• 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, 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
• 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
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · Oct 26, 2022 · IPR2021-00835 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–24 were not shown unpatentable because the asserted obviousness combinations did not establish the claimed image-processing control system or a sufficient basis to adapt the cited systems for lens surgery.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “The parties present compelling 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 MDs); 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., 5 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. See Nidec, 868 F.3d at 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[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 successNot shown unpatentableMotivation not foundNot shown unpatentable

    “We recognize Petitioner’s argument that the use of a controller for determining an anterior capsulotomy scanning pattern would have been “nothing more than automating a manual activity using well-known components (e.g., controllers and algorithms) in predictable ways, which would have been obvious to a [person of ordinary skill in the art]” because a controller would be programmed to determine automatically scanning patterns once the boundaries of the ocular tissue are identified. Pet 32 (citing Ex.1001 ¶ 181; MPEP 2144.04; In re Venner, 262 F.2d 91, 95 (CCPA 1958)); Reply 5–6. We also recognize Petitioner’s argument that “[t]he prior art teaches that integrating diagnostic imaging and treatment functionalities in a single automated system is not only desirable, but also straightforward.” Pet. 30 (citing Ex. 1001 ¶ 150); see also Reply 7–8 (quoting Venner, 262 F.2d at 95 (“[I]t is well settled that it is not ‘invention’ to broadly provide a mechanical or automatic means to replace manual activity which has accomplished the same result”); citing Leapfrog Enterprises, Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (updating mechanical invention with modern electronics is understood in the art)). Having considered the parties positions and evidence of record, however, 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 an automated, OCT-guided laser system. We provide further analysis below.” slip op. at 28

  • 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 40

  Patent outcomesUS 9,095,415 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 9,095,415
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

  The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11

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

    “C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659
• Argentum Pharmaceutical LLC v. Novartis AGNo claims unpatentable
  PTAB · Oct 5, 2020 · IPR2016-01479 · APJ Christopher L Crumbley · IPR · Final written decision

  Claims 1–3 were not shown unpatentable because the asserted prior-art combinations did not establish a reasonable expectation of success in treating advanced PNETs after chemotherapy failure.

  RulingsFinal written decision

  • Skill levelOther

    “demonstrate by a preponderance of the evidence that the claims are unpatentable. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time of the invention to a person having ordinary skill in the art. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations.10 See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). The level of ordinary skill in the art may be reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation not foundDecided for patent owner

    “Judged by the correct standard, the evidence leaves little doubt that a person of ordinary skill in the art would have been motivated to pursue everolimus as a potential treatment option for advanced PNETs after failure of cytotoxic chemotherapy. Novartis does not seriously contend otherwise, focusing its arguments instead on whether the motivation to pursue everolimus was greater than the motivation to pursue other possible treatments. Not only does Öberg 2004 discusses rapamycin as an “interesting new compound” that suggests clinical trials with rapamycin in combination with cytotoxic chemotherapy, it specifically provides a treatment algorithm that shows rapamycin among the potential “experimental therapies” following failure of cytotoxic chemotherapy. Ex. 1027, 60, Fig 1. And O’Donnell specifically demonstrates that administration of everolimus to human cancer patients was safe. Ex. 1029, 200. We credit Dr. Ratain’s testimony that by 2005, there was a “significant body” of data on the administration of everolimus to humans, but no reported clinical data on rapamycin. Ex. 1003 ¶ 135. Given the difference in information on everolimus and rapamycin, we find that the skilled artisan would have been motivated to pursue everolimus as an alternative to the rapamycin disclosed in Öberg 2004. Even if a person of ordinary skill would have had reason to pursue everolimus, however, our inquiry does not end there. Argentum must also prove that the skilled artisan “would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007). That “expectation of success need only be reasonable, not absolute.” Id. at 1364. “Whether an ordinarily skilled artisan would have reasonably expected success . . . is measured as of the date of the invention.” Amgen Inc. v. F. Hoffman–La Roche Ltd., 580 F.3d 1340, 1362 (Fed. Cir. 2009).” slip op. at 15

  • Obviousness (§103) › Analogous artNot shown unpatentableDecided for patent owner

    “the only prior art clinical trial of everolimus presented to us, was a Phase I trial designed to test dosages, not efficacy. Ex. 1029, 803. While Öberg 2004 does disclose the promise of rapamycin, we agree with the District Court that at the time of the invention the mTOR pathway was insufficiently understood, such that a person of ordinary skill in the art would not have reasonably expected rapamycin’s “promise,” as reported in Öberg 2004, to translate to everolimus. Ex. 1027, 60. And in regard to Boulay 2004, Novartis argues that the record lacks sufficient evidence to support Argentum’s contention that the CA20948 rat pancreatic tumor model described therein was applicable to the treatment of PNETs. Ex. 1005, 253. On this point, again we agree with the District Court. District Court Decision, 287 F. Supp. 3d at 526 (“I find that Defendant has failed to establish by clear and convincing evidence that CA20948 is a PNET model.”). Upon evaluating the full record before us, we find that the CA20948 tumor model line originated from a pancreatic adenocarcinoma, which is distinct from a neuroendocrine tumor (NET). Ex. 2038, 197–99; Ex. 2041 ¶¶ 132–134. We credit and rely on Dr. Kulke’s testimony that pancreatic adenocarcinomas and PNETs were known to differ in their origin, incidence, clinical behavior, molecular genetics, and responses to pharmacotherapies. Ex. 2041 ¶¶ 57, 135–136. Argentum does not dispute the distinction between CA20948 and PNETs, but instead argues that tests performed on CA20948 would nevertheless be understood to be applicable to PNETs. Reply 17–18. Argentum’s primary support for this argument derives from the De Jong reference, which discloses the use of the CA20948 pancreatic tumor line in a study of the treatment of neuroendocrine tumors. Ex. 1010, Abstract. As based treatment of tumors using radioactive somatostatin-analogues. PO Resp. 33; Ex.1010, 356–58. Both neuroendocrine tumors and CA20948 express somatostatin receptors; it is this commonality that made CA20948 useful as a model for NETs in De Jong’s study of radiation treatment. Ex. 2041 ¶¶ 139, 141. But just because some features of a cell line make it useful in studies of tumors where those features are relevant, it does not necessarily follow that the cell line is relevant to all studies of those tumors. See Tr. 14:15–25. As Dr. Kulke credibly explains, the person of ordinary skill in the art would not have understood from the De Jong radiation treatment study that CA20948 could be used as a model for NETs in a pharmacotherapy study. Ex. 2041 ¶ 143–146. For these reasons, we agree with the District Court that Argentum has not proven CA20948 to be a PNET model; nor is there reason to believe that a person of ordinary skill in the art would have considered CA20948 to be applicable to studying the treatment of PNETs with mTOR inhibitors, much less such treatment after the failure of cytotoxic chemotherapy.” slip op. at 18

  • ExcludeMotion to exclude, deniedMixed

    “We agree. If Argentum had submitted only certain portions of Dr. Kulke’s testimony into the record before us, Novartis would be entitled to rely on FRE 106 to request that the Board admit other portions of his testimony that, in fairness, should be considered. But that is not what Novartis requests here; nor could it, given that Exhibits 1070, 1095, and 1119 were already admitted in their entirety. And in any event, Novartis’ request would not have been proper as part of a motion to exclude. Upon reviewing the Motion, it is clear that Novartis is using its FRE 106 arguments as a vehicle for introducing additional citations to, and discussion of, Dr. Kulke’s testimony that were not introduced in the multiple other opportunities for merits briefing that Novartis had during this trial. For this” slip op. at 28

  Patent outcomesUS 9,006,224 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,006,224
• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCNo claims unpatentable
  PTAB · Jun 4, 2020 · IPR2019-00146 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, and 5 were not shown unpatentable because Nakamura did not disclose the claimed spacer, and Petitioner did not establish a basis to modify it.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “level of skill in the art than that proposed by Petitioner. PO Resp. 11‒12. In particular, Patent Owner disagrees with Petitioner’s requirement for an advanced degree in mechanical engineering or a closely related field as it would, for example, exclude both the named inventors of the ’679 patent as well as “a large majority of active workers in the field at the time of the invention.” Id. at 12 (citing Ex. 2002 ¶ 80). Rather, Patent Owner contends that the person of ordinary skill in the art at the time of the invention would have a Bachelor of Science degree in engineering and at least 3 years of experience working or studying in the field of heat pipes; or an equivalent level of education, training, and work experience. Id. at 11 (citing Ex. 2002 ¶¶ 77‒79). Dr. Pokharna comports with the qualifications a person would have needed to understand and implement the teachings of the ’679 patent and the prior art of record. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). Moreover, Petitioner concedes that this dispute as to the appropriate level of skill in the art “is immaterial because the challenged claims are invalid under both sides’ definitions.” Reply 1 n.2. We agree with Petitioner that the outcome of this proceeding is not dependent on our application of one party’s definition as compared to the other. Nonetheless, because Petitioner’s and Dr. Pokharna’s definition better reflects the level of ordinary skill in the art, we adopt and apply it here. C.” slip op. at 10

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

    “extending between and contacting said first and second plates,” claim 1 separately recites “a depression formed in said first plate,” which projects into said vapor chamber and is bonded to said second plate. PO Resp. 25–26 (emphasis added) (citing Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (“Where a claim lists elements separately, the clear implication of the claim language is that those elements are distinct components of the patented invention.”)); see Ex. 2002 ¶ 114. Whereas claim 1 requires that a spacer contact both the first and second plates, it makes clear (as do claims 4 and 6) that a depression formed in a first plate is bonded to only the opposing plate. See Ex. 1001, claim 7 (reciting that a “depression formed in said second plate . . . is in contact with an inner surface of said first plate”). We, thus, infer from the structure of the recited in claim 1 are distinct components with distinct properties. In particular, the claimed “spacer . . . extending between and contacting said first and second plates” is a distinct element between and in contact with two plates, whereas the claimed “depression” is a part of one plate that contacts, or is bonded to, an opposing plate.” slip op. at 14

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

    “whether a reference is a printed publication. Suffolk Techs., LLC v. AOL Inc., 752 F.3d 1358, 1364 (Fed. Cir. 2014). The determination of whether a given reference qualifies as a prior art “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding its disclosure to members of the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). The key inquiry is whether the reference was made “sufficiently accessible to the public interested in the art” before the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989); see In re Wyer, 655 F.2d 221, 226 (CCPA 1981). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (citation omitted). Bruckelmyer and Wyer specifically addressed the public accessibility of laid open patent applications.” slip op. at 24

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “The relevant language of independent claim 1 is not merely “spacer” but “spacer. . . extending between and contacting said first and second plates,” which we construe as referring to a “structure separate from and in 16 Petitioner also addresses obviousness under the construction of “spacer” that Patent Owner proposed before the district court but that we do not adopt here. See id. at 36–41; section II(C)(2), n.7, above. 17 Petitioner and its expert also reference Nakamura’s Figures 5 and 6, which show embossed depressions in only one plate. Pet. 39–40; Ex. 1002 ¶ 64. Nonetheless, we agree with Patent Owner that “Petitioner’s grounds are based on the concavities 9 described and illustrated with respect to Figure 4 of Nakamura,” and Petitioner’s passing reference to the alternative embodiment of Nakamura’s Figures 5 and 6 does not substantially affect our analysis, which focuses on the embodiment of Figure 4. See PO Resp. 46 (citing Inst. Dec. 15–18). clearance between the plates.” See section II(C)(2), above. Applying this panel’s construction, we agree with Patent Owner that Petitioner has neither shown how Nakamura discloses this limitation, nor identified any rationale or motivation to modify Nakamura to provide a “spacer. . . extending between and contacting said first and second plates,” as recited in claim 1. See PO Resp. 46–47. As discussed above, Petitioner seeks to satisfy this limitation by pointing to the “H-shaped structure” defined by concavities pressed into opposing plates of the heat pipe illustrated in Nakamura’s Figure 4. But as Patent Owner points out, “these concavities are integral with the portions of the container in which they are formed, and a concavity cannot be said to contact the same plate in which it is formed without rendering the term ‘contacting’ in claim 1 meaningless.” Id. (citing Ex. 2002 ¶¶ 116, 145).” slip op. at 35

  Patent outcomesUS 7,100,679 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,100,679
• Becton, Dickinson And Company v. Baxter Corporation EnglewoodNo claims unpatentable
  PTAB · Apr 29, 2020 · IPR2019-00119 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–13 and 22 were not shown unpatentable because the asserted obviousness combinations failed to establish required claim elements.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “The parties agree that a person of ordinary skill in the art as of the relevant date would have several years of experience with remote pharmacy work supervision and verification systems and a familiarity with basic pharmacy processes and have been aware of relevant regulations. Pet. 10– 11; PO Resp. 6 (referencing Inst. Dec. 9). As noted by Petitioner, the Board 10 previously applied this definition in an inter partes review of the Alexander reference asserted here. Pet. 10–11 (referencing IPR2015-00883, Paper 29 at 43). As the parties’ undisputed proposed definition is consistent with the cited prior art, we adopt it consistent with our Institution Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–164 (Fed. Cir. 1985)).” slip op. at 10

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

    “We address below the two claim terms provisionally construed in our Institution Decision, as well as element [8j], subsequently raised by the parties. No other terms require express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy and only to the extent necessary to resolve the controversy.”).” slip op. at 12

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

    “Whereas the plain language of element [8j] mandates that each step “must be verified before the operator can continue,” the parties initially appear to disagree about who––or what––is responsible for the verification. Patent Owner contends that element [8j] embodies the concept of a “hard stop,” wherein “the system will not allow the operator to proceed to the next step until the prior step has been verified.” PO Resp. 24; Sur-reply 1. To 14 the extent Patent Owner uses the term “hard stop” as a short hand for the words of element [8j], we agree with this portion of its construction.8 As we further understand Patent Owner’s position, however, verification that a step is properly completed requires input from a remote pharmacist overseeing the operator. See PO Resp. 27 (distinguishing Alexander as not requiring “the remote pharmacist must verify each and every step before the operator is allowed to proceed”). But reading claim 8 (directed to a system) to require a method step performed by a pharmacist would appear to “combine . . . two separate statutory classes of invention.” See IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005). Moreover, claim 8 makes no mention of a pharmacist and Patent Owner fails to explain adequately why we should import such a limitation from the Specification into the claim. Accordingly, we decline to apply Patent Owner’s construction of element [8j] to the extent it requires input from a remote pharmacist. We, nevertheless, note that in the Sur-reply, Patent Owner indicates that element [8j] may be satisfied where “the workstation . . . captur[es] the image and scan[s] the barcode in order to verify the step has been performed.” Sur-reply 6 (emphasis added).” slip op. at 14

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artReference is prior artMixed

    “issuance of Alexander would evidence prior invention under § 102(g)(2), our governing statute provides that “[a] petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C § 311(b). Although Alexander is a printed publication, Petitioner does not seek to use it as such under § 102(g)(2) but, instead, as evidence of prior invention, which is not a legitimate basis for challenge in inter partes review.10 For the above reasons, and as set forth at pages 15–17 of our Institution Decision, Alexander is not available as prior art in this proceeding under 35 U.S.C § 102(g)(2).” slip op. at 22

  Patent outcomesUS 8,554,579 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,554,579

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.