- PTAB · Oct 6, 2026 · IPR2025-00525 · APJ Scott C Moore · IPR · Final written decision
Original claim 21 was canceled; the Board denied substitute claim 22 for new matter and held it obvious under §103 based on six combinations.
RulingsFinal written decision- 112 supportMotion to amend, deniedDenied
“First, Patent Owner has not shown possession of the disputed feature of a “radio communication module [that] is configured to utilize a secure identifier, the secure identifier comprising a specified excitation.” In the ’406 application, the term “excitation” is used exclusively to refer to a light beam signal. See Ex. 2015, 7:8–13, 9:8–10, 23:9.2 The ’406 application discloses that an identification box on an aircraft may include both an RF module and a separate light sensor. See Ex. 2015, 7:3–11. But nowhere does the ’406 application describe receiving a light beam (e.g., an excitation) with the RF module of the identification box (as opposed to the light sensor), so as to provide support for proposed substitute claim 22’s recitation of a “radio communication module” configured to utilize “a secure identifier . . . comprising a specified excitation.” We disagree with Patent Owner that it suffices that one of ordinary skill in the art “would recognize that these disclosures are equally applicable to the RF-only embodiments” (Reply 5). “It is not sufficient for purposes of the written description requirement . . . that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). On this record, and having reviewed the ’959 Patent, the ’153 provisional, and the ’406 application, we find no evidence in those documents that the named inventor was in possession of the concept of a radio communications module “configured to utilize a secure identifier” where “the secure identifier compris[es] a specified excitation.” Second, setting aside the “radio communication module” in proposed substitute claim 22, Patent Owner also has not shown that the named inventor was in possession of the feature of a “secure identifier comprising a specified excitation.” Patent Owner’s argument that the ’406 application describes a light beam directed to a particular aircraft (see Reply 4–5) is 2 The same is true of the ’153 provisional. See Ex. 2016 ¶¶ 29, 34. unavailing. The fact that the properties of a particular light beam indicate that the light beam is intended for a particular aircraft does not demonstrate that the light beam is a “secure identifier,” as we have construed that term. Patent Owner has not identified any disclosure in the ’406 application of a “secure identifier” comprising a light beam, let alone that such light beam can be utilized by a “radio communication module.” The only references to “secure” identifiers in the ’406 application describe radio frequency signals. See Ex. 2015, 2:4–6, 15:21–17:12.3 Having reviewed the ’959 Patent, the ’153 provisional, and the ’406 application, we find no evidence in those documents that the named inventor was in possession of the concept of a “secure identifier comprising a specified excitation.”” slip op. at 15
- ScopeDecided for patent owner
“not impermissibly broaden the scope of the claims of the ’959 Patent. As Patent Owner suggests, there were no limitations in original claim 21 on the type of radio signal the radio communication module could receive, and so it follows that proposed substitute claim 22 does not now encompass receiving a broader set of radio signals. We see no basis for Petitioner’s argument that the past tense verb “received” limited original claim 21 to “signals of a compatible ‘type’ and ‘range.’” Opp. 7. Moreover, the claim language (with the proposed deletion shown double brackets) provides that “the radio communication module is configured to receive a [[received]] radio signal.” Any radio signal that the radio communications module receives would necessarily be a “received” radio signal. Thus, deleting the redundant word “received” does not enlarge the scope of this claim limitation. We also are not persuaded by Petitioner’s suggestion that removing the term “received” broadens original claim 21 by deleting a requirement that the radio signal have already been previously received by the claimed device. See Sur-reply 9. Original claim 21 simply recited, using redundant language, that “the radio communication module is configured to receive a received radio signal.” Ex. 1001, 18:5–7. The most natural reading of this language is that the phrase “received radio signal” is just a description of a radio signal that is received by the recited radio communications module. Petitioner has cited no persuasive evidence that one of ordinary skill in the art would have counterintuitively interpreted this language to impose an additional requirement that the “received radio signal” must have been received twice—a first time by some other component of the device, and a second time by the recited radio communication module. Accordingly, we determine that the proposed amendment does not improperly broaden claim scope.” slip op. at 10
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteNot shown unpatentable
“572 U.S. 898 (2014). See Memorandum: Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021).4 Under Nautilus, a claim is indefinite if fails to “inform those skilled in the art about the scope of the invention with reasonable certainty.” 572 U.S. at 910. We agree with Patent Owner that neither of the identified terms are indefinite. Regarding the term “low-altitude aircraft,” we determine the Specification provides a sufficient basis for understanding the scope and meaning of this term with reasonable certainty. The U.S. Court of Appeals for Federal Circuit has explained that, when a term of degree is recited in a claim, it is necessary “to determine whether the patent’s specification provides some standard for measuring that degree.” See Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984); see also Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350 (Fed. Cir. 2005) (“Some objective standard must be provided in order to allow the public to determine the scope of the claimed invention.”). Here, the Specification describes the related art as including “small UASs (e.g., aircrafts up to 25 pounds flying up to 500 ft of the low altitude airspace).” Ex. 1001, 1:50–52. One of ordinary skill in the art would understand from the Specification that the cited disclosure provides an objective standard for determining the scope of a low-altitude aircraft as one that is designed to fly up to a maximum altitude of about 500 feet.” slip op. at 20
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s proposal that one of ordinary skill in the art would have had the following qualifications: [E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace, avionics, telecommunications, or electronic device manufacturing industry, or (2) at least four years of industry experience in any of the above industries. Paper 13, 5 (citing Pet. 21). Patent Owner has not disputed this formulation; thus, we adopt it for purposes of this Decision. See Paper 13, 10–11 n. 8.” slip op. at 23
§ 103 obviousness§ 112 disclosurecites Graham · NautilusPatents in suitUS 10,713,959 - 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 · Oct 8, 2025 · IPR2025-00629 · APJ Scott C Moore · IPR · Institution
The Board instituted IPR of claims 1–20 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Beard and Laufer.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We may institute an inter partes review when “the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of one or more claims of the ’711 Patent. We, therefore, institute inter partes review of claims 1–20 on the grounds identified in the Petition. B.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that one of ordinary skill in the art would have had the following qualifications: [E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace or avionics fields, or (2) at least four years of experience in any of the above industries. 1 The Leahy-Smith America Invents Act (“AIA”) included revisions to 35 U.S.C. §§ 102 and 103 that became effective on March 16, 2013. Because the applications from which the ’711 Patent claims priority were all filed after this date, the post-AIA version of §103 applies. See Ex. 1001, codes (60), (63). 2 U.S. Patent No. 9,769,387 B1, iss. Sept. 19, 2017 (Ex. 1009). 3 U.S. Patent App. Pub. No. 2017/0059692 A1, pub. Mar. 2, 2017 (Ex. 1010). 4 U.S. Patent App. Pub. No. 2012/0106800 A1, pub. May 3, 2012 (Ex. 1021). 5 U.S. Patent App. Pub. No. 2017/0161911 A1, pub. June 8, 2017 (Ex. 1007). 6 U.S. Patent App. Pub. No. 2013/0301905 A1, pub. Nov. 14, 2013 (Ex. 1024). 7 U.S. Patent App. Pub. No. 2012/0004844 A1, pub. Jan. 5, 2012 (Ex. 1025). 8 PCT App. Pub. No. WO 2017/123477 A1, pub. July 20, 2017 (Ex. 1022). 9 U.S. Patent App. Pub. No. 2017/0160751 A1, pub. June 8, 2017 (Ex. 1005). Pet. 8 (citing Ex. 1003 ¶¶ 50–54). Patent Owner does not presently dispute Petitioner’s proposed formulation. See generally Prelim. Resp. For purposes of this Decision, we adopt and apply Petitioner’s formulation regarding the level of ordinary skill in the art because it is (1) consistent with the ’711 Patent and the asserted prior art; and (2) it is supported by the testimony of Dr. Singhose. B.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“But the Detecting Limitations of claims 1, 19, and 20, merely require that a target be “detected.” The Detecting Limitations do not require that target detection be performed “aboard the reference UAV,” and claim 19 does not recite or require “machine learning.” Moreover, the Specification makes clear that the claims should not be limited to aspects of the disclosed embodiments, as Patent Owner proposes to do here. See, e.g., Ex. 1001, 2:56–59 (“The invention is described in connection with such embodiments, but the invention is not limited to any embodiment. The scope of the invention is limited only by the claims . . . .”) Patent Owner additionally fails to cite any lexicographic definition or clear and unambiguous disclaimer of claim scope sufficient to limit the claims in the manner it proposes. We, thus, are not persuaded that the Detecting Limitations require “applying aboard the reference UAV a machine learning model to the capture image for: (i) identifying a target in the captured image.”” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Priority Date of the Challenged Claims Petitioner contends that claims 1–20 of the ’711 Patent “should not have priority to the October 9, 2016 filing date of U.S. provisional [patent] application 62/405,972 due to a lack of written description support.” Pet. 3. Petitioner thus “assumes” a priority date of October 1, 2017 (the filing date of U.S. Provisional Patent Application No. 62/556,449) for purposes of this proceeding. Id. at n.2; see also Ex. 1003, code (60). Patent Owner does not presently dispute Petitioner’s contention that the ’711 Patent is not entitled to a priority date earlier than October 1, 2017. See generally Prelim. Resp. For purposes of this decision, we accept Petitioner’s undisputed contention that the ’711 Patent is not entitled to a priority date prior to 10 Any determination, no matter how designated in this Institution Decision (except our ultimate decision to institute), is preliminary and non-binding. Our Final Written Decision, based on a fully developed record of arguments and evidence, will state our binding determinations, findings, and conclusions. If a party disagrees with this preliminary construction, or any other determination set forth in this Institution Decision, that party should present its arguments at trial. The parties are reminded that any arguments not made during trial will be considered waived. Patent Owner is further reminded that arguments in the Preliminary Response are not preserved and will be considered waived at trial unless those arguments are re-raised in the Patent Owner Response. The parties are additionally reminded that arguments raised in subsequent briefing must be set forth in full in the briefs themselves, and may not be incorporated by reference from prior filings such as the Preliminary Response. See 37 C.F.R. § 42.6(a)(3). October 1, 2017.11 Accordingly, Petitioner has made a sufficient showing that all of the cited references qualify as prior art. See Pet. 4–6. D.” slip op. at 11
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,514,711 - PTAB · Oct 8, 2025 · IPR2025-00525 · APJ Scott C Moore · IPR · Institution
The Board instituted review of claim 21 on all asserted grounds after finding a reasonable likelihood it is obvious over Beard.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of claim 21, the sole challenged claim. We, therefore, institute inter partes review of claim 21 on the grounds asserted in the Petition. B.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“[E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace, avionics, telecommunications, or electronic device manufacturing industry, or (2) at least four years of industry experience in any of the above industries. Pet. 21 (citing Ex. 1003 ¶ 47). Patent Owner does not presently dispute Petitioner’s proposed formulation. See generally Prelim. Resp. For 3 U.S. Patent App. Pub. No. US 2016/0253907 A1, published Sept. 1, 2016 (Ex. 1010). 4 PCT Pub. No. WO 2016/078093 A1, published May 26, 2016 (Ex. 1011). 5 PCT Pub. No. WO 2016/154949 A1, published Oct. 6, 2016 (Ex. 1012). 6 U.S. Pat. App. Pub. No. US 2016/0127890 A1, published May 5, 2016 (Ex. 1013). 7 PCT Pub. No. WO 2015/043123 A1, published Apr. 2, 2015 (Ex. 1014). purposes of this Decision, we adopt and apply Petitioner’s formulation regarding the level of ordinary skill in the art because it is (1) consistent with the ’959 Patent and the asserted prior art; and (2) it is supported by the testimony of Dr. Chowdhary. B.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“But before describing the embodiments cited by Patent Owner, the Specification plainly states: “Any terms not expressly defined herein have their conventional meaning as commonly understood by those having skill in the relevant art(s).” Ex. 1001, 4:64–67. Thus, the Specification itself cautions against construing the claim terms such as “secure identifier” as limited to the scope of the disclosed embodiments. Here, Patent Owner has not cited any express definition of “secure identifier,” or identified any explicit disclaimer of claim scope that might justify narrowing the scope of this claim term to specific embodiments disclosed in the Specification. In the absence of such a definition or disclaimer, we are not persuaded that the scope of the claim term “secure identifier” should be limited to specific aspects of the preferred embodiments cited by Patent Owner. See Prelim. Resp. 7–14. On this record, and at this stage of the proceeding, we decline to adopt Patent Owner’s proposed construction and preliminarily construe “secure identifier” as “a credential that can be used to securely verify the identity of a device, such as an airborne object or ground-based transmitter.”8” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“’071 Application lack adequate written description support for the “secure identifier” claim limitation. For a patent claim to be entitled to the priority date of an earlier-filed application, the earlier application must provide complete written description support for the claim as required by 35 U.S.C. § 112(a). L.A. Biomedical Rsch. Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“L.A. Biomed”). To satisfy this requirement, the written description must “reasonably convey” to a person of ordinary skill in the art that the inventor had possession on the claimed priority date of each limitation of the later-claimed subject matter. L.A. Biomed, 849 F.3d at 1057. It is not enough that an earlier application’s disclosure “renders the later-claimed invention obvious;” as “the disclosure must describe the claimed invention with all its limitations.” L.A. Biomed, 849 F.3d at 1057. On this record, we agree with Petitioner that the ’153 Provisional and ’071 Application lack adequate written description support for the “secure identifier” limitation of claim 21. We have preliminarily construed “secure identifier” as “a credential that can be used to securely verify the identity of a device, such as an airborne object or ground-based transmitter.” See supra § II.B. As discussed above, the Specification of the ’959 Patent does not use the term “secure identifier,” but the Specification contains extensive discussion of the need for an identification credential that is secure (e.g., difficult for a bad actor to clone or impersonate). See, e.g., Ex. 1001, 1:56– 65 (discussing the need for a system that is difficult to “clone”), 10:20–49 (discussing the need “trust” between a drone and ground-based equipment, and the need for a way to verifying the drone’s credentials), 11:5–12:62 (disclosing the use of encryption and a rotating SSID to generate a secure identifier for a drone). None of the portions of the Specification cited above is present in the ’153 Provisional or the ’071 Application. See generally Ex. 1006, 1007. The ’153 Provisional and ’071 Application discuss the need for identifiers for low-altitude aircraft (see, e.g., Ex. 1006, 2; Ex. 1007, 9), but there is no discussion of any need for an identification credential to be secure or resistant to cloning or impersonation. See generally Ex. 1006, 1007. The ’153 Provisional and ’071 Application do not disclose the use of encryption, SSIDs (much less rotating SSIDs), or any other technologies for the purpose of verifying the authenticity of an identification credential. See generally id. Based on our review of the ’153 Provisional and ’071 Application, we preliminarily conclude that neither of these applications would have reasonably conveyed to a person of ordinary skill in the art that the inventor then had possession of the concept of the “secure identifier” that was later claimed in the ’959 Patent.” slip op. at 12
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · GrahamPatents in suitUS 10,713,959 - 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 · 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 - Neuroderm Ltd. v. Abbvie Inc.InstitutedPTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution
The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19
- Skill levelSkill level board ownOther
“Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15
- Expert testimonyPetitioner expert creditedOther
“Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,091,507 - Sandoz Inc. v. Boehringer Ingelheim International GmbHInstitution deniedPTAB · Nov 7, 2022 · PGR2022-00037 · APJ Devon Zastrow Newman · PGR · Institution
The Board denied institution because Petitioner did not show that the patent was eligible for post-grant review; the challenged claims were entitled to the pre-AIA priority date.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that Petitioner has not identified any challenged claim that has an effective filing date on or after March 16, 2013. For this reason, we find that Petitioner has not shown sufficiently that the ’265 patent is eligible for post-grant review. IV. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has not shown that the ’265 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(d), the Petition is denied.” slip op. at 29
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“To interpret “stable,” we begin with how the term is used in independent claims 7 and 19. Both terms recite “stable” in relation to the pharmaceutical formulation as a whole by reciting “wherein the formulation is stable.” Ex. 1001, 189:62–190:27. From this, we conclude that the ordinary artisan, as defined above to have a relevant advanced degree and at least two years of experience in development or manufacture of therapeutic protein formulations, would have understood that the components of a “stable” formulation would maintain their integrity and desired function following preparation, including when stored as described. This meaning is supported by the following language in the specification pertaining to the disclosed pharmaceutical compositions: Pharmaceutical compositions according to the present invention are described in further details hereinbelow. In one aspect, the pharmaceutical compositions disclosed herein are physico-chemically stable and maintain the integrity of an antibody comprised in said pharmaceutical composition, for example when stored for 8 weeks at 40° C. as shown hereinbelow. Ex. 1001, 84:20–26. We also note, as Petitioner argued, that the prosecution history supports that the formulation components needed to remain functional during storage, and that Patent Owner cited to formulation integrity after a storage period of 8 weeks at 40° C as evidence of such integrity. Ex. 1004, 7380. As disclosed in the ’265 patent, Examples 9 and 12 measure function and identity of the components following storage to confirm formulation stability.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“burden of showing that claim 7 or 14 lacks written description support in the priority application, which Petitioner has conceded provides the same support as the ’265 patent specification. In this regard, we agree that the reasoning in Fresenius likewise applies: there is no legal requirement that a patent specification must include test results or working examples demonstrating stability for every possible composition that is covered by the claims. Fresenius at 13, citing Ariad Pharms., 598 F.3d at 1352 (stating that “the written description requirement does not demand either examples or an actual reduction to practice”). Formulations 2 and 3, disclosed in the ’265 patent specification, which Petitioner acknowledges falls within the scope of claims 7 and 14 (Pet. 26–27 (citing Ex. 1002 ¶¶ 134, 135)), were shown to be stable for 8 weeks in a syringe. Moreover, the ordinary artisan was provided with guidance in making such formulations from the teachings of the specification and has additional knowledge from the art. See Ex. 1001, 85:32–94:35. Claims 7 and 14 identify specific structures (risankizumab) and required excipients within a defined pH range, which are stable as confirmed by testing results presented in the specification. Prelim. Resp. 33; Ex. 1001, 94:14–36. On this record, we conclude that the evidence presented does not establish that it is more likely than not that an ordinarily skilled artisan would not have reasonably believed that the inventors of the ’265 patent possessed the claimed subject matter, each limitation of which is demonstrated as supported in the specification. As we have interpreted the claim term “wherein the formulation is stable” to mean “wherein the formulation maintains the functional integrity of the antibody and other components, for example when stored for 8 weeks at 40° C,” the specification supports maintenance of functional integrity as shown by the stability of Formulations 2 and 3, including when stored for a period of time. For this reason, we find that Petitioner has not shown that the ordinary artisan would not have understood the inventors of the ’265 patent possessed the subject matter of claims 7 and 14 as of the filing date of the priority application.” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable
“We acknowledge that in the Fresenius case, the extensive testing disclosed in that specification supported the ordinary artisan’s ability to formulate stable compounds using such guidance, and that the specification here discloses less testing. See, e.g., Sur-Reply. 8–9. Nevertheless, it is Petitioner’s burden on this issue, and we are not persuaded that the concerns raised by Dr. Klibanov provide sufficient evidence of actual instability to justify institution on this record. See, e.g., Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984) (finding lack of evidence that district court erred in upholding claims as enabled where defendant did not identify inoperable embodiments despite extensive testing). In particular, we are persuaded that, on this record, Petitioner’s lack of evidence of instability of any formulation falling within the limitations of claim 14 indicates that Petitioner has not established sufficiently, for purposes of trial institution, that it is more likely than not that an ordinarily skilled artisan would not have been able to practice the full scope of claim 14 invention based on the teachings of the specification.” slip op. at 28
Claim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,078,265
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.