• Restem, LLC. v. Jadi Cell, LLCNo claims unpatentable
  PTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52

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

    “21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38

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

    “Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64

  Patent outcomesUS 9,803,176 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,803,176
• Berkeley Lights, Inc. v. The University Of British ColumbiaNo claims unpatentable
  PTAB · Jan 19, 2023 · IPR2021-01249 · APJ Christopher L Ogden · IPR · Final written decision

  Claims 1, 6, 11, 16, 19, 24, 26, 27, and 30 were not shown unpatentable because the asserted references did not establish selective recovery or a sufficient motivation to combine.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Relying on Dr. Meinhart’s testimony, Petitioner argues that a person of ordinary skill in the art “would have had a bachelor’s degree in mechanical engineering, chemical engineering, biomedical engineering, molecular biology, (bio)chemistry, or an equivalent degree relevant to microfluidic biological cell analysis, and three to five years of experience with the construction of and application of microfluidic devices to cell culture and analysis.” Pet. 8–9 (citing Ex. 1002 ¶ 40). Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. See PO Resp. 3–4 (citing Ex. 2012 ¶¶ 19–20). We find Petitioner’s uncontested articulation to be reasonable in light of the subject matter involved in the ’408 patent and its description of the relevant prior-art background. See, e.g., Ex. 1001, 1:15–2:54 (describing the field and related art as relating to the construction and use of microfluidic devices in cell culture and analysis). Thus, we adopt it for our decision.” slip op. at 9

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

    “Petitioner contends that “no terms require express construction for purposes of resolving the challenges in this proceeding.” Pet. 9; accord Pet. 12. Petitioner also notes that in the parallel district court proceedings, Patent Owner has proposed constructions for the terms chamber and retaining position that differ from Petitioner’s proposed constructions. Pet. 9–10 (citing Ex. 1013 App’x A, 1, 3 (Patent Owner’s proposed constructions); Ex. 1021, 7, 8 (Petitioner’s proposed constructions); Ex. 1002 ¶ 44). In those proceedings, Patent Owner’s proposed construction for chamber is “an enclosed space within a microfluidic device,” and its proposed construction for retaining position is “a location in the chamber at which a cell is maintained during cell culture and media exchange.” Ex. 1013, 6, 8. Although Petitioner does not contend that its arguments rely on the choice of construction for these terms, Petitioner adopts Patent Owner’s constructions for this proceeding. Pet. 11. Patent Owner does not contest these proposed constructions, or propose any other explicit constructions. See generally PO Resp. We agree with Petitioner that we do not need to construe the terms chamber and retaining position to decide the issues presented in this proceeding, and to the extent we need to interpret the meaning of any claim language, we address the interpretations 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 11

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “selectively recovering a cell based on the response in the monitoring step. Although Dimov discloses non-selective recovery and briefly lists a few general techniques that might be used for either mixing or recovery, Dimov does not specifically indicate which of the techniques would be useful for recovery rather than just mixing, and Dimov does not explicitly disclose that any cell recovery would be selective. Nor has Petitioner shown that Dimov inherently discloses selectively recovering any particular cell that has been cultured and monitored, because, as Dr. Gale persuasively testifies, Dimov’s removal techniques could, as far as a person of ordinary skill in the art would have known based on Dimov’s disclosure, be merely for “removing . . . unwanted particles out of the capture chamber/trench.” Ex. 2012 ¶ 64; see also id. ¶ 63 (“Dimov . . . may suggest removing cellular materials (rather than intact cells) after capture . . . .”). In other words, given Dimov’s general focus on performing experiments within the trenches and the lack of any specific disclosure about how or why to remove cells, Petitioner has not met its burden to show that Dimov’s potential cell-removal techniques would have necessarily been based on a response of a specific cell being cultured and monitored in limitation 1D. We also agree with Patent Owner that Dimov does not disclose any specifics about how to carry out a selective cell removal based on one of Dimov’s listed techniques, such as laser tweezers. See PO Resp. 8–9. Nor does Petitioner meet its burden of showing that such a technique would have been within the ordinary skill in the art at the time of the claimed invention. “In order to anticipate, a prior art disclosure must also be enabling, such that one of ordinary skill in the art could practice the invention without undue experimentation.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005) (citing SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1342 (Fed. Cir. 2005)). Given the labyrinthine outlet channels leading from Dimov’s chambers to the common waste stream and Dimov’s lack of any disclosure of a way to identify and extract cells in the outlet streams, we credit Dr. Gale’s testimony that there would have been substantial obstacles to recovering any specific cells that had been liberated from a trench in Dimov’s device. See Ex. 2012 ¶ 63. Petitioner has not shown that a person of ordinary skill in the art would have overcome those obstacles without undue experimentation.” slip op. at 23

  • Strike new argumentNew argument disregardedOther

    “18 Patent Owner contends that these arguments are untimely, and we agree at least as to certain of the arguments. See Paper 27, Nos. 6, 9, 10; see Paper 28, Nos. 6, 9, 10 (Petitioner’s responses). The new arguments introduce new theories as to how to combine Park and Kovac, including additional steps or new modifications necessary for a successful combination, which could have been presented in the Petition but were not. Nevertheless, as we discuss below, we find these arguments unpersuasive. Petitioner also contends, for the first time, that a person of ordinary skill in the art would have addressed the problem of Park’s downward-forcing circulation patterns19 by starting with flow turned off and then turning on flow “after levitation begins, including after the cell has been pushed up out of a well high enough to be clear of recirculating flow lines created once it is turned on.” Pet. Reply 19–20 (citing Ex. 1039 ¶¶ 175– 177); see also id. at 22 (citing Ex. 1039 ¶ 193).” slip op. at 64

  Patent outcomesUS 10,087,408 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,087,408
• 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
• Polycom, Inc. v. Directpacket Research, Inc.No claims unpatentable
  PTAB · Aug 26, 2022 · IPR2019-01233 · APJ Sheila F Mcshane · IPR · Remand

  Claims 1–23 were not shown unpatentable over Ress or Ress and Doyle because the cited art did not teach receiving a multimedia data stream that includes media.

  RulingsRemand decision

  • RemandOther

    “Having analyzed the record in view of our reviewing court’s directive, we determine on remand, for the reasons that follow, that Petitioner has not shown by a preponderance of the evidence that claims 1–23 of the ’588 patent are unpatentable.” slip op. at 3

  • BurdenNot shown unpatentable

    “protocols for media stream communications (Pet. 24; Ex. 1004, 1:20–24), but the operative issue as to limitation1[a] is whether Ress teaches that a multimedia data stream, including media, is received at the communication controller (call server). We have reviewed the evidence and argument provided by Petitioner during trial, and we agree with Patent Owner that Petitioner fails to demonstrate that Ress teaches or suggests this limitation. PO Resp. 18–19. The evidence supports Patent Owner’s contention, referencing annotated Figure 3 reproduced below, that “Ress illustrates a ‘packetized media stream’ (in blue) communicated between gateways is not associated with the signaling messages (in red) communicated to the call server” and “[t]he ‘packetized media stream’ notably never reaches the call server 300 of Ress.” Id. at 14, 19.” slip op. at 16

  • Strike new argumentNew argument disregardedDecided for patent owner

    “We determine that Petitioner presents new evidence and arguments post-appeal, which is impermissible. In its Opening Brief On Remand, Petitioner refers to multiple portions of Ress which had not been cited in either the Petition or Petitioner’s Reply. See Pet. Rem. Br. 1–6 (citing Ex. 1004, 5:62–65, 4:35–42, 7:49–53, 11:62–65, 12:3–9, 4:36–38, 12:6–12, 13:54–59, 12:25–29, 12:31–33, 18:21–24, 18:51–52, 19:6–12). Petitioner also refers to evidence that was cited in Petition and Reply but was not previously relied upon for any assertions related to any transmission of media to the call server in Ress. Id. (citing Ex. 1004, 6:16–19, 10:45–49, 18:11–14, 12:13–17, 12:18–21, Figs. 7, 12–19).” slip op. at 19

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

    “protocols for media stream communications (Pet. 24; Ex. 1004, 1:20–24), but the operative issue as to limitation1[a] is whether Ress teaches that a multimedia data stream, including media, is received at the communication controller (call server). We have reviewed the evidence and argument provided by Petitioner during trial, and we agree with Patent Owner that Petitioner fails to demonstrate that Ress teaches or suggests this limitation. PO Resp. 18–19. The evidence supports Patent Owner’s contention, referencing annotated Figure 3 reproduced below, that “Ress illustrates a ‘packetized media stream’ (in blue) communicated between gateways is not associated with the signaling messages (in red) communicated to the call server” and “[t]he ‘packetized media stream’ notably never reaches the call server 300 of Ress.” Id. at 14, 19.” slip op. at 16

  Patent outcomesUS 7,773,588 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 7,773,588
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

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

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659
• Lenovo Holding Company, Inc. / Lenovo (United States) Inc. et al. v. Interdigital Technology CorporationNo claims unpatentable
  PTAB · Apr 14, 2022 · IPR2020-01505 · APJ John R Kenny · IPR · Final written decision

  Claims 1–10 were not shown unpatentable because Petitioner failed to establish that Zhang disclosed the claimed response to a non-zero grant construed as a power ratio greater than zero.

  RulingsFinal written decision

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

    “Here, we determine that the term “power ratio” in the involved parenthetical in the Specification is a definition, and not merely an illustrative example, of a “grant.” First, the Specification does not identify any other type of grant. Dr. Mahon testifies that the Specification does not provide an example of any other type of grant. Ex. 2001 ¶ 35. Petitioner offers no rebuttal expert testimony and identifies no other type of grant disclosed in the Specification. See Pet. Reply 1–5. We credit Dr. Mahon’s unrebutted testimony that the Specification does not identify any other type of grant. Ex. 2001 ¶ 35. Thus, the parenthetical at issue in this case does not exclude any grant described in the Specification (nor, as set forth in Section II.B.2.ii, any grant set forth by ordinary meaning of the term grant based on the extrinsic evidence of record).” slip op. at 11

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Petitioner offers no extrinsic evidence, other than the testimony of Dr. Kakaes, regarding the ordinary meaning of the term “grant,” and Dr. Kakaes cites no extrinsic evidence to support his definition of the term “non-zero grant.” Pet. 12; Pet. Reply 1–5; Ex. 1003 ¶¶ 63–65. Dr. Kakaes does not separately address the meaning of “grant.” Ex. 1003 ¶¶ 63–65. We find Dr. Mahon’s testimony and the 3GPP Technical Specification persuasive. As set forth above, the 3GPP Technical Specification describes grants as power ratios—a fact that Petitioner does not dispute. Pet. Reply 1– 5. Further, as set forth above, in light of the Specification’s references to 3GPP standards and the 3GPP recitations in the preambles of claims 1 and 6, 3GPP standards from the time of the ’873 patent are highly relevant evidence to an ordinarily skilled artisan of the ordinary meaning of the terms “grant” and “non-zero grant.” iii. A Non-zero Power Ratio is a Power Ratio Greater than Zero Dr. Mahon testifies that a “non-zero grant” should be construed as “a power ratio greater than zero.” Ex. 2001 ¶ 33. Dr. Mahon explains that a power ratio cannot be negative, so a “non-zero” power grant must be greater than zero. Id. ¶ 38. Petitioner does not dispute Dr. Mahon’s testimony that a power ratio cannot be negative. Pet. Reply 1–5. Petitioner further does not dispute that if a “grant” is construed to be a “power ratio,” a “non-zero grant” should be construed to be a “power ratio greater than zero.” Id. We credit Dr. Mahon’s testimony that a power ratio cannot be negative. Ex. 2001 ¶ 38. Thus, in light of the Specification’s and extrinsic evidence’s teachings that a “grant” is a “power ratio,” we construe “non-zero grant” to be a “power ratio greater than zero.”” slip op. at 19

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “2. Claim 1 Claim 1 recites the following limitation: triggering transmission of scheduling information (SI), from the WTRU to a Node-B, in response to the WTRU having a non-zero grant smaller than needed preventing the WTRU from sending a medium access control protocol data unit (PDU) of any of a plurality of scheduled medium access control-d (MAC-d) flows. [“responsive limitation of claim 1”] Ex. 1001, 7:36–8:6 (emphasis added). Petitioner does not argue, let alone prove, that Zhang discloses the transmission of scheduling information “in response to the WTRU having a non-zero grant smaller than needed” when “non-zero grant” is construed as a “power ratio greater than zero.” Pet. 25–29; Pet. Reply 1–5, 12–13. Thus, Petitioner has not proven that claim 1 is anticipated by Zhang. 3. Claim 5 Claim 5 depends on claim 1. Ex. 1001, 8:15–16. Petitioner relies on its showing for claim 1 for the limitations that claim 5 incorporates from claim 1. Pet. 29–30. Thus, Petitioner has not proven that claim 5 is anticipated by Zhang.” slip op. at 25

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

    “B. Ground 2: Asserted Obviousness over Zhang Petitioner asserts that claims 1, 5, 6, and 10 would have been obvious over Zhang. Pet. 5. For the responsive limitations of claims 1 and 6, Petitioner relies on its showing for Ground 1. Id. at 32–33. Thus, Petitioner has not proven that claims 1 and 6 would have been obvious over Zhang. For claims 5 and 10, Petitioner also relies on its showing for Ground 1. Id. at 33. Thus, Petitioner has not proven that claims 5 and 10 would have been obvious over Zhang. C. Ground 3: Asserted Obviousness over Zhang and TS 25.321 Petitioner asserts that claims 1–10 would have been obvious over Zhang and TS 25.321. Pet. 5. For this ground, Petitioner argues “[t]o the extent one might argue that Zhang does not . . . sufficiently disclose a WTRU configured to process ‘a plurality of scheduled medium access control-d (MAC-d) flows,’ it would have been obvious to include that functionality in the WTRU of Zhang in view TS 25.321.” Id. at 34 (emphasis omitted). For the responsive limitations of claims 1 and 6, Petitioner relies on its showing for Ground 1. Id. at 34–40, 48. Thus, Petitioner has not proven that claims 1–10 would have been obvious over Zhang and TS 25.321. D. Ground 4: Asserted Obviousness of Claims 1, 5, 6, and 10 over Zhang and Lohr Petitioner asserts that claims 1, 5, 6, and 10 would have been obvious over Zhang and Lohr. Pet. 5. For this ground, Petitioner argues “[t]o the extent one might argue that Zhang alone, or Zhang in combination with TS 25.321 do not does not sufficiently disclose a WTRU configured to process “a plurality of scheduled medium access control-d (MAC-d) flows,’ it would have also been obvious to include that functionality in the WTRU of Zhang in view” of Lohr. Id. at 52–53 (emphasis omitted). For the responsive limitations of claims 1 and 6, Petitioner relies on its showing for Ground 1. Id. at 52–55. Thus, Petitioner has not proven that claims 1, 5, 6, and 10 would have been obvious over Zhang and Lohr. E. Ground 5: Asserted Obviousness of Claims 1–10 over Zhang, Lohr, and TS 25.321 Petitioner asserts that claims 1–10 would have been obvious over Zhang, Lohr, and TS 25.321. Pet. 5. For this ground, Petitioner argues that claims 1, 5, 6, and 10 would have been obvious over Zhang and Lohr for the reasons set forth for Grounds 1–4. Id. at 56. Thus, Petitioner has not proven that claims 1–10 would have been obvious over Zhang, Lohr, and TS 25.321. See Sections III.A–D above.” slip op. at 27

  Patent outcomesUS 8,797,873 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 8,797,873
• Google LLC / Ecobee, Inc. v. Ecofactor, Inc.No claims unpatentable
  PTAB · Mar 3, 2022 · IPR2021-00792 · APJ Scott B Howard · IPR · Final written decision

  Claims 1–20 were not shown unpatentable over Wedekind and Ehlers because the petition did not show the claimed distinct inputs used to determine the start time.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We are persuaded that Petitioner’s formulation, except for the qualifier “at least,” is correct.6 On the one hand, Patent Owner’s formulation is attorney argument without any supporting evidence. See PO Resp. 5–6. It is well settled that mere attorney arguments and conclusory statements, which are unsupported by factual evidence, are entitled to no probative value. See Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989) (“Attorney’s argument is no substitute for evidence.”); In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (attorney argument is not evidence). On the other hand, Petitioner’s proposal is supported by Mr. Shah’s testimony. See Pet. 26 (citing Ex. 1002 ¶¶ 26–27). Because Mr. Shah’s testimony is based on his years of experience, we give it some weight. See Ex. 1002 ¶¶ 2–10.” slip op. at 14

  • ExcludeMotion to exclude, deniedDenied

    “has more relevant experience. Pet. Reply 4–5; Pet. Supp. Br. 4–5. Petitioner further moves15 to exclude Dr. Palmer’s testimony. Pet. Supp. Br. 5. As our analysis does not rely on Dr. Palmer’s testimony, we dismiss Petitioner’s motion as moot. CONCLUSION For the foregoing reasons, we conclude that Petitioner has not demonstrated by a preponderance of the evidence the unpatentability of claims 1–20 of the ’753 patent. Specifically, Petitioner has not demonstrated by a preponderance of the evidence that claims 1–20 would have been obvious under 35 U.S.C. § 103(a) in view of Wedekind and Ehlers. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has not shown by a preponderance of the evidence that claims 1–20 of the ’753 patent are unpatentable; FURTHER ORDERED that Petitioner’s motion to exclude the” slip op. at 30

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Reply: that the first internal temperature is acquired using the setpoint. See Pet. Reply 20. The Consolidated Trial Practice Guide states that a “Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019)10 73. Although “a reply . . . may . . . respond to arguments raised in the preceding brief,” “[r]espond . . . does not mean proceed in a new direction with a new approach as compared to the positions taken in a prior filing.” Id. at 74. As discussed below, we find Petitioner improperly shifted its position in the Reply by advocating a new approach. In the Petition, Petitioner argues that Wedekind teaches “acquiring at least a first internal temperature inside said structure at a third time prior to said target time” by the “continuous measurement of various air temperatures” including the internal temperature inside the structure. Pet. 42 (quoting Ex. 1006, code (57) and citing Ex. 1002 ¶ 97). According to Petitioner, “[t]he continuous measurement of temperatures includes measurement of a first a [sic] internal temperature inside said structure at or before time t3 in Fig. 2, which is the third time prior to said target time.” Id. (citing Ex. 1002 ¶ 98). Petitioner argues that “[e]ven during times of steady-state temperature, the temperature is being continuously measured to check against the current temperature setpoint.” Id. Nowhere does Petitioner mention acquiring a temperature by using the setpoint 10 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. temperature as opposed to a measured temperature. See Pet.; PO Sur-reply 9. In its Reply, Petitioner alternatively argues that the claim limitation is satisfied even if Wedekind uses the setback/setpoint11 temperature: Even Wedekind’s parameter Ti, however, would still meet the claim language. EcoFactor principally argues that Ti is not a measured temperature, but rather just a setpoint. A setpoint, according to EcoFactor, is at best a “predict[ion] [of] air temperature at or before time t3”. To this there are three responses. First, EcoFactor simply assumes that the “setback temperature” is a setpoint, but Wedekind refers to it in the relevant passage as “the setback temperature which exists at time, t3”. (Ex. 1006, 19:61)(Emphasis added). The phrase “setback temperature setpoint”, as used by EcoFactor, does not actually occur in Wedekind. Second, even if the setback temperature were a setpoint, the setpoint is a good estimate for the temperature (Ex. 1014, 19:23-21:3), and the claims do not require a measured “first internal temperature”, merely one that is “acquired”. Finally, even if the setback temperature of Wedekind were a predicted temperature, the ’753 patent works in exactly the same way, namely by using a “predicted initial temperature PT” as the temperature at the beginning of the recovery period. (Ex. 1001, 6:17-22)(Ex. 1014, 55:25-58:4). Thus, even if EcoFactor had made an express claim construction argument, the “first internal temperature” would not have been construed to exclude predicted temperatures.” slip op. at 22

  • BurdenNot shown unpatentable

    “Accordingly, Petitioner has not shown, based on the theory set forth in the Petition, that Wedekind teaches the disputed limitation.13 b) Conclusion Because Petitioner has not shown that one of the limitations was taught by the prior art, we conclude that Petitioner has failed to show by preponderance of the evidence that claim 1 would have been obvious to a person having ordinary skill in the art. 4. Analysis of Claims 2–8 Petitioner contends that the combination of Wedekind and Ehlers would have rendered the subject matter of claims 2–8 obvious to one of ordinary skill in the art. Pet. 61–65. Claims 2–8 depend from claim 1 and, therefore, recites the “determining a first time prior to said target time . . .” limitation. Accordingly, for the same reasons discussed with respect to claim 1, Petitioner’s analysis of these claims suffers from the same deficiency and Petitioner has failed to show by preponderance of the 13 Petitioner also states that Ehlers teaches the limitation. Pet. 54. The entirety of Petitioner’s statement follows: “Ehlers also teaches this limitation. (Ex. 1008, 29:23-36, 39:44-51, 19:39-40, 37:25-27. 11:53-63, 32:66-33:13, 36:27-38).” Id. Because Petitioner simply states Ehlers teaches the limitation and supplies a string citation without any explanation or supporting testimony, we do not consider Petitioner’s statement regarding Ehlers adequately explained or supported. See DeSilva v. DiLeonardi, 181 F.3d 865, 867 (7th Cir. 1999) (“[A] brief must make all arguments accessible to the judges, rather than ask them to play archaeologist with the record.”). Despite being warned in the Institution Decision that we would not consider such conclusory arguments (Inst. Dec. 16–17 n.10), Petitioner did not argue in its Reply that we should consider it or provide any additional evidence or argument (see Pet. Reply). evidence that claims 2–8 would have been obvious to a person having ordinary skill in the art.” slip op. at 27

  Patent outcomesUS 8,498,753 not shown unpatentable
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,498,753
• Google LLC / Ecobee, Inc. v. Ecofactor, Inc.No claims unpatentable
  PTAB · Mar 3, 2022 · IPR2020-01504 · APJ Scott B Howard · IPR · Final written decision

  Claims 1–20 were not shown unpatentable because the Wedekind and Ehlers combination did not teach the distinct inputs required to determine the claimed start time.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We are persuaded that Petitioner’s formulation, except for the qualifier “at least,” is correct.6 On the one hand, Patent Owner’s formulation is attorney argument without any supporting evidence. See PO Resp. 5–6. It is well settled that mere attorney arguments and conclusory statements, which are unsupported by factual evidence, are entitled to no probative value. See Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989) (“Attorney’s argument is no substitute for evidence.”); In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (attorney argument is not evidence). On the other hand, Petitioner’s proposal is supported by Mr. Shah’s testimony. See Pet. 26 (citing Ex. 1002 ¶¶ 26–27). Because Mr. Shah’s testimony is based on his years of experience, we give it some weight. See Ex. 1002 ¶¶ 2–10.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “After briefing, we issued an order inviting supplemental briefing of the preambles of the challenged claims. Paper 28. In the Order, we proposed that the preamble of each of the challenged claims was not limiting. Id. at 2–3. In supplemental briefing, both Petitioner and Patent Owner agreed with that construction. Paper 31, 1; Paper 32, 5. Because no express construction is needed for our decision, we do not construe any of the claim limitations. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that “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 15

  • ExcludeMotion to exclude, deniedDenied

    “has more relevant experience. Pet. Reply 4–5; Pet. Supp. Br. 4–5. Petitioner further moves15 to exclude Dr. Palmer’s testimony. Pet. Supp. Br. 5. As our analysis does not rely on Dr. Palmer’s testimony, we dismiss Petitioner’s motion as moot.” slip op. at 30

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

    “But it is there that our agreement with Petitioner ends. The “determining a first time prior to said target time” limitation recites five distinct inputs upon which the time is based at least in part: “[i] said one or more thermal performance values of said structure, [ii] said performance characteristic of said climate control system, [iii] said first internal temperature, [iv] said first external temperature, and [v] the forecasted temperature.” By setting forth five inputs, claim 1 requires that each of those inputs be a distinct component of the calculation of the “first time prior to said target time.” “Where a claim lists elements separately, ‘the clear implication of the claim language’ is that those elements are ‘distinct component[s]’ of the patented invention.’” Becton Dickinson & Co. v. Tyco Healthcare Group, LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (quoting Gaus v. Conair Corp., 363 F.3d 1284, 1288 (Fed. Cir. 2004); Engel Indus., Inc. v. Lockformer Co., 96 F.3d 1398, 1404–05 (Fed. Cir. 1996) (concluding that where a claim provides for two separate elements, a “second portion” and a “return portion,” these two elements “logically cannot be one and the same”). There is nothing in the asserted claims to suggest that one piece of data can be used to satisfy multiple inputs. See CAE Screenplates, Inc. v. Heinrich Fiedler GmbH & Co., 224 F.3d 1308, 1317 (Fed. Cir. 2000) (“In the absence of any evidence to the contrary, we must presume that the use of . . . different terms in the claims connotes different meanings.”). However, Petitioner’s theory does not use each of the five distinct inputs. According to Petitioner, Wedekind bases t3—which Petitioner maps to the first time prior to said target time—on the first internal temperature because the first internal temperature is used to determine the thermal performance values of said structure. Pet. 54 (“Furthermore, in predicting t3, the thermal performance values of said structure (as explained under element [1k]) and characteristic of said climate control system (as explained above under element [1l]) are used in the non-linear efficiency model. (Ex. 1006, 19:50-20:2)(Ex. 1002, ¶120). The thermal performance values of said structure (as explained under element [1d]) are based on the first internal temperature and the first external temperature.”); see also Tr. 21:13–22:17 (Petitioner conceding that it is “using the first internal temperature because it’s used to create -- determine the thermal performance value”). Doing so effectively ignores a claim limitation by double counting the “one or more thermal performance values of said structure.” That is, Petitioner uses the “one or more thermal performance values of said structure” to satisfy both inputs [i] and [iii]. Although, as discussed above, claim 1 allows the indirect use of an input, it still must be used distinctly from the other listed input. Petitioner’s theory does not do that. See Pet. 54; Tr. 21:13–22:17. Accordingly, Petitioner has not shown, based on the theory set forth in the Petition, that Wedekind teaches the disputed limitation.13 b) Conclusion Because Petitioner has not shown that one of the limitations was taught by the prior art, we conclude that Petitioner has failed to show by preponderance of the evidence that claim 1 would have been obvious to a person having ordinary skill in the art.” slip op. at 25

  Patent outcomesUS 8,498,753 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,498,753
• Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLCNo claims unpatentable
  PTAB · Feb 15, 2022 · IPR2020-01438 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 4 and 5 were not shown unpatentable because the evidence, including unexpected results, did not establish obviousness over the asserted prior art.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “to the earliest effective filing date of June 6, 2015, the filing date of the ’063 provisional application, Allgenesis PCT thereby does not qualify as prior art against the ’820 patent. See above II.D. Accordingly, Petitioner has not met the burden of establishing that the claims are unpatentable as obvious over Allgenesis PCT. F.” slip op. at 59

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “the reasoning to combine the references, and the evidence of secondary considerations in the form of surprising unexpected results, we determine that Petitioner has not shown that claims 4 and 5 of the ’820 patent are unpatentable. III. CONCLUSION For the foregoing reasons, we conclude that Petitioner has not established by a preponderance of the evidence that claims 4 and 5 of the ’820 patent are unpatentable.” slip op. at 78

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundNot shown unpatentable

    “equivalent for another. See In re Omeprazole Patent Litig., 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”). “Conclusive proof of efficacy is not necessary to show obviousness. All that is required is a reasonable expectation of success.” Hoffman-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014).” slip op. at 69

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia with nexusObjective indicia outweighedDecided for patent owner

    “Ex. 1001, 11. Table 2 shows three observation days comparing 0.05% sunitinib TID with 0.05% nintedanib. On all three days, 0.05% nintedanib TID shows significant improvements over 0.05% sunitinib TID. For example, on day 12, the 0.05% nintedanib TID group had a negative value (indicating a reduction in neovascular area), while the 0.05% sunitinib TID group had a positive number (indicating a growth in neovascular area) and the difference between the two is also statistically significant with a P value of 0.016. The comparative data of measuring the reduction in neovascularization in an established animal model as shown the ’820 patent provides a sufficient nexus to the claimed method of reducing hyperemia. The data presented in Table 2 (shown above) shows that nintedanib functions unexpectedly better than sunitinib. The ’820 patent further explains that nintedanib inhibits three kinase targets, FGFR4, Lyn and Src, that are not inhibited by sunitinib, pazopanib, or other common kinases inhibitors. Ex. 1001, 12:14–17; see also id. at 11 (Table 1). In addition, “nintedanib’s potencies on FGFRl-3 are substantially higher than that of sunitinib that may also contribute to the superior efficacy of nintedanib in the cornea suture rabbit model.” Id. 12:17–20. Given these surprising and unexpected results that nintedanib has improved efficacy and a better safety profile compared to sunitinib as reported in the ’820 patent specification convinces us that on balance the weight of the evidence supports a finding that claims 4 and 5 have not been shown to be unpatentable.” slip op. at 77

  Patent outcomesUS 10,149,820 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 10,149,820
• Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision

  Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8

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

    “Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19

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

    “In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18

  Patent outcomesUS 10,195,214 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,195,214

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.