- PTAB · Nov 15, 2024 · IPR2024-00851 · APJ Eric C Jeschke · IPR · Institution
The Board denied institution on all claims 1–7 because the Petition did not show a reasonable likelihood of prevailing on any challenged ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2023) (“The Board institutes the trial on behalf of the Director.”). 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. Upon consideration of the evidence and arguments in the record, for the reasons below, we determine that the information presented does not show a reasonable likelihood that Petitioner would prevail with respect to at least one of challenged claims 1–7. We thus deny institution of inter partes review. See 37 C.F.R. § 42.108(b) (“At any” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“we view the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The person of ordinary skill in the art is a hypothetical person presumed to have known the relevant prior art. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In determining the level of ordinary skill in the art, we may consider certain factors, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” Id. (internal quotation marks and citation omitted).” slip op. at 10
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner
“claim element creates a rebuttable presumption that § 112[(f)] applies” and that “the failure to use the word ‘means’ also creates a rebuttable presumption—this time that § 112[(f)] does not apply.”12 Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc in relevant part) (internal citations omitted). Because the “sealing means” limitation includes the word “means,” we start from the rebuttable presumption that § 112(f) applies. Petitioner does not address the applicability of § 112(f) and does not rebut the presumption. We continue the analysis, however, and, for the reasons below, we agree with Patent Owner that § 112(f) applies to the “sealing means” limitation.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“3. “fits behind” In wherein clause (vi), claim 1 recites: “the outwardly pointing outer flange of the first connecting device fits behind the inner flange of the nut unit.” Ex. 1001, 9:4–5 (emphasis added). In the Preliminary Response, Patent Owner discusses the term “fits behind” in this claim language. See Prelim. Resp. 41–45. We need not construe explicitly this language or any other claim terms because doing so would not change the outcome of the analysis. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 9,851,030 - PTAB · Nov 14, 2024 · PGR2024-00026 · APJ Hyun J Jung · PGR · Institution
Instituted PGR on claims 1–7 and all grounds because Petitioner showed it was more likely than not that at least one challenged claim lacks written-description support.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“At this stage, Petitioner’s arguments, cited portions of the Specification, and supporting testimonial evidence demonstrate that it is more likely than not that claims 1–7 are unpatentable.” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner
“patent describes that “angular position transducer 78 is placed on top of swing leg pivot shaft 24” and that “pivot shaft 24 is rotationally fixed to the connector plate and duplicates the angular movements of swing leg 20 about the pivot shaft.” Ex. 1001, 12:15–16, 12:20–22, Figs. 5, 7. The ’723 patent also describes that “[a]ngular position transducer 78 is mounted inside . . . protective can 90 . . . which is bolted to hinge bracket 28 via an upright holding arm 92” and that “trigger pin 94 projects upwardly from the top surface of pivot shaft 24 and cooperates with angular position transducer 78 to generate an angular position signal.” Id. at 12:28–33, Fig. 5. These descriptions expressly convey that angular position transducer 78 is on pivot shaft 24 and mounted inside protective can 90 that is bolted to hinge bracket 28. Id. at 12:15–16, 12:20–22, 12:28–30, Figs. 5, 7; see also Prelim. Resp. 17 (describing the same embodiment shown in Figs. 5 and 7). According to Petitioner, the ’723 patent describes the pivot shaft as part of the hinge bracket, not the modular frame or swing leg. Pet. 109–110 (citing Ex. 1001, 7:42–46, 12:17–22). On the preliminary record, we agree because the cited portions of the Specification describe that a “hinge bracket is interposed between each swing leg and an associated surface of the bolsters and includes a fixed, upright pivot shaft that pivotally engages the swing leg for pivotal movements” and “pivot shaft 24 is rotationally fixed to the connector plate.” Ex. 1001, 7:42–45, 12:20–21. We also agree that “even if one were to find that the hinge bracket is part of either the modular frame or swing leg (contrary to the claims and specification treating these all as separate components), the specification would only provide written description for one of the claimed alternatives.” Pet. 110 (citing Ex. 1002 ¶ 199).” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“At this preliminary stage, we determine that express claim interpretation is not necessary to determine whether it is more likely than not that at least one of the claims challenged in the petition is unpatentable. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 16
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“We will also not use our discretion under § 325(d) to deny the Petition based on arguments previously presented in IPR2021-00135, because Petitioner relies on a Board determination regarding claim 8 from IPR2021- 00136, not arguments previously made for claim 1 in IPR2021-00135. Pet. 111–115, 119; Prelim. Resp. 8–9; Prelim. Sur-reply 5. Furthermore, we determined the effective filing date of claim 8 of the ’571 patent without deciding, that other challenged claims, such as claim 1, were entitled to their earliest possible effective filing date. See Godberson-Smith, Paper 61 at 11, 12.” slip op. at 12
Claim construction§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,772,723 - PTAB · Nov 14, 2024 · IPR2024-00835 · APJ Hyun J Jung · IPR · Institution
The Board instituted IPR of claims 1–8 on all asserted grounds, finding a reasonable likelihood that claim 1 would be unpatentable over CIII and Rio.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Advanced Bionics stated that: If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Factor (c) focuses on the record developed by the Office in previously reviewing the art or arguments. It informs, therefore, the petitioner’s showing under factors (e) and (f), which focus on the petitioner’s evidence of previous Office error regardless of the context in which the same or substantially the same art or arguments were previously presented. For example, if the record of the Office’s previous consideration of the art is not well developed or silent, then a petitioner may show the Office erred by overlooking something persuasive under factors (e) and (f). On the other hand, if the alleged error is a disagreement with a specific finding of record by the Office, then ordinarily the petitioner’s required showing of material error must overcome persuasively that specific finding of record. That is, although Becton, Dickinson factor (c) evaluates “the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection,” the focus should be on the record when determining whether the Office erred in evaluating such art or arguments.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“d) Petitioner Shows a Reasonable Likelihood of Prevailing Based on the preliminary record, Petitioner shows a reasonable likelihood of prevailing in its challenge that CIII and Rio teach, suggest, or would have been understood to disclose the limitations of claim 1 and that one of ordinary skill in the art would have combined the references in the manner asserted with a reasonable expectation of success.” slip op. at 28
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“track” that “is configured to rotate . . . relative to the jacking column,” Petitioner proposes modifying CIII in view of Rio “by positioning Rio’s rotary actuator 44 between the jacking column and crawler track, and using that rotary actuator to rotate CIII’s crawler track relative to the entire jacking column, rather than just its outer cylinder.” Pet. 45 (citing Ex. 1002 ¶ 89) (emphasis added); see also id. at 47 (citing Ex. 1002 ¶ 92; Ex. 1006, 5:8–11, 6:2–6). Petitioner argues such a modification would have been a design choice, one of a finite number of alternatives, obvious to try, and a known design that provides maneuverability. Id. at 29–31 (citing Ex. 1002 ¶¶ 61–67; Ex. 1006, 5:8–11; Ex. 1007, 5:14–59, Figs. 4–5; Ex. 1008, 7:35– 53, Figs. 7, 20; Ex. 1009 ¶¶ 5, 19–20, Fig. 2; Ex. 1011, 4:7–16, Fig. 3; Ex. 1013 ¶¶ 41, 44–45). At this stage, Petitioner’s arguments and cited evidence sufficiently support for institution that the modification would have been made so that the proposed combination would have had “a crawler track” that “is configured to rotate . . . relative to the jacking column.” Regarding claim 1’s “slew drive,” as discussed above, Petitioner proposes modifying CIII so that rotary actuator 44, the asserted slew drive, would be between the jacking column and crawler track. See Pet. 29–31. Petitioner also argues that, in the proposed combination, “actuating the rotary actuator causes the crawler track to rotate relative to the entire jacking column.” Id. at 47 (citing Ex. 1002 ¶ 92). The present record supports Petitioner’s argument that Rio’s worm gear actuator would have been understood to disclose a slew drive with support from the ’318 patent itself, the opinion of its declarant, and deposition testimony of Patent Owner’s expert in related litigation. Id. at 46–47 (citing Ex. 1001, 11:40–61; Ex. 1002 ¶ 91; Ex. 1006, 4:61–5:3; Ex. 1032, 84:12–86:17). At this stage, the cited evidence sufficiently supports for purposes of institution Petitioner’s argument that the proposed combination would have included the recited “slew drive.”” slip op. at 28
- Skill levelSkill level petitioner adoptedOther
“had at least a four-year degree in mechanical engineering or a closely related field and at least two years of experience designing, developing, or operating heavy machinery, including their components and control systems.” Pet. 8– 9 (citing Ex. 1002 ¶¶ 22–24). Petitioner also argues that “[a]dditional experience could substitute for a formal degree, and an advanced degree could substitute for experience.” Id. at 9 (citing Ex. 1002 ¶¶ 22–25). Petitioner states that “[t]he Board adopted this definition of the level of ordinary skill for the related ’749 patent.” Id. (citing Godberson-Smith Const. Co. v. Guntert & Zimmerman Const. Div., Inc., IPR2020-01698, Paper 80, 21–24 (PTAB Apr. 12, 2022) (Final Written Decision)). For purposes of its Preliminary Response, Patent Owner applies Petitioner’s proposed level of ordinary skill in the art. Prelim. Resp. 13 (quoting Pet. 8–9). Based on the preliminary record, we adopt Petitioner’s asserted level of ordinary skill to determine whether there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. Pet. 8–9; Godberson-Smith, Paper 80 at 21–24 (determining level of ordinary skill after considering the parties’ competing proposals and evidence).” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,535,318 - Cub Elecparts Inc. v. Orange Electronic Co., Ltd.Institution deniedPTAB · Nov 12, 2024 · IPR2024-00744 · APJ Patrick R Scanlon · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority to determine whether to institute an inter partes review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2023). 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). For the reasons set forth below, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one challenged claim. Accordingly, we do not institute an inter partes review of the challenged claims on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person having ordinary skill in the art (“POSA”) “would have a bachelor’s degree in electrical engineering and at least one year of experience in sensor/detector design or RF communications (RFIDs)” and “would have a working knowledge of tire pressure management systems and, as most POSA would also be automobile owners, would have had personal experience with tire pressure management systems which have been required in all new cars, trucks, and SUVs in the United States since 2007.” Pet. 17. Petitioner adds that “[e]ducation may substitute for experience and vice versa.” Id.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that all claim terms should be given their ordinary and customary meaning. Pet. 17. Petitioner notes that, in the tire pressure detecting field, terms such as “detector,” “sensor,” and “monitor” relate to the same device and can be used interchangeably. Id. at 17–18. Patent Owner contends that no claim term needs construction to resolve the grounds asserted in the Petition. Prelim. Resp. 16. On the present record, we do not discern a need to construe explicitly any claim language because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We agree with Patent Owner that Petitioner’s unsupported assertion that tire pressure sensors typically are programmed with only the ID as part of the factory installation is insufficient to establish obviousness in this instance. Petitioner does not provide adequate reasoning or evidence to 11 Petitioner relies on the same analysis of this claim 26 limitation for the substantially similar limitation of claim 27. Pet. 66. Accordingly, our analysis of the claim 26 limitation applies equally to the corresponding limitation of claim 27. art would have known that tire pressure sensors typically are programmed at the factory with a single ID. Furthermore, even if assuming for the sake of argument that Petitioner’s assertion is correct, the Petition fails to explain adequately how or why one of ordinary skill in the art would have modified the combination of Tang and Lemense to store only the old identification in the old tire pressure detector.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 8,031,064 - PTAB · Oct 10, 2024 · IPR2024-00734 · APJ Steven M Amundson · IPR · Institution
The Board instituted IPR on claims 1, 3, 15, 17, and 19–21, finding a reasonable likelihood of success on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“to institute an inter partes review. We may institute an inter partes review only if “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) (2018). The “reasonable likelihood” standard is “a higher standard than mere notice pleading” but “lower than the ‘preponderance’ standard to prevail in a final written decision.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential). Based on the current record and for the reasons explained below, Petitioner has shown that there is a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we institute an inter partes review of claims 1, 3, 15, 17, and 19–21 in the ’518 patent on all challenges included in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art at the time of the alleged invention “would have been someone”: (1) “knowledgeable with the computer networking techniques available at the time”; and (2) “who had a bachelor’s degree in computer science, computer engineering, electrical engineering, or an equivalent, and two years of experience working with computer networks, including network security.” Pet. 7. Petitioner also asserts that “[l]ack of work experience can be remedied by additional education, and vice versa.” Id. Dr. Crovella’s testimony supports Petitioner’s assertions. See Ex. 1003 ¶¶ 15–16. Based on the current record and for purposes of this decision, we accept Petitioner’s description of an ordinarily skilled artisan because it comports with the technology and claims of the ’518 patent as well as the asserted references. See Ex. 1003 ¶ 16.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Based on the current record, we determine that no claim term requires an explicit construction to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Based on the current record, Petitioner establishes sufficiently for purposes of institution that an ordinarily skilled artisan would have had reasons, i.e., as articulated by Dr. Crovella, to combine the teachings of Gai, Yip, and Kwan in the way Petitioner proposes. See Pet. 14–21, 27, 29–31, 38; Ex. 1003 ¶¶ 51–58, 62–72, 91–92, 98, 101, 121. Based on the current record, Petitioner also establishes sufficiently that an ordinarily skilled artisan would have had a reasonable expectation of success in combining the teachings of the references. See Pet. 16–17, 22, 38; Ex. 1003 ¶¶ 59–60, 73–74, 121. (f) Preliminary Conclusion About Alleged Obviousness As discussed above, Petitioner’s analysis addresses how the combined disclosures in Gai, Yip, and Kwan teach claim 1’s subject matter. See supra §§ III.D.4(a)–(d). Additionally, Petitioner provides reasons with rational underpinnings as to why an ordinarily skilled artisan would have been motivated to combine the teachings of Gai, Yip, and Kwan in the way Petitioner proposes and would have had a reasonable expectation of success. See supra § III.D.4(e). Hence, Petitioner demonstrates a reasonable likelihood of proving that claim 1 is unpatentable under § 103(a) because the claim would have been obvious over Gai, Yip, and Kwan.” slip op. at 34
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,623,518 - 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.