- PTAB · Sep 23, 2024 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–4, 6–10, and 12–15 on all petitioned grounds, finding a reasonable likelihood of success on at least one challenge and declining Fintiv denial.
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 1–4, 6–10, and 12–15 of the ’975 patent are unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Obviousness is determined by looking to the scope and content of the prior art, differences between the prior art and the claims at issue, and the level of ordinary skill in the pertinent art resolved. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966). “[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“pending Maryland litigation has been stayed in its entirety pending resolution of IPR2024-00240, which involves a related patent that is also involved in the litigation. Reply, 1 (citing Order in Maryland litigation, dated June 29, 2024, Ex. 1100, 1); see Sur-Reply, 1 (acknowledging “the recent stay of the parties’ co-pending litigation involving the ’975 Patent.”). In its Memorandum Opinion, the court acknowledged that inter partes reviews of additional patents involved in the litigation could be instituted. See Ex. 1101, 3. Accordingly, the first Fintiv factor weighs heavily in favor of not exercising discretion to deny institution of inter partes review. Because of the stay, the second and third Fintiv factors also weigh heavily in favor of not exercising discretion to deny institution of inter partes review. The stay indicates that the court’s trial date will not be close to the Board’s projected statutory deadline for a final written decision and that neither the court nor the parties will invest further in the parallel proceeding. See Fintiv, at 6 (“A district court stay of the litigation pending resolution of the PTAB trial allays concerns about inefficiency and duplication of efforts. This fact has strongly weighed against exercising the authority to deny institution under NHK.”); see also Memorandum Opinion in Maryland litigation issued June 29, 2024, Ex. 1101, 2 (noting that the” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,325,975 - PTAB · Sep 23, 2024 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1, 6–11, 13–20, 22–24, and 26–28 on all petitioned grounds, finding a reasonable likelihood of success and declining discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Petitioner contends 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). Pet. 8. The parties agree that the MSI-H Study Record was publicly available by June 12, 2013. Id. at 7; 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”).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“summarized above, we determine that the information presented in the Petition establishes that Petitioner has a reasonable likelihood of prevailing in showing that claim 1 would have been obvious in view of the MSI-H Study Record. We are persuaded that the MSI-H Study Record discloses the limitations of claim 1. Pet. 16–24. We are further persuaded that a person of ordinary skill in the art would have been motivated to modify the MSI-H Study Record with Pernot and Benson to benefit from the improved outcomes in treating MSI-H colorectal patients with the drug therapeutic. Id. at 41–44. We are also persuaded that a person of ordinary skill would have been motivated to test patients to determine their MSI-H status as such testing was routine in the art. Id. at 44–45. We are also persuaded that a person of ordinary skill would have been motivated to combine the teachings of the MSI-H Study Record and Benson to treat patients with metastatic and advanced disease. Id. at 46–47.” slip op. at 27
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,934,356 - 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 - Chongqing Yanmei Technology Co., Ltd. v. Terves, LLCSome claims unpatentablePTAB · Aug 27, 2024 · IPR2023-00521 · APJ Jon B Tornquist · IPR · Final written decision
Claims 19–61, 63–77, and 79 are unpatentable as anticipated by Doud; claims 78, 80, and 81 are not shown unpatentable. The contingent motion to amend is granted in part and denied in part.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art “would have at least a Ph.D. in chemistry, metallurgy, or material science or material engineering” or, in the alternative, “would have a Bachelor of Science or Master of Science degree in one of these disciplines plus experience involving the use and design of dissolvable metal alloys for use in creating tools and other downhole parts for well drilling or completion activities.” Pet. 13–14. Patent Owner does not oppose Petitioner’s contentions regarding the level of ordinary skill in the art. PO Resp. 12 n.4. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the ordinarily skilled artisan as it is consistent with the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“With respect to claim 19, Petitioner proposes constructions for the terms “in situ precipitate” and “a plurality of particles of said in situ precipitate having a size of no more than 50 µm.” Pet. 11–12. With respect to claims 76–81, Petitioner proposes a construction for the term “wherein said additive material includes one or more metal materials selected from the group consisting of 0.1–35 wt. % copper, 0.1–24.5 wt. % nickel and 0.1–20 wt. % cobalt.” Id. at 13. Patent Owner contends no claims require construction for purposes of this Decision. PO Resp. 12 n.4, 17–18; Mot. 16–17. Upon review of the prior art of record, we determine that no claim terms require express construction for purposes of this Final Written Decision. 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 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed
“Ex. 2027, 20:25–21:5 (emphasis added). The disclosure that the “magnesium composite” of “[t]he present invention” “includes at least 50 wt% magnesium” is unambiguous and constitutes strong evidence that the inventors were not in possession of a magnesium composite with less than 50 wt. % magnesium, or additive concentrations above 50 wt. %. See SciMed Life Systems, Inc. v. Advanced Cardiovasular Systems, Inc., 242 F.3d 1337, 1343 (Fed. Cir. 2001) (noting that a description of the “present invention” as having a particular structure “is strong evidence that the claims should not be read to encompass the opposite structure”). Consistent with this conclusion, the original claims of the ’295 application all limited the additive material in the composite to 0.05 wt %–45 wt %. Ex. 2027, 26:1– 13, 29:9–15. Likewise, in each example where copper, nickel, or cobalt additives are used in the range recited in the proposed substitute claims, the magnesium composite is “over 50 wt% magnesium,” and any claims that do not require this range of magnesium are limited to an additive range of “about 0.05 wt%–45 wt% of said mixture.”8 Ex. 2027, 6:13–7:4, 7:16–19, 8 Written description support is considered from the view point of the ordinarily skilled artisan. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Patent Owner, bearing the burden to show written description support in any priority application for which it seeks the benefit of its filing date, provides no testimony from an ordinarily skilled artisan regarding written description support in the ’295 application, or any evidence to show what such an artisan would conclude from the express disclosures of the ’295 application. Lectrosonics, Paper 15 at 7; In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (noting that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority . . . Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120”). Where there is any ambiguity in the disclosures of the ’295 application, the absence of supporting testimony tends to cut against 26:2–31:2; see Ex. 1005 ¶¶ 12, 13, 18, 19, 16–21, 26, 28, claims 16–21, 26– 28. In view of the foregoing, we are not persuaded that Patent Owner has demonstrated that the inventors of the priority applications were in possession of a magnesium cast composite that included less than 50 wt. % magnesium, or greater than 50 wt. % additives. As proposed substitute claim 104 encompasses a magnesium cast composite with up to 90 wt. % additives, and therefore as little as 10 wt. % magnesium, Patent Owner has not demonstrated that the full scope of this claim finds written description support in any application prior to the ’915 application, filed on October 12, 2018.” slip op. at 17
- Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed
“The definiteness requirement of § 112(a) is satisfied when “a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable clarity.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014); see 37 C.F.R. § 42.100(b) (changing the claim construction standard used to review a claim proposed in a motion to amend from the broadest reasonable construction to the “same construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b)”). Proposed substitute claim 104 generically requires “in situ precipitate” and also a specific type of in situ precipitate: “in situ galvanically-active intermetallic precipitate.” Mot. Appendix A. Although this claim would have best been clarified by Patent Owner after seeking preliminary guidance on its Motion to Amend, upon review of the written description, claims, and figures of the ’740 patent, as well as Patent Owner’s clarification in its Reply to the Opposition, we agree with Patent Owner that one of ordinary skill in the art would have understood that the “in situ galvanically-active intermetallic precipitate” is merely a more complete description of the “in situ precipitate” mentioned earlier in the sentence. Mot. Reply 4. As such, we do not find that this part of proposed substitute claim renders claim 104 indefinite.” slip op. at 22
Patent outcomesUS 10,689,740 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Graham · NautilusPatents in suitUS 10,689,740 - Tesla, Inc. v. Relink US LLCInstitution deniedPTAB · Jul 16, 2024 · IPR2024-00389 · APJ Jane E Inglese · IPR · Institution
The Board denied institution on all grounds because neither Serban nor Somani sufficiently showed the claimed inverter and controller functionality.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“that Petitioner does not provide a sufficient showing to establish that Serban discloses a current-source inverter and a controller, each configured as required by the challenged independent claims. Our reasoning is two-fold. First, Petitioner does not directly address the claim requirement that the current-source inverter is configured to adjust an output power as a function of a frequency of the alternating current voltage source. Second, Petitioner’s characterization of select disclosures from Serban is inconsistent with Serban’s disclosure as a whole. We address these shortcomings below.” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“(“AIA”), Pub. L. No. 112–29, 125 Stat. 284 (2011), revisions to 35 U.S.C. § 100 et seq., because its earliest effective filing date is July 28, 2015. Ex. 1001, code (22). “[U]nder the AIA, a reference patent document need only meet the ‘ministerial requirements’ of §§ 119 and 120, and the Provisional or other earlier application(s) to which the reference patent document claims a right of priority must ‘describe[] the subject matter’ relied upon in the reference patent document as prior art. 35 U.S.C. § 102(d)(2).” Penumbra, Inc. v. RapidPulse, Inc., IPR2022-00608, Paper 34 at 29–31 (PTAB Mar. 10, 2023) (designated precedential in relevant part (§ II.E.3)).” slip op. at 28
- Skill levelSkill level petitioner adoptedDecided for petitioner
“held at least a bachelor’s degree and a master’s degree in electrical engineering or a related degree, as well as possessing at least two years of experience with grid-tied power supplies having electric energy sources including photovoltaic and battery systems.” Pet. 15 (citing Ex. 1003 ¶ 23). Petitioner further asserts that a “POSA [person of ordinary skill in the art] would have been familiar with the admitted prior-art systems of Figures 1 and 2 [of the ’755 patent] and associated descriptions of those systems.” Id. (citing Ex. 1001, 1:28–36, 1:66–2:2, 5:42–47).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Petitioner states that it “applied plain and ordinary meanings to all claim terms and no express constructions are required here.” Pet. 15 (citing Ex. 1003 ¶ 101). Patent Owner does not address claim construction. See generally Prelim. Resp. Taking into consideration the arguments and information Petitioner and Patent Owner present, we determine that none of the claim terms requires express construction for purposes of deciding whether to institute review.” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 9,793,755 - Gce Gas Control Equipment Inc. v. Vbox, Inc.Some claims unpatentablePTAB · Jun 18, 2024 · IPR2023-00326 · APJ Jane E Inglese · IPR · Final written decision
Claims 12–14 and 16 are unpatentable under § 103 over Deane alone and Deane, Dubois, and Berntson; claims 1–11 and 15 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for patent owner
“III. ANALYSIS A. Level of Ordinary Skill in the Art The level of ordinary skill in the art at the time of the invention is a factual determination that provides a primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)). Based on Petitioner’s contention, which Patent Owner does not dispute, we find that a person of ordinary skill in the art would have had a bachelor’s degree in mechanical engineering, chemical engineering, or a related field, and two years of experience in the research, design, or development of POCs and related hardware, software, and firmware. Compare Pet. 21, with Resp. 11. Our finding is supported by Dr. Knaebel’s testimony. Ex. 1003 ¶¶ 226–228. The level of ordinary skill in the art, as defined above, appears consistent with the disclosures of the asserted prior art and the written description of the invention provided in the ’614 patent.” slip op. at 8
- Expert testimonyPatent owner expert creditedDecided for patent owner
“Deane thus teaches that adsorbent housing 602 and adsorbent bed columns 508a, 508b—the asserted separation cartridge—are part of an apparatus that rests on a support surface such as a table or floor. Based on Deane’s disclosure, we find persuasive Patent Owner’s contention, and Patent Owner’s witness’s opinion, that Deane’s housing 602/adsorbent bed columns 508a, 508b (separation cartridge) cannot be removed from the receptacle by movement of the separation cartridge vertically downward. Resp. 37–38; Ex. 2001 ¶¶ 118–131. Neither Petitioner nor Petitioner’s witness, Dr. Knaebel, points to any evidence of record showing that one of ordinary skill in the art would have understood that Deane’s housing 602/adsorbent bed columns 508a, 508b (separation cartridge) could be removed from manifold 512 (receptacle) by moving housing 602/adsorbent bed columns 508a, 508b (separation cartridge) downward when the apparatus is resting on a table or floor, as taught by Deane. Pet. 42–43; Ex. 1078 ¶¶ 121–161. Petitioner fails to show that Deane’s housing 602/adsorbent bed columns 508a, 508b (separation cartridge) could be removed from the receptacle by movement of the separation cartridge in the downward (second) direction, as required by the removal direction limitation of claim 1. Petitioner, therefore, does not establish unpatentability under its axial movement theory.” slip op. at 26
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Giving effect to “by movement relative to the receptacle,” when interpreting this phrase in combination with “a separation cartridge selectively removable from a receptacle,” requires that the separation cartridge is removable from the receptacle by movement of the separation cartridge itself. Interpreting the removal direction limitation to encompass a stationary separation cartridge, as Petitioner proposes, would render “by movement relative to the receptacle” superfluous. Specifically, Petitioner’s interpretation of “relative movement” does not accord weight to the recitation “movement relative to the receptacle,” which requires something other than the receptacle—the separation cartridge—to move in order for movement to occur with reference to or in comparison with the receptacle. Petitioner’s interpretation of “relative movement” as permitting removal of the separation cartridge from the receptacle when the separation cartridge remains stationary, is inconsistent with the plain language of removal direction limitation as a whole. The plain language of the removal direction limitation indicates that the separation cartridge must be removable from the receptacle by movement of the separation cartridge in a specified (first) direction. Claim 1 defines the first direction as a direction opposite the (second) direction in which the inlet and outlet are oriented. The plain language of the removal direction limitation, therefore, requires that the separation cartridge is removable from a receptacle by movement of the separation cartridge in comparison to the receptacle in a direction opposite the direction in which the separation cartridge’s inlet and outlet are oriented.” slip op. at 15
- Strike new argumentNew argument disregardedDecided for patent owner
“(a) Untimely new theory of unpatentability We agree with Patent Owner (Sur-Reply 4) that Petitioner’s relative movement theory is an impermissible new theory of unpatentability improperly presented for the first time in the Reply. Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1008–09 (Fed. Cir. 2023) (A petitioner may not raise in a reply “‘an entirely new theory of prima facie obviousness absent from the petition,’ even if the new theory is responsive to the patent owner’s response or the Board’s institution decision.”) (quoting Wasica Finance GmbH v. Continental Automotive Systems, Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017); see also Henny Penny Corp. v. Frymaster LLC, 938 F. 3d 1324, 1330–31 (Fed. Cir. 2019) (“We conclude that the Board did not abuse its discretion in . . . disregarding its [petitioner’s] new theory first raised in reply.”). Petitioner does not present the relative movement theory in the Petition, and instead presents it for the first time in the Reply. Pet. 42–43. Far from fairly meeting any argument introduced by Patent Owner in the Response, this new theory unfairly changes the thrust of the challenge.” slip op. at 27
Patent outcomesUS 11,389,614 mixedClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,389,614 - 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
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.