- Micron Technology, Inc. v. Yangtze Memory Technologies Co., Ltd.No claims unpatentablePTAB · Jul 21, 2026 · IPR2025-00190 · APJ Kimberly Mcgraw · IPR · Final written decision
Claims 1, 3–11, 13, and 14 were not shown unpatentable because Dong did not disclose the claimed vertical wordline arrangement, and the proposed 3D NAND combination lacked support for motivation and reasonable expectation of success.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“understanding that the claim term “from bottom to top” refers to the vertical arrangement of word lines in the memory portions from bottom to top and not from source end to drain end, as asserted by Petitioner. Inst. Dec. 17. In other words, the claim terms describing the first and second portions having word lines “from top to bottom” refer to the relative vertical location of the word lines within the memory portions and not to location of the word lines relative to the source or drain. Our construction is based on the plain and ordinary meaning of the express language of the independent claims, which states that the second memory portion is formed either above or below the first memory portion. The forming of one memory portion above or below another portion establishes a top and bottom in relation to those portions. For example, claim 5 is directed to a “program method of memory” that requires a second portion formed above the first portion. A second memory portion that is formed above a first memory portion is on top relative to the first portion. Similarly, claims 1 and 1 and 11, which recite a memory having a second portion formed below a first portion, establish that the second portion is on the bottom relative to the first portion. Thus, the claim language itself establishes the vertical locations of the memory portions relative to each other (e.g., a second memory portion that is above the first portion is on top, relative to the first portion). It follows that claim terms referring to the top and bottom of word lines within the memory portions also refer to relative vertical locations of the word lines within the memory portions. Thus, we understand the plain and ordinary meaning of claim” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In our Decision, we treated the preambles of claims 5 and 11 as limiting, noting that these preambles provide antecedent basis for the word line limitations recited in the body of their respective claim. Dec. 14–15, 8. Neither party disputes that the preambles of claims 5 and 11 are limiting. See PO Resp. 34–35 (agreeing that the preambles are limiting); see generally Reply 1–6 (not disputing that the preambles are limiting). We maintain our construction of the preambles in this Decision.” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“we consider the level of ordinary skill at the time of filing. 35 U.S.C. § 103; see also Graham, 383 U.S. at 17 (discussing pre-AIA obviousness). Petitioner contends that a person of ordinary skill in the art (“POSITA”) would have had a had a bachelor’s degree in electrical engineering or a similar discipline, along with 2–3 years of professional experience working with (e.g., researching, designing, or teaching) NAND memory devices (including issues relating to the operation, e.g., programming, of said devices), or an equivalent level of skill, knowledge, and experience (e.g., an advanced degree may replace some of the professional experience). Pet. 22 (citing Ex. 1004 ¶¶ 40–42). Petitioner also asserts that a POSITA would have been aware of and generally knowledgeable about NAND memory’s structure and fabrication, its component parts, how it operates, and how it is controlled. Id. at 22–23 (citing Ex. 1004 ¶ 41). In the Institution Decision, we adopted the assessment offered by Petitioner, which Patent Owner did not contest. Inst. Dec. 13. Following institution, Patent Owner stated it does not dispute Petitioner’s definition of a POSITA. PO Resp. 9 (citing Khatri Dec. ¶¶ 42–47). Because Petitioner’s definition of the level of skill in the art appears consistent with the ’941 patent and the asserted prior art, we maintain it for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir 2001).” slip op. at 9
- Expert testimonyPatent owner expert creditedOther
“We disagree and find that Dong’s Figure 5a does not depict wordlines in a physical vertical orientation, but rather depicts voltage diagrams. We agree with Patent Owner’s argument, supported by persuasive testimony by Dr. Khatri, that a POSITA would have understood that Dong’s voltage charts (e.g., Fig. 5a) simply represent which voltages are applied to which word lines and do not depict the physical orientation of the wordlines. See, e.g., Ex. 2028 ¶ 171 (citing Ex. 1005 ¶ 20; Ex. 1009 ¶¶ 52–54). As Dr. Khatri explains, Dong Figures 5a–5h depict different examples of self-boosting modes showing voltages applied differently to the wordlines and are not intended to depict the physical orientation of these word lines. Ex. 2028 ¶ 171; see also Sur-reply 11–12 (citing Ex. 1005 ¶¶ 47, 65, 63–67; Ex. 2028 ¶¶ 177–186). We agree with Dr. Kahtri’s persuasive testimony that a POSITA would understand that Figures 5a–5h are illustrated vertically, but do not represent the actual physical arrangement of the word lines in memory, which are shown to be horizontal in Dong’s Figure 4. See, e.g., Ex. 2028 ¶ 172 (citing Ex. 1005 ¶¶ 20, 45, 47, 87).” slip op. at 24
Patent outcomesUS 11,568,941 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,568,941 - Google LLC v. Sandpiper CDN, LLCInstitutedPTAB · Dec 1, 2025 · IPR2025-01010 · APJ Michael T Cygan · IPR · Institution
The Board instituted IPR on claims 1–15 and all asserted grounds, 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
“review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2023). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons given below, on this record, Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one of challenged claims 1–15 of the ’322 patent. Accordingly, we institute an inter partes review of the ’322 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art (“POSITA”) at the critical time “would have had at least a bachelor’s degree in computer 3 Neither party presents evidence or arguments regarding objective evidence of non-obviousness. work or research experience in the field of content delivery management or networks,” and that “[w]ork experience can substitute for formal education and additional formal education can substitute for work experience.” Pet. 10 (citing Ex. 1003 ¶¶ 61–63). Patent Owner does not provide any such assessment in its Preliminary Response. Prelim. Resp. 11. For purposes of this Decision, we adopt Petitioner’s proposed level of ordinary skill, as it appears to be consistent with the specification of the ’322 patent and the prior art of record.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“On the current record, we determine that the “modified embedded resource” may be a “link.” Both Petitioner and Patent Owner point to claim 13, which explicitly states that a modified embedded resource is a link. Because claim 13 depends from claim 1, claim 1 must be broad enough to encompass a modified embedded resource that is a link. Patent Owner also points to a statement in the ’322 patent that “[t]he embedded resource is a link.” Prelim. Resp. 18 (citing Ex. 1001, 4:26–31). Patent Owner argues that every embodiment of the ’322 patent “involves embedding the ‘modified embedded resource’ in another resource when it is returned to the client.” Paper 16, 2–3. Patent Owner cites to description in the ’322 patent of a “document” or a “page” returned to the requesting client. Id. (citing Ex. 1001, 4:42–48, 7:48–55). However, claim 15 does not return the modified embedded resource to the client, only the origin system. Claim 1 recites only that the “modified embedded resource” is returned to the client device with the content resource. Neither claim 1 nor claim 15 recite returning a document or a page containing the modified embedded resource, only the modified embedded resource itself. We acknowledge some tension with the adjective “embedded,” which Patent Owner argues requires that the embedded resource be embedded in something. Paper 16, 1–3. However, the clear description of an embedded patent, more strongly guides our preliminary construction.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We are persuaded by Petitioner’s assertions for limitations [15pre]– [15a]. Dr. Mowry attests that Verna’s client browser sends a URL 28 to a content provider 22, which is then forwarded to broker 25, which selects the appropriate cache server to serve the content and returns a re-written URL to the content server that received the client request. Ex. 1003 ¶ 67 (citing Ex. 1005 ¶¶ 12, 26, 27, 37). On the current record, this function of Verna’s broker fulfills Dr. Russ’s characterization of an API as acting as bridge establishing a connection between client and server. Ex. 2010 ¶ 50. Verma also meets Dr. Russ’s characterization of an API as “an interface that allows the client to communicate with an application executing on the server.” Ex. 2010 ¶ 50. Dr. Russ describers Verma’s broker as sending availability inquiries from the content provider (client) to servers 23 and 24 to “find out whether they currently store the requested movie file,” and provide that information back to the content provider (client). Id. ¶ 53. On the current record, this function of Verna’s broker fulfills Dr. Russ’s characterization of an API acting as an interface that allows the client to provides availability information to the broker). Consequently, we determine that Petitioner has shown Verma to disclose limitation [15a] for purposes of institution on the current record.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,057,322 - Google LLC v. Sandpiper CDN, LLCInstitutedPTAB · Nov 25, 2025 · IPR2025-00860 · APJ Sheila F Mcshane · IPR · Institution
The Board instituted review of claims 1–20 on all asserted grounds, finding a reasonable likelihood that the Dilley, Pai, and Wang combination renders the claims obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“partes review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the petition and the preliminary 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.” For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We therefore institute inter partes review as to all of the challenged claims of the ’573 patent and all of the asserted grounds of unpatentability in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“III. ANALYSIS A. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art: would have had at least a bachelor’s degree in computer science, electrical engineering, or a related field, and at least two years of work or research experience in the field of content delivery management or networks. Work experience can substitute for formal education and additional formal education can substitute for work experience. Pet. 12 (citing Ex. 1006 ¶ 70). Patent Owner asserts that “the Board does not need to resolve the appropriate level of skill for a POSA [person of ordinary skill in the art] for purposes of deciding institution because the Petition fails under any articulation of a POSA.” Prelim Resp. 10. For the purposes of this Decision, we adopt the assessment offered by Petitioner as it is consistent with the ’573 patent and the prior art before us. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no claim terms need to be expressly construed by the Board and all terms should be given their ordinary meaning. Pet. 12. Patent Owner agrees that the Phillips standard applies. Prelim. Resp. 10. We determine that we need not expressly construe any claim terms at this juncture. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“We consider the disclosures of the Provisional Application, which refer to cases 1 and 2, in which requests are redirected to an origin server for lower popularity content and to a parent server for medium popularity content at steps 522 and 524 as shown in Figure 5, respectively, wherein the edge server receives a redirect from the popularity service without a “followme” flag. See Ex. 1011 ¶¶ 43, 44. The Provisional Application also discloses that, by comparison, if there is a “follow-me” redirect sent to the edge server, it obtains and caches a resource as shown at step 528 for higher popularity content. Id. ¶ 44. On this record, as Patent Owner asserts, these disclosures are consistent with technical reasons provided in the Provisional Application for instructing the edge server not to cache unpopular resources. See Ex. 1011 ¶¶ 68–69. In light of these disclosures, we preliminarily find support for Dr. Shenoy’s testimony that, even with the words “instruction to not cache” are not literally recited in the Provisional Application, caching and not caching are alternative options that indicate the instruction to the edge server that will be implemented for each option. See Ex. 2014 ¶ 56. Further, these disclosures provide support for Dr. Shenoy’s testimony that the disclosures “reasonably convey to those skilled in the art that Patent Owner had possession of the edge server receiving an instruction to not cache the resource (and instead simply forward the redirect).” Id. In re Johnson states that “it is not true that the factual context out of which the question under § 112 arises is immaterial. Quite the contrary. Here, . . . the ‘written description’ in the [] specification supported the claims in the absence of the limitation, and that specification, having described the whole, necessarily described the part remaining.” See Johnson, 558 F.2d at 1019. This is consistent with M.P.E.P. § 2173.05(i) which states, “[i]f alternative elements are positively recited in the specification, they may be explicitly excluded in the claims.” M.P.E.P. § 2173.05(i). Further, “the failure of the specification to specifically mention a limitation that later appears in the claims is not a fatal one when one skilled in the art would recognize upon reading the specification that the new language reflects what the specification shows has been invented.” All Dental Prodx, LLC v. Advantage Dental Prod., Inc., 309 F.3d 774, 779 (Fed. Cir. 2002). Even though we do not discern that the Provisional Application explicitly discloses an “instruction to not cache,” at least on this preliminary record, and for the purposes of this Decision, there is positive recital of instructions to cache in the Provisional Application and Petitioner has provided sufficient supporting evidence that caching and not caching are alternative options. Further, there is sufficient evidence, in the context of the disclosures of written description support in the Provisional Application, providing support for Dr. Shenoy’s testimony that Patent Owner had possession of an edge server receiving an instruction to not cache the resource. Nonetheless, we invite additional briefing on these issues, including issues relating to alternative options of caching and not caching. On this preliminary record, we find that the ’573 patent has a priority date of April 2, 2008, which predates the earliest possible date on which Newton-471 could be effective as prior art, September 30, 2014 (the date on which the earliest application in the priority chain of Newton-471 was filed). Accordingly, we preliminarily find that Newton-471 is not prior art to the challenged claims. Thus, on the present record, Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claims 1–20 are anticipated by Newton-471.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,924,573 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner
“Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30
Patent outcomesUS 11,643,462 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22
- Skill levelSkill level board ownDecided for petitioner
“In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
Patent outcomesUS 11,325,974 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,974 - Micron Technology, Inc. v. Yangtze Memory Technologies Company, Ltd.No claims unpatentablePTAB · Nov 5, 2025 · IPR2024-00792 · APJ Jo-Anne M Kokoski · IPR · Final written decision
Claims 1–6 were not shown unpatentable because the asserted references did not establish the claimed bias voltages and pre-verify stage.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedOther
“In the Institution Decision, we adopted the assessment offered by Petitioner. Dec. 5–6. Because Petitioner’s definition of the level of skill in the art is consistent with the ’957 patent and the asserted prior art, we maintain it for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 6
- Expert testimonyPatent owner expert creditedOther
“It is within our discretion to assign the appropriate weight to Dr. Przybylski’s testimony. See, e.g., Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding that the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declaration and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). On this record, we decline to generally discount Dr. Przybylski’s based on Petitioner’s contentions. When assigning upon which the testimony is based. See PTAB Consolidated Trial Practice Guide 40–41 (Nov. 2019). In our analysis of the asserted grounds of unpatentability, we weigh Dr. Przybylski’s testimony accordingly.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“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). Under this standard, claim terms are generally given their plain and ordinary 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. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Based on our review of the complete trial record and the arguments raised by the parties, we determine that it is not necessary to expressly construe any claim terms to resolve the parties’ dispute. Realtime Data, 912 F.3d at 1375.” slip op. at 7
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“claim 1 would have been obvious over the combined teachings of Hongtao and Yu by a preponderance of the evidence. 35 U.S.C. § 316(e) (2018); see also Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). After considering the parties’ arguments and evidence of record, and weighing the testimony of Dr. Liu and Dr. Przybylski, we are not persuaded that Petitioner meets its burden of establishing, by a preponderance of the evidence, that Hongtao teaches or suggests applying a second bias voltage that is smaller than the first bias voltage in the verify stage as recited in limitation [1.d]. Hongtao is silent with respect to the magnitudes of the pre-conduction and conduction voltages. Hongtao teaches that “a pre-conduction voltage is applied to both the unselected word line and the selected word line to turn on the channels of the selected string and the unselected string.” Ex. 1005 ¶ 23. Hongtao then teaches that, in the reading phase, “[t]he gates of the unselected memory cells on the selected string are applied with a conduction voltage through the unselected word lines.” Id. ¶ 25. Hongtao, however, describes the magnitudes of the pre-conduction and conduction relative to each other. See id. ¶¶ 21–26. Petitioner and Dr. Liu point to Hongtao’s statement that “the greater the conduction voltage, the greater the read disturbance” to support its contention that the conduction voltage is smaller than the pre-conduction voltage, but that statement refers to the relationship between conduction voltage and the read interference it causes and does not compare the conduction voltage to the pre-conduction voltage. See Pet. 40 (citing Ex. 1005 ¶ 26); Ex. 1003 ¶ 120 (citing Ex. 1005 ¶ 26). We also find credible Dr. Przybylski’s testimony that Hongtao lacks the details needed to determine how the gate voltages develop over time, in particular the length of the pre-conduction period. See Ex. 2003 ¶ 96. Dr. Przybylski’s testimony is consistent with the ’957 patent’s teaching that when the pre-pulse time is long enough that the bias voltages are fully developed before the TSG transistor is switched off at the unselected memory cell string, hot carrier injection “may not be generated from the selected memory cell to the upper adjacent memory cell of the selected memory cell in the selected memory cell.” Ex. 1001, 11:60–12:1. In contrast, when the pre-pulse time is insufficient for the bias voltages to fully develop, hot carrier injection may be generated. Id. at 12:1–9. And we are not persuaded that Petitioner and Dr. Liu sufficiently rebut Dr. Przybylski’s persuasive testimony that casts doubt on Petitioner’s contention that Hongtao teaches a second bias voltage that is smaller than a first bias voltage as recited in limitation [1.d]. For example, Dr. Liu’s testimony that Hongtao teaches applying voltages on gate terminals does not adequately address Patent Owner’s argument and Dr. Przybylski’s testimony that Hongtao depicts target values for the word line voltages instead of the See Ex. 1027 ¶¶ 16–40. Neither Petitioner nor Dr. Liu adequately establish that Hongtao’s applied voltages are sufficiently developed such that the preconduction voltage actually is bigger than the conduction voltage. Petitioner’s argument that Hongtao teaches or discloses a second bias voltage that is smaller than the first bias voltage hinges on a POSITA’s interpretation of Hongtao’s Figure 2. In light of Hongtao’s dearth of details regarding the absolute or relative magnitudes of the pre-conduction and conduction voltages, and Dr. Przybylski’s unrebutted testimony that Hongtao does not provide sufficient information to ascertain the actual bias voltages that will be applied on the gate terminals of the memory cells over time, we are not persuaded that Petitioner carries its burden of establishing that Hongtao discloses limitation [1.d]. For these reasons, we determine that Petitioner does not establish by a preponderance of the evidence, that independent claim 1, and claims 2–6 that depend, directly or indirectly, therefrom, would have been obvious over the combined teachings of Hongtao and Yu.” slip op. at 15
Patent outcomesUS 11,468,957 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 11,468,957 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24
Patent outcomesUS 11,325,975 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,975 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.
RulingsFinal written decision- BurdenUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
- Skill levelSkill level board ownDecided for petitioner
“Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’356 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
Patent outcomesUS 10,934,356 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,934,356 - 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
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.