- PTAB · Jul 23, 2024 · IPR2024-00669 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–8 and 11, finding a reasonable likelihood of success on at least one claim under the Saadat grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’077 patent’s challenged claims. Also, we decline to deny the Petition on a discretionary basis. Therefore, we institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“As discussed below (Section IV.D), we determine at this stage that Saadat is prior art. There is no argument from Patent Owner that Saadat was presented previously to the Office. Pet. 96 (Petitioner’s unrebutted argument that Saadat was not previously considered by the Examiner). And, beyond the unsuccessful attempt to antedate and, thus, disqualify Saadat as prior art, at this stage of the proceeding Patent Owner offers no argument or evidence to rebut Petitioner’s contention that Saadat anticipates and renders obvious the ’077 patent’s claims under Grounds 1–3. See generally Prelim. Resp. 8–26 (Patent Owner’s priority date arguments). For the above reasons, we find that Patent Owner has not shown that substantially the same prior art or arguments (i.e., Saadat and arguments based thereon) were previously presented to the Office and, thus, Patent Owner has not satisfied step one of Advanced Bionics’ two-step framework. Advanced Bionics, Paper 6 at 8. On this record, even if we accept Patent Owner’s contentions about the Office’s prior consideration of Makower or Fang (art asserted under Grounds 5 and 6), we do not find that § 325(d) is sufficiently implicated based on our determination on the priority issue and Petitioner’s otherwise uncontested argument that the challenged claims are unpatentable over Saadat—issues we discuss in more detail below.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not propose an alternate definition of the POSA’s qualifications or contest Petitioner’s definition. See generally Prelim. Resp. We apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner similarly does not propose any express claim construction for any of the challenged claims at this time. See generally Prelim. Resp. and based on our review of the record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Realtime Data, 912 F.3d at 1375.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,679,077 - PTAB · Jul 23, 2024 · IPR2024-00279 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claims 1–3, 7, 9, 10, and 17–25 on all petitioned grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–3, 7, 9, 10, and 17–25 of the ’675 patent are unpatentable.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Specification of the ’675 patent provides written description support for the challenged claims. The challenged claims are purportedly directed to treating a nasal condition comprising “delivering energy to the target tissue” to reduce mucus secretion or congestion. Ex. 1001, claims 1 and 17. As noted by Petitioner, the ’675 patent Specification does not describe the use to energy to treat a nasal condition in the manner recited in the claims. Pet. 24–25. Rather, the ’675 patent Specification discloses the use of neurotoxins to treat nasal conditions, and, more specifically, that neurotoxins are used to disrupt neural signals in the targeted tissue and, therein, disable mucus secretion by such tissues. Ex. 1001, 3:25–34, 8:18–21, 8:38–60, achieve cell membrane permeabilization or poration and effectuate the delivery of neurotoxin into to target cells. See, e.g., id. at 4:49–51, 8:4–21. Here, we note that the challenged claims do not recite administering neurotoxins, but instead only require the delivery of energy to the target tissue to administer therapy.” slip op. at 16
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“probe in a nasopharyngeal passage of a patient for the ablation of a posterior nasal nerve. Id. at 30 (citing Ex. 1002 ¶¶ 85–99). Petitioner also contends that “Saadat explains that RF ablation disrupts neural activity to reduce or eliminate rhinitis symptoms, including mucus secretion and congestion.” Id. at 36 (citing Ex. 1003, 3:6–14 (“Ablating [posterior nasal] nerves leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea in patients with chronic rhinitis (allergic or vasomotor).”), 16:44–51; Ex. 1002 ¶ 103). Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing, which we find sufficient for institution purposes. See generally Prelim. Resp. Rather, Patent Owner contends Saadat is not prior art because the ’675 patent is entitled to rely upon the July 21, 2006, filing date of the ’090 application. Id. at 24. For the reasons discussed above, we determine that the Specification of the ’675 patent fails to provide adequate written description support for the challenged claims, and thus, the challenged claims are entitled to an effective filing date no earlier than October 22, 2019. Saadat is a U.S. patent that issued June 4,” slip op. at 33
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,610,675 - PTAB · May 1, 2024 · PGR2024-00009 · APJ Tina E Hulse · PGR · Institution
The Board instituted PGR on claims 1–8, 12, and 20 on all asserted grounds, finding the petition showed a reasonable likelihood that at least one claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s definition of the level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 20. Although defining a person of ordinary skill in the art as a “team” of individuals is not conventional, because Patent Owner does not dispute the definition at this stage of the proceeding, we adopt Petitioner’s definition as it appears to be 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” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Patent Owner “agrees that the preamble is limiting as a statement of the intentional purpose for which the method is performed—treating patients with CLL or SLL.” Prelim. Resp. 18. But Patent Owner disagrees with an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2 amount” but not “therapeutically effective amount”). Thus, we construe the term “therapeutically effective amount” to mean “a sufficient amount of an agent of a compound being administered which will relieve to some extent one or more of the symptoms [of] B-cell lymphoproliferative disorder (BCLD).”” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,672,803 - PTAB · Mar 13, 2024 · IPR2023-01347 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claim 16 on both asserted obviousness grounds, finding a reasonable likelihood that Petitioner would show the claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that claim 16 of the ’344 patent is unpatentable.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Based on the preliminary record, we are persuaded by Petitioner’s contention that claim 16 does not comply with the written description requirement for the reasons set forth in the Petition (Pet. 11–17), summarized above. More specifically, on the current record, we do not recognize the ’344 patent to disclose a representative number of API, solvent and co-former combinations having the necessary recited features. We do not understand the ’344 patent to disclose structural features common to the recited solvents and co-formers such that a POSA could “visualize or recognize” the members of the claimed genus. Ariad, 598 F.3d at 1350. We recognize that a POSA’s perspective is key to the written description inquiry and many factors may inform the adequacy of a specification’s disclosure, including existing knowledge in the field and the content of the prior art. See Ariad, 598 F.3d at 1351. On the current record, however, we do not find evidence that a POSA would have considered the recited mechanisms to form supramolecular synthons via non-covalent hydrogen bonding by pairing solvents and co-formers having certain functionalities a concept that was well-known in the art. effective filing date for claim 16 is February 13, 2014, the filing date of the ’344 patent.2” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner contends that a POSA would have been motivated to combine Ueto with Li, Martindale, Zaworotko, and Remington “to improve physicochemical properties of the co-crystal components.” Id. at 49. In particular, furosemide was known as of 2014 to have low water solubility (Ex. 1506, Martindale at 1421; Ex. 1503, Appel ¶ 58; Ex. 1502, Rogers ¶¶ 232–34, 236), and water solubility, along with bioavailability, were properties that co-crystals had the potential to improve. Ex. 1507, Ueto at 485; Ex. 1503, Appel ¶ 59; Ex. 1502, Rogers ¶¶ 234, 236. As such, a POSA would have been motivated to pursue studies with the Ueto co-crystals, including the furosemide/nicotinamide/water co-crystal. Pet. 49. In view of the foregoing, we determine that Petitioner has established a reasonable likelihood of showing that the combination of Ueto, Li, Martindale, Zaworotko, and Remington renders obvious claim 16 for the purposes of our preliminary findings. Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing. Accordingly, we institute a inter partes review of claim 16 of the ’344 patent.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Petitioner proposes constructions for the terms “active pharmaceutical ingredient (API)”, “API homosynthons”, “carbonyl”, “carboxamide”, “co-former”, and “supramolecular synthon.” Pet. 9–10. According to Petitioner, “[t]he parties agree that co-former is used synonymously with cocrystal former and that a co-former is a component of a co-crystal.” Id. at 9. Petitioner represents that the proposed constructions have been agreed to between the parties in parallel litigation, or agreed upon such that “the disputed portions are not relevant to [the] issues raised in this Petition.” Id. at 8. We have reviewed each of these constructions and adopt Petitioner’s proposed construction for the purposes of this Decision. Petitioner’s construction aligns with the plain words of the claim, is consistent with the prosecution history of the ’344 patent, and finds support in the uncontroverted testimony of Dr. Rogers. Ex. 1502 ¶¶ 52–63; Ex. 1516, 256–58, 261–63. Petitioner construes the term “co-crystal” to mean “a multiple- component, single crystalline phase, having a fixed stoichiometry of its component compounds.” Id. at 10. Petitioner states that the proposed construction of the term “co-crystal” is “currently disputed in parallel litigation between the parties; however, because claim 16 is unpatentable under Patent Owners’ constructions, Petitioner adopts those constructions solely for the purpose of this Petition.” Id. at 8–9. We adopt Petitioner’s proposed construction of “co-crystal” for the purposes of this Decision. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (per curiam) (claim terms need to be construed “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))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,633,344 - PTAB · Mar 13, 2024 · IPR2023-01346 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 10, 11, and 18 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“priority to the filing date of a prior application only “for an invention disclosed [in the prior application] in the manner provided by” 35 U.S.C. § 112. This requires that the earlier application provides written description support for the invention claimed by the later application. See Paice LLC v. Ford Motor Co., 881 F.3d 894, 906 (Fed. Cir. 2018); PowerOasis, Inc. v. T- Mobile USA, Inc., 522 F.3d 1299, 1306–11 (Fed. Cir. 2008); Augustine Medical, Inc. v. Gaymar Indus., Inc., 181 F.3d 1291, 1302–03 (Fed. Cir. 1999). The test for sufficiency of a written description under 35 U.S.C. § 112, ¶ 1, is whether the earlier application’s disclosure “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description “test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. As articulated in Ariad, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Ariad, 598 F.3d at 1350 (citations omitted). One test of whether a claimed genus finds adequate support involves identifying in the specification “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (citing Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997)).” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least 1 of the challenged claims of the ’344 patent is unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“To anticipate a claim under 35 U.S.C. § 102, “a single prior art reference must expressly or inherently disclose each claim limitation.” Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008). 2 We note that Petitioner additionally challenges the Priority Applications for lack of enablement. Having found that the ’344 patent lacks written description support for all Challenged Claims, however, we need not address Petitioner’s enablement challenge in order to decide whether to institute. one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching’ that every claim element was disclosed in that single reference.” Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991)).” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Because Petitioner’s presently unopposed definition is consistent with the ’344 patent and the prior art of record, we adopt that definition in deciding whether to institute trial. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 15
§ 102 anticipation§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,633,344 - PTAB · Apr 24, 2023 · IPR2023-00074 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1, 2, 5–8, 11, and 15 on all asserted grounds, finding a reasonable likelihood that claims 1, 2, 5–7, and 11 are obvious over the May Article.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on our review of the record, we find that Petitioner has not shown persuasively that the Examiner did not consider the same or substantially the same art that Petitioner relies upon for its obviousness challenges. Petitioner’s grounds primarily rely on three different “May” references, only one of which the Examiner considered during prosecution, i.e., the May Article. The additional primary references relied upon by Petitioner are the May Thesis, which provides a more detailed disclosure than the May Article, and the May Abstract, which provides less detail than the May Article, in terms of the HS2, HS3, and HS4 fragments used to generate the disclosed TNS9 vector. Those differences are only material with respect to whether each reference discloses the fragments as recited in independent claim 1, or renders those fragments obvious. As discussed in Section II.D.2., however, we determine that the May Thesis is not prior art. 11 The ’221 application claims priority to provisional application no. 60/301,861 (Ex. 1034) (“the ’861 provisional application”), filed June 29, 2001, and provisional application no. 60/302,852 (Ex. 1035) (“the ’852 provisional application”), filed on July 2, 2001, referred to, collectively, as “the provisional applications,” “the provisionals” and “the Provisionals.” Article, but in less detail, the May Abstract may be considered cumulative to the May Article. Because the May Thesis provides more explicit details regarding the fragments disclosed in the May Article, it may not be considered to be cumulative to the May Article. However, as discussed in Section II.D.2., we determine that the May Thesis is not prior art. When considering the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the May Article or Patent Owner distinguishes the May Article, we note that Patent Owner alleged during prosecution and here that the May Article is not prior art for a number of reasons, including that it is the work of the inventors and that it was published one year or less before the priority date asserted by Patent Owner for the challenged claims. We note also that Petitioner contends that the challenged claims are not entitled to the priority date asserted by Patent Owner, and recognized by the Examiner. Based on the foregoing, we conclude that substantially the same prior art that Petitioner relies upon was previously presented to the Examiner during prosecution. The first part of the § 325(d) framework is, therefore, met. Accordingly, we turn to the second part of the § 325(d) and determine whether error by the Office has been shown. See Advanced Bionics at 8.” slip op. at 10
- Skill levelSkill level petitioner adoptedOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 18–19 (citing Ex. 1002 ¶¶ 14– 15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’061 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “that no term of the ’061 patent requires construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex. 1002 ¶¶ 50–51) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Based on our consideration of the arguments and evidence presented at this stage of the proceeding, we determine, for purposes of this Decision, that claims 1, 2, 5–7, and 11 of the ’061 patent are not entitled to receive benefit of the filing date for either the ’861 provisional application or the ’852 provisional application. In particular, we find persuasive Petitioner’s arguments that the provisional applications do not satisfy the written description requirements of 35 U.S.C. § 112 for those claims. Independent claim 1 recites, in part, “a recombinant lentiviral vector which comprises a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 11:57–67. Independent claim 11 recites, in part, “a recombinant lentiviral vector comprising a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 12:64–13:7. Based upon our review, we agree with Petitioner that these limitations are not adequately described in the provisional applications. The ’061 patent Specification (and the ’221 Application) describe the term “functional globin gene” as: that does not produce a hemoglobinopathy phenotype, and which is effective to provide therapeutic benefits to an individual with a defective globin gene. The functional globin gene may encode a wild-type globin appropriate for a mammalian individual to be treated, or it may be a mutant form of globin, preferably one which provides for superior properties, for example superior oxygen transport properties. . . . Suitably, the globin may encode α-globin, β-globin, or γ-globin. Ex. 1001, 2:44–55 (emphasis added); see also Ex. 1032, 3:24–4:3 (same). Based on this description, we agree with Petitioner that the ’061 patent claims cover a recombinant vector comprising a nucleic acid encoding a “functional globin” genus that includes wild-type globin and mutant forms of globin, wherein the globin may encode different globin types, i.e., α-, β-, or γ-globin. Patent Owner does not identify, nor do we see, any portion of the provisional applications describing the genus of functional globin. Rather, as Petitioner demonstrates, the provisional applications describe one species of that genus, i.e., the wild-type human β-globin. Pet. 14–18. The provisionals do not describe the “functional globin” genus. Indeed, as Petitioner correctly asserts, during the ’061 patent prosecution, Applicants/Patent Owner, relied on a description of “functional globin,” quoted above, that does not appear and has not counterpart in the provisional applications. Compare Ex. 1001, 2:44–55 and Ex. 1032, 3:24–4:3 with Ex. 1034 and Ex. 1035.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,058,061 - PTAB · Apr 24, 2023 · IPR2023-00070 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR of claims 1, 10, 19, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over the May Article.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In evaluating matters under § 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 7
- Skill levelSkill level petitioner adoptedOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 17 (citing Ex. 1002 ¶¶ 14–15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “no term of the ’179 patent requires construction to resolve the challenges in this Petition.” Pet. 22 (citing Ex. 1002 ¶¶ 49– 50) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As the Federal Circuit has noted, however, “[i]n order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 7,541,179 - PTAB · Apr 7, 2022 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Rehearing
The Board granted rehearing, reversed its discretionary denial, and instituted PGR on claims 6–8 based on the threshold showing of likely lack of enablement and anticipation.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We agree with Petitioner that a rehearing of our prior decision to deny institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“35 U.S.C. § 324(a) provides that a post-grant review may not be instituted “unless the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, and the evidence cited therein, we determine that Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we accept Petitioner’s proposed definition, which is supported by Dr. Lambert’s testimony (Ex. 1002 ¶ 20) and is consistent with the scope and content of the ’039 patent and the asserted prior art.” slip op. at 17
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted
“skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - Genome & Company v. The University Of ChicagoAll claims unpatentablePTAB · Apr 14, 2020 · PGR2019-00002 · APJ John E Schneider · PGR · Final written decision
Claims 1–29 are unpatentable: claims 1–17 and 19–28 for lack of enablement and obviousness; claims 18 and 29 for obviousness.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Dr. Braun, Petitioner’s proffered expert, defines a person of ordinary skill in the art as having an advanced degree or its substantial equivalent in the biological sciences, including specifically in the fields of immunology, microbiology and the microbiome, and oncology, coupled with research experience in those fields. Ex. 1002 ¶ 40. Patent Owner does not contest Petitioner’s definition of a person of ordinary skill in the art. See generally, PO Resp. We determine that Petitioner’s description of the level of ordinary skill in the art is supported by the current record. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“interprets claim terms in an unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b) (2018);3 Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to trial proceeding before the USPTO.). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of this Decision. See 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 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“We have considered the arguments presented by the parties and the evidence of record and conclude that the unpredictability of the art weighs in favor of finding non-enablement with respect to CPIs in general. While we agree with Patent Owner that CPIs can be effective in treating some cancers, the Specification and the evidence of record show that all of the effective CPIs are antibodies. For example, all of the CPIs listed in the chart of page 10 of Patent Owner’s Response are antibodies. Tr. 39. We find nothing in the record, other than attorney argument that one skilled in the art would know how to make of use other CPIs, such as an interfering nucleic acid molecule, in the claimed method. For example, as Petitioner points out, Patent Owner’s expert did not consider CPIs other than antibodies, in reaching his conclusions regarding enablement. Pet. Reply, 4; Ex. 1042, 19–29. The record also does not support the contention that one skilled in the art could predict the action of non-antibody CPIs based on the action of an antibody CPI. The art and the Specification identify one non-antibody CPI, and the Fe region of human IgG. Ex. 1001, col. 5, ll. 20–23; Ex. 2034, 206. At the time the ’302 patent was filed, studies of this potential CPI indicated that it acted differently than antibody CPIs and that efficacy was lacking compared to other CPIs. Id. This evidence supports Petitioner’s contention that the use of CPIs, especially non-antibody CPIs, was unpredictable at the time the ’302 patent was filed. We also agree with Petitioner that the selection of Bifidobacterium was unpredictable. The evidence of record supports Petitioner’s contention that the immunostimulatory activity of Bifidobacterium varies from strain to strain, even within the same species. Pet. 44–45. O’Mahony teaches that Bifidobacterium longum strain AH1714 is immunosuppressive while another stain of B. longum exhibits immunostimulatory activity. Ex. 1017 ¶¶ 103– 109. Similarly, Lopez evaluated 12 strains of four different species of Bifidobacterium and concluded that the properties exhibited by Bifidobacterium varied among the strains. Ex. 1038, Abstr. Patent Owner’s arguments regarding the credibility of O’Mahony and Lopez are unpersuasive. Patent Owner made specific representations to the Examiner on several occasions that strain AH1714 disclosed in O’Mahony was immunosuppressive to support Patent Owner’s argument that one would not combine an immunosuppressive agent with an immunostimulatory agent. See, e.g. Ex. 1014, 8–9. Patent Owner suggests that it was not asserting that the statements in O’Mahony were accurate, but merely argues that those statements would have led away from making the combination proposed by the Examiner. PO Sur-Reply 10. This argument fails in its logic. If one skilled in the art upon reading O’Mahony would have recognized the alleged errors in O’Mahony’s teachings and disregarded them as Patent Owner now combination advanced by the Examiner in prosecution as Patent Owner argued. With respect to Lopez, Lopez states unambiguously that the immune effects of Bifidobacteria are species and strain specific. Petitioner has advanced evidence that those skilled in the art accepted these conclusions, citing Lopez in subsequent articles. Pet. Reply 10–11 (citing Ex. 1044). Moreover, the present inventors found Lopez to be sufficiently credible to incorporate the teachings of Lopez in their entirety into the instant Specification of the ’302 patent. Ex. 1001, col. 37, l. 62–col. 38, l. 4.” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledEnabledMixed
“evidence of record and conclude that applying the all the Wands factors, Petitioner has demonstrated by a preponderance of the evidence that claims 1–17 and 19–28 are not enabled. In reviewing the evidence of record, we find that the nature of the invention that involves very broad claims, the high level of skill required in such an unpredictable art, and the dearth of working examples and lack of specific guidance on the full range of CPIs and cancers challenged claims are not enabled. Because claims 18 and 29 require known CPIs, however, we find that Petitioner has failed to show that these claims are not enabled.” slip op. at 26
Patent outcomesUS 9,855,302 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 9,855,302
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.