- PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,115,233 - Meta Platforms, Inc. / Meta Platforms Technologies, LLC et al. v. Eight KHZ, LLCAll claims unpatentablePTAB · Dec 3, 2024 · IPR2023-01020 · APJ Scott Raevsky · IPR · Final written decision
Claims 1–20 are unpatentable as obvious over Lyren and Reif; the Board did not reach the Clement, Osman, and Sauk ground.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“A POSA [person of ordinary skill in the art or “POSITA”] in the relevant timeframe (2015 to 2019) would have had a Bachelor’s degree in computer science/engineering, music technology, or a related field, and at least two years of industry experience, or academic research experience, in virtual/augmented reality, audio engineering, or an equivalent. Additional education can compensate for less experience, and vice-versa.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. environment Patent Owner initially argues that “environment” should mean “physical surroundings in which a user operates.” PO Resp. 6. Petitioner responds that the plain meaning of environment “encompasses physical and virtual environments.” Reply 2. During the hearing, Patent Owner conceded that Petitioner’s construction for environment is correct. Tr. 49:24–50:10. We agree with this construction and apply it here. See, e.g., Ex. 1001, 28:16 (referring to “a physical or a virtual environment”). “Environment” encompasses physical and virtual environments.” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“insufficient to support the concept of alerting a user that the user is leaving a virtual environment. In so deciding, we need not address the parties’ contentions about boilerplate. Regardless of whether the sentence at 168:15–16 of the ’140 application is boilerplate, we agree with Petitioner that “there is no suggestion of the specific claimed combination.” Reply 22 (citing Ex. 1146 ¶ 82). That is, if one views the “[e]xamples herein” from Figure 6 as taking place “in computer rendered spaces (VR)” or “in partially computer rendered spaces (AR),” there is still no disclosure of alerting a user that a user is leaving a virtual environment. See Ex. 1028, 168:15–16. For instance, if Alice in the Figure 6 example mentioned above is entering a virtual car instead of a real car, Alice is still in a virtual environment. See id. at 120:13–27. Thus, relying on Figure 6 to take place “in computer rendered spaces (VR)” does not support alerting that a user is leaving those virtual spaces. See id. at 168:15–16. Petitioner also correctly identifies a problem with analogizing the Alice example to a virtual environment—namely, it would no longer make sense to give Alice an audible warning. See Reply 22 (citing Ex. 1146 ¶ 82). In the example, Alice’s earphones switch from binaural sound to mono sound when Alice enters a real car because “[t]he state where Alice is located . . . prohibits drivers from localizing sound while driving a motorized vehicle.” Ex. 1028, 120:15–18. But it would not make sense (nor does the ’140 application disclose) for a state to prohibit Alice to localize sound while driving a virtual vehicle. We therefore find compelling Petitioner’s argument, supported by the testimony of Dr. Roginska, which we credit, that there is no “disclosure that 3D audio would not be permitted in a 3D virtual space.” Reply 22 (citing Ex. 1146 ¶ 82). Accordingly, Patent Owner’s second support argument fails.10” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“One benefit Petitioner proposes to support a rationale to combine is that a POSITA “would have implemented this feature to help protect the users from injury by bumping, hitting, tripping over, etc., real-world objects when moving around while viewing the virtual environment in the HMD (i.e., a type of head-mounted WED).” Id. at 43–44 (citing, e.g., Ex. 1003 ¶¶ 90, 251–254). Petitioner provides additional argument and evidence supporting a motivation to combine, with a reasonable expectation of success. See id. at 42–46. We agree that, in the combination, a POSITA would have implemented Lyren’s audible alerts to alert the user that the user is leaving Reif’s safe zone (and thus the virtual environment) to help keep users safe. Id. at 52 (citing Ex. 1003 ¶¶ 250–268). We also agree with Petitioner’s articulated benefit that the combination would “help protect the users from injury by bumping, hitting, tripping over, etc., real-world objects when moving around while viewing the virtual environment in the HMD (i.e., a type of head-mounted WED).” Id. at 43–44. Accordingly, we agree with Petitioner that the combination of Lyren and Reif discloses each limitation of claim 14, as well as similar limitations of claims 1 and 7, and that one of ordinary skill in the art would have combined Lyren and Reif in the manner proposed, with a reasonable expectation of success.” slip op. at 24
Patent outcomesUS 10,448,184 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,448,184 - Meta Platforms, Inc. / Meta Platforms Technologies, LLC et al. v. Eight KHZ, LLCAll claims unpatentablePTAB · Dec 3, 2024 · IPR2023-01019 · APJ Scott Raevsky · IPR · Final written decision
Claims 1–20 are unpatentable as obvious over Lyren and Reif; the Board did not reach the Clement, Osman, and Sauk ground.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Accordingly, we are not persuaded that the ’140 application supports the claimed concept of warning or alerting a user that the user is leaving the virtual environment. Thus, the ’140 application does not support the full scope of the limitations “warning the user that the user is leaving the 3D virtual environment” in claim 1 and “alerting the user that the user is leaving the environment” in claims 7 and 14. The parties have not made any additional arguments regarding support in the ’140 application for limitations of the dependent claims. We conclude that no claim of the ’179 patent is entitled to priority to the ’140 application.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We agree that, in the combination, a POSITA would have implemented Lyren’s audible alerts to alert the user that the user is leaving Reif’s safe zone (and thus the virtual environment) to help keep users safe. Id. at 51 (citing Ex. 1003 ¶¶ 250–263). We also agree with Petitioner’s articulated benefit that the combination would “help protect the users from injury by bumping, hitting, tripping over, etc., real-world objects when moving around while viewing the virtual environment in the HMD (i.e., a type of head-mounted WED).” Id. at 43. Accordingly, we agree with Petitioner that the combination of Lyren and Reif discloses each limitation of claim 14, as well as similar limitations of claims 1 and 7, and that one of ordinary skill in the art would have combined Lyren and Reif in the manner proposed, with a reasonable expectation of success.” slip op. at 26
- ExcludeMotion to exclude, deniedGranted in part
“paragraphs of Dr. Roginska’s declarations in Exhibits 1003 and 1146. Mot. 1; Reply to Opp. 1. Some of these paragraphs support Petitioner’s challenge based on Clement, Osman, and Sauk. Mot. 2–5, 7–11. Because we do not reach Petitioner’s challenge based on Clement, Osman, and Sauk, we do not rely on the portions of Dr. Roginska’s declarations addressing Clement, Osman, and Sauk. Accordingly, we dismiss this portion of Patent Owner’s Motion to Exclude as moot.” slip op. at 27
Patent outcomesUS 10,368,179 unpatentable§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,368,179 - 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 - PTAB · Dec 6, 2023 · IPR2023-01020 · APJ Scott Raevsky · IPR · Institution
Instituted review of claims 1–20 on all grounds; the Lyren and Reif combination showed a reasonable likelihood of obviousness for at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. After considering the parties’ arguments and evidence, and for the reasons set forth below, Petitioner demonstrates a reasonable likelihood of prevailing with respect to at least one of the challenged claims of the ’184 patent. Accordingly, we institute an inter partes review with respect to all challenged claims and grounds asserted in the Petition. 37 C.F.R. § 42.108(a) (2022).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“could have reasonably been raised before the PTAB.” Director’s Memo 3. With our authorization, Petitioner has filed a stipulation which stipulates that If the PTAB institutes the pending IPR in IPR2023-01020 challenging the patentability of claims 1-20 of the ’184 patent, then [Defendants Meta Platforms, Inc., Meta Platforms Technologies, LLC, and Twisted Pixel Games, LLC] will not pursue as to the challenged claims any ground raised or that could have been reasonably raised in the IPR in the above-captioned district court litigation (No. 6:22-cv-00575-ADA).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A POSA [person of ordinary skill in the art or “POSITA”] in the relevant timeframe (2015 to 2019) would have had a Bachelor’s degree in computer science/engineering, music technology, or a related field, and at least two years of industry experience, or academic research experience, in virtual/augmented reality, audio engineering, or an equivalent. Additional education can compensate for less experience, and vice-versa. Pet. 6 (citing Ex. 1003 ¶¶ 34–36). Patent Owner uses Petitioner’s proposed level of skill in the art at this stage. Prelim. Resp. 7. We are persuaded, on the present record, that Petitioner’s proposal is consistent with the problems and solutions in the ’184 patent and prior art of record. We adopt Petitioner’s definition of the level of skill for the purposes of this Decision.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“The parties do not propose any claim constructions. See Pet. 7; Prelim. Resp. 7. As no terms are in dispute, we determine that no terms require construction at this stage. 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 10
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 10,448,184 - PTAB · Dec 6, 2023 · IPR2023-01019 · APJ Scott Raevsky · IPR · Institution
The Board instituted review of claims 1–20 on all petitioned grounds, finding a reasonable likelihood of success on at least one claim, including over Lyren and Reif assuming Lyren is prior art.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. After considering the parties’ arguments and evidence, and for the reasons set forth below, Petitioner demonstrates a reasonable likelihood of prevailing with respect to at least one of the challenged claims of the ’179 patent. Accordingly, we institute an inter partes review with respect to all challenged claims and grounds asserted in the Petition. 37 C.F.R. § 42.108(a) (2022). Our factual findings and conclusions at this stage of the proceeding are based on the evidentiary record developed thus far. This is not a final decision as to patentability of the challenged claims.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“The Director’s Memo provides that “[c]onsistent with Sotera Wireless, Inc.,[8] 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.” Director’s Memo 3. With our authorization, Petitioner has filed a stipulation which stipulates that 7 Available at https://www.uspto.gov/sites/default/files/documents/ interim_proc_discretionary_denials_aia_parallel_district_court_ litigation_memo_20220621_.pdf. 8 Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 at 18–19 (PTAB Dec. 1, 2020) (precedential). If the PTAB institutes the pending IPR in IPR2023-01019 challenging the patentability of claims 1-20 of the ’179 patent, then [Defendants Meta Platforms, Inc., Meta Platforms Technologies, LLC, and Twisted Pixel Games, LLC] will not pursue as to the challenged claims any ground raised or that could have been reasonably raised in the IPR in the above-captioned district court litigation (No. 6:22-cv-00575-ADA). Prelim. Reply 1. Patent Owner concedes that Petitioner has filed a “Sotera-like stipulation” but argues that it is insufficient because it “leaves the door open to a duplication of efforts and the possibility of conflicting decisions.” Prelim. Sur-reply 1 (citing Ex. 1141, 4 (“This stipulation is not intended . . . to limit Meta’s ability to assert . . . invalidity under 35 U.S.C. §§ 102 and 103 not available in IPR and under 35 U.S.C. §§ 101 and 112[], regardless of whether IPRs are instituted.” (emphasis omitted))). Namely, Patent Owner argues that Petitioner’s stipulation carves out “the right to assert overlapping system art in the parallel district court proceeding,” such that institution here would not address the risk of “inconsistent outcomes between the PTAB and the district court.” Id. at 4. We disagree with Patent Owner, as Petitioner’s stipulation sufficiently” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Graham, 383 U.S. at 13, 17. Petitioner asserts that A POSA [person of ordinary skill in the art or “POSITA”] in the relevant timeframe (2015 to 2019) would have had a Bachelor’s degree in computer science/engineering, music technology, or a related field, and at least two years of industry experience, or academic research experience, in virtual/augmented reality, audio engineering, or an equivalent. Additional education can compensate for less experience, and vice-versa. Pet. 6 (citing Ex. 1003 ¶¶ 34–36). Patent Owner applies Petitioner’s proposed level of skill in the art at this stage. Prelim. Resp. 4. We are persuaded, on the present record, that Petitioner’s proposal is consistent with the problems and solutions in the ’179 patent and prior art of record. We adopt Petitioner’s definition of the level of skill for the purposes of this Decision.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In inter partes review, we construe 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), including construing 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. 37 C.F.R. § 42.100(b). The parties do not propose any claim constructions. See Pet. 6–7; Prelim. Resp. 4. We agree that no terms require construction at this stage. 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 11
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 10,368,179 - Sophos Ltd. / Sophos Inc. v. Open Text Inc.Institution deniedPTAB · Nov 29, 2023 · PGR2023-00031 · APJ Barbara A Parvis · PGR · Institution
The Board denied institution because Petitioner did not show that any challenged claim was more likely than not unpatentable over the asserted obviousness or indefiniteness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4. A post-grant review may not be instituted “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324 (2018). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has not demonstrated that it is more likely than not that at least one of the claims challenged in the patent is unpatentable. Accordingly, we do not institute a post-grant review of the challenged claims of the ’869 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 10 (citing Ex. 1004 ¶ 16). Patent Owner does not dispute Petitioner’s proposal. Prelim. Resp. 33. Considering the subject matter of the ’869 patent, the background technical field, and the asserted prior art, we agree with Petitioner’s proposed qualifications for an ordinary level of skill, except we decline to adopt “at least” as that language is vague and open-ended. Otherwise, Petitioner’s proposed definition is consistent with the level of skill reflected in the Specification of the ’869 patent and the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Accordingly, for purposes of this Decision, and based on the current record, except as noted above, we adopt Petitioner’s assessment of the level of skill for one of ordinary skill in the art.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“We agree with Patent Owner that the claims are directed to the classification stage, as they require extracting “a plurality of static data points” from an executable file and “generating a feature vector from [that] plurality of static data points using a classifier” (emphasis added). The claims also recite that the classifier has been “trained to classify” (emphasis added). Further, the claims recite that “features of the feature vector” are selectively turned on or off, indicating that the feature vector has been generated. We also agree with Patent Owner that Petitioner has not shown that Ideses teaches or suggests a classification method in which one or more features of a feature vector generated from a plurality of static data points are selectively turned on or off based on the value of the static data point. As explained in the summary of Ideses above, Ideses describes “methods and systems for generating classifiers” (Ex. 1005 ¶ 2) in which “extracted features [may be] identified for pruning to generate the group of classifying features,” and “the selection [may be] based on identifying a classification effectiveness rank for each of the features of the training software applications” or “based on identifying resource requirements for each of the features of the training software applications.” See id. ¶¶ 98, 99. “[T]he group of classifying features [may be] selected based on the significance of the extracted features,” such that “[s]ignificant features, such as those that have a large effect on the classification outcomes, may be retained” and “[i]nsignificant features, such as those that have a small, negligible or no effect on classification outcome may be pruned.” Id. ¶¶ 101, 106. Petitioner argues that “Ideses explains that in the method depicted in Figure 1, ‘[t]he full feature list is optionally selectively pruned,’ i.e., ‘selectively turned off’ as required by [1.e],” and “[f]urther, ‘each feature of the group is selected from-the-ground-up; added to the group as opposed to removed from or retained within a larger group,’ i.e., ‘selectively turned on’ as required by [1.e].” Pet. 33 (citing Ex. 1005 ¶ 71). Petitioner also argues element 1.e is taught by Ideses’s “approaches to pruning insignificant features,” which Petitioner argues are “to selectively includ[e]/exclud[e] features based on whether a feature coefficient ‘is within a predetermined range’ as required” by element 1.e. Id. at 34 (citing, e.g., Ex. 1005 ¶¶ 107, 109–110). But all of the selection and pruning described in Ideses concerns the” slip op. at 22
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that the claims are directed to the classification stage, as they require extracting “a plurality of static data points” from an executable file and “generating a feature vector from [that] plurality of static data points using a classifier” (emphasis added). The claims also recite that the classifier has been “trained to classify” (emphasis added). Further, the claims recite that “features of the feature vector” are selectively turned on or off, indicating that the feature vector has been generated. We also agree with Patent Owner that Petitioner has not shown that Ideses teaches or suggests a classification method in which one or more features of a feature vector generated from a plurality of static data points are selectively turned on or off based on the value of the static data point. As explained in the summary of Ideses above, Ideses describes “methods and systems for generating classifiers” (Ex. 1005 ¶ 2) in which “extracted features [may be] identified for pruning to generate the group of classifying features,” and “the selection [may be] based on identifying a classification effectiveness rank for each of the features of the training software applications” or “based on identifying resource requirements for each of the features of the training software applications.” See id. ¶¶ 98, 99. “[T]he group of classifying features [may be] selected based on the significance of the extracted features,” such that “[s]ignificant features, such as those that have a large effect on the classification outcomes, may be retained” and “[i]nsignificant features, such as those that have a small, negligible or no effect on classification outcome may be pruned.” Id. ¶¶ 101, 106. Petitioner argues that “Ideses explains that in the method depicted in Figure 1, ‘[t]he full feature list is optionally selectively pruned,’ i.e., ‘selectively turned off’ as required by [1.e],” and “[f]urther, ‘each feature of the group is selected from-the-ground-up; added to the group as opposed to removed from or retained within a larger group,’ i.e., ‘selectively turned on’ as required by [1.e].” Pet. 33 (citing Ex. 1005 ¶ 71). Petitioner also argues element 1.e is taught by Ideses’s “approaches to pruning insignificant features,” which Petitioner argues are “to selectively includ[e]/exclud[e] features based on whether a feature coefficient ‘is within a predetermined range’ as required” by element 1.e. Id. at 34 (citing, e.g., Ex. 1005 ¶¶ 107, 109–110). But all of the selection and pruning described in Ideses concerns the” slip op. at 22
§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,409,869 - PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision
The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28
- ExcludeMotion to exclude, deniedDenied
“All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49
- Strike new argumentNew argument consideredDenied
“On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46
§ 112 disclosurePatents in suitUS 11,091,507 - PTAB · Oct 13, 2023 · PGR2023-00022 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted PGR on claims 1–33 under all petition grounds, finding it more likely than not that at least one claim lacks written description and enablement.
RulingsInstitution decision- Skill levelSkill level board ownOther
“Based on the information presented, we agree with Patent Owner that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). We do not find it necessary to define the level of skill in the art at the time of the invention at this time. However, for purposes of deciding whether to institute trial, we find that Dr. Silverstone is qualified to provide helpful opinion testimony on the issues regarding which we cite his testimony in this decision. See Ex. 1003 ¶¶ 6–15.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on the above, we agree with Patent Owner that many of the arguments raised by the Examiner are highly similar to the challenges in this proceeding, particularly the written description challenge. However, some arguments differ. For instance, Petitioner’s enablement argument identifies that, contrary to Applicant’s statement during prosecution reproduced above, amino acids and protein structure outside the disclosed AAD-12 motif can also affect the activity of the claimed dioxygenases to degrade phenoxy auxin and pyridyloxy auxin. See Ex. 1003 ¶¶ 42–50, 79 (Dr. Silverstone describing the mechanics of protein binding and explaining why the ’055 patent disclosure fails to provide sufficient information to the skilled artisan to know which amino acids could be changed while retaining the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides). See also Pet. 27–34 (asserting, e.g., 85% homology to AAD-12 motif alone is insufficient to predict enzymatic degradation activity). While the Examiner’s rejections regarded the disclosure corresponding to the ability to degrade herbicides, the Examiner plainly relied on Applicant’s statements that the AAD-12 motif’s structure alone was responsible when deciding to withdraw the rejection. Ex. 1002, 355. The Examiner did not have the additional testimony supplied by the Silverstone declaration explaining otherwise. See Ex. 1003 ¶¶ 42–50, 79. Petitioner, through Dr. Silverstone, also addresses the effort the skilled artisan would have needed to undertake to determine what proteins outside of the AAD-12 motif would affect the ability of homologues to enzymatically degrade the recited herbicides, and provides evidence for consideration regarding the lack of a clear link between the AAD-12 motif and the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides. Ex. 1003, 347. Therefore, the arguments are not entirely overlapping. And while these issues do in part overlap with Petitioner’s arguments pertaining to enablement, we agree with Petitioner that the Examiner did not complete a written Wands analysis. Although we conclude that the arguments are not entirely overlapping, we proceed to the second step in the analysis, for completeness.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because Petitioner has shown that it is more likely than not that Petitioner will prevail in showing that at least one claim lacks sufficient written description and is not enabled, we conclude the challenged claims are eligible for post-grant review. V. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has shown it is more likely than not that at least one challenged claim of the ’055 patent lacks written description and is unpatentable. Accordingly, we institute a post-grant review. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a), a post-grant review of claims 1–33 of the ’055 patent is instituted with respect to all grounds set forth in the Petition; and” slip op. at 57
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“85% identity as “highly identical” in this field and that the “conserved motif residues comprise ‘the active site that is essential for catalytic activity.’” Prelim. Resp. 31 (citing Ex. 1001, 11:1–6)). However, on the record before us, we are unpersuaded that this is sufficient because the Specification lacks disclosure supporting that a polypeptide of, for example, 86% identity to SEQ ID NO: 2 would retain the ability to degrade herbicides if the 5 amino acids in the general formula of HX109D(X)111-134 T(X)136-261H(X)263-272R, and the required chain lengths are present. In this regard we are persuaded by the testimony of Dr. Silverstone (Ex. 1003 ¶¶ 48–93) regarding the limitations of the disclosure of the ’055 patent and the lack of information supporting the skilled artisan in understanding that the inventor possessed the entire claimed genus (e.g., lack of example at lower end of sequence identity and lack of information to assist the skilled artisan in predicting whether an α-ketoglutarate-dependent dioxygenase would interact with or degrade either phenoxy auxin herbicides and/or pyridyloxy auxin herbicides). Dr. Silverstone testifies, and we are persuaded on this record, that the skilled artisan would not have read the guidance in the disclosure and understood that the inventors possessed the ability to design a modified SEQ ID NO: 2 at the 85% identity level that retained the function of degrading the recited herbicides, let alone the full scope of the claimed genus. Id. Patent Owner argues that Dr. Silverstone’s testimony that conserved amino acids of the AAD-12 motif are present in other α- ketoglutarate-dependent dioxygenases but do not have the claimed dual activity (Ex. 1003 ¶ 48) is misplaced because it “ignores that the location and spacing of those residues in other αKG-dependent dioxygenases differ from those in the AAD-12 motif.” Prelim. Resp. 38. However, Patent Owner offers no evidence that supports its argument. Id. It is thus unpersuasive.” slip op. at 36
§ 112 disclosureDiscretionary denialPatents in suitUS 11,371,055 - Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution deniedPTAB · Jan 13, 2023 · PGR2022-00051 · APJ Jamie T Wisz · PGR · Institution
The Board denied institution on all challenged claims, finding no reasonable likelihood of unpatentability under §§ 101 and 112(a), and denying Grounds 4–6 under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence, we determine that the information presented fails to demonstrate it is more likely than not that at least one of the challenged claims of the ’742 patent is unpatentable for ineligibility, lack of written description, or non-enablement. We also exercise our discretion to deny institution of post-grant review under 35 U.S.C. § 325(d). slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“tramiprosate “showed a significant overall treatment effect” in “an APOE4+ sub-group,” including APOE4 homozygotes; “therapeutic interventions applied earlier in the course of AD more likely might achieve the goal of disease modification;” and that “AD would be optimally treated before significant cognitive impairment, during its pre-symptomatic or pre-clinical stages …”) (emphases removed). Accordingly, Caltagirone was previously presented to the Office and we also find that Caltagirone’s disclosures are substantially similar to, or cumulative of, other references previously considered by the Examiner.” slip op. at 49
- Adverse judgmentAdverse judgmentOther
“D. Statutory Disclaimer After the filing of the Petition in this proceeding, Patent Owner filed a statutory disclaimer, disclaiming claims 9 and 11–15 of the ’742 patent, effective October 7, 2022. Prelim. Resp. 12; Ex. 2001, 1. “No post-grant review will be instituted based on disclaimed claims.” 37 C.F.R. § 42.207(e). We do not analyze the validity of claims 9 and 11–15 based on Petitioner’s challenges (e.g., Grounds 2 and 3) because these claims have been statutorily disclaimed.” slip op. at 5
- Skill levelSkill level petitioner adoptedDecided for petitioner
“at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 14–15 (citing Ex. 1003 ¶ 62) (internal citation omitted). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 12–13. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’742 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9
Claim construction§ 101 eligibility§ 112 disclosureDiscretionary denialcites Alice · Mayo · GrahamPatents in suitUS 11,191,742
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.