• 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
• 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
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  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
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00298 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the other instituted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Rather, as the Federal Circuit reiterated, “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we consider whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)).” slip op. at 17

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

    “or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble.” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “arguments and the evidence, we find that the Specification expressly defines the terms “initial dose,” “secondary doses,” and “tertiary doses.” The Specification states, refer to the temporal sequence of administration of the VEGF antagonist. Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”); the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. Ex. 1001, 3:31–38 (emphasis added). Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist,” and that “the ‘tertiary doses’ are the doses which are administered after the secondary doses.” Ex. 1001, 3:31–38 (emphasis added). Patent Owner has not directed us to any portion of the Specification or other persuasive evidence that supports adding an efficacy requirement to that definition.” slip op. at 24

  Patent outcomesUS 9,254,338 unpatentable
  Claim construction§ 102 anticipationcites Phillips · Graham
  Patents in suitUS 9,254,338
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00258 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Rather, as the Federal Circuit reiterated, “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we consider whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)). Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” See Claims 1 and 14, Ex. 1001, 23:2–3; 24:3–4. The angiogenic eye disorders in patients. See, e.g., id. at 1:18–20, 63–66, 2:23– 27; 3:19–20; 5:11–13. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. As the Federal Circuit explained in Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339 (Fed. Cir. 2003), “preamble language will limit the claim if it recites not merely a context in which the invention may be used, but the essence of the invention without which performance of the recited steps is nothing but an academic exercise,” and that this principle frequently holds true for method claims. Id. at 1345 (citing Griffin v. Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002)). We find that such is the case here. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, in view of Federal Circuit case law regarding statements of intended purpose in claims directed to method of using compositions, and in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.”” slip op. at 17

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

    “We begin by noting that the claims do not recite any dosage amounts or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble. regarding the “Amount of VEGF Antagonist Administered.” See Ex. 1001, 6:29–7:14. In that discussion, the Specification explains, The amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount. As used herein, the phrase “therapeutically effective amount” means a dose of VEGF antagonist that results in a detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of VEGF antagonist that inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder. Id. at 6:48–55 (emphasis added). That description, along with the absence of the phrase “therapeutically effective” in the claims,11 signals for us the inventors’ intention to not limit the claims to the administration of doses that ultimately prove to be therapeutically effective in a given patient. Instead, the Specification describes administration of VEGF antagonist doses for treating angiogenic eye disorder in a manner that encompasses doses that result in disclosed improvements and benefits, referred to as “therapeutically effective amounts,” and doses that do not. Indeed, as guidance, the Specification discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” without any guarantee that any particular dosage regimen administered within that range of dosage amounts will necessarily be “therapeutically effective,” and without limiting the treatment methods based upon such results. Ex. 1001, 6:55–58 (emphasis added).” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “arguments and the evidence, we find that the Specification expressly defines the terms “initial dose,” “secondary doses,” and “tertiary doses.” The Specification states, refer to the temporal sequence of administration of the VEGF antagonist. Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”); the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. Ex. 1001, 3:31–38 (emphasis added). Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist,” and that “the ‘tertiary doses’ are the doses which are administered after the secondary doses.” Ex. 1001, 3:31–38 (emphasis added). Patent Owner has not directed us to any portion of the Specification or other persuasive evidence that supports adding an efficacy requirement to that definition.” slip op. at 24

  Patent outcomesUS 9,254,338 unpatentable
  Claim construction§ 102 anticipationcites Phillips · Graham
  Patents in suitUS 9,254,338
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00257 · APJ John G New · IPR · Final written decision

  Claims 1 and 8–12 are unpatentable: Dixon anticipates claims 1 and 9–12 and claim 8, and the Board also finds the claims obvious over Dixon.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “On February 9, 2022, we instituted an inter partes review in IPR2022- 00257 and granted the motion for joinder with IPR2021-00880, adding Celltrion, Inc. as a petitioner in the instant proceeding. Paper 35. On the same date, we also instituted an inter partes in IPR2022-00301 and likewise granted the motion for joinder with IPR2021-00880, adding Apotex, Inc. as a petitioner in the instant proceeding. Paper 36. We refer to Mylan Pharmaceuticals, Inc., Celltrion, Inc. and Apotex, Inc., collectively, as “Petitioner.”” slip op. at 3

  • ExcludeMotion to exclude, deniedDenied

    “We are not persuaded by Petitioner’s argument that the challenged Exhibits are not authenticated. Federal Rule of Evidence 901 sets a relatively low bar for authentication. See Comcast, 2020 WL 4687062, at *28. Rule 901(a) states: “To satisfy the requirement of authenticating or identifying an item of evidence, the proponent must produce evidence sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a). By way of example, Rule 901(b)(1) states that a witness with knowledge can provide authenticating testimony that an item is what it is claimed to be. Fed. R. 901(b)(1).” slip op. at 15

  • Strike new argumentNew argument consideredDenied

    “We deny the motion to exclude the referenced argument in Petitioners’ Reply, as well as the invitation to consider the motion as one to strike the argument. As Patent Owner notes in the motion, Patent Owner raised this issue previously in this proceeding. PO Mot. Exclude 5. At that time, we denied Patent Owner’s request for authorization to file a motion to strike the referenced argument in the Reply. It is improper for Patent Owner to now seek to strike the argument in a motion to exclude. A motion to exclude is not the proper vehicle to address arguments or evidence that a party believes exceeds the proper scope of a reply. See USPTO, Consolidated Trial Practice Guide (2019) at 79, available at: https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL= (last visited October 27, 2022) (“CTPG”). Moreover, as Petitioners correctly assert, Patent Owner has failed to satisfy the prerequisite for filing a motion to exclude by failing to timely file an objection. See 37 C.F.R. 42.64(b)(1); CTPG 78–79. Patent Owner has not been left without an opportunity to address the Reply argument. When we denied authorization to file a motion to strike, we authorized Patent Owner to file, with its Sur-Reply, a table identifying any portion of the Reply that Patent Owner considers to have exceeded the scope of the Reply. Further, we explained that Patent Owner, alternatively, may address that contention, or the merits of any newly-raised arguments or evidence in its Sur-Reply. Indeed, Patent Owner addressed the issue in its 26 Sur-Reply for our consideration. Thus, Patent Owner had sufficient opportunity to identify in its Sur-Reply its contentions regarding Petitioners’ allegedly inappropriate Reply argument and took advantage of that opportunity. That is sufficient for us to consider the issue and determine whether such argument should be disregarded. See CTPG 80.” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find that Petitioner’s definition is the better definition for purposes of this proceeding. We acknowledge that the claims of the ’069 patent are directed to a “method for treating an angiogenic eye disorder in a patient” 29 and that the actual practice of the method would therefore seem to be limited to those who have the ability to treat patients, i.e., physicians, etc. However, we find Patent Owner’s definition to be unduly limiting. Individuals who are involved in drug development or sub-clinical level testing of drugs for treating eye disorders may be extremely knowledgeable about the development of the treatment of eye disorders and drug development, and able to comprehend and evaluate the teachings of the prior art. See, e.g., Pet. 25. Such individuals might not possess an M.D. degree, but instead possess a Ph.D. in a “biotechnological, or pharmaceutical field,” or a lesser degree with a corresponding increased depth of experience, as suggested by Petitioner. We agree that such individuals should be considered persons of ordinary skill in the art. We also find that Petitioner’s definition is commensurate with the level of skill reflected in the prior art. See, e.g., Exs. 1006, 1010, 1030, 1033; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We consequently adopt Petitioner’s definition of a person of ordinary skill in the art has having an M.D. or Ph.D. or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field, and having practical academic or medical experience in developing treatments 30 for angiogenic eye disorders or treating angiogenic eye disorders including through the use of VEGF antagonists.” slip op. at 29

  Patent outcomesUS 9,669,069 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,669,069
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2021-00880 · APJ John G New · IPR · Final written decision

  Claims 1 and 8–12 are unpatentable: Dixon anticipates claims 1 and 8–12 and renders claims 1 and 9–12 obvious; other grounds were not reached.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedMixed

    “We therefore conclude that Patent Owner has met the standard set forth in Rule 901(b)(1) of presenting a witness with knowledge to authenticate the challenged Exhibits as being true and correct copies of records that are in the possession of Patent Owner. As a Senior Litigation Support Specialist, working in consultation with a Regeneron custodian of records, and with access to the restricted Regeneron server where the 16 Exhibits at issue are kept, Ms. Weber qualifies as a person with knowledge, under Rule 901(b)(1), that the Exhibits were true and correct copies of the records in Regeneron’s possession. Ms. Weber’s testimony does not speak to the substance of the challenged Exhibits, but merely that these are accurate copies of records that are in the possession of, and controlled by, Regeneron. As such, her testimony is sufficient to authenticate, under Federal Rule of Evidence 901, the challenged Exhibits as being what Patent Owner claims them to be. Petitioner’s Motion to Exclude the challenged Exhibits upon this ground is consequently denied.” slip op. at 16

  • Strike new argumentNew argument consideredDenied

    “We deny the motion to exclude the referenced argument in Petitioners’ Reply, as well as the invitation to consider the motion as one to strike the argument. As Patent Owner notes in the motion, Patent Owner raised this issue previously in this proceeding. PO Mot. Exclude 5. At that time, we denied Patent Owner’s request for authorization to file a motion to strike the referenced argument in the Reply. It is improper for Patent Owner to now seek to strike the argument in a motion to exclude. A motion to exclude is not the proper vehicle to address arguments or evidence that a party believes exceeds the proper scope of a reply. See USPTO, Consolidated Trial Practice Guide (2019) at 79, available at: https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL= (last visited October 27, 2022) (“CTPG”). Moreover, as Petitioners correctly assert, Patent Owner has failed to satisfy the prerequisite for filing a motion to exclude by failing to timely file an objection. See 37 C.F.R. 42.64(b)(1); CTPG 78–79. Patent Owner has not been left without an opportunity to address the Reply argument. When we denied authorization to file a motion to strike, we authorized Patent Owner to file, with its Sur-Reply, a table identifying any portion of the Reply that Patent Owner considers to have exceeded the scope of the Reply. Further, we explained that Patent Owner, alternatively, may address that contention, or the merits of any newly-raised arguments or evidence in its Sur-Reply. Indeed, Patent Owner addressed the issue in its 26 Sur-Reply for our consideration. Thus, Patent Owner had sufficient opportunity to identify in its Sur-Reply its contentions regarding Petitioners’ allegedly inappropriate Reply argument and took advantage of that opportunity. That is sufficient for us to consider the issue and determine whether such argument should be disregarded. See CTPG 80.” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find that Petitioner’s definition is the better definition for purposes of this proceeding. We acknowledge that the claims of the ’069 patent are directed to a “method for treating an angiogenic eye disorder in a patient” 29 and that the actual practice of the method would therefore seem to be limited to those who have the ability to treat patients, i.e., physicians, etc. However, we find Patent Owner’s definition to be unduly limiting. Individuals who are involved in drug development or sub-clinical level testing of drugs for treating eye disorders may be extremely knowledgeable about the development of the treatment of eye disorders and drug development, and able to comprehend and evaluate the teachings of the prior art. See, e.g., Pet. 25. Such individuals might not possess an M.D. degree, but instead possess a Ph.D. in a “biotechnological, or pharmaceutical field,” or a lesser degree with a corresponding increased depth of experience, as suggested by Petitioner. We agree that such individuals should be considered persons of ordinary skill in the art. We also find that Petitioner’s definition is commensurate with the level of skill reflected in the prior art. See, e.g., Exs. 1006, 1010, 1030, 1033; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We consequently adopt Petitioner’s definition of a person of ordinary skill in the art has having an M.D. or Ph.D. or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field, and having practical academic or medical experience in developing treatments 30” slip op. at 29

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

    “We agree that it is unnecessary to construe these claim terms in view of the express definitions set forth in the Specification. DePuy, 469 F.3d at 1014. Because the claim terms are undisputed, we adopt the definition of the claim terms “initial dose,” “secondary dose,” and “tertiary dose” as expressly defined by the Specification of the ’069 patent. Nidec, 868 F.3d at 1017.” slip op. at 32

  Patent outcomesUS 9,669,069 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,669,069
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · Nov 7, 2022 · IPR2021-00839 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–20 were not determined unpatentable because the cited combinations did not establish the claimed image guided, computer planned cataract surgery.

  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. 24; PO Resp. 10–11. 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

    “would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, we need only construe the claims to the extent necessary resolve the dispute between the parties. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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))). 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. 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” slip op. at 12

  • BurdenNot shown unpatentable

    “We have considered Petitioner’s assertions and evidence, summarized above, and agree with Patent Owner that the combination of Swinger, Baikoff, and Li fails to disclose or render obvious a control system configured to generate an anterior capsulotomy scanning pattern based on image data. PO Resp. 18–23. Petitioner relies on Li for this limitation, however, while Li discloses the use of OCT imaging to measure certain dimensions of the anterior chamber of the eye, Li suggests that a person of ordinary skill in the art manually use the measurement data collected by the system. (Ex. 1044, 1; Ex. 2087 ¶¶ 44–46). More specifically, as summarized by Patent Owner: Li does not suggest configuring the control system to do anything at all with the measurements that it makes, much less determine an anterior capsulotomy scanning pattern. Kang [Ex. 2087] ¶¶ 80, 128. To the contrary, Li’s suggestion of using measurements to “improve the fitting of AC-IOL” teaches a [skilled artisan] to manually use the measurement data. Id. Dr. Izatt testified that “in Li, the controller, so to speak, is a human.” Ex. 2057, 207:17–208:7; see also id., 207:20–21 (in Li, “the one who identifies the treatment region is the surgeon”). PO Resp. 19–20 (emphasis removed, alteration in original). That is, Li discloses a system capable of identifying boundaries of certain eye tissue structures, but fails to disclose a controller configured to determine an anterior capsulotomy scanning pattern. Id. at 17 (“Li teaches using its OCT images as a diagnostic tool.”). Thus, while Li discloses the use of OCT to identifying certain boundaries of tissue structures, Li does not disclose any controller configured to process image data for the purposes of determining a scanning pattern for scanning a focal zone of the laser beam for performing anterior capsulotomy as required by the claims.” slip op. at 26

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

    “The problem with Petitioner’s argument based on Leapfrog and the like is that Petitioner’s obviousness challenge does not simply require automating a manual step using commonplace modern electronics, but requires the conversion of one cataract surgery treatment region identification system into another. That conversion involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and implement eye surgery, two technological leaps that the record fails to show was 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 implement cataract surgery in the lens was commonplace. 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. 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 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; see also DSS Tech. Mgmt., Inc. v. Apple Inc., 885 F.3d 1367, 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 29

  Patent outcomesUS 9,101,448 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 9,101,448
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · Oct 27, 2022 · IPR2021-00840 · APJ Ryan H Flax · IPR · Final written decision

  The Board held claims 1, 2, 8–16, and 22–35 not unpatentable because the proposed combinations failed to establish the claimed control system and reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “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 ’732 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 18

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

    “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party seeks an express interpretation of any claim language. Pet. 7–8; see generally Resp. Therefore, we need not and do not expressly construe any claim language here. However, in our analysis below, as required for the sake of clarity, to resolve ambiguity, and for consistency with our decisions in the related proceedings addressing similar claim language and similar prior art, we address the claim language and its meaning as argued by the parties. We do so in accordance with the above-noted standards of law. C. slip op. at 20

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

    “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 solely 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 44

  • 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-Sys., 821 F.3d at 1369. Arguments made in a different document, such as an expert’s declaration, may not be merely incorporated-by-reference in the Petition (Petitioner does not even do so much). 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 58

  Patent outcomesUS 9,107,732 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,107,732

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.