- PTAB · Apr 7, 2022 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Rehearing
The Board granted rehearing, reversed its discretionary denial, and instituted PGR on claims 6–8 based on the threshold showing of likely lack of enablement and anticipation.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We agree with Petitioner that a rehearing of our prior decision to deny institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“35 U.S.C. § 324(a) provides that a post-grant review may not be instituted “unless the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, and the evidence cited therein, we determine that Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we accept Petitioner’s proposed definition, which is supported by Dr. Lambert’s testimony (Ex. 1002 ¶ 20) and is consistent with the scope and content of the ’039 patent and the asserted prior art.” slip op. at 17
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted
“skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - PTAB · May 20, 2014 · IPR2013-00124 · APJ Lora M Green · IPR · Final written decision
The Board granted cancellation of claims 1-26 and allowed substitute claims 27-44, but denied substitute claim 45 as unpatentable over Behan.
RulingsFinal written decision- ScopeMotion to amend, grantedGranted
“patent claims. 35 U.S.C. § 316(d)(3); 37 C.F.R. § 42.121(a)(2)(ii).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner
“partes review must set forth “[t]he support in the original disclosure of the patent for each claim that is added or amended.”” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundMixed
“In order to establish a prima facie case of obviousness based on structural similarity, the prior art must provide a reason to make the claimed compound, and there must also be “„adequate support in the prior art‟ for the 7 P.E.A. Teal et al., (Z)-11-Hexadecen-1-ol: A Behavioral Modifying Chemical Present in the Pheromone Gland of Female Heliothis Zea (Lepidoptera:Noctuidae), 116 CAN. ENTOMOLOGY 777-79 (1984). Ex. 2003. 8 Yih-Shen Hwang et al., Structure-Activity Relationship of Unsaturated Fatty Acids as Mosquito Ovipositional Repellents, 10 J. OF CHEM. ECOLOGY 145-51 (1984). Ex. 2004. change in structure.” Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007) (quoting In re Grabiak, 769 F.2d 729, 731-32 (Fed. Cir. 1985)). The United States Court of Appeals for the Federal Circuit noted that the test for obviousness of a compound based on structural similarity is in accordance with the legal principles enunciated by the Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), specifically, that it is important to identify “„a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does‟ in an obviousness determination.” Takeda, 492 F.3d at 1356-57 (quoting KSR, 550 U.S. at 418). Thus, “in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.” Takeda, 492 F.3d at 1357.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundDecided for petitioner
“We acknowledge that McMahon and the Zhang Declaration are evidence that the ordinary artisan would not have had a reasonable expectation that, because a compound is known to repel mosquitoes, such as Aedes aegypti, the compound would also repel ticks, such as Amblyomma variegatum. Claim 45, however, encompasses the use of isolongifolanone when R1 is a hydrogen atom and R2 is an oxygen atom, which is the same compound specifically taught by Behan. See Pet. 7-8 (showing the structure of isolongifolanone, and discussing how it is encompassed by the chemical formula set forth in claim 1). As discussed above, Behan teaches the use of isolongifolanone to repel mosquitoes or cockroaches. Patent Owner provides no evidence that ticks and mites would not be present on the same objects or areas where mosquitoes and cockroaches are found, which are the insects addressed by Behan. Thus, by applying the isolongifolanone taught by Behan to an object or airspace for the purpose of repelling mosquitoes or cockroaches, one would also inherently repel ticks and mites. “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); see also Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005) (noting that the realization of a new benefit of an old process does not render that process patentable); Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating in the context of a claimed process that was drawn to the same use comprising the same steps of the prior art, “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). We, therefore, conclude that the preponderance of the evidence does not support the patentability of proposed claim 45.” slip op. at 17
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSRPatents in suitUS 7,579,016
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.