- PTAB · Feb 6, 2023 · IPR2022-01318 · APJ Jason W Melvin · IPR · Institution
The Board instituted inter partes review of claims 1, 2, 5, 6, and 8 based on a reasonable likelihood of unpatentability over Duan, and Duan with Wu.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“involved two petitioners accused of infringement based on the same product—made by one petitioner and incorporating technology licensed from the other. Valve I, at 9–10 (finding a significant relationship between the two petitioners “with respect to Patent Owner’s assertion” of the challenged patent); Valve II, at 10 (same); see Prelim. Reply 3. Patent Owner has asserted no such relationship here, and we conclude that Patent Owner has failed to establish that Petitioner has a significant relationship with the -522 IPR petitioner. Representation by the same counsel and being accused of infringing the same patent does not create a relationship that justifies discretionarily denying institution. Accordingly, Factor 1 weighs strongly against denying institution.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we conclude that Petitioner has shown a reasonable likelihood it will prevail in establishing the unpatentability of at least one challenged claim, and we institute inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. LEVEL OF ORDINARY SKILL IN THE ART Petitioner proposes that a person of ordinary skill would have been knowledgeable regarding liquid cooling systems for computer systems, would have had a Bachelor of Science (B.S.) in electrical or mechanical engineering, or similar advanced post-graduate education in this area, or would have possessed at least 2-3 years of experience in liquid cooling systems for computer systems or similar systems. A POSITA would be knowledgeable of the concepts, components, and their functions described as “prior art” in the ’355 patent such as, e.g., pumps, radiators, fans, reservoirs, and other techniques of heat dissipation and liquid cooling. (Ex-1001,1:11-47.) In addition, a POSITA would be knowledgeable about electric motors and their components (e.g., electromagnetic coils, rotors, stators, AC/DC motors, etc.) Pet. 6–7 (citing Ex. 1003 ¶¶ 13–18). Patent Owner does not dispute this definition of a person of ordinary skill. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s proposed level of ordinary skill as it appears to be consistent with the level of skill reflected by the specification and in the asserted prior art references.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Based on our analysis of the issues in dispute at this stage of the proceeding, we conclude that no claim term requires express construction at this time. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017).” slip op. at 14
Claim constructionDiscretionary denialPatents in suitUS 10,078,355 - Arkema Inc. / Arkema France v. Honeywell International Inc.All claims unpatentablePTAB · Aug 25, 2022 · PGR2016-00011 · APJ Grace Karaffa Obermann · PGR · Remand
Claims 1–20 are unpatentable under § 102(a) for prior public use; the Board did not reach the other anticipation, obviousness, and enablement grounds.
RulingsRemand decision- RemandOther
“On October 1, 2019, the Federal Circuit held that we “abused [our] discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate,” and vacated our Final Written Decision. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345 (Fed. Cir. 2019). The Federal Circuit instructed us to “authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.” Id. at 1351. Pursuant to the Federal Circuit’s mandate, we gave our authorization, and Patent Owner filed its Motion for Leave to Request a Certificate of Correction. PGR11 Paper 61; PGR12 Paper 41. After additional briefing from the parties was complete, we granted Patent Owner’s Motion. PGR11 Paper 77; PGR12 Paper 57. Patent Owner filed its Request for a Certificate of Correction, as well as a Petition to Accept [Unintentionally] Delayed Claim to Priority under 35 U.S.C. § 120 and 37 C.F.R. § 1.78. PGR11 Ex. 2174; PGR12 Ex. 2172.” slip op. at 3
- Skill levelSkill level board ownDecided for petitioner
“develops new refrigerants for use as heat transfer fluids. Ex. 1002 ¶ 149. Such a person would have had a Ph.D. in Chemistry, Chemical Engineering, Mechanical Engineering, Material Science, or a related field or discipline and at least 3 to 5 years of experience, or alternatively an M.S. degree and 5 to 10 years of experience. Id. Patent Owner’s Declarant, Dr. Bivens, provides a similar description of the person of ordinary skill in the art, stating that such a person would have a B.S. degree in Chemical Engineering or Chemistry, and five years of work experience, or a Ph.D. or M.S. degree and 2–3 years of experience. Ex. 2001 ¶ 23. Based on these descriptions, we find that the parties’ definitions of ordinary skill in the art are substantially the same, and agree with the parties that an ordinarily skilled artisan would be educated in the Chemical and Chemical Engineering arts or related disciplines. We also agree with the parties that a person having less formal education, such as a B.S. or M.S. degree, would require more years of experience than a person with more formal education, such as a Ph.D., to qualify as an ordinarily skilled artisan. We also find that neither party states how any difference in the parties’ articulated levels of skill impacts this proceeding. Thus, our analysis would be the same regardless of any minor differences between the parties’ respective articulations. Finally, we note that the level of ordinary skill in the art is reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot shown unpatentable
“We agree with Petitioner that the ’525 application’s statement that the compounds are “adaptable for use” weighs against a finding of adequate written description. First, “adaptable for use” is vague, as Dr. Bivens acknowledges. See Ex. 1177, 151:15 (testifying that “adaptable for use can have a wide range of meaning”). Second, the ’525 application gives no direction on how a skilled artisan would need to adapt any particular composition for use in AAC, or even if any “adaptation” was necessary. We find that such a teaching is important in this case to show that the inventors had possession of the claimed invention, given our findings above that the art of AAC was unpredictable and that a heat-transfer composition for AAC required specific technical features that were unpredictable and unexpected. For completeness, we again reject Patent Owner’s argument that “[t]o show the inventors possessed claim 1 requires no more” than the statement in the written description that “‘the compositions of the present invention are believed to be adaptable . . . with or without system modification.’” PGR12 Resp. 27–28 (quoting Ex. 1001, 7:4–8). Regardless of the exact wording of claim 1, the inventors “still [had to have] describe[d] some way of performing the claimed methods.” Ariad, 598 F.3d at 1355. And here, with merely a passing reference to AAC, the ’525 application fails to provide any credible “technologic knowledge” to demonstrate to an ordinarily skilled artisan that Patent Owner “was in possession of the invention that is claimed.” Id.” slip op. at 43
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)UnpatentableUnpatentable
“unless . . . the claimed invention was . . . in public use . . . before the effective filing date of the claimed invention.” 35 U.S.C. § 102(a)(1). “The proper test for the public use prong . . . is whether the purported use was accessible to the public or was commercially exploited.” Delano Farms Co. v. Cal. Table Grape Comm’n, 778 F.3d 1243, 1247 (Fed. Cir. 2015) (quotation omitted). “Commercial exploitation is a clear indication of public use . . . .” Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005).” slip op. at 53
Patent outcomesUS 9,157,017 unpatentable§ 102 anticipation§ 112 disclosurePatents in suitUS 9,157,017 - PTAB · Dec 28, 2021 · IPR2021-01195 · APJ Jason W Melvin · IPR · Institution
The Board instituted IPR on claims 1, 6, 7, 11, and 12, finding a reasonable likelihood that the Batchelder-based obviousness grounds would prevail.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityNot reached
“Under the Board’s precedential decision in SharkNinja Operating LLC v. iRobot Corp., when no time-bar or estoppel would apply once determining Petitioner did not name all RPIs, the Board need not address the issue. IPR2020-00734, Paper 11 (Oct. 6, 2020) (precedential); see also Lumentum Holdings, Inc. v. Capella Photonics, Inc., IPR2015-00739, Paper 38 at 6 (PTAB Mar. 4, 2016) (precedential) (“[O]ur jurisdiction to consider a petition does not require a ‘correct’ identification of all RPIs in a petition.”); Mayne Pharma Int’l Pty. Ltd. v. Merck Sharp & Dohme Corp., 927 F.3d 1232, 1240 (Fed. Cir. 2019) (“[I]f a petition fails to identify all real parties in” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“the ’354 patent, the overlap in the asserted prior art, and our prior determination of unpatentability regarding the ’354 patent, we conclude that the merits of Petitioner’s case in this proceeding are substantively strong. Thus, this factor weighs strongly in favor of institution. 7. Holistic assessment of factors and conclusion We consider the above factors and take “a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv, Paper 11 at 6. In weighing the totality of the evidence, we decide not to exercise discretion under § 314(a) to deny institution.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“C. LEVEL OF ORDINARY SKILL IN THE ART Petitioner proposes that a person of ordinary skill would have been knowledgeable regarding liquid cooling systems for computer systems, would have earned at least a bachelor’s degree, such as a B.S. (bachelor of science), or equivalent thereof, in electrical or mechanical engineering or a closely related field, and would have possessed at least two or three years of experience in liquid cooling systems for computer systems or in similar systems. Pet. 7–8 (citing Ex. 1003 ¶¶ 23–26). Patent Owner does not dispute this definition of a person of ordinary skill. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s proposed level of ordinary skill as it appears to be consistent with the level of skill reflected by the specification and in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“construe claim terms “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). The parties stipulated to constructions of “reservoir” and “chamber” in the district-court litigation. Ex. 1005, 2. Petitioner proposes additional constructions for “impeller” and “radiator.” Pet. 8–10. Patent Owner does not dispute those constructions. See generally Prelim. Resp. Based on our analysis of the issues in dispute at this stage of the proceeding, we conclude that none of the claim terms identified by the parties require express construction at this time. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017).” slip op. at 15
Claim constructionDiscretionary denialPatents in suitUS 10,613,601 - Apple Inc. v. Voip-Pal.Com, Inc.Rehearing deniedPTAB · May 24, 2019 · IPR2016-01198 · APJ Scott R Boalick · IPR · Rehearing
The Board denied Apple’s rehearing request, leaving intact the finding that challenged claims of the ’005 and ’815 patents were not shown obvious over the asserted combinations.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“At the outset, we note that in a request for rehearing we do not review the merits of the Final Written Decision de novo. Instead, we consider whether Petitioner has met its burden of showing that a matter has been misapprehended or overlooked in the Final Written Decision. 37 C.F.R. § 42.71(d) (“The burden of showing a decision should be modified lies with the party challenging the decision. 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.”). We conclude that Petitioner has not met this burden in its Request for Rehearing.” slip op. at 2
- Expert testimonyPatent owner expert creditedDecided for patent owner
“view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“testimony by Dr. Mangione-Smith—when rejecting Petitioner’s view of the prior art and reason for the combination. See FWD 19 (citing Ex. 2016 ¶¶ 65–67); Reh’g Opp’n 6. Thus, when the panel concluded that Petitioner had not shown that Chu ’684’s method would apply to a number reformatted by the secondary references (see FWD 22–23), it relied on record evidence supporting its conclusion. We determine that the panel did not misapprehend the nature of the proposed combination; rather, based on the record, it resolved a factual dispute and concluded that Petitioner failed to show the proposed combination would operate as asserted.” slip op. at 5
§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,179,005 - Apple Inc. v. Virnetx Inc.All claims unpatentablePTAB · Jun 22, 2017 · IPR2016-00331 · APJ Karl D Easthom · IPR · Final written decision
Claims 1–11, 14–25, and 28–30 are unpatentable as obvious over Beser and RFC 2401.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Patent Owner’s contentions are not persuasive. Patent Owner fails to explain sufficiently why the notion of “performing an additional evaluation” constitutes an implicit part of the claimed intercept clause. Addressing similar arguments by Patent Owner, a Board panel made a similar determination in the ’237 FWD relied upon by Petitioner. ’237 FWD 11 (“the record show[s] that the additional functionality urged by Patent Owner should not be imported into the intercepting phrase”).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“broadest reasonable interpretation in light of the specification. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard under 37 C.F.R. § 42.100(b)). Under this standard, absent any special definitions, claim terms or phrases are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art, in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). For the purposes of this Decision, only the claim terms or clauses below need express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only those terms in controversy need to be construed and only to the extent necessary to resolve the controversy).” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find Dr. Tamassia’s testimony as to public accessibility of RFCs in general to be credible, especially given the independent support of RFC 2026 (Ex. 1036), the contents of which Patent Owner does not challenge.7 As part of routine discovery, see 37 C.F.R. § 42.51(b)(1)(ii), Patent Owner had the opportunity to cross-examine Dr. Tamassia, but does not point us to any discussion of this issue. Moreover, RFC 2401’s contents are consistent with the publication process described by RFC 2026 and Dr. Tamassia, including the inclusion of a date “November 1998” on the top right corner of the first page of the document. Ex. 1008, 1. In addition, this document—a request for suggestions and improvements for an Internet standards protocol, 7 As addressed below, Patent Owner objects and moves to dismiss a number of Exhibits based on hearsay and relevancy. See Paper 20 (Motion to Exclude). having no indication of being a mere draft or internal paper—is precisely the type of document whose very purpose is public disclosure, including on the Internet. Both of the magazine articles, Exhibits 1064 and 1065, further corroborate the indicia of availability on the face of RFC 2401, although they are not necessary to our finding of public accessibility. We do not rely on the testimony of Sandy Ginoza, Exhibits 1060 and 1063, which Patent Owner seeks to exclude as discussed further below.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Patent Owner does not articulate a persuasive reason for giving Dr. Tamassia’s declaration, as a whole, little or no weight in our analysis. We agree with Petitioner that experts are not required to opine on every relevant factual and legal issue in order to be accorded substantial weight. The cases upon which Patent Owner relies do not show otherwise. For example, Patent Owner cites Schumer v. Laboratory Computer Systems, Inc., 308 F.3d 1304, 1315 (Fed. Cir. 2002), for the proposition that “[expert] testimony . . . ‘must identify each claim element, state the witnesses’ interpretation of the claim element, and explain in detail how each claim element is disclosed in the prior art reference.’” PO Resp. 52–53. Patent Owner’s quotation, however, mischaracterizes Schumer by omitting introductory words necessary to the meaning of the quoted sentence. In its entirety, the quoted portion of Schumer states the following: Typically, testimony concerning anticipation must be testimony from one skilled in the art and must identify each claim element, state the witnesses’ interpretation of the claim element, and explain in detail how each claim element is disclosed in the prior art reference. The testimony is insufficient if it is merely conclusory. Schumer, 308 F.3d at 1315–16. The Federal Circuit then adds that it is not the task of the courts to “attempt to interpret confusing or general testimony to determine whether a case of invalidity has been made out” and “if the testimony relates to prior invention and is from an interested party, as here, it must be corroborated.” Id. at 1316. So, instead of laying out a specific, required format for the content of all testimony regarding invalidity, as asserted by Patent Owner, this portion of Schumer confirms the unremarkable proposition that conclusory, overly general, confusing, and self-interested testimony should not be relied upon. Id.; see also Koito Mfg. Co., Ltd. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1152 (Fed. Cir. 2004) (“General and conclusory testimony, such as that provided by Dr. Kazmer in this case, does not suffice as substantial evidence of invalidity.”). Patent Owner does not show that the whole of Dr. Tamassia’s testimony suffers from any of these failings. Under 35 U.S.C. § 316(e), the preponderance of the evidence standard governs in determining whether Petitioner establishes unpatentability. We exercise discretion to determine the appropriate weight to accord the evidence presented, including expert opinions, based on the underlying facts supporting the opinion. We accord relevant portions of Dr. Tamassia’s testimony the appropriate weight based on that particular testimony and supporting evidence.” slip op. at 14
Patent outcomesUS 8,504,696 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 8,504,696 - Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentablePTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision
Claims 1–8 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success using lomitapide in the claimed dosing regimen.
RulingsFinal written decision- BurdenNot shown unpatentable
“The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). As to reasonable expectation of success, we agree with Patent Owner that the ordinary artisan would not have had a reasonable expectation of success of combining Pink Sheet with Chang to arrive at the claimed invention. To the extent that Petitioner relies on our Institution Decision, we note that decision was based on the evidence of record at that time. The evidence advanced by Patent Owner during trial, discussed herein, however, tips the scale in favor of a finding different from that set forth in our Institution Decision. slip op. at 36
- ExcludeMotion to exclude, deniedMixed
“As to Exhibit 1052, which is the Deposition Transcript of S. David Kimball, and which Patent Owner acknowledges that Petitioner cites in its Reply, Patent Owner argues that it timely objected to the exhibit as an improper duplicate of Exhibit 2304. Mot. Exclude 7. Petitioner responds that Exhibits 2304 and 1052 are the transcripts of Petitioner’s expert. Opp. Mot. Exclude 4. Although acknowledging that the party taking the deposition normally files the transcript, Petitioner asserts that its Reply cites to Ex. 1056, and Patent Owner does not cite to either exhibit. Id. Patent Owner replies that Exhibit 2304 also contains Dr. Kimball’s signed errata sheet and is, thus, the more complete of the two documents. Reply Mot. Exclude. 3. Patent Owner asserts that the citations in Petitioner’s Reply can be updated to reflect the correct exhibit number, if necessary. Id. Given the posture of this proceeding, that is, it is at final written decision, and as Patent Owner notes, the two documents are not exact duplicates, we decline to exclude Ex. 1056, but will allow both Exhibit 1056 and 2034 to remain in the record.” slip op. at 44
- PTAB / AIA Trials › Motions to amend / substitute claimsNot reached
“the unrebutted evidence of commercial success further supports the patentability of the challenged claims. Looking at the entire record before us, we conclude that Petitioner has not meet its burden to establish unpatentability of challenged claims 1‒8 by a preponderance of the evidence over the combination of Pink Sheet and Chang. E. Motion to Amend As discussed above, because we conclude that Petitioner has not demonstrated the obviousness of the claims by a preponderance of the evidence, we need not reach the merits of Patent Owner’s contingent Motion to Amend (Paper 24). We, thus, dismiss the motion a moot.” slip op. at 44
- Expert testimonyPetitioner expert discountedDecided for patent owner
“biotechnology and medical device companies.” Id. The press release does not even mention Dr. Stein. Thus, there is nothing in the press release suggesting that the ordinary artisan in the cardiovascular/cardiac field, or interested in MTP inhibitors, should attend the presentation. We, therefore, decline to credit Dr. Mayersohn’s testimony that “[a]person of ordinary skill in the art interested in the development of MTP inhibitors could apparently have attended the meeting or accessed the presentation itself via webcast or on the PPD website shortly thereafter” (Ex. 1003 ¶ 25 (citing the PPD Press Release)), as there was nothing in the press release discussing MTP inhibitors. That finding informs our analysis of the factors set forth in Klopfenstein. Thus, although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.” slip op. at 19
Patent outcomesUS 7,932,268 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,932,268 - Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentablePTAB · Mar 6, 2017 · IPR2015-01835 · APJ Lora M Green · IPR · Final written decision
Claims 1–10 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success substituting lomitapide into Pink Sheet’s dosing protocol.
RulingsFinal written decision- BurdenFwd all claims patentableNot shown unpatentable
“We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish facts supporting its challenge by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Based on the record before us, we conclude that Petitioner has failed” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner
“under 35 U.S.C. § 102 “involves a case-by-case 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). “Because there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). “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.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation not foundMixed
“Although we find this issue to be very close, we find that the Petitioner has established by a preponderance of the evidence that the ordinary artisan would have looked at other MTP inhibitors, such as lomitapide as taught by Chang, that could be used in the dosing protocol taught by Pink Sheet. Specifically, Pink Sheet teaches a dosing method with the MTP inhibitor, implitamide, wherein, as discussed above, the dosing schedule meets the dosing schedule required by claim 1. Ex. 1013. In addition, Pink Sheet discusses MTP inhibitors generally, and notes that they may have efficacy in situations where high-dose statins are ineffective or inadequate, such as homozygous and severe heterozygous familial hypercholesterolemia. Id. Pink Sheet also acknowledges that the toxicity seen with MTP inhibitors may have been due to the high doses used during the clinical trials. Id. Chang discusses the clinical efficacy of MTP inhibitors, including implitapide (BAY-13-9952) and lomitapide (BMS-201038). Ex. 1015, 566. Specifically, Chang discusses the clinical efficacy of CP-346086, and then notes that similar efficacy was reported for implitapide and lomitapide. Id. Given that implitapide and lomitapide are from the same class of therapeutics, that is, MTP inhibitors, and that they are known to have similar clinical efficacy, based on the record before us, we determine that Petitioner has demonstrated a reasonable basis as to why the ordinary artisan would have substituted lomitapide as taught by Chang for implitapide in the method of Pink Sheet.” slip op. at 32
- Obviousness (§103) › Objective indicia / secondary considerations › Commercial successObjective indicia with nexusDecided for patent owner
“Initially, we note that Petitioner does not contest that Juxtapid is a commercial success, and, thus, in view of the unrebutted evidence provided by Patent Owner, we find that Patent Owner has established that Juxtapid is a commercial success. As to Petitioner’s argument that the Juxtapid website does not suggest a forced titration, as set forth in our section on claim construction above, we decline to construe independent challenged claim 1 as requiring a forced titration. Moreover, as shown in the table below, the dosing schedule of independent claim 1 encompasses the dosing method that is given to doctors on the Juxtapid website (Ex. 2301, 1):” slip op. at 43
Patent outcomesUS 8,618,135 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,618,135 - Vista Outdoor Operations LLC v. Liberty Ammunition, LLCRehearing deniedPTAB · Oct 31, 2016 · IPR2016-00539 · APJ Michael L Woods · IPR · Rehearing
The Board denied rehearing and left in place the denial of institution for claims 1–42 on all six grounds, finding no overlooked or misapprehended matter.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS The applicable standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. 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, opposition, or a reply. Furthermore, when rehearing a decision on a motion, the Board will review the decision for an abuse of discretion. Id. at § 42.71(c).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“The Board found that these embodiments were distinct, and determined that Petitioner failed to establish a reasonable likelihood of success on its challenges when combining features from these distinct embodiments. See Decision 13–16, 19, 20. With respect to the anticipation ground (Ground 1), the Board explained that “it is not enough that the prior art reference discloses multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Id. at 13 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371–72 (Fed. Cir. 2008)). With respect to Grounds 2 and 3, the Board determined that Petitioner failed to explain adequately how Woodring’s distinct embodiments are being combined with one another and the cited art to arrive at the claimed invention. Id. at 18, 20.” slip op. at 4
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“The Board found that these embodiments were distinct, and determined that Petitioner failed to establish a reasonable likelihood of success on its challenges when combining features from these distinct embodiments. See Decision 13–16, 19, 20. With respect to the anticipation ground (Ground 1), the Board explained that “it is not enough that the prior art reference discloses multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Id. at 13 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371–72 (Fed. Cir. 2008)). With respect to Grounds 2 and 3, the Board determined that Petitioner failed to explain adequately how Woodring’s distinct embodiments are being combined with one another and the cited art to arrive at the claimed invention. Id. at 18, 20.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“determined that Petitioner failed to establish a reasonable likelihood of success on its challenges when combining features from these distinct embodiments. See Decision 13–16, 19, 20. With respect to the anticipation ground (Ground 1), the Board explained that “it is not enough that the prior art reference discloses multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Id. at 13 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371–72 (Fed. Cir. 2008)). With respect to Grounds 2 and 3, the Board determined that Petitioner failed to explain adequately how Woodring’s distinct embodiments are being combined with one another and the cited art to arrive at the claimed invention. Id. at 18, 20.” slip op. at 4
§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,748,325 - Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentablePTAB · Oct 26, 2016 · IPR2015-01096 · APJ Michael P Tierney · IPR · Final written decision
Claims 1–32 are unpatentable as obvious over Thalomid PI in view of Cunningham, Keravich, Zeldis, and Mundt.
RulingsFinal written decision- Skill levelSkill level board ownPetitioner expert creditedOther
“representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003, 1006, 1009, 1012, 1018. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1021 ¶¶ 44–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“for close constant monitoring to identify noncompliance or other problems, but concluded by stating that Celgene was committed to making the program succeed and would be willing to make any modifications to the program necessary to ensure its effectiveness. Ex. 1012 at 329. This willingness to make any modifications is consistent with the understanding that the underlying drug remains a safety concern because controlling the distribution of the drug does not negate the actual side effects of the underlying drug. In dealing with such drugs, such as those capable of causing severe birth defects, the highest level of safety is desired. Under such circumstances, consistent with the teachings of Zeldis and the art of record one skilled in the art would understand that where significant safety risks exist with a drug, one would continuously search for safer ways to control the distribution of the drug. Put simply, where significant safety concerns exists, one of ordinary skill in the art would not wait until an accident occurred to seek out improvements.” slip op. at 23
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“limitations recited in independent claims 1 and 28, with the exception of the generation of a prescription approval code to be retrieved by a pharmacy before the prescription is filled. Pet. 52. Petitioner states that one skilled in the art, following the teachings of Thalomid PI and seeking to avoid treating pregnant women with thalidomide, would have implemented the methods disclosed in Cunningham to limit dispensation of a drug associated with adverse effects to certain risk groups. Id. at 54. We understand Petitioner as contending that the challenged claims represent a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects). For the reasons provided below, we conclude that Petitioner has demonstrated by a preponderance of the evidence that the challenged claims are obvious over the cited prior art.” slip op. at 20
Patent outcomesUS 6,315,720 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,315,720 - Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentablePTAB · Oct 26, 2016 · IPR2015-01103 · APJ Michael P Tierney · IPR · Final written decision
Claims 1–32 are unpatentable as obvious over Mitchell and Dishman in view of Cunningham and the additional cited references.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003; 1008; 1011; 2062; 2067. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1027 ¶¶ 43–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“their broadest reasonable interpretation in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b). Generally, Petitioner states that the claim terms are presumed to take on the ordinary and customary meaning that they would have to one of ordinary skill in the art. Pet. at 10. Petitioner proposes constructions for several claim terms including “consulted,” “teratogenic effect,” and “adverse side effect.” Id. at 10–11. Patent Owner does not propose distinct constructions of the identified terms. We determine that the identified claim terms should be given their ordinary and customary meaning, as would be understood by one with ordinary skill in the art, and need not be construed explicitly at this time for purposes of this Decision.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 14
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
Patent outcomesUS 6,315,720 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,315,720
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.