- Slayback Pharma LLC v. Eye Therapies, LLCAll claims unpatentablePTAB · May 15, 2023 · IPR2022-00142 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–6 are unpatentable as obvious over Gil, Norden, Dean, Alphagan, and Federal Register; anticipation over Gil and Walters was not shown for claims 1–2.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Although the parties disagree as to the specific qualifications of a person of ordinary skill in the art, the parties’ experts agree that their Ex. 1049 ¶ 6 (Sher); Ex. 2020 ¶ 28 (Noecker); Ex. 2021 ¶ 34 (Williams); Ex. 2022 ¶ 23 (Davies). Both parties’ proposed definitions and the prior art of record indicate a high level of skill in the relevant art. Because the parties’ respective experts agree that any dispute as to the level of ordinary skill in the art is not material to their opinions, we adopt Patent Owner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Ex. 2020 ¶¶ 28–31; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding 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))).” slip op. at 8
- Expert testimonyPetitioner expert creditedOther
“We are not persuaded. We credit the testimony of Petitioner’s expert, Dr. Sher, who explains that because of the “high degree of imprecision of Figures 2 and 6,” a POSA would be unable to reach any quantitative conclusions from the figures or “clinically distinguish” between brimonidine concentrations that differ by only five-thousandths of a percent. Ex. 1049 ¶¶ 10–18. For example, as Dr. Sher notes, there are no incremental hash marks that indicate where any non-enumerated concentrations such as 0.02% or 0.025% would fall. Id. ¶¶ 11–12. Moreover, the x-axis of both figures appears to be neither linear nor logarithmic. Id. The uncertainty of the scale of the x-axis calls into question the assumption by Dr. Noecker that the blue dot on the x-axis of Figure 6 is necessarily 0.025% as opposed to, for example, 0.02%, which is specifically called out in the Specification’s description of Figure 6 as a preferred concentration. See Ex. 1001, 19:57 (stating Figure 6 demonstrates that “the net effectiveness of brimonidine as a decongestant is greatest between about 0.01% and about 0.03%; preferably between about 0.012% and about 0.02%”) (emphasis added). Moreover, like Dr. Sher, we question the accuracy of Dr. Noecker’s statement that concentrations less than 0.03% have no rebound hyperemia. See Ex. 1049 ¶ 19 (citing Ex. 2020 ¶ 94). As seen by a magnified portion of Figure 2, reproduced below, the dark gray, solid line indicating rebound hyperemia appears to show at least some amount of rebound hyperemia below 0.03%: That is, the magnified portion of Figure 2 depicts the dark gray rebound hyperemia curve between 0.01% and 0.03% to be above the x-axis, indicating—on its face—that some rebound hyperemia occurs, contrary to Dr. Noecker’s testimony. Id. We, therefore, credit the reasoning of Dr. Sher, who explains that, in light of the imprecision of the figures, a POSA would not rely on the figures to discern when rebound hyperemia begins, but would rather rely on the Specification, which states “rebound hyperemia begins at around 0.03%.” Id. We are persuaded that those words of approximation suggest that rebound hyperemia could begin either a little less than, at, or a little more than 0.03% brimonidine. See Ex. 1049 ¶ 25. Thus, we agree with Dr. Sher that “a POSA would read the ’742 patent’s description of Figure 6 and reasonably conclude that ‘at around 0.03%’ includes 0.025%.” Id.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“As an initial matter, we agree with the parties that the preamble of the claims is limiting. “Whether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in the patent.” Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003). The Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021). And where, as here, the claims are directed to methods of using a composition for a specific purpose (i.e., reducing eye redness), and the method comprises a single step of administering that composition, the Federal Circuit “has generally construed statements of intended purpose in such method claims as limiting.” Id. at 1340. agree with Petitioner that it does not and find Eli Lilly to be instructive. In Eli Lilly, the preambles of the claims recite a “method for reducing incidence of or treating at least one vasomotor symptom in an individual” and a “method for treating headache in an individual.” 8 F.4th at 1335. There, the Federal Circuit held that the preambles “are not merely statements of effect but rather statements of the intentional purpose for which the methods must be performed.” Id. at 1342. Thus, the Federal Circuit did not require proof of actual clinical results from performing the claimed method, even though the claims also recited an “effective amount.” Id. The Federal Circuit held that because the specification defined an “effective amount” as an “an amount sufficient to effect beneficial or desired results” and provided examples of such results in the context of prophylactic or therapeutic uses, the claims “encompass a clinical result, [but] they do not require such a result.” Id. Here, similarly, the ’742 patent claims simply recite administering the brimonidine composition (at a concentration range) and do not recite any efficacy requirement, nor even the “effective amount” of note in the Eli Lilly claims. But, like Lilly and as explained below, the “ocular conditions” of the claims encompass prophylactic reduction of hemorrhage and hyperemia in addition to therapeutic uses. See Ex. 1001, 12:13–19. We, therefore, find the claims here do not require actual redness reduction and, thus, no clinical result is required to satisfy the claimed method. Thus, having considered the arguments and evidence presented at trial, we determine that the preamble of the claims is limiting and requires that the claimed brimonidine composition be administered with the actually reduced.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“evidence presented at trial, we agree with Petitioner that the term “about 0.025%” includes 0.03%. Our construction is supported not only by intrinsic evidence, but also by extrinsic evidence that demonstrates the alleged criticality of the “about 0.025%” limitation. terms of a specific numerical range. We must, therefore, determine how broadly a POSA reading the ’742 Specification would extend the numerical range around 0.025%. In doing so, we consider the described criticality of “about 0.025%” brimonidine and its purpose to the claimed invention. See Cohesive, 543 F.3d at 1368. The ’742 patent makes clear that the purpose of the “about 0.025%” limitation in the claims is to use “low doses of highly selective a-2 adrenergic receptor agonists to achieve vasoconstriction with significantly reduced hyperemia.” Ex. 1001, 2:39–41. Furthermore, the Specification explains that there is a need for methods that provide “safe and long term vasoconstriction with reduced or minimized side effects, such as rebound hyperemia.” Id. at 2:30–33. There is no dispute that both 0.025% and 0.03% constitute low doses of brimonidine, as described by the Specification. See id. at 3:60–65 (defining “low concentrations” as “between about 0.0001% to about 0.05%”). Thus, the question is whether there is a critical distinction between the two concentrations and their ability to provide vasoconstriction with reduced rebound hyperemia. Patent Owner argues they are clinically distinct, whereas Petitioner argues they are not. In light of the intrinsic evidence discussed below, we agree with Petitioner.” slip op. at 22
Patent outcomesUS 8,293,742 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,293,742 - PTAB · Apr 19, 2023 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted review on all challenged claims and the sole anticipation ground: claims 1–4, 8–14, and 18–26, with a reasonable likelihood of unpatentability except claim 19.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialInstitutedDenied
“This case differs from other situations where the Board has exercised discretion under § 314(a) to deny institution. For example, we are not presented with a later-filed petition after having considered an earlier-filed petition challenging the same patent. See, e.g., General Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19, 6–11, 15–22 (PTAB Sept. 6, 2017) (precedential)). This is the first petition filed against this patent and contains only a single ground. Also, as Petitioner asserts, and Patent Owner does not contest, the Fintiv factors are neutral or favor institution. See Pet. 61–63. Instead, Patent Owner asks us to deny institution because Petitioner” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “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.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts A person of ordinary skill in the art (“POSA”) in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a PharmD with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29. Pet. 15–16. Patent Owner asserts “that a POSA for purposes of the ’087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers).” Prelim. Resp. 13. Patent Owner asserts “Petitioner’s definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners’ definition of a POSA, on the other hand, accounts for the claims’ focus on lymphoma and leukemia.” Id. at 14. At this stage in the proceeding, we find that Patent Owner’s analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot entitled to earlier dateMixed
“reasonable likelihood that claims 1 and 9 are not entitled benefit of priority to the ’087 or earlier priority Specifications prior to the publication of the November 2018 Venclexta label. Claim 1, for example, recites a GDC-0199 dosing regimen “compris[ing] a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC- 0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.” This disclosure is not found in a single example, but must be selected from disparate parts of the Specification. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 4 (Fed Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 22
§ 102 anticipation§ 112 disclosureDiscretionary denialPatents in suitUS 11,110,087 - Restem, LLC. v. Jadi Cell, LLCNo claims unpatentablePTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64
Patent outcomesUS 9,803,176 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,803,176 - PTAB · Apr 12, 2023 · IPR2022-01563 · APJ Neil T Powell · IPR · Institution
The Board instituted IPR of claims 1–14 because Petitioner showed a reasonable likelihood that claims 1–14 would have been obvious over Yong and Xavier.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute an inter partes review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2021). To institute an inter partes review, we must determine that the information presented in the Petition shows “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 determine that the information presented in the Petition establishes a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim. We institute an inter partes review of claims 1‒14 based on the ground set forth in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“Weighing the arguments and evidence, we determine that Petitioner has met its burden under 35 U.S.C. § 314 of demonstrating a reasonable likelihood that Yong qualifies as prior art. Hulu at 13. As Petitioner asserts, the KIPO logo and the multiple instances of publication number 10-2007-0087811 on Yong’s first page provide some evidence of authenticity. Ex. 1009, 1; Reply to Prelim. Resp. 3. Additionally, KIPO Yong tends to show that Yong constitutes an authentic version of Korean Publication No. 10-2007-0087811. Yong’s and KIPO Yong’s Figures appear substantially the same. Compare Ex. 1009, 42–48, with Ex. 2001, 28–33. Additionally, the content starting on page 2 of Yong, where Patent Owner contends “claims appear to be present,” closely resembles the content starting on page 11 of KIPO Yong, which Patent Owner posits “may be claims.” Prelim. Resp. 22, 29; Ex. 1009, 2–30; Ex. 2001, 11–27. Consistent with Patent Owner’s observations, these portions of Yong and KIPO Yong appear to present claims. Specifically, these sections of Yong and KIPO Yong each appear to present exactly 140 claims. Ex. 1009, 2–30; Ex. 2001, 11–27. These sections share a number of other similarities, also. For example, in both Yong and KIPO Yong, in the midst of Korean characters, what appears to be claim 69 recites “POS.” Ex. 1009, 16; Ex. 2001, 19. Similar commonalities appear numerous places within these portions of Yong and KIPO Yong. Ex. 1009, 2–30; Ex. 2001, 11–27. The similarities between Yong and KIPO Yong tend to show that Yong is an authentic version of Korean Publication No. 10-2007-0087811 and has the same substantive content as KIPO Yong, just formatted and arranged differently. This is not significantly undermined by Patent Owner’s observations about certain differences between the documents, especially in the absence of a translation of KIPO Yong, which would have facilitated comparing the documents’ content. Indeed, considering Patent Owner’s omission of a translation of KIPO Yong, Patent Owner’s complaints of prejudice and “Petitioner’s hide-the-ball tactics” ring hollow. Prelim. Sur-reply 2, 5. Although we agree with Patent Owner that Petitioner has not yet met the requirements of Rule 42.63(b) for the translation of Yong, we do not find it warranted to deny institution on this basis. Instead, we treat Patent’s Owner’s pre-institution arguments that Petitioner fails to comply with Rule 42.63(b) as evidentiary objections. If Patent Owner wishes to preserve its objections, Patent Owner must formally object to Petitioner’s evidence after institution of inter partes review by this Decision.” slip op. at 16
- Parallel petitionsDecided for petitioner
“As discussed above, Petitioner filed four petitions challenging the ’435 patent on the same day, including this proceeding, IPR2022-01563, as well as IPR2022-01528, IPR2022-01561, and IPR2022-01564. In this proceeding, IPR2022-01563, and in IPR2022-01561 and IPR2022-01564, Petitioner challenges claims 1–14 of the ’435 patent over various prior art grounds. Pet. 11; Not. 2. In IPR2022-01528, Petitioner challenges claims 15–19 of the ’435 patent over various prior art grounds. Not. 2. Pursuant to the Board’s Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),3 Petitioner’s Notice provides a ranking of the four petitions in the order in which Petitioner wishes the Board to consider them on the merits and a succinct explanation of the differences between the Petitions. See TPG 59–60; Not. 1–5. Petitioner ranks the instant Petition as “3,” the petition in IPR2022-01528 as “1,” the petition in IPR2022-01561 as “2,” and the petition in IPR2022-01564 as “4.” Not. 2–5. Petitioner, however, contends that “all four Petitions merit institution” because “[a]ll four Petitions present significant material differences which are not redundant and which demonstrate different substantive bases for rendering obvious or for showing anticipation of each of the challenged claims of the ’435 Patent,” and “[d]ue to word count limitations, Petitioner 3 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. was not able to present all these grounds in a single petition.” Id. at 1, 3. Petitioner elaborates that 1) the claims of the ’435 Patent comprise over 1,500 words, such that to cover a plurality of grounds in one petition covering all the claims would use at least twenty percent of the 14,000-word petition limit; and 2) Patent Owner has asserted 15 of the 19 claims of the patent in the pending district court litigation (see Ex. 1026). Id. at 2. Patent Owner argues that “the panel should, at most, address the -01528 petition on the merits, as petitioner requested, and discretionarily deny the other three petitions under § 314(a).” Prelim. Resp. 3–4. Regarding the ’435 patent’s claims’ length, Patent Owner argues that “the ’435 Patent claims is indicative of the quality of examination, rather than an excuse for the piling on that Petitioner exhibits in these challenges.” Id. at 6. Under the circumstances presented, where Patent Owner does not dispute Petitioner’s observation that the ’435 patent has very long claims, we conclude it is not unreasonable for Petitioner to file multiple petitions. In our view, even if it were accurate, Patent Owner’s argument that the claims’ “narrowness” reflects quality examination does not detract from Petitioner’s argument that the length of the claims warrants more than one petition. Prelim. Resp. 6.” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“3. Discussion In asserting obviousness of claims 1–14 over Yong and Xavier, Petitioner argues that Yong discloses many of the challenged claims’ limitations. Pet. 13–43. For example, Petitioner relies primarily on Yong as allegedly disclosing claim 1’s limitations. Id. at 13–26. Petitioner relies on Xavier as “teach[ing] the use of a session between a mobile phone and se[r]ver in a self-checkout system.” Id. at 15. Petitioner argues that “[h]aving reviewed Xavier, a [person of ordinary skill in the art] would have been motivated to add the session handling of Xavier to Yong.” Id. According to Petitioner, “[a person of ordinary skill in the art] would have understood that a session manager would have been necessary to manage the communications between the mobile communication terminal 100 and the store POS server 200, the commercial transaction server 400 and the payment server 500.” Id. At this stage, aside from the arguments discussed above in Section II.C.1 that we should not consider Yong as prior art, Patent Owner does not dispute the merits of Petitioner’s challenge to claims 1–14. Having reviewed Petitioner’s arguments and evidence, we determine Petitioner has demonstrated a reasonable likelihood of establishing that claims 1–14 would have been obvious over Yong and Xavier. Pet. 1–43.” slip op. at 24
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,803,435 - PTAB · Apr 12, 2023 · IPR2022-01528 · APJ Neil T Powell · IPR · Institution
The Board instituted IPR of claims 15–19 on all petitioned grounds, finding a reasonable likelihood that Yong anticipates claim 15.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute an inter partes review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2021). To institute an inter partes review, we must determine that the information presented in the Petition shows “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 determine that the information presented in the Petition establishes a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim. We institute an inter partes review of claims 15‒19 based on the grounds set forth in the Petition.” slip op. at 2
- Parallel petitionsDenied
“We do not agree with Patent Owner’s argument that Petitioner’s parallel filing of four petitions warrants denying all four petitions. Prelim. Resp. 7 (“Petitioner’s abuse of process in filing four petitions justifies discretionary denial of all of the petitions.”). Accordingly, given that Petitioner ranks the instant Petition “1,” we decline to deny institution in this proceeding. Additionally, under the circumstances presented, where Patent Owner does not dispute Petitioner’s observation that the ’435 patent has very long claims, we conclude it is not unreasonable for Petitioner to file multiple petitions. In our view, even if it were accurate, Patent Owner’s argument that the claims’ “narrowness” reflects quality examination does not detract from Petitioner’s argument that the length of the claims warrants more than one petition. Prelim. Resp. 6.” slip op. at 33
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Weighing the arguments and evidence, we determine that Petitioner has met its burden under 35 U.S.C. § 314 of demonstrating a reasonable likelihood that Yong qualifies as prior art. Hulu at 13. As Petitioner asserts, the KIPO logo and the multiple instances of publication number 10-2007-0087811 on Yong’s first page provide some evidence of authenticity. Ex. 1009, 1; Reply to Prelim. Resp. 3.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. LEVEL OF ORDINARY SKILL Petitioner contends that [a] person having ordinary skill in the art (“POSITA”) as of the claimed priority date would have had a Bachelor’s degree in computer science, computer engineering, electrical engineering, or a related field or equivalent coursework or experience, and one to two years of experience with mobile device applications and retail POS systems. (Shamos ¶ 34.) More education can supplement practical experience and vice versa. (Id.) Pet. 12. Patent Owner does not dispute Petitioner’s description of a person of ordinary skill in the art. Prelim. Resp. 18. For purposes of deciding whether Petitioner has demonstrated a reasonable likelihood of prevailing, we adopt Petitioner’s definition of a person of ordinary skill in the art, which we find consistent with the ’435 patent and the asserted prior art.” slip op. at 11
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 10,803,435 - PTAB · Apr 11, 2023 · IPR2022-01564 · APJ Patrick R Scanlon · IPR · Institution
The Board instituted IPR on claims 1–14 and all asserted grounds, finding a reasonable likelihood that Keith anticipates at least claims 1 and 10.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2021). To institute an inter partes review, we must determine that the information presented in the Petition shows “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 determine that the information presented in the Petition establishes a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim. We institute an inter partes review of claims 1‒14 based on the grounds set forth in the Petition.” slip op. at 2
- Parallel petitionsDecided for petitioner
“Under the circumstances presented, where the priority date of the challenged claims is disputed, we conclude it is not unreasonable for Petitioner to present separate challenges, one of which relies on references that are prior art only if the challenged claims are not entitled to Patent Owner’s claimed priority date, which has yet to be finally determined. See TPG 59 (stating that “a dispute about priority date requiring arguments under multiple prior art references” can be a potential reason for the Board to institute trial on multiple petitions challenging the same patent). Thus, on the present record, we decline to exercise our discretion to deny institution of this Petition on the basis of Petitioner filing multiple petitions.” slip op. at 46
- Skill levelSkill level petitioner adoptedDecided for petitioner
“have had a Bachelor’s degree in computer science, computer engineering, electrical engineering, or a related field or equivalent coursework or experience, and one to two years of experience with mobile device applications and retail POS systems,” also noting that “[m]ore education can supplement practical experience and vice versa.” Pet. 20–21 (citing Ex. 1002 ¶ 34). Patent Owner, at this stage of the proceeding, does not dispute Petitioner’s definition of the person of ordinary skill in the art. Prelim. Resp. 18. For the purposes of this Decision, we apply Petitioner’s proffered level of skill in the art because it appears consistent with the problems addressed in the ’435 patent and the prior art.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We determine that an express construction of this or any other claim term is not necessary for purposes of this Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only 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 13
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialPatents in suitUS 10,803,435 - Bausch & Lomb Incorporated v. Zeavision, LLCAll claims unpatentablePTAB · Apr 10, 2023 · IPR2022-00089 · APJ Tina E Hulse · IPR · Final written decision
Claims 12–14, 16–21, 23, and 24 are unpatentable: Lang anticipates some claims, and the asserted Lang-based combinations render all challenged claims obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition (Dec. Inst. 6–7), which Patent Owner states that it “does not contest.” PO Resp. 17. Because the parties do not dispute the level of ordinary skill in the art, we adopt Petitioner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding 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))). Moreover, we find that Dr. Johnson and Dr. Dorey are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art. See Ex. 1024 ¶¶ 2–11, App’x A; Ex. 2001 ¶¶ 4–14, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Similarly, here, the Specification consistently states that the invention relates to oral formulations for protecting eye health and that the benefits of carotenoids, such as zeaxanthin and lutein, include the ability to absorb UV and blue light. See, e.g., Ex. 1001, Abstract (“Oral formulations for promoting eye health”), 4:25–31 (stating carotenoids such as zeaxanthin are “very good at absorbing ultraviolet (UV) and blue light”), 15:45–47 (“one object of this invention is to disclose multi-component orally-ingestible formulations for protecting eye health in mammals”). Like the preamble in Proveris, the preamble in claim 12 is the only reference in any of the independent claims to the allegedly inventive concept of protecting eye health from the harmful effects of blue light. Proveris, 739 F.3d at 1373. Moreover, the preamble of claim 12 recites: “A nutrient formulation for oral ingestion for protecting a user’s eyes from the harmful effect of blue light, the formulation comprising:.” Ex. 1001, 37:13–15. The body of claim from the group consisting of capsules, tablets, liquids, and powders for oral ingestion.” Ex. 1001, 37:22–24 (emphasis added). Similarly, claim 22, which depends from claim 12, relies on the preamble of claim 12 for antecedent basis for the limitation “wherein the user has macular degeneration and a lens-related disorder.” Id. at 38:21 (emphasis added). Thus, “the nutrient formulation” and “the user” in the claim body derives antecedent basis from the “nutrient formulation” and “user” that is “defined in greater detail in the preamble.” See Proveris, 739 F.3d at 1373. Accordingly, reading the patent as a whole, because the inventor clearly relied on both the preamble and the body of claim 12 to define the claimed invention, the preamble of claim 12 should be construed as limiting. See id.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would understand this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 19 (citing Ex. 1024 ¶ 57, Ex. 1031, 3). Petitioner also contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and delta-tocopherols.” Pet. 22–24 (citing Ex. 1024 ¶¶ 65–66). Patent Owner does not address either of these claim terms in its Response. See generally PO Resp. Because there does not appear to be any dispute over the construction of these terms, we adopt Petitioner’s proposed constructions as they are consistent with the plain and ordinary meaning of the terms. See Wellman, 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
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 13
Patent outcomesUS 10,307,384 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,307,384 - Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentablePTAB · Apr 4, 2023 · IPR2021-01565 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–24 are unpatentable: claims 1–10, 12–22, and 24 as anticipated by Kaiser, and claims 1–24 as obvious under the listed grounds.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Considering argument and evidence of record, we define a person of ordinary skill in the art as a member of a multidisciplinary team consisting of at least (1) a person (“Engineer POSA”) with either (a) a bachelor’s or master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32
- Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed
“demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at pages 11–12 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 31–32 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 44
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Although Kaiser exemplifies in detail a method involving IVC occlusion, its disclosure makes clear that the method is also applicable to the SVC. See, e.g., Ex. 1007, 6:60–64 (“the adjustable component may create a pressure gradient by . . . adjusting blood flow impedance through the superior vena cava”), 5:64–6:2 (disclosing “systems and methods may be provided to create a pressure differential” using “balloons . . . to increase a pressure drop through the . . . superior vena cava”), Claim 5 (reciting a “flow impedance device implantable within a patient’s inferior vena cava”), Claim 17 (“The method of claim 10, wherein the body lumen within which the adjustable component is positioned is . . . a superior vena cava.”), 6:31–36 (positioning pressure sensor in the superior vena cava); see also Ex. 1010, 19–22 (claims of provisional application directed to reducing blood flow through the superior vena cava); see also Pet. 29–34, 36–39; Reply 14–16; Ex. 1002 ¶¶ 152–153, 156–159, 165, 167–176 (Dr. Day’s testimony regarding the SVC positioning elements). Considering the arguments and evidence of record, including our own reading of Kaiser (see supra Section I.I.1), we find that Kaiser expressly discloses the contested element of Ground 1 relating to use of the restrictor in the SVC.” slip op. at 47
Patent outcomesUS 10,639,460 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,639,460 - Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentablePTAB · Apr 4, 2023 · IPR2021-01564 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–24 are unpatentable: claims 1, 3–13, and 15–24 are anticipated by Gelfand, and claims 1–24 are also obvious under Grounds 2–8.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedPetitioner expert creditedDecided for petitioner
“Considering argument and evidence of record, we define a person of ordinary skill in the art as a member of a multidisciplinary team consisting of at least (1) a person (“Engineer POSA”) with either (a) a bachelor’s or master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art”).” slip op. at 31
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“normal intravascular pressure at or near the region of intervention. To the contrary, the Specification repeatedly discloses the creation and maintenance of low-pressure zones at or near the catheter apparatus restrictors during the course of treatment. See, e.g., Ex. 1001, 15:33–36 (“control module 200 can include multiple feedback loops to adjust performance of the system 10 to create and maintain a low pressure zone while the lymphatic fluid is cleared”) (emphasis added), 13:2–7 (“A pressure sensing lumen, which is positioned proximately to the catheter suction port within the isolated area, can be used to control the rate of suction by maintaining the pressure of the isolated area between about 2–5 mmHg and thus prevent collapse of the thoracic duct due to excessive suction and ensure optimized lymph drainage.”) (emphasis added), 17:52–63 (“[T]he pressure gradient across the proximal restriction is achieved by the pressure reduction within the area between the two restrictions. Actuation of the pump helps to create a low pressure zone in the vicinity of the junction of the jugular vein and the subclavian vein by withdrawing fluid in this region, recirculating it through the pump, and discharging the fluid downstream of this region. Because the outflow of the thoracic and lymphatic ducts is located in this region, the lower pressure will facilitate drainage of lymphatic fluid.”) (emphases added). Accordingly, we agree with Petitioner that the ’460 Patent “teaches activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at pages 11–12 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 31–32 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 43
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Considering the posture of this case, it is Patent Owner’s burden to overcome the presumption that Gelfand is enabled. See, e.g., Amgen, 314 F.3d at 1354–55. This requirement is not excused in IPR proceedings. See Apple Inc. v. Corephotonics, Ltd., 861 F. App’x 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). Considering all the argument and evidence of record, we find that Patent Owner has not overcome the presumption with respect to Gelfand for at least the reasons set forth on pages 13–25 of Petitioner’s Reply, which we adopt in full and briefly summarize below.” slip op. at 48
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“On this record, we find persuasive Dr. Day’s testimony that, “there is no functional difference between the SVC and the IVC that would preclude a catheter from functioning once in the SVC.” Ex. 2006, 73:21–74:5; see also Ex. 1002 ¶ 134 (the “methods of balloon activation and operation are the same regardless of whether the occlusion balloon is placed in the SVC or the IVC”). We likewise find persuasive Dr. Day’s testimony that, “Gelfand’s methods, systems and devices . . . could be used in the SVC without any substantial modification other than the catheter potentially being inserted into a vein upstream of the SVC.” Ex. 1002 ¶¶ 122–126; see also id. ¶¶ 130– 134 (similar testimony specific to element [1e]); Ex. 2006, 93:11–99:16, 71:7–78:15, 86:13–87:19, 88:14–90:9, 97:10–13. But to the extent Gelfand’s device needed to be modified, we find persuasive Dr. Day’s testimony that an Engineer POSA would have found such modifications “routine.” Ex. 2006, 205:8–212:21 (“they’re just different variants or dimensions of the invention”). We, likewise, find persuasive Dr. Garcia’s testimony that “Gelfand discloses occluding the SVC or IVC with a balloon catheter device to reduce blood flow to the heart. Gelfand’s catheter is a type of Swan-Ganz catheter, a commonly used catheter with which I and other clinicians are very familiar, and Gelfand discloses that its catheter can be inserted and placed using conventional techniques.” Ex. 1004 ¶ 60; see also Ex. 1006 ¶¶ 27–31 (Dr. Day’s overview of therapeutic balloon catheters). Referencing Dr. Day’s testimony, Dr. Garcia further states that [f]rom a clinician’s perspective, there would have been no difference in using Gelfand’s device to partially occlude the SVC and in using it to fully occlude the SVC. The device would simply have been inserted percutaneously, advanced so that the balloon is in the SVC, and then operated to inflate the balloon to the inner diameter of the SVC. Id. ¶ 127; see also id. ¶¶ 81–83, 127 (detailed explanation of why one of ordinary skill in the art would know how “to place the occlusion balloon in the SVC as taught by Gelfand”). As further noted by Petitioner, “Garcia explained that Gelfand discloses, and a POSA would know, that a modified Swan-Ganz catheter like Gelfand’s could be inserted via the right internal jugular vein so as to place the occlusion balloon in the SVC.” Reply 17 (citing Ex. 1004 ¶¶ 73–83 (showing modified version of Gelfand’s Figure 1), 136, 145–159; Ex. 2006, 101:8–103:10); see also id. at 18–19 (citing Ex. 1032, 51:19–53:23, 204:4–205:22, 206:10–208:24) (Dr. Brecker’s admissions that diameters of Gelfand’s catheter would allow SVC placement via jugular vein and that placement of Swan-Ganz catheters through the SVC via the right internal jugular vein was known).” slip op. at 50
Patent outcomesUS 10,639,460 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,639,460 - Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentablePTAB · Apr 4, 2023 · IPR2021-01478 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–16 are unpatentable: claims 1–14 and 16 as anticipated by Kaiser, and claims 1–16 as obvious under the asserted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Considering argument and evidence of record, we define a person of ordinary skill in the art as a member of a multidisciplinary team consisting of at least (1) a person (“Engineer POSA”) with either (a) a bachelor’s or master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualifies him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is also an Engineering POSA, or is receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily” slip op. at 33
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualifies him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is also an Engineering POSA, or is receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily” slip op. at 34
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Accordingly, we agree with Petitioner that the ’871 Patent “teaches activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at page 11 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 30–31 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 46
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“It is Patent Owner’s burden in this proceeding to overcome the presumption that Kaiser is enabled. See, e.g., Amgen, 314 F.3d at 1354–55. This requirement is not excused in IPR proceedings. See Apple Inc. v. Corephotonics, Ltd., 861 F. App’x 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). Considering all the argument and evidence of record, we find that Patent Owner has not overcome the presumption with respect to Kaiser for the reasons set forth on pages 16–19 of Petitioner’s Reply, which we adopt in full and briefly address below. With respect to enablement of Kaiser’s device, we find persuasive Dr. Day’s testimony that no substantial modification of Kaiser’s IVC embodiment would be necessary to deploy it in the SVC. See Ex. 2006, 218:6–220:13; Ex. 1002 ¶ 109 (annotated version of Kaiser’s Fig. 2 showing that the lead/catheter passes through the SVC to reach the IVC). With respect to enablement of Kaiser’s method in the SVC, Dr. Brecker’s analysis also falls short of overcoming the presumption that Kaiser is enabling. Dr. Brecker asserts, for example, that Kaiser also does not describe what pressure differential would need to be created through the use of a flow impedance device in the SVC in order to successfully perform its method using such a device in the SVC, and does not provide any exemplary pressure recordings demonstrating that its method can be successfully performed using a device in the SVC. Ex. 2005 ¶ 110. We find persuasive, however, Petitioner’s argument that Kaiser discloses representative pressure differentials, including an effective pressure differential for occluding the IVC (3 mmHg), which Dr. Brecker could not say would be ineffective for the SVC— but which a Clinician POSA could test, along with other pressure differentials to see what results they produced if the SVC were occluded. Reply 16–17 (citing Ex. 1007, 14:22, Fig. 4 (table showing exemplary hemodynamic data obtained by creating a pressure differential in the inferior vena cava); Ex. 1032, 190:23– 192:3 (Dr. Brecker’s testimony that a Clinician POSA would know how to measure the pressures such as those disclosed in Figure 4), 193:14–194:17 (at least some information could be derived from animal testing)). At least because Patent Owner has not argued (let alone demonstrated) that such testing would be undue, Patent Owner has not satisfied its burden to show non-enablement.” slip op. at 50
Patent outcomesUS 10,653,871 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,653,871
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.