- PTAB · Mar 24, 2025 · IPR2024-01235 · APJ Hubert C Lorin · IPR · Institution
The Board instituted IPR of claims 1–3, 6–11, and 14–16 on all proposed grounds after finding a reasonable likelihood of prevailing on the §103 ground over Mañosa and Patel.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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), 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedPrinted publication not establishedMixed
“[T]here is no presumption in favor of institution or in favor of finding a reference to be a printed publication under § 42.108(c) or any other authority. . . . [T]he burden is on the petitioner to identify with particularity evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent, and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner
“May” expresses a possibility. The Specification reflects this interpretation of “may” when it states that “[i]n one embodiment, the organic material is not lyotropic. Thus, the organic material may not be a phospholipid.” Ex. 1001, 8:27–28 (emphasis added). One of ordinary skill would understand from this that the organic material “may not be” a phospholipid if the organic material is not lyotropic. It follows that if the organic material is lyotropic, then the organic material may be a phospholipid. Reading the statement “[t]he organic material may not be . . . a phospholipid” (id. at 8:59–63) in light of the earlier stated possibility that the organic material may be a phospholipid if the organic material is lyotropic, one of ordinary skill in the art would interpret “may not be” as excluding phospholipids under some conditions, not under all conditions. Taking the Specification’s discussion about phospholipids as exemplifying the permissive nature of the word “may,” we are unpersuaded that in stating that “[t]he organic material may not be [PMMA], a polyvinylidene difluoride-containing polymer, such as [PVDF] or PVDF- TrFE-CTFE, or a phospholipid, such as [DHPE]’” (Ex. 1001, 8:59–63), the specification “contains a clear and unmistakable disavowal of the compounds PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE” and “disclaims the listed compounds” from the “organic material” of the claims under all conditions, as Patent Owner argues. Prelim. Resp. 6–7. Moreover, the claims themselves limit the “organic material” only to the extent that it is “barocaloric cooling or heating agent” and can perform in the manner claimed. See Ex. 1001, claim 1, supra. As broadly worded, the claims do not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE per se from the group of organic materials employed by the claimed method. Adopting Patent Owner’s construction would impermissibly import a limitation (i.e., not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE) into the claims. For the reasons stated, at this stage of the proceeding, we agree with Petitioner’s broad construction of “organic material.” We do not adopt Patent Owner’s proposed construction whereby PMMA, PVDF, PVDF- TrFE-CTFE, and DHPE are excluded from the scope of the claim term “organic material.” The parties are invited to address this issue further during trial, if desired. slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner shows that (a) Mañosa (i.e., inorganic compounds such as Ni-Mn-In, Gd5Si2Ge2, and La-Fe-Co-Si) and (b) Patel (i.e., PVDF-TrFE- CTFE) teach materials exhibiting inverse BCEs. Pet. 59 (citing, inter alia, Ex. 1007, pages 4–8; Ex. 1009, 1, 4–5; Ex. 1004 ¶ 108). In our view, at this stage, Petitioner sufficiently shows (via the five reasons listed supra) why it would have been obvious to one of ordinary skill in the art to substitute the barocaloric cooling or heating agent of Patel for that taught in Mañosa, thereby reaching the claimed method with a reasonable expectation of success. Cf. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (U.S., 2007) (“The Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”)” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,230,656 - PTAB · Jan 27, 2025 · IPR2024-00965 · APJ Zhenyu Yang · IPR · Institution
Instituted review of claims 1–6 on all asserted grounds because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedInstituted
“We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 20; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for purposes of institution, Petitioner has met its burden to show a reasonable likelihood that Gloor was publicly accessible before the priority date of the ’200 patent. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“institution under § 325(d). Prelim. Resp. 21–29. Under 35 U.S.C. § 325(d), in determining whether to institute an inter partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 11
§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 11,768,200 - PTAB · Jan 27, 2025 · IPR2024-00964 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–8 based on both asserted obviousness grounds: Parameswaran with Gloor and Parameswaran with Bentley.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 27; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for the purposes of institution, with Dr. Gloor’s declaration and the supporting exhibits attached therein, Petitioner has met this burden. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“detailed analysis to support its argument that the combination of Parameswaran and Gloor teaches or suggests each limitation of claim 1. Pet. 23–36. Petitioner also contends that an ordinarily skilled artisan would have been motivated combine the teachings of the two references and would have had a reasonable expectation of success in doing so. Id. at 36–45. Patent Owner counters that the combination does not teach or suggest two limitations, namely the amplifying and discarding steps of the method. Prelim. Resp. 18–24. Patent Owner also challenges Gloor’s prior art status. Id. at 24–28. Based on the current record, we find Petitioner’s argument with respect to the amplifying and discarding steps more persuasive. With respect to the remaining limitations, we find persuasive Petitioner’s analysis on the prior art’s teachings. We also find persuasive Petitioner’s analysis on the motivation to combine and reasonable expectation of success. For the purposes of institution, we adopt those analyses as our own. We address Patent Owner’s counterarguments below.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“cross-over events (id. at 18–21). Based on the current record, we find Petitioner’s argument more persuasive. Petitioner relies on the combination of Parameswaran and Gloor as teaching the amplifying step. See Pet. 31–33. As such, Patent Owner cannot show non-obviousness “by attacking references individually.” In re Keller, 642 F.2d 413, 426 (CCPA 1981). Patent Owner argues that “because Parameswaran used pyrosequencing on the surface of beads in a Roche 454 sequencer, it does not disclose the formation of clusters.” Prelim. Resp. 21 (citing Pet. 31). Petitioner, however, relies on Gloor for teaching “amplifying said nucleic acid templates on a surface of a flow cell thereby to form clusters.” Pet. 31–32. Patent Owner does not challenge this reliance. See generally Prelim. Resp. Patent Owner contends that Petitioner “equat[es] the claimed chimeric sequences with ‘mismatched’ or ‘misassigned’ sequences containing an ‘unexpected’ pair of forward and reverse barcode motifs identified in Parameswaran.” Prelim. Resp. 18–19. But, according to Patent Owner, “Petitioner does not point to any disclosure in Parameswaran identifying these “mismatched” motifs as chimeric sequences—as opposed to mere sequencing or sample handling error—nor does Petitioner cite any disclosure in Parameswaran regarding such sequences resulting from cross-over events.” Id. at 19. We find Patent Owner’s characterization of Petitioner’s argument inaccurate. As we understand it, Petitioner does not “equat[e]” the claimed chimeric sequences with “mismatched” sequences in Parameswaran. Instead, as Patent Owner acknowledges, “Petitioner argues that ‘sequences with mismatched barcode motifs’ in Parameswaran ‘include chimeric sequences resulting from cross-over events.’” Id. (quoting Pet. 32) (emphasis added).” slip op. at 14
§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 11,041,852 - PTAB · Jan 13, 2025 · IPR2024-01156 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–30 on all grounds, finding it more likely than not that the claims are unpatentable.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the current record, there is no controversy over the meaning of any of the claim terms and neither party identifies a claim construction that would impact our analysis. We therefore find that, at this stage of the proceeding, there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts (without opposition): A person of ordinary skill in the art (“POSA”) at the time of invention would have a working knowledge of microbiology and would have been involved in developing testing methodologies for analysis of samples such as food products (“validation methodologies”). The POSA would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies. The POSA would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The motivation-to-combine analysis is a flexible one. “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed,” [but the] “analysis ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’” Intel Corp. v. PACT XXP Schweiz AG, 61 F.4th 1373, 1379–80 (Fed. Cir. 2023) (quoting KSR, 550 U.S. at 418, 420 (emphasis added)). “[I]f there’s a known technique to address a known problem using ‘prior art elements according to their established functions,’ then there is a motivation to combine,” because KSR explains that “if a technique has been used to improve one device [or method], and a person of ordinary skill in the art would recognize that it would improve similar devices [or methods] in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 1380 (quoting KSR, 550 U.S. at 417; and Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021)). If addressing a known problem, the prior art combination need not be “the best option, only . . . a suitable option.” Id. (quoting Intel, 21 F.4th at 800 (emphasis original)).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,845,486 - PTAB · Nov 8, 2024 · IPR2024-00834 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood of unpatentability and declining discretionary denial under §§ 325(d) and 314.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“anticipated by Sonti. Pet. 3. To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). The prior art need not, however, use the same words as the claims to find anticipation. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). In evaluating anticipation, it is permissible to take into account not only the literal teachings of the prior art reference, but also the inferences the skilled artisan would draw from it. Eli Lilly and Co. v. Los Angeles Biomedical Res. Inst. At Harbor-UCLA Med. Ctr., 849 F.3d 1073, 1074–75 (Fed. Cir. 2017) (holding that the “dispositive question regarding anticipation is whether one skilled in the art would reasonably understand or infer from a prior art reference that every claim element is disclosed in that reference”). As such, “a reference can anticipate a claim even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (internal quotation and alteration marks omitted).” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“b. Reasonable Expectation of Success Petitioner asserts that an ordinarily skilled artisan would have been motivated, with a reasonable expectation of success, to topically administer 1% tapinarof composition once a day to treat mild to severe plaque psoriasis in view of Sonti’s teaching to apply its compositions (including 1% tapinarof compositions) in various application frequencies (including once daily) to treat moderate to severe plaque psoriasis. Pet. 29–30 (citing, e.g., Ex. 1003 ¶¶ 182–184, 187–188; Ex. 1005 Abstract, ¶¶ 55, 196, 288, 387).” slip op. at 32
- Obviousness (§103) › Objective indicia / secondary considerationsInstituted
“d. Objective Indicia of Non-obviousness Patent Owner asserts that, although the “Petition notes the patent’s ‘surprising[] and unexpected[]’ finding that once daily application of 1% tapinarof cream was just effective as twice daily application, . . . the Petition does not analyze, as the law requires, this surprising, unexpected finding in its obviousness arguments.” Prelim. Resp. 52. We are not persuaded by this argument. Immediately after the Petition’s acknowledgement that “[t]he specification [of the ’088 patent] contends that it was ‘surprisingly’ found that once daily application was just as effective as twice daily,” the Petition notes that, “[h]owever, during prosecution the examiner cited a set of prior art by Chen et al. disclosing treating plaque psoriasis by topically applying a composition containing 1% tapinarof once a day.” Pet. 1 (footnote omitted). Indeed, Patent Owner acknowledges that Petitioner counters “Applicant’s surprising and unexpected findings” by referring to the Chen references cited during prosecution, but asserts that “Chen . . . does not undermine Applicant’s surprising and unexpected findings” because “Chen discloses applying a composition containing 1% mixture of cis and trans 3,5-dihydroxy-4-isopropylstilbene, and not one containing 1% tapinarof (3,5-dihydroxy-4-isopropyl-trans-stilbene).” Prelim. Resp. 52–53.16 As 16 Patent Owner refers to its earlier discussion on this issue. Prelim. Resp. 53 (“As already discussed . . .”). That earlier discussion is with respect to the Chen references cited in Sonti (i.e., Exs. 1012 & 1013), not the Chen 40” slip op. at 40
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,590,088 - PTAB · Oct 3, 2024 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR of claims 1–30 on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–30 of the ’462 patent is unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Design, Eligibility). At this point in the proceeding, we interpret the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients. The record is devoid of evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition to exclude the same treatment of other patients, such as the treatment of control patients not having the condition.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“5002). Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. See Ex. 1003 ¶¶ 124, 130, 132, 136. Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. Pet. 42–43 (citing Ex. 1003, ¶ 136). Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were actively treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. Pet. 43 (citing Ex. 1016; Ex. 1017; Ex. 1003 ¶¶ 131–132). According to Petitioner, these other references would have “independently urged” those of ordinary skill in the art to treat MSI-H cancer with PD-1 inhibitors or other immunotherapy, such as pembrolizumab, and would have given them a reasonable expectation of success. Pet. 44–45. Petitioner cites, along with other references, Pernot, which states “[colorectal cancers] associated with MSI could lead to a more intense immune response, but also to specific immunoregulatory phenomena, making them good candidates for immunotherapy.” (Ex. 1006,3 3741; see Pet. 43.) Petitioner also cites Champiat, which states that” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that one of ordinary skill in the art relevant to the ’462 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. Pet. 11 (citing Neugut Decl., Ex. 1003 ¶ 19). Petitioner argues further that the ordinarily skilled artisan would have had experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. Id. Patent Owner, having not entered a response, does not dispute Petitioner’s proposal about the POSA’s qualifications on this record.. For this Decision, we adopt and apply Petitioner’s proposal above, which is supported by Dr. Neugut’s testimony and does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - PTAB · Sep 27, 2024 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR of claims 1–28 on all six asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–28 of the ’187 patent are unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Anticipation is a question of fact, as is the question of what a prior art reference teaches. In re NTP, Inc., 654 F.3d 1279, 1297 (Fed. Cir. 2011). “Because the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates a claim is assessed from the skilled artisan’s perspective. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching that every claim element was disclosed in that single reference.” (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“The obviousness inquiry also typically requires an analysis of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). A petitioner cannot prove obviousness with “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Rather, a petitioner must articulate a sufficient reason why a person of ordinary skill in the art would have combined the prior art references. In re NuVasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner argues that we need not construe any terms of the challenged claims to resolve the issues presented in the Petition. Pet. 11. We determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 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))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,629,187 - PTAB · Sep 27, 2024 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–36 because the Petition showed a reasonable likelihood of prevailing on at least one challenged claim across the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving the unpatentability of at least one of claims 1–36 of the ’287 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“summarized above, we are persuaded by Petitioner that the MSI-H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); Ex. 1003, ¶¶ 58–62. We are also persuaded that Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated with pembrolizumab. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.3 Accordingly, we are persuaded by Petitioner that, on this record, the MSI-H Study Record discloses each element of claim 1. In view of the above, we determine that Petitioner has sufficiently shown a reasonable likelihood of establishing that the MSI-H Study Record anticipates claim 1. Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating a human patient having colorectal cancer that is microsatellite instability high or DNA mismatch repair deficient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. Ex. 1006, 3741; Ex. 1003 ¶ 136. Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with pembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD-1 inhibitor (Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (Ex. 1032, e27817-5). Pet. 44 (citing Ex. 1003 ¶ 49). Thus, based on the current record, we determine that Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art. Accordingly, in view of the above, we are persuaded that there is a reasonable likelihood that Petitioner will prevail with respect to at least one claim challenged under Ground 2 in the Petition.” slip op. at 21
- Skill levelSkill level petitioner adoptedOther
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention would be a medical doctor or a professional in a related field with at least five years of experience with treating cancer. . . . The POSA would also have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and a pathologist with comparable experience. . . . The inherent anticipation and obviousness grounds discussed herein would not change due to a modestly lesser or greater level of experience. Pet. 11–12 (citing Ex. 1003 ¶ 19). For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,649,287 - PTAB · Sep 27, 2024 · IPR2024-00650 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR of claims 1–38 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 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). We determine whether to institute an inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“determined to be microsatellite instability high or DNA mismatch repair deficient were placed into a study arm and then treated with pembrolizumab. (See Ex. 1005, Ex. 1003 ¶¶ 60–73.) Because treatment of the patients was performed only after MSI-H status was determined, the MSI-H Study Record teaches treating the patients “in response to” determining their MSI- H status.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“have been expected, Petitioner cites to Brown as teaching that PD-1 inhibitors are inherently more effective when treating tumors comprised of cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1034, 747).) Petitioner argues further that Duval teaches that MSI-H cancers have cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1087, 5002).) Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. (See Ex. 1003 ¶¶ 124, 130, 132; see Pet. 41.) Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. (See Pet. 41 (citing Ex. 1003 ¶ 130).) Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were successfully treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. (See Pet. 42 (citing Ex. 1003 ¶¶ 131, 132).)” slip op. at 18
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that one of ordinary skill in the art relevant to the ’219 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. (See Pet. 11 (citing Neugut Decl., Ex. 1003 ¶19).) Petitioner argues further that the ordinarily skilled artisan would have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. (See id.) Dr. Neugut’s testimony supports Petitioner’s arguments regarding the level of skill that an ordinarily skilled artisan in the relevant field would have. (See Ex. 1003 ¶ 19.) Accordingly, in the analysis below, and in the absence of argument by Patent Owner to the contrary, we apply the level of skill set forth by Petitioner and refer to Dr. Neugut’s testimony of what one of ordinary skill in the art would have understood at the time the application that became the ’491 patent was filed, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491 - PTAB · Sep 23, 2024 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR of claims 1–7 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that 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, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–7 of the ’974 patent is unpatentable, and we institute inter partes review of all challenged claims on all asserted grounds. Id.” slip op. at 2
- BurdenInstituted
“reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates a claim is assessed from the skilled artisan’s perspective. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching that every claim element was disclosed in that single reference.” (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))).” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“2. The Parties’ Contentions The parties agree that the MSI-H Study Record was publicly available by June 12, 2013. (See Pet. 7; see Prelim. Resp. 19 (“JHU submitted the MSI-H Study Record on June 10, 2013, and it was posted on clinicaltrials.gov on approximately June 12, 2013”). In its Preliminary Response, Patent Owner does not dispute Petitioner’s argument (see Pet. 8) that the MSI-H Study Record is prior art under 35 U.S.C. § 102(a) and is not covered by an exception under 35 U.S.C. § 102(b). See Prelim. Resp.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInstituted
“22. Our research group eventually approached Merck. Merck agreed in early 2013 to supply its then-unapproved anti-PD-1 antibody, MK-3475 (pembrolizumab) for use in the study. It was, however, the research team at Hopkins who secured IRB approval, conducted, and paid for the study. On June 12, 2013, the solicitation for patients was first posted on clinicaltrials.gov (Exhibit D). In my mind, the four arms allowed us to try to get at an answer to a question to which we did not know the answer-specifically whether or not patients with MSI-high or MMR deficient tumors would exhibit an improved response when treated with MK-3475, compared with the more common MSS [microsatellite stable] or MMR proficient colon cancers. Thus, the trial covered all patients with colon cancer, MSI and MSS, but separated into two groups. 23. The preliminary results of this study demonstrated clinical responses at an unexpectedly high rate (>50% objective response rate) in the MSI-high (MMR deficient) arm but not in the MSS (MMR proficient) arm. (Ex. 1002, 270–271.) This affidavit, submitted during prosecution of the ’974 patent, supports the argument that an improved outcome of treating a patient with a tumor exhibiting an MSI-high or a MMR deficiency status with pembrolizumab compared to similarly treating a patient without an MSI-high or a MMR deficiency status, a recited in claim 1, is an inherent result. Patent Owner does not dispute this result in the Preliminary Response. See Prelim. Resp. 7 (“The ’974 Patent reports that mismatch repair-deficient colorectal cancers (i.e., MSI-H CRC) had an immune-related objective response rate and immune-related progression-free survival rate of 40% and 78%, respectively—a huge improvement compared to the 0% and 11% rates found in mismatch repair-proficient colorectal cancers (i.e., MSI negative CRC).”).” slip op. at 17
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,325,974
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.