- Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentablePTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision
Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of 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. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32
Patent outcomesUS 11,278,505 unpatentableClaim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,278,505 - PTAB · Dec 19, 2023 · IPR2023-01037 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–29 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’283 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). 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 / argumentsInstitution denied 325dDenied
“35 U.S.C. § 325(d). In evaluating whether to deny institution under 325(d), the Board has considered several non-exclusive factors: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination; (d) the extent of the overlap between the arguments made during examination and the manner in which a petitioner relies on the prior art or a patent owner distinguishes the prior art; (e) whether a petitioner has pointed out sufficiently how the Office erred in evaluating the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. See Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first para.). Factors (a), (b), and (d) relate to whether the art or arguments in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 10 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in the Office’s prior consideration of that art or arguments. Id. Under Advanced Bionics’s two-part framework, we first determine whether the same or substantially the same art or arguments previously were presented to the Office. Id. at 8, 10. If “either condition of [the] first part of Office has been shown. Id. at 8, 10.” slip op. at 68
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing. Petitioner’s proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’283 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1002, 18:44–50 (citing Hogan (Ex. 1027)), 50:51–55 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about the POSA’s perspective at the time of the invention, appears to have academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“C. Claim Construction In inter partes review, we construe claims using the same claim construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims in accordance with the ordinary and customary meaning as understood by the POSA and the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only as needed to resolve the matters in dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). 17 The closest work we see from Dr. Nair related to herbicide resistant transgenic plants is his 2019 paper co-written with the applicant’s employees (e.g., Dr. Wright), which paper appears to be a follow-on investigation into the AAD-1 proteins of the patent. Ex. 1008, 594–595; Ex. 1019, Abstr. proceeding. Pet. 17; Prelim. Resp. 20. It is not apparent at this stage that any terms need further interpretation to resolve the matters in dispute.18” slip op. at 24
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,149,283 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCAll claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Final written decision
Claim 59 is unpatentable as anticipated by Brumfield, Marcus, and Chandran; the motion to amend proposing substitute claim 62 is denied because claim 62 is unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find this argument unpersuasive. As Patent Owner notes, Petitioner’s expert provides a definition of POSITA that is very similar to that recited by Patent Owner in its Motion to Amend, substantively differing only in the number of years of experience of the engineer at issue. This congruity supports the conclusion that the level of ordinary skill in the art may be recognized in the prior art itself. Okajima, 261 F.3d at 1355 (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’”).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In our Institution Decision, we agreed with Petitioner that the “portion of the preamble reciting ‘for compressing bone’ is not limiting to the claim” and found that other terms did not require construction. Dec. 8–9. We agreed with Petitioner that “[t]he phrase ‘for compressing bone’ merely identifies an intended use.” Pet. 20; Dec. 9. Patent Owner does not dispute this interpretation. See generally PO Resp. We agree with Petitioner that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Therefore, having considered the entire record developed during trial, we adhere to the preliminary construction that the limitation “for compressing bone” does not impose a structural limitation on claim 59 and that the other terms do not require construction.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Patent Owner disputes the Petition generally but Patent Owner does not identify any error in Petitioner’s foregoing arguments. Accordingly, we adopt the factual statements regarding the specific teachings of the references as findings of fact. See generally In re NuVasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make specific findings as to claim limitations that Patent Owner does not dispute are disclosed in the prior art). We have reviewed Petitioner’s analysis and the underlying evidence cited in support and conclude that Petitioner has shown, by a preponderance of the evidence, that the limitations of claim 59 are disclosed by Brumfield.” slip op. at 26
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“For the reasons discussed below, Patent Owner has shown that proposed substitute claim 62 meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. For the reasons discussed below, however, Petitioner has proven by a preponderance of the evidence that proposed substitute claim 62 is unpatentable over prior art. Therefore, we deny Patent Owner’s Revised Motion to Amend.” slip op. at 38
Patent outcomesUS 8,303,589 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 8,303,589 - Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentablePTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision
The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77
- ExcludeMotion to exclude, deniedDenied
“A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29
- Skill levelSkill level board ownOther
“Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26
- Expert testimonyPetitioner expert discountedDecided for patent owner
“With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25
Patent outcomesUS 10,766,685 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,766,685 - PTAB · Apr 19, 2023 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted review on all challenged claims and the sole anticipation ground: claims 1–4, 8–14, and 18–26, with a reasonable likelihood of unpatentability except claim 19.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialInstitutedDenied
“This case differs from other situations where the Board has exercised discretion under § 314(a) to deny institution. For example, we are not presented with a later-filed petition after having considered an earlier-filed petition challenging the same patent. See, e.g., General Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19, 6–11, 15–22 (PTAB Sept. 6, 2017) (precedential)). This is the first petition filed against this patent and contains only a single ground. Also, as Petitioner asserts, and Patent Owner does not contest, the Fintiv factors are neutral or favor institution. See Pet. 61–63. Instead, Patent Owner asks us to deny institution because Petitioner” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts A person of ordinary skill in the art (“POSA”) in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a PharmD with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29. Pet. 15–16. Patent Owner asserts “that a POSA for purposes of the ’087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers).” Prelim. Resp. 13. Patent Owner asserts “Petitioner’s definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners’ definition of a POSA, on the other hand, accounts for the claims’ focus on lymphoma and leukemia.” Id. at 14. At this stage in the proceeding, we find that Patent Owner’s analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot entitled to earlier dateMixed
“reasonable likelihood that claims 1 and 9 are not entitled benefit of priority to the ’087 or earlier priority Specifications prior to the publication of the November 2018 Venclexta label. Claim 1, for example, recites a GDC-0199 dosing regimen “compris[ing] a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC- 0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.” This disclosure is not found in a single example, but must be selected from disparate parts of the Specification. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 4 (Fed Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 22
§ 102 anticipation§ 112 disclosureDiscretionary denialPatents in suitUS 11,110,087 - PTAB · Apr 18, 2023 · IPR2022-00123 · APJ Zhenyu Yang · IPR · Final written decision
The Board cancelled original claim 1 and denied substitute claim 2 for lack of written-description support; it did not reach the obviousness or enablement grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“ordinary skill is inappropriate because it “requires qualifications that exclude even the sole inventor of the ’190 Patent, Dr. Edward Neuwelt.” MTA Opp. 1. According to Petitioner, Dr. Neuwelt is “a neurosurgeon,” not a pediatric oncologist, and lacks the requisite “at least 2 years” experience in platinum-based therapies. Id. (citing Ex. 1003, 18; Ex. 1038, 98:9–17, 100:15–101, 4). We agree with Petitioner. It is well settled that inventors are typically persons skilled in the field of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner presents persuasive evidence to show that under Patent Owner’s proposed definition of the level of ordinary skill, Dr. Neuwelt, the sole inventor, would not qualify as an ordinarily skilled artisan, because he is not a pediatric oncologist, even though he is considered “one of the world leading experts on this compound [STS] and otoprotection” and “an expert in the area of [STS] as a . . . drug to use in children with medulloblastoma.” Ex. 1038, 98:9–17, 99:17–18, 101:18–102:13.” slip op. at 10
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Paragraph 102 of Dr. Rassekh’s Declaration, however, does not support Patent Owner’s assertion. Instead, Dr. Rassekh testifies that [t]he stratum of previous craniospinal radiation therapy contained 8 participants: 2 of the 4 (50%) participants receiving STS had hearing loss compared to 4 of the 4 (100%) participants not receiving STS, and none of the hearing loss assessments were changed at the 1 year follow up period. (Ex. 1001 at 20: 28-32, 47-50.) Ex. 2024 ¶ 102. Dr. Rassekh offers no opinion on how many osteosarcoma patients with prior cranial irradiation and how many medulloblastoma patients with prior cranial irradiation had hearing loss.” slip op. at 20
- 112 supportMotion to amend, deniedDenied
“In sum, we find the disclosures of the ’243 application that Patent Owner relies on do not provide sufficient written-description support for the ototoxicity efficacy limitation.” slip op. at 21
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“F. Petitioner’s Asserted Unpatentability Grounds In light of our determination above that Patent Owner has not shown sufficient written-description support for proposed substitute claim 2 in the ’243 application, we do not reach the grounds of unpatentability set forth in Petitioner’s Opposition. See Revised MTA Opp. 17–25 (alleging non-enablement and obviousness).” slip op. at 26
§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,596,190 - PTAB · Feb 8, 2023 · IPR2022-01335 · APJ Arthur M Peslak · IPR · Institution
The Board instituted IPR on claims 19, 20, and 37–52 based on the §103 combination of Hardin and Salmre, finding a reasonable likelihood of prevailing.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Considering the Petition, the arguments presented in the Preliminary Response, as well as all supporting evidence, we conclude that the information presented in the Petition establishes that there is a reasonable likelihood that Petitioner would prevail in its challenge of at least one claim of the ’447 patent as unpatentable. Pursuant to 35 U.S.C. § 314, we hereby institute an inter partes review of all Challenged Claims of the ’447 patent on the ground stated in the Petition.” slip op. at 3
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“(1) Petitioner asserts that substantially the same two claim limitations lack written description support in the ’094 application and U.S. Patent Application No. 13/856,392 (“the ’392 application”) (compare Pet. 23–29, with IPR2022-01333, Paper 4 (petition) at 23–28); (2) Petitioner asserts that because these limitations lack written description support in the ’094 and ’392 applications, the Challenged Claims are not entitled to the priority date of either of these applications and, therefore, Hardin ’665 (the pre-issuance publication of the ’094 application) is available as prior art to the Challenged Claims (compare Pet. 1, 2, 28–29, with IPR2022-01333, Paper 4 at 1, 2, 28–29);” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“(3) Petitioner asserts that the same combination of references— Hardin ’665 and Salmre—would have rendered the subject matter of the claims challenged in each petition obvious to one of ordinary skill in the art at the time of the invention (compare Pet. 29–64, with IPR2022-01333, Paper 4 at 29–66); (4) Petitioner asserts the same reasons with rational underpinning as to why one of ordinary skill in the art would have been motivated to combine the teachings of Hardin ’665 and Salmre as proposed with a reasonable expectation of success (compare Pet. 65–71, with IPR2022-01333, Paper 4 at 66–71);” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“that we should exercise our discretion to deny institution pursuant to 35 U.S.C. § 314(a) and Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (compare Prelim. Resp. 61–66, with IPR2022-01333, Paper 9 at 61–66);” slip op. at 16
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,984,447 - PTAB · Feb 7, 2023 · IPR2022-01327 · APJ Bart A Gerstenblith · IPR · Institution
The Board instituted review of claims 1–9, 29, and 30 on the § 103 ground over Hardin ’665 and Salmre.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have reviewed Petitioner’s uncontested argument and evidence regarding the teachings of Hardin ’665 and Salmre, and we find, for the reasons provided by Petitioner and on the preliminary record before us, that Petitioner has shown sufficiently that the combined teachings of Hardin ’665 and Salmre satisfy the elements of the claims, and that one of ordinary skill in the art would have had a reason with rational underpinning to combine the teachings as proposed by Petitioner with a reasonable expectation of success.” slip op. at 33
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Analogous artInstituted
“Differences Between the Prior Art and the Claims; Motivation to Modify Petitioner sets forth a detailed analysis showing how the combined teachings of the references meet the elements of claims 1–9, 29, and 30. Pet. 28–63. In particular, Petitioner relies on Hardin ’665 as teaching most of the elements of the claims, but relies, on Salmre to meet the claim elements reciting application programs on mobile devices that can reserve geographic areas and a content delivery platform that can be implemented on the same mobile device as the application program. Id. at 29. Additionally, Petitioner contends that one of ordinary skill in the art would have been motivated to combine the teachings of Hardin ’665 and Salmre with a reasonable expectation of success. Id. at 63–69.” slip op. at 33
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Differences Between the Prior Art and the Claims; Motivation to Modify Petitioner sets forth a detailed analysis showing how the combined teachings of the references meet the elements of claims 1–9, 29, and 30. Pet. 28–63. In particular, Petitioner relies on Hardin ’665 as teaching most of the elements of the claims, but relies, on Salmre to meet the claim elements reciting application programs on mobile devices that can reserve geographic areas and a content delivery platform that can be implemented on the same mobile device as the application program. Id. at 29. Additionally, Petitioner contends that one of ordinary skill in the art would have been motivated to combine the teachings of Hardin ’665 and Salmre with a reasonable expectation of success. Id. at 63–69.” slip op. at 33
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“Objective Considerations of Nonobviousness Neither party presents evidence of objective considerations of nonobviousness at this stage of the proceeding.” slip op. at 34
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSRPatents in suitUS 10,049,387 - Boehringer Ingelheim Animal Health USA Inc. v. Kansas State University Research FoundationAll claims unpatentablePTAB · Jan 31, 2022 · PGR2020-00076 · APJ Erica A Franklin · PGR · Final written decision
Claims 1–16 are unpatentable under § 112(a) for lack of written description; the Board did not reach the remaining grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“As noted by the Drs. Nordgren and HogenEsch, the differences in these descriptions are “relatively minor.” See Ex. 1038, 238:21–24; Ex. 1039 ¶ 42. Dr. Nordgren explains that even under the higher skill level required by Patent Owner’s description of a POSITA, his opinions would not change. Id. at 1039 ¶ 42. Based upon our review, the differences in Petitioner’s and Patent Owner’s proposed definitions do not impact Petitioner’s grounds for unpatentability or Patent Owner’s responsive arguments. Nor does our consideration of the issues presented turn on which proposed definition is applied. In any event, having considered the evidence and the arguments, we find Patent Owner’s rationale for its more narrow description of the level of ordinary skill in the art to be persuasive and Patent Owner’s description of a person of ordinary skill in the art, while maintaining that the 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 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“In the Patent Owner Response, Patent Owner asserts that Petitioner’s proposed construction is actually a subject matter eligibility argument. PO Resp. 23. According to Patent Owner, “[t]he term ‘porcine circovirus type 3 recombinant protein’ has a plain and ordinary meaning of ‘genetically engineered PCV3 protein.’” Id. (citing Ex. 2052 ¶¶ 91–92). Having considered the positions of both parties, and the evidence of record, we find that for purposes of this Decision, the ordinary and customary meaning of the claim term “porcine circovirus type 3 recombinant protein,” is a PCV3 protein obtained by genetic engineering, and specifically by recombinant technology, wherein the recombinant protein may either have the same structure and same amino acid sequence as variation therein. See Ex. 1026 ¶¶ 217–218; Ex. 1038, 264:2–9, 266:13– 267:3). 2.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“In the Patent Owner Response, Patent Owner asserts that “[a] POSITA would have understood ‘the nucleotide sequence encoding [ORF1, ORF2 or ORF3]’ to mean ‘a nucleotide sequence having at least 90% sequence homology with SEQ ID NOS. 3, 5, or 7 or encoding a sequence having at least 90% sequence homology with SEQ ID NOS. 4, 6 or 8.’” PO Resp. 24 (citing Ex. 2052 ¶¶ 93–96). In support of that position, Patent Owner refers to the following Specification description: [a] preferred PCV3 ORF2 protein is that of SEQ ID NO. 6, but it is understood by those of skill in the art that this sequence, as well as those for ORF1 and ORF3 could vary by as much as 10% in sequence homology and still retain the antigenic characteristics that render it useful in immunogenic compositions. Patent Owner asserts, according to that Specification description, “the sequences described and identified by SEQ ID Nos. in the patent for PCV3 ORF1, ORF2 and ORF3 are representative sequences, and ‘ORF1,’ ‘ORF2’ and ‘ORF3’ in the patent also refers to those sequences with at least 90% sequence homology.” Id. (citing Ex. 2052 ¶ 95; Ex. 2006, 107:9–17). Further, Patent Owner asserts this interpretation is consistent with the language of the other claims. In particular, Patent Owner refers to the limitation in claim 1 reciting that the composition comprises a PCV3 recombinant protein selected from “ORF1, ORF2 and ORF3, wherein said protein is encoded by a nucleotide sequence having at least 90% sequence homology with a sequence selected from the group consisting of SEQ ID NO. 3, SEQ ID NO. 5, SEQ ID NO. 7.” Id. (quoting Ex. 1001, 71:14–21). Having considered the positions of the parties, and the evidence of record, we agree with Patent Owner that the Specification provides clarity and meaning for the use of the terms ORF1, ORF2, and ORF3, which are not set forth or defined in claim 4, from which claim 5 depends, or in claim 5. Petitioner, in its alternative argument regarding the construction of the phrase involving those terms in claim 5, agrees to some extent. See Pet. 26. For purposes of this Decision, and for the reasons discussed by Patent Owner, we construe the claim phrase “nucleotide sequence encoding ORF1, . . . ORF2, and . . . ORF3” recited in claim 5 as meaning “a nucleotide sequence having at least 90% sequence homology with SEQ ID NOS. 3, 5, or 7 or encoding a sequence having at least 90% sequence homology with SEQ ID NOS. 4, 6 or 8.”” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“We do not find that description to be adequate. Essentially, the Specification description that the sequences for PCV3 ORF 1, 2, and 3, could vary by as much as 10% sequence homology just rephrases what is claimed in terms of those sequences having at least 90% sequence homology, adding only that antigenic characteristics are retained that render it useful for immunogenic compositions. A claim, however, “does not become more descriptive by its repetition,” see Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568), and “a definition of a useful result rather than a definition of what achieves that result” does not sufficiently Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed. Cir. 2002)). As noted by Petitioner and Dr. Nordgren, the ’351 patent discloses nucleotide and amino acid sequences corresponding only to the naturally-occurring PCV3 ORFs 1–3. PO Resp. 52; Ex. 1026 ¶ 168. While those sequences may be characterized as “reference” sequences, as they reflect sequences with 100% homology with PCV3 ORFs 1–3, Patent Owner has not demonstrated that they are “representative” sequences for the broad range of sequences claimed. We find that the Specification does not reasonably convey that the inventor made or was otherwise in possession of any of the remaining members of the genus with at least 90% sequence or amino acid homology with ORFs 1–3. PO Resp. 53; Ex. 1026 ¶ 168. We find that Dr. Nordgren credibly characterizes the Specification, as follows: [T]he ’351 Patent outlines a preliminary research plan to eventually make and use the broad range of claimed proteins. That is, the inventor provides a number of DNA and primer sequences that could be used to clone homologous DNA sequences into an expression vector, and theorizes that proteins expressed from sequences having 90% sequence homology will be antigenic. Critically, however, the ’351 Patent does not disclose which of the thousands of different claimed homologous sequences, if any, the inventor possessed, much less had discovered to be antigenic. Instead, the inventor merely proposes, without any factual support, that PCV3-derived amino acid sequences “could vary by as much as 10% in sequence homology and still retain the[ir] antigenic characteristics.” Ex. 1001 at 8:49-56. A POSITA would not credit that unsupported speculation, and therefore would not believe that the inventors possessed such a wide range of proteins.” slip op. at 33
Patent outcomesUS 10,450,351 unpatentableClaim construction§ 112 disclosurecites GrahamPatents in suitUS 10,450,351 - Lassen Therapeutics 1, Inc. v. Singapore Health Services Pte Ltd., And National University Of SignaporeInstitution deniedPTAB · Feb 6, 2020 · PGR2019-00053 · APJ Jamie T Wisz · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that claims 1–10 were unpatentable on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4(a). We may not institute a post-grant review 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.” 35 U.S.C. § 324(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we determine that the information presented fails to demonstrate it is more likely than not that at least 1 of the challenged claims of the ’603 patent is unpatentable. Accordingly, we deny institution of post-grant review of claims 1–10 of the ’603 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, for purposes of the preliminary response only, it does not challenge Petitioner’s definition of a person of ordinary skill in the art. Prelim. Resp. 19. Based on the current record and for the purposes of this Decision, we adopt Petitioner’s proposed description of the person of ordinary skill in the art. Furthermore, we find that the prior art of record reflects this level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that “Interleukin 11 receptor α (IL- 11Rα) antibody” should not be construed to include antibodies that bind to IL-11Rα of non-human species but not to the human version of this protein because such a construction does not comport with the language of claim 1, which is clearly directed to treating a human subject. See Pause Tech. v. TiVo, 419 F.3d 1326, 1331 (Fed. Cir. 2005) (rejecting interpretation of claim element that ignored “other language appearing later in the claim” in stating that ‘“[p]roper claim construction . . . demands interpretation of the entire claim in context, not a single element in isolation.’”) (citing Hockerson– Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed.Cir.1999)). Construing this term to include antibodies that bind solely to non-human IL- 11Rα would be inconsistent with a claim directed to treatment of a human. Accordingly, for purposes of this decision, we construe “Interleukin 11 receptor α (IL-11Rα) antibody” to mean “any natural or synthetic, monoclonal or polyclonal antibody made using any animal system including phage, or fragment or derivative thereof, that binds to human IL-11Rα.”” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“We agree with Patent Owner that Petitioner appears to have overlooked the ’603 patent Specification’s disclosure of anti-IL-11Rα antibodies. Specifically, the ’603 patent lists “monoclonal antibody clone 025 (Sino Biological), clone EPR5446 (Abcam), clone 473143 (R & D Systems), clones 8E2 and 8E4 described in US 2014/0219919 A1 [Edwards] and the monoclonal antibodies described in Blanc et al (J. Immunol Methods. 2000 Jul. 31; 241(1–2); 43–59).” Ex. 1001, 18:41–46; Ex. 1003 ¶ 176.6 Edwards, which Petitioner relies on for its obviousness and anticipation grounds, is directed to antibodies “that bind to IL-11Rα and neutralize IL-11 signaling.” Ex. 1008 ¶ 13. Table 1 of Edwards lists clones 8E2 and 8E4 and sixty-three other antibodies (including variants of 8E2) as “exemplary IL-11Rα-binding proteins.” Id. ¶ 362. Table 1 of Edwards also includes the sequence ID numbers for the heavy and light chains of the variable regions of each of these sixty-five clones and the amino acid sequences for each are disclosed in the sequence listing. Id. ¶ 362, p. 46– 104.7” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,106,603
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.