- 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 - Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentablePTAB · Dec 28, 2018 · IPR2017-00440 · APJ Robert L Kinder · IPR · Final written decision
Claims 1–4, 6–7, 10–16, 18, and 20 are unpatentable; claims 5 and 8 are not shown unpatentable. Substitute claims 21, 30, and 38 are unpatentable as obvious over Sackier and Kirsch.
RulingsFinal written decision- Expert testimonyOther
“3. Dr. Nicosia’s Declaration in support of its Opposition to Patent” slip op. at 7
- Skill levelOther
“B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“B. “clip” The Parties now agree that “clip,” as the term is generally understood,” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableUnpatentableMixed
“as recited in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). We conclude that Petitioner has not met its burden of showing this element to be present in Sackier because Petitioner combines features from distinct embodiments in Sackier without establishing persuasively that those embodiments are so directly related to each other such that one of ordinary skill in the art, looking at the reference as a whole, would recognize a disclosure of the invention as claimed. Accordingly, although a very close call, we conclude that Petitioner has failed to demonstrate anticipation of claims 1, 12, and 20 by Sackier for this reason.” slip op. at 21
Patent outcomesUS 9,271,731 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,271,731 - Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.No claims unpatentablePTAB · Dec 28, 2018 · IPR2017-00435 · APJ Robert L Kinder · IPR · Final written decision
Claims 1–4, 6–18, and 20 were not shown unpatentable over Malecki; the contingent motion to amend was denied as moot.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“construction more persuasive because it is grounded in, and most consistent with, the specification of the ’731 patent. Contrastingly, Petitioner does not offer a specific interpretation of “inner walls” and its arguments are generally based on extrinsic evidence, including claim charts from the related district court litigation (Pet. 15), arguments from related proceedings (Pet. Reply 3), and the prior art reference (Malecki) relied on to challenge the claims (id. at 3–4). Petitioner criticizes the Patent Owner’s position but provides no express interpretation of “inner walls of the first and second clip arms;” instead, Petitioner argues why Patent Owner’s proposed construction is wrong. Pet. Reply 4–5. Dr. Nicosia does not expressly define or otherwise persuasively explain the definition of “inner walls” in his declarations either. See generally Exs. 1037, 1095, and 1109.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the time of the filing of the application that became the ’731 patent would have possessed the knowledge and skill of an engineer or similar professional 5 The parties have not introduced evidence of secondary considerations in this proceeding. with at least an undergraduate degree in engineering, or a physician having experience with designing medical devices. Pet. 10 (citing Ex. 1037 ¶ 11). Patent Owner does not dispute Petitioner’s proposal, and we adopt it based on the final record before us. It is also consistent with the level of skill evidenced by the references.” slip op. at 15
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id.” slip op. at 25
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id. Finally, Petitioner seems to recognize that a modification would be” slip op. at 25
Patent outcomesUS 9,271,731 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,271,731 - Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentablePTAB · Nov 15, 2018 · IPR2017-00135 · APJ Robert L Kinder · IPR · Final written decision
Claims 1, 3–5, and 10 are unpatentable as obvious over Kimura (claims 1, 3–5) and Kimura with Sackier (claim 10); claims 7, 11–15, and 17 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the time of the filing of the application that became the ’371 patent would have possessed the knowledge and skill of an engineer or similar professional with at least an undergraduate degree in engineering, or a physician having experience with designing medical devices. Pet. 8 (citing Ex. 1029 ¶ 11). Patent Owner does not dispute Petitioner’s proposal, and we adopt it for purposes of this Decision.” slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“The issue we have with Patent Owner’s contentions, as pointed out by Petitioner, is that Patent Owner does not establish persuasively how its claims require the “reversible open/close” feature and the “tactile feel features.” See Pet. Reply 27–29. Even presuming that these features did indeed drive tremendous commercial success and industry praise for the commercial products, Patent Owner does not adequately explain in its analysis how the claims of the challenged patent require these particular features that drive commercial success. Patent Owner seems to suggest that a break section in the control wire will fracture and that this feature in the commercial product relates to the tactile feel. PO Resp. 57 (citing Ex. 2029 ¶¶ 91–93) (“After the yoke has disengaged, if the handle spool is moved further proximally, a break section in the control wire will fracture, leaving the ball within the yoke and uncoupling the control wire from the distal components of the device.”). This “break section in the control wire” is not, however, claimed or covered in claim 1, the claim that purportedly embodies the commercial product. The claims alleged to cover the product do not specifically require any “tactile feel feature.”3 Likewise, while the claims may allow for an opening and closing of the clip assembly, there is no requirement in these claims that the clip assembly, as “demanded” by physicians, repeatedly open and close. Thus, both of the drivers of commercial success and industry praise are not commensurate in scope with the claims of the patented invention. See Ex. 1046 ¶¶ 23–29 (explaining how features are not claimed).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“district court proceeding, Petitioner contends that “coupled to the sheath” means “slideable inside the sheath” and “the sheath confines the bushing.” Pet. 9. Petitioner provides no additional support. The district court tentatively rejected this broad interpretation. See Ex. 2003, 27–28 (“[T]he Court recommends that ‘coupled to the sheath’ be construed as ‘linked together, connected, or joined, but not slidable inside the sheath.’”). Patent Owner contends that Petitioner’s proposed construction of “coupled to the sheath” is “unreasonably broad,” but provides little citation to the intrinsic record before us. Prelim. Resp. 13–14. Instead, Patent Owner notes that the plain and ordinary meaning of coupled is “linked together, connected, or joined,” citing to an unrelated Federal Circuit decision as well as the related district court determination. Id. at 14; Ex. 2003, 28. In our proceeding, Petitioner has not provided persuasive evidence or argument to support its claim interpretation by merely pointing to what Patent Owner purportedly argued in district court. Based on the final record before us, “coupled to the sheath” means “linked together, connected, or joined” to the sheath. Our construction is consistent with the district court’s analysis and reflects the common understanding of the term “coupled” in the mechanical arts to require more than simply abutting or contacting. See generally Ex Parte Paul Robert Homrich, Appeal 2014-005786, 2016 WL 3541285, at *3 (PTAB, June 27, 2016) (“When used in mechanical systems, the plain and ordinary meaning of ‘coupled’ means to link together or connect,” and coupled requires more than contact or abut.).” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We are not persuaded that Petitioner has demonstrated sufficiently that Adams discloses “a bushing extending between a proximal end coupled to the sheath,” (Ex. 1027, 17:4–5) as required by claim 1 of the ’371 patent. Based on the final record, Petitioner’s contention that retainer 110 [bushing] is slidable inside the sheath, or confined by the sheath, does not establish persuasively that the proximal end of the bushing is coupled to the sheath as required by claim 1. The claimed coupling must be “proximal coupling” and Petitioner can only point to distal coupling via distal tabs 118, 119 (Pet. Supp. Reply 6) – this is not “proximal” coupling. Further, for the bushing and the sheath to be coupled requires them to be “linked together, connected, or joined” in some manner and Petitioner has not established any such connection for proximal coupling. Petitioner also has failed to establish a persuasive reason for linking or connecting retainer 110 and sheath 112 – indeed, doing so would negatively impact the ability of retainer 110 to freely slide out of sheath 112. See Prelim. Resp. 27. Adams suggest that when control wire 108 is actuated and the clip is locked into the lock sleeve, retainer release 109 pulls retainer 110 back, disengaging retainer tabs 118, 119 from the two retainer holes as depicted in Figure 4.” Ex. 1023, 7:26–44 Finally, we note that our decision would not change if we adopted the district court’s claim interpretation. The district court adopted a claim construction of “a bushing extending between a proximal end coupled to the sheath” as “linked together, connected, or joined, but not slidable inside the sheath.” Ex. 2003, 28 (emphasis added). Should the district court’s interpretation be the correct one, Patent Owner’s position is much stronger whereas Petitioner’s theory is based on slidable movement. See Pet. 9 (arguing for “slideable inside the sheath” and “the sheath confines the bushing”); Pet. Supp. Reply 6. Having now considered the evidence in the complete record established during trial, we are not persuaded that Petitioner has demonstrated by a preponderance of the evidence that claim 1 would have been anticipated by Adams. Petitioner has not established persuasively that Adams discloses “a bushing extending between a proximal end coupled to the sheath.” For this reason, Petitioner has failed to prove by a preponderance of the evidence that Adams anticipates claim 1.” slip op. at 22
Patent outcomesUS 8,974,371 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,974,371 - 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 - Merck Sharp & Dohme Corp. v. Pfizer Inc.Rehearing deniedPTAB · May 4, 2018 · IPR2017-02138 · APJ Jeffrey N Fredman · IPR · Rehearing
The Board denied Pfizer’s rehearing request, leaving institution of review on claims 11–15 and 20–37 unchanged because the petition made a threshold showing that Pfizer 2012 was publicly accessible.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ServiceNow, Inc. v. Hewlett–Packard Co., Case IPR2015–00707, slip op. at 2 (PTAB August 26, 2015) (Paper 12, 2) (Crumbley, APJ, dissenting) (citations omitted). For the reasons set forth below, we determine that that Petitioner has made a threshold showing that Pfizer 2012 is a printed publication.” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“ServiceNow, Inc. v. Hewlett–Packard Co., Case IPR2015–00707, slip op. at 2 (PTAB August 26, 2015) (Paper 12, 2) (Crumbley, APJ, dissenting) (citations omitted). For the reasons set forth below, we determine that that Petitioner has made a threshold showing that Pfizer 2012 is a printed publication.” slip op. at 7
§ 102 anticipationPatents in suitUS 9,492,559 - PTAB · Aug 1, 2017 · IPR2016-01565 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied Mylan’s rehearing request, leaving claims 6–8, 10–18, 24, and 25 uninstituted because the Petition did not show the Januvia Label and Huettner were printed publications.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party “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. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined 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. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“a trial is based on “the information presented in the petition.” 35 U.S.C. § 314(a). Under 35 U.S.C. § 311(b), in an inter partes review, a petitioner may only challenge the claims of a patent based on “prior art consisting of patents or printed publications,” and the petitioner has the initial burden of production to show that an asserted reference is prior art to the challenged claims under a relevant subsection of 35 U.S.C. § 102. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379 (Fed. Cir. 2015); Dec. 16. As explained in our Decision, we have often required a petitioner to make a threshold showing that the reference relied upon was publicly accessible as a printed publication prior to the effective filing date of a challenged patent to satisfy the initial burden of production. See, e.g., Apple Inc. v. DSS Tech. Mgmt., Inc., Case IPR2015-00369, slip op. at 5 (PTAB Aug. 12, 2015) (Paper 14) (noting that petitioner has the burden to make a threshold showing that a reference is “printed publication” prior art under 35 U.S.C. §§ 102 and 311(b)); Frontier Therapeutics, LLC v. Medac Gesellschaft Für Klinische Spezialpräparate MBH, Case IPR2016-00649, slip op. at 22 (PTAB September 1, 2016) (Paper 10). We further explained that “[a] given reference is ‘publicly accessible’ ‘upon a satisfactory showing that such document has been 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.’” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (citing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)); Dec. 17.” slip op. at 4
- Expert testimonyPetitioner expert discountedDecided for patent owner
“To the extent Petitioner now argues that “the declaration testimony of Dr. Davidson and the facial indicia on Huettner are sufficient” to make a threshold showing that Huettner was publically accessible as of the relevant date (Reh’g Req. 13), we are not persuaded. We note that Dr. Davidson testifies, without elaboration, that “Huettner was published in June 2007.’” Ex. 1002 ¶ 56. Petitioner, however, did not rely on Dr. Davidson’s testimony on this issue in the Petition. Moreover, even if Dr. Davidson’s testimony had been relied on, Petitioner does not point to any evidence—nor can we discern any in Dr. Davidson’s Declaration—that would reasonably suggest that Dr. Davidson has personal knowledge as to when and how Huettner was made available to the public. Accordingly, Dr. Davidson’s conclusory declaration of Huettner’s publication date is entitled to little or no weight. See Dell, Inc. v. Selene Commc’n Techs., LLC, Case IPR2014- 01411, slip op. at 22–23 (PTAB Feb. 26, 2015) (Paper 23) (explaining that an expert declaration is not enough to prove a prior art reference’s publication date where the expert declaration merely repeats assertions made by the petitioner).” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied merits
“Decision on Institution, and Petitioner’s Request for Rehearing, we are not persuaded that we erred in declining to institute trial on claims 6–8, 10–18, 24, and 25. Petitioner, having failed to meet its burden of providing a threshold showing that the Januvia Label and Huettner are printed publications under 35 U.S.C. §§ 102 and 311(b), did not demonstrate a reasonable likelihood of prevailing in its assertion that the subject matter of claims 6–8, 10–18, 24, and 25 of the ’156 patent would have been obvious over the Januvia Label, Huettner, and Mikhail or the Knowledge of one of ordinary skill in the art..” slip op. at 8
§ 102 anticipationPatents in suitUS 8,853,156
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.