- Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - PTAB · Nov 7, 2025 · IPR2025-00988 · APJ Terrence W Mcmillin · IPR · Institution
The Board denied institution of IPR on claims 1–14 because Samsung took alternative claim-construction positions in the Board and district court without explaining why.
RulingsInstitution decision- Other 314aInstitution denied discretionary otherInstitution denied
“decision in Revvo Technologies, Inc. v. Cerebrum Sensor Technologies, Inc., IPR2025-00632, Paper 20 (Nov. 3, 2025 (“Revvo”)).12 Revvo provides that “when a petitioner takes alternative positions [on claim construction] before the Board and a district court, that petitioner should, at a minimum, explain why alternative positions are warranted.” Revvo at 3–4. On November 5, 2025, the Director of the Office issued an informative decision in Tesla, Inc. v. Intellectual Ventures II LLC, IPR2025- 00340, Paper 18 (Nov. 5, 2025) (“Tesla”)). Tesla provides that: “Allowing a petitioner to advance a claim construction before the Board when that petitioner has made inconsistent indefiniteness arguments in district court fails to further, but instead detracts from, the Office’s goal of ‘providing greater predictability and certainty in the patent system.’” Id. at 4 (citing Revvo at 4–5). Tesla further provides that when a petitioner raises inconsistent invalidity challenges in two forums, “that petitioner is required to explain why those different positions are warranted.” Id. at 3 (citing Revvo at 3–5). In this proceeding, Petitioner takes alternative positions on claim construction before the Board and a district court, but fails to explain why alternative positions are warranted. Therefore, in accordance with Revvo and Tesla, we deny institution.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“CONCLUSION For the foregoing reason, we determine that trial should not be instituted on claims 1–14 of the ’281 patent. ORDER Upon consideration of the record before us, it is ORDERED that an inter partes review is not instituted.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“In the Petition, “Petitioner submits that no formal claim constructions are necessary.” Pet. 3. Petitioner does not discuss its position on claim construction in district court nor why alternative positions before the Board and the district court are warranted. See id.” slip op. at 7
Claim constructionDiscretionary denialPatents in suitUS 10,687,281 - PTAB · Nov 7, 2025 · IPR2025-00933 · APJ Terrence W Mcmillin · IPR · Institution
The Board denied institution of review of claims 1–12 because Samsung advanced alternative claim-construction positions without explaining why they were warranted.
RulingsInstitution decision- Other 314aInstitution denied discretionary otherInstitution denied
“IPR2025-00632, Paper 20 (Nov. 3, 2025 (“Revvo”)).10 Revvo provides that “when a petitioner takes alternative positions [on claim construction] before the Board and a district court, that petitioner should, at a minimum, explain why alternative positions are warranted.” Revvo at 3–4.” slip op. at 6
Discretionary denialPatents in suitUS 11,470,595 - PTAB · Nov 7, 2025 · IPR2025-01044 · APJ Daniel J Galligan · IPR · Institution
The Board instituted IPR of claims 1–10 on all asserted grounds, finding a reasonable likelihood that Samsung would prevail on at least claim 1 under §103.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute review. Paper 11. 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 the information presented in the Petition and the Preliminary Response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons explained below, we institute an inter partes review of all challenged claims on all grounds raised in the Petition.” slip op. at 2
- Skill levelSkill level board ownDecided for petitioner
“had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field, and at least 3 years of experience in the research, design or development of wireless communication devices, systems, and/or networks, or the equivalent, as of the Critical Date,” which we understand Petitioner identifies as September 7, 2016. Pet. 2, 4 (citing Ex. 1003 ¶¶ 26–28). Petitioner also contends that “[i]ncreased educational experience can make up for less work experience, and vice versa.” Pet. 4. Patent Owner does not object to Petitioner’s definition at this stage. Prelim. Resp. 11. To the extent necessary, and for purposes of this Decision, we accept the uncontested assessment offered by Petitioner, which appears consistent with the ’879 patent and the asserted prior art, except that we delete the qualifier “at least” to eliminate vagueness as to the amount of experience.” slip op. at 5
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction The parties agree that no claim terms require express construction. Pet. 4; Prelim. Resp. 11. On this record, we determine that no terms need express construction. See Realtime Data, 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” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundOther
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,516,879 - PTAB · Nov 7, 2025 · IPR2025-01043 · APJ Daniel J Galligan · IPR · Institution
The Board instituted IPR of claims 1–10 on all petition grounds, finding a reasonable likelihood that Samsung would prevail on at least claim 1 as obvious over Zhou, Cherian, and Kim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute review. Paper 11. 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 the information presented in the Petition and the Preliminary Response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons explained below, we institute an inter partes review of all challenged claims on all grounds raised in the Petition.” slip op. at 2
- Skill levelSkill level board ownOther
“had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field, and at least 3 years of experience in the research, design or development of wireless communication devices, systems, and/or networks, or the equivalent, as of the Critical Date,” which we understand Petitioner identifies as September 7, 2016. Pet. 2, 4 (citing Ex. 1003 ¶¶ 26–28). Petitioner also contends that “[i]ncreased educational experience can make up for less work experience, and vice versa.” Pet. 4. Patent Owner does not object to Petitioner’s definition at this stage. Prelim. Resp. 11. To the extent necessary, and for purposes of this Decision, we accept the uncontested assessment offered by Petitioner, which appears consistent with the ’035 patent and the asserted prior art, except that we delete the qualifier “at least” to eliminate vagueness as to the amount of experience.” slip op. at 5
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction The parties agree that no claim terms require express construction. Pet. 4; Prelim. Resp. 11. On this record, we determine that no terms need express construction. See Realtime Data, 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” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundOther
“expressly discloses multiple options for resetting the timer, including “after the STA 106 transmits a scheduled UL transmission, or transmits a scheduled UL transmission and gets an ACK message.” Ex. 1005 ¶ 81. We find sufficiently persuasive Petitioner’s explanation that “after” in Zhou means after the transmission ends if an ACK is not requested; in the case of an ACK, Zhou expressly discloses starting the timer after receiving the ACK. See Pet. 46–49. Petitioner’s declarant, Dr. Valenti, testifies that “[a] STA measures the ‘completion’ of the transmission by receiving an ACK— if an ACK is requested—or upon completion of the physical transmission.” Ex. 1003 ¶ 152 (citing Ex. 1018 ¶ 9). On this record, we find this testimony to be sufficiently credible based on the evidence cited. See Ex. 1018 ¶ 9 (“A successful transmission occurs when the node either receives an expected acknowledgment correctly, or transmits a frame that does not require an acknowledgement.”).” slip op. at 13
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,116,035 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 · GrahamPatents in suitUS 11,325,974 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Maxell, Ltd.All claims unpatentablePTAB · Nov 6, 2025 · IPR2024-00867 · APJ Kevin C Trock · IPR · Final written decision
Claims 11, 12, 16, 17, 19, 20, and 84 are unpatentable as obvious over Nozaki and Haitani, alone or combined with Graham or Kim.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The parties’ descriptions of the level of skill in the art are very similar, with only a slight difference in the number of years of work experience suggested. Petitioner states that “[a]lthough the experts propose slightly different POSITA definitions, the differences are immaterial to the analysis here.” Pet. Reply. 1. Patent Owner does not believe the two definitions are materially different, and states that “the arguments herein do not change under either definition. PO Resp. 8. Petitioner’s description of a person of ordinary skill appears to be consistent with the technical complexity of the subject matter described in the ’848 patent. This understanding is supported by the testimony of Petitioner’s declarant, Dr. Bederson, who states that he is “well acquainted systems and methods described in the ’848 patent.” Ex. 1005 ¶ 36. Accordingly, we continue to use Petitioner’s assessment of a person of ordinary skill for purposes of this Decision. B. Claim Construction” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“the meaning of the claim term “mode” as it is used in the ’848 patent and as one of ordinary skill in the art would understand it at the time of the invention. First, the parties do not necessarily disagree as to the meaning of the term “mode.” Patent Owner asserts that a person of ordinary skill in the art “would understand ‘mode’ to mean “an operational state that a system has been switched to.” PO Resp. 13. Petitioner “do[es] not necessarily object to the concept of a ‘mode’ as an operational state,” but does object to how Patent Owner applies the term. Pet. Reply 1. Petitioner objects to Patent Owner’s “application of its construction,” which, Petitioner argues, “is far narrower than the words alone suggest.” Id. Second, the intrinsic evidence, including the claims and the ’848 specification, makes it readily apparent what the ordinary and customary meaning of the term “mode” would be to one of ordinary skill in the art at the time of the invention. Based upon our consideration of the claims and the ’848 specification, we find that the term “mode,” as it is used by the ’848 patent, means a “state,” “condition,” or “operational state” of a recording device, such as a video camera, that is selected by a user and may include a selection function using threshold values.” slip op. at 19
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“We disagree with Patent Owner. In determining obviousness, the scope of relevant prior art “necessarily encompasses not only the field of the inventor's endeavor but also any analogous art.” In re GPAC Inc., 57 F.3d 1573, 1577–78 (Fed. Cir. 1995). A reference qualifies as prior art for a determination under § 103(a) when it is analogous to the claimed invention. In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992). A reference is analogous to the claimed invention when it is from the same field of endeavor, regardless of the problem addressed. In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011). Similarity in the structure and function of the invention and the prior art is indicative that the prior art is within the inventor's field of endeavor.” slip op. at 37
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Here, Petitioner provides a persuasive rationale as to why a person of ordinary skill in the art would combine the teachings of Nozaki, Haitani, and Graham as described in the Petition. For example, Petitioner explains that a person of ordinary skill in the art would have recognized that Nozaki’s facedetection data could be used as an additional method by which to identify Figure 5 of Nozaki could be configured as a scrollable list of keyframe data similar to Graham. Pet. 37–38 (citing Ex. 1005 ¶ 141). Petitioner also explains that a person of ordinary skill in the art would have been motivated to implement this modification to improve the efficiency of searching for specific moments within a long video file. Pet. 38 (citing Ex. 1005 ¶ 142). Petitioner also explains that Graham’s video segmenting methods address this need and could have been easily implemented in the Nozaki device. Pet. 38 (citing Ex. 1005 ¶ 142). Dr. Bederson testifies that such implementation would have been within the skill of a person of ordinary skill in the art. Ex. 1005 ¶ 142. Accordingly, based upon the complete record, we are persuaded that Petitioner has demonstrated by a preponderance of the evidence that a person of ordinary skill in the art at the time of the claimed invention would have had a reasoned basis to combine the teachings of Nozaki, Haitani, and Graham in the manner described and would have had a reasonable expectation of success in that endeavor.” slip op. at 64
Patent outcomesUS 10,176,848 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,176,848 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Maxell, Ltd.All claims unpatentablePTAB · Nov 6, 2025 · IPR2024-00717 · APJ Kevin C Trock · IPR · Final written decision
Claims 1–11 are unpatentable under § 103 over the Chinn-based and Kim-based combinations listed in the decision.
RulingsFinal written decision- Expert testimonyOther
“Accordingly, based upon the complete record, we are persuaded that” slip op. at 39
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“d. Conclusion as to Independent Claim 1 Based on the complete record, we are persuaded that Petitioner has” slip op. at 73
Patent outcomesUS 11,223,757 unpatentable§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,223,757 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,975 - PTAB · Nov 3, 2025 · IPR2025-00934 · APJ Terrence W Mcmillin · IPR · Institution
The Board instituted IPR on claims 1–9 and all asserted grounds, finding a reasonable likelihood that claims 1–9 are obvious over Bharadwaj and Sun.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute review. Paper 11. The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that 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.” After considering the Petition and the Preliminary Response, as well as the evidence of record, we institute an inter partes review as to claims 1–9 of the ’210 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedNot reached
“We are aware, however, that we must not confuse access with accessibility. See Samsung Elecs. Co. v. Infobridge Pte. Ltd., 929 F.3d 1363, 1374 (Fed. Cir. 2019) (“[A] petitioner need not establish that specific persons actually accessed or received a work to show that the work was publicly accessible.”). Dr. Hansen notes that the cover of 802.11ax_D1.0 grants permission to reproduce the document to others for consideration. Ex. 1026 ¶ 72; see Ex. 1004, 1 (“Permission is hereby granted for IEEE Standards Committee participants to reproduce this document for purposes of international standardization consideration.”). Dr. Hansen also testifies that meetings to discuss 802.11ax_D1.0 were open to the public. Ex. 1026 ¶ 58 (citing Appendix J to declaration). Thus, it appears, on the current record, that the purpose of 802.11ax_D1.0 was to promote dialogue with interested artisans, which indicates public accessibility. See Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021) (“We have previously held that where a publication’s purpose is ‘dialogue with the intended audience,’ that purpose indicates public accessibility.” (citation omitted)). After having reviewed all the arguments and evidence presented by the parties, we would like to see further development of this issue during trial. The current record is not well-developed on this issue either factually or legally. With regard to the factual record, Patent Owner has not yet had the opportunity to depose Dr. Hansen or been given a full opportunity to marshal its own evidence on this issue. With regard to the law, we would like to see the parties apply the relevant case law to the developed facts as to the public accessibility and prior art status of 802.11ax_D1.0. We will determine, if necessary and appropriate, whether 802.11ax_D1.0 is prior art to the challenged claims of the ’210 patent based on the full record as developed during trial.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“As an initial matter, Bharadwaj and Sun are both analogous art to the ’210 Patent in that that they are both concerned with the design of the PHY data unit for supporting MU-MIMO transmissions in the downlink. SAMSUNG-1003, ¶¶153- 158. . . . In addition, both Bharadwaj and Sun describe MU- MIMO downlink PHY data unit structures in the context of 802.11ax. SAMSUNG-1013, ¶[0064]; SAMSUNG-1015, ¶[0031]; SAMSUNG-1003, ¶¶153-158. . . . . [A] POSITA implementing Bharadwaj’s preamble designs would have been motivated to look to another reference, like Sun, for an understanding of the format of the user field that would support non-MU-MIMO allocations and the single-user transmission scenario. A POSITA would have combined the teachings of Bharadwaj with Sun to realize implementation details for the HE-SIG-A and HE-SIG-B fields of the HE MU PPDU to better support both MU-MIMO and non-MU-MIMO allocations. SAMSUNG-1003, ¶¶153-158. . . . . A POSITA would have found it obvious to look to Sun for modifying Bharadwaj to include the user field format for SU (non-MU-MIMO) allocation to complement Bharadwaj’s disclosure of the MU-MIMO user field format and to provide a more complete system that would allow HE MU PPDUs to support both MU-MIMO allocations for multiple users and non-MU-MIMO allocations for a single user. SAMSUNG- 1003, ¶¶153-158. The combination also would have been obvious and predictable for at least the following reasons: 1) both Bharadwaj and Sun describe designs for a PHY data unit (or PPDU) to support communications between an AP and a station within a high-efficiency Wi-Fi network, consistent with 802.11ax; 2) both Bharadwaj and Sun describe the PPDU design for supporting MU-MIMO downlink transmission as including HE- SIG-A and HE-SIG-B fields; and 3) Bharadwaj already describes the format for the user field for the MU-MIMO allocation, while also recognizing the single-user scenario, and the combination merely involves the addition to Bharadwaj of the user field format for the single-user allocation, as taught by Sun. SAMSUNG-1003, ¶¶153- 158. The combination is obvious also because elements of the combined system would each perform similar functions they had been known to perform in similar contexts outside the combination. SAMSUNG-1003, ¶¶153-158. . . . . A POSITA would have reasonably expected success implementing the combination, especially considering the substantially similar 802.11ax techniques described in each reference. SAMSUNG-1003, ¶¶153-158. Additionally, combining the teachings of Bharadwaj with Sun would have merely involved combining prior art elements according to known methods to yield predictable results. SAMSUNG-1003, ¶¶153-158.” slip op. at 31
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner asserts that “no formal claim constructions are necessary.” Pet. 2. Patent Owner notes that “both parties have submitted terms for construction in the district court for this Patent” (Prelim. Resp. 6), but that “for purposes of [the] Preliminary Response, Patent Owner applies the plain and ordinary meaning of the challenged claims” (id. at 8). Accordingly, at this stage, no need exists to expressly construe any claim terms to resolve the parties’ disputes.9 See 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))).” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,159,210
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.