- Parse Biosciences, Inc. v. 10x Genomics, Inc.All claims unpatentablePTAB · Sep 17, 2024 · IPR2023-00876 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–6 are unpatentable: claims 1–4 and 6 as obvious over Linnarsson and McCloskey, and claim 5 as obvious over those references and ordinary skill.
RulingsFinal written decision- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1065 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s October, 27, 2023, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). Because it was not filed until March 29, 2024, Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration. In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 1–2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s October 27, 2023, objection to McCloskey. Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1065).” slip op. at 16
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“We find that both references are analogous art to the ’981 patent, as there is ample supporting evidence in the record, including that to which the Reply cites (citations identified in the immediately preceding paragraph). Indeed, Patent Owner does not dispute the merits of either argument. PO Sur-Reply 27–28. Rather, Patent Owner, argues that we “should not now permit Petitioner to rewrite its clearly-deficient Petition.” Id. at 28. Petitioner’s Reply does not re-write its Petition. What Petitioner’s Reply does, in response to Patent Owner’s arguments, is precisely what Sanofi-Aventis contemplates as being proper in a reply brief. Indeed, in ruling against the petitioner in Sanofi-Aventis, the Federal Circuit specifically noted that the petitioner could have used its reply brief “to explain how [the prior art reference] is analogous to the [challenged] patent” but did not do so. 66 F.4th at 1379–1380. Here, in contrast, Petitioner used its Reply brief to explain how Linnarsson and McCloskey are analogous to the ’981 patent. Petitioner’s explanation in its Reply brief was both proper and persuasive.” slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner
“That McCloskey is what it purports to be (a journal article) and that it was published in 2007 are corroborated by multiple pieces of evidence. McCloskey names four authors, all four of whom are named inventors of US 2007/0020640 A1, published Jan. 25, 2007 (“McCloskey ’640”). Ex. 1004, 1, Ex. 2001, code (76). Patent Owner concedes that McCloskey and McCloskey ’640 involve the same subject matter, having argued that the consideration of McCloskey ’640 supported discretionary denial of the Petition based on McCloskey. See, e.g., Prelim. Resp. 22 (“Petitioner’s secondary reference, an article by McCloskey, is at best cumulative of the far more detailed McCloskey ’640, which was raised by the Office and substantively discussed as the basis for a potential rejection using its asserted disclosure of a polynucleotide-specific tag—the same purported teaching for which Petitioner relies on McCloskey here.”). Notably, McCloskey ’640 was published on January 25, 2007. Ex. 2001, code (43). That is just days before McCloskey was received by BIOCHEMICAL GENETICS on January 31, 2007. See EX. 1004, 1 (“Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007”). In other words, it appears that the authors sought to have their research published in a scientific journal promptly after the subject matter of their research had been published by the Office. Further, the existence of McCloskey and its publication year of 2007 is confirmed by other sources in the record. See Ex. 1029, code (56) (United States Patent identifying as a cited reference: “McCloskey, et al. Encoding Pcr products with batch-stamps and barcodes. Biochem Genet. Dec. 2007;45(11-12):761-7. Epub Oct. 23, 2007.”); Ex. 1053, code (56) (same); Ex. 1060 (article’s bibliography citing “McCloskey ML, Stöger R, Hansen RS, Laird CD. Encoding PCR products with batch-stamps and barcodes. Biochem. Genet 2007;45:761–767. [PubMed: 17955361]”). Patent Owner’s Motion to Exclude is denied with respect to” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“The Petition states that “Petitioner does not believe that any terms require explicit construction in view of the prior art being presented.” Pet. 36. Despite this stated position, Petitioner proposed constructions for “multiplex-identifier (MID)” and “providing a sample.” Id. Patent Owner, in its Preliminary Response, stated that it “agrees that at this time, solely for purposes of an institution decision on the Petition, no terms require explicit construction.” Prelim. Resp. 45. In instituting the IPR, we found no need to provide an express construction of any claim term. Inst. Dec. 6. In the Patent Owner Response, Patent Owner repeats that it “does not believe any term needs construction,” but nonetheless “applies the Petition’s definitions for ‘MID’ and ‘sample.’” PO Resp. 19. The Petition defines MID as “‘a tag or combination of tags associated with a polynucleotide whose identity (e.g., the tag DNA sequence) can be used to differentiate polynucleotides in a sample.’” Pet. 36 (quoting Ex. 1001, 6:33–38). The Petition defines sample as “‘a quantity of material from a biological, environmental medical, or patient source in which detection, measurement, or labeling of target nucleic acids is sought.’” Id. (quoting Ex. 1001, 12:7– 10). We apply these same definitions in our analysis.” slip op. at 6
Patent outcomesUS 10,155,981 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,155,981 - 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 · Jul 24, 2024 · IPR2024-00465 · APJ Bart A Gerstenblith · IPR · Institution
The Board instituted IPR on claims 1–24 on all petition grounds, finding a reasonable likelihood that Irwin renders at least one challenged claim obvious.
RulingsInstitution decision- Other 314aInstitution denied discretionary otherDenied
“Even assuming Linq3 is a real party in interest to Petitioner and assuming we may exercise our discretion to deny institution based on unclean hands (see Kavo Dental Techs, LLC v. Osseo Imaging, Inc., IPR2020-00659, Paper 10 at 19 (PTAB June 10, 2020)), Patent Owner essentially asks us to resolve multiple factual issues related to its contract dispute with Linq3 to justify denial of institution. See, e.g., Prelim. Resp. 1– 26. Many, if not all, of these issues appear to be involved in the contract dispute, which will be resolved by the Arizona state court. We are not in a good position to make determinations about these particular issues at this stage of the proceeding, on the limited record before us. Rather, we find that the state court is better suited to address the conduct of Linq3 of which Patent Owner complains. Accordingly, we leave these matters for the state court. To the extent Patent Owner seeks to pursue its argument that Linq3 is a real party in interest to Petitioner, even though no time bar under 35 U.S.C. § 315(b) has been asserted, Patent Owner may raise the issue of real party in interest again in its Patent Owner Response, and the parties may brief and argue the issue during trial.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“We disagree. First, we agree with Patent Owner that the fact pattern presented here is not the typical situation in which the factors from General Plastic are considered. In particular, this proceeding challenges claims of a different patent than the patents at issue in PGR2020-00084 and IPR2023- 01235. Challenging claims of different patents significantly distinguishes the facts here from those in General Plastic, and we decline Patent Owner’s invitation to extend General Plastic in this regard. Accordingly, we do not exercise our discretion to deny institution.” slip op. at 11
- PTAB / AIA Trials › Real party in interest / privityNot reached
“Even assuming Linq3 is a real party in interest to Petitioner and assuming we may exercise our discretion to deny institution based on unclean hands (see Kavo Dental Techs, LLC v. Osseo Imaging, Inc., IPR2020-00659, Paper 10 at 19 (PTAB June 10, 2020)), Patent Owner essentially asks us to resolve multiple factual issues related to its contract dispute with Linq3 to justify denial of institution. See, e.g., Prelim. Resp. 1– 26. Many, if not all, of these issues appear to be involved in the contract dispute, which will be resolved by the Arizona state court. We are not in a good position to make determinations about these particular issues at this stage of the proceeding, on the limited record before us. Rather, we find that the state court is better suited to address the conduct of Linq3 of which Patent Owner complains. Accordingly, we leave these matters for the state court. To the extent Patent Owner seeks to pursue its argument that Linq3 is a real party in interest to Petitioner, even though no time bar under 35 U.S.C. § 315(b) has been asserted, Patent Owner may raise the issue of real party in interest again in its Patent Owner Response, and the parties may brief and argue the issue during trial.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Weighing the Graham Factors “Once all relevant facts are found, the ultimate legal determination [of obviousness] involves the weighing of the fact findings to conclude whether the claimed combination would have been obvious to an ordinary artisan.” Arctic Cat, 876 F.3d at 1361. On balance, considering the record presently before us, Petitioner has established a reasonable likelihood that it would prevail in showing that Irwin would have rendered the subject matter of claims 1–9 and 11–24 of the ’451 patent obvious to one of ordinary skill in the art at the time of the invention.” slip op. at 38
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,488,451 - PTAB · Jul 22, 2024 · IPR2024-00374 · APJ Jason M Repko · IPR · Institution
The Board instituted IPR on claims 1–10 and all asserted grounds because the petition showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“petition for inter partes review. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140 (2016). In determining whether to exercise that discretion on behalf of the Director, the Board considers an early trial date in related litigation, among other factors, as part of an assessment of all relevant circumstances of the case—including the merits—to balance considerations such as system efficiency, fairness, and patent quality. Fintiv, Paper 11 at 5. When the same prior art is submitted in district court and to the Board, there are “concerns of inefficiency and the possibility of conflicting decisions.” Id. at 12. Petitioner can mitigate those concerns by presenting a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“(2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. If a condition in the first part of the framework is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine “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). For the reasons discussed below, Petitioner has shown a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Thus, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“engineering, electrical engineering, or a related field, and (2) at least two years of industry experience in digital video processing, or a related field.” Pet. 3 (citing Ex. 10035 ¶¶ 76–78). Petitioner also asserts that “[a]dditional graduate education could substitute for professional experience, and vice versa.” Id. Patent Owner uses the same skill level in its Preliminary Response. Prelim. Resp. 21. We also apply Petitioner’s proposed skill level in this Decision. Pet. 3.” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 8,090,025 - PTAB · Jul 18, 2024 · IPR2024-00327 · APJ Nathan A Engels · IPR · Institution
The Board instituted review of claims 1 and 2 on all petitioned grounds, finding a reasonable likelihood that Demircin renders claim 1 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review is authorized by statute when “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); see 37 C.F.R. § 42.108. Upon consideration of the evidence currently of record, we conclude that the information presented shows that there is a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’303 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“III. DISCRETIONARY DENIAL Patent Owner argues that we should exercise our discretion to deny the Petition based on the parallel district court litigation. Prelim. Resp. 33– 39 (citing Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 6 (PTAB Mar. 20, 2020) (precedential)). Petitioner, however, presented a Sotera stipulation.8 Pet. 76 (citing Ex. 1029). Thus, we do not exercise our discretion to deny institution here. See Katherine K. Vidal, Interim” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“3. Preliminary Analysis Regarding Claim 1 At this stage, we are persuaded by Petitioner’s contentions that the teachings of Demircin satisfy each limitation of claim 1. On the current record, we do not agree with Patent Owner’s arguments that Demircin does not satisfy the parties’ agreed construction. As cited by Petitioner (see, e.g., Pet. 33, 43), Demircin teaches that when additional bandwidth becomes available, NAL units that were previously discarded or only partially transmitted may be transmitted in a delayed manner (Ex. 1005 ¶¶ 34, 104– 128, Fig. 13, 14). We are currently persuaded that Demircin teaches or reasonably suggests that such delayed NAL units could be received out of order and would be rearranged, as claimed.” slip op. at 16
§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,986,303 - PTAB · Jul 18, 2024 · IPR2024-00372 · APJ Jason M Repko · IPR · Institution
The Board instituted review of claims 2–4 and 11 on all petition grounds, finding a reasonable likelihood that Samsung would show them unpatentable as obvious over Phek, Segall, Martins, and He.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“such as system efficiency, fairness, and patent quality. Fintiv, Paper 11 at 5. When the same prior art is submitted in district court and to the Board, there are “concerns of inefficiency and the possibility of conflicting decisions.” Id. at 12. Petitioner can mitigate those concerns by presenting a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the Board. Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 at 19 (PTAB Dec. 1, 2020) (precedential). Here, Petitioner has presented such a stipulation: if the Board grants institution, Petitioner “agrees not to pursue any grounds raised in the petition, or any grounds [Petitioner] could have reasonably raised in the petition, in [the] district court litigation or any parallel proceeding” Ex. 1028, 1. “Consistent with [Sotera], the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB.” Katherine K. Vidal, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (USPTO June 21, 2022).5 Thus, we decline to exercise our discretion to deny the Petition.” slip op. at 7
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“present arguments specifically directed to the subject matter recited in the rest of the claim. See Prelim. Resp. Even so, Petitioner has the burden to show that the challenged claims are unpatentable. Thus, we have reviewed Petitioner’s arguments and evidence submitted in connection with the remaining limitations and find them to be sufficient at this stage and on this record. From the current record, Petitioner has established a reasonable likelihood that it will prevail in demonstrating that claim 2 is unpatentable.” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“digital video processing, or a related field.” Pet. 3–4 (citing Ex. 10036 ¶¶ 123–125). Petitioner also asserts that “[a]dditional graduate education could substitute for professional experience, and vice versa.” Id. at 4. Patent Owner uses the same skill level in its Preliminary Response. Prelim. Resp. 13. We also apply Petitioner’s proposed skill level in this Decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Patent Owner’s arguments, however, are based on an implicit construction for the second resolution converter. See § II.D.5.c supra. For the reasons discussed below, we disagree with Patent Owner’s arguments and the implicit construction. See id. Apart from rejecting the implicit construction of the second resolution converter, we agree with the parties that no claim term needs to be construed in this Decision.” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,218,995 - 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
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.