- Hope Medical Enterprises, Inc. v. Fennec Pharmaceuticals, Inc.No claims unpatentablePTAB · Sep 1, 2023 · IPR2022-00125 · APJ Julia Heaney · IPR · Final written decision
The Board granted the revised noncontingent motion to amend, canceled claims 18 and 20, and entered substitute claims 28 and 29, which were not proven obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner, relying on the testimony of Dr. Rogers, contends that a person of ordinary skill in the art would have [had] a bachelor’s degree or equivalent in any of the pharmaceutical sciences with at least 5 years of experience in solid state chemistry; a master’s degree in any of the pharmaceutical sciences with at least 3 years of experience in solid state chemistry; or a Ph.D. in any of the pharmaceutical sciences with 1 year of experience in solid state chemistry. Pet. 8 (citing Ex. 1008 ¶¶ 24–28). Petitioner further states that such “[a] person could also have qualified as a [person of ordinary skill in the art] with some combination of (1) more formal education and less technical or professional experience or (2) less formal education and more technical or professional experience.” Id. Patent Owner does not dispute Petitioner’s proposed definition of a person of ordinary skill. See generally MTA, RMTA. Having considered the parties’ arguments and evidence, we adopt the level of ordinary skill in the art proposed by Petitioner, because it is consistent with the disclosures of the ’363 patent and the prior art of record. We note, however, that neither party contends that the outcome of this case would differ based on our adoption of any particular definition of a person of ordinary skill in the art.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“In our Preliminary Guidance, we construed “for a pharmaceutical composition” to mean “in combination with pharmaceutically acceptable excipients,” based on the ’363 patent’s definition providing that “[t]he terms ‘formulation’ or ‘pharmaceutical composition’ as used herein refers to the drug in combination with pharmaceutically acceptable excipients.” Prelim. Guid. 5–6 (citing Ex. 1001, 12:26–28; Ex. 2010, 17:11–12; Ex. 2011, 26:26– 27). We also encouraged the parties to address whether “for a pharmaceutical composition,” which appears in the preamble of substitute claims 28 and 29, is limiting, as opposed to a statement of intended use or purpose. Id. at 6. Following our Preliminary Guidance, the parties submitted further arguments concerning the term “for a pharmaceutical composition.” Patent Owner argues the term requires that the claimed process provide STS that is sufficiently pure for use in a pediatric patient (see RMTA 8–11) and that the word “drug” in the ’363 patent’s definition of “pharmaceutical composition” requires that the anhydrous STS is of sufficient purity for pharmaceutical use. Reply RMTA 3. Petitioner argues that the construction set forth in our Preliminary Guidance was correct. See Sur-reply RMTA 2–3. Having considered the arguments and evidence, we do not further construe the term “for a pharmaceutical composition” in this Decision because, as discussed in our analysis of obviousness below, it is not necessary to construe the term in order to determine whether Petitioner has met its burden of demonstrating by a preponderance of the evidence that proposed substitute claims 28 and 29 are unpatentable. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we 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 13
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“1. Reasonable Number of Substitute Claims A motion to amend must “propose a reasonable number of substitute claims.” 35 U.S.C. § 316(d)(1)(B); see 37 C.F.R. § 42.121(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). Patent Owner proposes the same number of substitute claims as the original challenged claims that are cancelled, i.e., a one-to-one substitution for a total of two substitute claims. MTA 2; RMTA. “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, Paper 15 at 4; see 37 C.F.R. § 42.121(a)(3). Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner proposes a reasonable number of substitute claims. 2. Support in the Original Disclosure Patent Owner has identified written description support in the originally filed disclosure of the ’363 patent for the new limitations added for the proposed substitute claims. See RMTA 5–8. We have reviewed Patent Owner’s assertions of support in the original disclosure for the proposed revised substitute claims and determine that sufficient support exists. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement. 3. Respond to a Ground of Unpatentability “A motion to amend may be denied where . . . [t]he amendment does not respond to a ground of unpatentability involved in the trial.” 37 C.F.R. § 42.121(a)(2)(i). Patent Owner asserts that the proposed revised substitute claims are patentable over the combination of references that forms the basis of the obviousness ground on which we instituted trial. RMTA 12–13. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement. 4. Scope of the Claims Patent Owner asserts that the proposed revised substitute claims do not enlarge the scope of original claims 18 and 20. RMTA 5. We have reviewed Patent Owner’s assertion that the purity amendments of proposed revised substitute claims 28 and 29 narrow the claims’ scope. Id. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement.” slip op. at 17
- BurdenNot shown unpatentable
“determine the evidence relied on by Petitioner does not support Petitioner’s position that a person of ordinary skill in the art would have been motivated to combine Levenson, Sherman, Edwards, and USP. Petitioner’s contention that it would have been obvious to a person of ordinary skill in the art to combine the teachings of Levenson with Sherman is based on Dr. Rogers’s testimony that “[b]oth references disclose synthesis of sodium thiosulfate pentahydrate.” Ex. 1008 ¶ 151; see Pet. 36, 38. Dr. Rogers further testified it would have been obvious to add Edwards’s dehydrating step to the preparation of STS pentahydrate “which is obtained following the teachings of Levenson and Sherman” because “Edwards itself discloses dehydrating [STS] pentahydrate.” Id. ¶ 154. The Petition included these arguments even though they were inconsistent with Petitioner’s previous statement, during the Sherman prosecution, that Levenson taught STS heptahydrate, and therefore “does not provide any teaching with respect to [STS] pentahydrate.” Ex. 2013, 97. This prior inconsistent statement undercuts Petitioner’s rationale for combining Levenson, Sherman, and Edwards in this proceeding. Moreover, Petitioner’s rationale for combining the references in this proceeding is inconsistent with its statements about Levenson during the Sherman prosecution. Recognizing this inconsistency, Petitioner now takes the position that the Petition and Dr. Rogers’s testimony were incorrect. Paper 32; see Tr. 21:14–22:7, 59:1–2 (reemphasizing that “Petitioner maintains the statements that it made in the Sherman prosecution regarding Levenson”). Petitioner attempts to rationalize the inconsistency between its statements in the Sherman prosecution (including that “Levenson does not provide any teaching with respect to [STS] pentahydrate”) and its position in this proceeding by arguing that Dr. Rogers relies on Levenson as teaching surface activation “regardless of any particular hydrates Levenson discloses.” Tr. 22:8–9. That argument is not persuasive, because Dr. Rogers’s declaration clearly states the primary reason for his opinion that it would have been obvious to a person of ordinary skill in the art to combine the teachings of Levenson with Sherman: “[b]oth references disclose synthesis of sodium thiosulfate pentahydrate.” Ex. 1008 ¶ 151. Contrary to Petitioner’s argument, Dr. Roger’s reliance on the surface activation teachings of Levenson is because he believes that both references pertain to STS pentahydrate; the surface activation teachings are not stated as an independent reason to combine the references. Id. Petitioner provides no further explanation of how a person of ordinary skill in the art would have been motivated to combine Levenson’s teachings regarding manufacture of STS heptahydrate with Sherman’s and Edwards’s teachings regarding STS pentahydrate, or how a person of ordinary skill would have regarded the difference between STS hydrates. Dr. Rogers’s acknowledgement of stability differences among STS hydrates highlights the insufficiency of Petitioner’s showing in this regard. See Ex. 2005, 35, 39. Having changed its position at the close of trial and having effectively withdrawn Dr. Rogers’s testimony as to similarities between Levenson and” slip op. at 24
Patent outcomesUS 10,792,363 not shown unpatentableClaim constructioncites KSR · GrahamPatents in suitUS 10,792,363 - Dell Inc. / Riverbed Technology, Inc. et al. v. Realtime Data LLCNo claims unpatentablePTAB · May 15, 2018 · IPR2017-00365 · APJ Per Curiam · IPR · Final written decision
Claims 1–5, 9–12, 14, 18, 19, and 24 were not shown unpatentable under § 103 because Petitioner failed to establish a specific combination with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not observe a meaningful difference between the parties’ assessments of a person of ordinary skill in the art. We further note that either assessment appears consistent with the level of ordinary skill in the art at the time of the invention as reflected in the prior art in the instant proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Moreover, Dr. Creusere appears to satisfy either assessment. Our analysis in this Decision is supported by either assessment, but, for purposes of this Decision, we adopt Petitioner’s assessment.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not argue a claim construction for any terms. See generally PO Resp.; Reply. In the Decision to Institute, we did not construe any terms. Dec. 5–6. We determine that no terms require express construction for purposes of this Decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only those claim terms or phrases that are in controversy need to be construed, and only to the extent necessary to resolve the controversy).” slip op. at 9
- Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed
“the art would have a reasonable expectation of success (Ex. 1002 ¶¶ 168– 69), on this record, we cannot reconcile these portions of his declaration Dr. Creusere’s his own testimony on cross-examination to the contrary, such as his acknowledgement of “unlimited” permutations that were “impossible” to address. E.g., Ex. 2015, 81:21–83:24, 84:13–24, 143:20–144:3. Stated differently, in his initial position, Dr. Creusere testifies that a person having ordinary skill in the art would have a reasonable expectation of success (Ex. 1002 ¶¶ 168–69), while his later testimony vacillates to a stance that makes it difficult to demonstrate a reasonable expectation of success–– i.e., the existence of “unlimited” permutations that were “impossible” to address. Ex. 2015, 81:21–83:24, 84:13–24, 143:20–144:3. We find this testimony contradictory. In summary, neither the Petition, nor Dr. Creusere’s declaration, nor his deposition testimony, provide any indication as to how a person having ordinary skill in the art would select among the countless permutations or further narrow the set of choices.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successReasonable expectation not foundNot shown unpatentable
“Put another way, we do not find that Petitioner demonstrates a “reasonable expectation of success” when Dr. Creusere acknowledges that a person having ordinary skill in the art did not specify whether to discard or keep Franaszek’s sampling approach, or would use only Franaszek’s teachings of compression algorithms, or incorporate other such algorithms, or what data type or data types an intended system teaches would be created to compress, or what specific goals and objectives the person having ordinary skill in the art would have had reason to achieve. Compare id. at 75:18–76:19, 126:20–127:1, 76:24–78:6, 94:4–12, 96:4–98:14 with Ex. 1002 ¶¶ 154–71; Ex. 2017 ¶¶ 187–89.” slip op. at 17
Patent outcomesUS 7,415,530 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,415,530
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.