- Salvacion USA, Inc. v. Trutek CorpAll claims unpatentablePTAB · Dec 2, 2025 · IPR2024-00711 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–3 and 8 are unpatentable as anticipated by Chen, Baker, Wahi ’005, and, for claims 1, 2, and 8, Rolf; the Board also finds them obvious over the asserted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition of a person of ordinary skill in the art (“POSITA”) as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Based on our consideration of the full record, we maintain our determination that a POSITA at the time the application for the ’802 patent was filed “would have had at least an undergraduate degree in pharmacy, chemistry, biochemistry, biomedical engineering or a closely related field, such that the POSITA generally understand[s] pharmaceutical formulation.” Pet. 12. Additionally, we agree with Petitioner that “[a] POSITA would be familiar with the chemical ingredients in the [’802] Patent, biocidic agents, and cationic agents, have knowledge of airborne particles including viruses and bacteria, and understand electrostatic fields, electrostatic attraction and repulsion, adhesion and cohesion.” Id. (citing Ex. 1002 ¶¶ 38–39).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“of independent claims 1, 2, and 8 as limiting. Inst. Dec. 7–8. The parties do not dispute our construction of the preambles of claims 1, 2, and 8 as limiting. See generally PO Resp.; Pet. Reply 2–4. After consideration of the full trial record, we maintain our construction of the preamble of claims 1, 2, and 8 as limiting for the reasons set forth in our Institution Decision. Id. Briefly, the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body are used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.”” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“After consideration of the full trial record, we maintain our construction. From our perspective, the claims themselves support this construction as the claims expand upon the term “electrostatically inhibiting” with specific means for achieving such inhibition. Specifically, claims 1 and 2 recite electrostatically attracting the particulate matter, holding the matter in place, and inactivating the matter. Additionally, the Specification supports our construction as it describes the use of “an electrostatic field such that oppositely charged airborne particulates (including microorganisms) in the vicinity of the surface are electrostatically trapped, held thereto and one or more of the microorganisms so captured is neutralized, killed, inactivated, and rendered harmless.” Ex. 1001, 3:36–40; PO Resp. 10 n.6.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for petitioner
“We adopt the parties’ construction of “adequate impermeability” that has been accepted in the related district court litigation: “Adequate impermeability” refers to the “thin film holding harmful particles in place and inhibiting them from penetrating the thin film and contacting the skin or tissue of an individual’s nasal passages. This is done by varying the concentration of ingredients . . .[,] thereby adjusting the adhesion and cohesion of the thin film.” Pet. Reply 3 (quoting Ex. 1010, 17). Furthermore, as stated in our Institution Decision, along with that term, the claim language explains that the thin film is meant to stick to the skin or tissue and to hold the particulate matter in place. Inst. Dec. 9–10. The claim language also explains that the cohesion of the formulation is adjusted to provide adequate impermeability to the thin film. Thus, it is reasonable to consider the recited impermeability is a function of the cohesive properties of the thin film, and that such impermeability refers to a property of the thin film, i.e., inhibiting the penetration or passage of matter through it onto the skin or tissue at the application site.” slip op. at 10
Patent outcomesUS 8,163,802 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - Murray & Poole Enterprises Ltd. v. Institut De Cardiologie De MontrealAll claims unpatentablePTAB · Jan 14, 2025 · IPR2023-01064 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–50 are unpatentable: claims 27, 29–36, and 39 are anticipated by the COLCOT protocol; claims 1–50 are obvious over Nidorf, COLCOT Protocol, ESC Guidelines, and COLCRYS.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notTerm construed petitioner constructionDecided for petitioner
“requirement. Accordingly, we adopt Petitioner’s interpretation that the preamble simply describes the patient population that is to receive treatment. 2. “reducing the risk of a stroke” Petitioner contends that the limitation of “reducing the risk of a” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“applied art did teach that “[p]atients administered colchicine were at a lower risk of a cardiovascular event, such as MI, relative to a patient not being administered colchicine.” Ex. 1002, 398 (citing Ex. 1028). This third wherein clause was not entered in response to any rejection made by Examiner but instead is a limitation found in original claim 7. Ex. 1002, 383. Therefore, Examiner did not rely on the third wherein clause – “wherein the patient is at a lower risk of a cardiovascular event, relative to a patient not being administered colchicine” – to distinguish the claims over the prior art. Thereby, indicating that this third “wherein” clause was not material to Examiner’s patentability determination. Accordingly, we decline Patent Owner’s request that we treat the third “wherein” clause as material and limiting.” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner
“publicly accessible more than one year prior to filing date of Nov. 15, 2019. Reply 10–11. Exhibit 1006 appears to be identical to the document retrieved by Dr. Mullins using the same URL. Compare Ex. 1006 with Ex. 1073, 31–35 (attachment A-1). In addition, Dr. Mullins directed us to two contemporaneous articles that identify the same COLCOT protocol associated with the same URL. See Ex. 1073 ¶¶ 23–28 (attachment A–2 and A–3). Based on these disclosures, we determine that the totality of the evidence corroborates the testimony of Mr. Cruitt (Ex. 1038; Ex. 1072) or Dr. Mullins (Ex. 1073), or both, and is sufficient to show that Exhibit 1006 was publicly accessible more than one year prior to the filing date of the ’063 patent. Accordingly, we are not persuaded by Patent Owner’s contention that the COLCOT protocol is not prior art.” slip op. at 62
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“this strict standard for inherent anticipation. COLCOT merely provides an invitation to perform the clinical study.” PO Resp. 24 (citing In re Montgomery, 677 F.3d 1375, 1380 (Fed. Cir. 2012) citing Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (“[a]n invitation to investigate is not an inherent disclosure”)). Patent Owner contends that we should consider the COPS (Colchicine in Patients With Acute Coronary Syndromes) study, a post filing date study that published November 17, 2020, to arrive at the conclusion that the COLCOT protocol does not show a reduction in the risk of stroke. See id. at 24–26 (citing Ex. 2056).” slip op. at 27
Patent outcomesUS 11,400,063 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 11,400,063 - Salvacion USA, Inc. v. Trutek Corp.InstitutedPTAB · Dec 6, 2024 · IPR2024-00711 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1–3 and 8 on all asserted grounds, finding a reasonable likelihood that Chen anticipates or renders obvious each challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Accordingly, we determine that Petitioner has shown a reasonable likelihood of prevailing in its challenge of claims 1–3, and 8 as anticipated by, or obvious over Chen.” slip op. at 24
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not specifically address or dispute Petitioner’s proposed definition or a person of ordinary skill in the art. See generally Prelim. Resp. At this stage of the proceeding, we adopt Petitioner’s proposed level of ordinary skill in the art as we find it consistent with the cited prior art and it is undisputed on this record. 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” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“of independent claims 1, 2, and 8 are limiting. Prelim. Resp. 7. According to Patent Owner, for these claims, the preamble “recites specific steps in the process that are not recited in the body of the claim or are recited in a way particulate matter; infecting an individual through nasal inhalation; formulation is applied to the skin or tissue of nasal passages; and a thin film.” Id. Petitioner does not allege any contention regarding whether the preamble is limiting. See Pet. 14–16. Based on our review, we agree with Patent Owner that the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body have been used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.” Id.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“one “biocidic agent.” Petitioner asserts that this term means “an agent which has the capacity to neutralize, inactivate, render harmless or kill airborne particles, which include microorganisms, for example viruses and/or bacteria.” Pet. 14. Patent Owner asserts that the term refers to “a chemical substance that destroys or inhibits the growth or activity of living organisms.” Prelim. Resp. 12 (citing Merriam-Webster Dictionary). Independent claim 2 recites a formulation comprising at least one “cationic agent.” Dependent claim 3 recites that the “cationic agent is a polymeric quaternary ammonium compound.” Patent Owner asserts that a “cationic agent” is “a chemical substance that creates a positive electrostatic term. Based on our review, we determine that an explicit construction is not necessary for purposes of our determination whether to institute an inter partes trial, as there is no dispute as to whether the prior art discloses formulations comprising a biocidic agent and a cationic agent.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - 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 - Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc.Institution deniedPTAB · Sep 24, 2024 · PGR2024-00019 · APJ Ulrike W Jenks · PGR · Institution
The Board denied institution of PGR on claims 1–20 because the Petition did not show they were more likely than not unpatentable on any asserted 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 failed to demonstrate that it is more likely than not that claims 1–20 of the ’803 patent are unpatentable. Accordingly, we deny institution of a post-grant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“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 ’803 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” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 20. Patent Owner also does not construe and based on the record before us, we determine that none of the claim terms requires 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 successMotivation not foundReasonable expectation not foundNot shown unpatentable
“their cross ultimately resulted in the inbred variety 1PFLQ21. The ’803 patent explains that after the initial crossing of the parental lines, the selection of the progeny was based on genetic analysis predicting disease, insect, and agronomic phenotypic performance. Id. 37:64–66. “Inbred 1PFLQ21 was developed by producing a doubled haploid from the F1 plants, selfing and using pedigree selection amongst the D1 lines, and selfing and bulking from the subsequent generations.” Id. 37:66–38:3. The ’803 patent specification, therefore, makes it clear that simply crossing both parental inbred maize lines is not reasonably expected to result in the claimed inbred maize variety; rather, it explains that more plant breeding work is required to arrive at the 1PFLQ21 inbred maize line than just having both parental inbred maize lines available.” slip op. at 15
Claim construction§ 101 eligibility§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,659,803 - Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc.Institution deniedPTAB · Sep 24, 2024 · PGR2024-00020 · APJ Jeffrey W Abraham · PGR · Institution
Denied institution of PGR on claims 1–20 because Petitioner did not show a reasonable likelihood equivalent under § 324 that any challenged claim was unpatentable.
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 ’020 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 adoptedOther
“Petitioner asserts that a person of ordinary skill in the art “had a high 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 ¶¶ 19–21). 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,” but “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 ’020 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” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 22. 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 successMotivation not foundNot shown unpatentable
“Based on these disclosures in Smalley, we agree with Petitioner that a person of ordinary skill in the art would have understood that the parental line PH1D84 could have been used as a starting point to arrive at other inbred lines. See Pet. 41. Petitioner, however, fails to demonstrate sufficiently how or why a person of ordinary skill in the art would have had a reasonable expectation of success in developing 1PFHC43 specifically, when its other parent was not known in the art at the relevant time. As Dr. Schnable explains, 1PFHC43’s genome is derived from its parents. Ex. 2004 ¶ 115. Petitioner does not address how a person of ordinary skill in the art would have been able to produce the claimed seed, including its unique genotype, without having access to PH1VNA or its genomic and phenotypic information.” slip op. at 15
Claim construction§ 101 eligibility§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,666,020 - Ovid Therapeutics Inc. v. Marinus Pharmaceuticals, Inc.Institution deniedPTAB · Sep 20, 2024 · IPR2024-00726 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–21 were unpatentable under any of the three asserted obviousness grounds.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Based upon our review of the arguments and an examination of the claim language itself, the written description, and the prosecution history, we determine that the record supports finding that the entire “wherein” clause recited in independent claim 1 is limiting. This clause recites, wherein the effective amount of ganaxolone is administered as an intravenous bolus plus continuous infusion to produce and maintain a ganaxolone plasma concentration of about 500 ng/ml to about 1000 ng/ml for about 8 hours to about 12 hours.” slip op. at 10
- Skill levelOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) at the time the application for the ’100 patent was filed “would have had a medical degree or a Ph.D. in pharmacology or fields related to the development of pharmaceuticals and would have been familiar with the PK [pharmacokinetics] and PD [pharmacodynamics] of pharmaceuticals.” Pet. 18. Additionally, Petitioner asserts “[a] POSA also would have had several years of experience as a practicing neurologist treating patients who suffer from seizure disorders, including SE, and/or several years of experience in researching treatments for such seizure disorders.” Id. (citing Ex. 1002 ¶ 50). According to Patent Owner, a person of ordinary skill in the art at the time the application for the ’100 patent was filed, “would have had a medical degree, or a Ph.D. in pharmacology or other field related to the development of pharmaceuticals, or equivalent degree, and several years of with Refractory Status Epilepticus, Poster Abstract F53, 37 J. CLIN. NEUROPHYSIOLOGY 332 (July 2020) (Ex. 1009, “Husain 2020”). experience as a practicing neurologist treating patients who suffer from seizure disorders including status epilepticus and/or several years of experience in researching treatments for such seizure disorders.” Prelim. Resp. 17–18 (citing Ex. 2011 ¶ 44). We note that the parties’ proposed definitions are largely similar, except that Patent Owner additionally recognizes “an equivalent degree” as an alternative to a medical degree or Ph.D. in pharmacology or other field related to the development of pharmaceuticals. Compare Pet. 18 with Prelim. Resp. 17–18. We do not need to resolve this issue as our findings and conclusion in this Decision would be the same under either proposed definition.” slip op. at 7
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“agree with Patent Owner that Petitioner has not shown sufficiently for institution that the claimed invention would have been obvious over the combined teachings of During and NCT03350035. As discussed above, in Section II.B., we have determined that the “wherein” clause of independent claim 1 is liming. In other words, the claim requires that the effective amount of ganaxolone is administered as an IV bolus plus continuous infusion and that such administration produces and maintains a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. With respect to the recited plasma concentration limitation, Petitioner has alleged only that it is met inherently. Dr. Sankar has only offered the same conclusory position in his declaration. See Ex. 1002 ¶¶ 113, 115. While “inherency may supply a missing claim limitation in an obviousness analysis,” this doctrine “must be carefully circumscribed in the context of obviousness.” PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 1194–1195 (Fed. Cir. 2014). As the Federal Circuit has explained: The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. Id. at 1195 (quoting In re Oelrich, 666 F.2d, 578, 581 (C.C.P.A. 1981). Here, Petitioner and Dr. Sankar have not explained or demonstrated why or how the natural result of administering the dosages in During according to the method disclosed in NCT03350035 would produce and maintain a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. This deficit is more pronounced in view of the Specification disclosure of a Phase 2 Open-Label Dose Range Study that exemplifies how some ganaxolone dosages that suppressed SE did not produce and maintain ganaxolone plasma concentrations ≥ 500 ng/ml for about 8 to 12 hours. See Ex. 1001, Fig 15; see also Ex. 1001, 55:13–56:30. Thus, because Petitioner relies on inherency for the plasma concentration limitation without providing evidence that such inherency exists, Petitioner has failed to establish sufficiently for institution that During and NCT03350035 teach or suggest each limitation of the claim 1. Accordingly, we determine that Petitioner has not shown a reasonable” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“agree with Patent Owner that Petitioner has not shown sufficiently for institution that the claimed invention would have been obvious over the combined teachings of During and NCT03350035. As discussed above, in Section II.B., we have determined that the “wherein” clause of independent claim 1 is liming. In other words, the claim requires that the effective amount of ganaxolone is administered as an IV bolus plus continuous infusion and that such administration produces and maintains a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. With respect to the recited plasma concentration limitation, Petitioner has alleged only that it is met inherently. Dr. Sankar has only offered the same conclusory position in his declaration. See Ex. 1002 ¶¶ 113, 115. While “inherency may supply a missing claim limitation in an obviousness analysis,” this doctrine “must be carefully circumscribed in the context of obviousness.” PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 1194–1195 (Fed. Cir. 2014). As the Federal Circuit has explained: The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. Id. at 1195 (quoting In re Oelrich, 666 F.2d, 578, 581 (C.C.P.A. 1981). Here, Petitioner and Dr. Sankar have not explained or demonstrated why or how the natural result of administering the dosages in During according to the method disclosed in NCT03350035 would produce and maintain a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. This deficit is more pronounced in view of the Specification disclosure of a Phase 2 Open-Label Dose Range Study that exemplifies how some ganaxolone dosages that suppressed SE did not produce and maintain ganaxolone plasma concentrations ≥ 500 ng/ml for about 8 to 12 hours. See Ex. 1001, Fig 15; see also Ex. 1001, 55:13–56:30. Thus, because Petitioner relies on inherency for the plasma concentration limitation without providing evidence that such inherency exists, Petitioner has failed to establish sufficiently for institution that During and NCT03350035 teach or suggest each limitation of the claim 1.” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,110,100 - Foresight Diagnostics, Inc. v. Personalis, Inc.All claims unpatentablePTAB · Jun 12, 2024 · IPR2023-00317 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–23 are unpatentable: claims 1–7 and 10–23 as anticipated by Forshew, and claims 1–23 and 1–9 and 11–23 as obvious over Forshew with Wagle and Wagle with Chan, respectively.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner has not subsequently challenged the above definition. See Ex. 2031 ¶ 48 (Dr. Furneaux applying the above definition). For the reasons set forth in our Institution Decision, and because Petitioner’s proposed level is commensurate with the level of skill reflected in the prior art of record, we apply the same definition here. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). C. Claim Construction” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“adopt Petitioner’s proposed definition of “capture probes” as encompassing at least, “PCR primer capture probes and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits).” See DI 18–24. For the reasons set forth in our Institution Decision, and as further addressed below, we apply that definition here—albeit with a minor modification in wording. In particular, we credit Patent Owner’s argument that the phrase “PCR primer capture probe” is not a recognized term of art and its use in our construction “would improperly inject ambiguity into the claim.” POR 58– 59 (citing, e.g., Ex. 2018, 166:10–169:1, 171:16–175:2; Liquid Dynamics Corp. v. Vaughan Co., 355 F.3d 1361, 1367 (Fed. Cir. 2004)). Although we recognize Petitioner’s use of “PCR primer capture probe” as a shorthand for its position that, as read in light of the Specification, PCR primers are a species of, and/or indistinguishable from, the genus of capture probes, Patent Owner’s point is well taken. Accordingly, we clarify the meaning of “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). We do not view this modification as altering the substance of our provisional construction or the analysis in our Institution Decision.” slip op. at 11
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner
“Ex2112, slide 5 for the ‘plurality of capture probes’ limitation of step 1(a),” Petitioner contends that its “bare reference to ‘pullout’” suggests at most, “that by May 2012, Mr. West contemplated that a particular type of capture probe would be among many other ‘lab solutions’ for addressing accuracy.” Reply 7–8; see Ex. 1225 ¶¶ 123–126. In this respect we note Mr. West’s testimony that he understood “pullout” in Slide 5, as a reference to Agilent SureSelect biotinylated probe system. See Ex. 1222, 83:8–85:22, 88:7–16. We, nevertheless, find persuasive Dr. Quackenbush’s testimony that “a POSA reviewing Slide 5 in light of the overall record on conception would have insufficient information to determine how, specifically, Personalis intended to use the ‘Pullout,’ other than that their purpose was to provide a laboratory solution to improve the accuracy of 2012 sequencing technology in some way.” Ex. 1225 ¶ 125. Considering the evidence of record, we credit Dr. Quackenbush’s testimony that a person of ordinary skill in the art reading Personalis’ conception exhibits, including Exhibit 2112, “would have found, at most, an incipient research project for improving the accuracy of sequencing technology that would involve the use of an undefined combination of various conventional techniques.” Ex. 1225 ¶ 128. In addition to Dr. Quackenbush’s testimony as to claim steps involving capture probes (elements 1(a)–1(c)), we further find persuasive his testimony that Patent Owner provides no corroboration of the conception of steps 1(d)–1(f), which require assaying samples obtained from the same individual obtained at different time points. See id. ¶¶ 120–121, 126–127; Reply 9–10; Sur-Reply 6–8 (citing, e.g., Ex. 2032 ¶¶ 91–134; Ex. 2109; Ex. 2112; Ex. 2036). In sum, we find that Personalis’ exhibits and related testimony do not evidence sufficient conception of the invention set forth in the challenged claims. See, e.g., Ex. 1225 ¶¶ 120–128 (Dr. Quackenbush’s testimony about missing aspects of the claims in Patent Owner’s proofs, such that the “completed thought” is not shown).15 Considering the above, we find that Patent Owner has not satisfied the burden of establishing that its claimed invention is entitled to a priority date that precedes either of the respective publication dates of Forshew and Chan. Accordingly, Forshew and Chan qualify as prior art to the ’033 patent.” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In Section II.C. above, we construe “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). Accordingly, in disclosing the use of PCR primers, Forshew discloses “capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification. See Pet. 29–33 (citing Ex. 1020 ¶¶ 117–122; Ex. 1030, 2–3). Forshew further satisfies the “plurality of capture probes” “COSMIC: mining complete cancer genomes in the Catalogue of Somatic Mutations in Cancer,” 39 NAR D945-950 (2011)). limitation in disclosing the use of PCR primers for the detection and monitoring of cancer-associated alleles. See, e.g, id.; Ex. 1020, 3 (“We designed 48 primer pairs to amplify 5995 bases of genomic sequence covering coding regions (exons and exon junctions) of TP53 and PTEN, and selected regions in EGFR, BRAF, KRAS, and PIK3CA (table S1) by overlapping short amplicons (Fig. 1A).”). For the reasons set forth above, Petitioner has sufficiently shown that Forshew discloses “capture probes” and “a plurality of capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification.” slip op. at 36
Patent outcomesUS 11,408,033 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,408,033 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five 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
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968
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.