- PTAB · Jul 20, 2023 · IPR2023-00462 · APJ Jamie T Wisz · IPR · Institution
The Board instituted IPR on claims 1–18 because Petitioner showed a reasonable likelihood of prevailing on anticipation by Fraser and obviousness over the asserted combination.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“In evaluating the exercise of discretion to deny institution under Section 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), the Board “may not authorize an inter partes review to be instituted unless . . . the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the Petition, the Preliminary Response, the Reply, the Sur-reply, and the evidence of record, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–18 of the ’992 patent, based on all of the grounds identified in the Petition. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) at the time of the invention “would have had a Ph.D. in pharmaceutical sciences or a similar field, with at least several years of experience in the development, manufacture and characterization of formulations of therapeutic proteins, including, for example, fusion proteins or antibodies.” Pet. 30 (citing Ex. 1002 ¶¶ 39–43). Petitioner further asserts that the POSA “would have understood how to combine proteins with compatible excipients such as surfactants, stabilizers, salts and buffers of various pH values, and how to adjust these combinations in order to optimize their stability in liquid or solid form.” Id. at 30–31. Petitioner asserts that the Because Fraser uses the term “VEGF TrapR1R2” (Ex. 1009, 1115), we use the same nomenclature in this Decision. POSA would have been able to assess stability and compatibility by using “state-of-the-art analytical methods, such as SEC.” Id. at 31. Patent Owner does not contest the characterization offered by Petitioner. See Prelim. Resp. 16. For purposes of this Decision, we adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’992 patent and the cited prior art. 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 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner proposes claim construction for three terms under their plain and ordinary meaning. See Pet. 41–42. First, Petitioner asserts that the “POSA would have understood that the term ‘native’ in the phrase ‘native conformation’ in claims 1, 2, 10 and 11 refers to the fully intact and functional conformation of the protein.” Id. at 42 (citing Ex. 1002 ¶ 22). Second, Petitioner asserts that the “POSA would have understood the term ‘vial’ in claims 1–9 to refer to a small closed or closable vessel, especially for liquids.” Id. (citing Ex. 1031; Ex. 1002 ¶¶ 23, 190). Third, Petitioner asserts that the “[t]he POSA would have understood the term ‘multimerizing component’ in claims 1 and 10 to refer to a protein moiety that joins two or more protein domains together to form a multimer, such as a dimer or trimer.” Id. (citing Ex. 1002 ¶ 24). Patent Owner does not challenge Petitioner’s proposed claim constructions. Prelim. Resp. 16. For purposes of this Decision, however, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,464,992 - Eyenovia, Inc. v. Sydnexis, Inc.All claims unpatentablePTAB · Jul 13, 2023 · IPR2022-00414 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–7 and 11–20 are unpatentable as obvious over Chia and Akorn; the Board did not reach the Wu and Akorn ground.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not agree with Patent Owner that the level of ordinary skill in the art should be limited to experience with ophthalmic formulation. The claims at issue generally require a kit with a vial of a pharmaceutical composition of atropine, water, and buffer, and instructions for use. See Ex. 1001, 99:12–19 (claim 1). As Dr. Byrn points out, the technology surrounding use of atropine, a nonselective muscarinic antagonist, to treat myopia, has been extensively studied for over a hundred years and is known 7 Although Patent Owner disagrees with Petitioner’s definition of a POSA, Patent Owner does not provide its own definition apart from including expertise in ophthalmic formulation. See PO Resp. 4–7. development of myopia.” See Ex. 1002 ¶ 26 (quoting Ex. 1008, 1) (citing Ex. 1003, 1; Ex. 1012, 2). The degradation of atropine is also well known to primarily result from cleavage of the acyl-oxygen bond during ester hydrolysis, see id. ¶ 43 (citing Ex. 1017, 1; Ex. 1024, 5), with the rate of acid-catalyzed reaction being much slower than that of the base-catalyzed reaction, leading to stability of atropine at a lower pH range (pH < ~3), see id. ¶ 45 (citing Ex. 1005, 1,4–5). Concerning specifically the use of atropine in the eye, Dr. Byrn points out that it is well known that ophthalmic solutions should be “formulated to be sterile, isotonic and buffered for stability and comfort.” See Ex. 1002 ¶ 47 (quoting Ex. 1019, 52) (noting Ex. 1019, 54 (pH of tear fluid is 7.4). None of this chemistry concerning the stability of atropine or its administration in the eye is remarkable or not well understood by a POSA as defined by Petitioner. See PO Resp. 10 (stating “the stability of atropine was understood to be a ‘predictable function,’ and a ‘routine matter,’ of temperature and solution pH”), 40–41 (same). We see no reason why someone with drug formulation experience, but not specific experience with ophthalmic solutions, would not qualify as a POSA. Therefore, we continue to apply Petitioner’s definition of a POSA in this final written decision.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “[f]or the purposes of this proceeding only, Petitioner does not believe that any claim terms need to be construed.” Pet. 21. Patent Owner “agrees that the claims should be understood according to their ordinary and customary meaning.” PO Resp. 25. In reply, Petitioner asserts that the ordinary meaning of “about” is “approximately,” and the ordinary meaning of “buffering agent” or “buffer” “is nothing more than an excipient that helps control pH.” Reply 2. Petitioner asserts that Patent Owner agrees with the definition of “buffering agent” and “buffer” by stating that “[t]he patent uses terms buffer and buffering in their normal sense, which entails providing pH control or maintenance.” Id. (quoting PO Resp. 28). Based upon our review of the evidence of record, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”). Insofar as the parties dispute whether Akorn discloses a buffer, we address those contentions in our discussion below of the challenged claims.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find that Patent Owner’s criticism misses the mark. Petitioner is using the DailyMed exhibit as further evidence that Akorn was publicly available as of the revision date of 7/2014 as shown on Akorn, Ex. 1004. See Opp. to Mot. to Exclude 8 (“Moreover, public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on that site at least by July 24, 2014. See EX1057, 3.”) As set forth in the Petition, EX1004, a drug label to Akorn, bears July 2014 revision dates that comport with its FDA approval and publication well before the critical date. See Pet., 10–22; Hulu, 13. It also bears Akorn’s corporate insignia. EX1004, 5. Additional evidence confirms these dates are reliable. EX1056-58.”); 3 (“Public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on July 24, 2014.”). Whether a POSA could have searched this way for labels published before the critical date is irrelevant; Petitioner is only using the evidence to show that Akorn was, in fact, published in July 2014, before the critical date on a searchable website. See id. Patent Owner does not dispute that DailyMed was searchable by drug name, which would be the logical way a POSA would search such a database for information for a drug of interest. Petitioner also provides further evidence that the Akorn label was published on July 24, 2014, through a response by the National Library of Medicine (“NLM”) to a Freedom of Information Act request. See Ex. 1071. confirmation that the substance of the Akorn label was posted on July 24, 2014, on the DailyMed website. Id. The National Institutes of Health (“NIH”) responded that version 7 of the Akorn label was published on DailyMed on July 24, 2014, and provided the URL that is reflected in the Akorn label in Exhibit 1057 from the DailyMed website. See Ex. 1072, 6; Ex. 1057, 4–7. NIH also confirmed that NLM “received version 7 of this label from the FDA on 07/24/2014 @ 2:15:04 PM,” “published version 7 on DailyMed on the same day, 07/24/2014 @ 14:59:48 PM,” and confirmed that “NLM does not make changes to the content contained within any SPL [or structured product labeling] records that it receives from the FDA.” Ex. 1072, 6. We find that Petitioner has provided more than sufficient evidence that the Akorn label reflected in Ex. 1004 was publicly available before the critical date. For the reasons set forth above, we determine that Petitioner has shown by a preponderance of the evidence that Akorn, Ex. 1004, is a printed publication that was publicly available before the critical date.” slip op. at 21
- ExcludeMotion to exclude, deniedDenied
“We agree with Petitioner here that Patent Owner’s concerns about the sufficiency of the support for Dr. Byrn’s opinions goes more to the weight to be accorded such opinions rather than a need to exclude such opinions. See TPG 40–41, 79 (“A motion to exclude must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used to challenge the sufficiency of the evidence to prove a particular fact.”). We also note that the findings in the district court litigation are based on a different record that is not before us here. For instance, the district court relies on a Lewis reference and a Harris reference that is not before us and testimony from Dr. Richard Moreton that is also not before us here. See Ex. 2010 ¶¶ 63–69. Therefore, we determine that the district court’s findings are not sufficiently probative of the questions before us here. Also, the district court’s findings are not as definitive as Patent Owner states. The patent owner in the district court case attempted to prove infringement by the doctrine of equivalents for a formulation that did not expressly contain a buffer, but that it argued inherently contained a buffer from the chemical disassociation of the active ingredient in the product. See Ex. 2010, 64–65. The district court found that patent owner failed to prove case is in stark contrast with the underlying facts of this proceeding in which the prior art formulation expressly contains the same buffers as claimed in the ’145 patent. See Ex. 1001, 99:33–35 (claim 5); Ex. 1004, 3. (c) Conclusion Based on the foregoing, we deny Patent Owner’s motion to exclude Exhibit 1002, Dr. Byrn’s testimony.” slip op. at 28
Patent outcomesUS 10,940,145 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,940,145 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCNo claims unpatentablePTAB · Mar 24, 2023 · IPR2022-00034 · APJ John G New · IPR · Final written decision
Petitioner failed to show claim 6 unpatentable because none of the seven asserted grounds established the required absence of an outer graft covering between the fibers and outer frame.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“November 2012 would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“We determine that, as the plain language of the claim term suggests, an “outer graft covering” must circumferentially cover some, or all, of the metallic outer frame of the prosthetic heart valve. See Merriam-Webster, Cover, available at: https://www.merriam-webster.com/dictionary/cover (last visited March 2, 2023) (defining “cover,” relevantly, as “something that is placed over or about another thing”). See Ex. 3004. Consequently, we understand an “outer graft covering” to be a structure, such as a cloth or fabric or other material, that circumferentially covers all or part of, the metallic outer frame. Importantly, because an outer graft covering must cover the external surface of the outer frame, we understand this claim term to mean that the cover must extend over (i.e., “cover”) not only the struts and members of the metallic outer frame, but must also cover the open spaces, or interstices, in the intervals between those struts and members. Consequently, we construe the limitation reciting “free of an outer graft covering between the fibers and the outer frame” to mean that there can be no such outer graft covering present anywhere between the outwardly extending fibers and the metallic outer frame.” slip op. at 40
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Reply to Patent Owner’s Response, or otherwise provide any additional argument or evidence to demonstrate that the outer skirt of Levi does not constitute the outer graft covering prohibited by claim 6. Consequently, our initial determinations stand. Furthermore, our definition of outer graft covering herein as “a material or structure that circumferentially covers at least a portion of the outer surface of the prosthetic heart valve, such that both the struts and members of the metallic outer frame, as well as the 45 interstices between those struts and members, is covered by the outer graft covering” reinforces our prior conclusion that the outer skirt of Levi constitutes an outer graft covering that is prohibited by claim 6. We consequently conclude that Petitioner has not met its burden with respect to demonstrating, by a preponderance of the evidence, that Levi teaches or suggests the limitation reciting “wherein the outer seal is free of an outer graft covering between the fibers and the outer frame.”” slip op. at 45
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Both the descriptions and Figure 22 of Spenser II show a cloth covering the proximal outer surface of the metallic outer frame of the prosthetic heart valve, including the spaces between the struts and members of the frame. Furthermore, the reference discloses that any fibers extending outwardly from the cloth arise from the surface of the cloth, and are not attached directly to the frame, as depicted in Figure 11 of the ’846 Specification. Thus, even were such fibers made of the same material as the cloth, which is not clear from the reference’s disclosure, the cloth would be between the surface-residing fibers and the metallic outer frame. We conclude that a person of ordinary skill in the art would have recognized that the sleeve-like cloth or fabric of Spenser II corresponds to an outer graft covering between its fibers and its outer frame, and such a covering would be between Spencer II’s surface fibers and its metallic outer frame. Such an outer graft cover is expressly prohibited by the language of claim 6, even if it and associated extending fibers are of the same material.” slip op. at 48
Patent outcomesUS 10,966,846 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,966,846 - Guardant Health, Inc. v. University Of WashingtonInstitution deniedPTAB · Jan 13, 2023 · IPR2022-01159 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 6, 7, and 9–26 were obvious over Kinde and Craig.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In sum, Petitioner has not met its burden to sufficiently explain the reason to combine the teachings of Kinde and Craig. Thus, Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claim 1, as well as claims 6, 7, and 9–26, which depend from claim 1, would have been obvious over the combination of Kinde and Craig.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“adapter-DNA molecules.” Id. at 19. But, the Y-shaped adapters in Kinde are different from those in Craig: the former do not contain barcodes, whereas the latter do. Compare Ex. 1006, S9 (showing the adapters used in the endogenous method do not contain barcodes), with Ex. 1007, Supplementary Table 3 (showing adapters with barcodes). To the extent Petitioner argues that an ordinarily skilled artisan could have swapped Kinde’s Y-shaped adapters with Craig’s, that is insufficient for our analysis. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”). To answer the question why the artisan would have used Craig’s adapters with barcodes in Kinde’s Safe-SeqS approach, Petitioner contends that “Kinde cites Craig in discussing exogenous barcodes with DNA molecules.” Pet. 19; see also id. at 22–23 (“[C]iting to Craig, Kinde discusses methods including assigning exogenous barcodes to nucleic acid fragments.”). But, as Patent Owner points out, Kinde does not use Craig’s approach. Prelim. Resp. 1. Instead, immediately after citing Craig as teaching attaching exogenous UIDs through ligation, Kinde introduces its endogenous method as an “[e]ven more simpl[e]” approach. Ex. 1006, 9531. Thus, Kinde appears to teach Craig as an alternative, not an additional, method to assign UIDs.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 15; 2 Kinde et al., Detection and quantification of rare mutations with massively parallel sequencing, 108 PNAS 9530–35 (2011) (Ex. 1006, “Kinde”). Petitioner also submits, as part of Exhibit 1006, Supporting Information for Kinde. See Ex. 1006, S1–S10. 3 Craig et al., Identification of genetic variants using bar-coded multiplexed sequencing, 5 NATURE METHODS 887–93 (2008) (Ex. 1007, “Craig”). Petitioner also submits, as part of Exhibit 1007, supplementary figures and text associated with Craig. See Ex. 1007, 10–19. Prelim. Resp. 7. The parties nevertheless seek to provide context, or reiterate the plain meaning, of certain claim terms. Pet. 15–17; Prelim. Resp. 7–8. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term.” slip op. at 6
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,752,951 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Cardiovalve Ltd.No claims unpatentablePTAB · Dec 6, 2022 · IPR2021-01051 · APJ John G New · IPR · Final written decision
The Board granted the non-contingent motion to amend, canceling claims 1–10 and replacing them with claims 11–20, which Petitioner failed to prove unpatentable over Goldfarb ’267.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“We conclude that Petitioner’s arguments are insufficient to meet its burden of showing, by a preponderance of the evidence, that Goldfarb ’267 anticipates, or renders obvious, the limitation of proposed substitute claim 11 reciting “advancing the end of the first-clip arm and the end of the second-clip arm out of the delivery tube before advancing the support portion out of the delivery tube” merely requires advancing the ends of the clip arms out of the delivery tube “before advancing the support portion out of the delivery tube.” Moreover, Petitioner’s arguments are not persuasive with respect to proposed substitute dependent claims 12–20 due to their dependence from, and incorporation of, the limitations of proposed substitute claim 11. See Supp. Mot. Amend. 1, Reply Supp. Mot. Amend. 1. We therefore conclude that these proposed substitute claims are similarly neither anticipated by, nor obvious over, Goldfarb ’267. III. CONCLUSION We GRANT Patent Owner’s non-contingent Motion to Amend and Supplemental Motion to Amend, canceling original claims 1–10 and replacing them with substitute claims 11–20. Additionally, for the foregoing reasons, and after having analyzed the entirety of the record and assigning appropriate weight to the cited supporting evidence, we determine that Petitioner has failed to establish, by a preponderance of the evidence, that proposed substitute claims 11–20 are unpatentable.” slip op. at 57
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Having weighed the evidence and Petitioner’s argument, we adopt Petitioner’s definition of a person of ordinary skill in the art as: (1) a mechanical or biomedical engineer with at least three years of experience in designing or developing medical devices who would, where necessary or desired, work or consult with others including a physician to develop such a medical device; or (2) an interventional cardiologist or cardiac surgeon with at least three years of experience developing and/or using medical devices in the heart, and who would, where necessary, work or consult with others including an engineer to develop such a medical device. See Pet. 15–16.” slip op. at 11
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Vesely. Ex. 1003. We have reviewed the credentials of Dr. Vesely and consider him qualified to provide the opinions for which his testimony has 4 Goldfarb et al. (US 7,563,267 B2, July 21, 2009) (“Goldfarb ’267”) (Ex. 1005). 5 Petitioner refers to Goldfarb’s ’267 disclosure of a further alternative at Ex. 1005 col. 27 ll. 57–60 as Embodiment A. See Pet. 19. We understand the asserted Embodiment A to encompass the description that extends to Ex. 1005 col. 28, l. 9. See Pet. 24–48. 6 Goldfarb et al. (US 7,635,329 B2, December 22, 2009) (“Goldfarb ’329”) Ex. 1006. 7 Ex. 1005 cols. 17–23, ll. 66–29, Figs. 9–16; see Pet. 21–22. been submitted. See id. ¶¶ 1–9; see also Ex. 1004 (Dr. Vesely’s curriculum vitae).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“is described in Goldfarb ’267 as plainly a single, unitary structure and, as such, each portion argued as separate elements by Petitioner (i.e., male element (yellow), female element (green), coupling member 19 (blue) and flexible arms 19A and 19B (dark blue)) together form a solid, single component. Thus, all of the “elements” described by Petitioner as being “separate” are in fact a single unit that: (1) bears the weight of the fixation device during delivery; (2) absorbs and transfer the axial and rotational forces imposed by the shaft 12; and (3) holds the device in the correct orientation. Petitioner points to no disclosure of Goldfarb ’267 that suggests these elements act independently or separately to perform the functions of the unitary component, nor can we discern any such disclosure. We therefore find that Petitioner’s argument that only the “male element” portion of coupling member 19 constitutes the “support portion” recited in proposed substitute claim 11 is an arbitrary and unduly restrictive interpretation of the reference’s disclosure. This is particularly true given that Petitioner points to no portion of the male element of coupling member 19 performing a supporting function that is not shared by the other elements of coupling member 19. We conclude that the better understanding of the reference is that the entirety of coupling member 19 (including flexible arms 10A and 19B11) constitutes an analogous support portion, as recited by substitute claim 11, because it provides a unitary structure that performs the supporting functions enumerated by Petitioner.” slip op. at 41
Patent outcomesUS 10,702,385 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,702,385 - Guardant Health, Inc. v. University Of Washington Through Its Center For CommercializationInstitution deniedPTAB · Nov 17, 2022 · IPR2022-00935 · APJ John G New · IPR · Institution
The Board denied institution on all grounds because the petition did not show a reasonable likelihood that claims 1–23 were unpatentable over the asserted obviousness combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and Preliminary Response, and the evidence of record, we determine that the evidence presented does not demonstrate a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of the challenged claims of the ’631 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither Petitioner nor Patent Owner proposes a construction for any claim terms apart from their plain and customary meaning. Pet. 17–18; Prelim. Resp. 5. Nor do we perceive, at this stage of the proceeding, a need to construe any claim term of the ’631 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need to be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs in the context of an inter partes review).” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“filing would typically have had an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field. Pet. 15 (citing Ex. 1002, ¶¶ 53–54). Alternatively, Petitioner proposes, a skilled artisan could have less education but significant professional experience in one or more of these fields. Id. Patent Owner does not contest Petitioner’s proposed definition of a person of ordinary skill in the art. See generally Prelim. Resp. At this stage of the proceeding and for purposes of our analysis in this Decision, we therefore adopt Petitioner’s proposed definition. We find that this definition is consistent with the level of skill in the art as reflected by the prior art. See, e.g., Exs. 1003, 1006, 1007, 1010, 1021; 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” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“ordinarily skilled artisan could have swapped Kinde’s Y-shaped adapters with Craig was insufficient for our analysis. IPR2022-00816, Paper 16 at 14 (citing Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (holding that “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”)). In the ’816 IPR, we further observed that, to answer the question why the artisan would have used Craig’s adapters with barcodes in Kinde’s Safe- SeqS approach, Petitioner contends that “Kinde identifies Craig in expressly discussing exogenous barcodes with DNA molecules.” IPR2022-00816, Paper 16 at 14 (citing Paper 3 at 22, 30). Again, Petitioner repeats the same argument in the present Petition. See Pet. 44; see also Ex. 1002 ¶ 42. But, as we observed in the ’816 proceeding, Kinde does not use Craig’s approach. IPR2022-00816, Paper 16 at 14. Instead, we found that immediately after citing Craig as teaching attaching exogenous UIDs through ligation, Kinde introduces its endogenous method as an “[e]ven more simpl[e]” approach. Id. (quoting Ex. 1006, 9531). We therefore found that Kinde appears to teach Craig as an alternative, not an additional, method to assign UIDs. Id. The same reasoning applies equally here.” slip op. at 33
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,287,631 - Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Nov 9, 2022 · IPR2021-00881 · APJ Erica A Franklin · IPR · Final written decision
Petitioners proved claims 1, 3–11, 13, 14, 16–24, and 26 unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10
- Expert testimonyPetitioner expert creditedOther
“Insofar as Patent Owner relies on the extrinsic testimony of Drs. Do and Brown for that description, we do not assign that testimony persuasive weight as it lacks sufficient evidentiary support. As discussed above, we find Dr. Do’s testimony at odds with the Specification. In particular, for the reasons discussed above regarding the Specification description of the amount of VEGF antagonist administered to the patient, we find troubling not be a treatment.” Ex. 2051 ¶ 46. Additionally, we find much of her testimony regarding the a so-called “high level of efficacy” based on an asserted existing standard of care for angiogenic eye disorder is supported by little more than evidence relating to FDA approvals for Macugen and Lucentis. Dr. Brown’s testimony cited by Patent Owner to support the asserted efficacy requirement, simply relies on Dr. Do’s testimony without discussing any additional evidentiary support.” slip op. at 22
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Rather, as the Federal Circuit reiterated, “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we consider whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)).” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We begin by noting that the claims do not recite any dosage amounts or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble. regarding the “Amount of VEGF Antagonist Administered.” See Ex. 1001, 6:29–7:14. In that discussion, the Specification explains, The amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount. As used herein, the phrase “therapeutically effective amount” means a dose of VEGF antagonist that results in a detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of VEGF antagonist that inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder. Id. at 6:48–55 (emphasis added). That description, along with the absence of the phrase “therapeutically effective” in the claims,11 signals for us the inventors’ intention to not limit the claims to the administration of doses that ultimately prove to be therapeutically effective in a given patient. Instead, the Specification describes administration of VEGF antagonist doses for treating angiogenic eye disorder in a manner that encompasses doses that result in disclosed improvements and benefits, referred to as “therapeutically effective amounts,” and doses that do not. Indeed, as guidance, the Specification discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” without any guarantee that any particular dosage regimen administered within that range of dosage amounts will necessarily be “therapeutically effective,” and without limiting the treatment methods based upon such results. Ex. 1001, 6:55–58 (emphasis added).” slip op. at 19
Patent outcomesUS 9,254,338 unpatentableClaim construction§ 102 anticipationcites Phillips · GrahamPatents in suitUS 9,254,338 - Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Nov 9, 2022 · IPR2022-00301 · APJ John G New · IPR · Final written decision
Claims 1 and 8–12 are unpatentable: Dixon anticipates them, including claim 8 through its disclosure of a comparable VEGF Trap-Eye dosing regimen.
RulingsFinal written decision- Strike new argumentNew argument consideredDenied
“We deny the motion to exclude the referenced argument in Petitioners’ Reply, as well as the invitation to consider the motion as one to strike the argument. As Patent Owner notes in the motion, Patent Owner raised this issue previously in this proceeding. PO Mot. Exclude 5. At that time, we denied Patent Owner’s request for authorization to file a motion to strike the referenced argument in the Reply. It is improper for Patent Owner to now seek to strike the argument in a motion to exclude. A motion to exclude is not the proper vehicle to address arguments or evidence that a party believes exceeds the proper scope of a reply. See USPTO, Consolidated Trial Practice Guide (2019) at 79, available at: https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL= (last visited October 27, 2022) (“CTPG”). Moreover, as Petitioners correctly assert, Patent Owner has failed to satisfy the prerequisite for filing a motion to exclude by failing to timely file an objection. See 37 C.F.R. 42.64(b)(1); CTPG 78–79. Patent Owner has not been left without an opportunity to address the Reply argument. When we denied authorization to file a motion to strike, we authorized Patent Owner to file, with its Sur-Reply, a table identifying any portion of the Reply that Patent Owner considers to have exceeded the scope of the Reply. Further, we explained that Patent Owner, alternatively, may address that contention, or the merits of any newly-raised arguments or evidence in its Sur-Reply. Indeed, Patent Owner addressed the issue in its 26 Sur-Reply for our consideration. Thus, Patent Owner had sufficient opportunity to identify in its Sur-Reply its contentions regarding Petitioners’ allegedly inappropriate Reply argument and took advantage of that opportunity. That is sufficient for us to consider the issue and determine whether such argument should be disregarded. See CTPG 80.” slip op. at 26
- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find that Petitioner’s definition is the better definition for purposes of this proceeding. We acknowledge that the claims of the ’069 patent are directed to a “method for treating an angiogenic eye disorder in a patient” 29 and that the actual practice of the method would therefore seem to be limited to those who have the ability to treat patients, i.e., physicians, etc. However, we find Patent Owner’s definition to be unduly limiting. Individuals who are involved in drug development or sub-clinical level testing of drugs for treating eye disorders may be extremely knowledgeable about the development of the treatment of eye disorders and drug development, and able to comprehend and evaluate the teachings of the prior art. See, e.g., Pet. 25. Such individuals might not possess an M.D. degree, but instead possess a Ph.D. in a “biotechnological, or pharmaceutical field,” or a lesser degree with a corresponding increased depth of experience, as suggested by Petitioner. We agree that such individuals should be considered persons of ordinary skill in the art. We also find that Petitioner’s definition is commensurate with the level of skill reflected in the prior art. See, e.g., Exs. 1006, 1010, 1030, 1033; 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))). We consequently adopt Petitioner’s definition of a person of ordinary skill in the art has having an M.D. or Ph.D. or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field, and having practical academic or medical experience in developing treatments 30” slip op. at 29
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Patent Owner does not propose claim construction positions for these terms because construction of these terms is not necessary to resolve the arguments presented in Mylan’s Petition. PO Resp. 8 (citing Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)). We agree that it is unnecessary to construe these claim terms in view of the express definitions set forth in the Specification. DePuy, 469 F.3d at 1014. Because the claim terms are undisputed, we adopt the definition of the claim terms “initial dose,” “secondary dose,” and “tertiary dose” as expressly defined by the Specification of the ’069 patent. Nidec, 868 F.3d at 1017.” slip op. at 32
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable
“Patent Owner’s arguments are unavailing. The test for whether a reference inherently anticipates a claim is whether a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010) (emphasis added). Patent Owner has made multiple acknowledgements that the VEGF Eye-Trap used in the VIEW 1/VIEW 2 test disclosed by Dixon possessed the amino acid sequence recited in claim 1 of the ’069 patent.” slip op. at 54
Patent outcomesUS 9,669,069 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 9,669,069 - PTAB · Oct 26, 2022 · IPR2022-00886 · APJ John G New · IPR · Institution
The Board instituted review of claims 1–4 on all petition grounds, finding a reasonable likelihood that Mutz anticipates the claims.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Procedure for Discretionary Denials in AIA Postgrant Proceedings with Parallel District Court Litigation, June 21, 2022 available at: https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (last visited October 11, 222) (the “Guidance”). As stated by the Guidance, the Board will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation when: (1) a petition presents compelling evidence of unpatentability; (2) a petitioner presents a stipulation (a “Sotera stipulation”) not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB9; and (3) if all other Fintiv factors weighing against exercising discretion to deny institution, or are neutral, the proximity to trial should not alone outweigh all of those other factors.10 Guidance at 1–8.” slip op. at 40
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In performing an analysis under § 325(d): [T]he Board uses the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.… If, after review of [Becton, Dickinson] factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 45
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,266,816 - PTAB · Sep 8, 2022 · IPR2022-00556 · APJ John G New · IPR · Institution
The Board instituted review of claims 1–4 on all seven grounds, finding a reasonable likelihood that at least one challenged claim would have been obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and the Preliminary Response, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of the challenged claims of the ’236 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). See 37 C.F.R. § 100(b) (2020). Under that standard, claim terms “are generally ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). “In determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). Extrinsic evidence may also be considered, but is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)). Neither Petitioner nor Patent Owner proposes a construction for any claim terms apart from their plain and customary meaning. Pet. 29; see generally Prelim. Resp. Nor do we perceive, at this stage of the proceeding, a need to construe any claim terms of the ’236 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295, 803 (Fed. Cir. 1999) (holding that “only those terms need to be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes review).” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Person of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. Pet. 28. Petitioner contends that this combination with a medical device engineer to experiment with or manufacture a prosthetic heart valve. Id. at 28–29 (citing Ex. 1003 ¶ 45). Patent Owner does not argue otherwise or propose an alternative definition. See generally Prelim. Resp. At this stage of the proceeding and for purposes of our analysis in this Decision, we adopt Petitioner’s definition because we find that that definition is consistent with the level of skill in the art, as reflected by the prior art. See, e.g., Exs. 1007–1012; 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 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner contends that a skilled artisan would have found it obvious to deploy the valve within a patient’s native valve so that the outer cloth forms a sealing interface with the annulus and native leaflets, and would have been motivated to apply Walther’s outer cloth covering to reduce paravalvular leakage (“PVL”), a problem well known in the contemporaneous art. Pet. 42 (citing KSR Int’l Co. v. Teleflex, Inc., 550 U.S. skill in the art would also have had a reasonable expectation of success in deploying the cloth-covered SAPIEN in a patient’s native aortic valve based upon Walther’s teaching of a successful balloon deployment of the cloth-covered SAPIEN that “demonstrated excellent hydrodynamic performance” and that an in-patient procedure “is feasible.” Id. (citing Ex. 1007, 1125; Ex. 1003 ¶ 125).” slip op. at 19
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,987,236
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.