- Apotex Inc. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Mar 10, 2023 · IPR2022-01524 · APJ Ryan H Flax · IPR · Institution
Institution denied because Petitioner did not show a reasonable likelihood that claims 1–14 and 26–30 were unpatentable over the asserted anticipation and obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“APPLICABLE LEGAL STANDARDS “In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). An inter partes review may be instituted if the information presented by Petitioner in the Petition, in view of Patent Owner’s Preliminary Response and the preliminary record, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314.” slip op. at 19
- BurdenDecided for patent owner
“As an initial matter, we find Petitioner has insufficiently addressed the issue of inherent anticipation by Dixon (or any other prior art) and has done so in a merely conclusory manner. There is no dispute that Dixon (as well as the other asserted prior art) discloses angiogenic eye disorder treatment using the same drug (aflibercept), at the same dose (2 mg), administered in the same way (intravitreal injection), and administered at the same dosing regimen (an initial, a secondary, and a tertiary dose), as required by all challenged claims. See generally Pet.; Prelim. Resp. Petitioner relies on these facts, and the results of a phase 2 clinical trial that followed a different dosing protocol (one not claimed) to establish that the results limitations of claims 1, 26, and 29 are inherent to the phase 3 clinical trials (VIEW 1 and 2) with a dosing regimen that is claimed. See Pet. 38–39. Petitioner calls the claimed results limitations mere newly discovered results of a known process. Id. (citing Montgomery, 677 F.3d at 1381). As Patent Owner identifies, it is not so simple. The evidence of the results of the VIEW 1 and 2 trials itself (found in the ’572 patent) shows that some, but not all, patients treated with the claimed dosing regimen achieved “a gain in visual acuity” as recited by claim 1, “a gain in visual acuity” that is “as effective” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 26, or “maintaining visual acuity” “as effective[ly]” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 29. See Ex. 1001, 13:5–38 (Table 1). As Patent Owner points out, the ’572 patent’s described studies 1 and 2, when following the claimed dosing regimen (2Q8), were not always effective treatments––achieving mere maintenance (as opposed to improvement or “gains”) of vision 95.1% and 95.6% (respectively) of the time. Id.; see Prelim. Resp. 34–37 (citing Ex. 1001, 13:8–27; Ex. 1014, 4, 6; Ex. 1030, 9; Ex. 2021 ¶¶ 109–111; Ex. 2022). Thus, the evidence shows that, although most would, about 4–5% of patients (or, possibly, an even higher number based on Patent Owner’s cited evidence––Ex. 1030, 9) would not see the gains in visual acuity required by claims 1 and 26 or the maintenance in visual acuity required by claim 29. It is well established that “[i]nherency . . . may not be established by probabilities or possibilities” and “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re. Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, the evidence shows that the claimed results limitations may typically flow from the claimed method, but not necessarily.” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“Relating to the claim construction, the Federal Circuit found that patent at issue was “clear” that the tissue fibrosis, recited by the claim as arrested or regressed by the otherwise recited treatment, was not the same as and did not necessarily accompany the symptom of erectile disfunction (taught in and the focus of the relied-upon prior art), although the former (fibrosis) may frequently result in the latter (disfunction). Id. at 1059. The Federal Circuit held that the “arresting or regressing” clause was more than a mere statement of intended result, but was a limitation carrying patentable weight because the phrase was drafted as a part of a separate step of the method rather than of the preamble, the “arresting or regressing” language demanded efficacy, and the efficacy was linked to specific treatment minimum duration and dosage. Id. at 1060–61. The patients exhibiting these two issues were not necessarily the same. In part because the Board did not consider the arresting/regressing result limitation in its unpatentability analysis, the Federal Circuit agreed with the patent owner that the Board’s findings were insufficient. Id. at 1064, 1067. The Federal Circuit found that that prior art reference relied upon in the Board’s decision for teaching the claimed treatment, and also relied upon to link the condition of fibrosis with the symptom of erectile dysfunction, did not teach treating a population of patients suffering from erectile dysfunction only because of a fibrosis condition and, even though such patients may have had fibrosis, it was not certain; and further found that other cited prior art did not make certain a link between fibrosis and such dysfunction. Id. at 1065–66. This, the Federal Circuit found, was error. We find in agreement with Patent Owner that the results limitations of the challenged claims are limitations and must be given patentable weight for the same reasons arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed. Similarly, here the claims are directed to expressly required results of the administration of aflibercept to patients at 2 mg at an initial dose, in at least one secondary dose 4 weeks later, and in at least one tertiary dose 8 weeks later. Therefore, we find that in claim 1, “wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose,” is a limitation. Further, in claim 26, “wherein the method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation. And, in claim 29, “wherein the method is as effective in maintaining visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“A prior art reference without express reference to a claim limitation may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,253,572 - Adama Agan Ltd. v. Bayer Cropscience LPInstitution deniedPTAB · Feb 13, 2023 · PGR2022-00057 · APJ Susan L C Mitchell · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that claims 1–18 lacked written description or enablement, or were unpatentable over the asserted prior art.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have had at least a bachelor’s degree in agronomy, agricultural sciences, or a related field and at least 3-5 years of experience in the application of pesticides, including experience conducting weed science research, such as field trials to determine herbicide efficacy and safety.” Pet. 25 (citing Ex. 1002 ¶ 10). Patent Owner responds that it does not challenge Petitioner’s definition of a POSA at this stage of the proceeding. Prelim. Resp. 15. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case, as well as the ’463 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“When claim 1 is read in light of the Specification of the ’463 patent, we find that Petitioner’s construction is too expansive and not commensurate with the appropriate scope of claim 1 when the Specification of the ’463 patent is considered. As the Specification of the ’463 patent makes clear, indaziflam has been in use as an herbicide and is well-characterized. See Ex. 1001, 3:17–6:6. The Specification of the ’463 patent incorporates by reference U.S. Patent No. 8,114,991, which describes indaziflam, and the Specification of the ’463 patent also describes several commercially available herbicides incorporating indaziflam as their active ingredient. See id. at 3:22–27, 4:15–41. The Specification of the ’463 patent sets forth embodiments with specific ranges for the amount of indaziflam. See id. at 5:45–6:6. Finally, the Specification of the ’463 patent states: A person having ordinary skill in the art would understand how to adjust dosages and concentrations depending on whether the composition is to be applied to a desirable plant or seed, part or habitat thereof, or directly to a site in which no desirable plants are present or growing (e.g., a monoculture of unwanted annual grass).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITANo construction needed
“We find that Petitioner’s expansive construction of the claim phrase “a composition comprising a cellulose biosynthesis inhibitor” to be inconsistent with the meaning of the transitional phrase “comprising” within the context of the claim as a whole and also inconsistent with the teachings set forth in the Specification of the ’463 patent. The transitional phrase “comprising” is inclusive or open-ended and should be read to not exclude additional, unrecited elements or method steps. See, e.g., Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.”) (citing In re Baxter, 656 F.2d 679, 686 (CCPA 1981). Therefore, although the term “comprising” does not exclude additional steps or elements, that does not mean that any other step or element may or should be added, such as any other chemical, as Petitioner asserts. The Specification of the ’463 patent contemplates using indaziflam as the herbicidally active ingredient, but also contemplates the addition of other active ingredients in the composition. Ex. 1001, 5:59–65; 6:7–11. The Specification of the ’463 patent also contemplates the addition of other ingredients in the composition as well. Specifically, the Specification states: These formulations are produced in any desired or known manner, for example by mixing the active compounds with extenders, such as liquid solvents, pressurized liquefied gases and/or solid carriers, optionally with the use of surface-active agents, such as emulsifiers and/or dispersants and/or foam formers. Id. at 17:6–11. This and the remainder of the Specification does not suggest the expansive interpretation of the claim limitation argued by Petitioner. For example, the Specification explains that the point of the invention is to treat vegetation that is or will be consumed by livestock animals, and, more specifically, that such animals will provide food (e.g., milk or meat) for others (e.g., people or pets) further up the food chain. Id. at 2:31–35, 2:39– 59. Reason and the evidence of record support that such goals are not commensurate with co-applying any chemical in any amount to the same area. See also Ex. 1002 ¶¶ 22–23, 30, 34–36, 38–43, 55, 59–61, 63” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 11,166,463 - PTAB · Jan 11, 2023 · IPR2022-01225 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is anticipated by Dixon because the exclusion criteria likely lack patentable weight.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Decision. See Ex. 3001, 12–23. In the -00881 Decision, challenged claim 1 of US 9,254,338 B2 (the “’338 patent”) recited preamble language identical to that recited in claim 1 of the ’681 patent, viz., “a method for treating an angiogenic eye disorder in a patient.” See Ex. 1001 col. 21, ll. 40–41; Ex. 3001, 7. The Board found that this preamble was limiting upon the remainder of the claim. Ex. 3001, 18. Specifically, the Board found that: Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” The Specification repeatedly characterizes the method as one for treating angiogenic eye disorders in patients. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, … in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.” Id. at 17–18 (citations omitted). We adopt this same reasoning here and find, for the purposes of this Decision, that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting upon the claims.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“[W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner’s proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder, but does not require a “high level of efficacy,” as proposed by Patent Owner. See Ex. 3001, 22.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses “secondary doses” are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001 col. 3, ll. 36–44. We do not find persuasive Patent Owner’s argument that the definition of these terms require a high, or otherwise defined, degree of efficacy. As we stated in the -00881 Decision: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.” Ex. 3001, 25 (emphasis added). We see no need or reason to upend this construction now and, for the purposes of this Decision, we adopt Petitioner’s proposed definition of the claim terms “initial dose,” “secondary doses,” and “tertiary doses” as the express definition provided by the ’681 Specification.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“Claim(s) 35 U.S.C. § Reference(s)/Basis Challenged 4 1, 3–11, 13, 14, 103 Dixon alone or in view of 16–24, 26 Papadopoulos5 and/or Wiegand6 5 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Rosenfeld-20067, and if necessary, Papadopoulos patent and/or Wiegand 6 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Heimann-2007, and if necessary, Papadopoulos and/or Wiegand” slip op. at 5
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,130,681 - PTAB · Jan 11, 2023 · IPR2022-01226 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and all petition grounds, finding a reasonable likelihood that claim 34 is anticipated by Dixon.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’601 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“General Plastic, Paper 19 at 9–10. The purpose of the analysis thus established in General Plastic is to deny a Petitioner successive attacks on the claims of a single patent, and profiting from those prior attempts by altering a petition’s strategy in response to Patent Owner’s and the Board’s responses.” slip op. at 21
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“an Interim Procedure for Discretionary Denials in AIA Postgrant Proceedings with Parallel District Court Litigation, available at: https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (last visited December 22, 2022) (the “Interim Procedure”). The Interim Procedure explains that “to benefit the patent system and the public good, the PTAB will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation where a petition presents compelling evidence of unpatentability.” Interim Proc. 2. Specifically, the Interim Procedure states that: Where the information presented at the institution stage is merely sufficient to meet the statutory institution threshold, the PTAB has the authority, where warranted, to exercise discretion to deny institution in view of the other Fintiv factors. In contrast, where the PTAB determines that the information presented at the institution stage presents a compelling unpatentability challenge, that determination alone demonstrates that the PTAB should not discretionarily deny institution under Fintiv.” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In performing an analysis under § 325(d): [T]he Board uses the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.… If, after review of [Becton, Dickinson] factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). Consequently, we first turn to an analysis of Becton, Dickinson factors (a), (b), and (d) under this framework to determine whether the same or substantially the same art previously was presented to the Office or whether” slip op. at 26
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 10,888,601 - 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 - Beckman Coulter, Inc. v. Sirigen II LimitedInstitution deniedPTAB · Jan 6, 2023 · IPR2022-01208 · APJ Jon B Tornquist · IPR · Institution
The Board denied institution on all challenged claims and grounds because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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 stated below, we determine that Petitioner does not establish a reasonable likelihood that it would prevail with respect to at least one claim of the ’303 patent. Thus, we do not institute an inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denialNot reached
“1 Because we deny the Petition on the merits, we do not address the parties’ arguments related to discretionary denial.” slip op. at 2
- Skill levelOther
“Petitioner asserts that a person having 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 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. 9–10 (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, e.g., id. at 10 (noting that the arguments and conclusions reached in the Preliminary Response “would not change” if Petitioner’s definition of the ordinarily skilled artisan were applied).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“structure of Formula (Ia),” including specific MU, L1 and L2, G1 and G2, n, and a, b, c, and d (which define the mol % of each unit within the structure) constituents, wherein each R group must be a “[n]on-ionic side group capable of imparting solubility in water in excess of 10 mg/mL.” Ex. 1006, 239:29–240:56. The ’303 patent expressly defines the phrase “[n]on-ionic side groups capable of imparting solubility in water” to refer to “side groups which are not charged and allow the resulting polymer to be soluble in water or aqueous solutions with no visible particulates.” Id. at 54:31–34. In view of structure of claim 1 and the express definition provided in the ’303 patent, we agree with Patent Owner that claim 1 requires that the non-ionic side group R must be capable of imparting solubility to the claimed conjugated polymer (having constituents that satisfy the claimed variables noted above) in excess of 10 mg/mL. Prelim. Resp. 13. On this record, it is not sufficient to show that a particular R group is capable of” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 8,575,303 - 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
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.