- Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCNo claims unpatentablePTAB · Aug 25, 2023 · IPR2022-00556 · APJ John G New · IPR · Final written decision
Claims 1–4 were not shown unpatentable because the asserted references did not teach or suggest the limitation requiring no outer graft covering between the fibers and outer frame.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“As the plain language of the claim term suggests, an “outer graft covering” must cover some, or all, of the metallic outer frame of the prosthetic heart valve. Consequently, and according to the plain and ordinary meaning, we understand an “outer graft covering” to be a structure, 29 such as a cloth, fabric or other material, that covers all, or part of, the metallic outer frame. Importantly, because an outer graft covering must cover the external surface of the outer frame, and specifically “between the first portion of fibers and 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 spaces between those struts and members. Consequently, the ordinary and customary meaning of the limitation “free of an outer graft covering between the fibers and the outer frame” is that there can be no such outer graft covering present anywhere between the outwardly extending fibers and the metallic outer frame.” slip op. at 29
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“As an initial matter, there is little disagreement between the parties and their experts that PET can be a graft covering. However, the disputed limitation requires something more. Specifically, it requires that “the outer seal is free of an outer graft covering between the fibers and the outer frame.” We are not persuaded that Petitioner has demonstrated, by a preponderance of the evidence of record, that Levi, Spenser II, or Walther, upon which Petitioner relies, teaches or suggests the incorporated limitation of claim 1 reciting “wherein the valve assembly is free of an outer graft covering between the first portion of fibers and the outer frame.” In our analysis, we must first determine what is meant by the claim term “outer graft covering.”” slip op. at 29
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Furthermore, our understanding of an outer graft covering as a material or structure that 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 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 challenged claim 1. We consequently conclude that Petitioner has not met 35 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 35
Patent outcomesUS 10,987,236 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,987,236 - 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 - 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
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.