- Liquidia Technologies, Inc. v. United Therapeutics CorporationAll claims unpatentablePTAB · Jul 19, 2022 · IPR2021-00406 · APJ Christopher M Kaiser · IPR · Final written decision
Claims 1–8 are unpatentable as obvious over the ’212 patent, Voswinckel JESC, and Voswinckel JAHA; the Board did not reach the other grounds.
RulingsFinal written decision- Strike new argumentNew argument consideredDecided for petitioner
“Petitioner is permitted a “limited opportunit[y]” to present new evidence in or with its Reply, as long as that new evidence is “responsive to the prior briefing” and does not constitute “changing theories after filing [the] petition.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29, at 14–15 (PTAB Dec. 20, 2019) (precedential). Here, both of the arguments that Patent Owner alleges are new—the argument that Voswinckel JESC and Voswinckel JAHA were presented publicly and the argument that these references were cited in other publicly available references—respond to Patent Owner’s argument in the Patent Owner Response that Voswinckel JESC and Voswinckel JAHA were not publicly accessible. PO Resp. 11–18. The argument that Voswinckel JESC was publicly presented is not a change in theory from the Petition, because Petitioner presented this argument in the Petition. Pet. 22. As to both Voswinckel JESC and Voswinckel JAHA, Petitioner’s Reply evidence showing citation to the references in other publicly accessible documents is merely additional evidence supporting Petitioner’s original theory that a person of ordinary skill in the art could have located the references. Accordingly, we find that the following arguments made by Petitioner are not untimely: (1) that Voswinckel JESC was presented publicly, (2) that Voswinckel JESC was referenced in a publicly accessible document, and (3) that Voswinckel JAHA was referenced in a publicly accessible document.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Voswinckel JESC and Voswinckel JAHA were publicly accessible. “[T]he presence of a ‘research aid’ can . . . establish public accessibility” of a reference if that research aid “provide[s] a skilled artisan with a sufficiently definite roadmap leading to” the reference by “provid[ing] enough details [to] determine that an interested party is reasonably certain to arrive at the destination: the potentially invalidating reference.” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1350 (Fed. Cir. 2016). Here, Petitioner directs us to research aids for finding both Voswinckel JESC and Voswinckel JAHA: a “June 2005 Ghofrani article in the journal Herz” for the former, and “a March 2005 article authored by Roxana Sulica et al. in the Expert Review of Cardiovascular Therapy” for the latter. Reply 3, 7 (citing Ex. 1010, 298, 301; Ex. 1104, 359). The Ghofrani article cites Voswinckel JESC as providing a solution to patients experiencing “pain at the injection site” by replacing injected treprostinil for “pulmonary arterial hypertension” with “inhaled treprostinil.” Ex. 1010, 298 (citing reference 6), 301 (defining reference 6 as Voswinckel JESC). The Ghofrani article also discusses the study reported in Voswinckel JESC, summarizing both the “major reduction in pulmonary selective pressure and resistance” and the lack of “adverse effects” described in Voswinckel JESC. Id. The Sulica article cites to Voswinckel JAHA, explaining that the reference reports that “inhaled treprostinil demonstrated substantial pulmonary vasodilatory efficacy in acute administration, as well as symptomatic and functional benefit in chronic use in a small number of PAH patients.” Ex. 1104, 351, 359. Thus, both the Ghofrani article and the Sulica article provide roadmaps directing a person of ordinary skill in the art looking for successful studies discussing the use of inhaled treprostinil in pulmonary arterial hypertension straight to Voswinckel JESC or Voswinckel JAHA. Because these articles provide these roadmaps, they are “research aid[s]” that “establish [the] public accessibility” of Voswinckel JESC and Voswinckel JAHA. Blue Calypso, 815 F.3d at 1350.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“The preponderance of the evidence supports Petitioner’s position. Patent Owner is correct that Voswinckel JESC notes that side effects could occur more frequently at higher doses than at lower doses. Ex. 1007, 7. But there is considerable evidence of record that a person of ordinary skill in the art would not have avoided increasing Voswinckel JESC’s dose due to the side effects reported in Voswinckel JESC. First, Dr. Hill testifies that “[p]otential side effects are always weighed against potential clinical benefit, and pulmonary arterial hypertension is a serious, life-threatening disease where physicians and patients are more willing to tolerate side effects . . . to obtain clinical benefit.” Ex. 1106 ¶ 74. Second, Dr. Waxman testifies that “[u]sually the headache goes away” and “there are things that can be done to help ameliorate the cough so in general we are able to get over that issue.” Ex. 1108, 101:19–102:10. Together with Voswinckel JESC’s description of potential side effects as “mild and transient,” this evidence supports a finding that a person of ordinary skill in the art would not have been deterred from pursuing the course that is supported by the evidence to which Petitioner directs us. With respect to reasonable expectation of success, Petitioner argues that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of the ’212 patent, Voswinckel JESC, and Voswinckel JAHA because Voswinckel JAHA teaches that “[t]olerability is excellent” for its short-duration, high-concentration treprostinil inhalation therapy. Pet. 33 (citing Ex. 1008, 3). Other than the argument discussed above about side effects reported in Voswinckel JESC, Patent Owner does not raise any timely counter to this argument.8 PO Resp. 10–40. The record supports Petitioner’s argument. Ex. 1008, 3. Accordingly, Petitioner has shown by a preponderance of the evidence that a person of ordinary skill in the art would have had a reason to combine the teachings of the ’212 patent, Voswinckel JESC, and Voswinckel JAHA and that they reasonably would have expected to succeed in doing so.” slip op. at 20
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner
“[U]nexpected results must establish . . . a difference between the results obtained and those of the closest prior art.” Bristol-Myers Squibb v. Teva Pharms. USA, 752 F.3d 967, 977 (Fed. Cir. 2014). Petitioner argues that the prior art over which Patent Owner argues the challenged claims showed unexpected results is not the closest prior art. Reply 24. We agree. As noted above, Patent Owner argues that the challenged claims show unexpected results over inhaled iloprost, intravenous epoprostenol, and intravenous treprostinil. PO Resp. 55–57. But the challenged claims recite inhaled treprostinil, and, as discussed above, inhaled treprostinil is taught by each of the ’212 patent, Voswinckel JESC, and Voswinckel JAHA. Ex. 1001, 18:22–44; Ex. 1006, code (57); Ex. 1007, 7; Ex. 1008, 3; Ex. 1035, 582. Patent Owner does not even allege that the results of the challenged claims are unexpected over these references.9 Accordingly, we find that the evidence of record does not establish that the challenged claims produced a result that was unexpected over the closest prior art. slip op. at 22
Patent outcomesUS 10,716,793 unpatentable§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,716,793 - PTAB · Jul 15, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Patent Owner’s rehearing request was granted, and institution was denied for all challenged claims based on changed circumstances in the parallel district court proceeding under Fintiv.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that a rehearing of our prior institution decision is appropriate due to the changed circumstances of: (1) the statutory disclaimer of claims 6–8 of the ’039 patent, (2) Patent Owner’s request for adverse judgment of related proceeding PGR2021-00042, and (3) the additional investment in the parallel proceeding by the district court and the parties, including the completion of a jury trial that resulted in a jury verdict not finding invalidity of the challenged claims. We further agree with Patent Owner that “[c]ontinuing with this proceeding would result in duplicative efforts and potentially conflicting results between the district court and the Board.” Reh’g Req. 9. It is the combination of these changed circumstances, rather than any one of them individually, that compels the result we reach.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“In considering the parties’ positions and the evidence of record, we note that we have been instructed not to exercise discretion to deny a petition when “the information presented at the institution stage presents a compelling unpatentability challenge.” Guidance Memo 4–5. We previously described “Petitioner’s argument that the claims lack enablement” as presenting “strong merits.” Paper 17, 3. Despite that determination, we believe the record as it stands currently does not “present[] a compelling unpatentability challenge” on the lack-of-enablement issue. Guidance Memo 4–5. The district court already has substantially completed its review of the enablement issue, and a jury has determined that the claims do not lack enablement. Given this new information, we cannot conclude that Petitioner’s enablement case is compelling.” slip op. at 6
- Adverse judgmentOther
Discretionary denialPatents in suitUS 10,808,039 - Pillar Biosciences, Inc. v. Swift Biosciences, Inc.All claims unpatentablePTAB · Jun 27, 2022 · IPR2021-00401 · APJ Christopher M Kaiser · IPR · Final written decision
Claims 1–6 are unpatentable as obvious over Gardner and Lao; the Board did not reach anticipation by Xie or Lao.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Id. “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner proposes constructions for five terms: “third amplicon,” “target-specific primer,” “complementary sequence,” “noncomplementary sequence,” and “PCR.” Pet. 22–28. Patent Owner disputes only the proposed constructions of “third amplicon” and “target-specific primer.” PO Resp. 9–17. As discussed in more detail below, the parties do not dispute that the combination of Gardner and Lao teaches or suggests the subject matter of the challenged claims, so there is no need for us to resolve the parties’ claim-construction dispute as to either of the terms on which they disagree in order to resolve the question of obviousness. In addition, although the parties’ dispute over the construction of “target-specific primer” is germane to whether Petitioner has proven the anticipation of the challenged claims by either Lao or Xie, we do not reach the anticipation grounds. Thus, we need not, and we do not, construe any claim terms in order to resolve this proceeding.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“We agree with Petitioner. Although Gardner does, as Patent Owner notes, teach a method of avoiding the production of short amplicons, it does so only by carrying out two separate reactions. Ex. 1016, 4 (suggesting combining “the primers from parts 0, 2, and 4 . . . in one reaction and the primers from parts 1 and 3 . . . in another, so that short products would not be produced”). But Gardner makes clear that carrying out a single multiplex reaction would be preferable. Id. at 2 (“The method here . . . seeks to automatically design a minimal, degenerate set of multiplex compatible primers to amplify all the strains for a given region in a single reaction.”), 4 (carrying out “whole genome amplification in a single reaction . . . may yield longer amplicons . . . and should facilitate assembly across amplified regions”). Thus, Gardner favors finding a way to carry out a single reaction rather than settling for its collection of separate reactions. Gardner teaches that, without “staggering the primer sets into different multiplex reactions,” the short amplicons produced by “overlapping primer sets would dominate the PCR reaction.” Id. at 6. Patent Owner argues that this shows that Gardner disapproves of any means of controlling short amplicons other than its multiple-reaction approach and is “quite opposed to a single reaction.” Sur-Reply 6–7. We disagree. As noted above, Gardner also teaches that “a step to remove short amplicons before sequencing may be desired.” Ex. 1016, 4. Gardner’s multi-reaction solution avoids production of short amplicons in the first place, and amplicons that are never produced do not need to be removed. Thus, the fact that Gardner teaches the removal of short amplicons means that Gardner does not disapprove of the use of solutions other than its multi-reaction approach. Instead, Gardner considers its multi-reaction approach to be a compromise between the goal of avoiding problems caused by the production of short amplicons and the goal of minimizing the number of reactions carried out. Gardner’s teaching that adding “a step to remove short amplicons before sequencing may be desired,” id. at 4, is an express invitation to a person of ordinary skill in the art to find and incorporate such a removal step in lieu of avoiding the production of short amplicons. As discussed above, Lao teaches a method of removing short amplicons from a reaction. Specifically, Lao discloses “an event or state in which a portion of a nucleic acid strand is hybridized to another portion of itself,” which Lao refers to as “self-hybridizing.” Ex. 1014 ¶ 69. This “selfhybridized structure [may only be] formed for the shorter insert sections,” allowing for “selective amplification of longer insert sections over shorter insert sections.” Id. ¶ 116. This happens because the shorter insert sections “take themselves out of a reaction” through self-hybridization. Id. Because Gardner expressly teaches combining its method with “a step to remove short amplicons before sequencing,” and because Lao teaches such a step, we find that a person of ordinary skill in the art would have had a reason to combine the teachings of Lao with those of Gardner. The parties raise several other arguments, including whether the combination of Lao and Gardner would in fact achieve both Gardner’s benefit of avoiding overlapping amplicons and Lao’s benefit of saving time and cost due to avoiding having to run separate reactions, but we need not resolve those disputes. The presence of an express reason to combine is sufficient.” slip op. at 18
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“In reaching our conclusions on Petitioner’s asserted grounds of unpatentability, we do not rely on any portion of Exhibits 1023, 1025, or 1027. Accordingly, we dismiss Patent Owner’s Motion to Exclude those exhibits as moot. With respect to Patent Owner’s Motion to Exclude all portions of the record relying on Exhibits 1023, 1025, and 1027, Patent Owner identifies six pages of Petitioner’s Reply that it believes we should exclude. None of the identified pages cites any portion of Exhibits 1023, 1025, or 1027. See Reply 12–15, 17–18. Thus, even if we were persuaded that Exhibits 1023, 1025, and 1027 should be excluded, we would not be persuaded that Patent Owner had identified any reason for us to exclude the identified pages of Petitioner’s Reply. Accordingly, we deny Patent Owner’s Motion to Exclude as it applies to Petitioner’s Reply. To the extent there are other portions of the record that do cite Exhibits 1023, 1025, or 1027, Patent Owner’s failure to identify those portions is fatal to its motion. 37 C.F.R. § 42.22(a)(1) (a motion “must include . . . [a] statement of the precise relief requested”). Accordingly, we deny the motion as it applies to any unidentified portion of the record.” slip op. at 27
Patent outcomesUS 10,316,359 unpatentableClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,316,359 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Nanoco Technologies Ltd.No claims unpatentablePTAB · May 16, 2022 · IPR2021-00184 · APJ Erica A Franklin · IPR · Final written decision
Claims 1–16 and 21–25 were not shown unpatentable because Banin’s gold clusters were not shown to be molecular cluster compounds, and the Zaban combinations lacked motivation to combine.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art at the time of the invention would have had “at least a Ph.D. in chemistry, physics, chemical engineering, material science, or equivalent technical degree or equivalent work experience, with knowledge regarding nanoparticles and methods of synthesizing them” and “[a]dditional education might supplement practical experience and vice-versa.” Pet. 18–19 (citing Ex. 1002 ¶ 70). Patent Owner neither addresses Petitioner’s description of the level of ordinary skill in the art nor provides its own description. See PO Response. Accordingly, we adopt Petitioner’s definition as we find it is unopposed and consistent with the level of skill in the art at the time of the invention as reflected by the prior art in this proceeding.” slip op. at 10
- Expert testimonyPatent owner expert creditedPetitioner expert discountedMixed
“suggested formula” assigned to them is “based on a calculation that relied on the average of a wide distribution of particle sizes reported in the literature by Hutchison.” Ex. 2030 ¶ 103(citing Ex. 2017, 12891). We assign persuasive weight to her testimony because it is based upon the disclosures in Hutchison, which Banin explicitly identifies as the published procedures by which it synthesized its clusters. In particular, Dr. Cossairt’s testimony is supported by the following discussion in Hutchison: To calculate an average molecular formula for 1 it is necessary to know the number of gold atoms in the metal core. Given the average particle size (1.5 nm) this number is estimated to be ~101 by the method of Whetten et al. and leads to an estimated formula of Au101(PPh3)21Cl5. Ex. 2017, 12891. In other words, Hutchison explains that it calculated an average molecular formula for its synthesized nanoparticles by estimating the number of gold atoms in the metal core based upon the average particle size of 1.5 nm. Id. Indeed, as Dr. Cossairt has recognized, Banin’s “suggested formula” is exactly the same molecular formula that Hutchison discloses as the “average molecular formula” for its nanoparticles. Thus, we determine that the record as a whole supports finding that a person of ordinary skill in the art would have understood that Banin’s “suggested formula” represents an average molecular formula for a disperse mixture of gold clusters that are not identical and do not have sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula, as required for MCCs. slip op. at 23
- Prior constructionPrior construction adoptedDecided for patent owner
“Specification expressly defines the term “molecular cluster” in a manner that refers to the cluster compound. According to the Specification, “Molecular cluster” is a term which is widely understood in the relevant technical field but for the sake of clarity should be understood herein to relate to clusters of 3 or more metal or nonmetal atoms and their associated ligands of sufficiently well defined chemical structure such that all molecules of the cluster compound possess the same relative molecular mass. Ex. 1001, 5:3–9. We note that the District Court determined that “the term ‘molecular formula’ as opposed to ‘molecular mass’ is most appropriate. By necessity, a compound with the same molecular formula will necessarily have the same molecular mass.” Ex. 1091, 16. The District Court explained also, “it appears that the difference between a molecular formula and a molecular mass, at least for purposes of this claim construction, in inconsequential.” Id. We agree and do not find any dispute on the current record from the parties on this matter. Accordingly, for purposes of this Decision, we agree with the District Court that the term “molecular cluster compound” means “clusters of 3 or more metal atoms and their associated ligands of sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula.” Id. at 18.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“that Petitioner has not shown persuasively that a person of ordinary skill in the art would have considered Banin’s small Au clusters to be MCCs. According to Petitioner and Dr. Green, Banin’s gold clusters are MCCs because they are clusters of three or more metal atoms with their associated ligands and “each cluster is ‘identical to one another.’” Ex. 1002 ¶ 90; Pet. 23. To begin, we do not find that the record supports Petitioner’s contention or Dr. Green’s opinion that “each cluster is ‘identical to one another.’” Ex. 1002 ¶ 90; Pet. 23. Petitioner and Dr. Green do not identify any disclosure in Banin describing the clusters as being identical. Instead, they refer to Banin’s disclosure that the Au clusters have “the suggested formula Au101(PPh3)21Cl5” and are “1.4 nm in mean diameter.” In doing so, Petitioner and Dr. Green do not meaningfully address or adequately explain how Banin derived its “suggested” molecular formula for the gold clusters or why Banin reported a “mean” diameter for those clusters. To that end, Petitioner and Dr. Green have failed to provide any reason why a skilled artisan would have understood Banin’s disclosures of a “suggested formula” and a “mean diameter” to convey that the Au clusters are identical.” slip op. at 22
Patent outcomesUS 7,803,423 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,803,423 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Nanoco Technologies Ltd.No claims unpatentablePTAB · May 16, 2022 · IPR2021-00183 · APJ Erica A Franklin · IPR · Final written decision
Claims 1, 3–6, and 8–14 were not shown unpatentable because the asserted combinations failed to establish the claimed molecular cluster compounds or a reason to combine the references.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art at the time of the invention would have had “at least a Ph.D. in chemistry, physics, chemical engineering, material science, or equivalent technical degree or equivalent work experience, with knowledge regarding nanoparticles and methods of synthesizing them” and “[a]dditional education might supplement practical experience and vice-versa.” Pet. 20 (citing Ex. 1002 ¶¶ 72–75). Patent Owner neither addresses Petitioner’s description of the level of ordinary skill in the art, nor provides its own description. See PO Resp. Accordingly, we adopt Petitioner’s definition as we find it is unopposed and consistent with the level of skill in the art at the time of the invention as reflected by the prior art in this proceeding.” slip op. at 9
- Expert testimonyPatent owner expert creditedPetitioner expert discountedMixed
“on the average of a wide distribution of particle sizes reported in the literature by Hutchison.” Ex. 2030 ¶ 102 (citing Ex. 2017, 12891). We assign persuasive weight to her testimony because it is based upon the disclosures in Hutchison, which Banin explicitly identifies as the published procedures by which it synthesized its clusters. In particular, Dr. Cossairt’s testimony is supported by the following discussion in Hutchison: To calculate an average molecular formula for 1 it is necessary to know the number of gold atoms in the metal core. Given the average particle size (1.5 nm) this number is estimated to be ~101 by the method of Whetten et al. and leads to an estimated formula of Au101(PPh3)21Cl5. Ex. 2017, 12891. In other words, Hutchison explains that it calculated an average molecular formula for its synthesized nanoparticles by estimating the number of gold atoms in the metal core based upon the average particle size of 1.5 nm. Id. Indeed, as Dr. Cossairt has recognized, Banin’s “suggested formula” is exactly the same molecular formula that Hutchison discloses as the “average molecular formula” for its nanoparticles. Thus, we determine that the record as a whole supports finding that a person of ordinary skill in the art would have understood that Banin’s “suggested formula” represents an average molecular formula for a disperse mixture of gold clusters that are not identical and do not have sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula, as required for MCCs.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“Based on our consideration of the record as a whole, we find that the Specification expressly defines the term “molecular cluster” in a manner that refers to the cluster compound. According to the Specification, “Molecular cluster” is a term which is widely understood in the relevant technical field, but for the sake of clarity should be understood herein to relate to clusters of three or more metal atoms and their associated ligands of sufficiently well-defined chemical structure such that all molecules of the cluster compound possess approximately the same relative molecular formula. Ex. 1001, 3:28–34 (emphasis added). As there is no dispute that the term “molecular cluster compound” refers to “clusters of three or more metal atoms and their associated ligands of sufficiently well-defined chemical structure such that all molecules of the cluster compound possess approximately the same relative molecular formula,” we agree with the parties that no further construction of the claim is necessary for purposes of rendering this Decision. Additionally, we find that express construction of any remaining claim terms is unnecessary for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Moreover, we agree with Patent Owner that Petitioner has not demonstrated persuasively that a skilled artisan would have been motivated to replace Banin’s metal catalyst with Herron’s cluster compound. PO Resp. 44–49. Petitioner’s expert, Dr. Green, does not dispute that Banin’s SLS process requires the use of a metal catalyst. Ex. 1002 ¶ 79; Ex. 1005, 4:3–9, 6:9–16. Nor does Dr. Green dispute that Herron’s Cd32S14(SC6H5)36 cluster is not a metal, but rather a cadmium sulfide semiconductor. Ex. 1002 ¶ 80; Ex. 1016, 1426. According to Patent Owner and Dr. Cossairt, there is no indication on the record that anyone has ever tried or succeeded in using a semiconductor as a catalyst in SLS nanorod synthesis. PO Resp. 53; Ex. 2030 ¶ 137. We agree and determine that Petitioner has not shown otherwise by referring to the use of a semiconductor in a different type of nanoparticle synthesis, i.e., a vapor-liquid-solid nanoparticle synthesis. See Pet. Reply 12. In any event, we find that the Petition fails to support a motivation to combine Herron’s cadmium sulfide semiconductor with Banin’s process because the Petition fails to address sufficiently (or at all) the differences between metal catalysts and Herron’s semiconductor material and to explain why a person of ordinary skill in the art would have used such a semiconductor material in place of the metal as the catalyst in Banin’s process, despite Banin’s teachings that the catalyst must be a metal. Accordingly, for the foregoing reasons, we determine that Petitioner has failed to establish persuasively that a person of skill in the art would have been motivated to modify Banin’s nanoparticle synthesis by replacing its gold metal catalyst with Herron’s cadmium-based semiconductor.” slip op. at 30
Patent outcomesUS 7,588,828 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,588,828 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Nanoco Technologies Ltd.No claims unpatentablePTAB · May 16, 2022 · IPR2021-00185 · APJ Grace Karaffa Obermann · IPR · Final written decision
Claims 1–6, 16, and 17 were not proven unpatentable: Banin’s gold clusters were not shown to be MCCs, the Zaban combinations lacked adequate support, and the Lucey ground was withdrawn.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)). In Petitioner’s view, an ordinarily skilled artisan would have had “at least a Ph.D. in chemistry, physics, chemical engineering, material science, or equivalent technical degree or equivalent work experience, with knowledge regarding nanoparticles and methods of synthesizing them” and “[a]dditional education might supplement practical experience and vice-versa.” Pet. 22 (citing Ex. 1002 ¶ 76). Patent Owner does not address Petitioner’s view or propose a counter definition. We determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). To the extent a more specific definition is required, we adopt Petitioner’s definition for purposes of this Decision, because that definition is unopposed and consistent with the disclosures of the asserted prior art references.” slip op. at 9
- Prior constructionPrior construction adoptedDecided for patent owner
“Based on our consideration of the record as a whole, we agree with the District Court that the molecular cluster compound of the claimed invention must have “sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula.” Ex. 1091, 18. To the extent that this or any other claim term requires further discussion, we provide it in our analysis of the challenges. No further express claim construction is necessary for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11
- Expert testimonyPatent owner expert creditedPetitioner expert discountedMixed
“opinion, with supporting citations to evidence, that Banin describes gold clusters that range in size and, further, why the reference indicates that the suggested formula assigned to those clusters is based on a calculation that relies on the average of a wide distribution of particle sizes reported in the literature by Hutchison. Ex. 2030 ¶¶ 102–125; Ex. 2017, 12891. We assign persuasive weight to her testimony because it is supported by clear disclosures in Hutchison, which Banin explicitly identifies as the source of the procedures by which Banin synthesizes its gold clusters. In particular, Dr. Cossairt’s testimony comports with this discussion in Hutchison: To calculate an average molecular formula for [gold nanoparticle] 1 it is necessary to know the number of gold atoms in the metal core. Given the average particle size (1.5 nm) this number is estimated to be ~101 by the method of Whetten et al. and leads to an estimated formula of Au101(PPh3)21Cl5. Ex. 2017, 12891. In other words, as this disclosure makes plain, Hutchison calculates an average molecular formula for its gold clusters by estimating the number of gold atoms in the metal core based upon the average particle size of 1.5 nm. Id. Indeed, as Dr. Cossairt recognizes, Banin’s suggested molecular formula is exactly the same formula that Hutchison calculates based on the average molecular formula for the variably-sized gold clusters produced according to its process. Ex. 2030 ¶¶ 102–105. Dr. Cossairt provides persuasive reasons why a person of ordinary skill in the art would have understood that Banin’s suggested formula represents an average molecular formula for a disperse mixture of gold clusters that are not identical in size and do not have sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula, as required for MCCs. Id. ¶¶ 102–125.” slip op. at 26
- Strike new argumentNew argument disregardedDecided for patent owner
“Our rules require a petitioner to explain with particularity, at the outset in the petition, why the patent it challenges is unpatentable. Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). “Unlike district court litigation — where parties have greater freedom to revise and develop their arguments over time and in response to newly discovered material — the expedited nature of” inter partes review proceedings “bring with it an obligation for petitioners to make their case in their petition to institute.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). Accordingly, Petitioner carries a burden to “identify with particularity” at the outset, in the Petition, “the grounds on which the challenged to each claim is based, and the evidence that supports the grounds for the challenge to each claim.” 35 U.S.C. § 312(a)(3). Although “the introduction of new evidence in the course of the trial is to be expected in inter partes review trial proceedings,” Genzyme Therapeutic Prods. LP v. Biomarin Pharm. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016), the shifting of arguments is not, Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017).” slip op. at 30
Patent outcomesUS 7,867,557 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,867,557 - PTAB · Apr 7, 2022 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Rehearing
The Board granted rehearing, reversed its discretionary denial, and instituted PGR on claims 6–8 based on the threshold showing of likely lack of enablement and anticipation.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We agree with Petitioner that a rehearing of our prior decision to deny institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“35 U.S.C. § 324(a) provides that a post-grant review may not be instituted “unless the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, and the evidence cited therein, we determine that Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we accept Petitioner’s proposed definition, which is supported by Dr. Lambert’s testimony (Ex. 1002 ¶ 20) and is consistent with the scope and content of the ’039 patent and the asserted prior art.” slip op. at 17
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted
“skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - Miami International Holdings, Inc. / Miami International Securities Exchange, LLC et al. v. Nasdaq, Inc.Rehearing grantedPTAB · Jan 27, 2022 · CBM2018-00032 · APJ Meredith C Petravick · CBM · Rehearing
The Board granted Patent Owner’s request for rehearing to authorize a request for Director rehearing of the final written decision.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“Given the particular circumstances of this proceeding, particularly that the Request for Rehearing was filed prior to the Supreme Court’s Arthrex decision, we construe Patent Owner’s Request for Rehearing as requesting authorization to file a Request for Rehearing by the Director of the Final Written Decision and grant this request. Patent Owner is authorized to file a Request for Rehearing by the Director of the Final Written Decision within 30 days of the date of this decision. See 37 C.F.R. §§ 42.5, 42.71(d).” slip op. at 3
- Director reviewDirector review, grantedGranted
“Given the particular circumstances of this proceeding, particularly that the Request for Rehearing was filed prior to the Supreme Court’s Arthrex decision, we construe Patent Owner’s Request for Rehearing as requesting authorization to file a Request for Rehearing by the Director of the Final Written Decision and grant this request. Patent Owner is authorized to file a Request for Rehearing by the Director of the Final Written Decision within 30 days of the date of this decision. See 37 C.F.R. §§ 42.5, 42.71(d).” slip op. at 3
NonePatents in suitUS 7,933,827 - Miami International Holdings, Inc. / Miami International Securities Exchange, LLC et al. v. Nasdaq, Inc.Rehearing grantedPTAB · Jan 27, 2022 · CBM2018-00030 · APJ Meredith C Petravick · CBM · Rehearing
The Board granted Nasdaq’s rehearing request and authorized it to seek Director rehearing of the final written decision within 30 days.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“STANDARD A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision, we review the decision for an abuse of discretion. See generally 37 C.F.R. § 42.71 (b)–(d). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2
- Director reviewDirector review, grantedGranted
“The United States Patent and Trademark Office subsequently implemented an interim procedure1 whereby review of a final written decision by the Director may be requested by a party to a post-grant review proceeding.” slip op. at 3
NonePatents in suitUS 7,921,051
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.