- Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc.Institution deniedPTAB · Nov 1, 2024 · PGR2024-00025 · APJ Jeffrey W Abraham · PGR · Institution
The Board denied institution because Petitioner did not show that claims 1–20 were more likely than not unpatentable over either obviousness ground, for lack of utility, or as indefinite.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’033 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist along with genetics specialists) and field-side personnel.” Pet. 15 (citing Ex. 1003 ¶¶ 19–22, 44–45). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 15. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 25. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’033 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level”” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not offer a specific construction for any claim terms. Pet. 19–20. Rather, Petitioner contends that “the outer boundary of the Challenged Claims lacks reasonable certainty,” and, therefore, “the Challenged Claims are unpatentable as indefinite under §112(b).” Pet. 20. Petitioner further contends that the challenged claims are unpatentable as obvious “regardless of the outer boundary of the claims.” Pet. 21. Patent Owner disagrees with Petitioner’s arguments regarding indefiniteness, and does not construe any claim terms. See generally Prelim. Resp. As explained in detail below, based on the record before us, we are not persuaded by Petitioner’s indefiniteness arguments, and determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable
“Patent Owner is correct that Petitioner focuses its obviousness challenge on 1PNZQ23’s phenotype, and does not address its genotype. Prelim. Resp. 41–42; see Pet. 26–32 (comparing 1PNZQ23’s phenotype with the phenotypes of the asserted prior art). Petitioner does not direct us to, nor do we discern, any information in the Petition or Reply regarding 1PNZQ23’s genotype that supports Petitioner’s arguments regarding obviousness. Furthermore, Patent Owner offers information suggesting that “the breeding of 1PNZQ23 was unpredictable even with both parents being known in the art.” Prelim. Resp. 47. Dr. Schnable addresses unpredictability in the breeding process, stating: distinct even when the F1 plant itself results from a cross of two inbreds. A [person of ordinary skill in the art] would not expect that a cross of the same parents will produce F2 or D1 progeny identical to 1PNZQ23. . . . [T]he genome of a progeny plant is the result of genetic segregation and recombination in the F1 plant of the two parental genomes and the chance of the exact same child resulting from that initial biparental cross is infinitesimally small. Ex. 2004 ¶ 123. This information undermines Petitioner’s arguments regarding an expectation of success in achieving the claimed invention.” slip op. at 13
Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,707,033 - Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc.Institution deniedPTAB · Oct 15, 2024 · PGR2024-00023 · APJ Jeffrey W Abraham · PGR · Institution
The Board denied institution on claims 1–20 because the petition did not show they were unpatentable on any asserted obviousness, utility, written-description, or enablement ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’545 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist as along with genetics specialists) and field-side personnel.” Pet. 16 (citing Ex. 1003 ¶¶ 50–51). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 16. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 24. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’545 patent, and we adopt it for purposes” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.200(b) (2019). Under that standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 21. Patent Owner also does not construe any claim terms. See generally Prelim. Resp. For purposes of this Decision, and based on the record before us, we determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable
“additional reasons. For example, we agree with Patent Owner that Petitioner fails to demonstrate sufficiently that a person of ordinary skill in the art would have had a reasonable expectation of success in arriving at PH4CYJ based on Smalley’s disclosure alone. Prelim. Resp. 51–52. According to the ’545 patent specification, the claimed PH4CYJ inbred maize variety is a cross between inbred line PH1VNA and inbred line PH1KTF. Ex. 1001, 37:62–64. In the simplest terms, PH1VNA and PH1KTF are the parents, and their cross ultimately resulted in the inbred variety PH4CYJ. The ’545 patent explains that after the initial crossing of the parental lines, the” slip op. at 14
Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 11,696,545 - Ovid Therapeutics Inc. v. Marinus Pharmaceuticals, Inc.Institution deniedPTAB · Sep 20, 2024 · IPR2024-00726 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–21 were unpatentable under any of the three asserted obviousness grounds.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Based upon our review of the arguments and an examination of the claim language itself, the written description, and the prosecution history, we determine that the record supports finding that the entire “wherein” clause recited in independent claim 1 is limiting. This clause recites, wherein the effective amount of ganaxolone is administered as an intravenous bolus plus continuous infusion to produce and maintain a ganaxolone plasma concentration of about 500 ng/ml to about 1000 ng/ml for about 8 hours to about 12 hours.” slip op. at 10
- Skill levelOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) at the time the application for the ’100 patent was filed “would have had a medical degree or a Ph.D. in pharmacology or fields related to the development of pharmaceuticals and would have been familiar with the PK [pharmacokinetics] and PD [pharmacodynamics] of pharmaceuticals.” Pet. 18. Additionally, Petitioner asserts “[a] POSA also would have had several years of experience as a practicing neurologist treating patients who suffer from seizure disorders, including SE, and/or several years of experience in researching treatments for such seizure disorders.” Id. (citing Ex. 1002 ¶ 50). According to Patent Owner, a person of ordinary skill in the art at the time the application for the ’100 patent was filed, “would have had a medical degree, or a Ph.D. in pharmacology or other field related to the development of pharmaceuticals, or equivalent degree, and several years of with Refractory Status Epilepticus, Poster Abstract F53, 37 J. CLIN. NEUROPHYSIOLOGY 332 (July 2020) (Ex. 1009, “Husain 2020”). experience as a practicing neurologist treating patients who suffer from seizure disorders including status epilepticus and/or several years of experience in researching treatments for such seizure disorders.” Prelim. Resp. 17–18 (citing Ex. 2011 ¶ 44). We note that the parties’ proposed definitions are largely similar, except that Patent Owner additionally recognizes “an equivalent degree” as an alternative to a medical degree or Ph.D. in pharmacology or other field related to the development of pharmaceuticals. Compare Pet. 18 with Prelim. Resp. 17–18. We do not need to resolve this issue as our findings and conclusion in this Decision would be the same under either proposed definition.” slip op. at 7
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“agree with Patent Owner that Petitioner has not shown sufficiently for institution that the claimed invention would have been obvious over the combined teachings of During and NCT03350035. As discussed above, in Section II.B., we have determined that the “wherein” clause of independent claim 1 is liming. In other words, the claim requires that the effective amount of ganaxolone is administered as an IV bolus plus continuous infusion and that such administration produces and maintains a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. With respect to the recited plasma concentration limitation, Petitioner has alleged only that it is met inherently. Dr. Sankar has only offered the same conclusory position in his declaration. See Ex. 1002 ¶¶ 113, 115. While “inherency may supply a missing claim limitation in an obviousness analysis,” this doctrine “must be carefully circumscribed in the context of obviousness.” PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 1194–1195 (Fed. Cir. 2014). As the Federal Circuit has explained: The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. Id. at 1195 (quoting In re Oelrich, 666 F.2d, 578, 581 (C.C.P.A. 1981). Here, Petitioner and Dr. Sankar have not explained or demonstrated why or how the natural result of administering the dosages in During according to the method disclosed in NCT03350035 would produce and maintain a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. This deficit is more pronounced in view of the Specification disclosure of a Phase 2 Open-Label Dose Range Study that exemplifies how some ganaxolone dosages that suppressed SE did not produce and maintain ganaxolone plasma concentrations ≥ 500 ng/ml for about 8 to 12 hours. See Ex. 1001, Fig 15; see also Ex. 1001, 55:13–56:30. Thus, because Petitioner relies on inherency for the plasma concentration limitation without providing evidence that such inherency exists, Petitioner has failed to establish sufficiently for institution that During and NCT03350035 teach or suggest each limitation of the claim 1. Accordingly, we determine that Petitioner has not shown a reasonable” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“agree with Patent Owner that Petitioner has not shown sufficiently for institution that the claimed invention would have been obvious over the combined teachings of During and NCT03350035. As discussed above, in Section II.B., we have determined that the “wherein” clause of independent claim 1 is liming. In other words, the claim requires that the effective amount of ganaxolone is administered as an IV bolus plus continuous infusion and that such administration produces and maintains a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. With respect to the recited plasma concentration limitation, Petitioner has alleged only that it is met inherently. Dr. Sankar has only offered the same conclusory position in his declaration. See Ex. 1002 ¶¶ 113, 115. While “inherency may supply a missing claim limitation in an obviousness analysis,” this doctrine “must be carefully circumscribed in the context of obviousness.” PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 1194–1195 (Fed. Cir. 2014). As the Federal Circuit has explained: The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. Id. at 1195 (quoting In re Oelrich, 666 F.2d, 578, 581 (C.C.P.A. 1981). Here, Petitioner and Dr. Sankar have not explained or demonstrated why or how the natural result of administering the dosages in During according to the method disclosed in NCT03350035 would produce and maintain a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. This deficit is more pronounced in view of the Specification disclosure of a Phase 2 Open-Label Dose Range Study that exemplifies how some ganaxolone dosages that suppressed SE did not produce and maintain ganaxolone plasma concentrations ≥ 500 ng/ml for about 8 to 12 hours. See Ex. 1001, Fig 15; see also Ex. 1001, 55:13–56:30. Thus, because Petitioner relies on inherency for the plasma concentration limitation without providing evidence that such inherency exists, Petitioner has failed to establish sufficiently for institution that During and NCT03350035 teach or suggest each limitation of the claim 1.” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,110,100 - Resmed Corp. v. Cleveland Medical Devices, Inc.Institution deniedPTAB · 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 disclosurePatents in suitUS 11,602,284 - Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentablePTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision
Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32
Patent outcomesUS 11,278,505 unpatentableClaim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,278,505 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision
The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner
“d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32
Patent outcomesUS 11,110,087 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087 - PTAB · Dec 19, 2023 · IPR2023-01037 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–29 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’283 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“35 U.S.C. § 325(d). In evaluating whether to deny institution under 325(d), the Board has considered several non-exclusive factors: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination; (d) the extent of the overlap between the arguments made during examination and the manner in which a petitioner relies on the prior art or a patent owner distinguishes the prior art; (e) whether a petitioner has pointed out sufficiently how the Office erred in evaluating the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. See Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first para.). Factors (a), (b), and (d) relate to whether the art or arguments in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 10 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in the Office’s prior consideration of that art or arguments. Id. Under Advanced Bionics’s two-part framework, we first determine whether the same or substantially the same art or arguments previously were presented to the Office. Id. at 8, 10. If “either condition of [the] first part of Office has been shown. Id. at 8, 10.” slip op. at 68
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing. Petitioner’s proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’283 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1002, 18:44–50 (citing Hogan (Ex. 1027)), 50:51–55 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about the POSA’s perspective at the time of the invention, appears to have academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“C. Claim Construction In inter partes review, we construe claims using the same claim construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims in accordance with the ordinary and customary meaning as understood by the POSA and the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only as needed to resolve the matters in dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). 17 The closest work we see from Dr. Nair related to herbicide resistant transgenic plants is his 2019 paper co-written with the applicant’s employees (e.g., Dr. Wright), which paper appears to be a follow-on investigation into the AAD-1 proteins of the patent. Ex. 1008, 594–595; Ex. 1019, Abstr. proceeding. Pet. 17; Prelim. Resp. 20. It is not apparent at this stage that any terms need further interpretation to resolve the matters in dispute.18” slip op. at 24
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,149,283 - 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 · GrahamPatents in suitUS 10,947,555 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Rehearing grantedPTAB · 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 disclosurePatents in suitUS 10,993,942 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCAll claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Final written decision
Claim 59 is unpatentable as anticipated by Brumfield, Marcus, and Chandran; the motion to amend proposing substitute claim 62 is denied because claim 62 is unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find this argument unpersuasive. As Patent Owner notes, Petitioner’s expert provides a definition of POSITA that is very similar to that recited by Patent Owner in its Motion to Amend, substantively differing only in the number of years of experience of the engineer at issue. This congruity supports the conclusion that the level of ordinary skill in the art may be recognized in the prior art itself. Okajima, 261 F.3d at 1355 (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’”).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In our Institution Decision, we agreed with Petitioner that the “portion of the preamble reciting ‘for compressing bone’ is not limiting to the claim” and found that other terms did not require construction. Dec. 8–9. We agreed with Petitioner that “[t]he phrase ‘for compressing bone’ merely identifies an intended use.” Pet. 20; Dec. 9. Patent Owner does not dispute this interpretation. See generally PO Resp. We agree with Petitioner that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Therefore, having considered the entire record developed during trial, we adhere to the preliminary construction that the limitation “for compressing bone” does not impose a structural limitation on claim 59 and that the other terms do not require construction.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Patent Owner disputes the Petition generally but Patent Owner does not identify any error in Petitioner’s foregoing arguments. Accordingly, we adopt the factual statements regarding the specific teachings of the references as findings of fact. See generally In re NuVasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make specific findings as to claim limitations that Patent Owner does not dispute are disclosed in the prior art). We have reviewed Petitioner’s analysis and the underlying evidence cited in support and conclude that Petitioner has shown, by a preponderance of the evidence, that the limitations of claim 59 are disclosed by Brumfield.” slip op. at 26
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“For the reasons discussed below, Patent Owner has shown that proposed substitute claim 62 meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. For the reasons discussed below, however, Petitioner has proven by a preponderance of the evidence that proposed substitute claim 62 is unpatentable over prior art. Therefore, we deny Patent Owner’s Revised Motion to Amend.” slip op. at 38
Patent outcomesUS 8,303,589 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 8,303,589
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.