- Apotex Inc. / Apotex Corp. v. Celgene CorporationRehearing deniedPTAB · Apr 30, 2020 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied rehearing, leaving in place its denial of institution on all challenged claims under § 325(d) for grounds I and II and for failure to establish printed-publication status for ground III.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.”” slip op. at 3
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“presented in the petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 10 (Feb. 13, 4 2020) (precedential). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments. Id. If the same or substantially the same art or arguments were previously presented to the Office, we then consider whether petitioner has demonstrated the Office erred. Id. In evaluating the Petition and accompanying evidence in light of the Becton, Dickinson factors, we determined that grounds I and II were “based on substantially the same prior art and arguments previously presented to the office,” and that Petitioner had “neither sufficiently pointed out how the Examiner erred, nor provided additional evidence or facts that warrant reconsideration of the Examiner’s decision.” Inst. Dec. 26. Accordingly, we exercised our discretion under 35 U.S.C. §325(d) and denied institution of grounds I and II on that basis.” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3
§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,741,929 - Grünenthal GmbH v. Antecip Bioventures II LLCRehearing deniedPTAB · Apr 17, 2020 · PGR2018-00062 · APJ Grace Karaffa Obermann · PGR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving intact the Final Written Decision holding claims 1–30 unpatentable based on Varenna and other references.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Upon a request for rehearing, we review our decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. We deny the Request for Rehearing based on application of those principles.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“persons of skill in the art could have located it.” Req. Reh’g 1 (emphasis in original). On the contrary, we addressed with particularity the substantial evidence tending to show that Varenna “was ‘sufficiently accessible to the public interested in the art’ and ‘disseminated or otherwise made available’ to the interested public before the critical date.” Dec. 9 (quoting Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016)). In our Decision, we properly credited “indicia on the face of [the] reference, such as printed dates and stamps,” which are “part of the totality of the evidence” bearing on the issue of public accessibility. Hulu, Paper 29 at 17–18 (citing Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1377 (Fed. Cir. 2018)). Those indicia included not only details of the copyright notice, indicating publication of Varenna “by Oxford University Press on behalf of the British Society for Rheumatology” in “2012;” but also additional legends, including “the statement ‘Advance Access publication 30 November 2012,’” and a conventional edition identifier from the journal Rheumatology. Id. at 9–10 (quoting Ex. 1005). Patent Owner advanced no evidence tending to cast doubt on that publication date. Although the burden of proof never shifted to Patent Owner on the issue of Varenna’s public availability, where Patent Owner declined to advance counter evidence on point, the Board did not err by crediting the indicia, which appear on the face of Varenna, as part of the totality of evidence bearing on the issue.” slip op. at 6
- Strike new argumentNew argument consideredDecided for petitioner
“The precedential decision in Hulu is instructive here, and specifically recognizes “limited opportunities” that “exist for the petitioner to present new evidence” pertaining to the question of public availability. Hulu, Paper 29 at 14. One opportunity expressly identified in Hulu is “in a reply to the patent owner response” where “the patent owner challenges a reference’s status as a printed publication.” Id., Paper 29, 14–15. That is precisely the circumstance here. Patent Owner shows no reversible error in our finding that Dr. Robinson’s Declaration, submitted with Petitioner’s Reply, responds to arguments raised for the first time in Patent Owner’s Response. Dec. 13 (comparing Reply 3–7 and Ex. 1031, with Resp. 12–15). In any event, in our alternative holding, we explain why substantial evidence supports our finding of public availability, “[e]ven if we set aside Dr. Robinson’s Declaration.” Dec. 9. This is not a situation where Petitioner submitted Reply evidence that changed the theory of the patent challenge or, as Patent Owner suggests, represents a circumstance comparable to raising “a new obviousness argument” not advanced in the Petition. Req. Reh’g 11 (quotation omitted); see Pet. vii (identification of Varenna and its alleged publication date of “Nov. 2012”), 3–4 (bridging paragraph, asserting that Varenna was “published in 2012”), 33 (asserting that “Varenna 2012 is one of dozens of references” presented during patent prosecution). Moreover, no prejudice attended allowance of the Reply evidence, where we also allowed Patent Owner a Sur-Reply to address that evidence. Dec. 13. Patent Owner takes issue with the Board’s observation that “Patent Owner was afforded an opportunity (fully taken) to file a Sur-Reply on issues raised in Dr. Robinson’s Declaration.” Id. (citing Sur-Reply 2–11). Patent Owner points out that the Sur-Reply included “only a short paragraph” countering that Declaration, but acknowledges that this circumstance was the result of Patent Owner’s own assessment of the relative importance of the evidence. Req. Reh’g 2–3 n.2. Patent Owner’s strategic calculation, regarding how much space or effort to devote to countering Dr. Robinson’s testimony, does not denigrate the opportunity afforded in the Sur-Reply, or reveal reversible error in the Decision.” slip op. at 8
- BurdenDecided for petitioner
“The Board did not, as Patent Owner argues, “shift[] the burden of proof to Patent Owner to prove that Varenna was not disseminated or otherwise made available to the public.” Id. at 1 (emphasis in original). On the contrary, the Board reasonably weighed the objective proof of public availability against Patent Owner’s bare attorney arguments on point. See Dec. 8–15 (reasoning that the indicia of public accessibility appearing on the face of Varenna, combined with Patent Owner’s conduct during patent prosecution and information submitted under oath in Dr. Robinson’s Declaration, outweigh Patent Owner’s conclusory attorney arguments, which are supported by no objective proof). The objective evidence points in one direction; namely, that Varenna is what it appears to be, a copy of a journal article published in Rheumatology by the Oxford University Press in November of 2012. Id. Patent Owner shows no reversible error in the Decision relating to the Board’s assignment of Petitioner’s burden of proof, any inferences drawn from the evidence of record, or the alternative holding that Dr. Robinson’s testimony bolsters the substantial evidence of record showing that Varenna was publicly available at the time of the invention.” slip op. at 10
§ 102 anticipationPatents in suitUS 9,707,245 - Grünenthal GmbH v. Antecip Bioventures II LLCRehearing deniedPTAB · Mar 26, 2020 · PGR2018-00001 · APJ Grace Karaffa Obermann · PGR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 3–30 unpatentable for lack of enablement because the specification does not guide an artisan to practice their full scope without undue experimentation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Upon request for rehearing, we review our decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. Based on an application of those principles, we deny the Request for Rehearing.” slip op. at 2
- Expert testimonyOther
“zolendronic acid dosage forms could achieve bioavailabilities as high as 1.1% to “a belie[f] in ‘fairies.’” Req. Reh’g 2 (quoting Dec. 14; Ex. 2014, 137:21–138:8). That testimony represents a small fraction of the totality of evidence that undergirds our finding that an ordinarily skilled artisan generally would have expected that attaining a human bioavailability for zolendronic acid above 1% required an enhancer. See Dec. 12–21 (citing substantial evidence for that proposition). Even if we set aside the testimony misattributed to Dr. Wargin, substantial evidence supports that finding.” slip op. at 3
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“unenhanced dosage form of zoledronic acid disclosed in Aronhime or Exhibit 2026 would have attained a bioavailability that falls within the scope of the challenged claims. The key is whether an ordinarily skilled artisan, reading the disclosure of the ’268 Patent, would have been equipped to practice the full scope of the claimed invention. We did not overlook or misapprehend Exhibit 2026. We correctly determined that, in this unpredictable field of pharmaceutical formulation, an ordinarily skilled artisan would have required direction (lacking in the Specification or the prior art) explaining how to prepare dosage forms that meet the full range of bioavailabilities embraced by the challenged claims, including the specified high endpoint human bioavailability of about 4%. See, e.g., Dec. 11–12 (citing undisputed evidence of unpredictable nature of the field of invention (Ex. 1005 ¶ 60)).” slip op. at 7
§ 112 disclosurePatents in suitUS 9,539,268 - L’Oréal USA, Inc. v. Liqwd, Inc.Some claims unpatentablePTAB · Jul 30, 2019 · PGR2018-00025 · APJ Timothy G Majors · PGR · Final written decision
Claims 1–13, 19–23, 29, and 30 are unpatentable as obvious; claims 14–16, 18, and 24–28 were not shown unpatentable.
RulingsFinal written decision- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner
“combination of Pratt and Tanabe teaches or suggests all of claim 1’s limitations, and that the skilled artisan had a sufficient reason to combine the art as proposed with a reasonable expectation of success in arriving at the bleaching method that is claimed. Before reaching a conclusion of obviousness, however, we consider the parties’ argument and evidence related to alleged objective indicia of nonobviousness. WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1328 (Fed. Cir. 2016).” slip op. at 35
- ExcludeMotion to exclude, deniedMixed
“those exhibits) as discussed above in the context for which they were offered (objective indicia of nonobviousness as to alleged unexpected results and industry skepticism). We gave the exhibits little weight on those issues for the reasons explained, and ultimately found in Petitioner’s favor—that objective indicia of nonobviousness did not outweigh the evidence of obviousness on this record. Thus, excluding this evidence would not change the result. Accordingly, we dismiss Petitioner’s motion to exclude Exhibits 2038 and 2041 as moot.” slip op. at 85
Patent outcomesUS 9,668,954 mixed§ 103 obviousnesscites KSRPatents in suitUS 9,668,954 - Miami International Holdings, Inc. / Miami International Securities Exchange, LLC et al. v. Nasdaq Ise, LLCRehearing grantedPTAB · Feb 15, 2019 · CBM2018-00021 · APJ Kristi L R Sawert · CBM · Rehearing
The Board granted rehearing on the ethics rules and granted Interrogatories 4 and 5 and Document Request 2, while denying rehearing on the remaining specified discovery requests.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision, we review the” slip op. at 2
- Additional discoveryAdditional discovery, grantedGranted in part
“Upon reconsideration, we agree with Patent Owner that the timing of Dr. Hendershott’s preparation and the editing of common paragraphs 18–36 is unclear on the current record. For example, Dr. Hendershott testified that he could not remember whether Fish suggested that he provide a history of Wall Street and the exchanges, which are embodied in paragraphs 18–36. See Ex. 1062, 53:14–19. Dr. Hendershott also testified that he received from Fish versions of his declaration containing edits, but did not remember whether any of those edits were substantive in nature. See id. at 51:19–25, 52:8–22. Dr. Hendershott also did not review the edits to his declarations and thus was arguably not prepared to testify as to the circumstances surrounding the creation and editing of the common paragraphs. See id. at 58:2–8. Thus, we grant Interrogatories 4 and 5 and Discovery Request 2, as relevant information only in the possession of Fish and Reed Smith (Bloomberg Factor 3). We deny Document Request 3, however, because we remain unpersuaded that it is relevant to showing that confidential information could have found its way from Fish to Reed Smith. Ord. 11. In particular, Document Request 3 relates to information flowing from Reed Smith to Dr. Hendershott, and is therefore not relevant to whether Fish used or revealed information to Reed Smith relating to its prosecution of the Nasdaq patents.” slip op. at 12
NonePatents in suitUS 6,618,707 - Miami International Holdings, Inc. / Miami International Securities Exchange, LLC et al. v. Nasdaq Ise, LLCRehearing grantedPTAB · Feb 15, 2019 · CBM2018-00020 · APJ Kristi L R Sawert · CBM · Rehearing
The Board granted rehearing on the ethics rules and three discovery requests, denied it on five others, and ordered additional responses and production.
RulingsRehearing decision- RehearingRehearing, grantedRehearing, deniedGranted in part
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision, we review the 2 The parties filed identical papers in CBM2018-00020, CBM2018-00021, and CBM2018-00031. Patent Owner requested to file motions for additional discovery in CBM2018-00029, CBM2018-00030, and CBM2018-00032 on the same basis. See Ex. 2016. We held that request in abeyance. See Paper 21. The requested additional discovery would be substantially the same in all of these proceedings, and, thus, we include CBM2018-00029, CBM2018- 00030, and CBM2018-00032 in this order as well. See Ex. 2016. For efficiency, we only refer to the papers filed in CBM2018-00021. decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2
- Additional discoveryAdditional discovery, grantedGranted in part
“Upon reconsideration, we agree with Patent Owner that the timing of Dr. Hendershott’s preparation and the editing of common paragraphs 18–36 is unclear on the current record. For example, Dr. Hendershott testified that he could not remember whether Fish suggested that he provide a history of Wall Street and the exchanges, which are embodied in paragraphs 18–36. See Ex. 1062, 53:14–19. Dr. Hendershott also testified that he received from Fish versions of his declaration containing edits, but did not remember whether any of those edits were substantive in nature. See id. at 51:19–25, 52:8–22. Dr. Hendershott also did not review the edits to his declarations and thus was arguably not prepared to testify as to the circumstances surrounding the creation and editing of the common paragraphs. See id. at 58:2–8. Thus, we grant Interrogatories 4 and 5 and Discovery Request 2, as relevant information only in the possession of Fish and Reed Smith (Bloomberg Factor 3). We deny Document Request 3, however, because we remain unpersuaded that it is relevant to showing that confidential information could have found its way from Fish to Reed Smith. Ord. 11. In particular, Document Request 3 relates to information flowing from Reed Smith to Dr. Hendershott, and is therefore not relevant to whether Fish used or revealed information to Reed Smith relating to its prosecution of the Nasdaq patents.” slip op. at 12
NonePatents in suitUS 8,386,371 - L’Oréal USA, Inc. v. Liqwd, Inc.Rehearing deniedPTAB · Oct 18, 2018 · PGR2018-00024 · APJ Christopher M Kaiser · PGR · Rehearing
The Board denied rehearing, leaving in place its denial of institution because Petitioner did not show an abuse of discretion in construing “bleach powder” or assessing written-description support.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). We “review [our] decision for an abuse of discretion.” Id. § 42.71(c). In addition, we may not consider an argument made in a request for rehearing unless the request “specifically identif[ies] . . . the place where [that argument] was previously addressed in a motion, an opposition, or a reply.” Id. § 42.71(d). After considering the Request for Rehearing, we determine that Petitioner has not demonstrated that we abused our discretion in denying institution. Accordingly, we deny the Request for Rehearing. slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“reconsider the issue of our construction of “bleach powder.” The parties agree that the specification of the ’954 patent does not contain an express definition of “bleach powder,” so we are required to give the term its “ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure.” Translogic, 504 F.3d at 1257; see Pet. 27–28 (arguing that, “[a]bsent any . . . clear intent, the BRI must be consistent with the interpretation that those skilled in the art would reach,” then offering no particular construction of “bleach powder”); Prelim. Resp. 29–30 (“A person of ordinary skill in the art would have understood that bleach powder combines persulfates with alkalinizing compounds . . . in a fine dry particulate form.” (citing only sources outside the ’954 patent)). In arguments that we may consider, the parties draw our attention to six sources of evidence about the ordinary understanding in the art of “bleach powder.” Req. 2–5 (citing Ex. 1039, 48:9–49:9); Prelim. Resp. 29– 30 (citing Ex. 1002, 15:45–65; Ex. 1011, 17; Ex. 2005, 6; Ex. 2007, 3; Ex. 2012 ¶¶ 34–36). There is evidence that supports Patent Owner’s view that the ordinary meaning of “bleach powder” is a powder that contains an alkalizing agent in addition to persulfates, as opposed to merely a persulfate powder. A textbook called “Hair Preparations” by Thomas Clausen and others states that, at least in paste bleaches, “a bleach powder” is used that “consists of a peroxodisulfate, an alkalinizing agent,” and other ingredients. Ex. 1011, 17. In the context of cream and gel bleaches, this reference teaches that “[p]eroxosulfate . . . can be added as a bleaching powder” but is silent about whether the “bleaching powder” contains any additional ingredients. Id. In a book chapter on “Hair Coloring” by Keith C. Brown, a “bleach booster” powder is discussed that “is usually a mixture of ammonium and potassium persulfates” and that has “metasilicates mixed in with the persulfates” to provide “[a]lkaline pH.” Ex. 2005, 6. Against this evidence is the testimony of Dr. Borish that “powder lighteners” or “bleach powders” include “persulfate salts.” Ex. 1039, 48:9–49:9. But Dr. Borish does not state affirmatively that the persulfate salt is all that is required for a powder to be a bleach powder, only that a persulfate salt is a necessary component of a bleach powder. Id. Accordingly, his testimony does not outweigh the evidence that, to a person of ordinary skill in the art, a bleach powder contains both a persulfate salt and an alkalizing agent. We are not persuaded, therefore, that we abused our discretion by construing “bleach powder” to require both of those components.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“After considering the Request for Rehearing, we determine that Petitioner has not demonstrated that we abused our discretion in denying institution. Accordingly, we deny the Request for Rehearing.” slip op. at 2
Claim constructionPatents in suitUS 9,668,954 - Apotex Inc. / Apotex Corp. v. Celgene CorporationInstitution deniedPTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution
The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached
“support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,741,929 - Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentablePTAB · Jun 22, 2018 · PGR2017-00008 · APJ Sheridan K Snedden · PGR · Final written decision
Claims 1–17 are unpatentable under § 112(a) for lack of written description because the claimed dosing regimen is not supported by the specification.
RulingsFinal written decision- Skill levelSkill level board ownOther
“with regard to claim 17. Nonetheless, we are not persuaded by Petitioner’s contentions. Rather, we find that the ’239 patent contains a sufficient written description of an oral dosage form containing “at least 10% zoledronic acid.” The specification describes a full panoply of zoledronic acid concentrations. Liquid compositions may contain “about 10% (w/v) to about 15% (w/v), about 15% (w/v) to about 20% (w/v), about 20% (w/v) to about 30% (w/v), about 30% (w/v) to about 40% (w/v), or about 40% (w/v) to about 50% (w/v) of zoledronic acid.” Ex. 1003, 10:25–28. Solid dosage forms may contain “at least about 10% (w/w), at least about 20% (w/w) . . .” up to “at least about 80% [w/w]” zoledronic acid. Id. at 10:30–32. Solid dosage forms also are described as containing zoledronic acid in ranges beginning from “about 10% (w/w) to about 30% (w/w), about 10% (w/w) to about 20% (w/w) . . .” all the way up to a range of “about 80% (w/w) to about 90% (w/w).” Id. at 10:32–39. The breadth of zoledronic acid concentration ranges disclosed is more comprehensive than, and therefore distinguishable from, the more limited concentration ranges disclosed in Wertheim (claimed range of “at least 35%” not supported by disclosure of 25% to 60% range disclosed in priority application). In short, we determine that a person of ordinary skill in the art – a medical doctor with experience treating CRPS – would have recognized that the “inventor invented what is claimed” and did not overreach in claiming “at least 10% zoledronic acid” in an orally administered dosage form for treating CRPS. See University of Rochester, 358 F.3d at 928 (Fed. Cir. 2004).” slip op. at 21
- Expert testimonyOther
“Unocal or Wertheim where the specification clearly allowed persons of ordinary skill in the art to recognize the claimed invention despite the absence of literal support. In Unocal, the original disclosure explicitly described the effects of altering the variables, explicitly described the claimed endpoints as preferred, or explicitly recited them in an original claim. Moreover, persuasive expert testimony was offered to support the finding that the specification reasonably conveyed to one skilled in the relevant art that the inventor possessed the later claimed invention. Unocal, 208 F.3d at 993, 998–99. In Wertheim, the CCPA held that the specification supported the claimed range of 35–60% where the specification described the range of 25–60% along with specific embodiments of 36% and 50%. 541 F.2d at 264–65. In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed
“In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16
Patent outcomesUS 9,283,239 unpatentable§ 112 disclosurePatents in suitUS 9,283,239 - Watson Laboratories, Inc. v. United Therapeutics, Corp.Rehearing deniedPTAB · Jun 19, 2018 · IPR2017-01622 · APJ David Cotta · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, concluding it had not shown an abuse of discretion in instituting review on all challenged claims and grounds.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be found if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). The party requesting rehearing has the burden of showing the decision should be modified, which includes specifically identifying all matters the party believes we misapprehended or overlooked. 37 C.F.R. § 42.71(d).” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“requiring institution on each prior art ground, the statute permits review ‘only on the basis of prior art consisting of patents and printed publications.’” Req. Reh’g. 4 (citing 35 U.S.C. § 311(b)). Patent Owner then asserts that Grounds 2 and 3 fail to meet this statutory requirement because they rely on documents that do not constitute prior art. We have addressed the deficiencies regarding those grounds in the Institution Decision. Our determination to proceed on all grounds is based upon the policy set forth in the above-mentioned Office Guidance, in view of SAS, along with our determination that Petitioner has shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim in the petition. Regarding that determination, Patent Owner has not persuaded us that we have misapprehended or overlooked any matters. See 37 C.F.R. § 42.71(d).” slip op. at 5
- BurdenDecided for patent owner
“requiring institution on each prior art ground, the statute permits review ‘only on the basis of prior art consisting of patents and printed publications.’” Req. Reh’g. 4 (citing 35 U.S.C. § 311(b)). Patent Owner then asserts that Grounds 2 and 3 fail to meet this statutory requirement because they rely on documents that do not constitute prior art. We have addressed the deficiencies regarding those grounds in the Institution Decision. Our determination to proceed on all grounds is based upon the policy set forth in the above-mentioned Office Guidance, in view of SAS, along with our determination that Petitioner has shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim in the petition. Regarding that determination, Patent Owner has not persuaded us that we have misapprehended or overlooked any matters. See 37 C.F.R. § 42.71(d).” slip op. at 5
NonePatents in suitUS 9,339,507
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.