- Mediatek Inc. v. Parkervision, Inc.All claims unpatentablePTAB · May 22, 2026 · IPR2024-00796 · APJ Iftikhar Ahmed · IPR · Final written decision
Claims 1–20 are unpatentable as obvious over Nevo and Avitabile, Young and Estabrook, and Young, Estabrook-1988, and Estabrook-1989.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“Network LLC, 929 F.3d 1350, 1357 (Fed. Cir. 2019). On its face, the language “energy transfer signal” does not specify any restrictions on the type of system in which it is utilized, nor its characteristics. In the context of claims 1 and 11, the “energy transfer signal” is the basis on which the “switch” operates, so as to “sub-sample and transfer energy from a first electromagnetic (EM) signal.” Ex. 1001, 50:63–65, 51:56–58. Accordingly, based on the claim language, the term “energy transfer signal” need only be a signal for operating a switch to sub-sample and transfer energy from an electromagnetic signal. That is its plain and ordinary meaning.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“’686 patent broadly includes knowledge and experience as to RF circuit design. See supra § III.B. Petitioner contends that “Nevo’s transceivers [102a/102b] are for Bluetooth and IEEE 802.11,” and that a person of ordinary skill in the art would have understood that both protocols “required down-conversion in their receivers to obtain a baseband signal.” Id. at 35 (citing Ex. 1004, 4:45–50; Ex. 1002 ¶ 118). Nevo’s disclosure would have motivated a person of ordinary skill in the art to look to Avitabile, which provides the circuit level detail for down-converters. See Ex. 1006, Abstract. Avitabile specifically provides circuitry for down-conversion in the s-band frequency range, which is in the range of Bluetooth and IEEE 802.11 (2.4 GHz). Id. at Abstract, Figs. 6, 7. Accordingly, we determine a person of ordinary skill in the art would have been motivated to look to down-converters in the range of frequency needed, and would have been motivated to combine Avitabile’s teachings with those of Nevo, with a reasonable expectation of success.” slip op. at 55
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
Patent outcomesUS 7,483,686 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,483,686 - PTAB · Jan 15, 2026 · IPR2025-01231 · APJ Mary C Hoffman · IPR · Institution
The Board instituted IPR on claims 1–13 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“petition identifies all real parties in interest. 35 U.S.C. § 312(a)(2). Whether an unnamed party is a real party in interest “is a highly fact-dependent question.” See Applications in Internet Time, LLC v. RPX Corp., 897 F.3d 1336, 1351, 1360 (Fed. Cir. 2018) (“AIT”); Ventex Co., Ltd. v. Columbia Sportswear N. Am., Inc., IPR2017-00651, Paper 152 at 4–5 (PTAB Jan. 24, 2019) (precedential) (citing Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1242 (Fed. Cir. 2018)); Consolidated Trial Practice Guide, 13 (2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf (CTPG). “A common consideration is whether the non-party exercised or could have exercised control over a party’s participation in a proceeding.” CTPG at 16. Other considerations include whether the non-party is funding or directing the proceeding; the non-party’s relationship with the petitioner; the non-party’s relationship to the petition itself, including the nature and/or degree of involvement in the filing; and the nature of the entity filing the petition. Id. at 17–18.” slip op. at 8
- Skill levelSkill level board ownOther
“person of ordinary skill in the art (“POSITA”) “would have at least a bachelor’s degree in electrical engineering or a related field and at least two years of experience with lighting technology.” Pet. 2 (citing Ex. 1017 ¶ 35). Petitioner makes additional contentions about what a POSITA would have understood. Id. (“A POSITA would understand that all types of cameras (e.g., analog and digital, photo and video) generally involve the same lighting considerations . . . . [and] that it is important to provide light that evenly illuminates the target subject or object to minimize reflected glare and shadows.”). Patent Owner contends that a POSITA would have at least: (a) a bachelor’s degree in electrical engineering, optical engineering, or a related field; (b) two years of practical experience in designing and developing lighting systems, particularly those integrated with electronic devices such as webcams or computer monitors; and (c) knowledge of user-interface considerations for consumer electronics . . . . Additional experience can substitute for education and vice versa. Prelim. Resp. 12 (citing Ex. 2036 ¶ 48). Patent Owner disputes Petitioner’s contentions regarding what a POSITA would have understood. Prelim. Resp. 12–13 (“[O]ne of ordinary skill in the art would have understood that analog and digital cameras have different operating principles and lighting requirements [and] Petitioner’s lack of appreciation for the suitability and unsuitability of different lights for different applications infects and dooms its invalidity analysis.” (citing Ex. 2036 ¶¶ 36–47)). and years of experience required for a POSITA. Pet. 2; Prelim. Resp. 12. For purposes of this Decision, we consider a person of ordinary skill in the art to have a bachelor’s degree in electrical engineering or related field and two years of practical experience in lighting technology, and that additional experience may substitute for education and vice versa, which is consistent with the level of skill reflected in the ’729 patent and prior art of record. See Exs. 1001, 1005–1010, 1012–1015; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Patent Owner agrees that the Board need not formally construe any claim terms in order to adjudicate the merits of the Petition and argues Petitioner fails to show unpatentability of any claim under any reasonable construction of the claims. Prelim. Resp. 13 (citing Ex. 2036 ¶ 51). We determine that no express claim construction is necessary to determine whether institution is warranted in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only terms in controversy must be construed “and only to the extent necessary to resolve the controversy”) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“claimed subject matter and the prior art are “such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). When a ground in a petition is based on a combination of references, we consider “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). We base our obviousness inquiry on factual considerations including (1) the scope and content of the prior art, (2) any differences between the claimed subject matter and the prior art, (3) the level of skill in the art, and (4) any objective indicia of obviousness or non-obviousness that may be in evidence.14 See Graham, 383 U.S. at 17–18.” slip op. at 24
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,841,729 - PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,115,233 - Weatherford U.S., L.P v. Halliburton Energy Services, Inc.Some claims unpatentablePTAB · Dec 9, 2025 · IPR2024-00990 · APJ Brent M Dougal · IPR · Final written decision
Claims 11–12 and 14–20 are unpatentable; claims 1–10 and 21–23 are not shown unpatentable. Substitute claims 29–37 are unpatentable, and the motion to amend is denied as to them.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The level of skill is uncontested. Patent Owner adopts the level of skill identified by Petitioner as: [at] the time of the alleged invention in 2018, a POSITA[2] would have had a B.S. degree in mechanical or petroleum engineering or a similar technical discipline, with at least five years of experience in oil or gas well drilling, completion, and/or subsurface production operations or in technical support of such operations including at least some experience in unconsolidated formations utilizing sand control methods and means. Also,” slip op. at 8
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“on embodiments of Yeh with concentric sand screens having nine shunt tubes (six transport tubes and three packing tubes) (Yeh Figures 4A–B) and eccentric sand screens with four shunt tubes (two transport tubes and two packing tubes) (Yeh Figures 8A, 8C). See Pet. 32–37, 39, 41–43. Yet, Petitioner’s reasoning as to why “a higher-pressure shunt tube assembly necessitated greater wall thickness” rests on an unspoken one to one comparison between the shunt tubes of the different systems. See id.; see also Ex. 1003 ¶¶ 291–297 (Petitioner’s declarant comparing possible transport tubes of different pressure regions without considering or addressing any difference in the number of transport tubes). However, the embodiments relied on by Petitioner have different numbers of shunt tubes, and thus the greater wall thickness does not appear to be “necessitated” in the way inferred by Petitioner. Further, Petitioner’s analysis would seem to be most appropriate when comparing two concentric sand screens for different pressure regions, or two eccentric sand screens for different pressure regions. relies on Yeh’s teachings related to a horizontal well bore of 5000 feet for the “concentric screen → crossover tool → eccentric screen” arrangement, as well as, for why the concentric screen needs to be rated for a high pressure. Pet. 32–37, 39, 41–43. Petitioner also refers to these features for why one of skill in the art would combine the teachings of Yeh and Yeh2. Id. at 32. However, on cross-examination, Petitioner’s declarant agreed that it is concentric sand screens having a 6x3 shunt tube design that would provide the noted benefits of being rated for a higher pressure and being more robust (as relied on in the Petition), as compared to eccentric sand screens. Ex. 2013, 42:20–43:8; Sur-reply 4–5. This also exposes another issue with Petitioner’s arguments. Though Petitioner identifies that one of skill in the art would be aware that material choice, wall thickness, and pipe diameter all impact burst pressure of a pipe (Pet. 42 (citing Ex. 1017, 24 (Equation (14))), the Petition essentially ignores the fact that the claims do not require a single pipe in isolation. The claims require two shunt tube assemblies, each surrounding a base pipe within a wellbore. It is uncontested that a wellbore provides a confined space for such a system and thus any change in wall thickness of one pipe can result in a significant impact in the function of the other pipes. We find the testimony of Petitioner’s declarant (see, e.g., Ex. 1003 ¶¶ 290–297) unpersuasive when discussing wall thickness because it focusses on basic considerations of a standalone pipe, without sufficient consideration of the claimed completion assembly with its required pipe and tube structure. PO Resp. 20–26.” slip op. at 17
- Strike new argumentNew argument disregardedDecided for patent owner
“In response to Patent Owner’s argument concerning Yeh’s embodiments relied on in the Petition, Petitioner argues for the first time that Patent Owner’s declarant “conceded, Yeh discloses that both concentric and 47:19–48:21). Petitioner does not provide a citation to Yeh or a citation to where the Petition relies on the same number of shunt tubes between concentric and eccentric screens. The deposition cited by Petitioner discusses Yeh at column 16, lines 26 through 35. However, the Petition does not cite or rely on these teachings of Yeh. Thus, we decline to consider this late argument.4 See 35 U.S.C. § 312(a)(3) (requiring the petition to identify “with particularity . . . the grounds on which the challenge to each claim is based, and the evidence that supports the grounds”); 37 C.F.R. § 42.104(b)(5).” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“Thus, we agree with Petitioner that the combination of Yeh and Yeh2 teaches determining the shunt tube system operating pressures associated with the distal end of the production zone, but also more generally, determining the operating pressures along the entire production zone. With this knowledge of the system operating pressures, Petitioner argues that one of skill in the art would have selected eccentric screens for the distal end of the production zone “at any point at which the slurry pressure dropped below the pressure capacity of the eccentric screen shunt tubes.” Pet. 66 (citing Ex. 1005, 30:16–20; Ex. 1003 ¶ 388). In other words, knowing that the pressure decreases as you approach the toe, Yeh’s low-pressure rated eccentric screens could be used from some point prior to and covering the toe. determined pressure.” PO Resp. 37–38. We disagree. As discussed above, the record supports Petitioner’s position that one of skill in the art would have “understood the need to determine the shunt tube system operating pressure throughout the horizontal wellbore.” Ex. 1003 ¶ 383; see also Pet. 64–65. We find convincing Petitioner’s argument that one of skill with this understanding of the system pressures would select a shunt tube system rated to not only address the distal end, but also to address the needs of the adjacent region, so long as the pressure rating supported such a selection. See Pet. 65–67; Ex. 1003 ¶¶ 385–388.” slip op. at 22
Patent outcomesUS 11,333,007 mixedClaim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites GrahamPatents in suitUS 11,333,007 - Kia Corp. / Toyota Motor Corp. v. Emerging Automotive LLCAll claims unpatentablePTAB · Dec 9, 2025 · IPR2024-00981 · APJ Georgianna W Braden · IPR · Final written decision
Claims 1–20 are unpatentable over the Kleve-based grounds; the Board found the Zaid-based grounds did not render their challenged claims unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Pet. 2. Patent Owner filed a Preliminary Response (Paper 7, “Prelim. Resp.”). Petitioner filed an authorized Reply to Patent Owner’s Preliminary Response (Paper 8, “Prelim. Reply”), and Patent Owner filed an authorized Sur-reply to Petitioner’s Reply (Paper 9, “Prelim. Sur-reply”). Trial was instituted on the asserted grounds of unpatentability. Paper 10 (“Inst. Dec.”), 56.” slip op. at 3
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends express claim construction is unnecessary and states that all terms should be given their plain and ordinary meaning. Pet. 8. Patent Owner does not address claim construction in its Response. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). There are no claim terms in controversy that need be construed for our analysis.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Here, Petitioner asserts a person of ordinary skill in the art would have “had at least a four-year undergraduate degree in electrical engineering, automotive engineering, or [a] closely related field and [at] least two years of experience in the field of access control systems, vehicle electronics, and/or cryptography.” Pet. 2 (citing Ex. 1003 ¶¶ 79–82). Dr. Almeroth supports Petitioner’s position and further testifies that “[a]dditional education could substitute for professional experience and vice versa.” Ex. 1003 ¶ 79. Patent Owner does not assert a different level of skill in the art at the time of the alleged invention and appears to apply Petitioner’s proposed level of skill. See PO Resp. Patent Owner’s declarant, Dr. Malek, explicitly adopts Petitioner’s level of skill in the art but states that his opinions would be applicable under any reasonable definition for an ordinarily skilled artisan at the critical time. See Ex. 2001 ¶ 37. For the purposes of this Decision, we too adopt Petitioner’s level of ordinary skill in the art because it appears consistent with the problems addressed in the ’188 patent and the prior art of record.” slip op. at 11
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Additionally, we credit the testimony of Dr. Almeroth, who opines that Kleve discloses that certain restrictions are sent with the request to generate a virtual key. Ex. 1003 ¶¶ 118–123. Specifically, Dr. Almeroth testifies that Kleve discloses that the virtual key “enable[s] the keyless drive system for the appropriate Temporary User during a given rental period.” Id. According to Dr. Almeroth, this “indicates that rental agreement restrictions were sent with the request so that the virtual key could be associated with said restrictions.” Id. (citing Ex. 1004 ¶¶ 39, 68 (“Once the rental period has expired the virtual key may be reset and cleared from the VCS.”)). Dr. Almeroth further testifies that the virtual key in Kleve is always generated after the rental agreement. Id. (citing Ex. 1004 ¶¶ 39 (“[O]nce the Temporary User selects the vehicle, pays the appropriate amount and signs a consent agreement, th[e]n the system may generate a virtual key to distribute to the Temporary User and VCS.”), 68). We do not agree with Patent Owner’s argument that Dr. Almeroth’s declaration testimony contradicts Kleve. See PO Resp. 27–29. Rather, as discussed previously, we find that Kleve’s vehicle owner can set a restriction, such as the rental start period, prior to step 214 in Kleve’s Figure 2 and that such restrictions can be associated with the e-key. We also do not agree with Patent Owner’s argument that (1) Dr. Almeroth’s declaration testimony contradicts his deposition testimony or that (2) Dr. Almeroth “admitted his testimony was wrong.” See PO Sur-Reply 7 (citing Ex. 2030, 27:5–10, 27:21–28:1). In a particular embodiment to which Dr. Almeroth was citing, he noted that the e-key is always generated after the rental agreement. See Ex. 2030, 26:14–20. Then the following exchange occurs: Q. So you use typically and always. So always does not refer to all of the embodiments of Kleve, is that fair? A. I think a person of skill in the art could read Kleve and understand that there are probably multiple ways in which the flow of actions among the parties could occur. And I think thinking about a real world scenario, in most cases you have an agreement before you would generate an eKey, but maybe, maybe not. I don’t -- I don't know that the real world is necessarily cut and dry. So reading -- a person reading Kleve would understand it’s describing embodiments where it’s always the case. That might be a pretty common scenario, but I don't know that it would necessarily be a hard and fast rule in every embodiment or in the understanding a person of skill in the art would have. Id. at 28:3–20. There is nothing in the deposition testimony by Dr. Almeroth that appears inconsistent with his declaration testimony nor does there appear to be the kind of admission touted by Patent Owner. Instead, it is Dr. Malek who takes an overly narrow view of Kleve that appears inconsistent with Kleve’s disclosure when read as a whole. See, e.g., Ex. 2001 ¶¶ 56–57. Therefore, we do not credit or agree with Dr. Malek’s testimony that Kleve teaches away from the concept of a virtual key created with the agreed-upon rental period as a restriction. See id. ¶ 57.” slip op. at 31
Patent outcomesUS 9,365,188 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 9,365,188 - Toyota Motor Corp. v. Emerging Automotive LLCAll claims unpatentablePTAB · Nov 19, 2025 · IPR2024-00814 · APJ Frances L Ippolito · IPR · Final written decision
Claims 1, 2, and 4–20 are unpatentable as obvious over the stated combinations of Rector, Kleve, and, for certain claims, additional references.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art (“POSITA” or “POSA”) at the time of the invention of the ’244 patent “would have had at least a Bachelor’s degree in electrical engineering, computer science, or closely related field, with at least two-to-four years’ experience in cloud services for settings customization” and that computer science, or equivalent) could substitute for professional experience and vice-versa.” Pet. 12 (citing Ex. 1005 ¶ 89). Patent Owner does not address the level of ordinary skill in the art. See, generally PO Resp. Patent Owner’s Declarant, Dr. Malek, adopts the definition proffered by Petitioner and its Declarant, Dr. Almeroth. Ex. 2001 ¶ 37. We adopt Petitioner’s proposal as it is reasonable and consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Patent Owner asserts that the term “transferring is configured to instruct” should be construed according to its plain and ordinary meaning – the limitation.” PO Resp. 11. Patent Owner contends that the challenged claims require more than that the server is capable of the recited transferring (e.g., claims 1 and 17), and must be configured to accomplish the specific purpose of the claims. Id. at 12–17. Our analysis and the outcome of this dispute, however, would not change even if we were to adopt Patent Owner’s construction. Therefore, upon review of the entire record, including arguments by the parties and the relied upon evidence, we determine no terms require express construction to reach our decision. 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
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“With regard to this testimony, we note that Dr. Malek does not provide an underlying basis for these statements to support his conclusion that it is “common knowledge” that distributed software systems are less secure than local software systems. Id. In fact, when viewed with Kleve, Dr. Malek’s testimony appears to contradict Kleve’s express teaching that the “system may be further extended to facilitate the virtual key with additional security by requiring remote credential verification at the vehicle . . . by the VCS, using a server, or allowing the Owner to verify the Temporary User’s request.” Ex. 1007 ¶ 49 (emphases added). With regard to Kleve’s disclosure, Dr. Malek further testifies that [a] POSITA would understand that in Kleve credential authorization can be performed by: (1) VCS, (2) server, or (3) owner . . . . While Kleve discloses the verification can be performed by any of these entities, it states the client-side verification at the vehicle using VCS provides additional security. A POSITA would not have been motivated to modify side verification. Rector already uses the more secure client-side verification. Ex. 2003 ¶ 79 (emphases added). Dr. Malek, however, does not explain how Kleve’s express teachings limit “additional security” to client-side verification with VCS. Id. In fact, Kleve expressly discloses the opposite. Kleve teaches that the additional security may be provided by a remote credential certification that “may be done by the VCS, using a server, or allowing the Owner to verify the Temporary User’s request.” Ex. 1007 ¶ 49 (emphasis added). Kleve further teaches that the Temporary User may enter “a credential verification password at the vehicles touchscreen visual display while having the VCS, server, or owner compare and verify authorization.” Id. (emphasis added). Even Dr. Malek acknowledges that the verification can be performed by “any of these entities,” including the server. Id. We further note Dr. Almeroth testifies that “[t]he server-side verification may be done above and beyond any verification that takes place locally. The server-side verification could also be done as a check on local verification.” Ex. 1005 ¶ 122. This testimony is consistent with and supported by Kleve’s disclosure, which expressly states that “additional security” includes remote credential verification at the vehicle using a server. Ex. 1007 ¶ 49. As such, we credit Dr. Almeroth’s testimony as his testimony better supported by prior art disclosure.” slip op. at 28
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“With regard to this testimony, we note that Dr. Malek does not provide an underlying basis for these statements to support his conclusion that it is “common knowledge” that distributed software systems are less secure than local software systems. Id. In fact, when viewed with Kleve, Dr. Malek’s testimony appears to contradict Kleve’s express teaching that the “system may be further extended to facilitate the virtual key with additional security by requiring remote credential verification at the vehicle . . . by the VCS, using a server, or allowing the Owner to verify the Temporary User’s request.” Ex. 1007 ¶ 49 (emphases added). With regard to Kleve’s disclosure, Dr. Malek further testifies that [a] POSITA would understand that in Kleve credential authorization can be performed by: (1) VCS, (2) server, or (3) owner . . . . While Kleve discloses the verification can be performed by any of these entities, it states the client-side verification at the vehicle using VCS provides additional security. A POSITA would not have been motivated to modify side verification. Rector already uses the more secure client-side verification. Ex. 2003 ¶ 79 (emphases added). Dr. Malek, however, does not explain how Kleve’s express teachings limit “additional security” to client-side verification with VCS. Id. In fact, Kleve expressly discloses the opposite. Kleve teaches that the additional security may be provided by a remote credential certification that “may be done by the VCS, using a server, or allowing the Owner to verify the Temporary User’s request.” Ex. 1007 ¶ 49 (emphasis added). Kleve further teaches that the Temporary User may enter “a credential verification password at the vehicles touchscreen visual display while having the VCS, server, or owner compare and verify authorization.” Id. (emphasis added). Even Dr. Malek acknowledges that the verification can be performed by “any of these entities,” including the server. Id. We further note Dr. Almeroth testifies that “[t]he server-side verification may be done above and beyond any verification that takes place locally. The server-side verification could also be done as a check on local verification.” Ex. 1005 ¶ 122. This testimony is consistent with and supported by Kleve’s disclosure, which expressly states that “additional security” includes remote credential verification at the vehicle using a server. Ex. 1007 ¶ 49. As such, we credit Dr. Almeroth’s testimony as his testimony better supported by prior art disclosure.” slip op. at 28
Patent outcomesUS 11,396,244 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,396,244 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner
“Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30
Patent outcomesUS 11,643,462 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22
- Skill levelSkill level board ownDecided for petitioner
“In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
Patent outcomesUS 11,325,974 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,974 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24
Patent outcomesUS 11,325,975 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,975 - 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
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.