degree of attenuation of low frequencies or relative increase of high frequencies. Accordingly, we find that Shi does not disclose the “high-pass” aspect of the claimed low-light high-pass parameter.” slip op. at 18

  Patent outcomesUS 10,958,840 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,958,840
• Google LLC v. Cellular South, Inc.Institution denied
  PTAB · Nov 21, 2025 · IPR2025-00877 · APJ William V Saindon · IPR · Institution

  The Board denied institution for claims 1–11 because the Zhao-Kouzani combination did not sufficiently show a fractal representation based on landmarks.

  RulingsInstitution decision

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

    “review under 35 U.S.C. § 314(b) and 37 C.F.R. § 42.4(a). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons provided below, we determine that Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’853 patent is unpatentable, and we do not institute an inter partes review. 37 C.F.R. § 42.108(a).” slip op. at 2

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

    “generally known in the art, and that this is acknowledged by the ’853 patent. Pet. 40–41 (citing, e.g., Ex. 1001, 15:40–44). Petitioner asserts that Kouzani touts the benefits of fractal models and that it would have been obvious to use Kouzani’s fractal model as the object model in Zhou. Pet 44 (asserting that “[a] person of ordinary skill would have therefore been motivated to implement Kouzani’s techniques in Zhao’s system”); see also id. 42–45. (entire argument). Patent Owner argues that Kouzani’s fractals would not result in the claimed limitation. Prelim. Resp. 21–23. In particular, Patent Owner points out that Kouzani’s fractals use a block-based fractal system, which do not include “a representation of the object based on landmarks associated with the object” as required by claim 1. Id. at 21–22. Patent Owner’s argument is persuasive. Even if Kouzani teaches fractals, claim 1 is not broadly claiming any fractal, but rather one that is “based on landmarks” (e.g., eyes, nose, etc.). See Ex. 1001, 13:53–57. The block-based system of Kouzani is based on abstract, repeated patterns of pixels, without regard to what the pixels represent. See, e.g., Ex. 1006, 8 (describing a “search . . . through the domain pool to find a domain block whose contractive transformation best approximates the range block” and then storing all of the transformations that, together, “represent the compressed image of a person’s face”), Fig. 4 (showing example blocks). This is in contrast to looking for particular landmarks in the image. Thus, we find that Petitioner has not sufficiently established that Kouzani’s fractal is based on landmarks. In Petitioner’s ground, Petitioner asserts that Zhao already teaches the claimed landmarks (Pet. 39, citing Ex. 1003 ¶¶ 58, 65), but Petitioner’s ground replaces or modifies the object model of Zhao with the fractals of Kouzani, which are not based on landmarks. Petitioner does not explain how Zhao’s modified model, now using a block-based fractal system, would still have the landmarks of Zhao’s original model. Even if it were obvious to include fractals, we are persuaded that the fractals included by Kouzani are not based on landmarks. Alternatively, if Petitioner is asserting merely to use fractals in Zhao’s models, then Petitioner has not sufficiently accounted for the particular fractals claimed and explained persuasively how merely using fractals in Zhao would lead to the claimed subject matter, i.e., fractals based on landmarks. In either event, Petitioner has not sufficiently established that the proposed combination satisfies the “fractal includes a representation of the object based on landmarks” limitation of claim 1.” slip op. at 11

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Patent Owner’s argument is persuasive. Even if Kouzani teaches fractals, claim 1 is not broadly claiming any fractal, but rather one that is “based on landmarks” (e.g., eyes, nose, etc.). See Ex. 1001, 13:53–57. The block-based system of Kouzani is based on abstract, repeated patterns of pixels, without regard to what the pixels represent. See, e.g., Ex. 1006, 8 (describing a “search . . . through the domain pool to find a domain block whose contractive transformation best approximates the range block” and then storing all of the transformations that, together, “represent the compressed image of a person’s face”), Fig. 4 (showing example blocks). This is in contrast to looking for particular landmarks in the image. Thus, we find that Petitioner has not sufficiently established that Kouzani’s fractal is based on landmarks. In Petitioner’s ground, Petitioner asserts that Zhao already teaches the claimed landmarks (Pet. 39, citing Ex. 1003 ¶¶ 58, 65), but Petitioner’s ground replaces or modifies the object model of Zhao with the fractals of Kouzani, which are not based on landmarks. Petitioner does not explain how Zhao’s modified model, now using a block-based fractal system, would still have the landmarks of Zhao’s original model. Even if it were obvious to include fractals, we are persuaded that the fractals included by Kouzani are not based on landmarks. Alternatively, if Petitioner is asserting merely to use fractals in Zhao’s models, then Petitioner has not sufficiently accounted for the particular fractals claimed and explained persuasively how merely using fractals in Zhao would lead to the claimed subject matter, i.e., fractals based on landmarks. In either event, Petitioner has not sufficiently established that the proposed combination satisfies the “fractal includes a representation of the object based on landmarks” limitation of claim 1.” slip op. at 11

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

    “standard set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). That is, “the words of a claim ‘are generally given their ordinary and customary meaning’ . . . that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1312–13 (quoting in Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). We do not need to construe any claim terms to reach a decision in this proceeding. Realtime, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 6

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,126,853
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22

  • Skill levelSkill level board ownDecided for petitioner

    “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 ’974 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

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

  Patent outcomesUS 11,325,974 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,974
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Recor Medical, Inc. / Otsuka Medical Devices Co., Ltd. v. Medtronic Ireland Manufacturing Unlimited Co.Some claims unpatentable
  PTAB · Nov 3, 2025 · IPR2022-00431 · APJ Eric C Jeschke · IPR · Remand

  On remand, claims 1–3 and 8–12 are unpatentable over the instituted grounds; claim 4 was not shown unpatentable.

  RulingsRemand decision

  • RemandOther

    “Federal Circuit (Paper 33), which vacated the original Final Written Decision and remanded the proceeding to the Board. See ReCor Med., Inc. v. Medtronic Ir. Mfg. Unlimited Co., No. 2023-2251, 2025 WL 944511 (Fed. Cir. Mar. 27, 2025) (“the Appeal Decision” or “Appeal Dec.”); see also Paper 41 (copy of the Appeal Decision). The Federal Circuit’s mandate issued on May 5, 2025. See Paper 40. We have jurisdiction under 35 U.S.C. § 6, and we issue this Final Written Decision on Remand under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons below, on the complete record, we conclude that Petitioner has proven, by a preponderance of the evidence, the unpatentability of claims 1–3 and 8–12 of the challenged patent, and we conclude that Petitioner has not proven, by a preponderance of the evidence, the unpatentability of claim 4.” slip op. at 2

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentable

    “and Petitioner’s rebuttal evidence. Objective evidence of nonobviousness, when present, must be considered as part of an obviousness inquiry. Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Notwithstanding what the teachings of the prior art would have suggested to one of ordinary skill in the art, the totality of the evidence submitted, including objective evidence of nonobviousness, may lead to a conclusion that one or more of the challenged claims would not have been obvious to one of ordinary skill in the art. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984).” slip op. at 50

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “1. Claims 1–3 and 8–11 Because the obviousness ground based on Levin and Acker is dispositive as to challenged claims 1–3 and 8–11, we need not reach this additional ground as to those claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 371 (2018) (holding that a petitioner “is entitled to a final written decision addressing all of the claims it has challenged”); Boston Sci. Scimed, analysis in the appeal to the Federal Circuit. See Appeal Dec. *1–*2 (summarizing grounds at issue on appeal and not discussing anticipation based on Acker). Inc. v. Cook Grp. Inc., 809 F. App’x 984, 990 (Fed. Cir. 2020) (nonprecedential) (stating that the “Board need not address issues that are not necessary to the resolution of the proceeding,” such as “alternative arguments with respect to claims [the Board] found unpatentable on other grounds”); SK Hynix Inc. v. Netlist, Inc., IPR2017-00692, Paper 25 at 40 (PTAB July 5, 2018) (determining all challenged claims to be unpatentable and not addressing additional grounds). 2. Dependent Claim 4 As to dependent claim 4, in the context of this ground, Petitioner relies on Acker as to the additional limitations in claim 4 in the same manner as relied on in the context of the ground based on Levin and Acker. See Pet. 73 (“The combination teaches this element for the same reasons described in [the obviousness ground based on Levin and Acker], claim 4, with the exception that [one of ordinary skill in the art] would have been motivated based on his or her knowledge of prior renal denervation work, as noted above.”). Thus, for the same reasons discussed above (see § II.C.3.c), we determine, based on the complete record, that Petitioner has not demonstrated by a preponderance of the evidence that claim 4 would have been obvious based on Acker and the knowledge of one of ordinary skill in the art. G. Asserted Obviousness of Claim 12 Based on Acker, the Knowledge of a Person of Ordinary Skill in the Art, and Yock Petitioner asserts that claim 12, which depends from independent claim 1, would have been obvious based on Acker, the knowledge of one of ordinary skill in the art, and Yock. Pet. 12, 75; Pet. Reply 35–36. Patent Owner provides arguments addressing this ground. PO Resp. 57–60; PO” slip op. at 75

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

    “1. Independent Claim 1 Petitioner contends that Acker discloses each limitation of claim 1. Pet. 61–63; Pet. Reply 35. In the “Overview of the Ground” section, Petitioner references its proposed construction of the phrase “configured to” and states that “it is proper to consider whether the prior art is ‘capable of’ performing the recited functions, as opposed to requiring that a designer of a prior art device have actually conceived of the recited functional language.” Pet. 61. Petitioner continues: “If the PTAB agrees that this is the proper approach to claim construction, then Acker also anticipates the claims challenged in this ground.” Id. For the reasons below, we determine, based on the complete record, that Petitioner has not demonstrated by a preponderance of the evidence that claim 1 is anticipated by Acker. As to element 1d, which includes the phrase “configured to,”16 Petitioner states that Acker is capable of being used to target renal neural fibers outside of the blood vessel to thermally induce modulation of target neural fibers while protecting non-target tissue in the blood vessel wall from thermal injury for the reasons discussed under claim 1, limitation [1d] and in the section entitled “Reasonable Expectation of Success”, beginning on page 37 [of the Petition]. Pet. 62–63 (citing Daft Pet. Decl. ¶ 179) (first bracketed text added by Petitioner). Patent Owner argues that, in the context of this asserted ground based” slip op. at 71

  Patent outcomesUS 8,845,629 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,845,629
• Amazon.Com, Inc. / Amazon Web Services, Inc. et al. v. Datonics LLCInstituted
  PTAB · Oct 31, 2025 · IPR2025-00873 · APJ David Cotta · IPR · Institution

  The Board instituted review of claims 1–14 on all asserted grounds after finding a reasonable likelihood that claim 1 is obvious over Gilmour, Merriman, and Frauenhofer.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” Petitioner has established a reasonable likelihood of prevailing on at least one challenged claim is unpatentable. Thus, for reasons explained below, we institute inter partes review of claims 1–14 of the ’445 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Ex. 1002 ¶¶ 30–34). Petitioner asserts that the POSA’s education “could include a bachelor’s degree in business or economics, with an emphasis on the use of technology in marketing or advertising” or “similar knowledge gained through actual work experience.” Id. Alternatively, the POSA’s education could include “a bachelor’s degree in computer science or equivalent industry experience, and work with a team that includes software engineers.” Id. According to Petitioner, the POSA “could also have qualified with more formal education and less technical experience, or vice versa.” Id. Petitioner’s definition appears to be consistent with the field of the invention reflected in the prior art of record and the disclosure of the ’445 patent. Accordingly, for purposes of this Decision, we adopt Petitioner’s proposed definition of the person of ordinary skill in the art.” slip op. at 8

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

    “C. Claim Construction We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Petitioner “applies plain-and-ordinary meaning to all terms.” Pet. 20. We determine that no terms require express construction at this stage. See Realtime Data, LLC v. Iancu, 912 F.3d 1368 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, 8 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 8

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

    “Petitioner recognizes that the combination of Gilmour and Merriman alone “does not disclose that the profile owner computer automatically 17 selects a media property entity of a plurality of media property entities based on a comparison of the profile information with a plurality of stored requests from the plurality of media property entities.” Id. at 42. To address this deficiency, Petitioner asserts that Frauenhofer “discloses automatically selecting a user of a plurality of users based on a comparison of content with the plurality of stored requests from the users.” Pet. 44 (citing Ex. 1014, 3:12–19). Petitioner argues that it would have been obvious to combine Frauenhofer’s teachings with those of Gilmour and Merriman to arrive at the claimed method. Id. According to Petitioner a POSA “would have been motivated to make this combination because it would conveniently allow Gilmour’s requesting entities (which are media property entities) to make initial requests to the profile service provider, and then automatically receive profiles matching the requests on an ongoing or periodic basis.” Id. at 45. (citing Ex. 1010, 41; Ex. 1011, 39–40, 51; Ex. 1012 ¶ 25; Ex. 1013, 3:20– 23; Ex. 1002 ¶ 155).” slip op. at 17

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,984,445
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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

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.