- BTC Corporation v. TG Biotech Co., Ltd.No claims unpatentablePTAB · Nov 13, 2023 · IPR2022-00998 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–13 were not shown unpatentable under the asserted obviousness grounds; Patent Owner’s motion to strike Exhibit 1038 was granted.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We are not persuaded by Petitioner’s contention that we should disregard Dr. Naumovski’s testimony because she may have taken a leave of absence from work for a couple of years. The record supports that Dr. Naumovski not only meets the requirements of the person of ordinary skill in the art, but also appears to have relevant knowledge with respect to Gynostemma pentaphylum (“GP”) saponins. See Ex. 2015 (Appendix A). related field, and at least two years of experience using techniques for extraction and characterization of plant-based materials.” PO Resp. 11 (citing Ex. 2015 ¶ 74). Because there are more than 400 species of plants that contain saponins, Patent Owner disagrees that a person of ordinary skill in the art would be familiar with the structure and utility of saponins. Id. The level of skill in the art is a reference point for gauging what would have been obvious based on the reference disclosures. See Okajima, 261 F.3d at 1355. In other words, the lens of the level of ordinary skill in the art does not change a prior art’s disclosure, though it may change one’s understanding of what is disclosed. Patent Owner, however, does not explain how its definition provides a reference point that would meaningfully alter the Petition’s assertions of obviousness. For purposes of this decision, we analyze the asserted prior art with respect to the level of skill set forth by Petitioner, but there would be no difference in the outcome of this Decision if we were to apply the level of skill in the art set forth by Patent Owner. C.” slip op. at 13
- Expert testimonyPatent owner expert creditedDecided for patent owner
“during the full trial, we determine that Petitioner has not shown by a preponderance of the evidence that applying the methods of Kim 460 to the G. pentaphyllum starting material of Razmovski necessarily results in the damulin levels as claimed. We agree with Dr. Naumovski’s explanation that the use of an impure damulin B standard containing a double peak renders the results as shown in Exhibit 1013 unreliable. Ex. 2015 ¶¶ 141–143, 162–173; see Ex. 2007. Dr. Naumovski further explains that the use of an impure standard would require the application of a correction factor, but this correction factor would need to be reassessed as the purity of the standard decreases over time. See Ex. 2015 ¶ 166. As Dr. Naumovski explains that applying a correction factor to the linear regression would result in a shallower slope. Ex. 2015 ¶ 165 (citing 2006, 71:12–73:5; 99:2–9). “Reducing the calibration curve slope increases the amount of damulin B calculated from the experimental extracts.” Ex. 2015 ¶ 165. However, in the Experimental Report-1 the same correction factor for the damulin B standard was used to” slip op. at 41
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Petitioner requests construction of the terms “an effective amount for improving or treating the metabolic syndrome,” which is found in claims 11–13, as meaning “an amount that produces any measurable amount of improvement in the metabolic syndrome” (Pet. 13–15 (citing Ex. 1003 ¶ 91)) and “[a] pharmaceutical composition for improving and treating a metabolic syndrome, comprising at least one of at least 0.7% damulin A and at least 0.5% damulin B . . . and a pharmacologically acceptable carrier or excipient,” which is found in claim 8, as meaning “a pharmaceutical composition that includes an extract with 0.7% and 0.5% of damulin A and damulin B[, respectively,] along with a carrier or excipient” (id. at 15–16 (citing Ex. 1002, 64–65, 251–52, 280; Ex. 1001, 12:15–67, Table 2)). Patent Owner argues that “constructions are not necessary.” PO Resp. 11–12. We agree with Patent Owner and determine that it is not necessary for purposes of this Decision to construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Obviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re Droge, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903–04 (Fed.Cir.1988)); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016) (explaining that the expectation of success issue involves a showing of “a reasonable expectation of achieving what is claimed”) (emphasis added). Here, Petitioner relies on Kim 460 to show that heating ginseng, which contains the ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, results in a teaches that ginseng with the higher Rg3 and Rg5 content is 50-fold more potent in their vasodilation studies than the non-treated samples. Razmovski teaches that G. pentaphyllum contains over 100 saponins and eight of those saponins are the same as protoparaxadiol-type ginsenosides Rb1, Rc, Rb3, Rd, F2, Rg3, malonyl-Rb1, and malonyl-Rd that are found in P. ginseng. Ex. 1007, 4. Knowing that G. pentaphyllum also contains ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, we find Petitioner’s conclusion that heating a G. pentaphyllum extract that contains these ginsenosides would similarly increase the ginsenoside levels of Rg3 and Rg5 is a reasonable inference from the cited references. Based on the teachings in Kim 460, we agree with Petitioner that it would have been reasonable to expect that the same source material, although derived from a different plant, would behave similarly to heat treatment. See Pet. 24. Because G. pentaphyllum is a less expensive starting material, we also agree with Petitioner that there is sufficient motivation to substitute G. pentaphyllum for ginseng in the methods of Kim 460. slip op. at 29
Patent outcomesUS 8,357,786 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,357,786 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · Dec 12, 2022 · IPR2021-00862 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–24 were not shown unpatentable because Petitioner failed to establish the proposed prior-art combinations and the required motivation to combine with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“The parties present compelling argument and evidence that one of ordinary skill in the art would include those with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 25; PO Resp. 9–10. The evidence of record also demonstrates that few individuals actually had such comprehensive experience. Rather, teams of individuals with different expertise and various academic degrees (Ph.D.s, B.S.s, and M.D.s) would work together to design laser surgery systems intended to make incisions in the lens of the eye. See, e.g., Ex. 1041 (several authors are M.D.s); Ex. 1042 (the authors’ degrees include Ph.D.s, an M.D., and a B.S.); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019. Thus, we find that the person of ordinary skill in the art would have been either an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as nuclear engineering, having experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., five years of experience for a Ph.D. or more to compensate for lesser degrees), and that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not assert that any claim term requires express construction. See Pet. 6 (stating that it “reserves the right to respond to any constructions that [Patent Owner] submits”). Patent Owner does not present any remarks regarding claim construction. See generally PO Resp. On this record, we determine that no claim terms require express construction because it is not essential to our conclusions on patentability. See Nidec Motor., 868 F.3d at 1017 (quoting Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“summarized above, we find that the evidence of record does not support a conclusion that it would have been simple, straightforward, or otherwise routine to convert Swinger’s manual HeNe aiming system and Swinger’s surgeon-identification-of-target-tissue step to a computer-controlled, OCT-guided laser system. Even assuming that a person of ordinary skill in the art would have combined the teachings of Swinger and Baikoff to achieve a laser surgical system incorporating an OCT imaging system, that combination still would not have achieved the required “computer system” of the claims and all of its programmed surgical functionality, particularly, using a computer system to construct an anterior capsulotomy cutting region based on the image data. Petitioner relies on the ability of a person of ordinary skill in the art to configure Swinger’s computer control unit with the missing functionality, thus necessitating an electronic conversion of the steps performed using Swinger’s direct visualization method using a HeNe aiming beam to manually identify a surgical treatment region for laser surgery. Ex. 1039, 34:52–57; Ex. 2088 ¶¶ 55–59, 66. That conversion, however, involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and then implement the planned cataract surgery, two technological leaps that the record fails to show were known or suggested. In particular, the evidence of record does not support a conclusion that OCT was a well-known system used routinely, if at all, in the identification of treatment regions in the lens or lens capsule for cataract surgery, and further does not support a conclusion that a computer-controlled system to plan and to implement a planned cataract surgery in the lens was commonplace or even considered before the invention.” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundNot shown unpatentableNot shown unpatentable
“The evidence of record demonstrates, however, that modifying an existing corneal surgery system to image and perform surgery on the lens was not the simple task asserted by Petitioner. For example, in a patent application filed in November 2009, Petitioner asserted that due to the different depth ranges for the laser’s focus, “laser systems designed for corneal procedures do not offer solution[s] for the considerable challenges of performing surgery on the lens of the eye.” Ex. 2007, 4:65–67, 5:30–36, code (22). Similarly, in a different patent filed in December 2008, Petitioner outlined the various challenges in developing laser surgery systems for creating incisions in the lens, including the difficulty in focusing a laser beam that propagates through regions of the eye with different optical properties and different curvatures. Ex. 2014, 15:51–16:18, code (22). This patent then states: Because of all the described hard challenges, corneal surgical laser systems are qualitatively simpler than lens surgical lasers. This is well supported by the fact that even though corneal surgical systems were suggested about 40 years ago, none have been adapted successfully for lens surgery to date. Id. at 16:13–18. During prosecution of another patent filed in 2008, and in responses to office actions filed in 2012 and 2013, Petitioner argued that a corneal OCT system “simply will not work” on the lens and that it would not have been obvious to modify such an OCT system to image the lens. Ex. 2015, 898, 1591, 1788. This was because OCT systems designed to image the lens would be required to deliver and scan an imaging beam “to a depth ten times bigger and a depth range ten times bigger” than an OCT system designed to image the cornea. Id. at 1591. According to Petitioner, “it is not obvious” to modify an OCT imaging system to achieve a depth and scanning range that is ten times larger than that disclosed in the art. Id. at 898 (“Increasing a system’s performance by an order of magnitude cannot be regarded as obvious.”), 1590–1591. Petitioner’s arguments presented in its own patents and during their” slip op. at 39
Patent outcomesUS 8,709,001 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,709,001 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Cardiovalve Ltd.No claims unpatentablePTAB · Dec 6, 2022 · IPR2021-01051 · APJ John G New · IPR · Final written decision
The Board granted the non-contingent motion to amend, canceling claims 1–10 and replacing them with claims 11–20, which Petitioner failed to prove unpatentable over Goldfarb ’267.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“We conclude that Petitioner’s arguments are insufficient to meet its burden of showing, by a preponderance of the evidence, that Goldfarb ’267 anticipates, or renders obvious, the limitation of proposed substitute claim 11 reciting “advancing the end of the first-clip arm and the end of the second-clip arm out of the delivery tube before advancing the support portion out of the delivery tube” merely requires advancing the ends of the clip arms out of the delivery tube “before advancing the support portion out of the delivery tube.” Moreover, Petitioner’s arguments are not persuasive with respect to proposed substitute dependent claims 12–20 due to their dependence from, and incorporation of, the limitations of proposed substitute claim 11. See Supp. Mot. Amend. 1, Reply Supp. Mot. Amend. 1. We therefore conclude that these proposed substitute claims are similarly neither anticipated by, nor obvious over, Goldfarb ’267. III. CONCLUSION We GRANT Patent Owner’s non-contingent Motion to Amend and Supplemental Motion to Amend, canceling original claims 1–10 and replacing them with substitute claims 11–20. Additionally, for the foregoing reasons, and after having analyzed the entirety of the record and assigning appropriate weight to the cited supporting evidence, we determine that Petitioner has failed to establish, by a preponderance of the evidence, that proposed substitute claims 11–20 are unpatentable.” slip op. at 57
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Having weighed the evidence and Petitioner’s argument, we adopt Petitioner’s definition of a person of ordinary skill in the art as: (1) a mechanical or biomedical engineer with at least three years of experience in designing or developing medical devices who would, where necessary or desired, work or consult with others including a physician to develop such a medical device; or (2) an interventional cardiologist or cardiac surgeon with at least three years of experience developing and/or using medical devices in the heart, and who would, where necessary, work or consult with others including an engineer to develop such a medical device. See Pet. 15–16.” slip op. at 11
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Vesely. Ex. 1003. We have reviewed the credentials of Dr. Vesely and consider him qualified to provide the opinions for which his testimony has 4 Goldfarb et al. (US 7,563,267 B2, July 21, 2009) (“Goldfarb ’267”) (Ex. 1005). 5 Petitioner refers to Goldfarb’s ’267 disclosure of a further alternative at Ex. 1005 col. 27 ll. 57–60 as Embodiment A. See Pet. 19. We understand the asserted Embodiment A to encompass the description that extends to Ex. 1005 col. 28, l. 9. See Pet. 24–48. 6 Goldfarb et al. (US 7,635,329 B2, December 22, 2009) (“Goldfarb ’329”) Ex. 1006. 7 Ex. 1005 cols. 17–23, ll. 66–29, Figs. 9–16; see Pet. 21–22. been submitted. See id. ¶¶ 1–9; see also Ex. 1004 (Dr. Vesely’s curriculum vitae).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“is described in Goldfarb ’267 as plainly a single, unitary structure and, as such, each portion argued as separate elements by Petitioner (i.e., male element (yellow), female element (green), coupling member 19 (blue) and flexible arms 19A and 19B (dark blue)) together form a solid, single component. Thus, all of the “elements” described by Petitioner as being “separate” are in fact a single unit that: (1) bears the weight of the fixation device during delivery; (2) absorbs and transfer the axial and rotational forces imposed by the shaft 12; and (3) holds the device in the correct orientation. Petitioner points to no disclosure of Goldfarb ’267 that suggests these elements act independently or separately to perform the functions of the unitary component, nor can we discern any such disclosure. We therefore find that Petitioner’s argument that only the “male element” portion of coupling member 19 constitutes the “support portion” recited in proposed substitute claim 11 is an arbitrary and unduly restrictive interpretation of the reference’s disclosure. This is particularly true given that Petitioner points to no portion of the male element of coupling member 19 performing a supporting function that is not shared by the other elements of coupling member 19. We conclude that the better understanding of the reference is that the entirety of coupling member 19 (including flexible arms 10A and 19B11) constitutes an analogous support portion, as recited by substitute claim 11, because it provides a unitary structure that performs the supporting functions enumerated by Petitioner.” slip op. at 41
Patent outcomesUS 10,702,385 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,702,385 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · Dec 2, 2022 · IPR2021-00853 · APJ Ryan H Flax · IPR · Final written decision
Claims 1–3, 5, 6, 8, 12, and 13 were not proven unpatentable because the asserted combinations lacked a persuasive basis for achieving the claimed system with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“Petitioner’s proposed definition of the person of ordinary skill in the art appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’725 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as also including a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers, and that these people may collaborate. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate here, based on our review of the record. Thus, we find that the person of ordinary skill in the art would have been someone with a PhD, MS, or BS degree in physics, biomedical engineering, or a related science such as nuclear engineering, having more or less experience in research, manufacturing, or designing medical optics or medical lasers (e.g., 5 years for a PhD or more to compensate for lesser degrees), or an ophthalmic surgeon, but that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties and is appropriate in view of the record.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Patent Owner does not ask that this claim language be expressly construed or contest Petitioner’s proposed interpretation. See Resp. 11–15. Although it is not necessary for our final decision in this proceeding to construe this claim language because it is not essential to our conclusions on patentability, as it is uncontested, we adopt as our own Petitioner’s proposed construction of “imaging device configured to acquire point by point image data from locations distributed throughout a volume of a crystalline lens.”” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Turning to the disputed term “automatically” in this context, we agree with Patent Owner that the plain meaning of the term “automatically” is that the “control system” can, on its own and without human intervention, perform the subsequently recited step. Resp. 11–15; see also Pet. 10 (Petitioner agreeing this is the plain meaning). This is supported by the Specification, which states, inter alia, that “the entire system is controlled by the controller CPU” and describes alternative embodiments where (1) the system is fully in control and where (2) user input identifies targets. Ex. 1027, 12:23–25, 13:25–44, Figs. 14, 15. However, we also agree with Petitioner that just because the claimed “control system” is configured/programmed to perform (i.e., capable of performing) some tasks “automatically” (i.e., entirely on its own), this does not mean user input (e.g., from a surgeon) must be altogether excluded. Pet. 10–11. In fact, user input must be possible and is within the scope of the independent claim. “By definition, an independent claim is broader than a claim that depends from it, so if a dependent claim reads on a particular embodiment of the claimed invention, the corresponding independent claim must cover that embodiment as well.” Littelfuse, Inc. v. Mersen USA EP Corp., 29 F.4th 1376, 1380 (Fed. Cir. 2022). Here claim 2, requiring automatic target identification, and claim 5, requiring user input on target identification, each depends from claim 1 and illuminates its scope, which must be broad enough to encompass both. Thus, although requiring (in claim 1) that a “control system” can perform certain recited functions, and that some are performed (according to claim 2) “automatically,” that same “control system” must also be capable of allowing a user input on the locations of targets for laser treatment (according to claim 5). Such optional user input required by dependent claim 5 is described in the Specification, which includes embodiments where a surgeon can adjust the size, location, and shape of the treatment pattern, can determine the optimal cutting contours in patients, and can provide “user input” to define targets or adjust computer-defined parameters as necessary. Ex. 1027, 10:55–45; 10:67–11:2, 13:25–55, 13:63–14:2. Regardless, the configuration of independent claim 1’s “control system,” which must be programmed to and capable of performing its own recited steps/functions, is not diminished by the requirements of either dependent claim. Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corporation, 831 F.3d 1350, 1360 (Fed. Cir. 2016) (“[T]he language of a dependent claim cannot change the scope of an independent claim whose meaning is clear on its face.”).” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“generally. “The presence or absence of a reasonable expectation of success is . . . a question of fact,” and this “requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., 821 F.3d at 1366–67. Based on the record, we conclude that, even if it would have been potentially advantageous to in some way incorporate the use of Baikoff’s and Li’s OCT imaging and measuring into Swinger’s system and method for cataract surgery (for example, to replace the use of ultrasound imaging with OCT), we agree with Patent Owner that, other than the (ultimately) conclusory testimony of its witness Dr. Izatt (see, e.g., Ex. 1001 ¶¶ 110, 144, 151, 161, 163–165, 168), there is no persuasive evidence that the person of ordinary skill in the art would have combined these references with the result being a control system configured to (automatically or not in practice) image cataractous eye tissue, identify the targets therein (capsule and lens) to be cut with a laser, and then operate that laser to actually make those cuts based in some part on that imaging. See Resp. 15–34. We credit Dr. Kang’s testimony that, as of the invention, the person of ordinary skill in the art would not have relieved the surgeon of responsibility for identifying cutting regions for laser capsulotomy and cataract surgery (as taught by Swinger), and relegated such task to a computer, which subsequently performs the procedure. Ex. 2087 ¶¶ 36–38, 42, 46, 62–66; see also Ex. 2088 ¶¶ 56–59, 68–71 (Dr. Walter testifying similarly). Dr. Kang takes issue with Petitioner’s positions that Baikoff and Li teach or suggest such reliance on a computer because, according to Dr. Kang, neither Baikoff nor Li (and indisputably not Swinger) teaches using a computer to identify laser cutting regions or to control laser surgery, and, in fact, they suggest reliance on a surgeon to interpret their OCT images to plan a subsequent surgery. See, e.g., Ex. 2087 ¶¶ 36–38, 42, 46, 62–66. We further credit Dr. Kang’s testimony that Petitioner fails to adequately explain, even were the ordinarily skilled artisan intent on combining Baikoff’s and Li’s OCT imaging systems with Swinger’s cataract surgery system, how it would have been accomplished to overcome the “substantial challenges” and achieve the claimed invention. See id. ¶¶ 63– 66; see also Resp. 27–28 (addressing Petitioner’s lack of explanation as to how to implement the combination).19 We agree that, beyond merely suggesting plugging one system into another, Petitioner does not explain how the person of ordinary skill in the art would have programmed Swinger’s computer control system to use Baikoff’s and Li’s OCT imaging systems and tissue recognition and measurement algorithms to determine capsulotomy cutting regions and then implement the planned cutting with a laser, even from a rudimentary perspective. See Pet. 35–40. Indeed, Petitioner concedes:” slip op. at 50
Patent outcomesUS 9,125,725 not shown unpatentableClaim construction§ 103 obviousnesscites Alice · Phillips · KSR · GrahamPatents in suitUS 9,125,725 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,474,648 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 9,101,448 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,107,732 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 9,095,415
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.