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  • PTAB · Mar 7, 2023 · IPR2021-01532 · APJ Cynthia M Hardman · IPR · Final written decision

    The Board found claims 1, 2, 4, 10, 11, and 26 not unpatentable because Petitioner failed to show motivation to combine the cited references; it denied Patent Owner’s motion to exclude.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

      “Despite a lack of teaching in Lazarus to use telescoping functionality with the circumferential support structures, Petitioner asserts that a person of ordinary skill in the art would have modified Quiachon’s continuous wire frame to impart telescoping functionality to the struts, to “further improve the known attachment system in Quiachon to yield the predictable results of having a compressible and expandable device that could hold an endovascular graft open at the site of an aneurysm.” Pet. 40; see also Ex. 1003 (Chaikof Decl.) ¶¶ 146–47, 150. We are not persuaded. Like Lazarus’s circumferential support structures, Quiachon’s wire frame expands circumferentially. Compare, e.g., Ex. 1006 (Lazarus), 11:14–20 (describing circumferential support structures that expand to attach the graft to the vessel wall), with Ex. 1004 (Quiachon), 15:3–39 (describing self-expanding attachment system that provides a fluid tight seal between the graft and vessel wall). Thus, even if a person of ordinary skill in the art would have been motivated to incorporate Lazarus’s longitudinal support structures into Quiachon’s attachment system to “achieve the flexibility and adjustability disclosed in Lazarus” as Petitioner asserts (Pet. 41), we find that the specific combination Petitioner proposes to reach the claimed subject matter is not supported by the record. More specifically, we agree with Patent Owner and credit Dr. Berry’s testimony that “there is no motivation that [a] person of ordinary skill in the art would have used telescoping members of longitudinal support structures for an attachment system that expands radially or circumferentially” to hold an endovascular graft open or achieve stent compression and expansion. Ex. 2083 (Berry Decl.) ¶¶ 116, 118; see also PO Resp. 42–43. Petitioner does not point us to anything in Lazarus or Quiachon that teaches or suggests operatively connecting the telescoping longitudinal support structures to form “a perimeter of variable length” or a “closed loop” as claimed. See, e.g., Sur-reply 5, 7 (asserting that “none of the references suggests telescoping arms configured” as “a perimeter of variable length or a closed loop”); Ex. 2084 (Chaikof Tr.), 174:20–22 (agreeing that Lazarus’s longitudinal support structures are not in a ring shape); Ex. 2124 (Chaikof Second Tr.), 76:13–77:23 (same), 78:17–79:2 (agreeing that Lazarus does not teach connecting the longitudinal support structures in an M shape). Petitioner does not adequately explain why a person of ordinary skill in the art would have incorporated telescoping functionality into Quiachon’s wire frame, given the lack of any teaching or suggestion in Lazarus or Quiachon to use telescoping functionality in circumferentially-expanding devices like Quiachon’s wire frame.” slip op. at 27

    • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

      “(2) Analysis “[A] party seeking to invoke collateral estoppel must show: ‘(1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom collateral estoppel is being asserted] had a full and fair opportunity to litigate the issue in the first action.’” Google LLC v. Hammond Dev. Int’l, Inc., 54 F.4th 1377, 1381 (Fed. Cir. 2022) (quoting In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994)). We agree with Patent Owner that Petitioner’s collateral estoppel argument fails at least because the same issues were not “actually litigated.” PO Resp. 65–66. The prosecution of the ’331 application is an ex parte proceeding, not an adversarial proceeding such as a district court litigation or inter partes review. Patent Owner demonstrates that “[d]eterminations made during a prior ex parte prosecution do not arise from adversarial litigation.” Id. at 66. Rather, “there is a general consensus among courts that . . . [a] patent prosecution is not an adversarial, litigation-type proceeding, but a wholly ex parte proceeding before the PTO because although the process involves preparation and defense of legal claims in a” slip op. at 41

    • ExcludeMotion to exclude, deniedDenied

      “Patent Owner, as the moving party, bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. §§ 42.20(c), 42.62(a). We determine that Patent Owner has not met its burden. Dr. Berry testified about Exhibits 1067 and 1071 at his deposition. See Ex. 1066 (Berry Tr.), 53:1–75:3, 234:13–242:2. Thus, even if the exhibits are not discussed in a brief or in a declaration, we find that they give context to the deposition testimony of record. The Board is well-positioned to determine and assign appropriate weight to the presented evidence, including based on the depth of discussion of the evidence in the record. See, e.g., Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“[T]he Board, sitting as a non-jury tribunal, is well-positioned to determine and assign appropriate weight to the evidence presented in this trial.”). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). In view of the above, we are unpersuaded that the probative value of Exhibits 1067 and 1071 is substantially outweighed by potential prejudice or confusion of issues. Rather than excluding these exhibits, we simply give them appropriate weight in our analysis.” slip op. at 46

    • Skill levelSkill level petitioner adoptedOther

      “For purposes of this proceeding, Patent Owner applies Petitioner’s proposed definition of the skilled artisan. PO Resp. 12. We adopt Petitioner’s proposed level of ordinary skill in the art because it is unopposed and is consistent with the cited prior art and the disclosure of the ’393 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11

    Patent outcomesUS 7,101,393 not shown unpatentable
    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,101,393
  • PTAB · Feb 6, 2023 · PGR2021-00103 · APJ Patrick R Scanlon · PGR · Final written decision

    Claims 1–28 were not shown unpatentable on any asserted ground; the Board found the prior art failed to establish key limitations and rejected the enablement and indefiniteness challenges.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In reply, Petitioner argues that the ’764 patent’s control system is not complex as there are no detailed algorithms, logic, or software. Pet. Reply 4. Instead, the control system merely raises or lowers power of the pumps in accordance with the demand HHP of the job design. Id. (citing Ex. 1036, 97:15–98:18, 98:21–99:25, 100:1–101:25, 102:2–7, 115:4–9, 115:24–116:4, 116:17–22; Ex. 1001, 5:2–6, 6:36–7:7, 10:4–64). According to Petitioner, this “rudimentary control concept” does not necessitate the higher skill level proposed by Patent Owner. Id. Petitioner further notes that Dr. Adnan testifies that “a mechanical engineer who has worked in the industry developing programming and control systems could fall within this definition,” and the person of ordinary skill in the art “is ‘just a specifier.’” Id. (quoting Ex. 2003 ¶ 22; Ex. 1036, 161:21–164:18). Based on our review of the record before us, particularly the ’764 patent’s description and Dr. Adnan’s testimony, we agree with Petitioner that the ordinary level of skill in the art does not require the high level of specialized knowledge of control systems suggested by Patent Owner. Moreover, we find that Petitioner’s stated level of ordinary skill in the art is reasonable because it is consistent with the evidence of record, including the asserted prior art. Accordingly, for the purposes of this Decision, we apply Petitioner’s definition, although our conclusions with respect to obviousness would be the same if we were to apply Patent Owner’s definition.” slip op. at 9

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Based on the full record, we are not persuaded that Mr. Marscher is unqualified to serve as an expert in this proceeding. As noted above, a person of ordinary skill in the art is not required to have been a fracturing operator. Patent Owner’s proposed definition does not even require experience as a fracturing operator. See PO Resp. 20–21. Furthermore, Mr. Marscher testifies that he has extensive experience developing pumps for fracturing applications. Ex. 2027, 6:24–8:7. Mr. Marscher also testifies that he has experience with control systems relating to pumps and pumps units. Id. at 212:19–23. This testimony, as well as his declaration and curriculum vitae, show that Mr. Marscher has extensive education and experience in relevant fields. Ex. 1003 ¶¶ 8–17; Ex. 1004. Accordingly, we are not persuaded that Mr. Marscher’s qualifications or experience provide reason to discount the weight associated with Mr. Marscher’s testimony.” slip op. at 10

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

      “In its Reply, Petitioner argues that the maximum power output value is the pump unit’s highest HHP output and one of ordinary skill in the art would have understood this value is the pump unit’s output power in intermittent duty. Pet. Reply 2–3 (citing Ex. 1003 ¶¶ 71–72, 123–124; Pet. 9–10; Ex. 1036, 64:17–67:13, 119:17–120:11, 124:7–24, 198:9–200:9, 221:8–222:15). However, even if Petitioner is correct that the “maximum power output value” is near or equivalent to a pump unit’s output power in intermittent duty, we are still not persuaded that the term “maximum intermittent power” should be tied to the “maximum power output value,” in conflict with the definition provided in the Specification. Petitioner also argues that Patent Owner’s proposed construction is indefinite. Pet. Reply 3. For the reasons discussed below (see supra § II.I.1), we determine that Petitioner has not shown by a preponderance of the evidence that the term “maximum intermittent power,” as defined in the Specification, is indefinite. Thus, based on the complete record before us, we maintain our prior construction of “maximum intermittent power” for this Final Written Decision.” slip op. at 13

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “3. Additional Terms We determine that we need not expressly construe any other claim terms to resolve the parties’ disputes because doing so would have no effect on the analysis below. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 13

    Patent outcomesUS 10,815,764 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,815,764
  • 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
  • PTAB · 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 unpatentable
    Claim construction§ 103 obviousness
    Patents in suitUS 8,425,497
  • 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
  • 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
  • PTAB · Dec 2, 2022 · IPR2022-00361 · APJ Brent M Dougal · IPR · Final written decision

    The Board held claims 1–14 not shown unpatentable because Mann was not established as analogous art and the asserted obviousness grounds all relied on Mann.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(‘PHOSITA’) at the time of the ’924 Patent would have had at least a bachelor’s degree in electrical engineering or equivalent with at least one year of experience in the field of human computer interaction” and that “[a]dditional education or experience might substitute for the above requirements.” Pet. 5 (citing Ex. 1003 ¶¶ 29–31). Patent Owner does not dispute Petitioner’s level of ordinary skill in the art. PO Resp. 7. We are persuaded, on the present record, that Petitioner’s declarant’s statement is consistent with the problems and solutions in the ’924 patent and prior art of record. We adopt this definition for the purposes of this Decision.” slip op. at 7

    • Obviousness (§103) › Analogous artNon analogous artNot shown unpatentable

      “A reference qualifies as prior art for an obviousness determination only when it is analogous to the claimed invention. See In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011). The Federal Circuit has laid out two separate tests to determine whether a reference is analogous art to the claimed invention, i.e., whether one of ordinary skill in the art would even look to the 2004). They are: “(1) whether the art is from the same field of [the inventor’s] endeavor” and “(2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id.; see also In re Klein, 647 F.3d at 1348. Petitioner only addresses the first test (“field of endeavor”) and has thus waived any arguments related to the second test (“reasonably pertinent to the particular problem”).” slip op. at 10

    • BurdenNot shown unpatentable

      “For all of these reasons, Petitioner has not established by a preponderance of the evidence that Mann is analogous art to the ’924 patent. Nor has Petitioner established that Mann is a proper reference for use in an obviousness challenge. d) Conclusion for Claims 1–6, 11, 14 As Petitioner has not established that Mann is a proper reference for use in an obviousness challenge, Petitioner has not established by a preponderance of the evidence that claims 1–6, 11, and 14 are obvious over the combination of Mann and Numazaki.” slip op. at 16

    Patent outcomesUS 8,194,924 not shown unpatentable
    § 103 obviousness
    Patents in suitUS 8,194,924
  • PTAB · Dec 2, 2022 · IPR2022-00093 · APJ Brent M Dougal · IPR · Final written decision

    Claims 1–14 were not shown unpatentable because Mann was not established as analogous art and thus was not a proper reference for the asserted obviousness combinations.

    RulingsFinal written decision
    • Obviousness (§103) › Analogous artNon analogous artNot shown unpatentableNot shown unpatentable

      “A reference qualifies as prior art for an obviousness determination only when it is analogous to the claimed invention. See In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011). The Federal Circuit has laid out two separate tests to determine whether a reference is analogous art to the claimed invention, i.e., whether one of ordinary skill in the art would even look to the 2004). They are: “(1) whether the art is from the same field of [the inventor’s] endeavor” and “(2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id.; see also In re Klein, 647 F.3d at 1348. Petitioner only addresses the first test (“field of endeavor”) and has thus waived any arguments related to the second test (“reasonably pertinent to the particular problem”).” slip op. at 10

    • BurdenNot shown unpatentable

      “For all of these reasons, Petitioner has not established by a preponderance of the evidence that Mann is analogous art to the ’924 patent. Nor has Petitioner established that Mann is a proper reference for use in an obviousness challenge. d) Conclusion for Claims 1–6, 11, 14 As Petitioner has not established that Mann is a proper reference for use in an obviousness challenge, Petitioner has not established by a preponderance of the evidence that claims 1–6, 11, and 14 are obvious over the combination of Mann and Numazaki.” slip op. at 16

    Patent outcomesUS 8,194,924 not shown unpatentable
    § 103 obviousness
    Patents in suitUS 8,194,924
  • PTAB · Dec 2, 2022 · IPR2021-00923 · APJ Brent M Dougal · IPR · Final written decision

    Claims 1–14 were not shown unpatentable because Mann was not established as analogous art and a proper reference for the obviousness challenges.

    RulingsFinal written decision
    • Obviousness (§103) › Analogous artNon analogous artNot shown unpatentableNot shown unpatentable

      “A reference qualifies as prior art for an obviousness determination only when it is analogous to the claimed invention. See In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011). The Federal Circuit has laid out two separate tests to determine whether a reference is analogous art to the claimed invention, i.e., whether one of ordinary skill in the art would even look to the 2004). They are: “(1) whether the art is from the same field of [the inventor’s] endeavor” and “(2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id.; see also In re Klein, 647 F.3d at 1348.” slip op. at 10

    Patent outcomesUS 8,194,924 not shown unpatentable
    § 103 obviousness
    Patents in suitUS 8,194,924
  • PTAB · Nov 14, 2022 · IPR2021-00841 · APJ Ryan H Flax · IPR · Final written decision

    Claims 1–15 were not shown unpatentable because the asserted combinations failed to establish obviousness, including 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 ’648 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. B.” slip op. at 17

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “Petitioner asserts that, although dependent claim 12 is indefinite, its language, “to determine one or more axial locations of the anterior capsule of the lens; and or more anterior capsule axial locations,” (emphasis added) should be construed to mean “to determine one or more axial locations of the anterior capsule of the lens (i.e., one or more anterior capsule axial locations).” Pet. 7–8; see also Ex. 1030, 18:46–50 (claim 12). Petitioner’s position is that, as it reads in the ’648 patent, claim 12’s language is “a nonsense phrase,” rendering it indefinite, but that for the purposes of this proceeding it may be understood by the definition set forth above. Pet. 7–8.” slip op. at 19

    • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

      “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 ¶¶ 132, 135, 145, 149, 152–159, 459– 462), 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) image cataractous eye tissue, identify the regions thereof (capsule and lens) to be cut with a laser, and then operate that laser to actually make those cuts based is some part on that imaging. See Resp. 17–28. 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 ¶¶ 61–65. 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. Id.” slip op. at 45

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

      “We find Petitioner’s case unpersuasive based on Patent Owner’s arguments and the evidence of record. We find that the evidence of record does not support that Swinger, Baikoff, and Li would have been combined by the person of ordinary skill in the art to achieve the claimed invention with a reasonable expectation of success. Specifically, we find that the claimed elements of the invention directed to a control system configured to (1) operate an imaging device to generate image data of a patient’s lens, (2) process that image data to determine an anterior capsule incision scanning pattern, and (3) operate a laser to scan in the scanning pattern and perform an anterior capsule incision as determined in part by the control system based on the image data, are not taught by the cited prior art and would not have been obvious. Ex. 1030, 17:30–51 (claim 1). We address Patent Owner’s respective arguments and our analysis below. “The presence or absence of a reasonable expectation of success is . . . a question of fact.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1366 (Fed. Cir. 2016). “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Id. at 1367. The evidence of record suggests that the ordinarily skilled artisan would not have had a reasonable expectation of success in achieving the claimed invention based on Swinger’s, Baikoff’s, and Li’s teachings. Further, as our reviewing court has explained, “references to ‘common sense’—” or an ordinarily skilled artisan’s ordinary creativity, “whether to supply a motivation to combine or a missing limitation—cannot be used as a wholesale substitute for reasoned analysis and evidentiary support, especially when dealing with a limitation missing from the prior art references specified.” DSS Tech. Mgm’t, Inc. v. Apple Inc., 855 F.3d 1367, 1374 (Fed. Cir. 2018) (quoting Perfect Web Techs. Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1326 (Fed. Cir. 2009)). Although here Petitioner has not wholly omitted any reasoned analysis or evidence regarding the claimed computer control system programmed to automatically plan a cutting region based on image data and then perform that planned laser-cutting of the lens capsule (and, for some claims, also the lens), this subject matter is not disclosed in any cited art and we find Petitioner’s evidence and reasoning as to why it would have been obvious without such disclosure to be largely conclusory and unpersuasive.” slip op. at 40

    Patent outcomesUS 9,474,648 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,474,648

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.