- Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166 - Samsung Bioepis Co. Ltd. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jun 14, 2024 · IPR2023-00442 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as obvious over Dixon because Dixon anticipates them.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“We adopt the same reasoning here, and conclude that the evidence of record and the Specification of the ’681 patent 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 a patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, although the claims “encompass a clinical result, they do not require such a result.” (emphasis added). 8 F.4th 1331, 1343 (Fed. Cir. 2021). We consequently reject Patent Owner’s proposed construction that the language of the preamble reciting a “method for treating an angiogenic eye disorder” requires not only an intent to treat, but, additionally, a high degree of efficacy on par with monthly Lucentis. See PO Resp. 9–10.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We adopt Petitioner’s proposed 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 that 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. Patent Owner does not expressly dispute Petitioner’s construction, other than to argue that, by 2011, a person of ordinary skill in the art would have understood “initial” and “secondary” doses to correspond to loading doses and “tertiary” doses to correspond to maintenance doses. PO Resp. 13 (citing Ex. 2056 ¶ 66; Ex. 2349, 6–11. Patent Owner contends that the purpose (and expected effect) of loading doses was to achieve visual acuity gains and retina drying, and the goal of less frequent maintenance doses was to maintain the efficacy achieved with loading doses. Id. at 14 (citing Ex. 2056 ¶ 66). As we have explained above, we do not find persuasive Patent Owner’s argument that the definition of these terms requires a high, or otherwise defined, degree of efficacy. As we stated in the -00881 and -01225 Decisions: 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.”” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“If a claim limitation is directed to printed matter, the second step of the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner notes that the Petitioner in the ’00881 IPR proposed that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 17–18 (quoting -00881 IPR, Paper 94 at 9–10). Furthermore, it was asserted that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 18 (citing -00881 IPR Paper 94 at 10). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. In the -01225 IPR, we adopted the same definition of a person of ordinary skill in the art for the challenged claims of the ’681 patent, concluding that that definition was consistent with the level of skill in the art. See -01225 IPR, Paper 96 at 52–53. Having previously adopted this definition of the level of skill in the art for the claims of the ’681 patent, we do so again in the present proceeding.” slip op. at 25
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,130,681 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00566 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Owner and its experts proposed claim construction of “effectively treating” as meaning “noninferior,” “statistically noninferior,” or “comparable.” Pet. Reply 4. Petitioner asserts that Patent Owner, and its expert, Dr. Do, advance the proposed construction of “effectively treating, ” with no explanation for what that means, or how it comports with the challenged dependent claims that recite visual acuity limitations ranging from losing less than 15 letters to gaining more than 15 letters. Id. at 4–5.” slip op. at 32
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00533 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Id. at 18. The similar language of the challenged claims of the ’601 patent, and our reasoning in the related -00881 Decision, compel the same conclusion here, i.e., that the preamble is limiting upon the claims.” slip op. at 43
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2022-01225 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the remaining grounds.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“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 that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting.” slip op. at 34
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We adopt Petitioner’s proposed 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 that 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.” slip op. at 37
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“If a claim limitation is directed to printed matter, the next step in the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 46
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 28. Petitioner asserts that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 28–29 (citing Ex. 1002 ¶¶ 27–29; Ex. 1003 ¶¶ 21–25). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the level of skill in the art (see, e.g., Exs. 1006, 1020), we adopt Petitioner’s definition.” slip op. at 52
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,130,681 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Some claims unpatentablePTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision
The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology and cancer biology, which would encompass the blood cancers recited by Patent Owner. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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))). We find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed
“We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16
Patent outcomesUS 10,993,942 mixedClaim construction§ 112 disclosurePatents in suitUS 10,993,942 - Bausch & Lomb Incorporated v. Zeavision, LLCAll claims unpatentablePTAB · Apr 10, 2023 · IPR2022-00089 · APJ Tina E Hulse · IPR · Final written decision
Claims 12–14, 16–21, 23, and 24 are unpatentable: Lang anticipates some claims, and the asserted Lang-based combinations render all challenged claims obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition (Dec. Inst. 6–7), which Patent Owner states that it “does not contest.” PO Resp. 17. Because the parties do not dispute the level of ordinary skill in the art, we adopt Petitioner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Moreover, we find that Dr. Johnson and Dr. Dorey are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art. See Ex. 1024 ¶¶ 2–11, App’x A; Ex. 2001 ¶¶ 4–14, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Similarly, here, the Specification consistently states that the invention relates to oral formulations for protecting eye health and that the benefits of carotenoids, such as zeaxanthin and lutein, include the ability to absorb UV and blue light. See, e.g., Ex. 1001, Abstract (“Oral formulations for promoting eye health”), 4:25–31 (stating carotenoids such as zeaxanthin are “very good at absorbing ultraviolet (UV) and blue light”), 15:45–47 (“one object of this invention is to disclose multi-component orally-ingestible formulations for protecting eye health in mammals”). Like the preamble in Proveris, the preamble in claim 12 is the only reference in any of the independent claims to the allegedly inventive concept of protecting eye health from the harmful effects of blue light. Proveris, 739 F.3d at 1373. Moreover, the preamble of claim 12 recites: “A nutrient formulation for oral ingestion for protecting a user’s eyes from the harmful effect of blue light, the formulation comprising:.” Ex. 1001, 37:13–15. The body of claim from the group consisting of capsules, tablets, liquids, and powders for oral ingestion.” Ex. 1001, 37:22–24 (emphasis added). Similarly, claim 22, which depends from claim 12, relies on the preamble of claim 12 for antecedent basis for the limitation “wherein the user has macular degeneration and a lens-related disorder.” Id. at 38:21 (emphasis added). Thus, “the nutrient formulation” and “the user” in the claim body derives antecedent basis from the “nutrient formulation” and “user” that is “defined in greater detail in the preamble.” See Proveris, 739 F.3d at 1373. Accordingly, reading the patent as a whole, because the inventor clearly relied on both the preamble and the body of claim 12 to define the claimed invention, the preamble of claim 12 should be construed as limiting. See id.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would understand this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 19 (citing Ex. 1024 ¶ 57, Ex. 1031, 3). Petitioner also contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and delta-tocopherols.” Pet. 22–24 (citing Ex. 1024 ¶¶ 65–66). Patent Owner does not address either of these claim terms in its Response. See generally PO Resp. Because there does not appear to be any dispute over the construction of these terms, we adopt Petitioner’s proposed constructions as they are consistent with the plain and ordinary meaning of the terms. See Wellman, terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 13
Patent outcomesUS 10,307,384 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,307,384 - Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentablePTAB · Apr 4, 2023 · IPR2021-01565 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–24 are unpatentable: claims 1–10, 12–22, and 24 as anticipated by Kaiser, and claims 1–24 as obvious under the listed grounds.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Considering argument and evidence of record, we define a person of ordinary skill in the art as a member of a multidisciplinary team consisting of at least (1) a person (“Engineer POSA”) with either (a) a bachelor’s or master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32
- Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed
“demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at pages 11–12 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 31–32 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 44
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Although Kaiser exemplifies in detail a method involving IVC occlusion, its disclosure makes clear that the method is also applicable to the SVC. See, e.g., Ex. 1007, 6:60–64 (“the adjustable component may create a pressure gradient by . . . adjusting blood flow impedance through the superior vena cava”), 5:64–6:2 (disclosing “systems and methods may be provided to create a pressure differential” using “balloons . . . to increase a pressure drop through the . . . superior vena cava”), Claim 5 (reciting a “flow impedance device implantable within a patient’s inferior vena cava”), Claim 17 (“The method of claim 10, wherein the body lumen within which the adjustable component is positioned is . . . a superior vena cava.”), 6:31–36 (positioning pressure sensor in the superior vena cava); see also Ex. 1010, 19–22 (claims of provisional application directed to reducing blood flow through the superior vena cava); see also Pet. 29–34, 36–39; Reply 14–16; Ex. 1002 ¶¶ 152–153, 156–159, 165, 167–176 (Dr. Day’s testimony regarding the SVC positioning elements). Considering the arguments and evidence of record, including our own reading of Kaiser (see supra Section I.I.1), we find that Kaiser expressly discloses the contested element of Ground 1 relating to use of the restrictor in the SVC.” slip op. at 47
Patent outcomesUS 10,639,460 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,639,460 - Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentablePTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29
- ExcludeMotion to exclude, deniedDenied
“As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“For the above reasons, on the full trial record we determine that” slip op. at 26
Patent outcomesUS 10,682,414 mixed§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,682,414 - Apple, Inc. v. Alivecor, Inc.All claims unpatentablePTAB · Dec 6, 2022 · IPR2021-00972 · APJ David Cotta · IPR · Final written decision
Claims 1–23 are unpatentable as obvious: claims 1, 5, 7–9, 11, 12, 16, 18–20, 22, and 23 over Shmueli and Osorio; remaining claims over combinations adding Lee-2013 or Chan.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“Patent Owner argues that we should reject our originally proposed definition in light of, for example, Petitioner’s proposed definition before the ITC, which required an engineering background and “at least two years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals.” PO Resp. 27 (citing Ex. 2004, 6). As noted at oral argument, however, Patent Owner truncates the full extent of Petitioner’s ITC definition, which further states that “a hypothetical person of ordinary skill in the art could also be a person with a medical degree (MD or DO) and with at least two years of work experience using biomedical sensors and/or analyzing their data (in the context of industry, in biomedical academic research, or in practice treating patients).” Ex. 2004, 6; Tr. 40:13– 41:10. Patent Owner’s assertion that our originally proposed definition, would “classify all cardiologists as [persons of ordinary skill in the art],” is well taken. PO Resp. 25. Accordingly, we apply the following modified definition, which is consistent with Petitioner’s representation before the ITC. For the purpose of this proceeding, a person of ordinary skill in the art may be a member of an interdisciplinary team including persons with backgrounds in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology, and having at least two years of relevant work experience designing, using, or analyzing data from, cardiac monitoring devices.” slip op. at 24
- Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed
“Dr. Efimov has extensive experience in the design of cardiac monitoring and related technologies, but Petitioner asserts that he “is unable to offer credible testimony on the meaning of [relevant] medical terminology,” because he is not a doctor. Reply 28; Sur-reply 22 (arguing that “Dr. Efimov is a recognized expert in the field of clinical cardiac electrophysiology”). Considering the totality of Dr. Efimov’s background, including extensive work on the physiology, diagnostics, and therapy of cardiac arrhythmias, we do not adopt Petitioner’s position. See, e.g., Ex. 2001 ¶¶ 2–15. In light of the above, we determine that Dr. Chaitman and Dr. Efimov are both qualified to testify as to the understanding of a person of ordinary skill in the art, we, nevertheless, consider the weight of both parties’ experts on a particular topic in light of the strengths and weaknesses of their respective background. C. Claim Construction” slip op. at 26
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner offers a construction for the claim term “discordance,” proposing that it should be construed to mean “when a first sensed parameter value would not be expected to coincide with a second sensed parameter value.” Pet. 8–10. Patent Owner does not propose a competing construction and, in the ITC Investigation, proposed “[n]o construction required” for the term “discordance.” Ex. 2009, 4. Having reviewed the evidence and argument of record, we determine that we do not need to construe the term “discordance” in order to resolve this dispute. See Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). slip op. at 27
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Patent Owner’s proposed construction is consistent with the intrinsic and extrinsic evidence. See e.g., Ex. 1047 (medical dictionary defining arrhythmias as “[a]n abnormal rate or rhythm of the heartbeat” caused by “a disturbance in the electrical impulses within the heart”); Ex. 1001, 4:4 (“Heart function is also measured in terms of regularity of rhythm. . . . When there is an abnormality of rhythm, the condition is typically referred to as an arrhythmia.”). Although it is not clear that the term is in dispute, for clarity, we understand the term “arrhythmia” as used in the context of the ’941 patent to mean: a cardiac condition in which the electrical activity of the heart is irregular or is faster (tachycardia) or slower (bradycardia) than normal.” slip op. at 28
Patent outcomesUS 10,638,941 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,638,941
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.