- PTAB · Mar 19, 2024 · PGR2022-00052 · APJ Sheila F Mcshane · PGR · Final written decision
The Board cancelled claims 1–27 and denied substitute claims 28–51 because the original disclosure lacked written-description support for the claimed CSP limitations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s proposed level of ordinary skill in the art, with the exclusion of “at least” because it introduces ambiguity. Inst. Dec. 8. Patent Owner “does not dispute the Board’s findings on the qualifications of a POSA [person of ordinary skill in the art] for purposes of this proceeding.” See RMTA 13. We determine that Petitioner’s definition, with the exclusion of “at least,” is consistent with the prior art of record and the skill reflected in the Specification of the ’034 patent and we use this level of skill here in the evaluation of the Revised Motion to Amend.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Patent Owner argues that “claim construction is not necessary” and that “the meaning of the claims would be easily understood by a POSA.” RMTA 13. In the Petition, Petitioner proposed constructions for the terms “client device” and “first server,” and the original claims were rendered obvious under this construction. Pet. 23–27. Petitioner does not assert that the substitute claims of the Revised Motion to Amend are anticipated or rendered obvious by prior art or are patent ineligible. See generally RMTA Opp. Nor does Petitioner’s patentability challenge of the substitute claims contend that express construction is needed. See generally id. For purposes of this Decision, we determine that express claim construction is unnecessary. We need only construe terms that are necessary to resolve disputes. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDenied
“written description requirement. In re Wright, 866 F.2d 422, 425 (Fed. Cir. 1989); All Dental Prodx LLC v. Advantage Dental Prods., 309 F.3d 774, 779 (Fed. Cir. 2002). The issue here, however, is whether the disclosure of the ’034 patent would have reasonably conveyed to a person of ordinary skill that the inventors had possession of the CSP Limitations. Ariad, 598” slip op. at 14
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“to cancelling claims 1–27; and deny-in-part the Motion to Amend as to proposed substitute claims 28–51. In summary: Motion to Amend Outcome Claim(s) Original Claims Cancelled by Amendment 1–27 Substitute Claims Proposed in the Amendment 28–51 Substitute Claims: Motion to Amend Granted Substitute Claims: Motion to Amend Denied” slip op. at 20
Claim construction§ 112 disclosurePatents in suitUS 11,272,034 - 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, 2020 · PGR2019-00045 · APJ Christopher C Kennedy · PGR · Final written decision
The Board cancelled claims 13, 18, and 19, but denied substitute claims 23–25 because their percentage-and-range limitations introduced new matter.
RulingsFinal written decision- ScopeMotion to amend, grantedGranted
“3. Scope of Proposed Substitute Claims A motion to amend “may not enlarge the scope of the claims of the patent.” 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(a)(2)(ii). Although Patent Owner does not appear to separately address this requirement in the Revised Motion to Amend, see generally Revised MTA, we have reviewed the proposed substitute claims and determine that they do not enlarge the scope of the claims of the patent because they add limitations that render each proposed substitute claim narrower than original challenged claim 13.2 Petitioner does not contend otherwise. See generally Opp. On this record, we determine that the Revised Motion to Amend satisfies this requirement.” slip op. at 9
- 112 supportMotion to amend, deniedDenied
“description support for numerical ranges identified by the parties is General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372 (Fed. Cir. 2018).4 In that case, the Federal Circuit explained: The disclosure of a broad range of values does not by itself provide written description support for a particular value within that range. Instead, where a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to immediately discern the limitation at issue in the claims. Id. (emphasis added); cf. Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 1000 (Fed. Cir. 2006) (“[T]he disclosure of a range is no more a disclosure of the end points of the range than it is of each of the intermediate points.”). The Federal Circuit has also stated that, “[i]n the absence of blazemarks” that point to a particular species or sub-genus, “simply describing a large genus of compounds is not sufficient to satisfy the written description requirement.” Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). We find those cases to be instructive because we discern no guidance in the original disclosure that points to the percentage+range limitation of proposed substitute claim 23. Nor do we find anything in the original disclosure that would “allow one skilled in the art to immediately discern” 4 Despite the fact that Sienna was cited in (1) Petitioner’s opposition to Patent Owner’s original Motion to Amend, Paper 24 at 11; (2) the Preliminary Guidance issued by the Board, PG at 8; and (3) Petitioner’s opposition to Patent Owner’s Revised Motion to Amend, Opp. at 12, Patent Owner fails to cite or discuss Sienna, see generally Revised MTA; Reply. the percentage+range limitation. See Sienna, 888 F.3d at 1372. Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to any mesh sieve number range other than 3–35, and Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to having a particular proportion of particles (e.g., 61 wt%) falling within some narrower mesh sieve number range. See Ex. 1021 (Coffield Decl.) ¶¶ 23–24.” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner
“description support for numerical ranges identified by the parties is General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372 (Fed. Cir. 2018).4 In that case, the Federal Circuit explained: The disclosure of a broad range of values does not by itself provide written description support for a particular value within that range. Instead, where a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to immediately discern the limitation at issue in the claims. Id. (emphasis added); cf. Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 1000 (Fed. Cir. 2006) (“[T]he disclosure of a range is no more a disclosure of the end points of the range than it is of each of the intermediate points.”). The Federal Circuit has also stated that, “[i]n the absence of blazemarks” that point to a particular species or sub-genus, “simply describing a large genus of compounds is not sufficient to satisfy the written description requirement.” Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). We find those cases to be instructive because we discern no guidance in the original disclosure that points to the percentage+range limitation of proposed substitute claim 23. Nor do we find anything in the original disclosure that would “allow one skilled in the art to immediately discern” 4 Despite the fact that Sienna was cited in (1) Petitioner’s opposition to Patent Owner’s original Motion to Amend, Paper 24 at 11; (2) the Preliminary Guidance issued by the Board, PG at 8; and (3) Petitioner’s opposition to Patent Owner’s Revised Motion to Amend, Opp. at 12, Patent Owner fails to cite or discuss Sienna, see generally Revised MTA; Reply. the percentage+range limitation. See Sienna, 888 F.3d at 1372. Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to any mesh sieve number range other than 3–35, and Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to having a particular proportion of particles (e.g., 61 wt%) falling within some narrower mesh sieve number range. See Ex. 1021 (Coffield Decl.) ¶¶ 23–24.” slip op. at 14
§ 112 disclosurePatents in suitUS 10,071,852
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.