• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution denied
  PTAB · Jan 9, 2024 · IPR2023-01151 · APJ Timothy G Majors · IPR · Institution

  The Board denied institution on all asserted grounds because Petitioner did not show a reasonable likelihood that any challenged, undisclaimed claim was unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “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.” For reasons discussed below, we do not institute review of claims 2, 9, 17, and 18 of the ’834 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner proposes that the person of ordinary skill in the art (“POSA”) in November 2012 “would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. This [POSA] would, where necessary, work with a medical device engineer to experiment with or manufacture a prosthetic heart valve.” Pet. 21 (citing Ex. 1003 ¶ 49). Patent Owner does not expressly contest Petitioner’s proposed definition. For this Decision, we apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). This POSA level is also consistent with the level the Board applied in earlier decisions involving the same parties and related patents. See, e.g., Ex. 2124, 11; Ex. 1120, 11–12.” slip op. at 16

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “during prosecution. Pet. 18, 99. According to Petitioner, Spenser II never describes its compressible material as including “tightly knitted fibers” and a POSA would, instead, have understood Spenser II’s compressible material as comprising “loose, porous materials.” Pet. 18, 99. We agree with Petitioner that the phrases “tightly knitted” and “tightly knitted fibers” do not appear in Spenser II. At the same time, neither does Spenser II describe its compressible material as being “loose” and “porous.” Notably, in prior proceedings before the Board, Petitioner’s declarant Dr. Buller testified that Spenser II’s compressible material “includes a plurality of PET fibers on the inward-facing surface of the compressible material” (i.e., the “base layer” and alleged “second plurality” of fibers here; Paper 9, 5), that is “sufficiently dense to prevent blood from leaking through the cloth/fabric.” Ex. 2128 ¶ 222; see also Ex. 2122, 20:2–22:18 (testifying that “nonporous” as used in the Specification means “that fluid would not pass through it” and such fluid includes “all components of blood”). We find that Dr. Buller’s description of Spenser II as having a dense, blood impermeable base layer is, on balance, more consistent with applicant’s characterization of Spenser II as having an arrangement of “tightly-knitted fibers”—even if some imagined or microscopic spaces between fibers might still exist in a base layer. Ex. 2128 ¶ 222; see also Ex. 2002 (Brecker testimony) ¶¶ 42–45 (testifying, inter alia, that the description of a “tight fitted outer seal is . . . consistent with Spenser II’s Figure 22” and “knitted” is consistent with Buller’s testimony describing Spenser II’s compressible material as “velour-like woven or knitted” PET (citing Ex. 1003 ¶ 162; Ex. 2134 ¶ 56). We are, thus, unpersuaded on this record that applicant mischaracterized Spenser II.” slip op. at 38

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “Altogether, the parties’ alleged “plain meaning” yet otherwise undefined interpretation of the “spacing” limitations leaves the Board with insufficient clarity about what the claimed “spacing” means in the affirmative. Paper 9, 3 (arguing “plain meaning”); Paper 11, 3 (arguing applicant’s arguments are in “full harmony with the plain meaning”). The intrinsic evidence is minimally helpful: the Specification does not use the term “spacing” in relation to the positioning of adjacent fibers; the drawings might be helpful but neither party proposes a specific construction that is reliant on them.15 The prosecution history provides clues, but portions of the prosecution record are arguably confounding. The applicant distinguished 15 For example, Dr. Brecker, in support of Patent Owner’s argument, identifies several of the patent drawings and testifies that, “as is particularly clear in Figure 13 (but also present elsewhere), there are gaps and spaces between the fibers that extend to the frame” and then proceeds to testify that prior art, like Spenser II’s compressible material, “bears no resemblance” to the “exemplary” spacings identified in prosecution. See, e.g., Ex. 2002 ¶¶ 42–43. Dr. Brecker’s articulation of a “spacing” does not seem to add anything meaningful beyond the language of the claim as written. And, simply comparing the patent drawings to the prior art drawings presumes a sort of “know-it when you see it” interpretation—it is not an affirmative construction for a “spacing” as claimed. the claimed “spacings” from “tightly knitted fibers.” Ex. 1002, 1001. At what point, however, does a cloth of “tightly knitted fibers” qualify as more “loosely defined” and come within the scope of the claimed “spacing?”16 Id. The applicant also described the “spacing” in semi-functional terms based on “advantages” provided by the claim feature. See, e.g., id. (asserting, e.g., that the spacing permits “expansion and contraction” with “lesser rigidity”); see also id. at 1133, 1140 (asserting, e.g., “reduce[d] restrictions” and avoidance of “restrained valve foreshortening” with the then-claimed “openings”). It is not, however, evident where the Specification supports such “advantages”—no citations were given in prosecution. And, in prosecution of related applications, applicant argued, for example, that “[w]hile all fibers have some degree of being spaced-apart, the construction from Applicant’s claimed invention clearly requires some level more spacing.” Ex. 1149, 13–14 (assertion differences over “Dehdashtian” (alias to Spenser II)) (emphasis added). On this record, what would suffice as “some level more spacing” is unclear. Id.” slip op. at 39

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,337,834
• BTC Corporation v. TG Biotech Co., Ltd.No claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,357,786
• Ford Motor Company v. Safe Driving Technologies LLCSome claims unpatentable
  PTAB · Mar 10, 2023 · IPR2021-01446 · APJ Alyssa A Finamore · IPR · Final written decision

  Claims 1–4, 6, 10, 12–14, 16, 17, and 19–21 are unpatentable under §103; claim 15 was not shown unpatentable.

  RulingsFinal written decision

  • ExcludeMotion to exclude, grantedGranted

    “Our rules and Consolidated Trial Practice Guide are clear on this prohibition. And, the Consolidated Trial Practice Guide explains: “[w]here a party believes it has a basis to request relief on a ground not identified in the rules, the party should contact the Board and arrange for a conference call with the Board and opposing party to discuss the requested relief with the judge handling the proceeding.” CTPG 75. Thus, the Board identifies appropriate ways for a party to address matters that it considers to be beyond the specific procedures outlined in the rules. Merely submitting new evidence was not authorized by Board rules or guidance and Patent Owner did not seek authorization to file the new evidence. The facts warrant excluding Exhibits 2030–2032 and we grant the Motion. See CTPG 81.” slip op. at 83

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

    “underpinnings, why a person of ordinary skill would have been motivated to modify the prior art to achieve the claimed invention. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner . . . must . . . articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” (citing KSR, 550 U.S. at 418)). Nonetheless, “a disclosure that anticipates under § 102 also renders the claim invalid under § 103, for ‘anticipation is the epitome of obviousness.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (quoting In re Fracalossi, 681 F.2d 792 (CCPA 1982)); see also Application of Pearson, 494 F.2d 1399, 1402 (CCPA 1974) (“[T]his court has sanctioned the practice of nominally basing rejections on § 103 when, in fact, the actual ground of rejection is that the claims are anticipated by the prior art. The justification for this sanction is that a lack of novelty in the claimed subject matter, e.g., as evidenced by a complete disclosure of the invention in the prior art, is the ‘ultimate or epitome of obviousness.’” (citations and footnote omitted)).” slip op. at 14

  Patent outcomesUS 9,047,170 mixed
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,047,170
• Ford Motor Company v. Safe Driving Technologies LLCAll claims unpatentable
  PTAB · Feb 7, 2023 · IPR2021-01341 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–4 and 7–10 are unpatentable as obvious over Tan, Boies, Tan with Shuman and Behr, or Hardouin; Petitioner’s motion to exclude is granted.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “example, the types of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Petitioner asserts: An ordinary artisan would have been a person having, as of October 24, 2001, a Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Computer Engineering, or Computer Science, or an equivalent degree with at least two years of experience in electronic user interface systems and vehicle sensor systems or related technologies. Additional education may substitute for lesser work experience and vice-versa. (Ex.1003, ¶40.) Pet. 3 (citing Andrews Declaration). Patent Owner does not address the definition of the person of ordinary skill in the art, either to contest Petitioner’s proposal or to offer a different definition. See generally Resp. We adopt Petitioner’s unopposed 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 ’994 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We find Patent Owner’s reliance on the ’994 patent’s FIELD OF THE INVENTION Section misplaced. To quote it in its entirety, it states: The present invention relates to the field of telematics, namely to the field of integrating information, communication, computing and entertainment technologies into vehicles for civilian or military use. The invention particularly relates to safety control systems for vehicles to reduce driver distraction, avoiding potentially dangerous conditions tending to produce accidents. Ex. 1001, 1:21–27 (emphasis added). Thus, even were we to consider this portion of the Specification informative of the meaning of “telematic device,” it does not limit such to “a central multifunction device,” as argued by Patent Owner, but states that the field of telematics relates to integrating information, communication, computing, and entertainment technologies into vehicles, generally. Id. Nothing about this statement requires all these features to be integrated into a single device, unless the vehicle is considered the single device (which neither party suggests). See Reply 4 (discussing this section of the ’994 patent). Further, we find nothing in the ’994 patent supporting Patent Owner’s contention that the claim term “telematic device” should be restricted to a central multifunction device that integrates together the features of information, communication, computing, and entertainment technologies. The ’994 patent never states this. See Ex. 1001. Moreover, we find the ’994 patent to be much more inclusive than exclusive when describing what a telematic device can be, i.e., the scope of the term. Upon reviewing the written description of the ’994 patent, we find it makes the following statements (all emphasis added):” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “We agree with Petitioner that the disputed claim language is, indeed, somewhat confusing. It appears to us from reading the language of claim 2 as a whole that Patent Owner understood that the phrase “include at least one of” could have been used rather than the language “including at least” because Patent Owner used these different phrases at different portions of claim 2. Compare Ex. 1001, 23:2, with id. at 23:14–15. Had Patent Owner intended that the disputed claim language require only one of the listed devices, it appears that Patent Owner understood how to claim that. Further, the full disputed phrase of claim 2 recites a “communication device including at least a pager, a telephone, a global location sensor, a temporal sensor, an optical sensor, a heading sensor, a bearing sensor, and an altitude sensor.” Id. at 23:14–17. However, adding to the ambiguity of the claim, this list of communication device components is tacked onto the end of a clause listing software applications (e.g., a telephone application and a wireless communication application), not devices. And, moreover, the term “communication device” is not preceded by an associated “a” or “the,” and there is no other “communication device” recited earlier in claim 2 (or claim 1 from which it depends), which further adds to the claim’s ambiguity. Patent Owner asserts that “at least” means “at least one” and Petitioner, at least in an alternative argument, appears to potentially agree and presented a case for unpatentability based on such an interpretation. See Pet. 9 (compare Grounds 1 and 2 with Ground 3). Furthermore, following Patent Owner’s stated position on this claim language in its Response (at page 19), Petitioner does not argue the matter in its Reply, other than stating at one point (not at the claim construction section) that “at least” means “all.” See Reply 1–7; but see id. at 14 (stating that the plain language of claim 2 requires all of the devices). Thus, we could adopt Patent Owner’s interpretation of claim 2’s” slip op. at 24

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

    “Petitioner asserts that it would have been obvious to the ordinarily skilled artisan to combine Shuman with Tan because Shuman’s teachings on its GPS would illuminate the capabilities of and data provided by Tan’s GPS; these are the same or similar devices and may have the same or similar capabilities. Id. at 63 (citing Ex. 1003 ¶ 261). Petitioner asserts that it would have been obvious to the ordinarily skilled artisan to also combine Behr with Tan because Behr’s disclosure of monitoring the time of day to ensure its GPS provides relevant, safe, and legal instructions would also similarly support Tan’s GPS functioning, and also because there would have been a benefit to including Behr’s pager’s functionality in Tan’s system because such was a relevant communication technology. Id. at 64–65 (citing Ex. 1003 ¶¶ 263, 265). We agree with Petitioner’s assertions and reasoning regarding combining these prior art references with a reasonable expectation of success, and Patent Owner does not argue otherwise. See generally Resp.” slip op. at 50

  Patent outcomesUS 9,713,994 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,713,994
• Allstate Insurance Company v. Atos, LLCSome claims unpatentable
  PTAB · Jan 24, 2023 · IPR2021-01209 · APJ Richard H Marschall · IPR · Final written decision

  Claims 1–4, 6, and 9–25 are unpatentable; claims 5, 7, and 8 are not shown unpatentable, based on anticipation by Kim and obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art The level of ordinary skill in the art is “a prism or lens” through which” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “C. Claim Construction In inter partes reviews, we interpret claims under the same standard” slip op. at 10

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “Accordingly, Petitioner fails to establish that Kim discloses “determining that the individual is a driver of the vehicle based at least in part on acceleration, forces, velocity, the at least one location point, and time.”” slip op. at 46

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “nexus and therefore fails to establish that any alleged evidence of objective indicia supports a finding of non-obviousness. Accordingly, we give Patent Owner’s reliance on objective indicia of non-obviousness no weight in our obviousness analysis.” slip op. at 65

  Patent outcomesUS 9,152,609 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,152,609
• Allstate Insurance Company v. Atos, LLCSome claims unpatentable
  PTAB · Jan 9, 2023 · IPR2021-01118 · APJ Richard H Marschall · IPR · Final written decision

  Claims 1–5, 7, 8, 10–16, and 18 are unpatentable; claims 6, 9, and 17 were not shown unpatentable, because the asserted prior art did not establish all limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art The level of skill in the art is “a prism or lens” through which we view” slip op. at 9

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “2. Discussion Petitioner argues that Kim discloses every limitation of claim 1, and” slip op. at 23

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “2. Discussion We begin our analysis by addressing Patent Owner’s asserted objective indicia of non-obviousness, and then turn to the merits of Petitioner’s specific obviousness challenges before us.” slip op. at 52

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMotivation not foundMixed

    “the combination of Kim and Baker discloses “comparing the at least one current geographic location to the first geographic location; setting the location of the individual to the individual is in an outside of the vehicle location, when a distance between the at least one current and the first geographic locations exceeds a predetermined threshold.” Accordingly, we determine that Petitioner has not established by a preponderance of the evidence that claim 6 would have been obvious based on Kim and Baker.” slip op. at 90

  Patent outcomesUS 8,527,140 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,527,140
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,709,001
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCSome claims unpatentable
  PTAB · Dec 6, 2022 · IPR2021-00856 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–15 are unpatentable over the asserted §103 grounds; claims 17–23 were not shown unpatentable.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “persuasive and credit Dr. Kang’s testimony that Freedman’s ablating laser is incompatible with laser surgery on the lens or lens capsule during cataract surgery. Ex. 2087 ¶¶ 49–51, 79–82. This is because the ablating laser cannot pass through the cornea to reach the lens without destroying the cornea in the process. Id. ¶¶ 79, 82. In contrast, lasers used to cut internal tissues of the eye use laser photodisruption. Id. ¶ 80. Accordingly, we find that one of ordinary skill in the art would not have used Freedman’s system to perform surgery on the lens or lens capsule, as asserted by Petitioner.” slip op. at 76

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “exhibit provides no context or rationale for the award and, as discussed above, the Catalys product is composed of many components and systems not specifically covered by the challenged claims. Ex. 2043, 3. Patent Owner points also to a report dated June 28, 2012, as evidencing that this award was for the specific features of the Catalys product claimed, but this evidence lacks any identification of the author and the portion identifying features of the product appears to merely be listing features thereof rather identifying than any reason for the award. Ex. 2040. Additionally, the evidence of praise cited by Patent Owner is not specific to the subject matter of claim 1 (and its dependent claims) of the ’724 patent, but general praise for the FLACS system and laser-guided femtosecond laser procedures. See Ex. 2035; Ex. 2037; Ex. 2044; Ex. 2051. For these reasons, we are not persuaded by Patent Owner’s arguments or evidence on industry praise.” slip op. at 51

  Patent outcomesUS 8,500,724 mixed
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,500,724
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Cardiovalve Ltd.No claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 10,702,385
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousnesscites Alice · Phillips · KSR · Graham
  Patents 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.