- Precision Planting LLC v. Maschio Gaspardo S.P.A.No claims unpatentablePTAB · Mar 21, 2025 · IPR2024-00008 · APJ Benjamin D M Wood · IPR · Final written decision
Claims 1–5, 7–14, and 16 were not shown unpatentable because the asserted anticipation and obviousness grounds failed to establish the claimed thrust-bearing element and its required location.
RulingsFinal written decision- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner
“We determine that the evidence of record overcomes the presumption that § 112, para. 6 does not apply because “thrust-bearing element” does not recite sufficiently definite structure in this case. See, e.g., Pet. 22 (the term is not used here according to its common meaning). First, the word “element” is a “[g]eneric term[]” or “verbal construct[]” often “used in a claim in a manner that is tantamount to using the word ‘means’” because it does not “connote sufficiently definite structure.” Williamson, 792 F.3d at 1350. We find nothing in the ’121 patent or elsewhere in the record suggesting that “element” in the term “thrust-bearing element” should be considered other than a generic placeholder term. Second, although the term “thrust bearing” may connote certain structure, “thrust-bearing element” does not. A “thrust bearing” is “a well-known term of art in engineering and is ‘a bearing which sustains axial loads and prevents axial movement of a loaded shaft.’” Ex. 1003 ¶ 46 (citing Ex. 1017, 2147). “The balls of traditional thrust bearings are positioned inline with the axial force, as thrust bearings are designed specifically to transmit axial load.” Id. Here, however, “thrust-bearing” is hyphenated, and is therefore a phrasal adjective modifying “element” rather than the noun phrase “thrust bearing.”8 Further, there are “substantial differences”” slip op. at 15
- Claim Construction › Functional claiming / §112(f) means-plus-function › Corresponding structure / algorithm (indefinite if none)Term construed board ownDecided for patent owner
“We largely agree with Petitioner. “[S]tructure disclosed in the specification is ‘corresponding’ structure only if the specification or prosecution history clearly links or associates that structure to the function recited in the claim.” B. Braun Med. Inc. v. Abbott Labs., 124 F.3d 1419, 1424 (Fed.Cir.1997). The Specification of the ’121 patent “clearly links or associates” two components with the function of bearing axial thrust from the sowing disc: shaft 27 with flanging 30, and thrust-bearing plate 31. Ex. 1001, 3:25–35. Thrust-bearing plate 31 is expressly described as “bear[ing] on that surface of the disc which faces seal 24 . . . in order to withstand at least some of the axial load produced by the disc 16 on the seal 24. Ex. 1001, 3:28–31. Rotatably-mounted shaft 27 with flanging 30 is “fixed” to thrust-bearing plate 31 and therefore bears the axial load from the disc via the thrust-bearing plate. Id. at 3:25–28.10 10 Drive element 32 is described as part of thrust-bearing element 26 and permits thrust-bearing element 26 to be driven in rotation with sowing disc 16. Ex. 1001, 3:36–40. It is not described as bearing any axial load, however. Further, it is not necessary for the thrust-bearing element to rotate with the sowing disc for that element to bear axial load from the sowing disc. See id. at 3:58–59 (“Provision is also made for the thrust-bearing element 26 to be made idle and not driven in rotation by the [drive] shaft 20.”). Ultimately, however, whether drive element 32 is properly considered as part of the corresponding structure is not relevant to the outcome of this case. We disagree with Patent Owner that bearings 28 and seat 29 should be considered corresponding structure. The Specification does not associate these structures with any axial load-bearing function. Instead, bearings 28 and seat 29 are described as the means by which, and the location in which, shaft 27 is rotatably mounted. Ex. 1001, 3:25–27. Regardless, whether or not bearings 28 and seat 29 are considered corresponding structure does not affect the outcome of this case. In summary, we construe “thrust-bearing element” as a means-plus- function claim term under 35 U.S.C. § 112, para. 6. Its recited function is to bear thrust, or more specifically to “withstand at least some of the axial load produced by the disc on the seal.” The structure described in the Specification as corresponding to this function is shaft 27 with flanging 30, and thrust-bearing plate 31. We construe the limitation as directed to this structure, and equivalent structures.” slip op. at 21
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“The question is not whether the patentee disclaimed coverage over structures in which the thrust-bearing element is not located entirely in the movable portion of the housing. Instead, we must simply ascertain what the patentee meant by “supported rotatably in the movable portion.” To answer this question, we look to the Specification, which “is the single best guide to the meaning of a disputed term.” Phillips, 415 F.3d at 1315. “The construction that stays true to the claim language and most naturally aligns with the patent’s description of the invention will be, in the end, the correct construction.” Id. at 1316. Here, it is undisputed that in the sole embodiment described by the ’121 patent, the thrust-bearing element is supported by and entirely within the movable portion of the housing. Ex. 1001, Figs. 1, 2; Pet Post-Hearing Resp. 1; PO Post-Hearing Resp. 2. Construing “in the movable portion” to require the thrust-bearing element to be entirely within the movable portion both “stays true to the claim language and most naturally aligns” with the sole disclosed embodiment. Such a construction does not import the word “entirely” from the sole embodiment into the claims because the construction “arises from the claim language itself.” See SharkNinja Operating LLC v. iRobot Corp., 2024 WL 1132219, *2–*3 (Fed. Cir. 2024) (construing “primary brush assembly disposed within the round housing perimeter” to require that the primary brush assembly be “entirely within” the round housing perimeter is not an improper incorporation of “entirely” from embodiments into the claims because the construction “arises from the claim language itself”). Accordingly, having reviewed the complete record and the parties’ pre- and post-hearing briefing, we determine that “supported rotatably in the movable portion” means supported rotatably entirely in the space defined by the movable portion.” slip op. at 25
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“b. When “Thrust-Bearing Element” is Construed as a Means-Plus-Function Claim Limitation, there is Insufficient Evidence in the Record to Support a Finding that VenHuizen Discloses a Thrust- Bearing Element that is Supported Rotatably in the Movable Portion As noted above, Petitioner contends that VenHuizen’s shaft 55, retaining hub 56, and handle 58 together constitute the claimed thrust-bearing element “under a proper means-plus-function definition.” Pet. Reply 18–19.12 We do not discern sufficient evidence of record or persuasive technical reasoning from Petitioner to support a finding that these elements together are “supported rotatably in the movable portion” of the housing, as claim 1 requires. Ex. 1001, 4:38–39. We construed this limitation to require the thrust-bearing element to be supported rotatably entirely in the space defined by the movable portion (the space defined by VenHuizen’s second housing member 90). Petitioner does not contend, much less show, that these components are supported rotatably entirely in the movable second housing member 90. On the contrary, of the three components constituting VenHuizen’s thrust-bearing element, all of retaining hub 56 and most of shaft 55 are located in the fixed portion of the housing (first housing member 50), not the movable portion 90. See Ex. 1001, Fig. 6. Only handle 58 is ever located in the movable portion (when the fixed and movable portions are joined together). See id. Accordingly, Petitioner has not shown that VenHuizen discloses a thrust-bearing element rotatably supported in the movable portion.” slip op. at 35
Patent outcomesUS 8,770,121 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,770,121 - Orthocision, Inc. v. PTL Opco LLCNo claims unpatentablePTAB · Sep 18, 2024 · IPR2023-00625 · APJ Ryan H Flax · IPR · Final written decision
Claims 1, 2, 9, and 10 were not shown unpatentable under any asserted § 103 ground because Petitioner did not adequately explain how or why the prior art would be combined.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not specifically address Petitioner’s proposed definition. See generally Resp. Patent Owner’s witness, Dr. Bovinet, uses a slightly different, but not materially so, definition of the ordinarily skilled artisan than Petitioner. See Ex. 2005 ¶ 13. Thus, the parties appear to agree on who the person of ordinary skill in the art would have been in terms of education and field of work experience. We accept and adopt Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’129 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[]” 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)). B.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“3. Summary on Claim Construction We maintain our earlier constructions of “open tip” and “releasing means . . . .” See DI 16–24. We determine that no other express construction of any claim term is necessary for purposes of rendering this Decision. See Nidec Motor Corp., 868 F.3d at 1017. Although we maintain here our constructions of “open tip” and “releasing means . . . ,” we do so only for the sake of completeness. These claim constructions, ultimately, are not determinative of the outcome of this proceeding because, regardless of the meaning of any claim term, including these disputed terms, we find that Petitioner fails to adequately explain why any claim would have been obvious under the asserted grounds. We explain this in detail below. C.” slip op. at 29
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Ex. 1001, 6:28–38 (emphasis added). However, the language of claim 1 is very clear on the functionality of the “open tip,” expressly reciting that “the open tip cuts bone tissue away from the sacrum or the ilium.” Id. at 13:19– 20. Thus, the claim language itself provides the required functionality of the “open tip,” and we do not agree with Petitioner that additional functionality relating to where bone tissue might go once cut, as discussed in the Specification, should be read into the claims as a limitation. Patent Owner’s newly proposed interpretation is similar to Petitioner’s in that it requests addition of functionality discussed as an example in the Specification, but not recited in the claim’s expressly recited functional language relating to the “open tip.” We disagree with Patent Owner that the concept of dislodged tissue entering a void defined by the open tip is necessary to understanding the claim element. And, once more, Patent Owner reads too much structure from the written description into the claim language as a limitation because it is not apparent that the recited “open tip” language requires that we further clarify that any interior void defined by the open tip is on the interior of the abrading head, and behind the exterior abrading surfaces, or between interior surfaces of a first pair of opposing sides, as proposed by Patent Owner. “[W]hile it is true that claims are to be interpreted in light of the specification . . . , it does not follow that limitations from the specification may be read into the claims. . . . [T]he claims define the invention.” Sjolund v. Musland, 847 F.2d 1573, 1581–82 (Fed. Cir. 1988).” slip op. at 18
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner
“A claim limitation is presumed to invoke 35 U.S.C. § 112(f) (or pre- AIA § 112 ¶ 6) if, as here, it explicitly uses the term “means” and includes functional language; this presumption is overcome if the limitation further includes the structure, material, or acts necessary to perform the recited function. See Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc). Here, the word “means” is recited, followed by functional language, and the claim recites no structure associated with the means or function. Moreover, the parties agree that this is a means plus function limitation. See Pet. 19–20; Resp. 9. We find “releasing means” is a means plus function limitation and, based on the plain language of the claim, the recited “releasing means” is a part of the also recited “slide hammer assembly,” as the above-quoted claim language defines. Ex. 1001, 13:10–17. Construing a claim term under 35 U.S.C. § 112(f) involves two steps: (1) identifying the claimed function; and then (2) determining what structure, if any, disclosed in the Specification corresponds to the claimed function. Williamson, 792 F.3d at 1351. In conducting this analysis, we may not incorporate structure from the written description beyond that which is necessary to perform the claimed function. See Micro Chemical, Inc. v. Great Plains Chemical Co., 194 F.3d 1250, 1258 (Fed. Cir. 1999).” slip op. at 20
Patent outcomesUS 11,020,129 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,020,129 - BTC Corporation v. TG Biotech Co., Ltd.No claims unpatentablePTAB · Nov 13, 2023 · IPR2022-00998 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–13 were not shown unpatentable under the asserted obviousness grounds; Patent Owner’s motion to strike Exhibit 1038 was granted.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We are not persuaded by Petitioner’s contention that we should disregard Dr. Naumovski’s testimony because she may have taken a leave of absence from work for a couple of years. The record supports that Dr. Naumovski not only meets the requirements of the person of ordinary skill in the art, but also appears to have relevant knowledge with respect to Gynostemma pentaphylum (“GP”) saponins. See Ex. 2015 (Appendix A). related field, and at least two years of experience using techniques for extraction and characterization of plant-based materials.” PO Resp. 11 (citing Ex. 2015 ¶ 74). Because there are more than 400 species of plants that contain saponins, Patent Owner disagrees that a person of ordinary skill in the art would be familiar with the structure and utility of saponins. Id. The level of skill in the art is a reference point for gauging what would have been obvious based on the reference disclosures. See Okajima, 261 F.3d at 1355. In other words, the lens of the level of ordinary skill in the art does not change a prior art’s disclosure, though it may change one’s understanding of what is disclosed. Patent Owner, however, does not explain how its definition provides a reference point that would meaningfully alter the Petition’s assertions of obviousness. For purposes of this decision, we analyze the asserted prior art with respect to the level of skill set forth by Petitioner, but there would be no difference in the outcome of this Decision if we were to apply the level of skill in the art set forth by Patent Owner. C.” slip op. at 13
- Expert testimonyPatent owner expert creditedDecided for patent owner
“during the full trial, we determine that Petitioner has not shown by a preponderance of the evidence that applying the methods of Kim 460 to the G. pentaphyllum starting material of Razmovski necessarily results in the damulin levels as claimed. We agree with Dr. Naumovski’s explanation that the use of an impure damulin B standard containing a double peak renders the results as shown in Exhibit 1013 unreliable. Ex. 2015 ¶¶ 141–143, 162–173; see Ex. 2007. Dr. Naumovski further explains that the use of an impure standard would require the application of a correction factor, but this correction factor would need to be reassessed as the purity of the standard decreases over time. See Ex. 2015 ¶ 166. As Dr. Naumovski explains that applying a correction factor to the linear regression would result in a shallower slope. Ex. 2015 ¶ 165 (citing 2006, 71:12–73:5; 99:2–9). “Reducing the calibration curve slope increases the amount of damulin B calculated from the experimental extracts.” Ex. 2015 ¶ 165. However, in the Experimental Report-1 the same correction factor for the damulin B standard was used to” slip op. at 41
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Petitioner requests construction of the terms “an effective amount for improving or treating the metabolic syndrome,” which is found in claims 11–13, as meaning “an amount that produces any measurable amount of improvement in the metabolic syndrome” (Pet. 13–15 (citing Ex. 1003 ¶ 91)) and “[a] pharmaceutical composition for improving and treating a metabolic syndrome, comprising at least one of at least 0.7% damulin A and at least 0.5% damulin B . . . and a pharmacologically acceptable carrier or excipient,” which is found in claim 8, as meaning “a pharmaceutical composition that includes an extract with 0.7% and 0.5% of damulin A and damulin B[, respectively,] along with a carrier or excipient” (id. at 15–16 (citing Ex. 1002, 64–65, 251–52, 280; Ex. 1001, 12:15–67, Table 2)). Patent Owner argues that “constructions are not necessary.” PO Resp. 11–12. We agree with Patent Owner and determine that it is not necessary for purposes of this Decision to construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Obviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re Droge, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903–04 (Fed.Cir.1988)); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016) (explaining that the expectation of success issue involves a showing of “a reasonable expectation of achieving what is claimed”) (emphasis added). Here, Petitioner relies on Kim 460 to show that heating ginseng, which contains the ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, results in a teaches that ginseng with the higher Rg3 and Rg5 content is 50-fold more potent in their vasodilation studies than the non-treated samples. Razmovski teaches that G. pentaphyllum contains over 100 saponins and eight of those saponins are the same as protoparaxadiol-type ginsenosides Rb1, Rc, Rb3, Rd, F2, Rg3, malonyl-Rb1, and malonyl-Rd that are found in P. ginseng. Ex. 1007, 4. Knowing that G. pentaphyllum also contains ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, we find Petitioner’s conclusion that heating a G. pentaphyllum extract that contains these ginsenosides would similarly increase the ginsenoside levels of Rg3 and Rg5 is a reasonable inference from the cited references. Based on the teachings in Kim 460, we agree with Petitioner that it would have been reasonable to expect that the same source material, although derived from a different plant, would behave similarly to heat treatment. See Pet. 24. Because G. pentaphyllum is a less expensive starting material, we also agree with Petitioner that there is sufficient motivation to substitute G. pentaphyllum for ginseng in the methods of Kim 460. slip op. at 29
Patent outcomesUS 8,357,786 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,357,786 - 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 - Transgene / Bioinvent International AB v. Replimune LimitedNo claims unpatentablePTAB · May 25, 2023 · PGR2022-00014 · APJ Christopher G Paulraj · PGR · Final written decision
The Board held claim 13 not unpatentable over Silvestre or Du, Choi, and Zitvogel, finding insufficient motivation to combine and reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“or “POSITA”) “would have had a Ph.D. in molecular biology, or a related field, with expertise in virology (including expertise growing, isolating, and rescuing viruses), immunology, and cancer biology with at least four years of post-Ph.D. experience in those areas.” Pet. 6 (citing Ex. 1007 ¶¶ 35, 96). Patent Owner does not argue otherwise. See PO Resp. 5. We adopt Petitioner’s uncontested definition as that definition is consistent with the level of skill in the art reflected by the 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” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“claim terms of the ’513 patent for purposes of determining whether to institute trial. For purposes of our analysis in this Final Written Decision, however, we find that it would be useful to clarify the scope of “oncolytic virus.” We agree with Petitioner that the Specification defines an “oncolytic virus” as “a virus that infects and replicates in tumor cells, such that tumor cells are killed.” Ex. 1001, 9:10–12. The Specification further clarifies that “the virus is replication competent,” and is preferably selectively replication competent in tumor tissue. Id. at 9:12–13. “A patentee is free to be his own lexicographer.” Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, consistent with its express definition in the Specification, to be a virus that infects and replicates in tumor cells, such that tumor cells are killed, wherein such a virus is replication competent.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“but contends that “oncolytic virus” should not be construed to encompass “viral vectors” such as those disclosed in Zitvogel. PO Resp. 5. Although Petitioner does not expressly contend otherwise, we agree with Patent Owner that “oncolytic virus” would not encompass Zitvogel’s “viral vectors,” which are defined in that reference to be “replication-defective” or “replication-impaired.” Ex. 1004, 19:26–29. We do not construe any other claim terms. See Vivid Techs., Inc. v.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Petitioner acknowledges that “while the bulk of Silvestre’s disclosure, including the working examples, is directed towards creating an oncolytic poxvirus, Silvestre discloses preparing modified oncolytic virus using other virus types, including HSV.” Pet. 44. It is undisputed, however, that Silvestre does not disclose a single embodiment of an oncolytic HSV that includes both a heterologous GM-CSF encoding gene and a heterologous CTLA-4 inhibitor encoding gene. Rather, Petitioner points to where each element could be found among broader lists of possible oncolytic virus classes, immune checkpoint targets, and therapeutic genes. Ex. 1002, 7:10– 15:49. As noted by Dr. Chiocca, if one were to randomly select any of the 11 We need not decide whether Silvestre anticipates independent claim 1, as the sole challenged claim 13 depends directly from claim 11. Thus, our determination that Petitioner has not shown that claim 11 is anticipated is sufficient to establish that Petitioner has not met its prerequisite burden for claim 13. Ex. 2009 ¶ 29. This type of picking and choosing is not anticipation. See Arkley, 455 F.2d at 587–88.” slip op. at 19
Patent outcomesUS 10,947,513 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,947,513 - 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 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · Dec 12, 2022 · IPR2021-00862 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–24 were not shown unpatentable because Petitioner failed to establish the proposed prior-art combinations and the required motivation to combine with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“The parties present compelling argument and evidence that one of ordinary skill in the art would include those with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 25; PO Resp. 9–10. The evidence of record also demonstrates that few individuals actually had such comprehensive experience. Rather, teams of individuals with different expertise and various academic degrees (Ph.D.s, B.S.s, and M.D.s) would work together to design laser surgery systems intended to make incisions in the lens of the eye. See, e.g., Ex. 1041 (several authors are M.D.s); Ex. 1042 (the authors’ degrees include Ph.D.s, an M.D., and a B.S.); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019. Thus, we find that the person of ordinary skill in the art would have been either an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as nuclear engineering, having experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., five years of experience for a Ph.D. or more to compensate for lesser degrees), and that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not assert that any claim term requires express construction. See Pet. 6 (stating that it “reserves the right to respond to any constructions that [Patent Owner] submits”). Patent Owner does not present any remarks regarding claim construction. See generally PO Resp. On this record, we determine that no claim terms require express construction because it is not essential to our conclusions on patentability. See Nidec Motor., 868 F.3d at 1017 (quoting 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.”)). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“summarized above, we find that the evidence of record does not support a conclusion that it would have been simple, straightforward, or otherwise routine to convert Swinger’s manual HeNe aiming system and Swinger’s surgeon-identification-of-target-tissue step to a computer-controlled, OCT-guided laser system. Even assuming that a person of ordinary skill in the art would have combined the teachings of Swinger and Baikoff to achieve a laser surgical system incorporating an OCT imaging system, that combination still would not have achieved the required “computer system” of the claims and all of its programmed surgical functionality, particularly, using a computer system to construct an anterior capsulotomy cutting region based on the image data. Petitioner relies on the ability of a person of ordinary skill in the art to configure Swinger’s computer control unit with the missing functionality, thus necessitating an electronic conversion of the steps performed using Swinger’s direct visualization method using a HeNe aiming beam to manually identify a surgical treatment region for laser surgery. Ex. 1039, 34:52–57; Ex. 2088 ¶¶ 55–59, 66. That conversion, however, involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and then implement the planned cataract surgery, two technological leaps that the record fails to show were known or suggested. In particular, the evidence of record does not support a conclusion that OCT was a well-known system used routinely, if at all, in the identification of treatment regions in the lens or lens capsule for cataract surgery, and further does not support a conclusion that a computer-controlled system to plan and to implement a planned cataract surgery in the lens was commonplace or even considered before the invention.” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundNot shown unpatentableNot shown unpatentable
“The evidence of record demonstrates, however, that modifying an existing corneal surgery system to image and perform surgery on the lens was not the simple task asserted by Petitioner. For example, in a patent application filed in November 2009, Petitioner asserted that due to the different depth ranges for the laser’s focus, “laser systems designed for corneal procedures do not offer solution[s] for the considerable challenges of performing surgery on the lens of the eye.” Ex. 2007, 4:65–67, 5:30–36, code (22). Similarly, in a different patent filed in December 2008, Petitioner outlined the various challenges in developing laser surgery systems for creating incisions in the lens, including the difficulty in focusing a laser beam that propagates through regions of the eye with different optical properties and different curvatures. Ex. 2014, 15:51–16:18, code (22). This patent then states: Because of all the described hard challenges, corneal surgical laser systems are qualitatively simpler than lens surgical lasers. This is well supported by the fact that even though corneal surgical systems were suggested about 40 years ago, none have been adapted successfully for lens surgery to date. Id. at 16:13–18. During prosecution of another patent filed in 2008, and in responses to office actions filed in 2012 and 2013, Petitioner argued that a corneal OCT system “simply will not work” on the lens and that it would not have been obvious to modify such an OCT system to image the lens. Ex. 2015, 898, 1591, 1788. This was because OCT systems designed to image the lens would be required to deliver and scan an imaging beam “to a depth ten times bigger and a depth range ten times bigger” than an OCT system designed to image the cornea. Id. at 1591. According to Petitioner, “it is not obvious” to modify an OCT imaging system to achieve a depth and scanning range that is ten times larger than that disclosed in the art. Id. at 898 (“Increasing a system’s performance by an order of magnitude cannot be regarded as obvious.”), 1590–1591. Petitioner’s arguments presented in its own patents and during their” slip op. at 39
Patent outcomesUS 8,709,001 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,709,001 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · Dec 12, 2022 · IPR2021-00858 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–19 were not shown unpatentable because Petitioner failed to establish that the asserted prior-art combinations would have been made with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level board ownOther
“The parties present compelling argument and evidence that one of ordinary skill in the art would include those with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 26; PO Resp. 8–9. The evidence of record also demonstrates that few individuals actually had such comprehensive experience. Rather, teams of individuals with different expertise and various academic degrees (Ph.D.s, B.S.s, and M.D.s) would work together to design laser surgery systems intended to make incisions in the lens of the eye. See, e.g., Ex. 1041 (several authors are M.D.s); Ex. 1042 (the authors’ degrees include Ph.D.s, an M.D., and a B.S.); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019. Thus, we find that the person of ordinary skill in the art would have been either an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as nuclear engineering, having experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., five years of experience for a Ph.D. or more to compensate for lesser degrees), and that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not assert that any claim term requires express construction. See Pet. 7 (stating that it “reserves the right to respond to any constructions that [Patent Owner] submits”). Patent Owner does not present any remarks regarding claim construction. See generally PO Resp. On this record, we determine that no claim terms require express construction because it is not essential to our conclusions on patentability. See Nidec Motor., 868 F.3d at 1017 (quoting 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.”)). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“Having considered the parties’ positions and evidence of record, summarized above, we find that the evidence of record does not support a conclusion that it would have been simple, straightforward, or otherwise routine to convert Swinger’s manual HeNe aiming system and Swinger’s surgeon-identification-of-target-tissue step to a computer-controlled, OCTguided laser system. Even assuming that a person of ordinary skill in the art would have combined the teachings of Swinger and Baikoff to achieve a laser surgical system incorporating an OCT imaging system, that combination still would not have achieved the required “control system” of the claims and all of its programmed surgical functionality. Petitioner relies on the ability of a person of ordinary skill in the art to configure Swinger’s computer control unit with the missing functionality, thus necessitating an electronic conversion of the steps performed by a surgeon using Swinger’s direct visualization method using a HeNe aiming beam to manually identify a surgical treatment region for laser surgery. Ex. 1039, 34:52–57; Ex. 2088 ¶¶ 55–59, 66. That conversion, however, involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and then implement the planned cataract surgery, two technological leaps that the record fails to show were known or suggested. In particular, the evidence of record does not support a conclusion that OCT was a well-known system used routinely, if at all, in the identification of treatment regions in the lens or lens capsule for cataract surgery, and further does not support a conclusion that a computer-controlled system to plan and to implement a planned cataract surgery in the lens was commonplace or even considered before the invention. We recognize that Petitioner directs us to the testimony of Dr. Izatt who opines that a person of ordinary skill in the art would have found it obvious to, for example, use a controller to determine the claimed scanning pattern. Ex. 1001 ¶ 159; Pet. 32–33; Reply 3–5; see also Ex. 1123 ¶ 31 (“Once the anterior capsule is identified, it is a relatively simple process to determine the location to place the capsulotomy.”). Here, however, we agree with Patent Owner that the Petition and supporting testimony fails to provide the requisite reasoned analysis with sufficient evidence to support Petitioner’s position on obviousness. In particular, absent some evidentiary support beyond Dr. Izatt’s and Dr. Tipperman’s bare opinions that it would have been obvious to program a controller to bridge the gap between the functionality disclosed in Swinger and the required functionality of the challenged claims, we are unwilling to accept this line of reasoning. PO Resp. 27; Sur-Reply 4–7; Ex. 1001 ¶ 159; see also DSS, 885 F.3d at 1374 (Fed. Cir. 2018) (A skilled artisan’s “common sense” or “common knowledge” can potentially “fill in a missing limitation only when ‘the limitation in question was unusually simple and the technology particularly straightforward.’” (emphasis omitted)).” slip op. at 25
- Strike new argumentNew argument disregardedDecided for patent owner
“Inter partes review must proceed in accordance with the Petition and the arguments set forth therein. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018). “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 ground for the challenge to each claim.’” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). Arguments made in a different document, such as an expert’s declaration, may not be incorporated-by-reference in the Petition. 37 C.F.R. § 42.6(a)(3); see also General Access Solutions, Ltd. v. Sprint Spectrum L.P., 811 F. App’x 654, 658 (Fed. Cir. 2020) (noting that the Board did not abuse its discretion in enforcing its rules under 37 C.F.R. § 42.6(a)(3)) (non-precedential)).” slip op. at 35
Patent outcomesUS 8,425,497 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,425,497 - 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 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · Dec 2, 2022 · IPR2021-00853 · APJ Ryan H Flax · IPR · Final written decision
Claims 1–3, 5, 6, 8, 12, and 13 were not proven unpatentable because the asserted combinations lacked a persuasive basis for achieving the claimed system with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“Petitioner’s proposed definition of the person of ordinary skill in the art appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’725 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as also including a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers, and that these people may collaborate. 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)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate here, based on our review of the record. Thus, we find that the person of ordinary skill in the art would have been someone with a PhD, MS, or BS degree in physics, biomedical engineering, or a related science such as nuclear engineering, having more or less experience in research, manufacturing, or designing medical optics or medical lasers (e.g., 5 years for a PhD or more to compensate for lesser degrees), or an ophthalmic surgeon, but that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties and is appropriate in view of the record.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Patent Owner does not ask that this claim language be expressly construed or contest Petitioner’s proposed interpretation. See Resp. 11–15. Although it is not necessary for our final decision in this proceeding to construe this claim language because it is not essential to our conclusions on patentability, as it is uncontested, we adopt as our own Petitioner’s proposed construction of “imaging device configured to acquire point by point image data from locations distributed throughout a volume of a crystalline lens.”” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Turning to the disputed term “automatically” in this context, we agree with Patent Owner that the plain meaning of the term “automatically” is that the “control system” can, on its own and without human intervention, perform the subsequently recited step. Resp. 11–15; see also Pet. 10 (Petitioner agreeing this is the plain meaning). This is supported by the Specification, which states, inter alia, that “the entire system is controlled by the controller CPU” and describes alternative embodiments where (1) the system is fully in control and where (2) user input identifies targets. Ex. 1027, 12:23–25, 13:25–44, Figs. 14, 15. However, we also agree with Petitioner that just because the claimed “control system” is configured/programmed to perform (i.e., capable of performing) some tasks “automatically” (i.e., entirely on its own), this does not mean user input (e.g., from a surgeon) must be altogether excluded. Pet. 10–11. In fact, user input must be possible and is within the scope of the independent claim. “By definition, an independent claim is broader than a claim that depends from it, so if a dependent claim reads on a particular embodiment of the claimed invention, the corresponding independent claim must cover that embodiment as well.” Littelfuse, Inc. v. Mersen USA EP Corp., 29 F.4th 1376, 1380 (Fed. Cir. 2022). Here claim 2, requiring automatic target identification, and claim 5, requiring user input on target identification, each depends from claim 1 and illuminates its scope, which must be broad enough to encompass both. Thus, although requiring (in claim 1) that a “control system” can perform certain recited functions, and that some are performed (according to claim 2) “automatically,” that same “control system” must also be capable of allowing a user input on the locations of targets for laser treatment (according to claim 5). Such optional user input required by dependent claim 5 is described in the Specification, which includes embodiments where a surgeon can adjust the size, location, and shape of the treatment pattern, can determine the optimal cutting contours in patients, and can provide “user input” to define targets or adjust computer-defined parameters as necessary. Ex. 1027, 10:55–45; 10:67–11:2, 13:25–55, 13:63–14:2. Regardless, the configuration of independent claim 1’s “control system,” which must be programmed to and capable of performing its own recited steps/functions, is not diminished by the requirements of either dependent claim. Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corporation, 831 F.3d 1350, 1360 (Fed. Cir. 2016) (“[T]he language of a dependent claim cannot change the scope of an independent claim whose meaning is clear on its face.”).” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“generally. “The presence or absence of a reasonable expectation of success is . . . a question of fact,” and this “requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., 821 F.3d at 1366–67. Based on the record, we conclude that, even if it would have been potentially advantageous to in some way incorporate the use of Baikoff’s and Li’s OCT imaging and measuring into Swinger’s system and method for cataract surgery (for example, to replace the use of ultrasound imaging with OCT), we agree with Patent Owner that, other than the (ultimately) conclusory testimony of its witness Dr. Izatt (see, e.g., Ex. 1001 ¶¶ 110, 144, 151, 161, 163–165, 168), there is no persuasive evidence that the person of ordinary skill in the art would have combined these references with the result being a control system configured to (automatically or not in practice) image cataractous eye tissue, identify the targets therein (capsule and lens) to be cut with a laser, and then operate that laser to actually make those cuts based in some part on that imaging. See Resp. 15–34. We credit Dr. Kang’s testimony that, as of the invention, the person of ordinary skill in the art would not have relieved the surgeon of responsibility for identifying cutting regions for laser capsulotomy and cataract surgery (as taught by Swinger), and relegated such task to a computer, which subsequently performs the procedure. Ex. 2087 ¶¶ 36–38, 42, 46, 62–66; see also Ex. 2088 ¶¶ 56–59, 68–71 (Dr. Walter testifying similarly). Dr. Kang takes issue with Petitioner’s positions that Baikoff and Li teach or suggest such reliance on a computer because, according to Dr. Kang, neither Baikoff nor Li (and indisputably not Swinger) teaches using a computer to identify laser cutting regions or to control laser surgery, and, in fact, they suggest reliance on a surgeon to interpret their OCT images to plan a subsequent surgery. See, e.g., Ex. 2087 ¶¶ 36–38, 42, 46, 62–66. We further credit Dr. Kang’s testimony that Petitioner fails to adequately explain, even were the ordinarily skilled artisan intent on combining Baikoff’s and Li’s OCT imaging systems with Swinger’s cataract surgery system, how it would have been accomplished to overcome the “substantial challenges” and achieve the claimed invention. See id. ¶¶ 63– 66; see also Resp. 27–28 (addressing Petitioner’s lack of explanation as to how to implement the combination).19 We agree that, beyond merely suggesting plugging one system into another, Petitioner does not explain how the person of ordinary skill in the art would have programmed Swinger’s computer control system to use Baikoff’s and Li’s OCT imaging systems and tissue recognition and measurement algorithms to determine capsulotomy cutting regions and then implement the planned cutting with a laser, even from a rudimentary perspective. See Pet. 35–40. Indeed, Petitioner concedes:” slip op. at 50
Patent outcomesUS 9,125,725 not shown unpatentableClaim construction§ 103 obviousnesscites Alice · Phillips · KSR · GrahamPatents in suitUS 9,125,725
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.