- Penumbra, Inc. v. Rapidpulse, Inc.No claims unpatentablePTAB · Feb 17, 2026 · IPR2024-01261 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–20 were not shown unpatentable because the asserted combinations did not teach the claimed predetermined cycle for controlling distal fluid flow.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“(1) a person with a B.S. in engineering or an equivalent field, with two-four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where appropriate, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where appropriate, work or consult with others, including an engineer, to develop such a medical device. Pet. 11 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner states that for purposes of its PO Response, it “accepts ¶ 44). We adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’402 patent and the cited prior art. See 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 a 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 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“specification explicitly includes sensors similar to those in the prior art in support of their argument that the claimed “predetermined cycle” must not exclude the use of such sensors. Pet. Reply 15 (citing Ex. 1001, 32:55–33:7, 40:66–41:5, 44:9–29). We reviewed the portions of the specification cited by Petitioner. We agree with Patent Owner that one excerpt discussing sensor use appears to be directed to triggering the predetermined cycle rather than causing timing changes during the cycle itself (Ex. 1001, 32:55–66) (describing use of a pressure sensor to “determine when the vacuum channel 3 is clogged by a thrombus and automatically perform the unclogging procedures described herein”), while another excerpt discusses a sensor that Petitioner that the ’402 patent discusses the use of sensors to “tune” the system and that such “tuning” can be done statically (setting the cycle timing in advance) or dynamically (adjusting the timing during the cycle itself). See Ex. 1001, 48:19–49:50. Overall, we find that these disclosures involving sensors demonstrate that sensors may be used in various ways in different embodiments. However, none of these disclosures explicitly discuss the use of sensors in conjunction with a “pre-determined cycle.” Therefore, we find that the ’402 patent specification’s discussion of “sensors” are not particularly informative as to the appropriate construction of a “predetermined cycle” and do not outweigh the other explicit disclosures of “predetermined cycle” in the patent. We next turn to the other intrinsic evidence discussed by the parties — the prosecution history. As discussed by Patent Owner, in the Notice of Allowance, the Examiner found that Garrison did not teach or suggest a “predetermined cycle” because Garrison’s controller “changed the cycle of opening and closing the valves based on feedback from sensors.” Ex. 1004, 86. We acknowledge that the patent applicant filed subsequent comments during prosecution in which they stated that they “do[] not concede that the Examiner’s characterizations of the terms of the claims and the prior art are correct.” Id. at 29. However, we agree with Patent Owner that the importance of the Examiner’s statement in the Notice of Allowance does not rely on it being an express disclaimer (a standard which it does not meet). PO Sur-reply 8. We also considered Petitioner’s contention that the Examiner’s interpretation of Garrison may have been in error (PO Resp. 16); however, even if this were true, the Examiner’s statement still provides helpful insight into how the Examiner was interpreting the term sensors to change the opening and closing of valves during a cycle was not a “predetermined cycle.” Id. at 86. In sum, we find that Patent Owner’s proposed construction is consistent with the usage of the term “predetermined cycle” in the ’402 patent specification and prosecution history. Thus, after considering all of the cited evidence, we construe “predetermined cycle” to mean that “the timing of the sequence of valve operations in the cycle is determined beforehand, i.e., fixed, rather than varying based on feedback after operation begins.”” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“2. Other Terms The parties also provided proposed constructions for the limitations of “[limited/limiting] to a positive amount of exit flow” and “control[ling] fluid flow in and out from the distal end of the catheter.” See Pet. 15–16; Pet. Reply 1–8; PO Resp. 22–24; PO Sur-Reply 2–6. However, having evaluated the arguments and evidence before us, we determine that construction of these terms is not necessary for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“We agree with Patent Owner that neither Petitioner nor Mr. Brown propose any combination of Yang and Mullins that does not include Mullins’s pressure sensor in order “to control fluid flow in and out from the distal end of the catheter.” Indeed, in addressing the “predetermined cycle” limitation, Mr. Brown contends that Mullins discloses a “cycling controller that ‘varies aspiration pressure according to sensed pressure within the catheter lumen.’” Ex.1005 ¶¶ 131–32 (citing, e.g., Ex.1008, 27:40–28:20 (“[a] novel aspect of this pump system is the incorporation of feedback into the pump algorithm in order to produce more effective pressure cycling”)). This use of a sensor to change pressure during a cycle, is not a “predetermined cycle” under our construction. combinations is its discussion of distal end flow control, not for its sensors.” Pet. Reply 17 (citing Ex. 1035 ¶ 83). However, Petitioner’s obviousness grounds rely on the combination of Yang and Mullins, especially with regard to Mullins’s disclosure of “a controller” in order “to control fluid flow in and out.” As discussed above, Mullins relies on the sensor-feedback approach in order to control flow and we find that Petitioner has not presented persuasive evidence of how the combined disclosures of Yang and Mullins would control flow without using Mullins’s sensor feedback approach. See W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983) (error to “consider[] … references in less than their entireties, i.e., in disregarding disclosures in [them] … that diverge from and teach away from the invention”). Therefore, we determine that Petitioner has not sufficiently shown that the combination of Yang and Mullins discloses or renders obvious “a controller configured to open and close the vacuum valve and the vent valve in a predetermined cycle to change a level of vacuum at the distal end of the catheter and to control fluid flow in and out from the distal end of the catheter.” Accordingly, having considered the parties’ respective evidence and arguments, we find that Petitioner has not shown by a preponderance of the evidence that claim 1 of the ’402 patent would have been unpatentable as obvious over the combination of Yang and Mullins.” slip op. at 27
Patent outcomesUS 11,406,402 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,406,402 - Solaris Oilfield Site Services Operating, LLC / Solaris Oilfield Site Services Personnel, LLC v. Masaba, Inc.All claims unpatentablePTAB · Jan 26, 2026 · IPR2024-01179 · APJ Carl M Defranco · IPR · Final written decision
Claims 1–25 are unpatentable under § 103 over the asserted combinations of Waldner, Dynatek, and additional references; the Board cancelled all challenged claims.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Also, to the extent Masaba relies on extrinsic expert testimony, we note that Masaba’s expert cites absolutely no support for his understanding of the claims, much less explains why we should adopt his understanding over the plain and ordinary meaning of “conveying aggregate” and “moving aggregate.” See Ex. 2004 ¶ 34. Absent supporting citations, such extrinsic testimony is entitled to little, if any, weight. As such, we reject the notion that Waldner’s discharge chute member 242 is not a conveyor “for conveying aggregate” or “for moving aggregate,” as required by claim elements 1[h] and 1[i].” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“We disagree that Dr. Durham does not possess the necessary level of skill in the art to qualify as an expert in this case. Looking at the specification of the ’689 patent and the prior art of record, we think Masaba sets the bar too high. We acknowledge that one of ordinary skill in the art should have some education and/or experience in the mechanical art of conveying aggregate materials, but we do not think opining on the ’689 patent and asserted prior art necessarily requires that person to have the amount of education and experience that Masaba advocates. The ’689 patent relates generally to an “aggregate transferring system for receiving aggregate from a vehicle and elevating the aggregate to a higher vertical level for deposit into, for example, a silo.” Ex. 1001, 1:15– 18. And, as described in the ’689 patent and discussed later, the transferring system is an assembly of known types of conveyors, such as a belly-dump truck conveyor, a bucket elevator, and an articulated belt conveyor, for transferring the aggregate horizontally and vertically from a belly-dump truck to the discharge point, such as a silo. Without doubt, Dr. Durham has enough education and experience to reliably opine on the combination of known parts.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningNo construction needed
“We reject this argument for several reasons. First, nowhere does the plain language of the claims specify how the aggregate is conveyed or moved from the conveyor extension assembly’s inlet to its outlet, be it passively by means of gravity or actively by means of a conveyor belt. Instead, the claims simply use those verbs according to their plain and ordinary meaning, which is “to transfer or deliver” or “to cause to go or pass” from one place to another. See Ex. 3001, 253 (defining “convey”), 760 (defining “move”).10 Second, the specification of the ’689 patent similarly uses these terms in a plain and ordinary sense, without ever attributing to them some sort of special meaning. See, e.g., Ex. 1001, 4:9–12 (“The apparatus 10 is suitable for performing the transfer of aggregate from 10 We reference the original pagination of the dictionary in which these definitions appear. one location to another, such as, for example, from a vehicle carrying the aggregate to a silo 1 for storing the aggregate.”). The ’689 patent specification also makes clear that active conveyance of the aggregate is an option and not a requirement of the claimed invention, stating that the conveyor extension assembly “may further include a conveyor belt 150.” Ex. 1001, 10:60–66 (emphasis added). Limiting claim elements 1[h] and 1[i] to a device “for actively conveying” or “for actively moving aggregate” would improperly import limitations from the specification into the claims. Thus, based on the intrinsic evidence, we determine that claim elements 1h and 1k are properly construed to encompass passive and/or active movement of the aggregate via the conveyor extension assembly.” slip op. at 20
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)Not reached
“Owner asserts” that two claim terms—“unloader structure” and “trailer structure”—should be construed as means-plus-function limitations under 35 U.S.C. § 112(f), Solaris submits an express construction detailing the corresponding structure in the specification for performing the recited function of the claimed unloader and trailer structures. See id. at 24–25. Only in disputing Solaris’s Ground 3 does Masaba advocate that the claim term “trailer structure” should be construed under § 112(f), and then only in conjunction with dependent claims 3 and 21. See PO Resp. 58. As such, we address Masaba’s proposed construction in our analysis of Ground 3. We now turn to Solaris’s grounds of unpatentability.” slip op. at 12
Patent outcomesUS 11,780,689 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 11,780,689 - 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 - PTAB · Dec 19, 2025 · IPR2025-01078 · APJ Robert L Kinder · IPR · Institution
The Board instituted IPR on claims 1, 2, 4–12, 14–22, and 24–30, finding a reasonable likelihood that Kido anticipates at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a) (2024). An inter partes review may not be instituted “unless. . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Moreover, a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“At this juncture in the proceeding, and based on the current record, we do not agree with Patent Owner that “payout,” as claimed, should be limited to “the amount a player will win in relation to the amount wagered.” We recognize, as Patent Owner points out, that the examples provided in the Specification are listed in odds format. See id. at 2. The Specification, however, also states that “[a]ny suitable payouts can be used in some embodiments.” Ex. 1011, 5:18–21. This language suggests a broader interpretation of “payout” beyond just payout odds and we therefore decline to import the wager limitation into the claim term. Although the ’371 patent generally describes payouts in terms of odds, like 49:1, the intrinsic record lacks clear evidence necessary to limit the claims as Patent Owner proposes.” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes “a person having at least a Bachelor’s Degree in electrical engineering, computer science, or computer engineering, or undergraduate training in an equivalent field and at least two years of relevant experience in electronic gaming technology.” Pet. 10 (citing Ex. 1003 ¶¶ 22–26). Petitioner further notes that “[a]dditional graduate education could substitute for professional experience, and significant work experience could substitute for formal education.” Id. Patent Owner does not dispute this level of skill. See Prelim. Resp. 13–14 (“Evolution does not set forth an alternative level of skill for a person of ordinary skill in the art”). For purposes of this Decision, we adopt Petitioner’s proposal, which comports with the teachings of the ’371 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Based on the evidence before us, we find persuasive Petitioner’s contention that Kido’s accumulated jackpot paid when landing on a star mark reads on the claimed “a first selected position . . . to have an increased payout . . . greater than a first non-selected payout.” See Pet. 25–27, 30, 35, 36. As explained above, the current record does not support limiting the term “payout” to just the amount a player will win in relation to the amount wagered. As Petitioner notes, a payout that receives Kido’s accumulated Prog bonus payout is necessarily higher than a payout that does not receive the Prog bonus. Pet. 35–36 (“had the first selected position not been randomly selected, the player would only be eligible for the basic payout”). Further, Kido even describes its bonus routines and jackpots as payouts. Kido describes, for example, that “[w]hen the privilege unit 113 obtains the win information from the special game value award mark win determining unit 112, it awards, as a payout, the game value stored in the accumulated game value memory 117” and it describes the “jackpot (JP) amount” as “a special payout.” Ex. 1007 ¶¶ 119, 129.” slip op. at 14
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 11,756,371 - PTAB · Dec 17, 2025 · IPR2025-01072 · APJ Frederick C Laney · IPR · Institution
The Board instituted review of claims 1–3, 5–11, 13–19, and 21–24 on all asserted grounds, finding a reasonable likelihood that Kido anticipates claims 1, 9, and 17.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a) (2024). An inter partes review may not be instituted “unless. . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Moreover, a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“At this juncture in the proceeding, and based on the current record, we do not agree with Patent Owner that “payout,” as claimed, should be limited to “the amount a player will win in relation to the amount wagered.” Sur-reply 2. We recognize, as Patent Owner points out, that the examples provided in the Specification are listed in odds format. See id. The Specification, however, also states that “[a]ny suitable payouts can be used in some embodiments.” Ex. 1001, 5:16–17. This language suggests a broader interpretation of “payout” beyond just payout odds and we therefore decline to import the wager limitation into the claim term. Although the ’014 patent generally describes payouts in terms of odds, like 49:1, the intrinsic record lacks clear evidence necessary to limit the claims as Patent Owner proposes.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“Based on the evidence before us, we find persuasive Petitioner’s contention that Kido’s accumulated jackpot paid when landing on a star mark reads on the claimed “first payout . . . wherein the first payout is higher.” See Pet. 32–36. As explained above, the current record does not support limiting the term “payout” to just the amount a player will win in relation to the amount wagered. As Petitioner notes, a first payout that receives Kido’s accumulated Prog bonus payout is necessarily higher than a second payout that does not receive the Prog bonus. Id. at 35. Further, Kido even describes its bonus routines and jackpots as payouts. Kido describes, for example, that “[w]hen the privilege unit 113 obtains the win information from the special game value award mark win determining unit 112, it awards, as a payout, the game value stored in the accumulated game value memory 117” and it describes the “jackpot (JP) amount” as “a special payout.” Ex. 1007 ¶¶ 119, 129.” slip op. at 14
Claim construction§ 102 anticipationcites PhillipsPatents in suitUS 11,011,014 - PTAB · Dec 16, 2025 · IPR2025-01073 · APJ Robert L Kinder · IPR · Institution
The Board instituted IPR of claims 1–5, 7–12, 14–18, and 20 on all petitioned grounds, finding a reasonable likelihood that Kido anticipates at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a) (2024). An inter partes review may not be instituted “unless. . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Moreover, a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“At this juncture in the proceeding, and based on the current record, we do not agree with Patent Owner that “payout,” as claimed, should be limited to “the amount a player will win in relation to the amount wagered.” We recognize, as Patent Owner points out, that the examples provided in the Specification are listed in odds format. See id. at 2. The Specification, however, also states that “[a]ny suitable payouts can be used in some embodiments.” Ex. 1005, 5:13–17. This language suggests a broader interpretation of “payout” beyond just payout odds and we therefore decline to import the wager limitation into the claim term. Although the ’024 patent generally describes payouts in terms of odds, like 49:1, the intrinsic record lacks clear evidence necessary to limit the claims as Patent Owner proposes.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Based on the evidence before us, we find persuasive Petitioner’s contention that Kido’s accumulated jackpot paid when landing on a star mark reads on the claimed “first payout . . . wherein the first payout is higher.” See Pet. 33–35. As explained above, the current record does not support limiting the term “payout” to just the amount a player will win in relation to the amount wagered. As Petitioner notes, a first payout that receives Kido’s accumulated Prog bonus payout is necessarily higher than a second payout that does not receive the Prog bonus. Pet. 35. Further, Kido even describes its bonus routines and jackpots as payouts. Kido describes, for example, that “[w]hen the privilege unit 113 obtains the win information from the special game value award mark win determining unit 112, it awards, as a payout, the game value stored in the accumulated game value memory 117” and it describes the “jackpot (JP) amount” as “a special payout.” Ex. 1007 ¶¶ 119, 129. Patent Owner next contends that Kido does not disclose a first payout that is “for the spin of the roulette wheel.” Prelim. Resp. 29. Patent Owner’s argument is premised on the cumulative nature of Kido’s Prog bonus – it builds with every spin of the roulette wheel until won. Id. (“Each time the wheel is spun, 0.5% of the amount wagered is added to the progressive jackpot, and thus, the jackpot’s value reflects multiple spins of the roulette wheel.”). Thus, according to Patent Owner, the value of the jackpot is determined using multiple spins of the roulette wheel and is not “for a spin of the roulette wheel” as claimed.” Id. at 30. The claims, however, only require a first payout that is higher than a second payout. Nothing prohibits the higher payout from accumulating from prior spins of the roulette wheel because, when it is actually won, it will be for that last spin of the roulette wheel. Ex. 1005, 8:35–36 (“indicating that the first player is to be paid at the first payout for the spin of the roulette wheel”). Regardless of how Kido’s Prog bonus accumulated, it is paid for a spin of the roulette wheel – at that juncture Kido discloses each claim element. Anticipation occurs when a prior art reference discloses every element of a patent claim at a point in time, as Kido does with a single spin of the roulette wheel that pays the Prog bonus. As persuasively explained by Petitioner, “the steps of Figure 12 (including A13) occur within a single round of roulette, for a single spin of the roulette wheel, until the routine ‘returns to the step of A1 and is transited to a next game.’” Pet. 39 (quoting Ex. 1007 ¶ 233).” slip op. at 13
Claim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,629,024 - PTAB · Dec 8, 2025 · IPR2025-01064 · APJ George R Hoskins · IPR · Institution
The Board instituted IPR of claims 1–18 on all four §103 grounds, finding a reasonable likelihood that Volkswagen would prevail on at least claim 1 over Weese.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“A. Legal Standards — Petitioner’s Burden “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” 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 1 Amendments to 35 U.S.C. § 103 enacted by the Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”) took effect in March 2013. The ’353 patent issued from an application filed in September 2004. See Ex. 1001, code (22). Thus, we apply the pre-AIA version of § 103. grounds for the challenge to each claim”)). This burden of persuasion never shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). B. Legal Standards — Obviousness A patent claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness, if made available in the record, which has not happened here. See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“C. Level of Ordinary Skill in the Art Petitioner contends a person having ordinary skill in the art pertaining to the ’353 patent “would have possessed at least a four-year degree in physics, biophysics, medical physics, or a related field, and two years of experience in developing and/or applying computed tomography methods,” wherein “[a]dditional education and professional experience are interchangeable.” Pet. 1; Ex. 1003 ¶¶ 54–55. “Patent Owner utilizes Petitioner’s proposed level of skill in the art.” Prelim. Resp. 2. For purposes of this Decision, we adopt Petitioner’s formulation of ordinary skill in the art, as it appears to be consistent with the ’353 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
- Expert testimonyOther
“unpatentable as having been obvious over Weese, including supporting testimony from Dr. Peterson. See Pet. 17–22, 26–83; Ex. 1003 ¶¶ 138–149, 159–257. Patent Owner opposes. See Prelim. Resp. 1–2, 6–7. We conclude Petitioner has demonstrated a reasonable likelihood of prevailing on its assertions, as follows.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“(iii) Analysis Based on the present record, we determine Petitioner’s contentions regarding the third step of claim 1 are supported sufficiently by the cited disclosures in Weese and Dr. Peterson’s testimony to justify institution of review. In particular, Weese describes obtaining a plurality of second images of the patient’s internal organs (i.e., PET image I0 in Fig. 1, and PET image I10 in Fig. 3) using a second imaging technique (i.e., PET). See Ex. 1005, Figs. 1, 3, and 6, ¶¶ 47–49, 58–59, 72. In particular, PET image I0 in Figure 1 may be a reconstructed “volume image[]” composed of a plurality of “quasi two-dimensional” “slice images” that, when combined, represent a three-dimensional region inside the patient. Id. ¶¶ 48, 58, 61; see also Pet. 56–57. PET image I10 in Figure 3 may be a similarly reconstructed volume image composed of a plurality of slice images.4 See 4 We do not rely here on Petitioner’s alternative theory that Weese discloses a “plurality” of second images because PET images I0 and I10 are “superposed” images encompassing “several states of motion.” Pet. 58. Ex. 1005 ¶¶ 61, 83–84. Patent Owner’s sole opposition to Petitioner’s assertions in this regard are limited to whether Weese “obtain[s]” PET images I0 and I10 as recited in claim 1, which we address below. Also, it appears that PET images I0 and I10 are obtained while also obtaining second movement measurements of the patient’s internal organs using a second sensor system (i.e., motion acquisition unit 12 and motion sensor 15 / S1) which is independent from the PET imaging technique. See Ex. 1005, Figs. 1 and 6, ¶ 65 (“[T]he respiratory motion is determined during the acquisition of the PET projections P1 by means of a respiratory motion sensor provided on the patient and therefrom the frequency function f(r) or, more generally, a state of motion function F1 is derived for the construction of the motion model M2.”). Furthermore, Weese describes how frequency function f(r) is utilized to facilitate image comparison between CT and PET images at common motion states. See id. ¶¶ 31, 49–51, 70–71, 75–77, 79–80, 83; see also Ex. 1003 ¶¶ 214–216 (Dr. Peterson’s supporting testimony). Patent Owner’s sole opposition to Petitioner’s assertions in this regard are limited to whether Weese “obtain[s]” PET images I0 and I10 as recited in claim 1, which we address below. Patent Owner’s two opposing arguments are unavailing, based on the present preliminary record. First, Petitioner relies on reconstructed PET images I0 and I10 as satisfying the “plurality of second images” recited in claim 1, not PET projections P1 from which PET images I0 and I10 are derived. See, e.g., Pet. 56, 58 (“I0 and I10 disclose and render obvious a ‘plurality of second images’ in two ways” — “I0 and I10 may be ‘volume images’ formed using ‘known’ techniques,” and “I0 and I10 are ‘superposed’ PET images encompassing ‘several states of motion,’ which” slip op. at 18
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,265,353 - 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 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.