- 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 - PTAB · Sep 23, 2025 · IPR2025-00270 · APJ Bach V Hoang · IPR · Institution
The Board instituted IPR on claims 1–13, 15, 18, 20, 21, and 27 on all asserted grounds, finding a reasonable likelihood that claim 13 is obvious over Rohall and Schiavone.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” 35 U.S.C. § 314(a). Having reviewed the parties’ papers and the evidence of record, we determine that Petitioner has shown a reasonable likelihood it would prevail in establishing the unpatentability of at least one challenged claim. Accordingly, we institute an inter partes review on all challenged claims and on all grounds raised in the Petition. See 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner asserts a person of ordinary skill in the art in May 2004 would have had a working knowledge of the telecommunications and networking art that is pertinent to the [’911 patent]. A POSITA would have had a bachelor’s degree in electrical engineering, computer science, computer engineering, or an equivalent, and two years of relevant experience involving computer science fundamentals, including pointers, data structures, object-oriented programming, database principles, internet-based communication technologies and electronic mail systems that is pertinent to the [’911 patent]. Lack of professional experience can be remedied by additional education, and vice versa Pet. 3 (citing Ex. 1003 ¶ 22). Patent Owner asserts a person of ordinary skill in the relevant art — computer science — would have at least a bachelor’s degree in electrical or computer science/engineering, or a related field, with at least two years of experience in the design or implementation of content management and analysis systems or a master[’s] degree in electrical or computer science/engineering, or a related field, with at least one year of experience in the design or implementation of content management and analysis systems. A higher level of education or skill can make up for less experience, and vice versa. Prelim. Resp. 17 (citing Ex. 2002 ¶ 14). For purposes of this Decision, we adopt Petitioner’s proposed level of skill, as articulated above. Petitioner’s proposed definition generally teachings of the ’911 patent and the asserted prior art. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art). This definition is also supported by the testimony of Dr. Black.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“relational references” require using a relational model (or that they are a relational model) and, for purposes of this decision, we adopt Petitioner’s proffered construction. The relevant portion of claim 1 recites “a message container containing relational references pointing to a plurality of sent submessages stored externally to the message container in the message database.” Ex. 1001, 15:56–59. That express language does not recite a relational model, let alone that “relational references” connote required use of a relational model. Instead, the language supports Petitioner’s interpretation that “relational references” are pointers that point to related messages because the claim states that the “relational references” perform the task of “pointing to a plurality of sent submessages.” Although Patent Owner asserts that “pointers pointing” would be redundant (Prelim. Sur-reply 3), we disagree. In addition to being different parts of speech, i.e., a pointer is a noun and pointing is a verb defining what the noun is doing, the claim does not merely recite “relational references pointing.” Rather, Petitioner’s proposed construction outlines what the “relational references” include, i.e., “pointers,” and claim 1 further limits what the “relational references” are “pointing to,” i.e., “to a plurality of sent submessages.” Prelim. Resp. 9. Further, the Specification supports adopting Petitioner’s construction over Patent Owner’s. The Specification does not state that “relational references” require the use of, or are, a relational model, as Patent Owner argues. Rather, any discussion of “relational references” in the Specification describes them as message components that refer to content or other data, e.g., a pointer. Ex. 1001, 3:6–16 (“a message is a container having relational references to content and/or audit data”); see id. at 1:67–2:2, 4:61–64, slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“We agree with Petitioner that the ordinarily skilled artisan would have been motivated to combine Rohall and Schiavone because Schiavone provides reasons to apply its techniques to email systems such as Rohall’s. Schiavone describes a need for “ensuring compliance of e-mail messages with applicable standards and/or laws and/or otherwise determining appropriateness of a message for an intended recipient,” especially because there is “a patchwork of local, federal and international laws.” Ex. 1006 ¶ 6. Schiavone also states that filtering emails, e.g., to remove spam, is beneficial. Id. ¶¶ 1–2. As Schiavone describes problems in email systems, adequately shows that the ordinarily skilled artisan would have been motivated to combine Rohall and Schiavone. See KSR, 550 U.S. 401 (a reference which teaches, suggests, or motivates its combination may “identify a reason that would have prompted a person of ordinary skill in the art to combine the elements”).” slip op. at 17
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 8,073,911 - 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 - PTAB · Aug 29, 2025 · IPR2025-00479 · APJ Justin T Arbes · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–20 were obvious over Erskine, Scherzer, or Scherzer and Gillett.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“III. CONCLUSION Based on the arguments and evidence presented by the parties, we conclude that Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to at least one claim of the ’634 patent challenged in the Petition. Therefore, we do not institute an inter partes review. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied and no inter partes review is instituted.” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner argues that at the time of the ’634 patent (July 2018), a person of ordinary skill in the art would have had “a bachelor’s degree in electrical engineering, computer science, computer engineering, or a similar major with at least two years of experience in the field; or a master’s degree with specialization in the field,” where “[a] person with less education but more relevant practical experience may also meet this standard.” Pet. 7 (citing Ex. 1003 ¶¶ 12–13). Petitioner further argues that a person of ordinary skill in the art would have had knowledge of “[d]esigning and using systems that include endpoint devices (e.g., client devices) and servers for establishing network connections and data transfer,” “[r]ecognizing and applying the client-server architecture,” and “[u]sing and applying concepts from known telecommunication and networking frameworks, protocols and standards, including TCP/IP, IEEE 802.11, VoIP, cellular systems and other known frameworks and standards.” Id. (citing Ex. 1003 ¶ 14). Patent Owner does not address the level of ordinary skill in the art in its Preliminary Response. Based on the record presented, including our review of the ’634 patent and the types of problems and solutions described in the ’634 patent and cited prior art, we agree with Petitioner’s definition and apply it for purposes of this Decision. See, e.g., Ex. 1001, col. 1, ll. 4–29 (describing in the “Background” section of the ’634 patent a “network connection between two endpoints” and known methods of reaching “full effective bandwidth capacity” in a network).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Interpretation We interpret each challenged claim using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Petitioner notes that it proposed a construction for the claim term “geographical area” in the district court case, but states that it “do[es] not believe proposing a construction for the term is necessary in this proceeding because the relied upon teachings of the prior art references are consistent with examples of ‘geographical area’ included in the ’634 patent [S]pecification.” Pet. 8. Patent Owner argues that “[t]he Board need not engage in express claim construction at this stage of the proceeding.” Prelim. Resp. 5. We conclude that no express interpretation of any claim term is necessary to determine whether to institute an inter partes review in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe [a particular claim limitation] where the construction is not ‘material to the . . . dispute.’” (citation omitted) (emphasis added)).” slip op. at 9
- BurdenNot shown unpatentable
“Petitioner has not shown sufficiently that Erskine teaches or suggests the second requirement of limitation [1c], i.e., “initiating the next network connection . . . with a transmission bandwidth based on the parameter values for the past network connection.” Petitioner’s theory is that (1) the QoS parameters in Erskine are for a “past” connection from one zone to another, (2) the sliding maximum interzone bandwidth is “based on” the QoS parameters, and (3) a new call only proceeds if the transmission bandwidth needed for the call added to the current bandwidth being used over the interzone link is less than the sliding maximum interzone bandwidth, so Erskine therefore teaches a call with a transmission bandwidth determined “based on” the sliding maximum interzone bandwidth (which in turn is determined “based on” the QoS parameters). See Pet. 27–28; Ex. 1003 ¶¶ 59–60 (similar testimony from Dr. Crovella). As Patent Owner points out, however, Erskine only makes “a binary, accept/reject decision as to whether to allow a new call to proceed based on a comparison between the bandwidth needed for the call and a predetermined ‘sliding maximum interzone bandwidth value.’” See Prelim. Resp. 6–7. Specifically, the additional bandwidth that would be needed for the call is added to the current bandwidth being used on the interzone link; if the sum of those values is less than the sliding maximum interzone bandwidth for the link, the call “proceeds”; otherwise, it is “blocked.” Ex. 1004, col. 4, ll. 36–40, col. 6, l. 55–col. 7, l. 10, col. 8, ll. 36–43, col. 9, ll. 9–26, col. 10, ll. 23–25 (the sum is compared to the sliding maximum interzone bandwidth “to determine whether enough bandwidth is available to proceed with the new call”), Fig. 3 (steps 308, 310, and 312). Erskine repeatedly refers to the bandwidth for the new call as the amount of bandwidth that is “necessary” or “required” to handle the call. See, e.g., id. at col. 1, ll. 43–57 (“an amount of bandwidth necessary to handle the new call”), col. 6, ll. 61–64 (“the additional bandwidth required (of the new call)”), col. 8, ll. 36–40 (“the bandwidth necessary for the new call”), col. 9, ll. 16–21 (“the anticipated additional bandwidth necessary for the new call”), 54–56 (“the bandwidth amount the new call will utilize (if connected)”), col. 10, ll. 21–23 (same), 41–43 (same), col. 12, ll. 1–2 (“an amount of bandwidth necessary to handle the new call”). It is that value—determined prior to the addition and comparison to the sliding maximum interzone bandwidth—that will be used for the new call if it is allowed to “proceed[].” Id. at col. 6, ll. 64–67 (if the sum is less than the sliding maximum interzone bandwidth, the call “proceeds” and “the QoS table is updated with the additional bandwidth used by that call”). Erskine does not describe the transmission bandwidth for the new call as being based on any parameter values for a past network connection, but rather as “whatever bandwidth the system determined is necessary for the additional call.” See Prelim. Resp. 8–9. In other words, the transmission bandwidth needed for a new call is predetermined and independent of whatever the sliding maximum interzone bandwidth is currently. See id.” slip op. at 15
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,944,634 - 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 - Aylo Freesites Ltd v. Wellcomemat, LLCAll claims unpatentablePTAB · Aug 26, 2025 · IPR2024-00710 · APJ Brian P Murphy · IPR · Final written decision
Claims 13–15 and 17–20 are unpatentable: claims 13–15 and 20 as anticipated by Fegan, claim 17 as obvious over Fegan and Sull, and claims 13–14 and 17–20 as obvious over Vasilevsky and Logan.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“afforded experts in forming opinions in reliance on hypotheticals and “presentation of data to the expert outside of court and other than by his own perception,” i.e., hearsay. Id. (Adv. Comm. Notes). And where a court acts as fact finder, rather than a jury, the danger of unfair prejudice to the objecting party is substantially diminished. See Science Applications Int’l Corp. v. United States, 175 Fed. Cl. 389, 395 (2025) (“bench trials limit the ‘concern for juror confusion or potential prejudice’”) (citations omitted). The Board, sitting as a non-jury tribunal with administrative expertise, is well-positioned to determine and assign appropriate weight to evidence presented, as we have done in the present case. See Gnosis S.p.A. v. S. Alabama Med. Sci. Found., Case IPR2013-00118, slip op. at 43 (PTAB June 20, 2014) (Paper 64); see also Donnelly, 123 F.2d at 224 (“One who is capable of ruling accurately upon the admissibility of evidence is equally capable of sifting it accurately after it has been received.”). In rendering our Decision, we have assigned appropriate weight to Exhibit 2022 in view of the entire record before us. For the reasons given above, we deny Petitioner’s motion to exclude Exhibit 2022.” slip op. at 78
Patent outcomesUS 8,307,286 unpatentableNonecites KSRPatents in suitUS 8,307,286 - PTAB · Aug 13, 2025 · IPR2025-00430 · APJ Bach V Hoang · IPR · Institution
The Board instituted IPR on claims 1–3, 5–9, 13–15, 18, 19, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Rose.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“j) Conclusion as to Claim 1 For the reasons discussed above, and based on Petitioner’s contentions and evidence, summarized above, we are persuaded, on this record, that Petitioner shows a reasonable likelihood of prevailing in demonstrating that claim 1 would have been obvious over Rose. 3. Institution of Inter Partes Review Because we are persuaded that Petitioner has shown a reasonable likelihood of prevailing in demonstrating that the subject matter of claim 1 would have been obvious over Rose, we institute an inter partes review of all claims and all challenges raised in the Petition. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 365 (2018) (stating 35 U.S.C. § 314 “simply requires [the Director] to decide whether the petitioner is likely to succeed on ‘at least 1’ claim. Once that single claim threshold is satisfied, it doesn’t matter whether the petitioner is likely to prevail on any additional claims; the Director need not even consider any other claim before instituting review”); 37 C.F.R. § 42.108(a).” slip op. at 26
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s description is more restrictive than that of Petitioner because it requires the POSITA to have more experience or education in the relevant field. Based on the current record and for the purposes of this Decision, we adopt Petitioner’s proposed level of skill. Petitioner’s proposed definition generally comports with the level of skill necessary to understand and implement the teachings of the ’271 Patent and the asserted prior art. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art). Although we adopt Petitioner’s definition of a person of ordinary skill in the art, our determination regarding Petitioner’s challenge does not turn on the differences between Petitioner’s and Patent Owner’s definitions, and our conclusions would be the same under either definition.” slip op. at 8
- Expert testimonyPatent owner expert creditedDecided for patent owner
“Furthermore, the computer program module limitations are undisputedly coupled with respectively recited functions. See Pet. 11–16 (identifying corresponding functions for each recited module). Dr. Kahn testifies that the POSITA would understand the recited functions can be performed by existing or off-the-shelf systems and that the functions recited explain how to engineer, build, or implement the modules using known and available techniques. Ex. 2001 ¶¶ 25–35. For institution purposes, we credit Dr. Khan’s testimony and determine that a POSITA would have understood the module limitations connote structure. See Dyfan, LLC v. Target Corp., 28 F.4th 1360, 1369 (Fed. Cir. 2022) (“[B]ecause the recited functions can be performed by conventional off-the-shelf software, a person of ordinary skill in the art would have understood the alleged means-plus-function ‘code’ limitations in the asserted claims to connote structure.”) (citing Zeroclick, LLC v. Apple Inc., 891 F.3d 1003, 1008 (Fed. Cir. 2018)); WSOU Invs. LLC v. Google LLC, No. 2022-1063, 2023 WL 6889033, at *5 (Fed. Cir. Oct. 19, 2023) (“‘[C]omputer program code,’ when combined with a description of what the code is intended to accomplish, convey definite structure to the ordinarily skilled artisan.”). Accordingly, for institution purposes, we conclude that the computer program module limitations recited in claims 1 and 6 are not written in means-plus-function format because they would have connoted sufficiently definite structure to persons of ordinary skill in the art.” slip op. at 11
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) does not applyDecided for patent owner
“Id. 48:19–51. That language suggests that the module limitations are software instructions or code because the modules are defined as “computer program modules” or “computer program instructions.” Id. at 47:32, 48:20– 21. Moreover, the claims recite that the modules are stored in a computerreadable storage medium and are instructions to be executed by a processor, further suggesting the modules are software instructions or code. Id. at 47:30–32, 48:16–21. The testimony of Dr. Kahn, which we credit for institution purposes, supports that understanding; Dr. Kahn states a POSITA would understand that “‘computer program modules’ stored on a ‘computerreadable storage medium’ refers to software instructions or code.” Ex. 2001 ¶ 24. Furthermore, the computer program module limitations are undisputedly coupled with respectively recited functions. See Pet. 11–16 (identifying corresponding functions for each recited module). Dr. Kahn testifies that the POSITA would understand the recited functions can be performed by existing or off-the-shelf systems and that the functions recited explain how to engineer, build, or implement the modules using known and available techniques. Ex. 2001 ¶¶ 25–35. For institution purposes, we credit Dr. Khan’s testimony and determine that a POSITA would have understood the module limitations connote structure. See Dyfan, LLC v. Target Corp., 28 F.4th 1360, 1369 (Fed. Cir. 2022) (“[B]ecause the recited functions can be performed by conventional off-the-shelf software, a person of ordinary skill in the art would have understood the alleged means-plus-function ‘code’ limitations in the asserted claims to connote structure.”) (citing Zeroclick, LLC v. Apple Inc., 891 F.3d 1003, 1008 (Fed. Cir. 2018)); WSOU Invs. LLC v. Google LLC, No. 2022-1063, 2023 WL 6889033, at *5 (Fed. Cir. Oct. 19, 2023) (“‘[C]omputer program code,’ when combined with a description of what the code is intended to accomplish, convey definite structure to the ordinarily skilled artisan.”). Accordingly, for institution purposes, we conclude that the computer program module limitations recited in claims 1 and 6 are not written in means-plus-function format because they would have connoted sufficiently definite structure to persons of ordinary skill in the art.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 7,716,217 - Ceva Santé Animale S.A. / Egg-Chick Automated Technologies S.A.S et al. v. Targan, Inc.Some claims unpatentablePTAB · Jul 24, 2025 · IPR2024-00595 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–15 are unpatentable as obvious over the asserted §103 grounds; Petitioner did not show claims 16–18 unpatentable because the angled-conveyor combination lacked a supported rationale.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us, including the ’124 patent, the Gershman, Pierre, Yavnai, Tao, and Goodwin references, and the background and qualifications of both sides expert witnesses that reflect the knowledge and experience of a POSITA, including knowledge of systems for assessing and transporting poultry in an industrial setting. Patent Owner’s proposed skill level overlaps with Petitioner’s proposed skill level, and any differences would not alter the outcome of this proceeding. Therefore, we adopt Patent Owner’s proposed skill level with two modifications. A POSITA also could have a Bachelor of Science degree in Animal Science or similar discipline, and a POSITA would be familiar with techniques for assessing and transporting poultry in an industrial setting, such as visual and/or anatomical characteristics of a chick.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“Therefore, we find that Applicant distinguished Tao from “an unrestrained chick” because in Tao’s automated system a chick is restrained—the chick is held in place—by a retainer unit on a moving platform, whereas in Applicant’s claimed system a chick is not held in place on a moving platform. We further conclude that Applicant’s reason for distinguishing the claimed invention over Tao informs the claim construction even if the “prosecution history statements do not rise to the level of unmistakable disavowal . . . .” Personalized Media, 952 F.3d at 1345 (Fed. Cir. 2020). In view of the ’124 patent claims, specification, and prosecution history, we determine “an unrestrained chick” is a chick not held in place on the moving platform and free to open its wings.” slip op. at 19
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“For the reasons given below, we find the Petition has established that Gershman discloses and teaches “a moving platform to support an unrestrained chick of a particular breed” by a preponderance of the evidence.” slip op. at 29
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“to determine a characteristic [of the chick] . . . [that] manifests in one of two or more possible states, e.g., sex (male vs. female), health (healthy vs. unhealthy), genetic mutation (present vs. not present).” Reply 13 (citing Ex. 1004, 3). The recitation of a generic “database of images” does not distinguish limitation [1.4] from the asserted combination of Gershman-Pierre, particularly in view of Pierre’s disclosure of “a computerized processing process is implemented in order to compare the captured images to reference images,” as asserted in the Petition. Ex. 1004, 3 (emphasis added); see Pet. 23–24 (citing Ex. 1003, 2–5; Ex. 1004, 3, 5). Thus, we find that storage of Pierre’s reference images of male and female wing feathers in a database used for comparison in Gershman’s computerized digital chick image processing system would have been obvious to a POSITA and satisfies limitation [1.4].19 We agree with Petitioner that it would have been obvious and well within the skill level of a POSITA—someone with a Bachelor of Science degree in agricultural, industrial, or electrical engineering and two years of experience in industrial poultry sexing and/or image processing (Resp. 20)—to store reference images as taught by Pierre in a “computerized processing” database. The rationale argued by Petitioner, to organize the collection of reference images for comparison to determine whether the characteristic of interest was present, finds direct support in Gershman and Pierre. Both references disclose comparing digital images of a chick’s wing feathers to reference data (Gershman) or reference images (Pierre) of male and female chick wing patterns. Pet. 23–24; Reply 12–13. Storing digital reference images in a database for comparison to captured digital images is, moreover, a basic and straightforward task in any computerized image processing” slip op. at 44
Patent outcomesUS 10,806,124 mixedClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,806,124
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.