- PTAB · Oct 4, 2023 · IPR2023-00724 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR on claims 1–10, finding a reasonable likelihood that claim 1 is anticipated by WO421 and Lovshin and obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“The Examiner’s statement that NCT657 “does not teach or disclose a higher amount of 1 mg semaglutide” is incorrect and also fails to consider the teachings of the dosing ranges of WO421 and Lovshin, and the maximum dose of 1.2 mg of semaglutide taught in NCT773. For these reasons, we determine that Petitioner has sufficiently demonstrated a material error on the part of the Examiner, and we therefore decline to exercise our discretion to deny institution of inter partes review under 35 U.S.C. § 325(d).” slip op. at 15
- Other 314aInstitution denied discretionary otherDecided for petitioner
“Petition under Section 314(a), “particularly in light of the significant §325(d) concerns regarding Grounds 1 and 2—which address only claims 1–3—and in view of the substantive infirmities of Ground 3–5.” Prelim. Resp. 66–67. Patent Owner does not address Petitioner’s assertions that a trial here would most likely conclude before the parallel Delaware litigation, and Petitioner’s stipulation “that if the Board institutes, Petitioner will not pursue in the district court any instituted grounds against the originally-issued claims unless a change in law otherwise permits.” Pet. 65–66 (citing Sand Revolution II, LLC v. Cont’l Intermodal Grp., IPR2019-01393, Paper 24, 12 (PTAB June 16, 2020)). We do not agree with Patent Owner’s assertions concerning Section 325(d) as set forth above, and find nothing here that would warrant the exercise of our discretion to deny institution based on 35 U.S.C. § 314(a) to deny institution of an otherwise meritorious petition.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“VI. CONCLUSION Based on the current record, we determine Petitioner has shown a reasonable likelihood that it will prevail in establishing that at least one claim of the ’462 patent is unpatentable. Accordingly, we institute review of all claims challenged on all of the grounds in the Petition. See Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 64, available at https://www.uspto.gov/ sites/default/files/documents/tpgnov.pdf. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim. Our view with regard to any conclusion reached in the foregoing analysis could change upon completion of the record. VII. ORDER Accordingly, it is: ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is hereby instituted as to claims 1–10 of the ’462 patent based on the unpatentability challenges presented in the Petition; and” slip op. at 39
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Here, we agree with the parties that the preamble of claim 1 is limiting. The preamble provides context for the requirement of claim 1 that administration of the semaglutide is “to a subject in need thereof.” See Ex. 1001, 35:42–44. The preamble, when read in the context of the entirety of claim 1, recites a limitation of administering semaglutide to a subject with type 2 diabetes. Based on the constructions of the preamble provided by the parties, it appears they agree that the preamble does not require any particular level of efficacy. We agree. The Specification of the ’462 patent makes clear that “treatment” or “treating” as used in the ’462 patent does not require any particular degree of efficacy as these terms include the “full spectrum” of treatments for a condition. See Ex. 1001, 5. For instance, the Specification of the ’462 patent provides: In one embodiment the term “treatment” or “treating” as used herein means the management and care of a patient for the purpose of combating a condition, such as a disease or a disorder. In one embodiment the term “treatment” or “treating” is intended to include the full spectrum of treatments for a given condition from which the patient is suffering, such as administration of the active compound to alleviate the symptoms or complications; to delay the progression of the disease, disorder or condition; to alleviate or relieve the symptoms and complications; and/or, to cure or eliminate the disease, disorder, or condition as well as to prevent the condition. Ex. 1001, 5:16–27.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,335,462 - Novartis Pharmaceuticals Corporation v. Shilpa Pharma, Inc.All claims unpatentablePTAB · Sep 29, 2023 · IPR2022-00886 · APJ John G New · IPR · Final written decision
Claims 1–4 are unpatentable under §102 over Mutz; the Board did not reach the §103 Mutz and Gidwani or §102 Gidwani grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- ExcludeMotion to exclude, grantedMixed
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“claims, Petitioner’s request that we do so as a sanction against Patent Owner is denied. Furthermore, having reviewed the arguments and evidence presented by Petitioner and Patent Owner, we conclude that the evidence is not sufficiently conclusive to warrant the additional imposition of financial sanctions. We consequently deny Petitioner’ Motion for Sanctions.” slip op. at 82
Patent outcomesUS 9,266,816 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 9,266,816 - PTAB · Aug 8, 2023 · IPR2023-00546 · APJ Robert A Pollock · IPR · Institution
Instituted IPR on claims 1–5, 9–11, 13, 18, 19, and 28–30; Petitioner showed a reasonable likelihood of unpatentability under each asserted Ley and Newman anticipation and obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Quackenbush, Petitioner asserts that a person of ordinary skill in the art (“POSA”) would have had: 1) an advanced degree (such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences, engineering, or mathematics discipline) . . . 2) an understanding of various sequencing and next generation sequencing methods, sample preparation methods, targeted enrichment methods, bioinformatics methods for interpreting sequencing data, and methods for identifying genetic variants in a sample . . . . technology to conditions associated with nucleic acid variation, such as cancer, non-invasive prenatal testing, and transplant rejection . . . [and] 4) an understanding of cancer biology as it relates to mutations associated with tumor diagnosis, progression, and treatment, as well as awareness of the various types of mutations that can occur in and influence the course of a patient’s cancer. Pet. 4–5 (citing Ex. 1061 ¶ 37) (numbering added). Patent Owner does not presently challenge Petitioner’s definition. Prelim. Resp. 9. Based on the record before us, Petitioner’s proposed definition is consistent with the level of skill indicated in the cited references and the problems addressed in the ’611 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we provisionally adopt Petitioner’s proposed definition of the person of ordinary skill in the art. C. Claim Construction” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In general, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Moreover, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Considering the record before us, the preamble of claim 1 merely recites a purpose or intended use for the claimed method. In general, step (a) in the body of claim 1 entails obtaining sequence data from at least one biological sample from a subject. In step (b) the sequence data is used in to identify a set of genetic variants present in the biological sample. Step (c) entails creating a probe set corresponding to identified genetic variants. In step (d) the probe set is used to selectively enrich or amplify those variants if present in a second biological sample from the same or related individual, and thereby create a sequencing library. This library is sequenced in step (e) to identify the presence or absence of at least a subset of the genetic variants identified in step (b). As such, steps (a) through (e) define a complete invention, with the preamble merely stating a 4 To the extent Patent Owner maintains that the preamble is both limiting and distinguishes over the applied prior art, Patent Owner should clearly and explicitly identify during trial how it proposes the preamble should be construed—identifying evidentiary support for such construction according to well-established precedents. out the positively recited steps of the claim. As such, we do not presently view the preamble of claim 1 to be limiting and accord it no patentable weight.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“nucleic acid probe molecules” Claim step 1(c) recites “obtaining a probe set comprising a plurality of nucleic acid probe molecules . . . configured to selectively enrich or amplify sequences.” Relying on the testimony of Dr. Quackenbush and disclosure of the ’611 patent, Petitioner contends that one of ordinary skill in the art “would have understood that the claimed ‘nucleic acid probe molecules’ include PCR primers, hybrid capture baits, and other such nucleic acid probe molecules for selectively amplifying or enriching sequences.” Pet. 17–18 (citing Ex. 1061 ¶ 98; Ex. 1001, 4:54–55, 5:16–18, 6:64–67). At this stage of the proceeding, Patent Owner does not address the meaning of “nucleic acid probe molecules.” Although the term is not presently contested, Petitioner’s definition is reasonable in light of the present record, and we provisionally adopt it for clarity. slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,450,611 - PTAB · Aug 8, 2023 · IPR2023-00545 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–9, 13–19, and 21–29 on all three grounds, 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
“For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’783 patent is unpatentable, we institute an inter partes review of all challenged claims on each of the grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/trials/guidance-impact-sas-aia-trial) (“Guidance”). C. Real Parties-in-Interest” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Quackenbush, Petitioner asserts that a person of ordinary skill in the art (“POSA”) would have had: 1) an advanced degree (such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences, engineering, or mathematics discipline) . . . 2) an understanding of various sequencing and next generation sequencing methods, sample preparation methods, targeted enrichment methods, bioinformatics methods for interpreting sequencing data, and methods for identifying genetic variants in a sample . . . . 3) an understanding of clinical applications of sequencing technology to conditions associated with nucleic acid variation, such as cancer, non-invasive prenatal testing, and transplant rejection . . . [and] 4) an understanding of cancer biology as it relates to mutations associated with tumor diagnosis, progression, and treatment, as well as awareness of the various types of mutations that can occur in and influence the course of a patient’s cancer. Pet. 4–5 (citing Ex. 1020 ¶¶ 35) (numbering added). Patent Owner does not presently challenge Petitioner’s definition. Prelim. Resp. 11. Based on the record before us, Petitioner’s proposed definition is consistent with the level of skill indicated in the cited references and the problems addressed in the ’783 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we provisionally adopt Petitioner’s proposed definition of the person of ordinary skill in the art.” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In general, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Moreover, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Considering the record before us, the preamble of claim 1 merely recites a purpose or intended use for the claimed method. In general, steps (a) through (c) in the body of claim 1 require the use of “a personalized probe set” to identify the presence or absence of genetic variants in a subject, whereupon this information is used to generate a report in step (d). We presently read the body of claim 1 to define a 7 Pointing to isolated passages in the Specification, Patent Owner further contends that, “methods that existed at the time of invention were specific to a particular disease or cancer rather than personalized to a specific subject’s family genetics,” whereas the claimed method “is directed to personalized genetic testing and is ‘better focused on the personal characteristics of the subject.’” Prelim. Resp. 20–21 (citing Ex. 1001, 4:37–47, 31:27–28). We find this argument confusing, as we do not presently read the challenged claims as limited to a “subject’s family genetics.” 8 To the extent Patent Owner maintains that the preamble is both limiting and distinguishes over the applied prior art, Patent Owner should clearly and explicitly identify during trial how it proposes the preamble should be construed—identifying evidentiary support for such construction according to well-established precedents. complete invention, with the preamble merely stating a purpose or intended use, or, in another sense, simply the result of carrying out the positively recited steps of the claim. As such, we do not presently view the preamble of claim 1 to be limiting and accord it no patentable weight.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“2) “nucleic acid probe molecules” Claim 1 recites the use of “nucleic acid probe molecules . . . configured to selectively enrich or amplify sequences.” Relying on the testimony of Dr. Quackenbush and disclosure of the ’783 patent, Petitioner contends that one of ordinary skill in the art “would have understood that the claimed ‘nucleic acid probe molecules’ include PCR primers, hybrid capture baits, and other such nucleic acid probe molecules for selectively amplifying or enriching sequences.” Pet. 15 (citing Ex. 1020 ¶ 95; Ex. 1001, 4:60–61, 5:23–25, 7:5–8, 7:25–26). At this stage of the proceeding, Patent Owner does not address the meaning of “nucleic acid probe molecules.” Although the term is not presently contested, Petitioner’s definition is reasonable in light of the present record, and we provisionally adopt it for clarity.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,299,783 - Syngenta Crop Protection AG v. Upl Ltd.InstitutedPTAB · Jul 31, 2023 · PGR2023-00017 · APJ Zhenyu Yang · PGR · Institution
Instituted PGR on claims 1–10 and all asserted grounds because the Board found it more likely than not that Tobler anticipates and renders obvious at least claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We review the Petition under 35 U.S.C. § 324, which provides that a post-grant review may not be instituted unless “it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 324(a). Accordingly, we institute a post-grant review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PTAB Consolidated Trial Practice Guide (“Practice Guide”),1 5–6 (Nov. 2019).” slip op. at 2
- Other 314aInstitution denied discretionary otherDenied
“We disagree. It is unclear which aspect of the Petition that Patent Owner takes issue with. If it is the “multitudinous grounds” presented in the Petition, Patent Owner points to no authority that permits us to deny institution merely because a petition presents numerous grounds. In any event, on the facts of this case, we do not view eight grounds asserted in the Petition to be excessive.6 To the extent Patent Owner urges that we should deny institution because Petitioner’s grounds are “futil[e],” we understand that to be an argument on the merits, and not related to our discretion. See Prelim. 6 The Petition presents five grounds. See generally Pet. We agree with Patent Owner, however, the ground based on Tobler, in fact, encompasses three grounds, and the ground based on De Oliveira, in fact, encompasses two grounds. See Prelim. Resp. 2. Resp. 45. As explained below, we find Petitioner has established that it is more likely than not that claims 1–10 of the ’727 patent are unpatentable over Tobler. See infra Section II.D.2. Because the grounds based on Tobler apply to all challenged claims,7 at least these grounds are not, as Patent Owner asserts, futile. Thus, we decline to exercise discretion to deny the Petition under § 324(a).” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“review, we “may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. 7 The cases Patent Owner cites do not support its argument on discretionary denial under § 324(a). See Prelim. Resp. 45–46. In those cases, the Board exercised discretion to deny institution because the petitions only met the threshold requirement for institution with regard to a small percentage of the challenged claims. See Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 11 (PTAB Nov. 7, 2018) (stating “instituting a trial with respect to all twenty claims based on evidence and arguments directed to dependent claims 3 and 4 is not an efficient use of the Board’s time and resources”); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7, 2 (PTAB Jan. 24, 2019) (denying institution because the petitioner only “demonstrated a reasonable likelihood of prevailing with respect to only two of twenty-three challenged claims as to only one of four asserted grounds of unpatentability”). MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). The parties agree that, during prosecution, the relevant disclosure in Tobler was before the Examiner in U.S. Patent Application Publication 2010/0216640, which was cited in an Information Disclosure Statement (“IDS”). Pet. 12; Prelim. Resp. 46. In other words, the first prong of the Advanced Bionics analysis is satisfied. Thus, we must determine whether Petitioner has shown a material error by the Office. We find Petitioner has met its burden on this issue.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, all claim terms should be given their plain and ordinary meaning. Pet. 18; Prelim. Resp. 13. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,445,727 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01513 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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))). Even if there were a distinction between the parties’ respective definitions of the level of ordinary skill in the art, Patent Owner’s expert, Dr. Weitz, notes that his opinion would not change regardless of which definition is applied. See Ex. 2060 ¶ 26. Moreover, we find both Dr. Zusman and Dr. Weitz qualified to opine from the perspective of a POSA for purposes of this Decision as both possess at least the level of ordinary skill in the art. See Ex. 1002 ¶¶ 1–11; Ex. 2060 ¶¶ 1–11; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369,” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“3. Remaining Claim Terms Patent Owner also offers constructions for “coronary artery disease,” and the preamble (PO Resp. 23–32, 39–40), but none of these claim phrases Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We now turn to the patentability challenges presented by Petitioner.” slip op. at 21
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Patent Owner again, however, misses the point. The question is not whether clinical trials may exist where the disclosed dosing regimen may not be clinically proven effective, or whether a POSA would necessarily recognize clinical proof of efficacy from the COMPASS protocol taught by Foley. Id. at 53–54. On the contrary, the question is whether “the [prior art] disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275 (Fed. Cir. 2010) (citation omitted). If it is, the Federal Circuit has held that it is “well-settled that the disclosure should be regarded as sufficient.” Id. As such, here, we consider whether the disclosure in Foley is sufficient to show that the natural result of the disclosed dosing regimen would be “clinically proven effective” by the COMPASS study disclosed by Foley. In this case, we know that to be true because the claimed process was confirmed by the same COMPASS study disclosed by Foley. See Bristol- Myers, 246 F.3d at 1376; see also Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1369 (Fed. Cir. 2006) (finding method claims anticipated where prior art method disclosed the same steps in furtherance of the same purpose, and all that was contributed by the patent claims is the the claim term were limiting, we find Foley inherently discloses “clinically proven effective” amounts of rivaroxaban and aspirin. Having considered the arguments and evidence presented at trial, we find Petitioner has shown by a preponderance of the evidence that claims 1 and 2 are anticipated by Foley.” slip op. at 26
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01515 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“2. Analysis “A claim is anticipated if each and every element as set forth in the claim is found, either expressly or inherently, in a single prior art reference.” Arbutus Biopharma Corp. v. ModernaTX, Inc., 65 F. 4th 656, 662 (Fed. Cir. 2023). The Federal Circuit explains that “[a]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation.” Monsanto Tech. LLC v. Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, Petitioner must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 28
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-00517 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2 and 5–8 as obvious over Foley, and claims 3–4 and 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner disagrees with Petitioner’s definition and contends that a POSA would have been a “clinician with experience in the design, conduct, analysis, and interpretation of results from clinical trials involving antithrombotic agents (anticoagulants and antiplatelet agents), as well as experience with the treatment of patients with anticoagulants and antiplatelet 7 Although we find certain of Patent Owner’s arguments not persuasive, this should never be taken as an indication that we have assigned Patent Owner the burden of proof on patentability. patients with coronary artery disease and/or peripheral artery disease.” PO Resp. 22 (citing Ex. 2060 ¶¶ 24–26). In response, Petitioner asserts that its definition encompasses Patent Owner’s definition, as the experience of an M.D. includes the ability to interpret the results of clinical trials to evaluate therapies. Pet. Reply 2–3 (citing Ex. 1037 ¶ 7). We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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 › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 24
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“aspirin was taken with the first 2.5 mg dose of rivaroxaban, with the second 2.5 mg dose of rivaroxaban, or at a different time than either dose of rivaroxaban. Pet. 67 (citing Ex. 1002 ¶¶ 336–338). Nevertheless, Petitioner asserts that a POSA would have understood that “unless there is a cause for concern in terms of potential drug interactions, concomitant administration of multiple drugs in a dosing regimen is preferred for patient-compliance reasons.” Id. (citing Ex. 1002 ¶¶ 337–338). 13 We further note that we have considered, but are not persuaded that Patent Owner’s objective evidence of nonobviousness, discussed below, outweighs this strong evidence of obviousness. “first product,” Patent Owner does not argue that Foley does not teach a “first product.”14 See PO Resp. 51–56; PO Sur-reply 19–24. As set forth above, we agree with Petitioner’s construction of “first product” as not requiring, although allowing, a single combination dosage form. See supra Section II.B.2. We, therefore, find Petitioner has shown that a POSA considering Foley would have found it obvious to administer aspirin together with one of the rivaroxaban doses. We credit the testimony of Petitioner’s expert, Dr. Zusman, who notes that a POSA would have known that there were no concerns about administering rivaroxaban and aspirin together, and that it is easier for patients to take two drugs at the same time rather than at different times throughout the day. See Ex. 1002 ¶¶ 337–338; see also Ex. 1009,15 981 (noting “there is no clinically relevant interaction between rivaroxaban and aspirin and that the 2 drugs could be administered concomitantly”). We, therefore, find Petitioner has shown that Foley teaches or suggests each limitation of claims 5 and 8 and that a POSA would have had a reason to modify Foley to administer rivaroxaban together with aspirin with a reasonable expectation of success.” slip op. at 29
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCAll claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Final written decision
Claim 59 is unpatentable as anticipated by Brumfield, Marcus, and Chandran; the motion to amend proposing substitute claim 62 is denied because claim 62 is unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find this argument unpersuasive. As Patent Owner notes, Petitioner’s expert provides a definition of POSITA that is very similar to that recited by Patent Owner in its Motion to Amend, substantively differing only in the number of years of experience of the engineer at issue. This congruity supports the conclusion that the level of ordinary skill in the art may be recognized in the prior art itself. Okajima, 261 F.3d at 1355 (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’”).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In our Institution Decision, we agreed with Petitioner that the “portion of the preamble reciting ‘for compressing bone’ is not limiting to the claim” and found that other terms did not require construction. Dec. 8–9. We agreed with Petitioner that “[t]he phrase ‘for compressing bone’ merely identifies an intended use.” Pet. 20; Dec. 9. Patent Owner does not dispute this interpretation. See generally PO Resp. We agree with Petitioner that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Therefore, having considered the entire record developed during trial, we adhere to the preliminary construction that the limitation “for compressing bone” does not impose a structural limitation on claim 59 and that the other terms do not require construction.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Patent Owner disputes the Petition generally but Patent Owner does not identify any error in Petitioner’s foregoing arguments. Accordingly, we adopt the factual statements regarding the specific teachings of the references as findings of fact. See generally In re NuVasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make specific findings as to claim limitations that Patent Owner does not dispute are disclosed in the prior art). We have reviewed Petitioner’s analysis and the underlying evidence cited in support and conclude that Petitioner has shown, by a preponderance of the evidence, that the limitations of claim 59 are disclosed by Brumfield.” slip op. at 26
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“For the reasons discussed below, Patent Owner has shown that proposed substitute claim 62 meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. For the reasons discussed below, however, Petitioner has proven by a preponderance of the evidence that proposed substitute claim 62 is unpatentable over prior art. Therefore, we deny Patent Owner’s Revised Motion to Amend.” slip op. at 38
Patent outcomesUS 8,303,589 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 8,303,589 - Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentablePTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision
The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77
- ExcludeMotion to exclude, deniedDenied
“A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29
- Skill levelSkill level board ownOther
“Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26
- Expert testimonyPetitioner expert discountedDecided for patent owner
“With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25
Patent outcomesUS 10,766,685 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,766,685
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.