- 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 - Quasar Science LLC v. Colt International Clothing, Inc. D/B/A Colt LedNo claims unpatentablePTAB · Oct 7, 2024 · IPR2023-00614 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–3, 6–18, 21–24, and 27–29 were not shown unpatentable under either § 103 ground because the evidence did not establish all limitations or a reason to combine the cited teachings.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim Construction In an inter partes review, we construe a claim term “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). The parties agree that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 14; PO Resp. 10. 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 expressly construe any claim term.” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Here, Petitioner argues that a person of ordinary skill in the art (“POSITA”) would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LEDs.” Pet. 14 (citing Ex. 1003 ¶ 32). Patent Owner argues that a POSITA would have had “2 to 4 years’ experience in electrical engineering/design of film and television lighting systems, including the design and use of LED lights, combined with two to three years of work experience as a set lighting technician in television and/or motion picture industry.” PO Resp. 9 (citing Ex. 2047 ¶¶ 16–17; Ex. 2100 ¶¶ 156–161). Patent Owner does not identify any specific instance in which the differences between the parties’ respective descriptions of the level of ordinary skill in the art impacts the analysis or conclusions of either party, or either party’s declarant, in this case. In fact, Patent Owner acknowledges that any differences between the parties’ respective descriptions do not impact the conclusions in this case. Id. (“Regardless of which definition of a POSITA is applied, the conclusion(s) would be the same.”). For purposes of this Decision, and to the extent necessary, we adopt Petitioner’s definition of a POSITA because it is consistent with the prior art’s demonstration of the skill level at the time of the invention.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“would have been obvious to combine the cited teachings of Kit and Katzir. Petitioner argues that “Katzir further discloses daylight and tungsten temperature ranges within the claimed temperature ranges.” Pet. 24 (citing Ex. 1006 ¶¶ 53, 54, Figs. 5A, 5B). Petitioner relies on the Holmes Declaration to show that “[a] POSITA would have been motivated to look to Katzir to design an LED array to be retrofit in a fluorescent tube.” Id. at 19 (citing Ex. 1003 ¶ 102). Mr. Holmes testifies that [b]oth Kit and Katzir teach using LEDs of various colors in a fluorescent tube form factor, like a T8 or T12 fluorescent tube. Katzir also discloses various LED array layouts that a POSITA would have a looked to when designing an LED tube lighting like that disclosed in Kit. A POSITA would have had strong motivation to look to Katzir to design an LED array to be retrofit in a fluorescent tube form factor. Ex. 1003 ¶ 102 (internal citations omitted). As discussed above, however, the cited passages of Kit describe a light with LEDs that produces a single, consistent temperature of warm white, commercial white, or cool white. Ex. 1004, 3:28–36, 22:9–25. Neither Petitioner nor Mr. Holmes sufficiently explains why a POSITA would have modified Kit to include Katzir’s particular layout that includes both cool white LEDs and warm white LEDs. See Pet. 19, 24; Ex. 1003 ¶ 102; In re Nuvasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016) (instructing that we must articulate a reason why a POSITA would combine the prior art references). We identified the aforementioned deficiencies for this asserted challenge in the Decision on Institution. DI 21–23. Petitioner did not address those deficiencies in the Reply. See generally Reply; Tr. 6:16–7:10. Thus, based on the entire record developed at trial, and for the foregoing reasons, Petitioner has not shown that claim 1 would have been obvious over Kit, Ianiro, Ducharme, and Katzir.” slip op. at 13
- Expert testimonyPetitioner expert discountedOther
“Petitioner asserts that Mr. Holmes cited Hasnain’s heat dissipation techniques. Reply 10 (citing Ex. 1003 ¶ 490; Ex. 1049 ¶¶ 41–49). Paragraph 490 of Exhibit 1003 relates to Ducharme, not Hasnain, and thus, does not support Petitioner’s argument. Although paragraphs 41 to 49 of Exhibit 1049 span more than seven pages, other than the single citation in the Reply, Petitioner does not discuss any of the testimony presented therein. We, thus, do not consider this portion of the Holmes Supplemental Declaration. See 37 C.F.R. §§ 42.6(a)(3). Furthermore, we would not be persuaded by Mr. Holmes’ testimony even if we considered it. For example, Mr. Holmes testifies that Hasnain’s heat-dissipating structure “a variety of heat dissipating techniques are disclosed by Hasnain, any one of which could readily be used in a T12 form factor LED light, as expressly recognized by Hasnain.” Ex. 1049 ¶ 46. We disagree with Mr. Holmes that Hasnain teaches enclosing its heat-dissipating structure in a fluorescent light tube. Hasnain teaches “a replacement LED light source for fluorescent tube 22 [that] plug[s] into the same connectors and operate[s] from the voltage patterns generated by the ballasts.” Ex. 1008, 3:23–26. Hasnain also teaches that “the replacement LED light source has a plurality of LEDs mounted on a heat-dissipating substrate that has a width that is less than or equal to the diameter of the fluorescent tube that the light source is designed to replace.” Id. at 5:52–56. Thus, Hasnain teaches that its LED light fits into, and connects with, an existing structure that previously held a fluorescent light tube. Id. at 2:50–56, 3:23–26, 4:58–64, 5:52–56, Figs. 1A, 4. As discussed above, however, Hasnain’s heat-dissipating structure is not enclosed in a tubular housing in order to dissipate heat to the surrounding air or via thermal contact with the existing structure that a fluorescent light tube is inserted into. Id. at 2:50–56, 4:23–28, 4:51–64, Figs. 1A, 3, 4.” slip op. at 22
Patent outcomesUS 10,566,895 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,566,895 - Quasar Science LLC v. Colt International Clothing, Inc. D/B/A Colt LedNo claims unpatentablePTAB · Oct 7, 2024 · IPR2023-00613 · APJ Robert J Weinschenk · IPR · Final written decision
Claims 1–3, 6–14, 16–19, 21–24, and 26–31 were not shown unpatentable over either asserted obviousness combination.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedOther
“Patent Owner does not identify any specific instance in which the differences between the parties’ respective descriptions of the level of ordinary skill in the art impacts the analysis or conclusions of either party, or either party’s declarant, in this case. See id. In fact, Patent Owner acknowledges that any differences between the parties’ respective descriptions do not impact the conclusions in this case. Id. at 9 (“Regardless of which definition . . . is applied, the conclusion(s) would be the same.”). Therefore, to the extent necessary, we adopt Petitioner’s description, which is supported by the testimony of Petitioner’s declarant, Mr. Fred Holmes, and is consistent with the asserted prior art. Ex. 1003 ¶ 32.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“the same standard used in a civil action under 35 U.S.C. § 282(b), including construing the claim in accordance with the ordinary and customary meaning of the claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Neither party proposes an express construction for any claim terms. Pet. 13; PO Resp. 10. We determine that no claim terms require an express construction to resolve the parties’ disputes regarding the asserted grounds of unpatentability. See Sections II.D.1, II.E.1.” slip op. at 8
- BurdenNot shown unpatentable
“Thus, Petitioner’s assertion that Hasnain’s LED light emits at least 1000 lumens requires distributing LEDs on a heat-dissipating structure that transfers heat to the surrounding air or via thermal contact with another existing structure. Id. at 4:23–28, 4:51–5:6, Figs. 3, 4; see Ex. 2080 ¶¶ 49, 5 Figure 4 shows heat-dissipating structure 59, not heat-dissipating structure 47. Ex. 1008, Fig. 4. But Hasnain describes those structures similarly. Id. at 4:51–5:6. 66. Petitioner, though, does not explain how Hasnain’s heat-dissipating structure would work when combined with Ducharme’s tubular housing. See Pet. 62–63; Pet. Reply 10; Ex. 1003 ¶ 490; Ex. 1049 ¶¶ 41–49. In particular, Petitioner does not explain how Hasnain’s heat- dissipating structure would dissipate sufficient heat to the surrounding air when enclosed in Ducharme’s tubular housing. See id. Petitioner also does not explain how Hasnain’s heat-dissipating structure would dissipate sufficient heat via thermal contact with another existing structure when enclosed in Ducharme’s tubular housing. See id. Furthermore, Petitioner does not propose combining Ducharme and Hasnain so that Hasnain’s heatdissipating structure is in thermal contact with Ducharme’s tubular housing. See id. Thus, Petitioner does not show sufficiently how the proposed combination of Ducharme and Hasnain was supposed to work. See Personal Web Techs., LLC v. Apple, Inc., 848 F.3d 987, 994 (Fed. Cir. 2017) (“[T]he Board nowhere clearly explained, or cited evidence showing, how the combination of the two references was supposed to work.”).” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“person of ordinary skill in the art would have had reason to achieve high lumen output, we determine that Petitioner does not show sufficiently that a person of ordinary skill in the art would have had reason to combine the specific cited teachings of Ducharme and Hasnain.” slip op. at 17
Patent outcomesUS 10,411,582 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,411,582 - 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 - PTAB · Sep 10, 2024 · IPR2024-00563 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1, 12, and 28 because Petitioner showed a reasonable likelihood of prevailing on obviousness over Gil, Norden, Dean, Alphagan, and Federal Register.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). “If a condition in the first part of the framework 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.” Id. at 8–9. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 17
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“the District of New Jersey is more than three years, argues that “a trial may not be held until 2026—well after a FWD would be expected in this proceeding.” Pet. 15 (citing Ex. 1027, 2); Reply 8. Based on this evidence of the median time to trial in the district, we find factor 2 weighs in favor of institution. See Fintiv Memo 3 (“[W]hen considering the proximity of the district court’s trial date to the date when the PTAB final written decision will be due, the PTAB will consider the median time from filing to disposition of the civil trial for the district in which the parallel litigation resides.”)” slip op. at 22
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther
“guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“In claim construction, “the claims themselves provide substantial guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,596,600 - PTAB · Aug 30, 2024 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Remand
On remand, the Board instituted inter partes review of claims 1–17, 20–21, 24–26, and 29–34 on all grounds stated in the Petition.
RulingsRemand decision- Director reviewOther
“Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17 (“Inst. Dec.”). Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel. Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Director Review Panel (“DRP”) vacated our decision and remanded the case to this panel with a revised construction for claim 1. Paper 23 (“DRP Dec.”).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect (2018). Upon reconsideration of the briefing and the evidence of record in light of the DRP’s claim construction, we conclude that Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable. Accordingly, we grant institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We find that Petitioner has demonstrated a material error by the Office in the prior consideration of Morales-Sanfrutos, Straus, Singh, and Lees. For instance, under the second prong of Advanced Bionics, we consider “(c) the extent to which the asserted art was evaluated during “(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art.” Becton, Dickinson, 17–18. We agree with Petitioner that the Office overlooked Morales- Sanfrutos’ and Singh’s teachings during examination and reexamination. Pet. 79. Although Morales-Sanfrutos, Straus, and Singh were listed on an IDS, they were not the subject of a rejection during examination or reexamination. Moreover, for the reasons discussed below at this stage with regard to Petitioner’s grounds over Morales-Sanfrutos, as evidenced by Straus, and over Singh, Petitioner sufficiently demonstrates that the Office materially erred in overlooking Morales-Sanfrutos’s and Singh’s teachings regarding their linker structures. Id. Further, to the extent the Lees’ teachings were considered during examination and reexamination, Lees’ disclosure of a homobifunctional sulfone linker was overlooked. Lees’ homobifunctional linker, which Patent Owner argues is substantially similar to Harris’ homobifunctional linker, which Petitioner chiefly relies upon in Grounds 2–5, was not the subject of a rejection during examination. Pet. Resp. Brief 1; Prelim. Resp. 25–26. We agree with Petitioner that only Lees’ heterobifunctional linker was applied in a rejection during examination. Pet. Resp. Brief 1; Ex. 1018, 42–43, 62. 4. Conclusion For the foregoing reasons, we decline to exercise discretion to deny institution under § 325(d).” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the (prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we apply Petitioner’s unopposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - PTAB · Aug 23, 2024 · IPR2024-00526 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR of claims 36–70 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on the challenged claims.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314(a), which provides that an 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.” For the reasons discussed below, we determine Petitioner has demonstrated a reasonable likelihood that the challenged claims of the ’554 patent are unpatentable. Accordingly, we institute an inter partes review of all challenged claims on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 3
- BurdenDecided for petitioner
“We are not persuaded by Patent Owner’s arguments. Even if Chen does not explicitly determine three-dimensional positional information of nucleic acid molecules in its paper, Petitioner has provided sufficient evidence, for purposes of institution, that the combination of asserted prior art would have given a skilled artisan reason to use MERFISH to “determin[e] three-dimensional positional information of . . . nucleic acid molecules,” as recited in claim 36, with a reasonable expectation of success.29 Petitioner does not rely on the bare disclosure of optical sectioning and/or z-scanning to argue that the combination of asserted art suggests the limitation at issue. Rather, Dr. Cyzmmek testifies that, because Chen “had the goal of identifying ‘distinct spatial distribution pattern of RNAs,” a skilled artisan “would have been motivated to use the MERFISH 29 In this regard, we also make clear that claim 36, a system claim, does not require a step of determining three-dimensional positional information of nucleic acid molecules. Rather, it only requires program instructions that are executable by a processor to cause the processor to perform the step. 39 method for 3D investigation.” Ex. 1002 ¶ 207. Citing to Larsson30 and Parillo,31 Dr. Cyzmmek further testifies that “[t]hree-dimensional FISH was routine and well-known long before the 2015 priority date.” Id. ¶ 208. Dr. Cyzmmek opines that, because “MERFISH was an extension of existing FISH technologies,” a skilled artisan would have reasonably expected it to also be capable of similar three-dimensional imaging.” slip op. at 39
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“36 Petitioner also asserts that the Board should not exercise our discretion to deny institution under 35 U.S.C. § 325(d). Pet. 66–68. Patent Owner did not address issues relating to 35 U.S.C. § 325(d) in the Preliminary Response. Under these circumstances, we decline to exercise our discretion to deny institution under 35 U.S.C. § 325(d).” slip op. at 48
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“At this point, it appears, based on the parties’ submissions that, as of the institution decision date, fact discovery will still be ongoing, expert discovery will not have begun, and the deadline for filing dispositive motions will still be some time away. Furthermore, we note that, although the Court has issued a claim construction order, none of the construed terms were of the ’554 patent claims. See generally Ex. 2020.” slip op. at 54
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,542,554 - PTAB · Aug 13, 2024 · IPR2024-00467 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on all challenged claims based on the asserted obviousness ground over Gil, Norden, Dean, Alphagan, and Federal Register.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Advanced Bionics, 8. As explained above, during prosecution of the ’245 patent, the examiner issued a nonstatutory double patenting rejection because the claims were “not patentably distinct from” the ’742 patent claims.13 See supra Section I.H (citing Ex. 1010, 96). Petitioner argues that “[i]t was material error for the Examiner to both acknowledge that the ’245 claims were patentably indistinct from the ’742 claims and yet ignore the FWD and allow the claims despite the Board’s prior findings.” We find Petitioner’s argument persuasive. To determine whether Petitioner has sufficiently shown material error, we look at, for example, “the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection.” Advanced Bionics, 9 (citing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 10–11 (Dec. 15, 2017)). Petitioner asserts Gil, Norden, Dean, Alphagan, and Federal Register in this” slip op. at 18
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“previously denied its motion to stay. Ex. 2029. Thus, factor 1 weighs in favor of denying institution.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner. 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 expressly construe any claim term. Patent Owner appears to suggest, although it does not explicitly argue, that the claims require “a single drop of [0].025% brimonidine.” See Prelim. Resp. 6; see also id. at 27 (arguing Gil is “with multi-dosed 0.03% brimonidine”); id. at 28 (arguing Dean is with “multi-dosed concentrations”). To the extent our understanding is correct, Patent Owner should expressly discuss at trial any construction that would so limit the claim. Such discussion should be set forth in a separate section of a response, if filed, designated for claim construction; claim construction positions should not be merely included in arguments over the merits on patentability.” slip op. at 24
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art Petitioner asserts that: A person of ordinary skill in the art (“POSA”) would have been a composite person (or team) that included a medical doctor and pharmaceutical formulator. EX-1014, ¶¶60-61; EX-1013, ¶¶16, 22-24. The medical doctor would be an ophthalmologist with at least three to four years of experience in clinical trials and FDA regulation of eye products and would have experience in the use of topical brimonidine and apraclonidine and topical vasoconstrictors such as naphazoline and tetrahydrozoline. EX-1014, ¶60. The pharmaceutical formulator would have a doctorate in pharmaceutics or a related degree and at least three to five years of experience developing eye drop formulations for clinical trial and regulatory approval. EX-1013, ¶16. Pet. 16–17. Patent Owner does not, at this point, dispute this proposed definition of the ordinarily skilled artisan. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s definition of the person of ordinary skill in the art as it appears consistent with the skill level reflected in the prior art of record and the disclosure of the ’245 patent.” slip op. at 24
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,833,245 - Marinus Pharmaceuticals, Inc. v. Ovid Therapeutics, Inc.All claims unpatentablePTAB · Aug 1, 2024 · PGR2023-00020 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 22 and 25–31 are unpatentable because the Board found them obvious over Zhang with Saporito P1 and Saporito P2, and not enabled.
RulingsFinal written decision- Skill levelDecided for petitioner
“IV. LEVEL OF ORDINARY SKILL IN THE ART We consider the grounds of unpatentability in view of the” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“3. Analysis We start with the language of claim 22 that recites “the pharmaceutical composition provides improvement to the patient after administration for more than 8 hours.” Claim 22 does not indicate whether this is after the start of administration, after the completion of administration, or after some intermediate point. However, the plain language suggests that recited “improvement” occurs “after” the recited “administration” period. See, e.g., KEYnetik, Inc. v. Samsung Electronics Co., Ltd., 837 F. App’x 786, 792 (Fed. Cir. 2020) (“use of the word ‘after’ in the claim indicates a temporal relationship.”) We therefore turn to the ’817 patent specification for clarification. The ’817 patent repeats the claim language in a number of locations. See, e.g., Ex. 1001, 5:1–2, 5:9–11; 14:21–41; 15:18–19; 24:45–49. The ’817 patent provides definitions of “Improvement” and of “Improvement in next functioning,” but neither of these definitions addresses the timing issue. See id. at 29:57–30:5. The schematic drawing in Figure 2, however, addresses timing, and is reproduced below: “FIG. 2 is a schematic drawing depicting a timeline for an evaluation study of the ability of allopregnanolone, ganaxolone and gaboxadol to block benzodiazepine resistant status epilepticus in rats.” Ex. 1001, 3:48–51. Figure 2 differentiates between a 30 minute administration period, a 120 minute post-drug dosing period during which the animals are observed, and a 24 hour timepoint after which the animals are weighed, consistent with the ’817 patent disclosure that “[a]ll rats are observed and scored for seizure severity for 120 min post drug administration.” Ex. 1001, 35:64–65. This disclosure tends, on balance, to support Patent Owner’s proposed interpretation. Turning to the extrinsic evidence, Dr. Sankar similarly stated whether a patient with SE has sustained any improvement after administration of a drug is typically assessed at a point in time after a full dose is administered, rather than starting the clock after the first administration of only part of the dose. This is because the full dose of the drug is generally required to provide the expected effect.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“3. Analysis a. Claim 22 It is Petitioner’s burden to show by a preponderance of the evidence that claim 22 of the ’817 patent is unpatentable as anticipated by Zhang, and we find that Petitioner has failed to meet its burden. See 35 U.S.C. § 326(e). We agree with Petitioner, as discussed in our claim interpretation section above, that patients within the scope of claim 22 include animals such as rats, and also that Zhang teaches “[s]eizure disorders that may be treated with the substituted β-cyclodextrin-ganaxolone injectable formulation include status epilepticus.” Ex. 1009 ¶ 70. As to the intravenous administration requirement in claim 21, from which claim 22 depends, we also agree with Petitioner that Zhang teaches embodiments where the “substituted β-cyclodextrin-ganaxolone injectable formulation is administered as an intravenous infusion dose.” Id. ¶ 76. We therefore agree that Zhang teaches intravenous treatment using a ganaxolone formulation in patients with status epilepticus. See, e.g., id. ¶¶ 22, 70, 76. As discussed above, we agree with Patent Owner that claim 22 is properly interpreted to require improvement 8 hours after total administration of the ganaxolone dose. A preponderance of the evidence of record does not support Petitioner’s position that Zhang inherently, and therefore necessarily, provides improvement after administration for more than 8 hours. Even if claim 22 simply required improvement 8 hours after initiation of a ganaxolone dose, we would still conclude that a preponderance of evidence does not support Petitioner’s position. Zhang provides no evidence of improvement at an 8 hour timepoint” slip op. at 29
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner
“disclosure suggesting that treatment with ganaxolone will result in “improvement to the patient after administration for more than 8 hours.” Also, as we discussed above with regard to anticipation, a preponderance of the evidence does not show that Zhang alone would inherently and necessarily result in 8 hour improvement in any particular species of patient after administration of ganaxolone. That conclusion is supported by Petitioner’s own expert, Dr. Rogawski, who stated with regard to the claimed 8 hour improvement that “I think it’s possible that there could be improvement, there might not be improvement. When one is treating a medical condition, there’s always a degree of variability and one doesn’t expect a certain outcome.” Ex. 2015, 155:9–16. Dr. Rogawski therefore acknowledges that improvement at the 8 hour timepoint is not necessarily the natural result of ganaxolone treatment and may not necessarily occur.” slip op. at 41
Patent outcomesUS 11,395,817 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents 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.