- Novartis Pharmaceuticals Corporation v. Shilpa Pharma, Inc.All claims unpatentablePTAB · Sep 29, 2023 · IPR2022-00886 · APJ John G New · IPR · Final written decision
Claims 1–4 are unpatentable under §102 over Mutz; the Board did not reach the §103 Mutz and Gidwani or §102 Gidwani grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- ExcludeMotion to exclude, grantedMixed
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“claims, Petitioner’s request that we do so as a sanction against Patent Owner is denied. Furthermore, having reviewed the arguments and evidence presented by Petitioner and Patent Owner, we conclude that the evidence is not sufficiently conclusive to warrant the additional imposition of financial sanctions. We consequently deny Petitioner’ Motion for Sanctions.” slip op. at 82
Patent outcomesUS 9,266,816 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 9,266,816 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Rehearing grantedPTAB · Aug 10, 2023 · PGR2022-00023 · APJ Jeffrey N Fredman · PGR · Rehearing
On Patent Owner’s rehearing request, the Board held claim 25 unpatentable under § 112(a) because it depends from claim 14, which lacks written description support.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We therefore agree with Petitioner that we overlooked the correct dependency of claim 25. Claim 25, as a claim dependent from claim 14, lacks written descriptive support because claim 25 fails to cure the absence of descriptive support for claim 14.” slip op. at 4
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“In the Final Written Decision, we determined that claim 14 lacked descriptive support. We noted that Claim 14, in particular, recites a GDC-0199 dosing regimen “compris[ing] a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day.” Unlike for claim 1, such disclosure is not found in a single example, but results from picking and choosing three separate selections from column 24. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 *4 (Fed. Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 3
§ 112 disclosurePatents in suitUS 10,993,942 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01513 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Even if there were a distinction between the parties’ respective definitions of the level of ordinary skill in the art, Patent Owner’s expert, Dr. Weitz, notes that his opinion would not change regardless of which definition is applied. See Ex. 2060 ¶ 26. Moreover, we find both Dr. Zusman and Dr. Weitz qualified to opine from the perspective of a POSA for purposes of this Decision as both possess at least the level of ordinary skill in the art. See Ex. 1002 ¶¶ 1–11; Ex. 2060 ¶¶ 1–11; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369,” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“3. Remaining Claim Terms Patent Owner also offers constructions for “coronary artery disease,” and the preamble (PO Resp. 23–32, 39–40), but none of these claim phrases Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We now turn to the patentability challenges presented by Petitioner.” slip op. at 21
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Patent Owner again, however, misses the point. The question is not whether clinical trials may exist where the disclosed dosing regimen may not be clinically proven effective, or whether a POSA would necessarily recognize clinical proof of efficacy from the COMPASS protocol taught by Foley. Id. at 53–54. On the contrary, the question is whether “the [prior art] disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275 (Fed. Cir. 2010) (citation omitted). If it is, the Federal Circuit has held that it is “well-settled that the disclosure should be regarded as sufficient.” Id. As such, here, we consider whether the disclosure in Foley is sufficient to show that the natural result of the disclosed dosing regimen would be “clinically proven effective” by the COMPASS study disclosed by Foley. In this case, we know that to be true because the claimed process was confirmed by the same COMPASS study disclosed by Foley. See Bristol- Myers, 246 F.3d at 1376; see also Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1369 (Fed. Cir. 2006) (finding method claims anticipated where prior art method disclosed the same steps in furtherance of the same purpose, and all that was contributed by the patent claims is the the claim term were limiting, we find Foley inherently discloses “clinically proven effective” amounts of rivaroxaban and aspirin. Having considered the arguments and evidence presented at trial, we find Petitioner has shown by a preponderance of the evidence that claims 1 and 2 are anticipated by Foley.” slip op. at 26
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01515 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“2. Analysis “A claim is anticipated if each and every element as set forth in the claim is found, either expressly or inherently, in a single prior art reference.” Arbutus Biopharma Corp. v. ModernaTX, Inc., 65 F. 4th 656, 662 (Fed. Cir. 2023). The Federal Circuit explains that “[a]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation.” Monsanto Tech. LLC v. Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, Petitioner must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 28
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-00517 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2 and 5–8 as obvious over Foley, and claims 3–4 and 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner disagrees with Petitioner’s definition and contends that a POSA would have been a “clinician with experience in the design, conduct, analysis, and interpretation of results from clinical trials involving antithrombotic agents (anticoagulants and antiplatelet agents), as well as experience with the treatment of patients with anticoagulants and antiplatelet 7 Although we find certain of Patent Owner’s arguments not persuasive, this should never be taken as an indication that we have assigned Patent Owner the burden of proof on patentability. patients with coronary artery disease and/or peripheral artery disease.” PO Resp. 22 (citing Ex. 2060 ¶¶ 24–26). In response, Petitioner asserts that its definition encompasses Patent Owner’s definition, as the experience of an M.D. includes the ability to interpret the results of clinical trials to evaluate therapies. Pet. Reply 2–3 (citing Ex. 1037 ¶ 7). We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 24
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“aspirin was taken with the first 2.5 mg dose of rivaroxaban, with the second 2.5 mg dose of rivaroxaban, or at a different time than either dose of rivaroxaban. Pet. 67 (citing Ex. 1002 ¶¶ 336–338). Nevertheless, Petitioner asserts that a POSA would have understood that “unless there is a cause for concern in terms of potential drug interactions, concomitant administration of multiple drugs in a dosing regimen is preferred for patient-compliance reasons.” Id. (citing Ex. 1002 ¶¶ 337–338). 13 We further note that we have considered, but are not persuaded that Patent Owner’s objective evidence of nonobviousness, discussed below, outweighs this strong evidence of obviousness. “first product,” Patent Owner does not argue that Foley does not teach a “first product.”14 See PO Resp. 51–56; PO Sur-reply 19–24. As set forth above, we agree with Petitioner’s construction of “first product” as not requiring, although allowing, a single combination dosage form. See supra Section II.B.2. We, therefore, find Petitioner has shown that a POSA considering Foley would have found it obvious to administer aspirin together with one of the rivaroxaban doses. We credit the testimony of Petitioner’s expert, Dr. Zusman, who notes that a POSA would have known that there were no concerns about administering rivaroxaban and aspirin together, and that it is easier for patients to take two drugs at the same time rather than at different times throughout the day. See Ex. 1002 ¶¶ 337–338; see also Ex. 1009,15 981 (noting “there is no clinically relevant interaction between rivaroxaban and aspirin and that the 2 drugs could be administered concomitantly”). We, therefore, find Petitioner has shown that Foley teaches or suggests each limitation of claims 5 and 8 and that a POSA would have had a reason to modify Foley to administer rivaroxaban together with aspirin with a reasonable expectation of success.” slip op. at 29
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCAll claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Final written decision
Claim 59 is unpatentable as anticipated by Brumfield, Marcus, and Chandran; the motion to amend proposing substitute claim 62 is denied because claim 62 is unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find this argument unpersuasive. As Patent Owner notes, Petitioner’s expert provides a definition of POSITA that is very similar to that recited by Patent Owner in its Motion to Amend, substantively differing only in the number of years of experience of the engineer at issue. This congruity supports the conclusion that the level of ordinary skill in the art may be recognized in the prior art itself. Okajima, 261 F.3d at 1355 (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’”).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In our Institution Decision, we agreed with Petitioner that the “portion of the preamble reciting ‘for compressing bone’ is not limiting to the claim” and found that other terms did not require construction. Dec. 8–9. We agreed with Petitioner that “[t]he phrase ‘for compressing bone’ merely identifies an intended use.” Pet. 20; Dec. 9. Patent Owner does not dispute this interpretation. See generally PO Resp. We agree with Petitioner that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Therefore, having considered the entire record developed during trial, we adhere to the preliminary construction that the limitation “for compressing bone” does not impose a structural limitation on claim 59 and that the other terms do not require construction.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Patent Owner disputes the Petition generally but Patent Owner does not identify any error in Petitioner’s foregoing arguments. Accordingly, we adopt the factual statements regarding the specific teachings of the references as findings of fact. See generally In re NuVasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make specific findings as to claim limitations that Patent Owner does not dispute are disclosed in the prior art). We have reviewed Petitioner’s analysis and the underlying evidence cited in support and conclude that Petitioner has shown, by a preponderance of the evidence, that the limitations of claim 59 are disclosed by Brumfield.” slip op. at 26
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“For the reasons discussed below, Patent Owner has shown that proposed substitute claim 62 meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. For the reasons discussed below, however, Petitioner has proven by a preponderance of the evidence that proposed substitute claim 62 is unpatentable over prior art. Therefore, we deny Patent Owner’s Revised Motion to Amend.” slip op. at 38
Patent outcomesUS 8,303,589 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 8,303,589 - Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentablePTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision
The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77
- ExcludeMotion to exclude, deniedDenied
“A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29
- Skill levelSkill level board ownOther
“Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26
- Expert testimonyPetitioner expert discountedDecided for patent owner
“With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25
Patent outcomesUS 10,766,685 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,766,685 - Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision
Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “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 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24
Patent outcomesUS 10,900,034 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,900,034 - Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · May 17, 2023 · IPR2022-00402 · APJ Michael A Valek · IPR · Final written decision
Claims 1–30 are unpatentable: claims 1–7, 9, 10, 12–15, 17, 18, 20–25, and 27–30 are anticipated; the remaining challenged claims are obvious.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’001 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 12 (citing Ex. 1003 ¶ 60). Petitioner further asserts that “[a] POSA would have understood the chemical structure of nucleic acids, such as DNA and RNA, and would have understood the role of such nucleic acids in cellular biology” and been aware of various prior art “methods to chemically modify RNA, including gRNAs for use in gene regulation.” Id. at 12–13 (citing Ex. 1003 ¶¶ 61–72, 80). Patent Owner agrees that a POSA would have this educational level. Resp. 24. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties may disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“Independent claims 1 and 12 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to a target polynucleotide.” Ex. 1001, 243:20–22, 244:28–31. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 17 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 17. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:36–40. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 12. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24–25. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “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 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We find Petitioner’s arguments and evidence persuasive. It is well established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 24–26. There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. Smithkline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 21
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional. Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 79 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 79, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 23
Patent outcomesUS 10,337,001 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,337,001 - Slayback Pharma LLC v. Eye Therapies, LLCAll claims unpatentablePTAB · May 15, 2023 · IPR2022-00142 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–6 are unpatentable as obvious over Gil, Norden, Dean, Alphagan, and Federal Register; anticipation over Gil and Walters was not shown for claims 1–2.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Although the parties disagree as to the specific qualifications of a person of ordinary skill in the art, the parties’ experts agree that their Ex. 1049 ¶ 6 (Sher); Ex. 2020 ¶ 28 (Noecker); Ex. 2021 ¶ 34 (Williams); Ex. 2022 ¶ 23 (Davies). Both parties’ proposed definitions and the prior art of record indicate a high level of skill in the relevant art. Because the parties’ respective experts agree that any dispute as to the level of ordinary skill in the art is not material to their opinions, we adopt Patent Owner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Ex. 2020 ¶¶ 28–31; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8
- Expert testimonyPetitioner expert creditedOther
“We are not persuaded. We credit the testimony of Petitioner’s expert, Dr. Sher, who explains that because of the “high degree of imprecision of Figures 2 and 6,” a POSA would be unable to reach any quantitative conclusions from the figures or “clinically distinguish” between brimonidine concentrations that differ by only five-thousandths of a percent. Ex. 1049 ¶¶ 10–18. For example, as Dr. Sher notes, there are no incremental hash marks that indicate where any non-enumerated concentrations such as 0.02% or 0.025% would fall. Id. ¶¶ 11–12. Moreover, the x-axis of both figures appears to be neither linear nor logarithmic. Id. The uncertainty of the scale of the x-axis calls into question the assumption by Dr. Noecker that the blue dot on the x-axis of Figure 6 is necessarily 0.025% as opposed to, for example, 0.02%, which is specifically called out in the Specification’s description of Figure 6 as a preferred concentration. See Ex. 1001, 19:57 (stating Figure 6 demonstrates that “the net effectiveness of brimonidine as a decongestant is greatest between about 0.01% and about 0.03%; preferably between about 0.012% and about 0.02%”) (emphasis added). Moreover, like Dr. Sher, we question the accuracy of Dr. Noecker’s statement that concentrations less than 0.03% have no rebound hyperemia. See Ex. 1049 ¶ 19 (citing Ex. 2020 ¶ 94). As seen by a magnified portion of Figure 2, reproduced below, the dark gray, solid line indicating rebound hyperemia appears to show at least some amount of rebound hyperemia below 0.03%: That is, the magnified portion of Figure 2 depicts the dark gray rebound hyperemia curve between 0.01% and 0.03% to be above the x-axis, indicating—on its face—that some rebound hyperemia occurs, contrary to Dr. Noecker’s testimony. Id. We, therefore, credit the reasoning of Dr. Sher, who explains that, in light of the imprecision of the figures, a POSA would not rely on the figures to discern when rebound hyperemia begins, but would rather rely on the Specification, which states “rebound hyperemia begins at around 0.03%.” Id. We are persuaded that those words of approximation suggest that rebound hyperemia could begin either a little less than, at, or a little more than 0.03% brimonidine. See Ex. 1049 ¶ 25. Thus, we agree with Dr. Sher that “a POSA would read the ’742 patent’s description of Figure 6 and reasonably conclude that ‘at around 0.03%’ includes 0.025%.” Id.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“As an initial matter, we agree with the parties that the preamble of the claims is limiting. “Whether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in the patent.” Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003). The Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021). And where, as here, the claims are directed to methods of using a composition for a specific purpose (i.e., reducing eye redness), and the method comprises a single step of administering that composition, the Federal Circuit “has generally construed statements of intended purpose in such method claims as limiting.” Id. at 1340. agree with Petitioner that it does not and find Eli Lilly to be instructive. In Eli Lilly, the preambles of the claims recite a “method for reducing incidence of or treating at least one vasomotor symptom in an individual” and a “method for treating headache in an individual.” 8 F.4th at 1335. There, the Federal Circuit held that the preambles “are not merely statements of effect but rather statements of the intentional purpose for which the methods must be performed.” Id. at 1342. Thus, the Federal Circuit did not require proof of actual clinical results from performing the claimed method, even though the claims also recited an “effective amount.” Id. The Federal Circuit held that because the specification defined an “effective amount” as an “an amount sufficient to effect beneficial or desired results” and provided examples of such results in the context of prophylactic or therapeutic uses, the claims “encompass a clinical result, [but] they do not require such a result.” Id. Here, similarly, the ’742 patent claims simply recite administering the brimonidine composition (at a concentration range) and do not recite any efficacy requirement, nor even the “effective amount” of note in the Eli Lilly claims. But, like Lilly and as explained below, the “ocular conditions” of the claims encompass prophylactic reduction of hemorrhage and hyperemia in addition to therapeutic uses. See Ex. 1001, 12:13–19. We, therefore, find the claims here do not require actual redness reduction and, thus, no clinical result is required to satisfy the claimed method. Thus, having considered the arguments and evidence presented at trial, we determine that the preamble of the claims is limiting and requires that the claimed brimonidine composition be administered with the actually reduced.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“evidence presented at trial, we agree with Petitioner that the term “about 0.025%” includes 0.03%. Our construction is supported not only by intrinsic evidence, but also by extrinsic evidence that demonstrates the alleged criticality of the “about 0.025%” limitation. terms of a specific numerical range. We must, therefore, determine how broadly a POSA reading the ’742 Specification would extend the numerical range around 0.025%. In doing so, we consider the described criticality of “about 0.025%” brimonidine and its purpose to the claimed invention. See Cohesive, 543 F.3d at 1368. The ’742 patent makes clear that the purpose of the “about 0.025%” limitation in the claims is to use “low doses of highly selective a-2 adrenergic receptor agonists to achieve vasoconstriction with significantly reduced hyperemia.” Ex. 1001, 2:39–41. Furthermore, the Specification explains that there is a need for methods that provide “safe and long term vasoconstriction with reduced or minimized side effects, such as rebound hyperemia.” Id. at 2:30–33. There is no dispute that both 0.025% and 0.03% constitute low doses of brimonidine, as described by the Specification. See id. at 3:60–65 (defining “low concentrations” as “between about 0.0001% to about 0.05%”). Thus, the question is whether there is a critical distinction between the two concentrations and their ability to provide vasoconstriction with reduced rebound hyperemia. Patent Owner argues they are clinically distinct, whereas Petitioner argues they are not. In light of the intrinsic evidence discussed below, we agree with Petitioner.” slip op. at 22
Patent outcomesUS 8,293,742 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,293,742
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.