- Unified Patents, LLC v. Ideahub Inc.All claims unpatentablePTAB · Feb 5, 2024 · PGR2022-00044 · APJ Monica S Ullagaddi · PGR · Final written decision
Claims 1–13 are unpatentable for lack of written description under § 112(a); the Board did not reach the anticipation and obviousness grounds based on HEVC265.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that: A person of ordinary skill in the art at the priority date for the ’274 Patent (“POSITA”) would have had a bachelor’s degree in electrical or computer engineering, or a closely related scientific field such as physics or computer science, and two years of work experience with video processing. A lack of experience can be remedied with additional education (e.g., a Master’s degree), and likewise, a lack of education can be remedied with additional work experience (e.g., 4–5 years). This definition would apply at the earliest claimed priority date of the ’274 Patent as well as any later date. Pet. 12 (citing Ex. 1005 ¶¶ 50–52). Patent Owner does not dispute the level of ordinary skill in the art. See generally PO Resp. We adopt Petitioner’s definition as it appears to be consistent with the Specification of the ’274 patent and the cited reference.” slip op. at 14
- PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner
“A party is collaterally estopped from relitigating an issue if: (1) a prior action presents an identical issue; (2) the prior action actually litigated and adjudged that issue; (3) the judgment in that prior action necessarily required determination of the identical issue; and (4) the prior action featured full representation of the estopped party. VirnetX Inc. v. Apple, Inc., 909 F.3d 1375, 1377 (Fed. Cir. 2018) (citing Stephen Slesinger, Inc. v. Disney Enterprises, Inc., 702 F.3d 640, 644 (Fed. Cir. 2012)).” slip op. at 21
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“For the reasons that follow, we determine that the ’928 application does not provide sufficient written description support, for at least independent claim 1 of the ’274 patent, so as to “reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” of the ’928 application. Ariad, 598 F.3d at 1351. Accordingly, we are persuaded that the ’928 application lacks sufficient written description support for the invention recited in claim 1 of the ’274 patent, and thus, claim 1 does not receive an effective filing date as early as that of the ’928 application (i.e., December 23, 2010). We further determine that Petitioner filed the Petition within the 9-month statutory period for requesting post-grant review in accordance with 35 U.S.C. § 321(c). The ’274 patent issued on September 14, 2021 (see Ex. 1001, code (45)), and the present Petition was accorded a filing date of June 9, 2022 (see Paper 5). Accordingly, the Petition was filed less than 9 months after the date of issuance of the ’274 patent. In view of the above, we are persuaded that the ’274 patent is eligible for post-grant review.” slip op. at 16
Patent outcomesUS 11,122,274 unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,122,274 - Apple Inc. v. Rfcyber Corp.All claims unpatentablePTAB · Jan 19, 2024 · IPR2022-01256 · APJ Kevin W Cherry · IPR · Final written decision
Claims 1–11 are unpatentable as obvious over Buhot, GPC, and Zhu.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“earlier applications, in particular Application No. 11/534,653 (“the ’653 application”), which issued as U.S. Patent No. 8,118,218 B2 (“the ’218 patent”). “‘It is elementary patent law that a patent application is entitled to the benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.’” PowerOasis, Inc. v. T- Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008). The test for determining compliance with the written description requirement under § 112(a) is whether the original disclosure of the earlier-filed application reasonably would have conveyed to one with ordinary skill in the art that the inventor had possession of the claimed subject matter at the time of the earlier-filed application. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). It is well settled that “[e]ntitlement to a filing date does not extend to subject matter which is not disclosed but would be obvious over what is expressly disclosed.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571−72 (Fed. Cir. 1997). “It is not sufficient for purposes of the written description requirement of § 112 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.” Id. We agree with Petitioner there does not appear to be support for limitation [1(j)] in the ’653 application. We find that the disclosure of the ’653 application—limited to general teachings of a smart card, an operating system, and a smart card manager—is insufficient to show possession of limitation [1(j)]. See Ex. 2001 (’218 patent), 4:47–56. As we explained above, “[e]ntitlement to a filing date does not extend to subject matter which is not disclosed but would be obvious over what is expressly disclosed.” Lockwood, 107 F.3d at 1571−72. The ’653 Application contains no disclosure of replacing applications, even if the disclosure might render such replacing obvious, it is not sufficient to show the possession required to establish entitlement to a priority date. Accordingly, we agree with Petitioner that the challenged claims of the ’724 patent are entitled to a priority date no earlier than March 4, 2012.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the declaration testimony of Mr. Smith, Petitioner contends that an ordinarily skilled artisan for the ’724 patent “would have had at least a bachelor’s degree in computer engineering, computer science, electrical engineering, or a related field, with at least one year of experience in the field of mobile payment technology. Additional pertinent education might substitute for the requisite experience and vice versa.” Pet. 6–7 (citing Ex. 1007 (Smith Decl.) ¶¶ 34–35). Patent Owner states that “[t]he parties agree on the level of skill in the art.” PO Resp. 11. Accordingly, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’724 patent and the asserted prior art, and we apply it in our obviousness evaluations below. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner contends that it applies “the plain and ordinary meaning as understood by a [person of ordinary skill in the art] for all terms not expressly construed below,” and indicates that in parallel District Court litigation, the parties agreed to claim construction for the term “emulator device” to mean “hardware device, alone or containing software, that pretends to be another particular device or program that other components expect to interact with.” Pet. 8. Petitioner proposes that the term “application” should be construed to mean “‘software program suitable for being executed on a portable device,’” but that the “distinction between the parties’ respective proposals need not be resolved for this proceeding.” Id. at 8–9. Petitioner finally contends that the phrase “a portion of or in entirety” in each independent claim means “in its entirety or partially,” but not both. Id. at 9. Patent Owner submits that “[t]he parties agree that the Board should construe ‘emulator device’ as ‘hardware device, alone or containing software, that pretends to be another particular device or program that other components expect to interact with.’” PO Resp. 11. Patent Owner “does not believe that any other terms require construction to resolve the issues presented in this proceeding.” Id. We apply the agreed upon constructions above, but otherwise find that no express constructions are necessary for this decision.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We agree with Petitioner that, even if the applications were stored in “generic memory” as Patent Owner contends, Zhu provides adequate security and would not undermine Petitioner’s motivation to combine. See Intel, 61 F.4th at 1380 (“It’s not necessary to show that a combination is the best option, only that it be a suitable option.”). Indeed, Zhu addresses the problem Patent Owner contends it would cause in the combination.3 As Zhu 3 Patent Owner argues that Petitioner should be precluded from discussing Zhu’s encryption embodiment because it was not raised in the Petition. See Sur-Reply 6–7. We disagree. The claims do not recite anything about how the data should be stored. Thus, it is not surprising that the Petition did not address it. Patent Owner raised the teaching away argument regarding the security of the data. See PO Resp. 12–16. Petitioner relies on the exact same mapping, same motivation, and same arguments why Zhu accounted for certain limitations. See Reply 4–11. Petitioner’s Reply merely explained that Zhu did address the problem Patent Owner contended would “teach away” from the combination. Indeed, Patent Owner was aware of Zhu’s teachings and addressed them in their Patent Owner Response. The Federal recognizes, “[l]oading one of the smart card applications already resident on the smart card to another memory location on the mobile device can provide sufficient memory for the selected smart card application, but can also create a security problem.” Ex. 1006 (Zhu), 3:25–34. To address this problem, Zhu proposes encrypting these applications in generic memory which “reduces the possibility of unauthorized access to the information.” Id. at 3:59–61, 8:30–55, 9:28–33; Ex. 1033 (Smith Supp. Decl.) ¶¶ 5–6. Although acknowledging this disclosure, Patent Owner’s expert, Dr. Weaver, testifies that Zhu’s encryption is inadequate and that encryption would have certain drawbacks. See Ex. 2002 (Weaver Decl.) ¶ 69. We find this testimony, which directly contradicts the teachings of Zhu that encryption is an adequate solution, lacks sufficient support to be entitled to much weight. Dr. Weaver provides no citations to support his contention that a person of ordinary skill at the time of the invention would find encryption so inadequate or problematic as he now contends. Moreover, we find that Dr. Weaver’s testimony on cross examination provides an additional, independent basis to give this testimony little weight. On cross examination, Dr. Weaver contended that there was nothing uniquely inadequate about the particular encryption scheme disclosed in Zhu, but rather that his “opinion was more general, that encryption schemes known in the 2012 time frame were all breakable with computing power and time,” and thus, inadequate Circuit has explained that “the petitioner in an inter partes review proceeding may introduce new evidence after the petition stage if the evidence is a legitimate reply to evidence introduced by the patent owner.” Anacor Pharm., Inc. v. Iancu, 889 F.3d 1372, 1380–81 (Fed. Cir. 2018). That is the case here, so we find that Petitioner’s arguments and evidence regarding Zhu’s encryption are proper. for storing payment applications in a mobile device’s general memory. Ex. 1027 (Weaver Tr.), 26:11–23; see also id. at 23:3–8 (“[D]oes encryption ever provide a sufficiently high security to permit storing payment application on a mobile device’s general memory? A. No”); 24:15–25:23 (testifying all publicly known encryption schemes in 2012 were breakable). However, when confronted with the fact that the ’724 patent discloses storing payment application on general baseband memory using an encryption method that was breakable, id. at 26:24–29:7, Dr. Weaver testified that this encryption method was sufficient to allow storing payment applications in general baseband memory even though it was “not perfectly secure,” id. at 29:8–14. Dr. Weaver provides no explanation or rationale why the encryption method in the ’724 patent, which he admits suffers from the same drawbacks he identified with respect to Zhu, is sufficient, but other encryption methods would not be sufficient. In its Sur-reply, Patent Owner attempts to rehabilitate Dr. Weaver’s testimony with justifications and qualifications not found in his original testimony. Sur-Reply 7–8. Yet, Dr. Weaver’s testimony discussed above was clear and unequivocal. See Ex. 1027 (Weaver Tr.), 24:15–29:14. Patent Owner made no effort to redirect his testimony at his deposition, so it cannot now do so through mere attorney argument. We find the inconsistency between Dr. Weaver’s treatment of Zhu and his treatment of similar disclosure in the ’724 patent exposes the insufficient reasoning supporting his opinions regarding the adequacy of Zhu’s use of encryption in the combination. Accordingly, we give no weight to his testimony that a skilled artisan would not have combined Zhu with a Buhot/GPC system due to security concerns. In contrast, we find the testimony of Mr. Smith regarding the use of encryption and the tradeoffs with the benefits of adopting Zhu’s memory management technique, which he offers in his Supplemental Declaration, to be well-reasoned, consistent with the disclosure of Zhu and the ’724 patent4, and entitled to substantial weight. See Ex. 1033 (Smith Supp. Decl.) ¶¶ 4–15. As Petitioner recognizes, “‘[a] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.’” Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825 F.3d 1373, 1381 (Fed. Cir. 2016). As Mr. Smith and Dr. Weaver testified, decryption without access to the security keys is an extremely computationally intensive and time-consuming process. Ex. 1033 (Smith Supp. Decl.) ¶¶ 6–8; Ex. 1027 (Weaver Tr.), 23:17–25:2; see also Ex. 10175, 132. Mr. Smith testifies that the benefits of using encryption would be sufficient to resolve the security concerns Patent Owner raises, and that any burden of generating a certificate would be outweighed by the benefits of using encryption and the memory advantages Zhu’s technique would offer. See Ex. 1033 (Smith Supp. Decl.) ¶¶ 4–15. Accordingly, we find that Patent Owner’s security concerns would be” slip op. at 25
Patent outcomesUS 11,018,724 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,018,724 - 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 - PTAB · Aug 11, 2023 · IPR2023-00538 · APJ Kevin W Cherry · IPR · Institution
The Board instituted IPR on claims 1–10, 13–18, and 20–32 on all asserted grounds, finding a reasonable likelihood of unpatentability and declining § 325(d) denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute an inter partes review. The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” The Supreme Court has held that the Board, in a decision to institute under 35 U.S.C. § 314(b), may not institute review on less than all claims challenged in the petition. SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018). Moreover, in accordance with our rules, “[w]hen 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.” 37 C.F.R. § 42.108(a) (2020); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Based on this record, it appears that the main distinction between Petitioner’s ordinary skilled artisan and Patent Owner’s is that Patent Owner further requires familiarity with wireless networks. We note, however, that the monitoring systems of the asserted prior art include wireless networks. In view of this, because Petitioner’s requirement of experience designing railcar, train, vehicle, or any other similar monitoring systems includes some familiarity with wireless networks, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’223 patent and the asserted prior art, and we apply it in our obviousness evaluations below. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art). We note that our decision would be the same applying either party’s definition of a person of ordinary skill in the art.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“this proceeding. Pet. 15. Patent Owner asserts that the term “housing” means “an enclosure.” Prelim. Resp. 29. Having considered the record, we determine that no express claim construction is necessary for any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“30 of the ’223 patent are entitled to claim priority back to the ’713 application. The test for sufficiency of written description “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In particular, we do not agree with Patent Owner that it can simply pluck the temperature sensor from LeFebvre and insert it into the sensor device disclosed in the ’713 application. Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349 (Fed. Cir. 2013) (“Working backward from a knowledge of [the claims], that is by hindsight,” [patentee] seeks to derive written description support from an amalgam of disclosures plucked selectively from the [prior] application.”) (first alternation in original).” slip op. at 17
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,365,223 - Unified Patents, LLC v. Ideahub Inc.InstitutedPTAB · Feb 6, 2023 · PGR2022-00044 · APJ Monica S Ullagaddi · PGR · Institution
The Board instituted post-grant review of claims 1–13 on all grounds, finding it more likely than not that at least claim 1 lacks written-description support.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a) (2021). Under 35 U.S.C. § 324(a), 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.” After considering the Petition, Patent Owner’s Preliminary Response, Petitioner’s Preliminary Reply, Patent Owner’s Preliminary Sur-reply, as well as all supporting evidence, we determine that Petitioner satisfies its burden under 35 U.S.C. § 324(a) to show that it is more likely than not that at least one of the challenged claims of the ’274 patent is unpatentable. Therefore, we authorize a post-grant review to be instituted as to all grounds and all challenged claims. 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 and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“Id. at 7:24–8:4 (emphasis added). The ’928 application repeatedly makes clear that directionality and intra mode are related, but distinct concepts. They are not interchangeable as Patent Owner argues. On this point, we find Dr. Freedman’s explanation in paragraph 85 of his Declaration on the relationship between “intra mode” and “directionality” to be particularly well-reasoned and persuasive. As Dr. Freedman explains, [t]hroughout the ’928 application, the text uses the term “directionality” to refer to characteristics of neighboring blocks, whereas the term “intra mode” is used when referring to the current block. For example, the ’928 application describes that “directionality” of neighboring blocks is “estimated from the neighboring blocks” that “have already been reconstructed” while the “intra mode” is selected for the current block for purposes of reconstructing that current block. This is likely because the neighboring blocks “have already been reconstructed” and thus, the intra mode number that was used in reconstructing those blocks is no longer pertinent. Instead, what is pertinent in the ’928 application’s method is the directionality characteristic of those neighboring blocks. Phrased differently, in the ’928 application, directionality is a concept that is evaluated after performance of intra prediction (i.e., after reconstruction), whereas the intra mode or number is a concept used during performance of intra prediction. They are not equivalent in the context of the ’928 application. Ex. 1005 ¶ 86 (citing Ex. 1028, 11:14–12:4, 25:10–15; Ex. 1036, 706 (“The DCT coefficients gathered from the MPEG 2 process are used to estimate the directional features in a picture. The estimated directional features are then used to compute the intra prediction modes in the H.264 encoding stage.”)).8 Thus, we are persuaded by Dr. Freedman’s testimony, supported by Kalva, that these terms are not synonymous, as is Patent Owner’s and its expert’s position.” slip op. at 31
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityNot reached
“Patent Owner argues that HEVC265 is not prior art because it was published in 2013. Prelim. Resp. 24. Insofar as we determine that the ’928 application does not provide sufficient written description support for at least claim 1, and insofar as no other patent or application in the priority chain of the ’274 patent was filed before 2013 (see Pet. 19), Patent Owner’s argument is unavailing as to this claim. As we preliminarily conclude that Petitioner demonstrates that it is more likely than not to prevail on its challenge to independent claim 1 based on lack of written description support, we institute review on all challenged claims on all grounds set forth in the Petition, including Petitioner’s anticipation and obviousness challenges to claims 1–4 and 6 applying HEVC265. See SAS, 138 S. Ct. at 1354; PGS, 891 F.3d at 1360.” slip op. at 38
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“F. Anticipation and Obviousness Challenges Based on HEVC265 Petitioner contends that claims 1–4 and 6 are anticipated by, or alternatively, rendered obvious in view of HEVC265. Pet. 49–52. Patent Owner argues that HEVC265 is not prior art because it was published in 2013. Prelim. Resp. 24. Insofar as we determine that the ’928 application does not provide sufficient written description support for at least claim 1, and insofar as no other patent or application in the priority chain of the ’274 patent was filed before 2013 (see Pet. 19), Patent Owner’s argument is unavailing as to this claim. As we preliminarily conclude that Petitioner demonstrates that it is more likely than not to prevail on its challenge to independent claim 1 based on lack of written description support, we institute review on all challenged claims on all grounds set forth in the Petition, including Petitioner’s anticipation and obviousness challenges to claims 1–4 and 6 applying HEVC265. See SAS, 138 S. Ct. at 1354; PGS, 891 F.3d at 1360.” slip op. at 38
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,122,274 - Apple Inc. v. Rfcyber Corp.InstitutedPTAB · Jan 23, 2023 · IPR2022-01256 · APJ Kevin W Cherry · IPR · Institution
The Board instituted IPR of claims 1–11 based on the § 103 ground over Buhot, GPC, and Zhu, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute an inter partes review. The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” The Supreme Court has held that the Board, in a decision to institute under 35 U.S.C. § 314(b), may not institute review on less than all claims challenged in the petition. SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018). Moreover, in accordance with our rules, “[w]hen 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.” 37 C.F.R. § 42.108(a) (2020); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Applying those standards, and upon considering the Petition, the Preliminary Response, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’724 patent. Accordingly, we institute an inter partes review of all challenged claims (i.e., claims 1–11) of the ’724 patent, based on the ground asserted in the Petition.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Having considered the record, we determine that no express claim construction is necessary for any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“contends that an ordinarily skilled artisan for the ’724 patent “would have had at least a bachelor’s degree in computer engineering, computer science, electrical engineering, or a related field, with at least one year of experience in the field of mobile payment technology. Additional pertinent education might substitute for the requisite experience and vice versa.” Pet. 6–7 (citing Ex. 1007 (Smith Decl.) ¶¶ 34–35). Patent Owner states that it “utilizes Petitioner’s proposed level of skill in the art,” but only for its Preliminary Response. Prelim. Resp. 9. Based on this record, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’724 patent and the asserted prior art, and we apply it in our obviousness evaluations below. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“earlier applications, in particular Application No. 11/534,653 (“the ’653 application”), which issued as U.S. Patent No. 8,118,218 B2 (“the ’218 patent”). “It is elementary patent law that a patent application is entitled to the benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.” PowerOasis, 522 F.3d at 1306; New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294 (Fed. Cir. 2002); Lucent Techs., Inc. v. Gateway, Inc., 543 F.3d 710, 718 (Fed. Cir. 2008) (“Patent claims are awarded priority on a claim-by-claim basis based on the disclosure in the priority applications.”). The test for determining compliance with the written description requirement under § 112(a) is whether the original disclosure of the earlier-filed application reasonably would have conveyed to one with ordinary skill in the art that the inventor had possession the claimed subject matter at the time of the earlierfiled application. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). It is well settled that “[e]ntitlement to a filing date does not extend to subject matter which is not disclosed but would be obvious over what is expressly disclosed.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571−72 (Fed. Cir. 1997). “It is not sufficient for purposes of the written description requirement of § 112 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.” Id. Nor could the claimed subject matter have been “envisioned” from the earlier disclosure to establish written description support. Goeddel v. Sugano, 617 F.3d 1350, 1356 (Fed. Cir. 2010). We agree with Petitioner that, on this record, there does not appear to be support for limitation [1(j)] in the ’653 application. Patent Owner identifies the following disclosure from the ’218 patent (the patent that issued from the ’653 application) as supporting limitation [1(j)]: According to one embodiment, a smart card has a preloaded smart card operation system that provides security framework to control the access to the Smart card (e.g., an installation of external applications into the smart card). In order to manage the life cycle of an external application, a card manager module is configured by using the smart card security framework. For instance, a Java based smart card, SmartMX, is preloaded with an operating system JCOP 4.1. The Global Platform 2.1 installed on the SmartMX performs the card manager functionality. Ex. 2001 (’218 patent), 4:47–56. Patent Owner argues that “this description is substantively identical to that on which Apple relies for disclosure of the “emulator device” and “replace out of the emulator device . . . replacing out of the emulator device . . .” limitations. Prelim. Resp. 26. Patent Owner contends that “Apple relies on Buhot’s discussion of an ‘operating system 314 (running on processor 400) for the ‘emulator device’ limitation (Pet. at 31), and relies on Zhu’s alleged teachings regarding a ‘smart card manager . . . which governs the process of loading and unloading applications out of an emulator’ for the ‘replace out of the emulator device . . . replacing out of the emulator device’ limitations.” Id. (citing Pet. 43). Patent Owner asserts that Petitioner “cannot argue with a straight face that its proposed combination discloses” slip op. at 21
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,018,724 - 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.