• Hope Medical Enterprises, Inc. v. Fennec Pharmaceuticals, Inc.No claims unpatentable
  PTAB · Sep 1, 2023 · IPR2022-00125 · APJ Julia Heaney · IPR · Final written decision

  The Board granted the revised noncontingent motion to amend, canceled claims 18 and 20, and entered substitute claims 28 and 29, which were not proven obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner, relying on the testimony of Dr. Rogers, contends that a person of ordinary skill in the art would have [had] a bachelor’s degree or equivalent in any of the pharmaceutical sciences with at least 5 years of experience in solid state chemistry; a master’s degree in any of the pharmaceutical sciences with at least 3 years of experience in solid state chemistry; or a Ph.D. in any of the pharmaceutical sciences with 1 year of experience in solid state chemistry. Pet. 8 (citing Ex. 1008 ¶¶ 24–28). Petitioner further states that such “[a] person could also have qualified as a [person of ordinary skill in the art] with some combination of (1) more formal education and less technical or professional experience or (2) less formal education and more technical or professional experience.” Id. Patent Owner does not dispute Petitioner’s proposed definition of a person of ordinary skill. See generally MTA, RMTA. Having considered the parties’ arguments and evidence, we adopt the level of ordinary skill in the art proposed by Petitioner, because it is consistent with the disclosures of the ’363 patent and the prior art of record. We note, however, that neither party contends that the outcome of this case would differ based on our adoption of any particular definition of a person of ordinary skill in the art.” slip op. at 12

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

    “In our Preliminary Guidance, we construed “for a pharmaceutical composition” to mean “in combination with pharmaceutically acceptable excipients,” based on the ’363 patent’s definition providing that “[t]he terms ‘formulation’ or ‘pharmaceutical composition’ as used herein refers to the drug in combination with pharmaceutically acceptable excipients.” Prelim. Guid. 5–6 (citing Ex. 1001, 12:26–28; Ex. 2010, 17:11–12; Ex. 2011, 26:26– 27). We also encouraged the parties to address whether “for a pharmaceutical composition,” which appears in the preamble of substitute claims 28 and 29, is limiting, as opposed to a statement of intended use or purpose. Id. at 6. Following our Preliminary Guidance, the parties submitted further arguments concerning the term “for a pharmaceutical composition.” Patent Owner argues the term requires that the claimed process provide STS that is sufficiently pure for use in a pediatric patient (see RMTA 8–11) and that the word “drug” in the ’363 patent’s definition of “pharmaceutical composition” requires that the anhydrous STS is of sufficient purity for pharmaceutical use. Reply RMTA 3. Petitioner argues that the construction set forth in our Preliminary Guidance was correct. See Sur-reply RMTA 2–3. Having considered the arguments and evidence, we do not further construe the term “for a pharmaceutical composition” in this Decision because, as discussed in our analysis of obviousness below, it is not necessary to construe the term in order to determine whether Petitioner has met its burden of demonstrating by a preponderance of the evidence that proposed substitute claims 28 and 29 are unpatentable. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we 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))).” slip op. at 13

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “1. Reasonable Number of Substitute Claims A motion to amend must “propose a reasonable number of substitute claims.” 35 U.S.C. § 316(d)(1)(B); see 37 C.F.R. § 42.121(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). Patent Owner proposes the same number of substitute claims as the original challenged claims that are cancelled, i.e., a one-to-one substitution for a total of two substitute claims. MTA 2; RMTA. “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, Paper 15 at 4; see 37 C.F.R. § 42.121(a)(3). Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner proposes a reasonable number of substitute claims. 2. Support in the Original Disclosure Patent Owner has identified written description support in the originally filed disclosure of the ’363 patent for the new limitations added for the proposed substitute claims. See RMTA 5–8. We have reviewed Patent Owner’s assertions of support in the original disclosure for the proposed revised substitute claims and determine that sufficient support exists. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement. 3. Respond to a Ground of Unpatentability “A motion to amend may be denied where . . . [t]he amendment does not respond to a ground of unpatentability involved in the trial.” 37 C.F.R. § 42.121(a)(2)(i). Patent Owner asserts that the proposed revised substitute claims are patentable over the combination of references that forms the basis of the obviousness ground on which we instituted trial. RMTA 12–13. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement. 4. Scope of the Claims Patent Owner asserts that the proposed revised substitute claims do not enlarge the scope of original claims 18 and 20. RMTA 5. We have reviewed Patent Owner’s assertion that the purity amendments of proposed revised substitute claims 28 and 29 narrow the claims’ scope. Id. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement.” slip op. at 17

  • BurdenNot shown unpatentable

    “determine the evidence relied on by Petitioner does not support Petitioner’s position that a person of ordinary skill in the art would have been motivated to combine Levenson, Sherman, Edwards, and USP. Petitioner’s contention that it would have been obvious to a person of ordinary skill in the art to combine the teachings of Levenson with Sherman is based on Dr. Rogers’s testimony that “[b]oth references disclose synthesis of sodium thiosulfate pentahydrate.” Ex. 1008 ¶ 151; see Pet. 36, 38. Dr. Rogers further testified it would have been obvious to add Edwards’s dehydrating step to the preparation of STS pentahydrate “which is obtained following the teachings of Levenson and Sherman” because “Edwards itself discloses dehydrating [STS] pentahydrate.” Id. ¶ 154. The Petition included these arguments even though they were inconsistent with Petitioner’s previous statement, during the Sherman prosecution, that Levenson taught STS heptahydrate, and therefore “does not provide any teaching with respect to [STS] pentahydrate.” Ex. 2013, 97. This prior inconsistent statement undercuts Petitioner’s rationale for combining Levenson, Sherman, and Edwards in this proceeding. Moreover, Petitioner’s rationale for combining the references in this proceeding is inconsistent with its statements about Levenson during the Sherman prosecution. Recognizing this inconsistency, Petitioner now takes the position that the Petition and Dr. Rogers’s testimony were incorrect. Paper 32; see Tr. 21:14–22:7, 59:1–2 (reemphasizing that “Petitioner maintains the statements that it made in the Sherman prosecution regarding Levenson”). Petitioner attempts to rationalize the inconsistency between its statements in the Sherman prosecution (including that “Levenson does not provide any teaching with respect to [STS] pentahydrate”) and its position in this proceeding by arguing that Dr. Rogers relies on Levenson as teaching surface activation “regardless of any particular hydrates Levenson discloses.” Tr. 22:8–9. That argument is not persuasive, because Dr. Rogers’s declaration clearly states the primary reason for his opinion that it would have been obvious to a person of ordinary skill in the art to combine the teachings of Levenson with Sherman: “[b]oth references disclose synthesis of sodium thiosulfate pentahydrate.” Ex. 1008 ¶ 151. Contrary to Petitioner’s argument, Dr. Roger’s reliance on the surface activation teachings of Levenson is because he believes that both references pertain to STS pentahydrate; the surface activation teachings are not stated as an independent reason to combine the references. Id. Petitioner provides no further explanation of how a person of ordinary skill in the art would have been motivated to combine Levenson’s teachings regarding manufacture of STS heptahydrate with Sherman’s and Edwards’s teachings regarding STS pentahydrate, or how a person of ordinary skill would have regarded the difference between STS hydrates. Dr. Rogers’s acknowledgement of stability differences among STS hydrates highlights the insufficiency of Petitioner’s showing in this regard. See Ex. 2005, 35, 39. Having changed its position at the close of trial and having effectively withdrawn Dr. Rogers’s testimony as to similarities between Levenson and” slip op. at 24

  Patent outcomesUS 10,792,363 not shown unpatentable
  Claim constructioncites KSR · Graham
  Patents in suitUS 10,792,363
• Apple Inc. v. Memoryweb, LLCNo claims unpatentable
  PTAB · Jun 30, 2023 · IPR2022-00032 · APJ Jason M Repko · IPR · Final written decision

  Claims 1–12 were not shown unpatentable over A3UM, Belitz, and Rasmussen because the obviousness challenge relied on an unsupported account of A3UM’s Places view and an inadequate combination rationale.

  RulingsFinal written decision

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

    “Because there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). “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.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)). slip op. at 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art in 2011 (or 2014) would have had (1) at least a bachelor’s degree in computer science, computer engineering, or electrical engineering, and (2) at least one year of experience designing graphical user interfaces for applications such as photo management systems. Pet. 9 (citing Ex. 1003 ¶¶ 41–43). In the Institution Decision, we applied Petitioner’s proposed definition. Inst. Dec. 10. Patent Owner does not dispute Petitioner’s proposed level of ordinary skill in the art. PO Resp. 18. We continue to find that the skill level identified by Petitioner (Pet. 9) is consistent with the record. Thus, we use the same definition here that we used in the Institution Decision.” slip op. at 31

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

    “C. Claim Construction Only those claim terms that are in controversy need to be construed, 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) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We do no need to construe any terms to resolve the issues in this case.” slip op. at 31

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

    “size version of the selected image in the Places view. PO Resp. 55 (citing Ex. 2025 ¶¶ 156–157). Patent Owner’s argument is adequately supported by Dr. Surati’s testimony. Ex. 2025 ¶¶ 156–157. We credit Dr. Surati over Dr. Terveen on this issue because Dr. Surati’s testimony is consistent with the teachings in A3UM. See id.; Ex. 1003 ¶ 186. Specifically, the Petition and Dr. Terveen’s declaration rely on page 251 of A3UM to support the assertion that the Places view displays the original digital image in the Viewer. See Pet. 50; Ex. 1003 ¶ 186. The cited part of A3UM provides an overview of the Viewer. Ex. 1005, 251. A screenshot showing the Viewer and Browser is reproduced below. Id. The screenshot shows a Viewer displaying the image selected in the Browser. Id. The Browser displays several thumbnail images. Id. The Viewer displays a larger detailed view of the selected thumbnail image. Id. Dr. Surati testifies that this part of A3UM is not describing the Places view. Ex. 2025 ¶ 159. According to Dr. Surati, “clicking the thumbnail in the Browser in the Places view does not cause the Places view map to be replaced with a full size image corresponding to the selected thumbnail image.” Id. ¶ 156. Dr. Surati’s testimony (id. ¶¶ 155–157) is adequately supported by” slip op. at 38

  Patent outcomesUS 9,552,376 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 9,552,376
• Google LLC v. Neonode Smartphone LLCNo claims unpatentable
  PTAB · Jan 11, 2023 · IPR2021-01041 · APJ Christopher L Ogden · IPR · Final written decision

  Google did not show claims 1–7, 9, 12, 13, and 15–17 unpatentable because the asserted combinations did not teach or suggest the claimed multi-step activation involving gliding away.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “For Google, Dr. Wobbrock testifies that a person of ordinary skill in the art at the time of the invention, would have had “at least a bachelor’s degree in Computer Science, Human-Computer Interaction, Symbolic Systems, or related engineering disciplines, and at least two years of experience designing and programming graphical user interfaces,” but that “[r]elevant work experience can substitute for formal education and advanced degree studies could substitute for work experience.” Ex. 1003 ¶ 49. Testifying for Neonode, Dr. Rosenberg states that for his declaration, he “will apply the same definition of the level of skill of a [person of ordinary skill in the art]” as Dr. Wobbrock. Ex. 2019 ¶ 27. We find Dr. Wobbrock’s uncontested articulation to be reasonable in light of the subject matter involved in the ’879 patent and the asserted prior art. See, e.g., Ex. 1001, 1:49–61 (stating that the ’879 patent addresses technical problems including “to provide a user-friendly interface . . . on a small handheld computer unit”). Thus, we adopt it for our decision.” slip op. at 9

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

    “Google does not propose any explicit claim constructions in its Petition. See Pet. 4. Neonode does not propose any explicit constructions either, but in its Response, Neonode raises a number of claim construction arguments regarding the term gliding . . . away as it appears in limitation 1c, to which Google responds in its Reply. See PO Resp. 31–50, 66–69; Pet. Reply 7–12, 19–21; see also PO Sur-reply 1–10, 19–21. We do not need to construe this term explicitly for our decision, and to the extent we need to interpret this or any other terms, we address the terms below in the context of the prior art. 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))).” slip op. at 10

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

    “We find Google’s argument unpersuasive.10 Tarpenning’s assignment operation for hotkey 82 is in the nature of a drag-and-drop operation, where the user drags the pen from hotkey 82 to the intended menu item to which hotkey 82 will be assigned. But Google identifies the “function [to be] activated”—not as the actual assignment of hotkey 82 to the menu item when the user lifts from the intended menu item—but as the underlying software process that looks to see whether the user has lifted yet from the selected menu item. See Pet. Reply 19–20; Tr. 37:17–39:16. Essentially, Google asserts that the recited function is part of processing the gesture itself, which we do not find persuasive. As counsel for Neonode argued at the hearing, unless the user lifts off from a menu item, no assignment to hotkey 82 has been made and nothing has actually been done. See Tr. 80:4– 13. 10 We also consider this argument untimely, as it appears to contradict Google’s original theory of obviousness in the Petition, which states that the “‘assignment’ function” is “completed when the user reaches the target item to be assigned.” Pet. 79; see also Tr. 80:2–3 (counsel for Neonode arguing, “I submit that’s not only a new point they’re making, it’s unsupported and . . . incorrect.”); 37 CFR § 42.23(b) (“A reply may only respond to arguments raised in the corresponding . . . patent owner response[] or decision on institution.”). We also find unpersuasive Google’s original argument in the Petition that the recited “function” is activated when the user reaches the target menu item being assigned to hotkey 82. See Pet. 79. This is essentially a traditional drag-and-drop operation. But we credit Dr. Rosenberg’s testimony that when the user lifts from the intended menu item, no function has actually been activated. See Ex. 2019 ¶ 139. Rather, at this point a function has merely been assigned to the hotkey for future activation by touching the hotkey. See id. Thus, we determine that Google has not identified any disclosure in Tarpenning in which any “function is activated by a multi-step operation” as recited in limitation 1c. Absent that teaching or suggestion, Google’s argument (Pet. 80–82) does not adequately articulate why a person of ordinary skill in the art would have modified Tarpenning’s book menu key 84 or library menu key 86 to achieve limitation 1c, and we find Google’s obviousness argument unpersuasive as to claim 1.” slip op. at 36

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “would have understood Robertson’s “flick” gesture to comprise “gliding . . . away” as we interpret that term. Robertson says very little about the “flick” gestures themselves, other than using the word flick. See, e.g., Ex. 1005, 39. Robertson teaches that its gestures should be “easily differentiated,” and in addition to “flick” gestures, Robertson also teaches “drag and drop” operations. Id. at 36 (“[Y]ou can drag a document icon and drop it into a printer icon to print the document . . . .”). We credit Dr. Rosenberg’s testimony that, for the XButton system to immediately distinguish between dragging and flicking, there must be some distinction between a “flick” and a “drag,” and that the most plausible difference is in terms of their speed, distance, or both. See Ex. 2019 ¶ 90. Although Robertson discloses that its system is capable of recognizing gestures that start on an XButton and extend outside it (see Ex. 1005, 43), a “glide” or that the distinction is arbitrary. Cf. Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349, 1360 (Fed. Cir. 2014) (“Descriptive words . . . are commonly used in patent claims, to ‘avoid[] a strict numerical boundary to the specified parameter.’” (alteration in original) (quoting Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995))) the only gesture for which Robertson specifically indicates this would be necessary is a “circling gesture[] for grouping, moving, and copying graphical objects” (id. at 39). Thus, we disagree with Google that Robertson’s teaching in this regard is relevant to what Robertson means by a “flick” gesture. We also find persuasive Neonode’s dictionary definitions, spanning from 1993 to 2012, which consistently indicate that the word flick describes a movement that is “light,” “sharp” or “quick,” and “jerky” or “sudden,” as opposed to definitions of “glide” referring to a movement that is “smooth,” “continuous,” and possibly “quiet” or “effortless.” Exs. 2049, 2050, 2052, 2057.9 And although the evidence postdates Robertson, we find relevant the supporting evidence that modern Apple and Google developers maintain a meaningful distinction between “flick” and “swipe” gestures. See Ex. 2022, 4; Ex. 2023, 6; Ex. 2025, 21; Ex. 2026, 5; Ex. 2029, 2; Ex. 2019 ¶¶ 80–81. We further credit Dr. Rosenberg’s opinion that in the relevant time frame, a person of ordinary skill in the art would have interpreted a “flick” gesture as one in which “the pen would touch the screen, but only moves on the screen for a very short distance and is quickly lifted from the screen in a ‘jerky’ motion.” Ex. 2019 ¶¶ 85–86. 9 The earliest dictionary definitions (Ex. 2052) are from 1993, which is roughly contemporary with Robertson (1991), and are sufficiently close in time to be relevant. Google does not present any evidence suggesting that the meaning of flick had changed between 1991 and 1993. See PO Sur-reply 2. Thus, we agree with Neonode that Google has not shown that Robertson’s “flick” gesture comprises “gliding . . . away,” and thus falls within the scope of claim 1. Finally, we also agree with Neonode that Google has not established that Robertson’s “insert” (caret) gesture comprises “gliding . . . away.” Although Robertson does not provide much information about this gesture, we find Dr. Rosenberg’s interpretation and annotated version of Figure 1 (Ex. 2019 ¶¶ 99–102) more credible than those of Dr. Wobbrock (Ex. 1003 ¶ 108). We credit Dr. Rosenberg’s testimony that a person of ordinary skill in the art would have understood the “insert” gesture to be similar to the way a person would draw a caret to indicate an insertion within existing text. See Ex. 2019 ¶ 99. Thus, we agree it would involve two brief, connected movements with a sharp peak, neither of which would be a continuous gliding or swiping motion. Id. ¶¶ 100–102.” slip op. at 27

  Patent outcomesUS 8,095,879 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,095,879
• Laboratory Corporation Of America Holdings v. Ravgen, Inc.No claims unpatentable
  PTAB · Dec 12, 2022 · IPR2021-01026 · APJ David Cotta · IPR · Final written decision

  Claims 1–9 and 21–30 were not shown unpatentable: Lee did not establish that ACD dextrose impeded cell lysis, and Sorenson/Rao lacked motivation to combine because formaldehyde was known to damage nucleic acids.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Dr. Van Ness’s proposed POSA level is too broad. Under that proposal, an individual with, for example, an undergraduate degree in microbiology and three years’ work experience studying the habitats of bacteria might qualify as a POSA. It is not clear that such a person would have sufficient, relevant experience in the detection of chromosomal abnormalities, especially through non-invasive methods for detecting fetal 10 genetic abnormalities in maternal samples, as described in the ’720 patent. See, e.g., Ex. 1001, 1:22–5:44 (Field of Invention and Background Art). Petitioner’s proposal of the POSA level is more precise because it requires familiarity with techniques for detecting cell-free DNA in biological samples, which is relevant to the prior art and the claimed technology. Petitioner’s proposal also appears to be more consistent with the cited prior art. 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). Accordingly, we adopt Petitioner’s POSA level here, but note that our other determinations on this record would not change under Patent Owner’s POSA level.12” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed board ownDisclaimer foundDecided for patent owner

    “Owner relied not on properties unique to EDTA, but on the fact that it was a “well-known chelator” and anticoagulant: [T]he assertion by the Office that EDTA is a cell lysis inhibitor is simply incorrect. . . EDTA is not an “agent that inhibits cell lysis.” Rather, EDTA is a well-known chelator of calcium and magnesium. EDTA is routinely added to blood during the blood collection process as an anticoagulant due to its ability to chelate calcium. Ex. 2064, 1196. Given Patent Owner’s clear intent to exclude EDTA from the scope of the claimed “agent” on the basis that it was a chelator and an anticoagulant, we find that a POSA would have understood other chelators and anticoagulants to also be excluded from the scope of the claimed agent. Consistent with this understanding, during subsequent prosecution of the application that issued as the ’720 patent, Patent Owner argued that the Holodniy reference, which disclosed a method of detecting free nucleic acid in which blood was collected in tubes containing ACD, “fail[ed] to teach or suggest a method for detecting free nucleic acid comprising, inter alia, isolating free nucleic acid from a non-cellular fraction of a sample, wherein an agent that impedes cell lysis has been added.” Ex. 1003, 1428 (emphasis added). On the salient point here, the Examiner agreed, concluding that “Holodniy et al. teach a method of detecting free nucleic acid which comprises all of the limitations of Claim 1, except these authors do not teach that their samples comprise an agent that impedes cell lysis.” Id. at 1344 (emphasis added); see also id. at 1156 (finding that Adams et al., a reference that also collects blood in tubes containing ACD, taught “all of the limitations recited in Claim 1 except these authors do not teach adding an agent that impedes cell lysis to the sample.”). And Patent Owner argues 15 persuasively, without dispute from Petitioner, that ACD is the “only” addition to the collection tubes besides the blood sample itself. Sur-reply 4 (citing Ex. 1016, 2; Ex. 2023, 20:52–54). This supports that neither the Examiner nor the Patent Owner considered ACD as an anticoagulant chelator to be an “agent,” as that term is used in claim 1. Accordingly, we construe the phrase “agent that impedes cell lysis” to” slip op. at 15

  • Strike new argumentNew argument consideredDecided for petitioner

    “function to prevent cell lysis, “by: (1) interacting with and stabilizing the cell membrane; (2) maintaining osmolarity so that the cells do not rupture; and (3) providing a nutrient source.” Reply 3 (citing Ex. 1002 ¶¶ 22–23; 2001 ¶ 169; Ex. 1059 ¶ 5; Ex. 1054, 125:3–127:12; 1057, 3–4, and Ex. 1056, 7– 13, 15–19, 24). Patent Owner argues that the evidence as to how dextrose functions to prevent cell lysis should have been presented in the Petition. Sur-reply 16. On this record, we do not agree. While this evidence could have been included in the Petition, it is responsive to arguments raised in Patent Owner’s response. See PO Resp. 18–22. In any event, consideration of this evidence simply explains how and why dextrose has the capacity to impede cell lysis, and we have already found that the ’720 patent provides 25 evidence that dextrose has this capacity. Under the circumstances, it was therefore reasonable for Petitioner, in the Petition, to rely on such disclosures of the patent itself. Further, consideration of how and why dextrose impedes cell lysis largely benefits Patent Owner, by providing reasons why dextrose might not inhibit cell lysis under the specific circumstance present in Lee.” slip op. at 25

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “interact with and stabilize the cell membrane. Reply 3 (citing Ex. 1002 ¶¶ 22–23). In the cited testimony, Dr. Edwards states, “it was known that carbohydrates have a role in membrane stabilization” and that dextrose “is a membrane stabilizer.” Ex. 1002 ¶¶ 22–23. This is consistent with the teaching in the ’720 patent that glucose is “[a]n agent that stabilizes cell membranes.” See e.g., Ex. 1001, 6:49–56. The evidence thus supports that dextrose can help to stabilize cell membranes. However, this evidence is tempered by evidence supporting that the “impact of carbohydrates on biological membranes is extremely complex” and that it is “extremely difficult to predict how solutes such as carbohydrates will affect biological membranes.” Ex. 2231, 60:18–61:2, 83:14–18 (Dr. Edwards testimony). This is because “there’s a finite but long – long list of variables that will impact the – the mechanism by which carbohydrate interacts with the cell membrane.” Id. at 66:20–67:7; see also id. at 66:1–15 (identifying temperature, concentration and pressure as variables that play a role in how carbohydrates interact with biological membranes); id. at 68:1–17 (identifying prior and simultaneous exposure to other substances as variables that play a role in how carbohydrates interact with biological membranes). 26 Petitioner also provides evidence that dextrose helps prevent cell lysis by “maintaining osmolarity so that cells do not rupture.” Reply 3 (citing Ex. 2001 ¶ 169; Ex. 1056, 7–13, 24; Ex. 1059 ¶ 5). We agree that the cited evidence supports that dextrose has the ability to prevent cell rupture by maintaining isotonicity. In particular, Rapoport found that erythrocytes in an acid-citrate glucose solution underwent osmotic hemolysis at a slower rate than erythrocytes in a simple citrate solution. Ex. 1056, 613. However, Patent Owner introduces evidence, which we credit, that the failure to maintain isotonicity does not necessarily cause cell lysis. Ex. 2299, 237:4– 16 (Dr. Edward’s testimony). For example, cells placed in a hypertonic solution may “shrink or kind of shrivel” rather than burst, and cells placed in a hypotonic solution may swell, but will not necessarily lyse. Id. at 245:3– 16, 246:17–247:8.” slip op. at 26

  Patent outcomesUS 7,727,720 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,727,720
• 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
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Cardiovalve Ltd.No claims unpatentable
  PTAB · Dec 6, 2022 · IPR2021-01051 · APJ John G New · IPR · Final written decision

  The Board granted the non-contingent motion to amend, canceling claims 1–10 and replacing them with claims 11–20, which Petitioner failed to prove unpatentable over Goldfarb ’267.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “We conclude that Petitioner’s arguments are insufficient to meet its burden of showing, by a preponderance of the evidence, that Goldfarb ’267 anticipates, or renders obvious, the limitation of proposed substitute claim 11 reciting “advancing the end of the first-clip arm and the end of the second-clip arm out of the delivery tube before advancing the support portion out of the delivery tube” merely requires advancing the ends of the clip arms out of the delivery tube “before advancing the support portion out of the delivery tube.” Moreover, Petitioner’s arguments are not persuasive with respect to proposed substitute dependent claims 12–20 due to their dependence from, and incorporation of, the limitations of proposed substitute claim 11. See Supp. Mot. Amend. 1, Reply Supp. Mot. Amend. 1. We therefore conclude that these proposed substitute claims are similarly neither anticipated by, nor obvious over, Goldfarb ’267. III. CONCLUSION We GRANT Patent Owner’s non-contingent Motion to Amend and Supplemental Motion to Amend, canceling original claims 1–10 and replacing them with substitute claims 11–20. Additionally, for the foregoing reasons, and after having analyzed the entirety of the record and assigning appropriate weight to the cited supporting evidence, we determine that Petitioner has failed to establish, by a preponderance of the evidence, that proposed substitute claims 11–20 are unpatentable.” slip op. at 57

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having weighed the evidence and Petitioner’s argument, we adopt Petitioner’s definition of a person of ordinary skill in the art as: (1) a mechanical or biomedical engineer with at least three years of experience in designing or developing medical devices who would, where necessary or desired, work or consult with others including a physician to develop such a medical device; or (2) an interventional cardiologist or cardiac surgeon with at least three years of experience developing and/or using medical devices in the heart, and who would, where necessary, work or consult with others including an engineer to develop such a medical device. See Pet. 15–16.” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Vesely. Ex. 1003. We have reviewed the credentials of Dr. Vesely and consider him qualified to provide the opinions for which his testimony has 4 Goldfarb et al. (US 7,563,267 B2, July 21, 2009) (“Goldfarb ’267”) (Ex. 1005). 5 Petitioner refers to Goldfarb’s ’267 disclosure of a further alternative at Ex. 1005 col. 27 ll. 57–60 as Embodiment A. See Pet. 19. We understand the asserted Embodiment A to encompass the description that extends to Ex. 1005 col. 28, l. 9. See Pet. 24–48. 6 Goldfarb et al. (US 7,635,329 B2, December 22, 2009) (“Goldfarb ’329”) Ex. 1006. 7 Ex. 1005 cols. 17–23, ll. 66–29, Figs. 9–16; see Pet. 21–22. been submitted. See id. ¶¶ 1–9; see also Ex. 1004 (Dr. Vesely’s curriculum vitae).” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “is described in Goldfarb ’267 as plainly a single, unitary structure and, as such, each portion argued as separate elements by Petitioner (i.e., male element (yellow), female element (green), coupling member 19 (blue) and flexible arms 19A and 19B (dark blue)) together form a solid, single component. Thus, all of the “elements” described by Petitioner as being “separate” are in fact a single unit that: (1) bears the weight of the fixation device during delivery; (2) absorbs and transfer the axial and rotational forces imposed by the shaft 12; and (3) holds the device in the correct orientation. Petitioner points to no disclosure of Goldfarb ’267 that suggests these elements act independently or separately to perform the functions of the unitary component, nor can we discern any such disclosure. We therefore find that Petitioner’s argument that only the “male element” portion of coupling member 19 constitutes the “support portion” recited in proposed substitute claim 11 is an arbitrary and unduly restrictive interpretation of the reference’s disclosure. This is particularly true given that Petitioner points to no portion of the male element of coupling member 19 performing a supporting function that is not shared by the other elements of coupling member 19. We conclude that the better understanding of the reference is that the entirety of coupling member 19 (including flexible arms 10A and 19B11) constitutes an analogous support portion, as recited by substitute claim 11, because it provides a unitary structure that performs the supporting functions enumerated by Petitioner.” slip op. at 41

  Patent outcomesUS 10,702,385 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 10,702,385
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · Dec 2, 2022 · IPR2021-00853 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–3, 5, 6, 8, 12, and 13 were not proven unpatentable because the asserted combinations lacked a persuasive basis for achieving the claimed system with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Petitioner’s proposed definition of the person of ordinary skill in the art appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’725 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as also including a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers, and that these people may collaborate. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate here, based on our review of the record. Thus, we find that the person of ordinary skill in the art would have been someone with a PhD, MS, or BS degree in physics, biomedical engineering, or a related science such as nuclear engineering, having more or less experience in research, manufacturing, or designing medical optics or medical lasers (e.g., 5 years for a PhD or more to compensate for lesser degrees), or an ophthalmic surgeon, but that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties and is appropriate in view of the record.” slip op. at 17

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “Patent Owner does not ask that this claim language be expressly construed or contest Petitioner’s proposed interpretation. See Resp. 11–15. Although it is not necessary for our final decision in this proceeding to construe this claim language because it is not essential to our conclusions on patentability, as it is uncontested, we adopt as our own Petitioner’s proposed construction of “imaging device configured to acquire point by point image data from locations distributed throughout a volume of a crystalline lens.”” slip op. at 19

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

    “Turning to the disputed term “automatically” in this context, we agree with Patent Owner that the plain meaning of the term “automatically” is that the “control system” can, on its own and without human intervention, perform the subsequently recited step. Resp. 11–15; see also Pet. 10 (Petitioner agreeing this is the plain meaning). This is supported by the Specification, which states, inter alia, that “the entire system is controlled by the controller CPU” and describes alternative embodiments where (1) the system is fully in control and where (2) user input identifies targets. Ex. 1027, 12:23–25, 13:25–44, Figs. 14, 15. However, we also agree with Petitioner that just because the claimed “control system” is configured/programmed to perform (i.e., capable of performing) some tasks “automatically” (i.e., entirely on its own), this does not mean user input (e.g., from a surgeon) must be altogether excluded. Pet. 10–11. In fact, user input must be possible and is within the scope of the independent claim. “By definition, an independent claim is broader than a claim that depends from it, so if a dependent claim reads on a particular embodiment of the claimed invention, the corresponding independent claim must cover that embodiment as well.” Littelfuse, Inc. v. Mersen USA EP Corp., 29 F.4th 1376, 1380 (Fed. Cir. 2022). Here claim 2, requiring automatic target identification, and claim 5, requiring user input on target identification, each depends from claim 1 and illuminates its scope, which must be broad enough to encompass both. Thus, although requiring (in claim 1) that a “control system” can perform certain recited functions, and that some are performed (according to claim 2) “automatically,” that same “control system” must also be capable of allowing a user input on the locations of targets for laser treatment (according to claim 5). Such optional user input required by dependent claim 5 is described in the Specification, which includes embodiments where a surgeon can adjust the size, location, and shape of the treatment pattern, can determine the optimal cutting contours in patients, and can provide “user input” to define targets or adjust computer-defined parameters as necessary. Ex. 1027, 10:55–45; 10:67–11:2, 13:25–55, 13:63–14:2. Regardless, the configuration of independent claim 1’s “control system,” which must be programmed to and capable of performing its own recited steps/functions, is not diminished by the requirements of either dependent claim. Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corporation, 831 F.3d 1350, 1360 (Fed. Cir. 2016) (“[T]he language of a dependent claim cannot change the scope of an independent claim whose meaning is clear on its face.”).” slip op. at 22

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

    “generally. “The presence or absence of a reasonable expectation of success is . . . a question of fact,” and this “requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., 821 F.3d at 1366–67. Based on the record, we conclude that, even if it would have been potentially advantageous to in some way incorporate the use of Baikoff’s and Li’s OCT imaging and measuring into Swinger’s system and method for cataract surgery (for example, to replace the use of ultrasound imaging with OCT), we agree with Patent Owner that, other than the (ultimately) conclusory testimony of its witness Dr. Izatt (see, e.g., Ex. 1001 ¶¶ 110, 144, 151, 161, 163–165, 168), there is no persuasive evidence that the person of ordinary skill in the art would have combined these references with the result being a control system configured to (automatically or not in practice) image cataractous eye tissue, identify the targets therein (capsule and lens) to be cut with a laser, and then operate that laser to actually make those cuts based in some part on that imaging. See Resp. 15–34. We credit Dr. Kang’s testimony that, as of the invention, the person of ordinary skill in the art would not have relieved the surgeon of responsibility for identifying cutting regions for laser capsulotomy and cataract surgery (as taught by Swinger), and relegated such task to a computer, which subsequently performs the procedure. Ex. 2087 ¶¶ 36–38, 42, 46, 62–66; see also Ex. 2088 ¶¶ 56–59, 68–71 (Dr. Walter testifying similarly). Dr. Kang takes issue with Petitioner’s positions that Baikoff and Li teach or suggest such reliance on a computer because, according to Dr. Kang, neither Baikoff nor Li (and indisputably not Swinger) teaches using a computer to identify laser cutting regions or to control laser surgery, and, in fact, they suggest reliance on a surgeon to interpret their OCT images to plan a subsequent surgery. See, e.g., Ex. 2087 ¶¶ 36–38, 42, 46, 62–66. We further credit Dr. Kang’s testimony that Petitioner fails to adequately explain, even were the ordinarily skilled artisan intent on combining Baikoff’s and Li’s OCT imaging systems with Swinger’s cataract surgery system, how it would have been accomplished to overcome the “substantial challenges” and achieve the claimed invention. See id. ¶¶ 63– 66; see also Resp. 27–28 (addressing Petitioner’s lack of explanation as to how to implement the combination).19 We agree that, beyond merely suggesting plugging one system into another, Petitioner does not explain how the person of ordinary skill in the art would have programmed Swinger’s computer control system to use Baikoff’s and Li’s OCT imaging systems and tissue recognition and measurement algorithms to determine capsulotomy cutting regions and then implement the planned cutting with a laser, even from a rudimentary perspective. See Pet. 35–40. Indeed, Petitioner concedes:” slip op. at 50

  Patent outcomesUS 9,125,725 not shown unpatentable
  Claim construction§ 103 obviousnesscites Alice · Phillips · KSR · Graham
  Patents in suitUS 9,125,725
• 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
• Laboratory Corporation Of America Holdings v. Ravgen, Inc.No claims unpatentable
  PTAB · Nov 1, 2022 · IPR2021-00902 · APJ Timothy G Majors · IPR · Final written decision

  Claims 81–96 and 133 were not shown unpatentable because a skilled artisan would not have been motivated to combine the asserted art with Chiu.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s proposed POSA level is too broad. Under that proposal, an individual with, for example, an undergraduate degree in microbiology and three years’ work experience studying the habitats of bacteria might qualify as a POSA. It is not clear that such person would have sufficient, relevant experience in the detection of chromosomal abnormalities, especially through non-invasive methods for detecting fetal genetic abnormalities in maternal samples, as described in the ’277 patent and the prior art here. See, e.g., Ex. 1001, 1:31–5:59 (Field of Invention and Background Art); Ex. 1003 (Chiu). Petitioner’s proposal of the POSA level is more precise because it requires familiarity with techniques for detecting cell-free DNA in biological samples, which is relevant to the prior art and the claimed technology. Petitioner’s proposal also appears to be more consistent with the cited prior art. Okajima v. Bourdeau, 261 F.3d 1350, 14 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). Accordingly, we adopt Petitioner’s POSA level here, but note that our other determinations on this record would not change under Patent Owner’s POSA level.13” slip op. at 14

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

    “n.3; PO Sur-Reply 14–15; see generally Papers 51 and 52.14 It is not necessary for us to further construe those dependent claims to resolve this case. Petitioner relies on formaldehyde or formaldehyde donors, as disclosed in Bianchi, Granger, and Rao, to satisfy the claimed “agent” term, and urges the addition of such compounds to Chiu’s method for isolating and detecting cffDNA in a maternal sample. There is no dispute on this record that formaldehyde and formaldehyde donors meet the claimed “agent” term. We are, thus, able to determine if the asserted art discloses an “agent” as claimed and whether a POSA would have been motivated to add formaldehyde or a formaldehyde donor to Chiu, which issue we find is decisive here, without further interpreting dependent claims 90, 91, or 133. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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.”) (internal quotation marks omitted). 14 The disagreement on interpretation of this handful of dependent claims arose in relation to Rao’s prior-art status for those claims (Pet. Reply 5 n.3; PO Sur-Reply 14–15), and Patent Owner’s nexus showing for secondary considerations of nonobviousness (id. at 21). See Pet. Reply 3 n.2 (noting the priority “arguments are only relevant to Ground 3” because the prior art status of Chiu, Bianchi, or Granger is uncontested). But, as we discuss below, Petitioner’s challenge to the claims fails on this record regardless of the disagreement on Rao’s prior art status and, because Petitioner has not made the necessary threshold showing that a POSA would have combined the asserted art in the manner proposed, we need not reach secondary considerations of nonobviousness.” slip op. at 16

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “detection method of Chiu.27 More specifically, we find on this record that a POSA would have been dissuaded from adding Bianchi’s paraformaldehyde because the POSA would have expected Bianchi’s paraformaldehyde to create gaps in the cell membranes, providing a means for maternal DNA to escape into the sample. We also find on this record that a POSA would have been dissuaded from adding paraformaldehyde to Chiu’s methods because formaldehyde was known to damage nucleic acids.28 Patent Owner’s reasoning and evidence on those issues, separately and cumulatively, outweigh Petitioner’s comparatively weak showing on whether a POSA would have combined the art in the manner proposed. We discuss in greater detail below. We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 27 WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016) (“Whether an ordinarily skilled artisan would have been motivated to modify the teachings of a reference is a question of fact.”) (citations omitted); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”). 28 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 38 ¶¶ 96–98; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 99–101. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 38

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

    “detection method of Chiu.27 More specifically, we find on this record that a POSA would have been dissuaded from adding Bianchi’s paraformaldehyde because the POSA would have expected Bianchi’s paraformaldehyde to create gaps in the cell membranes, providing a means for maternal DNA to escape into the sample. We also find on this record that a POSA would have been dissuaded from adding paraformaldehyde to Chiu’s methods because formaldehyde was known to damage nucleic acids.28 Patent Owner’s reasoning and evidence on those issues, separately and cumulatively, outweigh Petitioner’s comparatively weak showing on whether a POSA would have combined the art in the manner proposed. We discuss in greater detail below. We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 27 WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016) (“Whether an ordinarily skilled artisan would have been motivated to modify the teachings of a reference is a question of fact.”) (citations omitted); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”). 28 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 38 ¶¶ 96–98; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 99–101. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 38

  Patent outcomesUS 7,332,277 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,332,277

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