- 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 - PTAB · Jul 15, 2024 · PGR2024-00011 · APJ Jean R Homere · PGR · Institution
The Board instituted PGR on claims 1–15 and all asserted grounds, finding a reasonable likelihood that at least claim 1 is obvious over Chang, Chang II, and POSITA knowledge.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 324(a) (2018); 37 C.F.R. § 42.4(a) (2023) (“The Board institutes the trial on behalf of the Director.”). Section 324(a) provides that 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.” Upon considering the evidence and arguments in the Petition (including its supporting testimonial evidence) and the evidence and arguments in the Preliminary Response (including its supporting testimonial evidence), we determine that the information presented shows that it is more likely than not that Petitioner would prevail with respect to at least one of the challenged claims. Accordingly, we institute post-grant review on all” slip op. at 2
- Other 314aDenied
“Petitioner hereby stipulates that, if the PTAB institutes this post-grant review, Petitioner will not pursue invalidity of the Challenged Claims in a parallel district court proceeding on the same grounds or any grounds that could have reasonably been raised before the PTAB in this Petition. Pet. 106. Petitioner cites the Director’s Memorandum, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation, issued June 21, 2022 (“Guidance Memo”)3 in support of its contentions. Pet. 106.” slip op. at 11
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“§ 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). In applying the two-part framework, we consider several non-exclusive factors, including: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which petitioner relies on the prior art or patent owner distinguishes the prior art; (e) whether petitioner has pointed out sufficiently how the examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first paragraph) (“Becton, Dickinson”). Becton, Dickinson factors (a), (b), and (d) relate to whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, Paper 6 at 10. Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments. Id. Only if the same or substantially the same art or arguments were previously presented to the Office do we consider whether the petitioner has demonstrated a material error by the Office. Id. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 14
- Skill levelSkill level patent owner adoptedDecided for patent owner
“At the time of the invention, a POSITA would have had a bachelor’s degree in computer science, electrical engineering, or an equivalent, and two years of professional experience working with computer network protocols such as USB. Lack of work experience can be remedied by additional education, and vice versa. Id. (citations omitted). At this stage, we find Patent Owner’s proposed level of a POSITA to be consistent with the problems and solutions disclosed in the ’643 patent and prior art of record, and adopt it as our own for purposes of this Decision. See, e.g., In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (approving the determination of the level of ordinary skill in the art by appeal to the references of record). We nonetheless invite the parties to further address this issue, if they deem it necessary and appropriate. The parties should also specifically explain how different definitions for one of ordinary skill in the art relate to specific arguments and issues of unpatentability or claim construction, to the extent that a dispute remains as to who constitutes a POSITA.” slip op. at 20
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham · NautilusPatents in suitUS 11,681,643 - 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 - Intel Corporation v. Ax Wireless, LLCInstitution deniedPTAB · Mar 5, 2024 · IPR2023-01146 · APJ Michael T Cygan · IPR · Institution
The Board denied institution on all grounds because Petitioner did not show Huang or Sun was prior art to claims 1–10, which it argued were obvious over those references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“II. ANALYSIS A. Legal Standards Petitioner bears the burden to demonstrate unpatentability. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). For purposes of institution, Petition bears the burden to establish, by a reasonable likelihood that at least one of the challenged claims would have been obvious over the cited art. See 35 U.S.C. § 314(a). Where unpatentability rests on a document that is prior art to a challenged patent but for that patent’s priority claim to an earlier effective filing date, such a priority claim is not presumed valid. PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008) (noting that the USPTO does not routinely determine whether such priority claims meet the requirements of 35 U.S.C. § 120).” slip op. at 5
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Id. at 13, 17. Petitioner asserts that a person of ordinary skill in the art would have had at least a Master’s degree in electrical engineer-ing or a similar discipline, and/or at least two to three years of experience working or conducting research in wireless commu-nication protocols, or an equivalent combination of education and experience. Pet. 6 (citing Ex. 1003 ¶¶ 71, 72). Patent Owner does not contest Petitioner’s assertion as to the level of ordinary skill in the art. Prelim. Resp. 6. We are persuaded, on the present record, that Petitioner’s proposal is consistent with the problems and solutions in the ’146 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 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“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) (2022). The Board is required to construe “only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner and Patent Owner, in extended briefing, contest the construction of the phrase “detecting, from the received wireless packet, the second header field which repeats the first header field,” as it appears in claim 1. Pet. 9; Prelim. Resp. 1; Pet. Reply 3; PO Sur-Reply 3. However, both parties appear to agree that the plain and ordinary meaning of the term should apply. See Pet. 6; Prelim. Resp. 15. Further, Petitioner has clarified that its statements as to the scope of the term are directed to its assertions that the ’146 patent lacks support for the claimed subject matter in its parent applications. Pet. Reply. 5–6. Consequently, we address claim construction arguments in their context of the parties’ priority contentions. See infra at II.D.1.” slip op. at 7
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateDecided for patent owner
“Patent Owner has shown sufficient written description support for the claims, including the disputed “detecting” limitation. The “decode-to-learn- ‘D’” description in the specification of the ’146 patent and in the provisional application to which the ’146 patent claims priority describe a specific procedure for the claimed “detecting, from the received wireless packet, the second header field which repeats the first header field.”3 See Ex. 1001, 2 Petitioner specifically asserts that Huang qualifies under 35 U.S.C. §102(b). Pet. 2, 19 (“by more than a year”). However, Huang’s patent issuance date of April 28, 2020 does not qualify under § 102(b) because it is less than one year before the December 29, 2020 filing date of the ’146 patent. Nevertheless, Petitioner has made an effective showing that Sun would qualify as prior art sufficient to shift the burden of production to Patent Owner. 3 Patent Owner does not explicitly show support for each of the applications in the priority chain. Patent Owner also cites to a Pre-Grant Publication rather than the underlying application despite the fact that such a Publication may include amendments to the originally filed application that would not evidence written description. See 37 C.F.R. § 1.215 (a); MANUAL OF PATENT EXAMINING PROCEDURE §1121; Ex. 2003, 7 (showing amendments 3:1–11; Ex. 2001 ¶ 35; Ex. 1008, 5–6; PO Sur-Reply 6. The “D” information is received in the wireless packet, and the receiver determines therefrom whether there is a second header field that repeats the first header field. See Ex. 1008, 5–6; PO Sur-Reply 6. The written description further includes descriptions of other embodiments for receiver detection with variable repetition, including detection “without knowing D a priori.” Ex. 1001, 2:18–3:59.” slip op. at 9
Claim construction§ 112 disclosurePatents in suitUS 11,212,146 - Motorola Mobility LLC v. Largan Precision Co., Ltd.All claims unpatentablePTAB · Jan 3, 2024 · IPR2022-01156 · APJ John D Hamann · IPR · Final written decision
Claims 1–4, 6–16, 18–24, 28, and 29 are unpatentable as anticipated by Chen-069, which is prior art because the 2012 application lacks written-description support for their full scope.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“ordinary skill in the art at the time of the invention of the ’948 patent would have had “(i) a Bachelor’s degree in Physics, Optical Sciences, or equivalent education or training, as well as (ii) approximately three years of experience in designing multi-lens optical systems.” Id. at 12 (quoting Pet. 13–14 (citing Ex. 1003 ¶ 28)). We also found that “[l]ack of work experience could have been offset by additional education, and vice versa,” and that one of ordinary skill in the art “would have understood the fundamentals of optical aberration theory, and understood and used standard techniques for making lenses cheaper and more effective, especially for lens systems used in mobile devices.” Id. (quoting Pet. 14; Ex. 1003 ¶¶ 28, 30). We also agreed with Petitioner and found that one of ordinary skill in the art “would have known how to use lens design software such as Code V, Oslo, and ZEMAX, and would have taken a lens design course or had equivalent training.” Id. (quoting Pet. 14; Ex. 1003 ¶ 29). We also agreed with Petitioner and found that one of ordinary skill in the art “would have regularly used such software to create new lens designs, often using pre-existing lens designs as a starting point and then performing routine optimizations to reach a desired design.” Id. at 12–13 (quoting Pet. 14; Ex. 1003 ¶ 29). Patent Owner does not identify a level of skill in the art that one would have had at the time of the invention of the ’948 patent or identify any shortcoming in Petitioner’s formulation. See PO Resp. 16–17. Because Petitioner’s definition of the level of skill in the art is consistent with the ’948 patent and the asserted prior art, we maintain it for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC, 57 F.3d at 1579; In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“Patent Owner argues that construing the challenged “claims to include first and second lens elements having the same refractive power . . . is improper.” PO Resp. 21. According to Patent Owner, one of ordinary skill in the art “would construe the [’]948 [p]atent claims to include first and second lens elements in the form of a ‘doublet,’ which requires the respective lens elements to have opposite refractive power, and thus includes only configurations” of “positive-negative” and “negative-positive” for the first and second lens elements, respectively. Id. at 20–21. In other words, “[t]he proper construction of the ’948 [p]atent claims is that the first and second lens elements may have positive-negative or negative-po[sitive] refractive powers, but would not include first and second lens elements having the same refractive polarity,” according to Patent Owner. Id. at 26. Thus, the parties agree that the challenged claims should be construed to encompass at least a lens system having a first lens element with a negative refractive power and a second lens element with a positive refractive power. See, e.g., Pet. 33; PO Resp. 21. We conclude that such a lens system is consistent with the plain language of the challenged claims. See, e.g., Ex. 1001, 12:8–26, 13:14–38, 14:16–46 (reciting first and second lens elements without reciting a specific refractive power polarity for the independent claims). And we determine that no claim terms require further construction in light of our findings below. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’”).” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“In sum, we determine that the 2012 application does not provide written description support for an imaging lens system with a negative refractive power first lens and a positive refractive power second lens. And the agreed scope of the challenged claims includes such a configuration, and thus, the written description of the 2012 application does not support the full breadth of the challenged claims. We therefore determine that the challenged claims of the ʼ948 patent do not benefit from the priority date of the 2012 application. Therefore, we determine that Chen-069 is prior art to the challenged claims of the ʼ948 patent.” slip op. at 23
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“After reviewing Petitioner’s arguments and evidence, which are not addressed by Patent Owner (see generally PO Resp.), we determine that Petitioner demonstrates by a preponderance of the evidence that Chen-069 anticipates claim 1. D. Remaining Challenged Claims Petitioner argues that Chen-069 discloses the limitations recited in claims 2–4, 6–16, 18–24, 28, and 29. Pet. 48–65. Patent Owner does not address Petitioner’s arguments directed to these claims. See generally PO Resp. 32–34. Based on the evidence and arguments of record, we find that Petitioner demonstrates by a preponderance of the evidence that Chen-069 anticipates claims 2–4, 6–16, 18–24, 28, and 29.” slip op. at 24
Patent outcomesUS 9,784,948 unpatentableClaim construction§ 102 anticipation§ 112 disclosurecites Phillips · GrahamPatents in suitUS 9,784,948 - 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 - Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentablePTAB · Sep 6, 2023 · IPR2022-00608 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–21 are unpatentable: claims 1–14, 17–19, and 21 as obvious over Teigen and Grey; claims 15–16 over Teigen, Grey, and Yang; and claim 20 over Teigen, Grey, and Matteo.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. PERSON OF ORDINARY SKILL IN THE ART In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The level of ordinary skill in the art is “a prism or lens through which . . . the Board views the prior art and claimed invention” to prevent hindsight bias. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“as adopted by the Board in the Institution Decision. The ’253 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 38:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’253 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 3:8–11. In the ’253 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’253 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1034 ¶¶ 13–14. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” We disagree with Patent Owner’s contention that our construction imports limitations from a single embodiment into the claims. As explained above, the ’253 patent clearly defines the term “forward flow” and this definition is not limited to a single embodiment. In fact, the ’253 patent indicates that, while “[f]orward flow is defined as greater than 6 microliters of fluid . . . [l]ess forward flow is also included in this definition.” Ex. 1001, 38:21–24. The ’253 patent specifies that “the amount of forward flow can be restricted to no greater than 2 microliters or, in a particularly beneficial embodiment, forward flow is approximately zero microliters.” Id. at 38:24– 29. This language indicates that our construction encompasses multiple embodiments from the ’253 patent. We also disagree with Patent’s Owner’s proposed construction of “forward flow” because it is not supported by the ’253 patent specification. Patent Owner contends that “there is ‘no forward flow’ until the full extent of the distal portion” exits the distal end and thus forward flow is prevented when only less than “the full extent of the distal portion” exits the distal end. PO Resp. 9 (emphasis omitted). To adopt Patent Owner’s proposed construction, we would have to essentially ignore the ’253 patent’s express definition of this term. Further, there is no support in the ’253 patent specification for “full extent” or “fully exiting.” We also agree with Petitioner that Patent Owner’s construction effectively eliminates the concept of preventing forward flow because, as Patent Owner acknowledges, it could allow, for example, 20 milliliters of fluid to exit the catheter, which could displace the thrombus into the patient’s vasculature, a problem that the ’253 patent seeks to avoid. See PO Resp. 10–12 (citing Ex. 2014 ¶¶ 48–51); Pet. Reply 8–9 (citing Ex. 1034 ¶¶ 14–15).” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As discussed above, we construe “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosures from the ’011 provisional application that describe the desire to have “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” these disclosures would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 35 (citing Ex. 1003 ¶¶ 15, 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 36–37 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges that fall within the ’253 patent’s definition of “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1034 ¶ 25; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Further, we note that the ’253 patent differentiates between embodiments that allow forward flow and embodiments in which no forward flow occurs. See Ex. 1001, 32:58–60, 37:19–22; Pet. Reply 10–11. For example, the ’253 patent describes an embodiment in which the “momentum causes a small amount of fluid to move through the distal portion of the catheter [] and create a small distal movement of the clot.” Ex. 1001, 32:47– 51. This same embodiment is disclosed in the ’011 provisional application. Compare Ex. 1003 ¶ 126 with Ex. 1001, 32:16–60. The ’253 patent describes this disclosure as an “exemplary embodiment” in which the “flow of fluid forward . . . is intentional, which is in contrast to other exemplary embodiments herein where substantially no forward flow occurs.” Ex. 1001, 32:57–60; see also, id. at 37:19–22 (“Turning now to embodiments . . . without the forward flow”).8 The ’011 provisional application does not include the subsequent embodiments from the ’253 patent that are described as being “without the forward flow.” See Ex. 1005 ¶ 68; Ex. 1034 ¶¶ 22–23. This further demonstrates that the ’011 provisional application does not support the limitation of “prevent[ing] forward flow.” We also note that the ’011 provisional application does not contain adequate support for the limitation of “substantially prevent[ing] forward flow” even under Patent Owner’s proposed construction. While the ’011 provisional discloses “controlling the distal movement of the fluid column” (Ex. 1003 ¶¶ 15, 16), this does not support Patent Owner’s assertion that the ’011 provisional teaches that “the distal portion of the fluid column is substantially prevented from fully exiting the distal end.” PO Resp. 35–36. For example, as discussed above, the ’011 provisional application discloses permitting distal flow of up to 1,000 microliters, which would likely exceed the amount that could be characterized as the full distal portion. Ex. 1003 ¶ 91; Ex. 1034 ¶ 25. Thus, we find that the ’011 provisional application does not “clearly allow persons of ordinary skill in the art to recognize that [the inventors] invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989); Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 8 Patent Owner contends that the statement in the ’253 patent regarding the “exemplary embodiment” of “forward flow” is referring to an embodiment in which the volume of the liquid drawn out from the lumen of the catheter is “approximately 0.2 ml.” PO Resp. 40–41 (citing Ex. 1001, 32:35–36; Ex. 1003 ¶ 126; Ex. 2014 ¶ 99). Even if this is correct, the ’011 provisional application does not include the embodiments that the ’253 patent specifically characterizes as being “without the forward flow.” Pet. Reply 10–11; Ex. 1005 ¶ 68; Ex. 1034 ¶ 22–25.” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“Based on the above, we determine that, for prior-art determinations under AIA § 102, “there is no need to evaluate whether any claim of [a reference] patent document is actually entitled to priority or benefit under 35 U.S.C. 119, 120.” MPEP § 2154.01(b) (emphasis added). Rather, under 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). Patent Owner has not contested that Teigen meets the procedural requirements for claiming priority to the ’712 patent or the ’095 PCT application. Teigen also appears to meet the ministerial requirements for claiming priority to the provisional applications because it properly claims the benefit of these applications, the ’095 PCT application was filed co-pending with the provisional applications, and the applications share common inventors. Ex. 1007, codes (22), (60), (63), (72); Ex.1008, 2; Ex. 1009, 2; Ex. 2005, codes (22), (30), (72). Patent Owner does not dispute that Teigen meets the “ministerial requirements” of § 119. Because we find that the Dynamic Drinkware analysis does not apply here, we agree with Petitioner and Patent Owner, that we need not reach the issue of whether a claim from Teigen is supported by either Teigen provisional application. PO Sur-Reply 8; Pet. Reply 12–13.” slip op. at 30
Patent outcomesUS 10,722,253 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,722,253 - PTAB · Apr 18, 2023 · IPR2022-00123 · APJ Zhenyu Yang · IPR · Final written decision
The Board cancelled original claim 1 and denied substitute claim 2 for lack of written-description support; it did not reach the obviousness or enablement grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“ordinary skill is inappropriate because it “requires qualifications that exclude even the sole inventor of the ’190 Patent, Dr. Edward Neuwelt.” MTA Opp. 1. According to Petitioner, Dr. Neuwelt is “a neurosurgeon,” not a pediatric oncologist, and lacks the requisite “at least 2 years” experience in platinum-based therapies. Id. (citing Ex. 1003, 18; Ex. 1038, 98:9–17, 100:15–101, 4). We agree with Petitioner. It is well settled that inventors are typically persons skilled in the field of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner presents persuasive evidence to show that under Patent Owner’s proposed definition of the level of ordinary skill, Dr. Neuwelt, the sole inventor, would not qualify as an ordinarily skilled artisan, because he is not a pediatric oncologist, even though he is considered “one of the world leading experts on this compound [STS] and otoprotection” and “an expert in the area of [STS] as a . . . drug to use in children with medulloblastoma.” Ex. 1038, 98:9–17, 99:17–18, 101:18–102:13.” slip op. at 10
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Paragraph 102 of Dr. Rassekh’s Declaration, however, does not support Patent Owner’s assertion. Instead, Dr. Rassekh testifies that [t]he stratum of previous craniospinal radiation therapy contained 8 participants: 2 of the 4 (50%) participants receiving STS had hearing loss compared to 4 of the 4 (100%) participants not receiving STS, and none of the hearing loss assessments were changed at the 1 year follow up period. (Ex. 1001 at 20: 28-32, 47-50.) Ex. 2024 ¶ 102. Dr. Rassekh offers no opinion on how many osteosarcoma patients with prior cranial irradiation and how many medulloblastoma patients with prior cranial irradiation had hearing loss.” slip op. at 20
- 112 supportMotion to amend, deniedDenied
“In sum, we find the disclosures of the ’243 application that Patent Owner relies on do not provide sufficient written-description support for the ototoxicity efficacy limitation.” slip op. at 21
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“F. Petitioner’s Asserted Unpatentability Grounds In light of our determination above that Patent Owner has not shown sufficient written-description support for proposed substitute claim 2 in the ’243 application, we do not reach the grounds of unpatentability set forth in Petitioner’s Opposition. See Revised MTA Opp. 17–25 (alleging non-enablement and obviousness).” slip op. at 26
§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,596,190 - Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentablePTAB · Mar 10, 2023 · IPR2021-01466 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–18 are unpatentable under §103: claims 1–12, 15, 16, and 18 over Teigen and Grey; claims 13–14 over Teigen, Grey, and Yang; claim 17 over Teigen, Grey, and Matteo.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Based on our consideration of the full record, we find that, overall, Patent Owner’s definition is more specifically tailored to the claimed subject matter of the ’883 patent. We also find that, a person with a biomedical engineering degree could have the required background in fluid mechanics. See Ex. 1031, 45:21–46:7. Therefore, we find that a person of ordinary skill in the art would have a B.S. in mechanical or biomedical engineering with at least three years of experience in designing systems for minimally invasive intravascular procedures for treating occluded vessels or the equivalent and in consultation with medical professionals such as interventional neurosurgeons. Although we agree with, and have primarily adopted Patent Owner’s definition for an ordinarily skilled artisan in this proceeding, our analysis and conclusions herein would not change even under Petitioner’s definition. The parties also do not indicate that the outcome would differ based on the definition of the person of ordinary skill in the art. See Pet. 15; PO Resp. 6; Pet. Reply 1.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“as adopted by the Board in the Institution Decision. The ’883 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 36:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’883 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 2:62–65. In the ’883 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’883 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1030 ¶¶ 13–14; Ex. 2001 ¶¶ 53, 62. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.”” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As discussed above, we construed “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosure from the ’011 provisional application which describes “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” it would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 33 (citing Ex. 1003 ¶¶ 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 34 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the disclosure of the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges which fall within the ’883 patent’s definition of no “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1030 ¶ 29; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996).” slip op. at 21
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“AIA § 102 draws a distinction between actually being entitled to a right of priority to, or the benefit of, a prior-filed application according to the definition of “effective filing date” of a claimed invention in AIA 35 U.S.C. § 100(i)(1)(B), and merely being entitled to claim a right of priority to, or the benefit of, a prior-filed application for prior-art purposes according to the use of “effectively filed” in AIA 35 U.S.C. § 102(d). See 35 U.S.C. §§ 100(i)(1)(B), 102(a)(2), 102(d)(2); MPEP § 2154.01(b). USPTO guidance also indicates that AIA § 102 prior-art reference effective-filing-date determinations differ from pre-AIA law. For example, a 2018 Memorandum to the Patent Examining Corps states, in the context of prior-art determinations, that “[t]he requirement that one of the claims in the patent [document] . . . be supported by the written description of the provisional application in compliance with pre-AIA 35 U.S.C. § 112, first paragraph (or AIA 35 U.S.C. § 112(a)), is not applicable when examining an application subject to the first inventor to file provisions of the AIA.” Robert W. Bahr, Memorandum re: Critical Reference Date Under pre-AIA 35 U.S.C. §102(e) (Apr. 5, 2018), available at http://www.uspto.gov/sites/ default/files/documents/dynamic_memo_05apr2018_0.pdf (emphasis added) (citing Dynamic Drinkware, 800 F.3d at 1381 n.2; 157 Cong. Rec. 3423 (2011) (explaining the distinction between being entitled to claim priority or benefit in AIA 35 U.S.C. § 102(d) and actually being entitled to priority or benefit under 35 U.S.C. § 119, 120, or 365)). This Memorandum further indicates: The date subject matter was “effectively filed” under AIA 35 U.S.C. § 102(d) for purposes of considering a U.S. patent, a U.S. patent application publication, or an international application publication as prior art under AIA 35 U.S.C. § 102(a)(2) is discussed in MPEP § 2154.01(b), and is not affected by Dynamic Drinkware or [Amgen v. Sanofi, 872 F.3d 1367, 1380 (Fed. Cir. 2017)] and is not being modified by this memorandum. Id. at 2. MPEP § 2154.01(b) explicitly states, as a result of the distinction discussed above, in application of the AIA version of § 102, “the question of whether a patent or published application is actually entitled to priority or benefit with respect to any of its claims is not at issue in determining the date the patent or published application was ‘effectively filed’ for prior art purposes.” MPEP § 2154.01(b) (emphases added).” slip op. at 31
Patent outcomesUS 10,531,883 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,531,883
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.