- PTAB · Apr 25, 2024 · IPR2024-00009 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petition grounds, declined discretionary denial, and granted joinder with IPR2023-00724.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Director Vidal set forth in the Interim Procedure that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Interim Procedure, 7, 9. This guidance does not condition or otherwise qualify the effect of a Sotera stipulation on our exercise of discretion to deny the Petition based on any remaining defendants in the parallel litigation that are not subject to the stipulation. Petitioner has filed such a stipulation. Reply 2 (“Petitioners stipulate that, if instituted, they will not pursue in the parallel district court proceeding the same grounds as in the Petition or any grounds that could have reasonably been raised therein”). Therefore, we will not exercise our discretion to deny the Petition. We also find that with the change of the district court trial date to over two months after the current statutory due date for the Mylan IPR, the Mylan IPR should be completed before a trial in the district court begins. See Ex. 1098. This change in trial date, in addition to the lack of complete overlap in the claims asserted here and in the Delaware Litigation, provide further reason for us to refrain from exercising our discretion to deny the Petition under 35 U.S.C. § 314(a) regardless of remaining defendants in the Delaware Litigation that are not bound by any estoppel arising from the Mylan IPR.10” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the same reasons set forth in our institution decision in the Mylan IPR, we determine that Petitioner has shown a reasonable likelihood that at least one claim is unpatentable. Mylan IPR, Paper 10, 17–29 (PTAB Oct. 4, 2023). We therefore institute trial as to all challenged claims on all grounds stated in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter parties review under section 314. As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 12
Discretionary denialPatents in suitUS 10,335,462 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision
The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as 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 › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. 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)).” slip op. at 5
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner
“d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32
Patent outcomesUS 11,110,087 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087 - PTAB · Mar 19, 2024 · IPR2024-00181 · APJ Timothy G Majors · IPR · Institution
The Board instituted inter partes review of claims 1–29 and granted Inari’s contingent motion to join the Bayer 1038 IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petition, and has not otherwise addressed Inari’s contentions. Inasmuch as Patent Owner raised counterarguments to the grounds in the preliminary response that it filed in the Bayer 1038 IPR, we addressed those arguments in our Institution Decision in that proceeding. Bayer 1038 IPR, Paper 12. From our review of the preliminary record, we are persuaded that Inari’s Petition challenges the same claims of the ’745 patent, based on the same grounds and substantially the same evidence, compared to the challenge in the Bayer 1038 IPR.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Furthermore, a motion for joinder should (1) set forth reasons why joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15, 4 (PTAB Apr. 24, 2013); Patent Trial and Appeal Board, Consolidated Trial Practice Guide, 76 (Nov. 2019), https://www.uspto.gov/sites/default/files/ documents/tpgnov.pdf. Inari addresses these considerations in its Motion, and we generally agree with Petitioner’s assertions in favor of joinder. Mot. 3–10. We discuss below.” slip op. at 7
- Other 314aOther
“prevailing, as it is substantively identical to the successful petition upon which we instituted the Bayer 1038 IPR. However, institution of an inter partes review is discretionary. See 35 U.S.C. § 314(a) (authorizing institution of an inter partes review under particular circumstances, but not requiring institution under any circumstances); Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 273 (2016) (“[T]he agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion.”); SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018) (“[Section] 314(a) invests the Director with discretion on the question whether to institute review . . . .” (emphasis omitted)); Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). I would exercise that discretion here and deny the Petition. The Bayer 1038 IPR is governed by the petition filed by Bayer. See Facebook, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321, 1336 (Fed. Cir. 2020) (“The already-instituted IPR to which a person may join as a party is governed by its own petition and is confined to the claims and grounds challenged in that petition.”). However, “[t]he instant Petition is substantively identical to the petition filed by Bayer, challenging the same claims of the ’745 patent on the same grounds and relying on substantively identical expert testimony.” Pet. 3. Thus, institution based on the instant Petition creates a second inter partes review that is duplicative of the Bayer 1038 IPR. As we are already granting Inari’s request to join the Bayer 1038 IPR as a petitioner, I see no benefit to granting Inari’s Petition to institute a second inter partes review. I would deny Inari’s Petition.” slip op. at 11
Discretionary denialPatents in suitUS 11,299,745 - PTAB · Mar 19, 2024 · IPR2024-00180 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR of claims 1–29 based on a reasonable likelihood of success and granted Inari’s motion to join the Bayer 1037 IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petition, and has not otherwise addressed Inari’s contentions. Inasmuch as Patent Owner raised counterarguments to the grounds in the preliminary response that it filed in the Bayer 1037 IPR, we addressed those arguments in our Institution Decision in that proceeding. Bayer 1037 IPR, Paper 12. From our review of the preliminary record, we are persuaded that Inari’s Petition challenges the same claims of the ’283 patent, based on the same grounds and substantially the same evidence, compared to the challenge in the Bayer 1037 IPR.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Furthermore, a motion for joinder should (1) set forth reasons why joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15, 4 (PTAB Apr. 24, 2013); Patent Trial and Appeal Board, Consolidated Trial Practice Guide, 76 (Nov. 2019), https://www.uspto.gov/sites/default/files/ documents/tpgnov.pdf. Inari addresses these considerations in its Motion, and we generally agree with Petitioner’s assertions in favor of joinder. Mot. 3–10. We discuss below.” slip op. at 7
NonePatents in suitUS 11,149,283 - PTAB · Mar 19, 2024 · IPR2024-00179 · APJ Timothy G Majors · IPR · Institution
The Board instituted review of claims 1–34 on all four asserted grounds and granted Inari’s motion to join the Bayer 1036 IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petition, and has not otherwise addressed Inari’s contentions. Inasmuch as Patent Owner raised counterarguments to the grounds in the preliminary response that it filed in the Bayer 1036 IPR, we addressed those arguments in our Institution Decision in that proceeding. Bayer 1036 IPR, Paper 11. From our review of the preliminary record, we are persuaded that Inari’s Petition challenges the same claims of the ’555 patent, based on the same grounds and substantially the same evidence, compared to the challenge in the Bayer 1036 IPR.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15, 4 (PTAB Apr. 24, 2013); Patent Trial and Appeal Board, Consolidated Trial Practice Guide, 76 (Nov. 2019), https://www.uspto.gov/sites/default/files/ documents/tpgnov.pdf. Inari addresses these considerations in its Motion, and we generally agree with Petitioner’s assertions in favor of joinder. Mot. 3–10. We discuss below.” slip op. at 7
NonePatents in suitUS 10,947,555 - PTAB · Jan 31, 2024 · IPR2024-00298 · APJ Ryan H Flax · IPR · Institution
Instituted IPR on claims 1–30 of the ’572 patent on all asserted grounds and granted Biocon’s motion to join IPR2023-00884.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We explained in our Institution Decision in IPR’884 why we conclude that Samsung demonstrated a reasonable likelihood of prevailing at trial in showing that the challenged claims are unpatentable. See generally IPR’884 DI. The present Petition advances identical arguments, challenging the same claims over the same combinations of prior art. We consequently adopt the same reasoning here as in our IPR’884 Institution Decision, and conclude that Petitioner is likely to prevail in demonstrating the unpatentability of the same challenged claims. Id. We incorporate our previous analysis regarding the asserted grounds of unpatentability and conclude that Petitioner demonstrates a reasonable likelihood of prevailing at trial with respect to at least one claim of the ’572 patent challenged in the Petition for the same reasons as in IPR’884. See id. Therefore, we determine that the Petition warrants institution of inter partes review on all claims and all grounds asserted in the Petition. 37 C.F.R. § 42.108(a) (“When instituting . . . 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.”); see also SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 9
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“joinder is discretionary. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. We determine whether to grant joinder on a case-by-case basis, taking into account the particular facts of each case, substantive and procedural issues, and other considerations. When exercising that discretion, we are mindful that patent trial regulations, including the rules for joinder, must be construed to secure the just, speedy, and inexpensive resolution of every proceeding. See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: (1) set forth the reasons joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; and (3) explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview, LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013); see also, USPTO, America Invents Act (AIA) Frequently Asked Questions,” available at: uspto.gov/patents/laws/americainvents-act-aia/america-invents-act-aia-frequently-asked#type-inter-partesreview_3244 (last visited February 2, 2022). B.” slip op. at 10
NonePatents in suitUS 11,253,572 - PTAB · Jan 30, 2024 · IPR2024-00260 · APJ Ryan H Flax · IPR · Institution
Instituted review of claims 1–30 on all asserted grounds and granted Celltrion’s motion to join IPR2023-00884.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We explained in our Institution Decision in IPR’884 why we conclude that Samsung demonstrated a reasonable likelihood of prevailing at trial in showing that the challenged claims are unpatentable. See generally IPR’884 DI. The present Petition advances identical arguments, challenging the same claims over the same combinations of prior art. We consequently adopt the same reasoning here as in our IPR’884 Institution Decision, and conclude that Petitioner is similarly likely to prevail in demonstrating the unpatentability of the same challenged claims. Id. We incorporate our previous analysis regarding the asserted grounds of unpatentability and conclude that Petitioner demonstrates a reasonable likelihood of prevailing at trial with respect to at least one claim of the ’572 patent challenged in the Petition for the same reasons as in IPR’884. See id. Based on the record before us, we determine that the Petition warrants institution of inter partes review on all claims and all grounds asserted in the Petition. 37 C.F.R. § 42.108(a) (“When instituting . . . 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.”); see also SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Petitioner certifies and we agree that the Petition is substantively identical to that of IPR’884, where we found Samsung had met its burden to show a reasonable likelihood it would prevail at trial in establishing at least one challenged claim unpatentable under the asserted grounds. Mot. 5; see generally IPR’884 DI. Petitioner also certifies, and we agree, that it relies on the same evidence here as in IPR’884. Mot. 5. Patent Owner waives its right to file a preliminary response in this proceeding, for the sake of efficiency. See Paper 7, 2. Petitioner also certifies that it will be a “silent understudy” to Samsung in IPR’884 if the proceedings are joined, thus, there will be no impact to the schedule of that instituted trial. Mot. 5–6. Moreover, Petitioner asserts that, structured in this way, the joined proceeding will simplify briefing and discovery (i.e., they will be singular, rather than occurring in two proceedings). Id. at 6–7.” slip op. at 12
NonePatents in suitUS 11,253,572 - PTAB · Jan 16, 2024 · IPR2024-00201 · APJ John G New · IPR · Institution
The Board instituted review of claims 10–12, 17–19, 21, 25–28, and 33 on three §103 grounds, and granted Biocon’s motion to join IPR2023-00739.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“concluded that Samsung had demonstrated a reasonable likelihood of prevailing at trial in showing that the challenged claims are unpatentable. See, generally, -00739 IPR, Paper 9 (“Inst. Dec.”). The present Petition advances essentially identical arguments, challenging the same claims over the same combinations of prior art. We consequently adopt the same reasoning as in our -00739 Institution Decision, and conclude that Petitioner is similarly likely to prevail in demonstrating the unpatentability of the same challenged claims.” slip op. at 7
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“(c) JOINDER. — If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314. As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: (1) set forth the reasons joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; and (3) explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview, LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013); see also, USPTO, America Invents Act (AIA) Frequently Asked Questions,” available at: uspto.gov/patents/laws/americainvents-act-aia/america-invents-act-aia-frequently-asked#type-inter-partes-review_3244 (last visited February 2, 2022). We are persuaded by Petitioner’s arguments that joinder in these circumstances is appropriate. Petitioner undertakes to act as a “silent understudy” in the joined inter partes reviews and to take no active role in the joined inter partes reviews, unless Samsung ceases to act as a party. Mot. 6–7. The challenged claims and grounds of the Petition are identical to those of the -00739 IPR. Id. at 7. Petitioner’s Motion is timely and should have no effect upon the trial schedule established for the -00739 IPR. Id. at 8.” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“As for the Fintiv factors, we considered Patent Owner’s arguments in the Institution Decision of the -00739 IPR, and we find the substantially same arguments in Patent Owner’s Opposition no more persuasive upon repetition. See Inst. Dec. 55–61. Again, we emphasize that although trial may have concluded in the district court litigation, as well as in the -01226 IPR, there nevertheless remains a substantial number of ’601 patent claims that have been challenged only in the -00739 IPR. We conclude that this fact warrants exercise of our discretion to institute inter partes review and to grant Petitioner’s Motion for Joinder of the present inter partes review with the -00739 IPR.” slip op. at 9
Discretionary denialPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an [inter partes review], 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) (2012) (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). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). 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, a party that petitions the Board for a determination of unpatentability based on obviousness 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) (internal quotations omitted). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))). D. Overview of Asserted References” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,129,343 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2
- BurdenNot shown unpatentable
“Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,536,122
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.