- PTAB · Sep 5, 2024 · IPR2023-01300 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–13 and 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
“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). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a). A decision to institute is “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of the challenged claims is unpatentable. Accordingly, we institute an inter partes review of the challenged claims in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have possessed a strong understanding in the use and development of genetics and genomics approaches for detecting or monitoring human diseases, such as spatial detection of a target analyte (e.g., mRNA or DNA) in a tissue, and would typically have a Ph.D. in a relevant field (e.g., molecular biology, genetics, and bioinformatics) with two years of experience. Pet. 21–22 (citing Ex. 1044 ¶¶ 24–36). For the purposes of its Preliminary Response, Patent Owner does not provide its own proposed level of skill. Prelim. Resp. 7. For purposes of this Decision, we apply Petitioner’s unchallenged definition as it is consistent with the cited prior art and disclosure of the ’142 patent.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Thus, according to claim 1, to synthesize a first/second plurality of DNA products by performing a synthesis reaction, the “DNA products” must 1) use the oligonucleotides collected in steps (a) and (b) as templates from which the DNA is synthesized, and 2) incorporate a source location-identifying nucleic acid sequence.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner
“(2) Analysis Neither party has offered a construction for “collecting oligonucleotides under conditions that release them” in claim 1. We note that, in the related litigation, the district court determined that “under conditions that release” should have its plain and ordinary meaning. Ex. 1052, 38. For purposes of institution, we also apply the plain and ordinary meaning of this claim phrase and do not need to expressly construe the claim phrase for purposes of institution. On this record, for the reasons explained by Petitioner and as supported by its declarant testimony, we conclude Petitioner has sufficiently shown that So-456 discloses the “collecting oligonucleotides under conditions that release them” limitation recited in claim 1.” slip op. at 42
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,473,142 - PTAB · Aug 30, 2024 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Remand
On remand, the Board instituted inter partes review of claims 1–17, 20–21, 24–26, and 29–34 on all grounds stated in the Petition.
RulingsRemand decision- Director reviewOther
“Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17 (“Inst. Dec.”). Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel. Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Director Review Panel (“DRP”) vacated our decision and remanded the case to this panel with a revised construction for claim 1. Paper 23 (“DRP Dec.”).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect (2018). Upon reconsideration of the briefing and the evidence of record in light of the DRP’s claim construction, we conclude that Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable. Accordingly, we grant institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We find that Petitioner has demonstrated a material error by the Office in the prior consideration of Morales-Sanfrutos, Straus, Singh, and Lees. For instance, under the second prong of Advanced Bionics, we consider “(c) the extent to which the asserted art was evaluated during “(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art.” Becton, Dickinson, 17–18. We agree with Petitioner that the Office overlooked Morales- Sanfrutos’ and Singh’s teachings during examination and reexamination. Pet. 79. Although Morales-Sanfrutos, Straus, and Singh were listed on an IDS, they were not the subject of a rejection during examination or reexamination. Moreover, for the reasons discussed below at this stage with regard to Petitioner’s grounds over Morales-Sanfrutos, as evidenced by Straus, and over Singh, Petitioner sufficiently demonstrates that the Office materially erred in overlooking Morales-Sanfrutos’s and Singh’s teachings regarding their linker structures. Id. Further, to the extent the Lees’ teachings were considered during examination and reexamination, Lees’ disclosure of a homobifunctional sulfone linker was overlooked. Lees’ homobifunctional linker, which Patent Owner argues is substantially similar to Harris’ homobifunctional linker, which Petitioner chiefly relies upon in Grounds 2–5, was not the subject of a rejection during examination. Pet. Resp. Brief 1; Prelim. Resp. 25–26. We agree with Petitioner that only Lees’ heterobifunctional linker was applied in a rejection during examination. Pet. Resp. Brief 1; Ex. 1018, 42–43, 62. 4. Conclusion For the foregoing reasons, we decline to exercise discretion to deny institution under § 325(d).” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the (prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we apply Petitioner’s unopposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - PTAB · Aug 9, 2024 · IPR2024-00385 · APJ Michael L Woods · IPR · Institution
The Board instituted inter partes review of claims 1–4, 6, and 7 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“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.” 35 U.S.C. § 325(d). The Board evaluates discretionary denial under § 325(d) using a two-part framework: first, the Board considers whether the same or substantially the same art or arguments were previously presented to the Office; and if so, second, the Board considers whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019- 01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). In determining whether the same or substantially the same art or arguments were previously presented to the Office, the Board considers the following nonexclusive factors: (1) the similarities and material differences between the asserted art and the prior art involved during examination; (2) the cumulative nature of the asserted art and the prior art evaluated during examination; and (3) the extent of the overlap between the arguments” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a), we have authority to institute an inter partes review if “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, the Preliminary Response, the Reply, the PO Sur-reply, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the Challenged Claims of the ’332 patent. Accordingly, we institute an inter partes review of claims 1–4, 6, and 7 of the ’332 patent on the grounds asserted in the Petition.” slip op. at 2
- Skill levelSkill level board ownOther
“A person of ordinary skill in the art (POSITA) would have had: (i) a B.S. degree in Chemical Engineering, Petroleum Engineering, or an equivalent field and (ii) two or three years of academic or industry experience in chemical processing systems, oil and gas production and/or refining; or comparable experience. Additional work experience can substitute for educational or research experience, and vice versa. Pet. 8 (citing Ex. 1002 ¶¶ 26–29); see also Prelim. Resp. 16 (agreeing with Petitioner’s proposed definition of a POSITA). For purposes of this Decision, we adopt the parties’ assessment of the level of ordinary skill in the art.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“At this stage of the proceeding, we decline to adopt Patent Owner’s interpretation that cryogenic conditions occur only below 50°F. See Prelim. Resp. 19 (citing Ex. 2001 ¶ 55). For purposes of this Decision, we need not and do not formally determine the temperature at which cryogenic conditions occur, as our construction would not affect our decision to institute. 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)). We agree with Petitioner that “[e]xplicit construction of terms is unnecessary because it is not dispositive—the art teaches the claims under any reasonable construction.” Pet. 8 (citing Vivid Techs., 200 F.3d at 803). As explained below, for purposes of institution, Petitioner has shown a reasonable likelihood that Aycaguer does not disclose subjecting the recited streams to “cryogenic conditions” at any temperature, as recited in Limitation 1.6. See Pet. 34–36; see also infra § IV.D.2.g.” slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,505,332 - Hum Industrial Technology, Inc. v. Amsted Rail Company, Inc.Some claims unpatentablePTAB · Aug 7, 2024 · IPR2023-00538 · APJ Kevin W Cherry · IPR · Final written decision
Claims 1, 5–10, 13–18, 20–22, 24, 31, and 32 are unpatentable; claims 2–4, 23, and 25–30 were not shown unpatentable. The revised motion to amend was granted in part and denied in part.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“d. Summary For the above reasons, we determine that Patent Owner has not shown” slip op. at 100
- ExcludeMotion to exclude, deniedOther
“IV. PATENT OWNER’S MOTION TO EXCLUDE Patent Owner seeks to exclude Exhibit 1034 and page 10 of the Reply” slip op. at 86
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“A. “housing” Patent Owner proposes that we construe the term “housing” to mean” slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner
“suggested to one skilled in the art, objective evidence of non-obviousness (“secondary considerations”) may lead to a conclusion that the challenged claims would not have been obvious. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). Objective evidence of non-obviousness “may often be the most probative and cogent evidence in the record” and “may often establish that an invention appearing to have been obvious in light of the prior art was not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012) (citation omitted). For us to give substantial weight to objective evidence of nonobviousness, a proponent must establish a nexus between the evidence and the merits of the claimed invention. ClassCo, Inc., v. Apple, Inc., 838 F.3d 1214, 1220 (Fed. Cir. 2016). Nexus is a legally and factually sufficient connection between the objective evidence and the claimed invention, such that the objective evidence should be considered in determining non-” slip op. at 21
Patent outcomesUS 9,365,223 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,365,223 - Hum Industrial Technology, Inc. v. Amsted Rail Company, Inc.All claims unpatentablePTAB · Aug 6, 2024 · IPR2023-00540 · APJ Kevin W Cherry · IPR · Final written decision
Claims 1, 21–30, 36, and 37 are unpatentable as obvious; the Revised Motion to Amend is denied, and the Motion to Exclude is dismissed as moot.
RulingsFinal written decision- Skill levelDecided for petitioner
“G. Level of Ordinary Skill in the Art We consider the asserted grounds of unpatentability in view of the” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“B. Other Claim Terms The parties do not dispute the construction of any other claim terms and we find that no other terms require express construction to resolve the controversy between the parties. Accordingly, we do not construe any other claim terms expressly. See Realtime Data, 912 F.3d at 1375 (“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., 200 F.3d at 803).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Accordingly, we find that Petitioner has shown sufficiently that a person of ordinary skill in the art would have been motivated to combine the teachings of Armitage and Barone in the manner suggested. ix. Summary as to Claim 1 We find that Petitioner has shown sufficiently that the combination accounts for the limitations of claim 1, and that a person of ordinary skill would have been motivated to combine Armitage and Barone with a reasonable expectation of success. Accordingly, we find that Petitioner has shown by a preponderance of the evidence that claim 1 would have been obvious over Armitage and Barone.” slip op. at 35
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“include selection of data along certain axes or combinations of axes measured by the accelerometer and ignoring unselected data, well-supported and entitled to substantial weight. See Ex. 1025 ¶¶ 4–6. We find Dr. Shamos’s testimony to the contrary, Ex. 2006 ¶¶ 40–42, inconsistent with the disclosure of the challenged patent, and entitled to little weight. Patent Owner argues that Armitage does not monitor all of the axes, like the ’915 patent. See Sur-reply 1–3. However, the ’915 patent, just like in Armitage, isolates the data from a single axis for further analysis. See Ex. 1001, 13:17–24. Thus, we do not find Patent Owner’s distinction to be persuasive. Accordingly, we find that Petitioner has shown that Armitage accounts for this limitation.” slip op. at 24
Patent outcomesUS 10,137,915 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 10,137,915 - Jeisys Medical Inc. v. Serendia, LLCInstitutedPTAB · Jul 22, 2024 · IPR2024-00386 · APJ Michael L Woods · IPR · Institution
The Board instituted IPR on claims 1–29, finding a reasonable likelihood that claims 1–29 are unpatentable on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“D. Analysis The Director’s recent Videndum decision provides that where no “significant relationship [exists] under Valve, General Plastic factor one necessarily outweighs the other General Plastic factors.” See Videndum, Paper 12 at 6. Moreover, the Director’s decision in Ford clarified that “court-ordered” coordination alone between parties having different accused products does not establish a significant relationship absent “other relevant or extenuating facts or circumstances” that might evidence a significant relationship, such as “interactions or agreements regarding the implementation of the accused [technology] into their respective accused products.” Ford, Paper 28 at 10–11. We do not find a significant relationship exists between the prior and current petitioners so as to warrant discretionary denial under General Plastic. First, like the parties in Ford, the prior and current petitioners are competitors selling different products, and there is no evidence of agreements regarding the implementation of the claimed technology into their respective accused products. See Ford, Paper 28 at 10; cf. Valve, Paper 11 at 10 (“Valve represented that ‘HTC’s VIVE devices incorporate certain Valve technologies under a technology license from Valve,’ and that ‘Valve employees did provide HTC with technical assistance during the development of the accused VIVE devices.’”). Second, and also like in Ford, the “Ground Rules” for the ITC Investigation required that “[p]arties with similar interests should coordinate and consolidate motion practice to the extent practicable” (Ex. 1041 § 2) and “must coordinate and consolidate depositions and all other discovery” (id. § 3.1). Indeed, we understand that all fourteen co-respondents in the ITC Investigation submitted the joint expert report of Dr. Jean Woloszko. See Ex. 2004, 1; see also Ford, Paper 28 at 3. Third, we do not find the current Petitioner’s mere knowledge of litigation—either in the ITC or district court—against competitors in RF microneedling to establish a significant relationship with those competitors. Cf. Ford, Paper 17 at 3 (noting that where the patent at issue had been asserted against multiple competitors regarding their respective accused products, “merely engag[ing] in court-ordered pretrial coordination” is by itself insufficient to establish a “significant relationship” between the parties). Fourth, we do not find the current Petitioner to have engaged in improper gamesmanship through “tactical delay.” As Petitioner explains, the Prior Petition was filed in response to a district court action filed by Patent Owner against the prior petitioners, but not Petitioner, while the current Petition was filed in response to an ITC Investigation initiated after the denial of the Prior Petition. Patent Owner’s remaining arguments are directed to other factors in the General Plastic analysis and do not evidence a significant relationship between the prior and current Petitioners. Accordingly, we do not exercise our discretion to deny institution under General Plastic.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a), we have authority to institute an inter partes review if “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, the Preliminary Response, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the Challenged Claims of the ’836 patent. Accordingly, we institute an inter partes review of claims 1–29 of the ’836 patent on the grounds asserted in the Petition.” slip op. at 2
- Skill levelSkill level board ownOther
“IV. ANALYSIS A. Level of Ordinary Skill in the Art The parties agree that a person of ordinary skill in the relevant art (“POSITA”) would have had (1) 7–10 years of experience with developing and/or using treatment systems for delivery of electromagnetic radiation energy to skin or other tissues, and (2) a related graduate engineering degree or M.D. and may have worked as part of a multidisciplinary team and drawn upon not only his or her own skills, but also would have taken advantage of certain specialized skills of others on the team when solving a technical problem. Ex. 1028, 14–15; see also Pet. 9 (citing Ex. 1028, 15; Ex. 1003 ¶¶ 50, 51); see also Prelim. Resp. 29. For purposes of this Decision, we adopt the parties’ assessment of the level of ordinary skill in the art, as it is consistent with the prior art of record and the ’836 patent.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither Petitioner nor Patent Owner expressly construe any term. See Pet. 9; see also Prelim. Resp. 30. For purposes of this Decision, we need not and do not formally construe any claim term. 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 15
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,480,836 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 13, 2024 · IPR2022-01600 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–20 are unpatentable as obvious: claims 1–7 and 9–20 over Olmos and Varela ’774, and claim 8 over Olmos, Varela ’774, and Oglaza.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“invention. Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”): would have had a bachelor’s degree in mechanical engineering or biomedical engineering and two or more years of experience in biomechanical engineering, biomedical engineering, and/or spinal implant devices. A person could also have qualified as a POSITA with some combination of more formal education (e.g., an M.D.) and less technical experience or less formal education and more technical or professional experience in the foregoing fields, and would have had further appreciation of various technical concepts in this field. Pet. 18 (citing Ex. 1002 ¶¶ 32–35). Patent Owner does not dispute Petitioner’s proposal. See Response 8. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 13
- Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed
“We credit Mr. Drewry’s testimony that it would have been well within the ordinary skill of a POSITA to make the proposed modifications. See Ex. 1002 (Drewry Decl.) ¶¶ 34, 56–71 (discussing the qualifications of a POSITA and the types of engineering concepts the POSITA would have understood); Ex. 1030 (Drewry Reply Decl.) ¶¶ 37, 48–56, 59–66. To the extent Mr. Culbert testifies otherwise, we do not find such testimony persuasive. Indeed, Olmos itself further supports Mr. Drewry’s testimony that a POSITA would have known how to modify dimensions to fit specific needs and make changes necessary to adapt features from one embodiment to fit another. See Ex. 1006 (Olmos) ¶¶ 153, 188 (providing a range of implant sizes and noting that “specific dimensions” of any disclosed 9 Patent Owner’s citation to Mr. Drewry’s deposition transcript at 87:13– 88:9 appears to be incorrect. We understand that the intended citation is 69:34–70:7. embodiment can be varied as is apparent to a POSITA and “all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein to form various combinations and sub-combinations”). Given the POSITA’s ability to make the proposed modifications, we do not find that Patent Owner’s evidence regarding the number of modifications required undermines Petitioner’s articulated reasoning for the combination.” slip op. at 35
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that “no terms require constructions differing from their plain and ordinary meaning.” Pet. 19. Patent Owner states that it “takes no position on Petitioner’s assertion because the Board need not construe any claim term to find that the Challenged Claims are not unpatentable.” Response 8. We find that for purposes of this Decision, we need not construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
Patent outcomesUS 10,973,649 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,973,649 - PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution
The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Director may not authorize an inter partes review “unless the 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 a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Patent Owner has not directed us to 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 excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe 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.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“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); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, 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. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient 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. (See Ex. 1006, 3741.) 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 prembrolizumab 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 (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,591,393 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28
Patent outcomesUS 9,956,087 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,956,087 - Yita LLC / Jinrong (SH) Automotive Accessory Industrial Development Co. Ltd. v. Macneil IP LLCAll claims unpatentablePTAB · Jun 6, 2024 · IPR2023-00173 · APJ Arthur M Peslak · IPR · Final written decision
Claims 1–6 are unpatentable as obvious: claims 1–2 over Stanesic, Rothkop, and Cicotte; claims 3–6 over that combination with Lee, Fisker, Gruenwald, or Fu, respectively.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer not foundDecided for petitioner
“tray is “deeply concave” but fails to direct us to any part of the Specification using the term “deeply concave” let alone a clearly stated definition of “deeply concave” in the context of a vehicle floor tray. The response to office action, cited by Patent Owner, refers to the tray as concave not deeply concave and thus, does not support Patent Owner’s proposed construction. Ex. 2097, 11. For these reasons, to the extent that Patent Owner relies on the prosecution history as a disclaimer of the full scope of claims, we find that the cited response to the office action does not constitute “a clear and unmistakable disclaimer of claim scope.” Uship, 714 F. 3d at 1315.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“As explained below in our conclusion on motivation to combine, we” slip op. at 56
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“argument that Fu is not analogous art. PO Resp. 51. Dr. Kurfess first testifies that an ordinarily skilled artisan “never would have looked to Fu, or anything related to those fields, let alone micro-devices such as hearing aid shells to solve problems related to the automotive industry.” Ex. 2023 ¶ 144. Dr. Kurfess then testifies that “Fu is a disclosure for a hearing aid shell . . . and a [person of ordinary skill in the art] . . . would not consider the art of medical devices when trying to solve problems with vehicle floor mats.” Id. ¶ 188. Lastly, Dr. Kurfess testifies that “I completely disagree with Mr. Perreault’s conclusion that ‘a [person of ordinary skill in the art]” slip op. at 97
Patent outcomesUS 9,138,917 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,138,917
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.