• Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc.Institution denied
  PTAB · 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 Phillips
  Patents in suitUS 11,707,033
• Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc.Institution denied
  PTAB · 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 Phillips
  Patents in suitUS 11,696,545
• Ovid Therapeutics Inc. v. Marinus Pharmaceuticals, Inc.Institution denied
  PTAB · 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 · Graham
  Patents in suitUS 11,110,100
• Resmed Corp. v. Cleveland Medical Devices, Inc.Institution denied
  PTAB · Jun 24, 2024 · PGR2024-00012 · APJ Ulrike W Jenks · PGR · Institution

  The Board denied institution of PGR on claims 1–20 because Petitioner did not show the patent was PGR-eligible, having failed to show inadequate written-description support or lack of enablement in the pre-AIA priority applications.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “Petitioner has the burden of establishing eligibility for post-grant review. See Mylan Pharms. Inc. v. Yeda Res. & Dev. Co., PGR2016-00010, Paper 9 at 10 (PTAB Aug. 15, 2016). To show that the ’284 patent is eligible for post-grant review, Petitioner bears the burden of proving that the challenged claims lack the priority benefit of the filing date of an earlier 7 The ’284 patent issued from a transition application. A “transition application” is a patent application filed on or after March 16, 2013 (the effective date of the AIA), but which claims priority to an application that was filed prior to the effective date of the AIA. See, e.g., MPEP § 2159.04. challenged claims, or a claim pending during examination of the ’266 application, “was not disclosed in compliance with the written description and enablement requirements of § 112(a) in the earlier application for which the benefit of an earlier filing date prior to March 16, 2013 was sought.” Inguran, LLC v. Premium Genetics (UK) Ltd., PGR2015-00017, Paper 8 at 11 (PTAB Dec. 22, 2015).” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “Thus, the ’284 patent specification explains that the system can adjust the positive airway pressure supplied to the subject without human intervention. The system gathers information from the sensors and uses it to “monitor the condition of the subject” and “determine a level of severity of the subject’s sleeping disorder.” Ex. 1001, 23:20–41. Based on this the subject,” for example by adjusting the positive airway pressure provided to the subject. See id. at 19:3–17, 3:37–55. In this way, the ’284 patent specification discloses generating “an index of treatment efficacy” where “the index [is] based in part on data of severity of sleep disorder symptoms of the subject and data of usage of the PAP device by the subject,” because the system uses data collected from the sensors to evaluate the severity of the subject’s sleeping disorder and efficacy of the current treatment, and can adjust the treatment without human intervention as needed. Accordingly, Petitioner has not demonstrated that it is more likely than not that the ’284 patent claims lack written description support in the pre-AIA priority applications for “an index of treatment efficacy” claim term.” slip op. at 13

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable

    “’284 patent claims are not enabled. Prelim. Resp. 24–30. We find that Petitioner has failed to demonstrate, more likely than not, that any experimentation would have been undue in view of the Wands factors. Prelim. Resp. 25 (citing Wands, 858 F.2d at 737). On this record, Petitioner has not demonstrated that the claimed subject matter is unpredictable or would require undue experimentation. Petitioner argues that “the challenged claims are not enabled regarding the ‘index of treatment efficacy’ claim elements.” Pet. 24. But as Patent Owner establishes, Petitioner acknowledges that determining treatment efficacies was merely applying a known technique. See Prelim. Resp. 26 (citing Pet. 36 (determining treatment efficacy “would amount to merely applying a known technique (i.e., determining treatment efficacy based on multiple factors) to a known device ready for improvement (e.g., CPAP treatment system comprising multiple devices) to yield predictable results (i.e., improve operation of CPAP treatment to better treat the patient and its disorder)”). On this record, Patent Owner further demonstrates that “it was well- known in the art [] how to determine indices of treatment efficacy based on breathing metric data over a period of time.” Prelim. Resp. 26; Ex. 2001 at 175 (“Efficacy, in the context of [obstructive sleep apnea] OSA, reflects the ability of treatment to prevent the occurrence of obstructive breathing events during periods when the treatment is being physically applied.”); Ex. 2002 at 1–2 (based on the apnea-hypopnea index (AHI) the severity of obstructive sleep apnea (OSA) can be calculated); Ex. 2003 at 1 (“ResLink presents this efficacy information along with integrated oximetry data for simultaneous onscreen viewing and analysis.”)). index of treatment efficacy on a cell phone or transmitting it to a remote internet site.” Pet. 25. Petitioner, however, has not demonstrated, more likely than not, that it would take undue experimentation to carry out such display or transmission. The Petition merely suggests that the specification lacks enablement of these claim limitations, but fails to provide any analysis of pertinent factors, such as the state of the prior art, the level of ordinary skill, or the level of predictability in the art with regard to displaying and transmitting data on a cell phone at the time of the invention. In sum, we conclude that Petitioner has failed to show that it is more likely than not that the challenged claims are not enabled.” slip op. at 23

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “In this post-grant review, we construe the claims of the ’284 patent “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 “[n]o claim term needs formal construction for purposes of evaluating the prior art in this Petition.” Pet. 16. 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 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 8

  Claim construction§ 112 disclosure
  Patents in suitUS 11,602,284
• Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentable
  PTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision

  Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32

  Patent outcomesUS 11,278,505 unpatentable
  Claim construction§ 112 disclosurecites Phillips
  Patents in suitUS 11,278,505
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentable
  PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

  The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner

    “d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32

  Patent outcomesUS 11,110,087 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,110,087
• Bayer Cropscience LP / Monsanto Company v. Corteva Agriscience LLCInstituted
  PTAB · Dec 19, 2023 · IPR2023-01037 · APJ Timothy G Majors · IPR · Institution

  The Board instituted IPR on claims 1–29 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’283 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “35 U.S.C. § 325(d). In evaluating whether to deny institution under 325(d), the Board has considered several non-exclusive factors: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination; (d) the extent of the overlap between the arguments made during examination and the manner in which a petitioner relies on the prior art or a patent owner distinguishes the prior art; (e) whether a petitioner has pointed out sufficiently how the Office erred in evaluating the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. See Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first para.). Factors (a), (b), and (d) relate to whether the art or arguments in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 10 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in the Office’s prior consideration of that art or arguments. Id. Under Advanced Bionics’s two-part framework, we first determine whether the same or substantially the same art or arguments previously were presented to the Office. Id. at 8, 10. If “either condition of [the] first part of Office has been shown. Id. at 8, 10.” slip op. at 68

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s contentions are, at this stage, unavailing. Petitioner’s proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’283 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1002, 18:44–50 (citing Hogan (Ex. 1027)), 50:51–55 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about the POSA’s perspective at the time of the invention, appears to have academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the” slip op. at 23

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed

    “C. Claim Construction In inter partes review, we construe claims using the same claim construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims in accordance with the ordinary and customary meaning as understood by the POSA and the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only as needed to resolve the matters in dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). 17 The closest work we see from Dr. Nair related to herbicide resistant transgenic plants is his 2019 paper co-written with the applicant’s employees (e.g., Dr. Wright), which paper appears to be a follow-on investigation into the AAD-1 proteins of the patent. Ex. 1008, 594–595; Ex. 1019, Abstr. proceeding. Pet. 17; Prelim. Resp. 20. It is not apparent at this stage that any terms need further interpretation to resolve the matters in dispute.18” slip op. at 24

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
  Patents in suitUS 11,149,283
• Bayer Cropscience LP / Monsanto Company v. Corteva Agriscience LLCInstituted
  PTAB · Dec 19, 2023 · IPR2023-01036 · APJ Timothy G Majors · IPR · Institution

  The Board instituted IPR on claims 1–34 and all petitioned grounds, finding a reasonable likelihood of success on at least one challenged claim.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’555 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 17–18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’555 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1001, 18:2– 7 (citing Hogan (Ex. 1027)), 51:6–12 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 7–8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II ¶¶ 10–13 (describing the research in Hogan and Hotopp as that of “skilled artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the clarifications noted above, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 22

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’555 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1001, 18:2– 7 (citing Hogan (Ex. 1027)), 51:6–12 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 7–8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II ¶¶ 10–13 (describing the research in Hogan and Hotopp as that of “skilled artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the clarifications noted above, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 22

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “We agree with Petitioner that the priority applications do not disclose sufficient representative species compared to the breadth of the claims. As Petitioner contends, SEQ ID NO: 9 and the two AAD-1 variants that differ from SEQ ID NO: 9 by just one or two amino acids do not fairly represent the diversity of proteins within genus of at least 2044 variants. Pet. 30–31; Ex. 1054 ¶¶ 81–82 (showing the minimal sequence differences in AAD-1 v2 (alanine substituted for histidine at position 2, and cysteine substituted for arginine at position 212), and v3 (alanine insertion at position 2)); Ex. 1001, Dr. Hausinger testifies persuasively that the > 99% identity shared by these three AAD-1 variants “are simply not representative of proteins having as little as 85% sequence identity to AAD-1 v1 (SEQ ID NO: 9).” Ex. 1054 ¶¶ 83–86 (testifying, e.g., that the specification “does not provide any structural information that might have allowed the POSA to make inferences about the effect of a given change” and that nothing in the disclosure “would have suggested to the POSA that changes at [the positions in which v2 and v3 differ] would be particularly informative.”). Patent Owner provides no argument or evidence to the contrary on the question whether sufficient representative species are disclosed.27” slip op. at 43

  § 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
  Patents in suitUS 10,947,555
• Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentable
  PTAB · Sep 6, 2023 · IPR2022-00608 · APJ Jamie T Wisz · IPR · Final written decision

  Claims 1–21 are unpatentable: claims 1–14, 17–19, and 21 as obvious over Teigen and Grey; claims 15–16 over Teigen, Grey, and Yang; and claim 20 over Teigen, Grey, and Matteo.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. PERSON OF ORDINARY SKILL IN THE ART In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The level of ordinary skill in the art is “a prism or lens through which . . . the Board views the prior art and claimed invention” to prevent hindsight bias. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “as adopted by the Board in the Institution Decision. The ’253 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 38:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’253 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 3:8–11. In the ’253 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’253 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1034 ¶¶ 13–14. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” We disagree with Patent Owner’s contention that our construction imports limitations from a single embodiment into the claims. As explained above, the ’253 patent clearly defines the term “forward flow” and this definition is not limited to a single embodiment. In fact, the ’253 patent indicates that, while “[f]orward flow is defined as greater than 6 microliters of fluid . . . [l]ess forward flow is also included in this definition.” Ex. 1001, 38:21–24. The ’253 patent specifies that “the amount of forward flow can be restricted to no greater than 2 microliters or, in a particularly beneficial embodiment, forward flow is approximately zero microliters.” Id. at 38:24– 29. This language indicates that our construction encompasses multiple embodiments from the ’253 patent. We also disagree with Patent’s Owner’s proposed construction of “forward flow” because it is not supported by the ’253 patent specification. Patent Owner contends that “there is ‘no forward flow’ until the full extent of the distal portion” exits the distal end and thus forward flow is prevented when only less than “the full extent of the distal portion” exits the distal end. PO Resp. 9 (emphasis omitted). To adopt Patent Owner’s proposed construction, we would have to essentially ignore the ’253 patent’s express definition of this term. Further, there is no support in the ’253 patent specification for “full extent” or “fully exiting.” We also agree with Petitioner that Patent Owner’s construction effectively eliminates the concept of preventing forward flow because, as Patent Owner acknowledges, it could allow, for example, 20 milliliters of fluid to exit the catheter, which could displace the thrombus into the patient’s vasculature, a problem that the ’253 patent seeks to avoid. See PO Resp. 10–12 (citing Ex. 2014 ¶¶ 48–51); Pet. Reply 8–9 (citing Ex. 1034 ¶¶ 14–15).” slip op. at 13

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “As discussed above, we construe “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosures from the ’011 provisional application that describe the desire to have “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” these disclosures would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 35 (citing Ex. 1003 ¶¶ 15, 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 36–37 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges that fall within the ’253 patent’s definition of “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1034 ¶ 25; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Further, we note that the ’253 patent differentiates between embodiments that allow forward flow and embodiments in which no forward flow occurs. See Ex. 1001, 32:58–60, 37:19–22; Pet. Reply 10–11. For example, the ’253 patent describes an embodiment in which the “momentum causes a small amount of fluid to move through the distal portion of the catheter [] and create a small distal movement of the clot.” Ex. 1001, 32:47– 51. This same embodiment is disclosed in the ’011 provisional application. Compare Ex. 1003 ¶ 126 with Ex. 1001, 32:16–60. The ’253 patent describes this disclosure as an “exemplary embodiment” in which the “flow of fluid forward . . . is intentional, which is in contrast to other exemplary embodiments herein where substantially no forward flow occurs.” Ex. 1001, 32:57–60; see also, id. at 37:19–22 (“Turning now to embodiments . . . without the forward flow”).8 The ’011 provisional application does not include the subsequent embodiments from the ’253 patent that are described as being “without the forward flow.” See Ex. 1005 ¶ 68; Ex. 1034 ¶¶ 22–23. This further demonstrates that the ’011 provisional application does not support the limitation of “prevent[ing] forward flow.” We also note that the ’011 provisional application does not contain adequate support for the limitation of “substantially prevent[ing] forward flow” even under Patent Owner’s proposed construction. While the ’011 provisional discloses “controlling the distal movement of the fluid column” (Ex. 1003 ¶¶ 15, 16), this does not support Patent Owner’s assertion that the ’011 provisional teaches that “the distal portion of the fluid column is substantially prevented from fully exiting the distal end.” PO Resp. 35–36. For example, as discussed above, the ’011 provisional application discloses permitting distal flow of up to 1,000 microliters, which would likely exceed the amount that could be characterized as the full distal portion. Ex. 1003 ¶ 91; Ex. 1034 ¶ 25. Thus, we find that the ’011 provisional application does not “clearly allow persons of ordinary skill in the art to recognize that [the inventors] invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989); Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 8 Patent Owner contends that the statement in the ’253 patent regarding the “exemplary embodiment” of “forward flow” is referring to an embodiment in which the volume of the liquid drawn out from the lumen of the catheter is “approximately 0.2 ml.” PO Resp. 40–41 (citing Ex. 1001, 32:35–36; Ex. 1003 ¶ 126; Ex. 2014 ¶ 99). Even if this is correct, the ’011 provisional application does not include the embodiments that the ’253 patent specifically characterizes as being “without the forward flow.” Pet. Reply 10–11; Ex. 1005 ¶ 68; Ex. 1034 ¶ 22–25.” slip op. at 20

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

    “Based on the above, we determine that, for prior-art determinations under AIA § 102, “there is no need to evaluate whether any claim of [a reference] patent document is actually entitled to priority or benefit under 35 U.S.C. 119, 120.” MPEP § 2154.01(b) (emphasis added). Rather, under the AIA, a reference patent document need only meet the “ministerial requirements” of §§ 119 and 120, and the provisional or other earlier application(s) to which the reference patent document claims a right of priority must “describe[] the subject matter” relied upon in the reference patent document as prior art. 35 U.S.C. § 102(d)(2). Patent Owner has not contested that Teigen meets the procedural requirements for claiming priority to the ’712 patent or the ’095 PCT application. Teigen also appears to meet the ministerial requirements for claiming priority to the provisional applications because it properly claims the benefit of these applications, the ’095 PCT application was filed co-pending with the provisional applications, and the applications share common inventors. Ex. 1007, codes (22), (60), (63), (72); Ex.1008, 2; Ex. 1009, 2; Ex. 2005, codes (22), (30), (72). Patent Owner does not dispute that Teigen meets the “ministerial requirements” of § 119. Because we find that the Dynamic Drinkware analysis does not apply here, we agree with Petitioner and Patent Owner, that we need not reach the issue of whether a claim from Teigen is supported by either Teigen provisional application. PO Sur-Reply 8; Pet. Reply 12–13.” slip op. at 30

  Patent outcomesUS 10,722,253 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 10,722,253
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Rehearing granted
  PTAB · Aug 10, 2023 · PGR2022-00023 · APJ Jeffrey N Fredman · PGR · Rehearing

  On Patent Owner’s rehearing request, the Board held claim 25 unpatentable under § 112(a) because it depends from claim 14, which lacks written description support.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “We therefore agree with Petitioner that we overlooked the correct dependency of claim 25. Claim 25, as a claim dependent from claim 14, lacks written descriptive support because claim 25 fails to cure the absence of descriptive support for claim 14.” slip op. at 4

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “In the Final Written Decision, we determined that claim 14 lacked descriptive support. We noted that Claim 14, in particular, recites a GDC-0199 dosing regimen “compris[ing] a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day.” Unlike for claim 1, such disclosure is not found in a single example, but results from picking and choosing three separate selections from column 24. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 *4 (Fed. Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 3

  § 112 disclosure
  Patents in suitUS 10,993,942

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.