- 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 · IPR2016-01201 · APJ Scott R Boalick · IPR · Rehearing
The Board denied Apple’s rehearing request, leaving intact the finding that the challenged claims were not shown obvious over the asserted Chu and Chen 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
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“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
- Expert testimonyPatent owner expert creditedDecided for patent owner
“evidence that, in Chu ’684, users would dial according to the dialing conventions of their geographic area. Reh’g Opp’n 8 (citing Ex. 2016 ¶ 66). Patent Owner’s expert witness, Dr. Mangione-Smith, testified that “in Chu ’684, the users would dial PSTN ‘public numbers’ based on the location of the customer premises.” Ex. 2016 ¶ 66 (citing Ex. 1006, Fig. 2). Figure 2 of Chu ’684 supports Dr. Mangione-Smith’s testimony, in that Figure 2 of Chu ’684 illustrates customer premises 105 (which includes IP phones) as connected to a service provider central office 205. See Ex. 1006, Fig. 2; Reh’g Opp’n 9 (contrasting Petitioner’s assertion” slip op. at 4
§ 103 obviousnessPatents in suitUS 8,542,815 - 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 - Black Swamp IP, LLC v. Virnetx Inc.Rehearing deniedPTAB · Jul 24, 2017 · IPR2016-00957 · APJ Stephen C Siu · IPR · Rehearing
The Board denied VirnetX’s rehearing request, leaving claims 27 and 51 unpatentable as anticipated by Kiuchi.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“path to address the claimed ‘first location’” and relies on In re Magnum Oil Tools Int’l., Ltd., 829 F.3d 1364 (Fed. Cir. 2016) to support Patent Owner’s implied contention that the Final Decision may not address new arguments raised by Patent Owner in Patent Owner’s Preliminary Response and/or Patent Owner’s Response. Req. Reh’g. 6. We disagree. In the present matter and in accordance with Magnum Oil, the ultimate burden of proof remained with Petitioner and was never shifted to Patent Owner at any time during the proceedings and, as discussed above, at no time was an “entirely new path to address the claimed ‘first location’” introduced in the Decision.” slip op. at 3
- BurdenDecided for petitioner
“path to address the claimed ‘first location’” and relies on In re Magnum Oil Tools Int’l., Ltd., 829 F.3d 1364 (Fed. Cir. 2016) to support Patent Owner’s implied contention that the Final Decision may not address new arguments raised by Patent Owner in Patent Owner’s Preliminary Response and/or Patent Owner’s Response. Req. Reh’g. 6. We disagree. In the present matter and in accordance with Magnum Oil, the ultimate burden of proof remained with Petitioner and was never shifted to Patent Owner at any time during the proceedings and, as discussed above, at no time was an “entirely new path to address the claimed ‘first location’” introduced in the Decision.” slip op. at 3
NonePatents in suitUS 7,921,211 - Black Swamp IP, LLC v. Virnetx Inc.Rehearing deniedPTAB · Jul 24, 2017 · IPR2016-00693 · APJ Stephen C Siu · IPR · Rehearing
The Board denied VirnetX’s rehearing request, leaving intact its determination that claims 27 and 51 are anticipated by Kiuchi.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“path to address the claimed ‘first location’” and relies on In re Magnum Oil Tools Int’l., Ltd., 829 F.3d 1364 (Fed. Cir. 2016) to support Patent Owner’s implied contention that the Final Decision may not address new arguments raised by Patent Owner in Patent Owner’s Preliminary Response and/or Patent Owner’s Response. Req. Reh’g. 6. We disagree. In the present matter and in accordance with Magnum Oil, the ultimate burden of proof remained with Petitioner and was never shifted to Patent Owner at any time during the proceedings and, as discussed above, at no time was an “entirely new path to address the claimed ‘first location’” introduced in the Decision.” slip op. at 3
- BurdenDecided for petitioner
“path to address the claimed ‘first location’” and relies on In re Magnum Oil Tools Int’l., Ltd., 829 F.3d 1364 (Fed. Cir. 2016) to support Patent Owner’s implied contention that the Final Decision may not address new arguments raised by Patent Owner in Patent Owner’s Preliminary Response and/or Patent Owner’s Response. Req. Reh’g. 6. We disagree. In the present matter and in accordance with Magnum Oil, the ultimate burden of proof remained with Petitioner and was never shifted to Patent Owner at any time during the proceedings and, as discussed above, at no time was an “entirely new path to address the claimed ‘first location’” introduced in the Decision.” slip op. at 3
NonePatents in suitUS 7,418,504 - Swiss Pharma International AG v. Biogen IdecRehearing deniedPTAB · Feb 3, 2017 · IPR2016-00912 · APJ Lora M Green · IPR · Rehearing
The Board denied Swiss Pharma’s rehearing request, leaving institution denied for claims 1–16, 21, and 22 because the petition did not show a reasonable likelihood of obviousness.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). An abuse of discretion occurs 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. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“however, that the variable to be optimized had to be recognized as a result effective variable. Id. at 620. In the instant case, Petitioner only suggests changing the concentration of the antibody to allow it to be stored in known vials. Petitioner does not explain, however, how merely adding a sufficient concentration of natalizumab to a known vial is a result effective variable. As noted by Patent Owner (Prelim. Resp. 40), Dr. Brod testified that “the concentration of natalizumab is not important from the stand-point of administration as partial, single or multiple vials can be added to an intravenous bag in order to provide the proper dose.” Ex. 1011 ¶ 27. Thus, although the testimony may be read as demonstrating that the concentration is not critical, it also demonstrates that the concentration of the antibody in terms of its storage was not recognized as a result effective variable.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“however, that the variable to be optimized had to be recognized as a result effective variable. Id. at 620. In the instant case, Petitioner only suggests changing the concentration of the antibody to allow it to be stored in known vials. Petitioner does not explain, however, how merely adding a sufficient concentration of natalizumab to a known vial is a result effective variable. As noted by Patent Owner (Prelim. Resp. 40), Dr. Brod testified that “the concentration of natalizumab is not important from the stand-point of administration as partial, single or multiple vials can be added to an intravenous bag in order to provide the proper dose.” Ex. 1011 ¶ 27. Thus, although the testimony may be read as demonstrating that the concentration is not critical, it also demonstrates that the concentration of the antibody in terms of its storage was not recognized as a result effective variable.” slip op. at 8
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We disagree. We noted in our decision that similarly to Soberra, Gordon also taught a 3 mg/ml infusion, and used a 5 mg/ml formulation. Dec. 12‒13. We then looked at the references relied upon by Dr. Schöneich in establishing that formulations were available in stoppered vials in a number of different volumes. Id. at 13. We noted that only one antibody solution was referenced by Dr. Schöneich, and that antibody solution contained 5 mg/ml of antibody. Id. The other references were directed to small molecule drugs, and we noted that Dr. Schöneich did not explain why the ordinary artisan would look to those references when formulating an antibody solution. Id. The fact that Petitioner may not agree with our consideration of the evidence does not mean that we overlooked that evidence, or that we misapprehended it.” slip op. at 11
§ 103 obviousnessPatents in suitUS 8,815,236 - Swiss Pharma International AG v. Biogen IdecRehearing deniedPTAB · Feb 3, 2017 · IPR2016-00915 · APJ Lora M Green · IPR · Rehearing
The Board denied Swiss Pharma’s rehearing request, leaving institution denied for claims 1–4 because the petition did not show a reasonable likelihood of obviousness.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). An abuse of discretion occurs 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. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As noted in our Decision, however, Petitioner failed to demonstrate that the adjustment of the concentration of natalizumab would have been only routine optimization. Dec. 11. Gordon teaches a 5 mg/ml formulation of natalizumab. Id. The other references relied upon by Petitioner to establish that “IgG formulations containing between 5 and 50 mg/ml were known in the art” do not relate to natalizumab, nor are they limited to the claimed excipient, and Petitioner does not address our concern as to how the concentrations of those antibodies could be extrapolated to natalizumab in the claimed excipient. Id. at 10‒12 (quoting Pet. 27). In fact, the references relied upon by Petitioner to teach the claimed excipient, contained 10 mg/ml (van Oosten) or 5 mg/ml (Zenepax) of antibody. Id. at 10. Moreover, Petitioner does not address our concern that two of the three references relied upon by Dr. Schöneich to establish that stoppered vials in different sizes were known related to small molecule drugs, and the one that related to antibodies, Zenepax, contained 5 mg/ml of antibody. See Dec. 12‒13.” slip op. at 7
- Obviousness (§103) › KSR rationalesMotivation not foundDecided for patent owner
“The court held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” Id. at 456. The court noted, however, that “changes such as these may impart patentability to a process if the particular ranges claimed produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art.” Id. In concluding that the patentability of the claims was not demonstrated, the court noted that “[a]ny chemist reading the article could logically assume that higher yields might be obtainable, and by experimentally varying the conditions of temperature and acidity could find the most productive conditions.” Id. at 458. In In re Antonie, 559 F.2d 618 (CCPA 1977), the court noted, however, that the variable to be optimized had to be recognized as a result effective variable. Id. at 620. In the instant case, Petitioner only suggests changing the concentration of the antibody to allow it to be stored in known vials. Petitioner does not explain, however, how merely adding a sufficient concentration of natalizumab to a known vial is a result effective variable. As noted by Patent Owner (Prelim. Resp. 40), Dr. Brod testified that “the concentration of natalizumab is not important from the stand-point of administration as partial, single or multiple vials can be added to an intravenous bag in order to provide the proper dose.” Ex. 1011 ¶ 27. Thus, although the testimony may be read as demonstrating that the concentration is not critical, it also demonstrates that the concentration of the antibody in terms of its storage was not recognized as a result effective variable.” slip op. at 7
- BurdenDecided for patent owner
“37 C.F.R. § 42.108 relates to institution of inter partes review. 37 C.F.R. § 42.108(c) states: Sufficient grounds. Inter partes review shall not be instituted for a ground of unpatentability unless the Board decides that the petition supporting the ground would demonstrate that there is a reasonable likelihood that at least one of the claims challenged in the petition is unpatentable. The Board’s decision will take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence, but a genuine issue of material fact created by such testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review. A petitioner may seek leave to file a reply to the preliminary response in accordance with §§ 42.23 and 42.24(c). Any such request must make a showing of good cause. 37 C.F.R. § 42.108(c), therefore, applies to those situations in which patent owner submits testimonial evidence to support its preliminary response. In those situations where that testimonial evidence creates an issue of material fact, the evidence will be considered in the light most favorable to the petitioner. Patent Owner did not submit any such testimonial evidence in support of its Preliminary Response in the instant proceeding. Moreover, the rule does not relieve Petitioner of its burden of demonstrating in its Petition a reasonable likelihood that at least one of the challenged claims is unpatentable, such that inter partes review may be instituted. In the instant proceeding, for the reasons discussed in the Decision, we determined that the Petition failed to make such a showing.” slip op. at 11
§ 103 obviousnessPatents in suitUS 8,349,321 - Swiss Pharma International AG v. Biogen IdecRehearing deniedPTAB · Feb 3, 2017 · IPR2016-00916 · APJ Lora M Green · IPR · Rehearing
The Board denied rehearing of its denial of institution because Petitioner did not show an abuse of discretion in finding the obviousness showing insufficient.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). An abuse of discretion occurs 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. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As noted in our Decision, however, Petitioner failed to demonstrate that the adjustment of the concentration of natalizumab would have been only routine optimization. Dec. 11. Gordon teaches a 5 mg/ml formulation of natalizumab. Id. The other references relied upon by Petitioner to establish that “IgG formulations containing between 5 and 50 mg/ml were known in the art” do not relate to natalizumab, nor are they limited to the claimed excipient, and Petitioner does not address our concern as to how the concentrations of those antibodies could be extrapolated to natalizumab in the claimed excipient. Id. at 11‒12 (quoting Pet. 27‒28). In fact, the references relied upon by Petitioner to teach the claimed excipient, contained 10 mg/ml (van Oosten) or 5 mg/ml (Zenepax) of antibody. Id. at 11. Moreover, Petitioner does not address our concern that two of the three references relied upon by Dr. Schöneich to establish that stoppered vials in different sizes were known related to small molecule drugs, and the one that related to antibodies, Zenepax, contained 5 mg/ml of antibody. See Dec. 13.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“that the adjustment of the concentration of natalizumab would have been only routine optimization. Dec. 11. Gordon teaches a 5 mg/ml formulation of natalizumab. Id. The other references relied upon by Petitioner to establish that “IgG formulations containing between 5 and 50 mg/ml were known in the art” do not relate to natalizumab, nor are they limited to the claimed excipient, and Petitioner does not address our concern as to how the concentrations of those antibodies could be extrapolated to natalizumab in the claimed excipient. Id. at 11‒12 (quoting Pet. 27‒28). In fact, the references relied upon by Petitioner to teach the claimed excipient, contained 10 mg/ml (van Oosten) or 5 mg/ml (Zenepax) of antibody. Id. at 11. Moreover, Petitioner does not address our concern that two of the three references relied upon by Dr. Schöneich to establish that stoppered vials in different sizes were known related to small molecule drugs, and the one that related to antibodies, Zenepax, contained 5 mg/ml of antibody. See Dec. 13.” slip op. at 7
§ 103 obviousnessPatents in suitUS 8,900,577
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.