- 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 · Mar 30, 2023 · IPR2023-00026 · APJ Grace Karaffa Obermann · IPR · Institution
The Board instituted IPR of claims 1–8 on all asserted grounds, finding a reasonable likelihood that claims 1 and 5 are anticipated by Prevost-2006.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We understand “filled” to have a broad plain and ordinary meaning. That is, “filled” broadly embraces the circumstances where something is fully filled or partially filled. Here, Petitioner’s declarant, Dr. Hoare, provides an opinion that is consistent with our understanding of the regular meaning of the word. Pet. 23; Ex. 1002, ¶ 142. We understand that Patent Owner’s position essentially contends that “filled” does not include “fully filled”—arguing that Prevost-2006 does not describe the extent to which the core material “filled” the shell structure, or that Petitioner does not show sufficiently that “filled” means “completely occupies.” Prelim. Resp. 8–10; Ex. 2001, ¶ 39. As an initial matter, we observe that neither Petitioner’s nor Patent Owner’s declarant directs us to information that would help us understand why an ordinarily skilled artisan would have understood “filled” to exclude the circumstance of being completely filled. Because of this, for purposes of deciding whether to institute review, we see no reason to interpret “filled” in a manner inconsistent with the term’s plain and ordinary meaning, which broadly includes the circumstance of being completely filled. Patent Owner is free to develop this issue in timely filed response to the Petition. On this record, however, we preliminarily find that Prevost-2006 meets the “completely occupies” limitation of claim 1 because its fiber is described as a shell structure that is “filled” with a core structure. Ex. 1010, 345, 349. That circumstance distinguishes Provost-2006 from the Lee reference, which unlike Provost-2006 concerned “hollow fibers” and, during examination, was overcome by an amendment that added the “completely occupies” limitation. Prelim. Resp. 9 (quoting Ex. 1004, 616) (emphasis omitted).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We understand “filled” to have a broad plain and ordinary meaning. That is, “filled” broadly embraces the circumstances where something is fully filled or partially filled. Here, Petitioner’s declarant, Dr. Hoare, provides an opinion that is consistent with our understanding of the regular meaning of the word. Pet. 23; Ex. 1002, ¶ 142. We understand that Patent Owner’s position essentially contends that “filled” does not include “fully filled”—arguing that Prevost-2006 does not describe the extent to which the core material “filled” the shell structure, or that Petitioner does not show sufficiently that “filled” means “completely occupies.” Prelim. Resp. 8–10; Ex. 2001, ¶ 39. As an initial matter, we observe that neither Petitioner’s nor Patent Owner’s declarant directs us to information that would help us understand why an ordinarily skilled artisan would have understood “filled” to exclude the circumstance of being completely filled. Because of this, for purposes of deciding whether to institute review, we see no reason to interpret “filled” in a manner inconsistent with the term’s plain and ordinary meaning, which broadly includes the circumstance of being completely filled. Patent Owner is free to develop this issue in timely filed response to the Petition. On this record, however, we preliminarily find that Prevost-2006 meets the “completely occupies” limitation of claim 1 because its fiber is described as a shell structure that is “filled” with a core structure. Ex. 1010, 345, 349. That circumstance distinguishes Provost-2006 from the Lee reference, which unlike Provost-2006 concerned “hollow fibers” and, during examination, was overcome by an amendment that added the “completely occupies” limitation. Prelim. Resp. 9 (quoting Ex. 1004, 616) (emphasis omitted). Claim 5 further recites that “a cell or cell culture is contained in the micro gel fiber.” As we observe above, Prevost-2006 discloses that its “hollow fibers were filled with islets [cells] suspended in agarose.” Ex. 1010, 345; Pet. 24. Thus, on this record, we also find that Prevost-2006 discloses the claimed microfiber containing “a cell or cell culture” within the micro gel fiber. Accordingly, we determine that Petitioner has established a reasonable likelihood that it “would prevail with respect to” claim 1 and claim 5 based on anticipation by Provost-2006. 35 U.S.C. § 314(a). To provide guidance to the parties and streamline the issues for trial, we discuss below the other challenges asserted in the Petition.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundInstituted
“For example, Petitioner does not identify a reason why an ordinarily skilled artisan would have combined the teachings of double-layer and single-layer fibers. We recognize that “it is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.” In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). Nevertheless, to support a conclusion of obviousness when combining the teachings of multiple references, an articulated reason with some rational underpinning to combine the known elements in the fashion claimed must be provided. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007); see also In re Magnum Oil Tools, Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (It is the petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention[s], and that the skilled artisan would have had a reasonable expectation of success in doing so.”) (citation and internal quotation omitted). Having reviewed the parties’ arguments and evidence of record, we have doubts that Petitioner provides sufficient reasons an ordinarily skilled artisan would have combined the teachings of the multiple references asserted in this challenge to achieve the claimed invention or would have reasonably believed they would have been successful in doing so. Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350, 1360–61 (Fed. Cir. 2017) (showing of a motivation to combine references must include evidence that a skilled artisan would have reasonable expectation of success in doing so).” slip op. at 19
- Expert testimonyPetitioner expert discountedOther
“We have concerns about whether Petitioner shows sufficiently that Nelson- 603’s disclosures would have led an ordinarily skilled artisan to create an “alginate-alginate bicomponent fiber.” Petitioner’s arguments and Dr. Hoare’s opinions contain similar wording and do not explain adequately why an ordinarily skilled artisan would have created such a fiber—beyond Nelson-603’s general disclosure that “it will be apparent to those of skill in the art that variations may be applied to the compositions and methods.” Pet. 39–40; Ex. 1002, ¶¶ 162, 199, 120; Ex. 1011, 12:57–66; 33:58–66. Without additional evidence and reasoning, we assign Dr. Hoare’s testimony on this issue little weight. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (designated: February 10, 2023) (holding declaration is entitled to little weight when it contains an exact restatement of the petition’s arguments without any additional supporting evidence or reasoning). On this record, that general instruction is not sufficient to establish that Nelson-603 would have prompted an ordinarily skilled artisan to modify any fiber disclosed in the reference to achieve the claimed invention.” slip op. at 15
§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 8,785,195 - PTAB · Jan 6, 2023 · IPR2022-01204 · APJ Donna M Praiss · IPR · Institution
Instituted IPR on claims 1–10, 12, 13, and 15–20 because the petition showed a reasonable likelihood of prevailing on asserted anticipation and obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–10, 12, 13, and 15–20 of the ’285 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“district court trial dates are set to occur before the issuance of the Board’s final written decision. The facts and reasoning of Fintiv are, at a minimum, only applicable to cases in which a trial date has been set by the district court in a copending litigation. But here, as will be discussed below, the parties agree that no trial date has been set, and the District Court has stayed the litigation. Prelim. Reply 8; Prelim. Sur-Reply 6 (“There has never been a trial date). Furthermore, that stay will continue until our final determination should we decide to institute trial. Without a trial date, we see no need to engage in a full analysis of the Fintiv factors, as there is no basis for Patent Owner’s argument for discretionary denial. Nevertheless, we address the Fintiv factors below13 and explain our reasons for not exercising discretion to deny institution based on § 314(a).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“While we recognize that the plain language and grammar of the claims supports Petitioner’s proposed construction, we have also considered the District Court’s adopted construction and Patent Owner’s arguments which find support in the written description of the ’285 patent. In the end, however, we need not resolve this dispute at this time. Because the Petition provides sufficient evidence that the prior art references disclose the claimed functional groups, biomolecules, or organic dyes under either construction, it is not necessary for us to construe this claim term at this stage of the proceeding.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“including Petitioner’s Reply Brief (Paper 10, “Reply Br.”) and Patent Owner’s Sur-Reply Brief (Paper 11, “Sur-Reply Br.”), we agree with Petitioner that Patent Owner’s proposed definition reads into the claim a numeric threshold for solubility from an embodiment that is nowhere apparent from the claim itself. Reply Br. 1–2. “[I]nterpreting what is meant by a word in a claim is not to be confused with adding an extraneous limitation appearing in the specification, which is improper.” In re Cruciferous Sprout Litigation, 301 F.3d 1343, 1348 (Fed. Cir. 2002) (internal quotation marks and citations omitted; emphasis in original). Although courts must read a patent’s claims in light of the specification, see, e.g., Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998), that obligation does not authorize “reading a limitation from the written description into the claims,” which is characterized as “one of the cardinal sins of patent law,” SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1340 (Fed. Cir. 2001). Confining the scope of “capable of imparting solubility” to an unexpressed minimum solubility taken from one of the Specification’s embodiments crosses that line. See, e.g., E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1432–34 (Fed. Cir. 1988) (Claims to a co-polymer improperly interpreted to include two properties). In view of the foregoing, we construe the phrase “a non-ionic side group capable of imparting solubility in water” to not require any particular numeric threshold of solubility. No further construction of the claim is necessary to resolve the dispute between the parties with respect to institution of trial.. See Nidec Motor Corp. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,365,285 - PTAB · Jan 6, 2023 · IPR2022-01206 · APJ Brian D Range · IPR · Institution
The Board instituted IPR on claims 1–10, 12–14, and 17–19, finding a reasonable likelihood of prevailing on the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–10, 12–14, and 17–19 of the ’648 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“The express language of claim 1 requires no solubility threshold, and dependent claim 10 of related U.S. Patent No. 10,288,620 B2 demonstrates that, where a solubility threshold was intended by the inventors of these patents, they knew how to expressly set forth that threshold in the claims. Compare Ex. 1004, 222:47–49 (“capable of imparting solubility in water”), with Ex. 1005, 218:12–14 (“The method according to claim 1, wherein each R is a non-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.”). Thus, the claim language does not support applying a particular solubility threshold in claim 1. As noted by Patent Owner, the written description of the ’648 patent explains that “each R is independently a non-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.” Ex. 1004, 2:21–22; Prelim. Resp. 17. This solubility threshold, however, is not in claim 1. Also, the ’648 patent states that this solubility applies only to some embodiments. See, e.g., Ex. 1004, 53:9–12, 55:6–20. We decline to import such a limitation from the written description into claim 1 absent reason for doing so. See SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1340 (Fed. Cir. 2001) (explaining that “reading a limitation from the written description into the claims” is “one of the cardinal sins of patent law”); see also Thorner v. Sony Comp. Ent’m Am., LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012) (“It is likewise not enough that the only embodiments, or all of the embodiments, contain a particular limitation. We do not read limitations from the specification into claims; we do not redefine words.”). After considering the parties’ arguments and evidence presented, we agree with Petitioner that Patent Owner’s proposed definition reads into the claim a numeric threshold for solubility from an embodiment that is nowhere apparent from the claim itself. “[I]nterpreting what is meant by a word in a claim is not to be confused with adding an extraneous limitation appearing in the specification, which is improper.” In re Cruciferous Sprout Litigation, 301 F.3d 1343, 1348 (Fed. Cir. 2002) (internal quotation marks and citations omitted; emphasis in original). Although we must read a patent’s claims in light of the specification, see, e.g., Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998), that obligation does not authorize “reading a limitation from the written description into the claims.” SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1340 (Fed. Cir. 2001). Confining the scope of “non-ionic side group capable of imparting solubility in water” to an unexpressed minimum solubility taken from only “some” embodiments encompassed by the ’648 patent crosses that line. See, e.g., E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1432–34 (Fed. Cir. 1988) (Claims to a co-polymer improperly interpreted to include two properties). In view of the foregoing, we construe the phrase “a non-ionic side group capable of imparting solubility in water” to not require any particular numeric threshold of solubility. No further construction of the claim is necessary to resolve the dispute between the parties with respect to institution of trial.15” slip op. at 13
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“in situations where a district court trial date is set to occur before the issuance of the Board’s final written decision. The facts and reasoning of Fintiv are, at a minimum, only applicable to cases in which the district court has actually set a trial date in a copending litigation. But here, as will be discussed below, the parties agree that no trial date has been set, and the District Court has stayed the litigation. Prelim. Reply 8; Prelim. Sur-Reply 6 (“There has never been a trial date). Furthermore, that stay will continue until our final determination should we decide to institute trial. Without a trial date, we see no need to engage in a full analysis of the Fintiv factors,17 as there is no basis for Patent Owner’s argument for discretionary denial.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We are not persuaded by Patent Owner’s argument. Xue expressly discloses that its glycopolymers utilizing poly(ethylene glycol)-tethered spacers (Polymers B and C) “are highly water-soluble due to their long, flexible, hydrophilic spacers.” Ex. 1010, Abstr., 2289–90. As claim 1 does not require any particular solubility threshold, on this record, Petitioner sufficiently demonstrates that Xue expressly discloses the solubility limitation of independent claim 1.” slip op. at 33
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,302,648 - PTAB · Jan 6, 2023 · IPR2022-01205 · APJ Brian D Range · IPR · Institution
The Board instituted review of claims 1–10, 18, and 20 based on the asserted § 102 and § 103 grounds.
RulingsInstitution decision- Adverse judgmentAdverse judgmentOther
“Here, Patent Owner filed a statutory disclaimer of claims 11–17 of the ’417 patent. Prelim. Resp. 1–2; Ex. 2019. Based on our review of Exhibit 2019, we determine that a disclaimer of claims 11–17 of the ’417 patent under 35 U.S.C. § 253(a) has been filed with the Office as of October 5, 2022. Based on the information in the public record, we find that the disclaimer complies with the above-listed requirements of 37 C.F.R. § 1.321(a). Because claims 11–17 have been disclaimed under 35 U.S.C. § 253(a), in compliance with 37 C.F.R. § 1.321(a), we do not reach challenges to claims 11–17. As a result, the remaining challenged claims are claims 1–10, 18, and 20 (“the challenged claims”).” slip op. at 5
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“in situations where a district court trial date is set to occur before the issuance of the Board’s final written decision. The facts and reasoning of Fintiv are, at a minimum, only applicable to cases in which the district court has actually set a trial date in a copending litigation. But here, as will be discussed below, the parties agree that no trial date has been set, and the 14 Available at https://www.uspto.gov/sites/default/files/documents/ interim_proc_discretionary_denials_aia_parallel_district_court_litigation_ memo_20220621_.pdf. District Court has stayed the litigation. Prelim. Reply 8; Prelim. Sur-Reply 6 (“There has never been a trial date). Furthermore, that stay will continue until our final determination should we decide to institute trial. Without a trial date, we see no need to engage in a full analysis of the Fintiv factors,15 as there is no basis for Patent Owner’s argument for discretionary denial.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“IV. CONCLUSION For the reasons above, we determine that the information presented in the Petition establishes that there is a reasonable likelihood that Petitioner would prevail with respect to challenged claims 1–10, 18, and 20 of the ’417 patent. At this juncture in the proceeding, we have not made a final determination with respect to the patentability of the challenged claims, or with respect to claim construction. V. ORDER For the foregoing reasons, it is ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes review of claims 1–10, 18, and 20 of the ’417 patent is hereby instituted with respect to the ground of unpatentability set forth in the Petition; and FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; the trial will commence on the entry date of this Decision.” slip op. at 44
- Skill levelOther
“would have at least a Ph.D. degree in chemistry, or a bachelor’s or master’s degree plus experience involving the use and design of fluorescent probes or dyes.” Pet. 18 (citing Ex. 1007 ¶¶ 14–18). Patent Owner agrees that a POSITA may have a Ph.D. degree or master’s degree in chemistry, but asserts that a POSITA would also have “some experience with fluorescence” in addition to a Ph.D. degree in chemistry and that the experience of a POSITA with a master’s degree in chemistry is alternatively “industry experience in the field of biological detection systems.” Prelim. Resp. 5–6 (citing Ex. 2001 ¶ 7). For purposes of this Decision, we need not resolve these differences between the parties’ definitions, because any differences do not affect our analysis.13 If either party believes that adopting its preferred definition of the level of ordinary skill would have a material effect on the outcome of this proceeding, the party should address this issue during the instituted trial. slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,955,417 - PTAB · Jan 6, 2023 · IPR2022-01207 · APJ Jon B Tornquist · IPR · Institution
Instituted IPR of claims 1–14, 18, and 19 on all asserted grounds after finding a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), 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.” For the reasons set forth below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. Thus, we hereby institute an inter partes review as to claims 1–14, 18, and 19 of the ’620 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“be lifted for each patent for which the petition is denied. As noted above, there are six related petitions at the Board involving the patents before the court. The district court stayed the litigation “pending resolution of the IPR proceedings that have been instituted on the patents at issue in this case.” Ex. 2006, 2. Regarding the length of the stay, the district court explicitly ordered the parties not to use continuance of the fact discovery to October 28, 2022 “as grounds for . . . opposing institution of any post-grant proceeding.” Ex. 2007, 2. Regarding when the stay will be lifted, the order merely gives Patent Owner the opportunity to “seek to lift the stay as to any patents that are not instituted for review.” Ex. 2006, 2 (emphasis added). But we decline to speculate whether the district court would grant such a motion directed only to one of the six patents. Among the reasons warranting a stay of the litigation, the district court found “IPR has the potential to streamline issues for trial” and “the resources the parties will need to expend for experts could be significantly impacted by the outcome of any instituted IPR proceedings.” Id. Thus, the litigation is stayed pending the outcome of the six related proceedings, not merely the outcome of this institution decision, and the district court stayed the litigation for the explicit purpose of gaining efficiency and avoiding duplication of efforts by letting this inter partes review proceed to its conclusion first.14 See Prelim. Reply. 4–5. While Patent Owner may seek to lift the stay as to any patent for which institution is denied, the grant of any such request is uncertain. Accordingly, this factor strongly weighs against discretionary denial of institution.” slip op. at 15
- Skill levelOther
“Petitioner asserts that a person of ordinary skill in the art (POSITA) “would have at least a Ph.D. degree in chemistry, or a bachelor’s or master’s degree plus experience involving the use and design of fluorescent probes or dyes.” Pet. 17 (citing Ex. 1007 ¶¶ 14–18). Patent Owner agrees that a POSITA may have a Ph.D. degree or master’s degree in chemistry, but asserts that a POSITA would also have “some experience with fluorescence” in addition to a degree in chemistry and that the experience of a POSITA with a master’s degree in chemistry is alternatively “industry experience in the field of biological detection systems.” Prelim. Resp. 10 (citing Ex. 2001 ¶ 7). For purposes of this Decision, we need not choose between the parties’ proposed levels of one of ordinary skill in the art, which are quite similar, as neither party asserts that the anticipation or obviousness analyses in this case would turn on which definition is adopted. See Prelim. Resp. 10 (Patent Owner stating that its arguments and conclusions “would not change” if Petitioner’s definition were applied).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Decided for patent owner
“The express language of claim 1 requires no solubility threshold, and dependent claim 10 demonstrates that where a solubility threshold was intended by the inventors of the ’620 patent they knew how to expressly set forth that threshold in the claims. Compare Ex. 1005, 213:26–27 (“capable of imparting solubility in water”), with id. at 218:12–14 (“The method according to claim 1, wherein each R is a non-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.”). Thus, the claim language does not support applying a particular solubility threshold in claim 1. As noted by Patent Owner, the written description of the ’620 patent explains that “[i]n some embodiments, each R is independently a non-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.” Id. at 54:2–10; Prelim. Resp. 12–13. This solubility threshold, however, is not in claim 1, and we decline to import such a limitation from the written description into claim 1 absent compelling reasons for doing so. See SciMed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 1340 (Fed. Cir. 2001) (explaining that “reading a limitation from the written description into the claims” is “one of the cardinal sins of patent law”); see also Thorner v. Sony Comp. Entm’t Am., LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012) (“It is likewise not enough that the only embodiments, or all of the embodiments, contain a particular limitation. We do not read limitations from the specification into claims; we do not redefine words.”). In view of the foregoing, we construe the term “non-ionic side group capable of imparting solubility in water” to not include any particular numeric solubility threshold.13” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,288,620 - PTAB · Jan 6, 2023 · IPR2022-01203 · APJ Christopher L Crumbley · IPR · Institution
The Board instituted IPR on claims 1–10, 12–14, and 17–19 on all asserted grounds, finding a reasonable likelihood of prevailing on at least one challenge.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. Patent Owner has not persuaded us that we should exercise our discretion to deny institution. We hereby institute an inter partes review as to claims 1–10, 12–14, and 17–19 of the ’989 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“in situations where a district court trial date is set to occur before the issuance of the Board’s final written decision. The facts and reasoning of Fintiv are, at a minimum, only applicable to cases in which the district court has actually set a trial date in a copending litigation. But here, as will be discussed below, the parties agree that no trial date has been set, and the District Court has stayed the litigation. Prelim. Reply 8; Prelim. Sur-Reply 6 (“There has never been a trial date.”). Furthermore, that stay will continue until our final determination should we decide to institute trial. Without a trial date, we see no need to engage in a full analysis of the Fintiv factors,14 as there is no basis for Patent Owner’s argument for discretionary denial.” slip op. at 18
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“numerical solubility limit into the claims, noting that the ’989 patent expressly defines “non-ionic side groups capable of imparting solubility in water” as simply “side groups which are not charged and allow the resulting polymer to be soluble in water or aqueous solution with no visible particulates.” Prelim. Reply 1 (citing Ex. 1001, 54:9–13). Petitioner notes that this definition contains no numerical limit, and that it is followed by a statement that in some embodiments, the R group is capable of imparting solubility in excess of 10 mg/mL. Id. at 2 (citing Ex. 1001, 54:13–16). Petitioner contends that reading a limitation from “some embodiments” into the claims would be “one of the cardinal sins of patent law.” Id. (citing Phillips, 415 F.3d at 1320; Polaris Innovations Ltd. v. Brent, 48 F.4th 1365, 1375–76 (Fed. Cir. 2022)). Petitioner also directs our attention to related patents that expressly claim a solubility in excess of 10 mg/mL, arguing that when Patent Owner sought to claim such polymers, it knew how to do so. Id. (citing Ex. 1005, 218:11–12; Ex. 1006, 239:43–45, 252:51–52, 254:39–40, 262:56–57, 269:31–35).” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“proposed claim construction on solubility above, which we declined to do on the present record. For this reason, we find them unpersuasive. In addition, we note that Xue expressly discloses that its glycopolymers utilizing PEG-tethered spacers (Polymers B and C) “are highly water-soluble due to their long, flexible, hydrophilic spacers.” Ex. 1010, Abstract, 2289–90. Petitioner sufficiently sets forth why a person of ordinary skill in the art would have considered the PEG side chains of Xue to impart solubility in water, which is all we have construed the claims to require.” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 10,458,989 - Neuroderm Ltd. v. Abbvie Inc.InstitutedPTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution
The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19
- Skill levelSkill level board ownOther
“Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15
- Expert testimonyPetitioner expert creditedOther
“Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,091,507 - PTAB · Sep 14, 2022 · IPR2022-00673 · APJ Richard H Marschall · IPR · Institution
The Board instituted IPR on claims 1–18 under § 103 based on WO684 and NO366, finding a reasonable likelihood of success and declining discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“prior situations, how the New Hampshire District Court would rule should a stay be requested in the New Hampshire litigation. See Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 15 at 12 (PTAB May 13, 2020) (informative) (“A judge determines whether to grant a stay based on the facts of each specific case as presented in the briefs by the parties. We decline to infer, based on actions taken in different cases with different facts, how the District Court would rule should a stay be requested by the parties in the parallel case here.”). We view this factor as neutral because neither of the parties in the New Hampshire litigation has requested a stay thus far. See id. at 12 (determining that Factor 1 is neutral when neither party has requested a stay and the issue has not been ruled on by the district court).” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We agree with Patent Owner that both WO684 and NO366 were at least considered by the Examiner, even if the Examiner never discussed the references or relied on them in any manner. See Ex. 1001, code (56) (listing both WO684 and NO366 among the references cited). Under these circumstances, we find the first part of the Advanced Bionics satisfied because the prior art before the Examiner and the prior art relied on in the Petition include the same prior art references.” slip op. at 16
- Skill levelOther
“person having ordinary skill in the art “has a Master’s degree in Mechanical Engineering or Robotics and at least three to four years of experience working as an engineer in the field of AS/RS [Automated Storage and Retrieval Systems].” Pet. 26 (citing Ex. 1003 ¶ 62). Petitioner argues in the alternative that one of ordinary skill in the art “has at least a Bachelor’s degree in Mechanical Engineering, and at least four to five years of experience working as an engineer in the field of AS/RS.” Id. (citing Ex. 1003 ¶ 63). Patent Owner argues that “the level of ordinary skill in the art is ‘at least a bachelor’s degree in mechanical engineering, and at least two to three years’ experience working in the field of the design of robotic vehicles for material handling system[s].” Prelim. Resp. 29 (citing Ex. 2001 ¶ 50). Patent Owner contends that the parties agreed that this level of skill applies to WO684 in a related ITC proceeding, and should be adopted here. Id. at 29–30 (citing Ex. 2007, 19–20). We note that the parties’ respective proposals overlap considerably, with Petitioner’s alternative proposal nearly identical to Patent Owner’s proposal. We need not resolve which proposal most closely aligns with the level of ordinary skill in the art here, however, because even if we adopt Patent Owner’s proposal we would come to the same ultimate conclusion that Petitioner satisfies its burden of showing a reasonable likelihood of establishing the unpatentability of any of the challenged claims.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not propose any constructions for any claim terms, and “Patent Owner also believes no claim term requires construction and submits that the Petition is defective under any reasonable claim construction.” Prelim. Resp. 30. Based on our review of the current record, we need not formally construe any claim terms to determine whether to institute an inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (stating that “we need only construe 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 20
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,961,051 - PTAB · Jun 9, 2022 · IPR2022-00100 · APJ Scott Raevsky · IPR · Institution
The Board instituted IPR on claims 8–10 and 15–18 on all asserted grounds, finding a reasonable likelihood that the challenged claims would have been obvious.
RulingsInstitution decision- Parallel petitionsDecided for petitioner
“Typically, “one petition should be sufficient to challenge the claims of a patent,” but “there may be circumstances in which more than one petition may be necessary.” CTPG 59. We agree that the claims challenged by these two petitions differ significantly. For example, as Petitioner notes:” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner bears the burden to demonstrate unpatentability. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). At this preliminary stage, we determine whether the information presented in the Petition shows a reasonable likelihood that Petitioner would prevail in establishing that at least one of the challenged claims would have been obvious over the proposed combinations of prior art. See 35 U.S.C. § 314(a). A claim is unpatentable as obvious if “the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting 35 U.S.C. § 103(a)). We resolve the question of obviousness based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the prior art and the claims; (3) the level of skill in the art; and (4) when in evidence, objective indicia of nonobviousness. See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Graham, 383 U.S. at 13, 17. Petitioner asserts that [a] person of ordinary skill in the art [“POSITA”] . . . would have had at least a bachelor’s degree in electrical engineering, computer engineering, computer science, physics, or the equivalent, and two or more years of experience with LED devices and/or related circuit design, or a related field. . . . More education can supplement practical experience and vice versa. Pet. 5–6 (citing Ex. 1002 ¶¶ 20–21). Patent Owner does not dispute Petitioner’s proposed level of skill in the art at this stage. Prelim. Resp. 12. We are persuaded, on the present record, that Petitioner’s proposal is consistent with the problems and solutions in the ’583 patent and prior art of record. We adopt Petitioner’s definition of the level of skill for the purposes of this Decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In inter partes review, we construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b) (2021). The parties do not propose any constructions. Pet. 7; Prelim. Resp. 12. Based on our review of the preliminary record, we determine that no terms require construction at this stage. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms that are in controversy, and only to the extent necessary to resolve the controversy.”) (internal quotation omitted).” slip op. at 8
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,750,583
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.