- 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 - Freedom To Operate, Inc. v. Compass Pathfinder LimitedInstitution deniedPTAB · Jun 22, 2022 · PGR2022-00012 · APJ Tina E Hulse · PGR · Institution
The Board denied institution of PGR on claims 1–23 because Petitioner did not show it was more likely than not that any challenged claim was unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has not demonstrated that it is more likely than not that any of the claims challenged in the Petition are unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“had an advanced degree (i.e., a Master’s degree with two or more years of experience, or a Ph.D.) in inorganic or organic chemistry, chemical engineering, pharmacology, or a related discipline” and “would be familiar with medicinal chemistry or pharmaceutical chemistry, and with analytical methods to characterize and differentiate solid forms of compounds, particularly XRPD, but also including differential scanning calorimetry (‘DSC’) and thermogravimetric analysis (‘TGA’).” Pet. 28 (citing Ex. 1006 ¶ 35). Petitioner further contends that “[a]lternatively, one of ordinary skill could have less education and approximately five or more years of relevant experience.” Id. Patent Owner does not dispute Petitioner’s definition of the level of ordinary skill in the art. See generally Prelim. Resp. Absent opposition from Patent Owner, we adopt Petitioner’s definition because it is consistent with the level of ordinary skill in the art reflected by the prior art in this proceeding. 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 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“We agree with Patent Owner’s proposed construction, as it is most consistent with the intrinsic evidence. The claim language makes clear that “Polymorph A” is “characterized by” the specific peaks set forth in claim 1. Ex. 1001, claim 1. Thus, regardless of the alleged conventional definition of a “polymorph,” urged by Petitioner, the inventors are entitled to act as their own lexicographers to define “Polymorph A” according to the recited peaks on the XRPD diffractogram. See Honeywell Int’l, Inc. v. Universal Avionics a claim term, the patentee’s definition governs, even if it is contrary to the conventional meaning of the term.”). That the Specification consistently refers to “Polymorph A” as a proper noun and describes Polymorph A as “characterized by” the recited peaks in an XRPD diffractogram further highlights the inventors’ clear intent to act as their own lexicographer. See, e.g., Ex. 1001, 4:4–5:36; Merck & Co. v. Teva Pharms. USA, 395 F.3d 1364, 1370 (Fed. Cir. 2005) (“When a patentee acts as his own lexicographer in redefining the meaning of particular claim terms away from their ordinary meaning, he must clearly express that intent in the written description.”). Finally, during prosecution of the ’257 patent application, the examiner rejected original claim 1 as indefinite because it did not define “Polymorph A,” and required one to “refer to the specification to determine what is Polymorph A.” Ex. 1060, 7. Patent Owner then amended the claims to define Polymorph A by adding the specific XRPD peaks recited in claim 1. Ex. 1062, 2; see also id. at 6. Thus, we find the intrinsic evidence supports Patent Owner’s proposed construction.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“Having considered the parties’ respective arguments and evidence, we find Patent Owner has the better position. Although we agree with Petitioner that some degree of experimental error should be factored into the specific peaks of a diffractogram, the claim language already does so by expressly reciting a variance of “±0.1°2θ.” See Ex. 1001, claim 1. Construing the claims to include an additional degree of variance would effectively read out the “±0.1°2θ” limitation of the claims. See Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A claim construction that gives meaning to all the terms of the claim is preferred over one that does not do so.”). Moreover, we note that the express recitation of a specific variance distinguishes the ’257 patent claims from the claims of the Astrazeneca cases cited by Petitioner, which did not recite such a variance. See Pet. 11–12. In addition, the Specification consistently refers to a variance of ±0.1°2θ whenever it refers to peaks on a diffractogram. See generally Ex. 1001, 3:58–5:24. Petitioner acknowledges that the claims recite a range of peak locations, but argues that the Specification “does not explain the basis for the claimed range.” Pet. 10. Petitioner, however, does not explain why the Specification would need to explain that basis, particularly if a person of ordinary skill in the art would understand that ±0.1°2θ is an acceptable variance for XRPD.” slip op. at 13
Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,947,257
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.