- Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 23, 2025 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–28 are unpatentable: claims 1, 2, 4–7, 9–12, 14–17, and 19–28 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 9
- Skill levelSkill level board ownOther
“In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Inst. Dec. 7. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such cancers and the associated conditions and immunotherapy.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“holding is limited to anticipation of a claimed genus through disclosure of individual species, whereas the facts of this case involve the disclosure of a genus. PO Resp. 14. Because the facts before us, including the testimony of Patent Owner’s witness, indicate that one of ordinary skill in the art would have immediately understood that the third arm of the study described in the MSR includes patients with cancers recited in claim 1, including endometrial, gastric, and small-bowel cancers, we are persuaded that one of ordinary skill in the art would have understood that the MSR discloses species that fall within the scope of claim 1. Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 63; Ex. 1005, 4. We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1.6” slip op. at 29
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Regarding the dependent claims that Petitioner challenges only on obviousness grounds (claims 3, 8, 13, 18), Patent Owner must show a nexus between the claimed methods and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner does not direct us to evidence of a nexus to limitations recited in the dependent claims, for example to claims 3 and 13, which recite testing a biological sample that is a bodily fluid, claims 8 and 18, which recite testing that comprises assessing one or more markers selected from the group consisting of BAT-25, BAT-26, MONO-27, NR-21 and NR-24. Even if there is a nexus to the Patent Owner’s evidence of secondary considerations, the evidence addresses the methods of independent claims 1 and 11, not the limitations of the claims Petitioner challenges as being obvious. PO Resp. 55–83. Patent Owner directs us only to evidence regarding treating patients determined to have certain MSI-H cancers with pembrolizumab, which we determine to be anticipated by the MSR. Id. at 58. When evidence of a “secondary consideration is exclusively related to a single feature that is in the prior art,” our reviewing court has held the evidence is of no relevance to the obviousness inquiry. See Yita LLC v. MacNeil IP LLC, 69 F.4th 1356, 1363–65 (Fed. Cir. 2023), cert. denied, 144 S. Ct. 499 (2023) (distinguishing WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330–31 (Fed. Cir. 2016)); see also Ethicon Endo-Surgery, Inc. v. Covidien LP, 812 F.3d 1023, 1034 (Fed. Cir. 2016) (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”). In Yita, the prior art taught close-conformance of a floor tray with the walls of a vehicle foot well, which one of ordinary skill in the art would have had reason to use in combination with other prior-art teachings to arrive at the claimed invention. See Yita, 69 F.4th at 1359–61. The court held that because the asserted evidence of secondary consideration related exclusively to close-conformity, the evidence was not persuasive of non-obviousness, even though the claimed floor tray was coextensive with the product that produced the evidence. See id. at 1364–65 (“The coextensiveness inquiry bears only on the presumption of nexus; it does not decide the overall nexus question.”). Because Patent Owner directs us only to evidence that the methods recited in claims 1 and 11 produced evidence of secondary considerations, we are not persuaded that this evidence is persuasive of the non-obviousness of the specific methods recited in the dependent claims. For example, Patent Owner fails to direct us to evidence that a method of treating MSI-H colorectal cancer in a patient “wherein the biological sample is a body fluid from the patient,” as recited in claim 3, or “wherein the at least one marker comprises BAT-25, BAT-26, MONO-27, NR-21 or NR-24,” as recited in claim 8, demonstrated unexpected results or commercial success. Accordingly, having considered the evidence of record as a whole, we determine that Petitioner has demonstrated by a preponderance of the evidence that the methods of claims 3, 8, 13, and 18 would have been obvious. We are not persuaded to the contrary by Patent Owner’s arguments or evidence of second secondary considerations.” slip op. at 47
Patent outcomesUS 11,629,187 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,629,187 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 23, 2025 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–36 are unpatentable: claims 1–2, 4–8, 11–12, 14–18, and 21–36 as anticipated, and claims 3, 9, 10, 13, 19, and 20 as obvious.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The ’287 patent claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. See Ex. 1001, 24:42–52; Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Dec. 7– 8. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such cancers and the associated conditions and immunotherapy.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). We credit Dr. Neugut’s and Dr. Oberstein’s testimony about what one of ordinary skill in the art would have understood after reviewing the MSR. slip op. at 34
Patent outcomesUS 11,649,287 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,649,287 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 19, 2025 · IPR2024-00650 · APJ Deborah Katz · IPR · Final written decision
Claims 1–38 are unpatentable: claims 1, 2, 4–7, 11–17, 19–22, and 26–38 are anticipated by the MSR; the remaining claims are obvious over the MSR and cited references.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would be a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. (See Pet. 11 (citing Ex. 1003 ¶ 19).) To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. (See PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 91–99).) Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’491 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:36–52, 26:24–41, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’491 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. C. Claim Construction” slip op. at 8
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Dr. Lonberg, Patent Owner’s witness, does not dispute any of Dr. Neugut’s or Dr. Oberstein’s testimony, but asserts only that Dr. Neugut’s testimony relies only on what was generally done, not on what is expressly disclosed in the MSR. (See Ex. 2072 ¶¶ 105–107.) On cross-examination, Dr. Lonberg agreed with Dr. Oberstein that patients who had received prior cancer therapy were not excluded from the study described in the MSR. (See Ex. 1245, 57:5–58:2, 40:5–14, 49:2–12.) Thus, after considering the evidence cited by each party, we find Dr. Neugut’s and Dr. Oberstein’s testimony to be the most directly relevant and persuasive about what one of ordinary skill in the art would have understood from the MSR itself. We are also persuaded by the lack of a specific contradiction regarding the understanding of one of ordinarily skill in the art by Dr. Lonberg. Even if some patients who had been previously treated with specific drugs were excluded from the study described in the MSR, we are persuaded that one of ordinary skill in the art would have understood the MSR as including other patients who have been treated with a prior cancer therapy drug. We are persuaded that Petitioner has met its burden of proving whether a skilled artisan would reasonably understand or infer that the limitations of claims 13, 28, 32, and 36 were disclosed in the MSR. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSR, not what it inherently discloses. (Contra PO Resp. 19–22.)” slip op. at 38
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Patent Owner argues that the “in response to” limitation of claim 1 describes administering the claimed treatment only to patients determined to have an MSI-H tumor. (See PO Resp. 6.) But neither claim 1 nor claim 16 includes a limitation excluding the treatment of any patient, such as specifically excluding treatment of any patient who has a tumor that is not MSI-H or dMMR. Neither claim 1 nor claim 16 recites any language differentiating between patients or identifying a patient population to be excluded from treatment. Instead, claims 1 and 16 provide that if the colorectal cancer patient is tested and the cancer is determined to be MSI-H or dMMR, the patient is treated with a therapeutically effective amount of pembrolizumab. We note that the methods of claims 1 and 16 use the open-ended transitional phrase “comprising” that is generally interpreted to not exclude additional, unrecited elements. See Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language that means that the named elements are essential, but that other elements may be added and still form a construct within the scope of the claim.”). The use of the open-ended transitional phrase “comprising” in claims 1 and 16 further suggests to us that any additional steps taken in conjunction with expressly recited method steps, such as the treatment of patients who are not MSI-H or dMMR, are not excluded from the scope of the claim.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“discloses species that fall within the scope of claim 1. (See Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 67; Ex. 1005, 4.) We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1. d) Element [1.3]: “thereby determining that the patient’s cancer is” slip op. at 26
Patent outcomesUS 11,634,491 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 18, 2025 · IPR2024-00625 · APJ Deborah Katz · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–4 and 6–8 are anticipated by MSR, and claim 5 is obvious over MSR with the additional marker-testing teachings of Chapelle.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). Although Patent Owner argues that a missing element cannot be filled by what an ordinarily skilled artisan would have envisioned, Petitioner’s argument is based on what one of ordinary skill in the art would have understood from what the MSR expressly teaches. (See Pet. 20 (“Indeed, prior art concerning the MSI-H Study indicates that the physicians understood postings on clinicaltrials.gov indicated that patients had ‘metastatic tumors.’ (EX1049, 444; see also EX1050, S4; EX1003, ¶62.)”).) Unlike the facts of Nidec, where a missing signal could have been envisioned but was not present, we are persuaded by the evidence Petitioner presents that those of ordinary skill in the art understood the MSR express disclosure to include patients with unresectable or metastatic tumors because references referring to the study underlying the MSR discuss the inclusion of patients with metastatic tumors in the study. Even if Dr. Neugut’s reasoning that the reference to “measurable” disease in the MSR would have indicated patients having metastatic cancer is flawed, we are persuaded by Petitioner’s evidence of publications referring to the MSR as a study of metastatic colorectal cancer, and we are further persuaded that one of ordinary skill in the art would have understood the MSR to disclose treating patients having metastatic colorectal cancer with pembrolizumab. (See Ex. 1049, 444, Ex. 1050, S4.) Patent Owner does not address this evidence. Instead, Patent Owner acknowledges that “the MSR discloses treating cancer patients that could be within the claimed subset,” but argues that the MSR does not inherently anticipate results later obtained by treating only patients within the claimed subset. (See Pet. Sur- Reply 5–6.) We are persuaded, though, that Petitioner’s challenge is based on what one of ordinary skill in the art would have understood from the MSR (that patients who had an unresectable or metastatic tumor were selected), not on what is inherent to the disclosure of the MSR. We are persuaded that one of ordinary skill in the art at the time would have understood the MSR to teach selecting a patient “who has an unresectable or metastatic,” as required in claim 1. c) Element 1.2: “microsatellite instability-high (MSI-H) or mismatch slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Patent Owner argues further that the MSR discloses an experimental use that does not qualify as prior art. (See PO Resp. 16–23.) Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. (See id. at 16 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998).) According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). (See PO Resp. 17–23.) For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. (See PO Resp. 18–20.) Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. (See id. at 19–20.) Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” (Id. at 21.) In City of Elizabeth, the Supreme Court was concerned that “[i]t is sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024). After considering the parties’ arguments and evidence, we are” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“In order to show that objective evidence renders the method of claim 5 non-obvious, Patent Owner must show a nexus between the subject matter recited in claim 5 and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner argues that there is a nexus between the development and commercialization of pembrolizumab and the patented method of treatment recited in the challenged claims, citing, inter alia, the package insert for Keytruda® (pembrolizumab), but Patent Owner does not direct us to evidence of a nexus to MSI-H or MMR deficient tumors that exhibit instability in the microsatellite markers recited in claim 5 and the unexpected results, commercial success, or other objective measures of non-obviousness flowing from these additional limitations. (See PO Resp. 50–63 (citing Ex. 2129, Ex. 2072 ¶ 190, Ex. 2090 ¶¶ 82–92).) Patent Owner directs us only to evidence regarding determining MSI-H status and then using Keytruda® to treat MSI-H cancer patients, which we determine to be anticipated by the MSR. (See PO Resp. 60.) When evidence of a “secondary consideration [] is exclusively related” slip op. at 34
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“(Ex. 1001, 26:19–28.) In Grounds 3 and 5, Petitioner argues, relying on Dr. Neugut’s testimony, that Chapelle teaches standard methods of testing whether a tumor is MSI-H, including determining whether the patient’s tumor exhibits instability in a microsatellite marker, such as BAT-25 or BAT-26. (See Pet. 42 (citing Ex. 1007, 3380, 3383; Ex. 1003 ¶ 107).) For example, Chapelle states that “‘a standard test’ using a ‘[p]anel consisting of … BAT26, BAT25’ has ‘stood the test of time.’” (Ex. 1007 at 3382.) Dr. Neugut testifies that one of ordinary skill in the art would have been motivated to treat a patient with an unresectable or metastatic MSI-H dMMR tumor, wherein the tumor exhibits instability in the BAT-25 and BAT-26 microsatellite marker, and would have expected success in doing so, in light of the teachings of Chapelle. (See Ex. 1003 ¶¶ 105–108.) We find that the record as recounted above supports Petitioner’s challenges of claim 5 in Grounds 3 and 5.” slip op. at 31
Patent outcomesUS 11,339,219 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,339,219 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. et al. v. Chien-Min SungAll claims unpatentablePTAB · Sep 17, 2025 · IPR2024-00533 · APJ Frances L Ippolito · IPR · Final written decision
Claims 1–8 are unpatentable as obvious: claims 1, 3–8 over Chou and Sung ’479; claims 6–7 also over SungECS; and claim 2 over Goers.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We secondly conclude a POSITA would have had at least two years of experience designing and/or developing CMP technology per Patent Owner’s formulation, but we reject Patent Owner’s additional contention that this experience must include designing and/or developing pad dressers specifically. The ’270 patent claims are directed to the structure of a pad dresser, not to a method of making a pad dresser. See Ex. 1001, 17:35– 18:38. According to the ’270 patent specification, the claimed pad dresser structure is designed to condition a polishing pad so the pad may be used to attain “high performance levels in aspects such as uniformity of polished wafer, smoothness of the IC circuitry, removal rate for productivity, longevity of consumables for CMP economics, etc.” during a CMP process. Id. at 1:20–24 (Background of the Invention). Thus, the ’270 patent’s invention generally focuses on optimizing a pad dresser structure to achieve desired results in a CMP process, not necessarily on how to manufacture a pad dresser. As such, we reject Petitioner’s POSITA formulation requiring “experience in the field of integrated circuit processing and fabrication techniques” (Pet. 19) as too generic in the context of the ’270 patent’s claimed invention. We also conclude, in view of the ’270 patent disclosures discussed above, that Dr. Tsai’s opinion that ordinary skill requires experience with manufacturing pad dressers (see Ex. 2011 ¶ 28) is too conclusory and lacking in evidentiary support to be persuasive. See Best Med. v. Elekta, 46 F.4th at 1353 (“The patent’s purpose can also be informative.”).” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“The Federal Circuit has held: “To offer expert testimony from the perspective of a skilled artisan in a patent case — like for claim construction, validity, or infringement — a witness must at least have ordinary skill in the art.”9 Kyocera Senco Indus. Tools Inc. v. Int’l Trade Commission, 22 F.4th 1369, 1375–77 (Fed. Cir. 2022); see also Osseo Imaging, LLC v. Planmeca USA Inc., 116 F.4th 1335, 1340–41 (Fed. Cir. 2024) (holding that the proffered expert does not need to have acquired the 9 Petitioner cites the Practice Guide’s statements that there is “no requirement of a perfect match between the expert’s experience and the relevant field” and “[a] person may not need to be a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather must be ‘qualified in the pertinent art.’” Practice Guide 34 (citing SEB v. Montgomery Ward, 594 F.3d at 1373; Sundance v. DeMonte, 550 F.3d at 1363–64). To the extent there is any tension between the Practice Guide (issued in 2019) and the Kyocera holding (issued in 2022), we apply the latter here.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We determine Dr. Shanfield has sufficient education and experience to qualify as a person of ordinary skill in the art pertaining to the ’270 patent. Dr. Shanfield’s Ph.D. in physics satisfies the educational prerequisite of at least a bachelor’s degree in an engineering related field such as physics. See Ex. 1002 ¶ 2, App. A. Furthermore, his advanced degree (Ph.D. in physics) versus ordinary skill (a bachelor’s degree in an engineering related field) provides considerable leeway when turning to the experiential component for ordinary skill. Nonetheless, Dr. Shanfield also has at least two years of experience with designing and developing CMP technology per the experience prerequisite, as follows. Dr. Shanfield worked at Raytheon Corporation for over 10 years, during which he “worked directly with engineers in the selection, installation, and optimization of several chemo-mechanical polishing systems (CMP), including analysis of operational maintenance and performance monitoring,” and he “directly participated in establishing the required metrology (optical thickness monitoring) for maintaining polishing uniformity standards.” Ex. 1002 ¶ 3 (emphasis added). He later joined Draper Laboratory in 2003, where he currently is the Division Leader of Advanced Hardware Development. See id. ¶ 5. During Dr. Shanfield’s time at Draper, the laboratory “acquired several semiconductor-grade CMP systems for the purpose of fabricating multi-chip modules and for planarization operations in MEMS devices,” and he was “involved in their operation and optimization.” Id. (emphasis added). When asked during a deposition whether he is “an expert in CMP equipment design,” Dr. Shanfield stated he is “very familiar with the design of CMP equipment” because he has “seen many systems” and “installed or supervised the installation of systems.” Ex. 2003, 17:22–19:3. He testified he has “designed apparatus that worked with CMP equipment” although he has not “designed the CMP equipment itself.” Id. at 18:13–19. As an example of being “involved in the manufacture of CMP pad dressers” specifically, Dr. Shanfield stated that during his time at Raytheon, he worked with other professionals “to use the CMP system to process MEMS, M-E-M-S, devices” which “needed a certain kind of planarization process [that] required constant conditioning,” so the team “had to try to fabricate something that would provide conditioning that would last longer.” Id. at 19:4–20:9. Thus, we conclude Dr. Shanfield qualifies as a POSITA pertaining to” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“apply the same claim construction standard “used in the federal courts, in other words, the claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b),” which is articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 83 Fed. Reg. 51,340, 51,358 (Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b) effective November 13, 2018) (now codified at 37 C.F.R. § 42.100(b) (2019)). Under the Phillips standard, the “words of a claim are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips, 415 F.3d at 1312–13. Petitioner proposes constructions for terms: “superabrasive,” “protrusion,” “sharp portion,” and “attitude.” Pet. 20–21. Patent Owner does not propose constructions for any claim term. See generally, PO Resp. We discern constructions of these claim phrases or others are not required for the purposes of this Decision. 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 the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 15
Patent outcomesUS 8,974,270 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,974,270 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. et al. v. Chien-Min SungSome claims unpatentablePTAB · Sep 17, 2025 · IPR2024-00535 · APJ George R Hoskins · IPR · Final written decision
Claims 1–9 and 12–21 are unpatentable over the asserted grounds; claims 10 and 11 were not shown unpatentable because Tsai and Sung ’026 did not establish the required number of working particles.
RulingsFinal written decision- Skill levelOther
“Level of Ordinary Skill in the Art and Patent Owner’s Motion to Exclude Dr. Shanfield’s Testimony ..................................................... 9 1. Person of Ordinary Skill in the Art Pertaining to the ’802 Patent .................................................................................... 9 2. Patent Owner’s Motion to Exclude Dr. Shanfield’s” slip op. at 2
- ExcludeMotion to exclude, deniedDenied
“Level of Ordinary Skill in the Art and Patent Owner’s Motion to Exclude Dr. Shanfield’s Testimony ..................................................... 9” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“16–18 being obvious over Tsai and Sung ’026 as our own in this Decision. See Pet. 56–62, 70–75. We accordingly conclude a preponderance of the evidence presented here establishes the unpatentability of these claims. Patent Owner has waived any opposition other than his filing date priority arguments discussed above. See Inst. Dec. 78; Paper 15, 10.” slip op. at 106
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“concluded: “It is not clear to us, and Dr. Shanfield does not explain persuasively, how Tsai’s disclosure that its ODD has more cutters (i.e., working particles per claim 9) than the conventional BDD leads to his conclusion that all of the diamond particles in the ODD are cutters.” Inst. Dec. 76 (emphasis added). Patent Owner urges us to maintain that conclusion, for various reasons, including testimony from Dr. Tsai. See PO Resp. 49–52; Ex. 2011 ¶¶ 43–47. Patent Owner also reiterates his opposition to Dr. Shanfield’s “extrapolation” from Tsai’s Figures to reach a conclusion as to the total number of diamond grits in the Tsai ODD, including the “working” particles of claims 8, 9, and 12. See id. at 50–51 (citing Ex. 1002 ¶¶ 186–189).” slip op. at 108
Patent outcomesUS 9,724,802 mixed§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,724,802 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. et al. v. Chien-Min SungAll claims unpatentablePTAB · Sep 17, 2025 · IPR2024-00534 · APJ Barry L Grossman · IPR · Final written decision
Claims 1–20 are unpatentable: claims 1–6, 9–12, and 20 are anticipated by or obvious over Sung ’026; claims 5–10 and 13–19 are obvious over the listed combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“We secondly conclude a POSITA would have had at least two years of experience designing and/or developing CMP technology per Patent Owner’s formulation, but we reject Patent Owner’s additional contention that this experience must include designing and/or developing pad dressers” slip op. at 21
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“In his deposition testimony, Dr. Tsai testifies that the Sung ’026 patent application publication “intends to make a diamond disk that has all the protrusion[s] with identical heights and with the same orientation.” Ex. 1049, 50:2–4. Dr. Tsai also testified that “[i]n addition, [Sung ’026] also intends to control the depths of penetrating into the pad. For example, if I want to penetrate 10 micron into the pad, then the protrusion height should be at least 10 micron.” Id. at 50:10–13. So, contrary to Dr. Tsai’s Declaration testimony in Ex. 2011 ¶ 69, Dr. Tsai clarifies in his deposition testimony that Sung ’026 intends to combine three distinct aspects or embodiments. He testifies that “first one is that you need to have the same orientation, same shape so you can have the consistency; and No. 2, you would like to have the same height; and No. 3, you would like to control the penetration depths.” Ex. 1049, 51:2–6. Dr. Tsai was then asked “[s]o Sung ’026 is trying to combine all three of those together, correct?” Id. at 51:9– 10. His answer was “[t]hat’s correct, because if you can have a very good control of those, then -- and that time period back then, then you can make a very perfect diamond disk.” Id. at 51:11–13. Based on the evidence as discussed above, we determine that Sung ’026 discloses the elements and limitations in clause 1[C]. In particular, we credit Dr. Shanfield’s testimony (as summarized above) over Dr. Tsai’s declaration testimony, because Dr. Tsai’s deposition testimony essentially agreed with Dr. Shanfield that Sung ’026 discloses all the aspects recited in claim 1 together in a single embodiment.” slip op. at 48
- ExcludeMotion to exclude, deniedDenied
“Moreover, our general approach for considering challenges to the admissibility of evidence was outlined in Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014). As stated in Corning, similar to a district court in a bench trial, the Board, sitting as a non-jury tribunal with administrative expertise, is well-positioned to determine and assign appropriate weight to evidence presented. Id. (citing Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941) (stating, in the context of reviewing an administrative determination of the National Labor Relations Board based on findings by a Trial Examiner, “We think that experience has demonstrated that in a trial or hearing where no jury is present, more time is ordinarily lost in listening to arguments as to the admissibility of evidence and in considering offers of proof than would be consumed in taking the evidence proffered . . . One who is capable of ruling accurately upon the admissibility of evidence is equally capable of sifting it accurately after it has been received . . . .”)). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00010, Paper 59 at 40 (PTAB February 24, 2014). Rather than excluding evidence that is allegedly hearsay, confusing, misleading, untimely, and/or irrelevant, we will simply not rely on it or give it little or no probative weight, as appropriate, in our analysis. “In an inter partes review, we regard it as the better course to have a complete record of the evidence to facilitate public access, as well as appellate review.” Sony Computer Entm’t Am. LLC v. Game Controller Tech. LLC, IPR2013-00634, Paper 32 at 31 (PTAB Apr. 14, 2015); see also Gnosis S.p.A. v. S. Alabama Med. Sci. Found., IPR2013-00118, Paper 64 at 43 (PTAB June 20, 2014) (citing Donnelly, 123 F.2d at 224 (“If the record on review contains not only all evidence which was clearly admissible, but also all evidence of doubtful admissibility, the court which is called upon to review the case can usually make an end of it, whereas if evidence was excluded which that court regards as having been admissible, a new trial or rehearing cannot be avoided.”)).” slip op. at 32
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“According to Patent Owner, Petitioner’s argument is that “several distinct portions of Sung ’026 purportedly, when viewed together, disclose an embodiment that satisfies the recitation of Claim Limitation [1C].” Id. at 20. Patent Owner asserts, however, that “these individual embodiments of Sung ’026—which it describes in separate portions of the reference as discrete ‘aspects’ of the invention of Sung ’026—cannot not be used collectively to satisfy the anticipation standard.” Id. (citing Net MoneyIN, 545 F.3d at 1371). Simply put, it is Patent Owner’s position that because Sung ’026 fails to disclose these various aspects in a single embodiment as Claim Limitation [1C] recites, Sung ’026 cannot anticipate claim 1. It is Petitioner’s position that Dr. Tsai’s deposition testimony supports Petitioner’s assertions that Sung ’026 anticipates independent claim 1 because the various alleged “individual embodiments” are part of a unified whole that overcome the circumstances discussed in Net MoneyIN. In his deposition testimony, Dr. Tsai testifies that the Sung ’026 patent application publication “intends to make a diamond disk that has all the protrusion[s] with identical heights and with the same orientation.” Ex. 1049, 50:2–4. Dr. Tsai also testified that “[i]n addition, [Sung ’026] also intends to control the depths of penetrating into the pad. For example, if I want to penetrate 10 micron into the pad, then the protrusion height should be at least 10 micron.” Id. at 50:10–13. So, contrary to Dr. Tsai’s Declaration testimony in Ex. 2011 ¶ 69, Dr. Tsai clarifies in his deposition testimony that Sung ’026 intends to combine three distinct aspects or embodiments. He testifies that “first one is that you need to have the same orientation, same shape so you can have the consistency; and No. 2, you would like to have the same height; and No. 3, you would like to control the penetration depths.” Ex. 1049, 51:2–6. Dr. Tsai was then asked “[s]o Sung ’026 is trying to combine all three of those together, correct?” Id. at 51:9– 10. His answer was “[t]hat’s correct, because if you can have a very good control of those, then -- and that time period back then, then you can make a very perfect diamond disk.” Id. at 51:11–13. Based on the evidence as discussed above, we determine that Sung ’026 discloses the elements and limitations in clause 1[C]. In particular, we credit Dr. Shanfield’s testimony (as summarized above) over Dr. Tsai’s declaration testimony, because Dr. Tsai’s deposition testimony essentially agreed with Dr. Shanfield that Sung ’026 discloses all the aspects recited in claim 1 together in a single embodiment.” slip op. at 48
Patent outcomesUS 9,138,862 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,138,862 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Anthony Inc. v. Controltec, LLCInstitutedPTAB · Aug 25, 2025 · IPR2025-00559 · APJ Barry L Grossman · IPR · Institution
The Board instituted IPR of claims 1–20 on all asserted grounds after finding a reasonable likelihood that Petitioner would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“After considering the Petition, the Preliminary Response, and the evidence of record, based on the analysis in this Decision, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of the challenged claims is unpatentable. A decision to institute is “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). Accordingly, we institute an inter partes review of all challenged claims and on all grounds asserted in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“Petitioner asserts that a person of ordinary skill in the art would have had “a bachelor’s degree in mechanical engineering, electrical engineering, or a comparable field and at least three to five years of experience related to heating, ventilating, air conditioning, and refrigeration (HVAC&R) systems.” Pet. 4 (citing Ex. 1003 ¶¶ 31–35). Dr. Henze’s Declaration testimony states he considered some of the factors listed above. Ex. 1003 ¶¶ 31–35). Dr. Henze testifies that, in his opinion, the level of ordinary skill is as stated by Petitioner. Id. at 31. He also states that “[s]uch experience could be obtained through research and study in a graduate program or through comparable exposure through industry employment, and additional years of experience could substitute for the advanced-level degree.” Id. Patent Owner does not assert a level of ordinary skill, nor does Patent Owner dispute Petitioner’s definition of the level of ordinary skill. See generally Prelim. Resp. For purposes of this Decision, based on the prior art, the sophistication of the disclosed technology in the ’181 patent, and Dr. of ordinary skill.9” slip op. at 13
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesTerm construed petitioner constructionDecided for petitioner
“Petitioner asserts that nine terms are “mean-plus-function claim terms.” Pet. 4–10. As required by our rule, (37 C.F.R. § 104(b)(3)), for each of the mean-plus-function claim terms, Petitioner identifies the function as well as the specific portions of the ’181 patent’s specification that describe the corresponding structures. Id. Patent Owner does not comment on Petitioner’s proposed means-plus- function claim constructions. See generally Prelim. Resp. Thus, for purposes of this initial decision, we will adopt the means-plus-function constructions proposed by Petitioner.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededPlain and ordinary meaningOther
“We do not perceive the need to construe any additional claim limitation. Our conclusion concerning instituting an inter partes review would be unaffected by a determination that the preambles of the claims are limiting. Accordingly, for this initial Decision to institute an inter partes review, the words “display” or “frame,” and the term “display case” will be given their ordinary and customary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure.” slip op. at 15
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,207,181 - PTAB · Aug 11, 2025 · IPR2025-00560 · APJ Barry L Grossman · IPR · Institution
The Board instituted IPR on claims 1–29 and every asserted ground, finding a reasonable likelihood that claim 1 is unpatentable over Chang and Fang.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” 35 U.S.C. § 314(a). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art would have had “bachelor’s degree in mechanical engineering or a similar field and at least two years of experience designing human breast pump equipment. More education could substitute for experience and vice versa.” Pet. 8 (citing Ex. 1003 ¶¶ 15–18). Mr. Bauer’s Declaration testimony states he considered some of the factors listed above. Ex. 1003 ¶ 17. Mr. Bauer testifies that based on his background and experience, in his opinion, the level of ordinary skill is as stated by Petitioner. Id. at 18. For purposes of this Decision, based on the prior art, the sophistication of the disclosed technology in the ’381 patent, and Mr. Bauer’s undisputed testimony, we adopt Petitioner’s definition of the level of ordinary skill.13” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because binding. We wish to have the record developed before rendering any binding determination, finding, or conclusion. 14 The citation to Ex. 1005, 2290 appears to be an error. We do not find the cited claim construction at this location. we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Petitioner also asserts that “[m]ultiple reasons would have prompted a POSITA to implement a diaphragm pump in Chang’s breast pump device in accordance with Fang’s suggestions.” Id. at 21–24. Based on the record before us, we agree that Fang discloses a diaphragm, as recited in clause 1[a][1]. We also agree, based on the record before us, that a person of ordinary skill would have had multiple reasons to use Fang’s diaphragm pump in Chang’s device with a reasonable expectation of success.” slip op. at 21
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,813,381
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.