- Caption Health, Inc v. University Of British ColumbiaInstitution deniedPTAB · Dec 19, 2025 · IPR2025-01066 · APJ Mary C Hoffman · IPR · Institution
Institution was denied because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable, including failure to show the claimed image-receiving quality-assessment neural network.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted “unless . . . the information presented in the petition . . . and any response . . . 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.” Based on the current record and for the reasons explained below, Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to at least one of the challenged claims of the ’591 patent. Thus, we do not institute this inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Because Petitioner’s formulation is supported by declaratory testimony and appears consistent with the level of skill reflected in the asserted prior art and the ’591 patent, and because Patent Owner does not provide any supporting evidence, we adopt Petitioner’s formulation of the level of ordinary skill in the art. See Ex. 1002 ¶¶ 31–33. Our decision would be the same regardless of the differences between Petitioner’s and Patent Owner’s formulations.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not propose any express claim construction. Pet. 11– 12; Prelim Resp. 17. We also determine that no express claim construction is necessary for our Decision, apart from that discussed in our below analysis. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only terms in controversy must be construed “and only to the extent necessary to resolve the controversy”) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“Petitioner also fails to provide sufficient rationale and a reasonable expectation of success in combining Krishnan and Lee to arrive at a quality assessment neural network configured to receive an image. See Pet. 34–37. For example, the Petition lacks an explanation of why a POSITA would have been motivated to modify Krishnan’s quality assessment neural network to be configured to receive an image, instead of extracted features, in view of Lee’s image-receiving category classifying neural network. Id. Without such further explanation, Petitioner’s challenge falls short. Petitioner’s argument that neural networks for image quality assessment were “well-known” is not persuasive—it does not address the particular scope of limitation 1i, which also requires that the neural network is configured to receive images. Pet. 35 (citing Ex. 1002 ¶¶ 47–51, 118; Exs. 1017, 1023, 1024, 1026). Petitioner’s argument that combining Krishnan and Lee “would merely amount to applying known work from the field . . . to yield predictable results” is not persuasive because the Petition ties this reasoning to modifying Krishnan with Lee’s view-category-specific assessment parameters, not modifying Krishnan’s quality assessment neural network to receive images instead of extracted features. Id. at 37 (citing Ex. 1002 ¶ 126). Lastly, we note Petitioner’s expert’s discussion regarding neural networks for image quality assessments. Ex. 1002 ¶¶ 43–53 (citing Exs. 1010, 1015, 1016, 1017, 1018, 1023, 1024, 1026). However, the Petition does not explain how this evidence demonstrates that the proposed combination teaches or suggests a quality assessment neural network configured to receive images, or that such would have been obvious in the context of the claimed invention. See Pet. 32–37.” slip op. at 19
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,129,591 - 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 - 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 - 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 · Oct 30, 2025 · IPR2025-00817 · APJ Kevin F Turner · IPR · Institution
The Board instituted IPR on claims 1–20, finding a reasonable likelihood of success on the Boerjes-Geng and Boerjes-Geng-Babayoff obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On this record, we determine that Petitioner has developed this ground sufficiently to meet the reasonable likelihood standard for institution. Having determined that Petitioner has met its burden as to its Ground 2 arguments, and because the Board must institute on all grounds or none, SAS Institute Inc. v. Iancu, 584 U.S. 357, 364–65 (2018) and 37 C.F.R. § 42.108(a), we institute trial in on all grounds presented in this proceeding. Nevertheless, we address the additional grounds below.” slip op. at 24
- Skill levelSkill level petitioner adoptedOther
“Pet. 16 (citing Ex. 1003 ¶¶ 27–30). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9
- Prior constructionPrior construction adoptedDecided for petitioner
“The parties indicate that in the co-pending litigation in the District Court for the Western District of Texas (see supra Section I.B), the Court provided preliminary constructions of two specific claim limitations. Pet. 16–17; Prelim. Resp. 8. Patent Owner adds that “district court subsequently adopted these constructions in its final claim construction order.” Prelim. Resp. 8 (citing Ex. 2001). We determine that the constructed limitations do not impact the analysis below, but nonetheless, we adopt this those constructions for purposes of this Decision.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“identify areas that need replacing, such as ‘a margin line’ to be removed, ‘areas of poor margin preparation,’ and ‘holes or areas of incomplete scan[s],’” and that the user can identify regions of a prepared tooth surface requiring additional preparations and “supplemental scanning” (Pet. 32 (citing Ex. 1004 ¶¶ 189, 193, 196)), Boerjes is silent with respect to replacing at least a portion of the removed surface portion of the model using the received second scan data of the patient’s teeth, per claim 1. Boerjes certainly contemplates the re-scanning of the dentition, but does not assert partial insertion of new data into an existing 3D model. Even under the “comprising” language of claim 1, for example, the complete replacement of a 3D model cannot teach or suggest “replacing at least a portion of the removed surface portion” without repudiating the language of the claim by making a portion be the entire model. Even if, as Petitioner asserts, “removing portions of a virtual model has been a well-known and routine technique in 3D modeling,” and the “process of replacing a user-identified portion would have been well within the skills of a POSITA” (Pet. 35), the disclosure of Boerjes does not teach or suggest such processes. Although Boerjes allows for the possibility that portions of a model can be identified as needing replacement or supplementation, it does not disclose the partial replacement required by the instant, independent claims. Boerjes’s actual disclosure details that supplemental scanning is used to compensate for an inadequate scan, but not disclosed to be used to stitch together before-and-after models that have undergone an intervening physical change. slip op. at 18
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 10,791,936 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.
RulingsFinal written decision- BurdenUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
- Skill levelSkill level board ownDecided for petitioner
“Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’356 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
Patent outcomesUS 10,934,356 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,934,356 - PTAB · Oct 27, 2025 · IPR2025-00816 · APJ Kristina M Kalan · IPR · Institution
Instituted IPR on all challenged claims 1–19; Ground 1 met the reasonable-likelihood threshold, while Ground 2 was instituted under the all-grounds rule.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of the Chishti patents and Sachdeva to meet the limitations of the claims challenged under this ground.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of the Chishti patents and Sachdeva to meet the limitations of the claims challenged under this ground.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away found
“with Chishti-876’s purported teaching away and disparagement, we note again that “round-tripping” is defined in the Specification as “the technique of moving a first tooth out of the path of a second tooth, and once the second tooth has moved sufficiently, moving the first tooth back to its previous position before proceeding to a desired final position of that first tooth.” Ex. 1001, 13:8–12. Chishti-876 teaches that its “path scheduling algorithm determines the treatment path while avoiding ‘round-tripping,’ i.e., while avoiding moving a tooth along a distance greater than absolutely necessary to straighten the teeth. Such motion is highly undesirable, and has potential negative effects on the patient.” Ex. 1005, 14:46–51. The Petition does not expressly address this teaching in Chishti-876, nor does it address the prior Board finding in the ’444 IPR, in which the Board recognized that this teaching constitutes a teaching away from round-tripping. See Ex. 1008, 11– 12. On this record, it appears that Chishti-876 teaches away from “moving a tooth along a distance greater than absolutely necessary to straighten the teeth.” In short, Chishti-876 disparages “moving a tooth along a distance greater than absolutely necessary to straighten the teeth” (Ex. 1005, 14:46– 51) which is a broad statement that appears to encompass the more specific round-tripping movement taught in Becker. Petitioner itself concedes that “indirect movement was understood to be avoided if possible.” Pet. 17. Although Petitioner attempts to characterize indirect movement or round-tripping as a preferable or necessary option (see, e.g., Pet. 15–17), these arguments are insufficiently supported on this record.” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“as of August 30, 2006 (the earliest claimed priority date) would have been part of an interdisciplinary team. This team would have included a member with an advanced degree related to dentistry (e.g., BDS, MDS, DDS, DMD) with experience in orthodontics, including 1–3 years of orthodontic training or equivalent experience, and experience using clear aligners. The team may have also included members with a degree in a technical area related to software, graphics, computers, or a related discipline. This technical team member would have had 1–3 years of software development experience. For all team members, more education could substitute for experience and vice versa.” slip op. at 8
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 11,369,456 - Clearcorrect Operating, LLC v. Align Technology Inc.Institution deniedPTAB · Oct 23, 2025 · IPR2025-00814 · APJ Kevin F Turner · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim over the asserted obviousness combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. 35 U.S.C. § 103(a); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved based on underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) any objective indicia of nonobviousness.7 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). An obviousness determination requires finding a reason to combine accompanied by a reasonable expectation of achieving what is claimed in the challenged patent. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at 419–20.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away foundMotivation not foundNot shown unpatentable
“tripping” as “any motion of a tooth in any direction other than directly toward the desired final position.” Ex. 1004, 4:12–13. Chishti-511 teaches minimizing round-tripping (“teeth are moved in the quickest fashion with the least amount of round-tripping”), but acknowledges that “[r]ound-tripping is sometimes necessary to allow teeth to move past each other.” Id. at 4:9–15. In an attempt to counter Patent Owner’s teaching away arguments, Petitioner relies heavily on Chishti-511’s statement that “[r]ound[-]tripping is sometimes necessary.” See Pet. 29–30; see also Ex. 1003 ¶ 83 (Dr. Yadav relying on Chishti-511). This reliance is unavailing, because as noted above, Chishti-511 defines “round-tripping” more broadly than is claimed here. Indeed, in the ’444 IPR, the Board stated that “the ‘round tripping’ described in Chishti ’511 is something different than the ‘round tripping’ required by the ’444 patent.”10 Ex. 1008, 16. Despite being aware of this prior finding 10 In the ’444 IPR, the Board employed the same construction of “round-tripping” that we use here. Compare Ex. 1008, 6, with Section II.C supra. (see Pet. 6), Petitioner here fails to address the difference between Chishti- 511’s round-tripping and the claimed round-tripping. That is, Petitioner places great weight on Chishti-511’s statement that “round-tripping is sometimes necessary,” but has not established that Chishti-511 contemplates round-tripping as claimed, as opposed to some other, different movement pattern encompassed by Chishti-511’s broader statement about round-tripping.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“discussion of “need[ing] collision-free treatment paths,” skilled artisans would have turned to Becker. Pet. 23–24 (citing Ex. 1004, 4:15–22). But on this record, and especially in view of the teachings away from round-tripping, Petitioner does not demonstrate a reasonable likelihood that a skilled artisan would have combined Becker’s movement pattern with the Chishti systems and Sachdeva. In particular, the Petition and supporting materials lack sufficient argument and evidence for us to conclude that a person of ordinary skill in the art would have had reason to apply Becker’s movement pattern in the context of an aligner treatment. Becker is a textbook relating to the orthodontic treatment of impacted teeth. Ex. 1006, 1 (Title). Patent Owner correctly states that “Becker is a different orthodontic treatment modality compared to the Chishti references,” using “braces and numerous brackets, wires, and rubber bands, with the wire-and-bracket systems being attached directly and permanently to the teeth.” Prelim. Resp. 21–22; see also supra Section II.D.4. “Becker involves traditional orthodontic practice: manual, by-eye adjustment of its archwires, elastic thread, and palatal wires by a treating orthodontist in repeated office visits.” Prelim. Resp. 22. Chishti-511, in contrast, uses “treatment planning software” to “pre-stag[e] a series of tooth positions from which a sequence of appliances can be manufactured.” Id. On this record, we agree with Patent Owner that “Becker at best shows that round-tripping was an option in limited circumstances involving wire-and-bracket treatment.” See Prelim. Resp. 3. Petitioner does not direct us to any persuasive evidence that using aligners to effect Becker’s tooth transposition “would be appropriate or even possible.” Id. at 22. As Patent Owner correctly notes, Petitioner does not point to any teaching in Becker regarding aligner treatment or corresponding treatment planning software. Id. at 23. Nor are we directed to any portions of Chishti-511, Chishti-876, or Sachdeva that mention using aligners to transpose teeth. These omissions are important because “[i]n contrast to treatment with braces, in which wires are manually adjusted by the orthodontist to move teeth reactively, aligner treatment involves treatment planning in which a detailed path of teeth is calculated in advance.” Id. at 4. Given these differences, Petitioner has not persuasively explained why Becker’s tooth movement pattern and mechanism would have been of interest to a skilled artisan who was” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“as of the August 30, 2006 claimed priority date would have been part of an interdisciplinary team. This team would have included a member with an advanced degree related to dentistry (e.g., BDS, MDS, DDS, DMD) with experience in orthodontics, including 1–3 years of orthodontic training or equivalent experience, and experience using clear aligners. The team may have also included members with a degree in a technical area related to software, graphics, computers, or a related discipline. This technical team member would have had 1–3 years of software development experience. For all team members, more education could substitute for experience and vice versa. Pet. 7–8 (citing Ex. 1003 ¶¶ 23–24; Ex. 1017 ¶¶ 23–25; Ex. 1029; Ex. 1030). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 8
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,456,217 - Clearcorrect Operating, LLC v. Align Technology Inc.Institution deniedPTAB · Oct 23, 2025 · IPR2025-00815 · APJ Cynthia M Hardman · IPR · Institution
The Board denied institution because ClearCorrect did not show a reasonable likelihood that claims 1–24 would have been obvious over Chishti-511, Chishti-876, Sachdeva, and Becker.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“3. Analysis In view of the arguments and cited evidence, we find on this record that Petitioner has not demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine Becker’s round-tripping with the teachings of the Chishti patents and Sachdeva.” slip op. at 20
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Neither party indicates that any other claim term requires express construction. Only claim terms in controversy need be construed. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). For purposes of this Decision, we determine that no other claim term requires construction.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITA
“Court for the Western District of Texas (see supra Section I.B), they jointly adopted the definition of “round-tripping” set forth in the ’879 patent Specification. Pet. 9; Prelim. Resp. 8; Ex. 1013, 8. The ’879 patent Specification defines “round-tripping” as moving a first tooth out of the path of a second tooth, and once the second tooth has moved sufficiently, moving the first tooth back to its previous position before proceeding to a desired final position of that first tooth. See Ex. 1001, 13:9–13. We adopt this agreed-upon construction for purposes of this Decision.” slip op. at 9
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,524,879 - PTAB · Oct 21, 2025 · IPR2025-00749 · APJ Sean P O’Hanlon · IPR · Institution
The Board instituted IPR on claims 1–16 based on the petition’s grounds and granted ZF’s motion to join the Mobileye IPR, subject to participation limits.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because the grounds of unpatentability in the instant Petition are identical to those in the Mobileye IPR and for the same reasons stated in our Decision to Institute in the Mobileye IPR, we institute inter partes review in this proceeding on the grounds presented in the Petition. See Mobileye IPR, Paper 14 (analyzing challenges in the Mobileye Petition).” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“A motion for joinder should (1) set forth reasons why joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013); Patent Trial and Appeal Board Consolidated Trial Practice Guide 76 (Nov. 2019).2 Petitioner’s Motion addresses each of these considerations. Mot. 4–8. According to Petitioner, “the Petition involves the same patent, challenges the same claims, relies on the same expert declaration, and is based on the same grounds and combinations of prior art submitted in the Mobileye Petition” and “does not present any new grounds of unpatentability and is substantively identical to the Mobileye Petition.” Id. at 5. Petitioner argues that, “[b]ecause the Petition is substantively identical to the Mobileye Petition, with the same grounds challenging the same claims as instituted by the Board, there are no new issues for Patent Owner to address” and, therefore, joinder with the Mobileye IPR would “not unduly burden or negatively impact the trial schedule in any meaningful way.” Id. at 6. Further, “Petitioner explicitly agrees to take an ‘understudy’ role in the joined proceeding” and “will assume the primary role only if Petitioner in the Mobileye IPR ceases to participate.” Id. at 7–8 (quoting Noven Pharms., Inc. v. Novartis AG, IPR2014-00550, Paper 38 at 5 (PTAB Apr. 10, 2015).” slip op. at 6
NonePatents in suitUS 9,671,328
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.