- PTAB · Oct 14, 2025 · IPR2025-00688 · APJ Avelyn M Ross · IPR · Institution
The Board instituted IPR on claims 1–18 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“The mere existence of some relationship between a petitioner and another entity, however, is not sufficient to place that petitioner in privity with that entity. Google LLC v. DDC Technology, LLC, IPR2023-00707, Paper 27 at 37 (PTAB Oct. 25, 2023). Instead, that relationship must be related to an earlier lawsuit and be “sufficiently close that it can be fairly said that the petitioner had a full and fair opportunity to litigate the validity of the patent in that lawsuit” or the evidence must show “the petitioner is simply serving as a proxy to allow another party to litigate the patent validity question that the other party raised in an earlier-filed litigation.” WesternGeco, 889 F.3d at 1319.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that “[a] person of ordinary skill in the art [“POSITA”] would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 11 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition of a person of ordinary skill in the art because it is consistent with the skill level reflected in the disclosures of the ’370 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner “do[es] not, at this time, contend that any term requires construction,” and instead, states that “[a]ll terms have been accorded their plain and ordinary meaning.” Pet. 10 (citing Ex. 1002 ¶¶ 212–215). Patent Owner does not propose any constructions at this time. See generally Prelim. Resp. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner
“We are not persuaded by this argument. The Federal Circuit has instructed that [e]ntitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. It extends only to that which is disclosed. While the meaning of terms, phrases, or diagrams in a disclosure is to be explained or interpreted from the vantage point of one skilled in the art, all the limitations must appear in the specification. The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought. Lockwood, 107 F.3d at 1571–72. Here, what “a POSITA would understand,” without disclosure in the specification, is insufficient to show written-description support. Prelim. Resp. 24. Thus, on this record, and for purposes of institution, Patent Owner has not shown that the Provisional Application provides sufficient support for adding the claimed genus to the coal. 3. Summary In sum, on this record, Patent Owner has not shown that either the Provisional Application or the Pre-2018 Applications provide sufficient written-description support for the challenged claims. As a result, we determine that the ’370 patent cannot claim priority to the Provisional Application. Thus, all asserted prior art qualifies as prior art.” slip op. at 25
Claim construction§ 102 anticipation§ 112 disclosurecites PhillipsPatents in suitUS 10,933,370 - PTAB · Oct 9, 2025 · IPR2025-00425 · APJ Kristina M Kalan · IPR · Institution
The Board instituted IPR on all challenged claims and all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“After reviewing the evidence of record, we are persuaded the instant Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. 9 Petitioner asserts that the supply agreements between the Chem-Mod Purchasers and Chem-Mod expired in 2021. For the reasons discussed herein, we determine that the language of these agreements does not establish privity. In the event Patent Owner maintains its argument that the Chem-Mod Purchasers are in privity with Chem-Mod, the parties should address the legal impact, if any, of the expiration of these agreements on Patent Owner’s arguments. WesternGeco LLC, 889 F.3d at 1321 (a “contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 7–8). We acknowledge, but disagree with, Patent Owner’s argument that the terms of the indemnity “specifically targeted” the activities at the “heart of the alleged infringement.” Sur-reply 7–8. Rather, the indemnification language in these agreements appears to be standard and typical of supply agreements. See Ex. 2037, 26;10 Ex. 2038, 10–12; Ex, 2039, 10–12; Ex. 2040, 10–12; Ex. 2041, 10–12; Ex. 2042, 24–27. Such language, without more, “does not amount to a sufficiently-close relationship to warrant finding . . . privity.” WesternGeco LLC, 889 F.3d at 1321–22.” slip op. at 11
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“Patent Owner does not point to any record evidence that suggests the parties to the Delaware Action adequately represented the Chem-Mod Purchasers’ interests or that the Chem-Mod Purchasers controlled, directed, or funded the Delaware Action. See generally Prelim. Resp.; Sur-reply. Nor does Patent Owner suggest that the indemnified Petitioners are acting as a proxy for Chem-Mod and its affiliates in this case. Thus, the relationship with Chem-Mod, its affiliates, and the indemnified Petitioners was not “sufficiently close that it can be fairly said petitioner had a full and fair opportunity to litigate the validity of the patent in that lawsuit.” Google, IPR2023-00707, Paper 27 at 37. In sum, Petitioner bears the burden of demonstrating compliance with 35 U.S.C. § 312(a)(2) and § 315(b), but the current record does not provide sufficient reason to doubt Petitioner’s assertion that Chem-Mod was not “funding this petition, advising on strategy for this petition, or exercising any control over Petitioner’s decision to file the petition (or the arguments included therein).” Pet. 2; see also Reply 1–2. Indeed, the current record supports that the relationship between Chem-Mod and the Chem-Mod Purchasers was a standard supplier/customer relationship. Exs. 2037–2042. The evidence does not support that Chem- Mod negotiated a license on behalf of the Chem-Mod Purchasers or that the Chem-Mod Purchasers owned power plants that were at issue in the Delaware Litigation. Ex. 2009, 91; Ex. 2010, 107. Therefore, on this record, we determine that the relationship between Chem-Mod and the Chem-Mod Purchasers does not support that the Petition is time-barred.” slip op. at 15
- Skill levelSkill level petitioner adoptedDecided for petitioner
“may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Petitioner asserts that a person of ordinary skill in the art (“POSITA”) “would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’225 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner discusses the term “pyrolysis char” and states that, for the purposes of the Petition, it adopts and applies the Delaware court’s construction that “allow[s] for the pyrolysis char to be created within the combustor, so long as it is then present (and combusted) with the coal and the bromine compound.” Pet. 11–12 (citing Ex. 1071). Patent Owner does not appear to propose any express claim constructions. See generally Prelim. Resp. 7. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,589,225 - PTAB · Oct 6, 2025 · IPR2025-00423 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–4 and 6–29 on all asserted grounds, finding a reasonable likelihood of unpatentability based on the asserted obviousness and anticipation challenges.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“After reviewing the evidence of record, we are persuaded the instant Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. WesternGeco LLC, 889 F.3d at 1321 (“a contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 7–8).” slip op. at 12
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“In sum, Petitioners bear the burden of demonstrating compliance with 35 U.S.C. § 312(a)(2) and § 315(b), but the current record does not provide sufficient reason to doubt Petitioners’ assertion that Chem-Mod was not “funding this petition, advising on strategy for this petition, or exercising any control over Petitioners’ decision to file the petition (or the arguments included therein).” Pet. 2; see also Reply 2. Indeed, the current record supports that the relationship between Chem-Mod and the Chem-Mod Purchasers was a standard supplier/customer relationship. Exs. 2037–2042. The evidence does not support that Chem-Mod negotiated a license on behalf of the Chem-Mod Purchasers or that the Chem-Mod purchasers owned power plants that were at issue in the Delaware Litigation. Ex. 2009, 91; Ex. 2010, 107. Therefore, on this record, we determine that the relationship between Chem-Mod and the Chem-Mod Purchasers does not support that the Petition is time-barred.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is 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).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 11–12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioners’ proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’430 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,668,430 - Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc.Institution deniedPTAB · Nov 1, 2024 · PGR2024-00025 · APJ Jeffrey W Abraham · PGR · Institution
The Board denied institution because Petitioner did not show that claims 1–20 were more likely than not unpatentable over either obviousness ground, for lack of utility, or as indefinite.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates 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). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’033 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist along with genetics specialists) and field-side personnel.” Pet. 15 (citing Ex. 1003 ¶¶ 19–22, 44–45). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 15. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 25. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’033 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level”” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not offer a specific construction for any claim terms. Pet. 19–20. Rather, Petitioner contends that “the outer boundary of the Challenged Claims lacks reasonable certainty,” and, therefore, “the Challenged Claims are unpatentable as indefinite under §112(b).” Pet. 20. Petitioner further contends that the challenged claims are unpatentable as obvious “regardless of the outer boundary of the claims.” Pet. 21. Patent Owner disagrees with Petitioner’s arguments regarding indefiniteness, and does not construe any claim terms. See generally Prelim. Resp. As explained in detail below, based on the record before us, we are not persuaded by Petitioner’s indefiniteness arguments, and determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable
“Patent Owner is correct that Petitioner focuses its obviousness challenge on 1PNZQ23’s phenotype, and does not address its genotype. Prelim. Resp. 41–42; see Pet. 26–32 (comparing 1PNZQ23’s phenotype with the phenotypes of the asserted prior art). Petitioner does not direct us to, nor do we discern, any information in the Petition or Reply regarding 1PNZQ23’s genotype that supports Petitioner’s arguments regarding obviousness. Furthermore, Patent Owner offers information suggesting that “the breeding of 1PNZQ23 was unpredictable even with both parents being known in the art.” Prelim. Resp. 47. Dr. Schnable addresses unpredictability in the breeding process, stating: distinct even when the F1 plant itself results from a cross of two inbreds. A [person of ordinary skill in the art] would not expect that a cross of the same parents will produce F2 or D1 progeny identical to 1PNZQ23. . . . [T]he genome of a progeny plant is the result of genetic segregation and recombination in the F1 plant of the two parental genomes and the chance of the exact same child resulting from that initial biparental cross is infinitesimally small. Ex. 2004 ¶ 123. This information undermines Petitioner’s arguments regarding an expectation of success in achieving the claimed invention.” slip op. at 13
Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,707,033 - Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc.Institution deniedPTAB · Oct 15, 2024 · PGR2024-00023 · APJ Jeffrey W Abraham · PGR · Institution
The Board denied institution on claims 1–20 because the petition did not show they were unpatentable on any asserted obviousness, utility, written-description, or enablement ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates 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). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’545 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist as along with genetics specialists) and field-side personnel.” Pet. 16 (citing Ex. 1003 ¶¶ 50–51). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 16. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 24. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’545 patent, and we adopt it for purposes” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.200(b) (2019). Under that standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 21. Patent Owner also does not construe any claim terms. See generally Prelim. Resp. For purposes of this Decision, and based on the record before us, we determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable
“additional reasons. For example, we agree with Patent Owner that Petitioner fails to demonstrate sufficiently that a person of ordinary skill in the art would have had a reasonable expectation of success in arriving at PH4CYJ based on Smalley’s disclosure alone. Prelim. Resp. 51–52. According to the ’545 patent specification, the claimed PH4CYJ inbred maize variety is a cross between inbred line PH1VNA and inbred line PH1KTF. Ex. 1001, 37:62–64. In the simplest terms, PH1VNA and PH1KTF are the parents, and their cross ultimately resulted in the inbred variety PH4CYJ. The ’545 patent explains that after the initial crossing of the parental lines, the” slip op. at 14
Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 11,696,545 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision
The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner
“d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32
Patent outcomesUS 11,110,087 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087 - Guardant Health, Inc. v. University Of WashingtonAll claims unpatentablePTAB · Jan 11, 2024 · IPR2022-01158 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–28 are unpatentable because Eltoukhy anticipates them; the Board found they were not entitled to a priority date before Eltoukhy’s publication.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that an ordinarily skilled artisan “would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields.” Pet. 8–9 (citing Ex. 1002 ¶ 38). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 2 (citing Ex. 2023 ¶¶ 21, 22). After reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“1. “Sequence Reads” Petitioner argues that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 10–11. Petitioner, however, seeks to provide context for understanding the scope of the term “sequence reads.” Specifically, Petitioner contends that “sequence reads” are produced by sequencing at least some of the tagged strands, whereas “consensus sequences” are generated by collapsing sequence reads. Id. at 11 (citing Ex. 1001, 4:45–47, 20:50–22:25, 23:29–57, 24:46–48, claim 1, claim 6). In the Decision to Institute, we agreed with Petitioner that “[t]he claims of the ’951 patent as well as the specification make clear that a ‘sequence read’ is different and distinct from a ‘consensus sequence.’” DI 7 (quoting Pet. 11). Patent Owner does not dispute Petitioner’s assertion. PO Resp. 12. Based on the complete record, we see no reason to change our determination of the scope of the term “sequence reads.”” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“We disagree with Patent Owner’s proposed construction of the terms “paired sequence reads” and “unpaired sequence reads.” Even though the ’951 patent Specification discloses grouping sequence reads “sharing a unique set of SMI tags” into paired families,4 “[t]he written description part of the specification itself does not delimit the right to exclude. That is the function and purpose of claims.” Phillips, 415 F.3d at 1312 (“[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude.”). Here, claim 1 explicitly defines the terms “paired sequence reads” and “unpaired sequence reads.” Indeed, in the context of paired versus unpaired sequence reads, claim 1 specifies that the complementarity is related to the “original parent polynucleotide molecule,” and not the duplex tags. For example, claim 1 recites that “each unpaired read represents a first tagged strand having no second differently tagged complementary strand derived from an original parent polynucleotide molecule represented among said sequence reads in said set of sequence reads.” Ex. 1001, 37:50–55 (emphasis added). Thus, the plain claim language contradicts Patent Owner’s argument” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Claim 1 defines the terms “paired sequence reads” and “unpaired sequence reads” based on the complementarity of the target sequence strands derived from the “original parent polynucleotide molecule.” Ex. 1001, 37:46–55. As explained above, we reject Patent Owner’s contention that a sequence read is considered unpaired solely based on the complementarity of the SMI tags. See supra Section II.C.2. Due to the “errors introduced during sample preparation and sequencing” (Ex. 1029 ¶ 5), there are four outcomes when determining the complementarity of the sequence reads of two strands of SMI-linked target sequence: (1) the first SMI tag and the first strand target sequence are complementary to the second SMI tag and the second strand target sequence, respectively; (2) the first SMI tag is complementary to the second SMI tag but the first strand target sequence is not complementary to the second strand target sequence; (3) the first SMI tag is not complementary to the second SMI tag but the first strand target sequence is complementary to the second strand target sequence; and (4) the first SMI tag is not complementary to the second SMI tag, and the first strand target sequence is not complementary to the second strand target sequence. It is undisputed that Schmitt groups sequence reads into paired families based on the SMI tags, and Schmitt only considers sequences in which “information from both DNA strands was in perfect agreement.” Ex. 1029 ¶¶ 14, 96; PO Resp. 18. Thus, among the four outcomes, only scenario (1), in which both the SMI tags and the target sequences are complementary, represents a “paired sequence read,” which claim 1 defines as corresponding to “sequence reads generated from a first tagged strand and a second differently tagged complementary strand derived from an original parent polynucleotide molecule.” Ex. 1001, 37:46–50. Contrary to Patent Owner’s argument (see PO Resp. 26), in Schmitt,” slip op. at 18
Patent outcomesUS 10,752,951 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,752,951 - Painteq, LLC v. Orthocision, Inc.All claims unpatentablePTAB · Dec 1, 2023 · IPR2023-00451 · APJ Michael A Valek · IPR · Final written decision
Claims 1–23 are unpatentable as obvious over Vestgaarden-981, Vestgaarden-818, and Lins, with Paltzer additionally applied to claims 6, 7, and 10–23.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s description of the level of ordinary skill in the art is sufficiently supported by the record. Therefore, we apply that understanding in our analysis herein.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner submits that the parties have submitted joint claim construction in the Florida litigation, and asserts that “[t]he grounds set forth in this [P]etition render the challenged claims obvious under either party’s construction.” Pet. 8 (citing Ex. 1002 ¶ 34; Ex. 1017). Nevertheless, Petitioner urges that “express construction is not necessary.” Id. at 7. We agree that no express construction is required for this decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We agree with Petitioner. Figures 30, 32A and 32B in the Specification depict a working channel with tangs 180a and 180b. See Ex. 1001, Figs. 30, 32A–B. These figures and all of the related description in the Specification describing a working channel with tangs appear in the Parent (Ex. 1006, Figs. 30, 32A–B, 3:17–21, 6:47–54, 15:25–51), but not in the Grandparent. See also Ex. 1002 ¶¶ 42–43 (explaining the same). Accordingly, the Grandparent application does not provide sufficient written description for the limitations requiring that the working channel have tangs in the independent claims. See Ex. 1001, 42:7 (limitation 1.b.4 “at least one tang on a distal end”), 43:9–11 (limitation 10.b.2 “two bilateral blunt tangs on a distal end”), 44:31–32 (limitation 18.b.2 “plurality of blunt tangs on a distal end”). For this reason, the challenged claims are not entitled to the benefit of the Grandparent’s filing date.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find that Petitioner has articulated sufficient reasoning with rational underpinning for combining the asserted references. Vestgaarden- 818 expressly incorporates the teachings of Vestgaarden-981, providing a motivation to use the implant and related tools taught in Vestgaarden-981 in its method for fusing a SI joint. Ex. 1010, 4:10–16. Moreover, we credit Dr. Bovinet’s testimony describing additional reasons for combining Vestgaarden-981’s implant and surgical implants with Vestgaaren-818’s method. Ex. 1002 ¶¶ 67–74. Petitioner’s reasoning for combining Lins’s guidance slots and protrusions is also supported by the evidence of record. Ex. 1002 ¶¶ 77–84. In particular, Dr. Bovinet persuasively testifies that a POSA would have motivated to make this combination because it “enables a surgeon to visually align the guide protrusions on a shaft with the guidance slots of the working channel,” which is “a major improvement” over the flat portion depth stop taught in Vestgaarden-981. Id. ¶ 83; see also id. ¶ 84 (“As someone who has personally performed hundreds of SI joint fusion surgeries, I can attest that the guide protrusions and guidance slots taught in Lins would offer a surgeon a significantly better user experience” as compared to Vestgaarden- 981’s flat portions). Finally, Petitioner has demonstrated that the combination would have produced a “predictable result” and therefore that a (citing Ex. 1002 ¶¶ 76, 85).” slip op. at 21
Patent outcomesUS 11,083,511 unpatentableClaim construction§ 103 obviousness§ 112 disclosurePatents in suitUS 11,083,511 - PTAB · Oct 13, 2023 · PGR2023-00022 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted PGR on claims 1–33 under all petition grounds, finding it more likely than not that at least one claim lacks written description and enablement.
RulingsInstitution decision- Skill levelSkill level board ownOther
“Based on the information presented, we agree with Patent Owner that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). We do not find it necessary to define the level of skill in the art at the time of the invention at this time. However, for purposes of deciding whether to institute trial, we find that Dr. Silverstone is qualified to provide helpful opinion testimony on the issues regarding which we cite his testimony in this decision. See Ex. 1003 ¶¶ 6–15.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on the above, we agree with Patent Owner that many of the arguments raised by the Examiner are highly similar to the challenges in this proceeding, particularly the written description challenge. However, some arguments differ. For instance, Petitioner’s enablement argument identifies that, contrary to Applicant’s statement during prosecution reproduced above, amino acids and protein structure outside the disclosed AAD-12 motif can also affect the activity of the claimed dioxygenases to degrade phenoxy auxin and pyridyloxy auxin. See Ex. 1003 ¶¶ 42–50, 79 (Dr. Silverstone describing the mechanics of protein binding and explaining why the ’055 patent disclosure fails to provide sufficient information to the skilled artisan to know which amino acids could be changed while retaining the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides). See also Pet. 27–34 (asserting, e.g., 85% homology to AAD-12 motif alone is insufficient to predict enzymatic degradation activity). While the Examiner’s rejections regarded the disclosure corresponding to the ability to degrade herbicides, the Examiner plainly relied on Applicant’s statements that the AAD-12 motif’s structure alone was responsible when deciding to withdraw the rejection. Ex. 1002, 355. The Examiner did not have the additional testimony supplied by the Silverstone declaration explaining otherwise. See Ex. 1003 ¶¶ 42–50, 79. Petitioner, through Dr. Silverstone, also addresses the effort the skilled artisan would have needed to undertake to determine what proteins outside of the AAD-12 motif would affect the ability of homologues to enzymatically degrade the recited herbicides, and provides evidence for consideration regarding the lack of a clear link between the AAD-12 motif and the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides. Ex. 1003, 347. Therefore, the arguments are not entirely overlapping. And while these issues do in part overlap with Petitioner’s arguments pertaining to enablement, we agree with Petitioner that the Examiner did not complete a written Wands analysis. Although we conclude that the arguments are not entirely overlapping, we proceed to the second step in the analysis, for completeness.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because Petitioner has shown that it is more likely than not that Petitioner will prevail in showing that at least one claim lacks sufficient written description and is not enabled, we conclude the challenged claims are eligible for post-grant review. V. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has shown it is more likely than not that at least one challenged claim of the ’055 patent lacks written description and is unpatentable. Accordingly, we institute a post-grant review. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a), a post-grant review of claims 1–33 of the ’055 patent is instituted with respect to all grounds set forth in the Petition; and” slip op. at 57
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“85% identity as “highly identical” in this field and that the “conserved motif residues comprise ‘the active site that is essential for catalytic activity.’” Prelim. Resp. 31 (citing Ex. 1001, 11:1–6)). However, on the record before us, we are unpersuaded that this is sufficient because the Specification lacks disclosure supporting that a polypeptide of, for example, 86% identity to SEQ ID NO: 2 would retain the ability to degrade herbicides if the 5 amino acids in the general formula of HX109D(X)111-134 T(X)136-261H(X)263-272R, and the required chain lengths are present. In this regard we are persuaded by the testimony of Dr. Silverstone (Ex. 1003 ¶¶ 48–93) regarding the limitations of the disclosure of the ’055 patent and the lack of information supporting the skilled artisan in understanding that the inventor possessed the entire claimed genus (e.g., lack of example at lower end of sequence identity and lack of information to assist the skilled artisan in predicting whether an α-ketoglutarate-dependent dioxygenase would interact with or degrade either phenoxy auxin herbicides and/or pyridyloxy auxin herbicides). Dr. Silverstone testifies, and we are persuaded on this record, that the skilled artisan would not have read the guidance in the disclosure and understood that the inventors possessed the ability to design a modified SEQ ID NO: 2 at the 85% identity level that retained the function of degrading the recited herbicides, let alone the full scope of the claimed genus. Id. Patent Owner argues that Dr. Silverstone’s testimony that conserved amino acids of the AAD-12 motif are present in other α- ketoglutarate-dependent dioxygenases but do not have the claimed dual activity (Ex. 1003 ¶ 48) is misplaced because it “ignores that the location and spacing of those residues in other αKG-dependent dioxygenases differ from those in the AAD-12 motif.” Prelim. Resp. 38. However, Patent Owner offers no evidence that supports its argument. Id. It is thus unpersuasive.” slip op. at 36
§ 112 disclosureDiscretionary denialPatents in suitUS 11,371,055 - PTAB · Aug 17, 2023 · PGR2023-00020 · APJ Jeffrey N Fredman · PGR · Institution
Instituted PGR on claims 22 and 25–31; the Board found a reasonable likelihood of success on anticipation over Zhang and obviousness grounds for claim 22.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Feb. 13, 2020) (“Advanced Bionics”) (precedential), we further apply the following two-step framework in determining whether discretionary denial under § 325(d) is appropriate: (1) 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, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Becton, Dickinson Factors (a), (b), and (d) relate to the first step, and Becton, Dickinson Factors (c), (e), and (f) relate to the second step. Id. Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Advanced Bionics, at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise [her] discretion not to institute inter partes review.” Id. at 8–9 (“If a condition in the first part of the framework [i.e., substantially same art or arguments] is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.”). “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9. An “example of a material error” could be “misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id. at 8 n.9” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . 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) (2018). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 22 and 25–31 of the ’817 patent.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We find that on the present record, the evidence more likely than not supports Petitioner’s claim interpretation which is based on the express definition of the term “patient” in the ’817 patent specification. That express definition states: “‘Patient’ and ‘subject’ are used interchangeably herein and include, but not limited to, primates such as humans, canines, porcine, ungulates, rodents, poultry, and avian.” Ex. 1001, 32:65–67.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted
“We appreciate Patent Owner’s point that for a reference to anticipate without disclosing the relevant feature of the claimed invention, it is required that the “missing characteristic is necessarily present . . . in the single anticipating reference.” Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003). In this case, Zhang demonstrates that ganaxolone continues to improve status epilepticus in rats for 5+ hours, supporting the inherency position. Moreover, the ’817 patent’s Specification shows that 10 and 20 mg/kg ganaxolone doses that bracket the 12 and 15 mg/kg ganaxolone doses tested by Zhang, result in improved 24-hour survival relative to lower doses. See Ex. 1001, Fig. 4; Ex. 1009, 21 ¶ 117. This evidence further supports Petitioner’s inherency position because it shows that doses bracketing those recited in Zhang provide continued improvement to patients for periods exceeding 8 hours. “Extrinsic evidence can be used to demonstrate what is ‘necessarily present’ in a prior art embodiment even if the extrinsic evidence is not itself prior art.” Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329 (Fed. Cir. 2020). As to the issue of whether Zhang’s teaching to treat with multiple doses also teaches “improvement to the patient after administration for more than 8 hours” as required by claim 22, on this record we find that Petitioner’s position is more persuasive. Claim 22 does not distinguish between a single administration event or multiple administrations, and therefore is reasonably interpreted as broadly open to both single administration and multiple administrations. This understanding is consistent with the ’817 patent, which teaches that “[g]anaxolone or a pharmaceutically acceptable salt thereof can be administered, e.g., once daily, twice daily, three times daily, or four times daily.” Ex. 1001, 8:35–37. Zhang teaches “[d]osing schedules in which the substituted β-cyclodextrin-ganaxolone injectable formulation is injected every 1 hr, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs, or 24 hours are included herein.” Ex. 1009, 13 ¶ 74. We agree with Petitioner that, on this record, Zhang directly demonstrates that where doses are administered every 1, 2, or 4 hours, the ganaxolone would have been expected to necessarily result in improvement in status epilepticus treatment over more than 8 hours based on the five hour efficacy results reported in Zhang. See Ex. 1009, 25 ¶ 135.9” slip op. at 27
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,395,817
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.