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  • PTAB · Mar 23, 2023 · IPR2022-01526 · APJ David Cotta · IPR · Institution

    The Board denied institution because the petition did not show a reasonable likelihood that claim 1 was anticipated by Klimesch or Jin, or obvious over their combination.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons discussed below, Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claim 1 of the ’259 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “encountered in the art, the art’s solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Petitioner contends that the person of ordinary skill in the art (“POSA”) would have had “a medical degree plus at least two years of academic and/or industry experience in the field of TMS.” Pet. 10. According to Petitioner, “[a]dditional professional and/or technical experience could substitute for education, and vice versa.” Id. Patent Owner does not challenge Petitioner’s proposed definition of the POSA for purposes of its preliminary response. See generally, Prelim. Resp. Petitioner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’259 patent. Accordingly, for purposes of this Decision, we accept Petitioner’s proposed definition of the person of ordinary skill in the art. 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)).” slip op. at 7

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “Importantly, however, Dr. Silvetz does not cite anything to support his opinion that stimulation at a frequency above the peak alpha frequency moves the peak frequency. Id. Nor does Dr. Silvetz explain why such stimulation moves the peak frequency. Id. Accordingly, Dr. Silvetz’s testimony is entitled to little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (Decision Denying Institution) (precedential) (finding that conclusory testimony that “does not cite to any additional supporting evidence or provide any technical reasoning to support [that testimony] . . . is entitled to little weight”); see also, 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”) (quoting Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)); Carella v. Starlight Archery & Pro Line Co., 804 F.2d 135, 138 (Fed. Cir. 1986) (“Although in some circumstances unsupported oral testimony can be sufficient to prove prior knowledge or use, it must be regarded with suspicion and subjected to close scrutiny.”). peak alpha frequency moves the peak frequency to a higher frequency is not specific to the conditions under which rTMS was administered in Klimesch. This is problematic because Dr. Silvetz also testifies that the brain’s response to rTMS varies depending on the conditions under which it was administered. Ex. 1003 ¶ 20 (“The brain’s natural response varies depending on factors such as: a) the location of the electromagnet; b) the frequency of stimulation; c) the duration of stimulation; d) the number of stimulation pulses administered; e) the amplitude of the pulses administered; and f) the patient’s physiology.”). In summary, given that it not accompanied by supporting evidence, does not provide any technical reasoning, and is not specific to Klimesch, we give little weight to Dr. Silvetz’s testimony in determining whether Petitioner has established a reasonable likelihood that Klimesch inherently discloses the intrinsic frequency limitation. We do not determine here that Dr. Silvetz’s testimony is incorrect, only that it is insufficiently supported by evidence and technical reasoning to be accorded substantial weight.” slip op. at 18

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

      “Although the parties have briefed construction of the terms “preselected intrinsic frequency” and “preselected Q-factor” (Pet. 13–20; Prelim. Resp. 11–16), there does not appear to be any dispute regarding the “preselected” aspect of these claim terms. Pet. 18, 20 (proposing that “preselected intrinsic frequency” and “preselected Q-factor” be construed to require “a fixed target [intrinsic frequency/Q-factor] . . . chosen before treatment”); Prelim. Resp. 16 (proposing that the Board should adopt the district court’s claim construction: “a targeted [intrinsic frequency/Q-factor] chosen before treatment”); Reply 4 (“the parties to the IPRs have agreed that, for the purposes of these IPRs, the Board should accept the claim construction as adopted by the district court”). Accordingly, we do not find it necessary to construe any claim terms in order to resolve this proceeding. See Vivid Techs. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,446,259
  • PTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution

    The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19

    • Skill levelSkill level board ownOther

      “Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15

    • Expert testimonyPetitioner expert creditedOther

      “Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16

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

      “We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,091,507
  • PTAB · Oct 25, 2022 · IPR2022-00803 · APJ Carl M Defranco · IPR · Institution

    The Board denied institution because Zak did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted anticipation or obviousness grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Yamashita meets each of the recited claim elements. See id. at 15–42. Based on our review of Zak’s mapping, however, we find that Zak fails to show that Yamashita discloses or otherwise suggests element [1.11] of claim 1, namely, “a user release mechanism adapted to automatically disengage the first and second catch structures upon actuation of the user release mechanism and thereby release the mouthpiece assembly to move via its bias from the stowed configuration to the dispensing configuration.”” slip op. at 10

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

      “But, although Figures 7 and 9 of Yamashita depict the catch structures engaged for stowed configuration of straw 20 and disengaged for dispensing configuration of the straw, Zak ignores intervening Figure 8 of Yamashita, which shows that merely sliding user release mechanism 33 to the left does not “automatically disengage the first and second catch structures” so as “to release of mouthpiece assembly 20 to move via its bias from the stowed configuration to the dispensing configuration,” as required by claim 1. That is because, in addition to user release mechanism 33 on the left-most end of rotating hood 35, Yamashita’s Figure 8 shows a snap-fit closure in the form of a protrusion and corresponding recess on the right-most end of hood 35 that keeps the hood in a closed state despite actuation of user release mechanism 33.6 See Ex. 1006, Fig. 8. Indeed, Yamashita explains that the straw remains in a “closed state,” i.e., a stowed configuration, despite the leftward movement of user release mechanism 33: “when the slider 33 moves to the left in the direction of the arrow X shown in FIG. 8, the hood stopper 33d separates from the hood 35 . . . [a]t this moment, [] the opening of the straw 20 is in the closed state due to the closed hood 35.” Id. at 19– 20. That hood 35 is still “closed” after actuation of user release mechanism 33 can only mean that the snap-fit closure on the right-most end of hood 35 must be actuated to automatically open the hood and release the straw from a stowed configuration to a dispensing configuration.” slip op. at 11

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

      “We find that Zak’s reasoning for the asserted combination lacks rational basis. In particular, we fail to comprehend why one skilled in the art would look to Dall’Agnese’s elastic tab given that Yamashita’s snap-fit closure is already pressure-actuated for conveniently popping open hood 35. Indeed, Zak’s declarant expressly admits that one skilled in the art would have known from “studying the other teachings in Yamashita and from the general context” that “the user might apply pressure to the hood with the thumb to disengage these catch structures and pop the hood open.” Ex. 1003 ¶115 (citing Ex. 1006 ¶ 59). So, given Zak’s admission that Yamashita’s snap-fit closure already has the capability of being pressure-actuated, there is no need to add Dall’Agnese’s user release mechanism for performing the same function. Thus, Zak fails to provide sufficient reasoning with evidentiary underpinning for combining Dall’Agnese’s elastic tab with Yamashita’s snap-fit closure. As such, Zak fails to demonstrate a reasonable likelihood of showing that claims 1 and 21 are unpatentable as obvious over Yamashita and Dall’Agnese. And, because Zak’s challenge of dependent claims 2 and 5–9, which are not argued separately, suffers the same deficiency of a reason to combine Yamashita and Dall’Agnese t. 83–90), we likewise determine that Zak falls short in demonstrating a reasonable likelihood that those dependent claims are unpatentable as obvious over Manganiello and Dall’Agnese.” slip op. at 15

    § 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 9,782,028
  • PTAB · Aug 17, 2022 · PGR2021-00050 · APJ Ulrike W Jenks · PGR · Final written decision

    Claims 1–7 are unpatentable over Greenhalgh; claims 8–9 are unpatentable over Greenhalgh alone or with Lynn. Substitute claims 20–28 lack written-description support.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “The parties generally agree that a person of ordinary skill in the art would have been a mechanical or biomedical engineer with several years of 6 We note that a Second Dr. Serhan Declaration is referenced in one of Patent Owner’s exhibit lists, but this document was never filed in this proceeding. See Tr. 33:15–25. experience or an orthopedic surgeon or neurosurgeon with experience designing or developing medical devices. Pet. 18–19; PO Resp. 31. On this record, we adopt the parties’ definition of the level of skill in the art. 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 9

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

      “We note that “act upon” is not defined in the Specification of the ’575 patent. “Act upon” appears for the first time in claim 1 of the ’575 patent. The Specification describes that “the cage assembly may comprise an expander such as an expansion screw or a shim which, when inserted, selectively expands the body of the cage assembly to a desired size.” Ex. 1001, 4:26–29. The Specification further describes that “translation of the elongate expander proximally toward the trailing end expands the cage body by separating the at least a portion of the upper portion from at least a portion of the lower portion.” Id. at 6:56–59. (emphasis added). We determine that “expander expands the cage” is construed in light of the Specification to mean that the expander acts upon both the upper and lower portion of the cage to move the upper and lower portions further apart. We note, however, there is no requirement that each portion is moved away from the longitudinal expander by the same amount.” slip op. at 13

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

      “The Specification does not define “unobstructed” or “obstructed.” Based on the disclosure in the Specification, the prosecution history, 7 and the annotated Figure 5A and 5B above, the term “unobstructed” is understood to mean that there are no obstacles or structures lying in the path of the window created by the upper portion, lower portion, and elongate expander that would impede the view through the window. Figure 5B does not show any features that impede the view through the aligned window and thereby shows an “unobstructed view.” Tr. 40:20–41:11, see id. 41:5–6 (“Figure 5B shows nothing extending into the window, and that’s the only 7 Petitioner explains that “the plain meaning of an ‘open’ window is well understood to be a state allowing passage through the window.” Pet. 21 (citing Ex. 1003 ¶ 63). According to Petitioner, Patent Owner expressly defined “unobstructed” during prosecution to “mean there are no features lying in the path and blocking the window.” Id. at 21–22. Patent Owner acknowledges that the term “unobstructed” was added during prosecution in order to distinguish over Baynham (US 2007/0270968 Al, published Nov. 22, 2007). PO Resp. 36–37; Ex. 1002, 29–30. The only example of an obstructing feature identified during prosecution is an axle (or jack screw) that extends down the center of the opening which acts like a bar. Id. at 22 (citing Ex. 1002, 29–30); see Tr. 41:5–8 (“Figure 5B [of the ’575 patent] shows nothing extending into the window, and that’s the only support that there is. There’s no[] qualifying language in the specification that would allow a retreat to specify a particular amount that was considered acceptable.”) support that there is.”). Unobstructed does not refer to the entirety of each window, but rather where they overlap relative to one another. We determine that “unobstructed” means “there are no features lying in the path and blocking the window.”” slip op. at 15

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “disclose bidirectional cage expansion. We note that “bidirectional” does not 8 Newton’s third law states that for every action (force) in nature there is an equal and opposite reaction. appear in the language of claim 1 of the ’575 patent nor does it appear anywhere in the Specification of the ’575 patent. All that is required by claim 1 is for the cage body to expand, which requires “the expander to act upon portions of the upper portion and the lower portion to expand the cage body by separating at least a portion of the upper portion from at least a portion of the lower portion.” Ex. 1001, 8:27–31. Thus, separation of the upper portion and lower portion upon the longitudinal translation of the elongate expander is all that is required to meet the claim element.” slip op. at 22

    Patent outcomesUS 10,709,575 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 10,709,575
  • PTAB · Aug 16, 2022 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Institution

    The Board instituted IPR of claim 59 on all three asserted § 102(b) anticipation grounds: Brumfield, Marcus, and Chandran.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “XI. CONCLUSION Petitioner has, at this stage, established a reasonable likelihood of prevailing in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XII. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 314(a) an inter partes review of claim 59 of the ’802 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial.” slip op. at 34

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial. slip op. at 10

    § 102 anticipationcites Phillips
    Patents in suitUS 8,303,589
  • Haas Automation, Inc. v. Olati LLCAll claims unpatentable
    PTAB · May 13, 2022 · IPR2021-00146 · APJ Patrick R Scanlon · IPR · Final written decision

    Claims 1–8 are unpatentable: claims 1, 2, 4, and 6 are anticipated by Oraby; claims 7 and 8 are obvious over Oraby and Edie, among other grounds.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “In the Decision on Institution, we agreed with Patent Owner’s arguments and adopted Patent Owner’s proposed level of ordinary skill in the art, stating it was “consistent with the evidence of record, including the asserted prior art.” Dec. Inst. 10. Petitioner indicates that it does not challenge this determination for the purposes of this proceeding. Pet. Reply 1. Based on our review of the complete record, we continue to apply the level of ordinary skill in the art adopted in the Decision on Institution.” slip op. at 10

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

      “1. “at least one controller . . . adjusts the power” In the Decision on Institution, we determined that there was no need to construe explicitly the phrase “at least one controller . . . adjusts the power.” Dec. Inst. 11–12 (citing Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)). Neither party disagrees with this determination. Pet. Reply 7 & n.4; PO Resp. 8–9. Thus, on the full record, there is no controversy between the parties regarding the construction of this phrase. Furthermore, explicitly construing this phrase would have no effect on the analysis below. Accordingly, we need not construe this phrase to resolve the issues in dispute in this proceeding. See Nidec, 868 F.3d at 1017; see also Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)). After considering the parties’ arguments regarding Patent Owner’s proposed claim construction for the phrase “adjusts the power exerted by at least one of the spindle drive system and the feed drive system in real-time based on the real-time determinations,” we declined to adopt the proposed construction in the Decision on Institution. Dec. Inst. 13–16 (citing Prelim. Resp. 9–11; Paper 8, 2–4; Paper 9, 2–3). Neither party has addressed this proposed construction in their post-institution briefing. Therefore, on the complete trial record before us, we need not construe this phrase to resolve Realtime Data, 912 F.3d at 1375.” slip op. at 11

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

      “d) Conclusion In summary, we construe “real-time” to mean “autonomously during a machining operation and performed quickly enough to achieve a desired machining system performance.”” slip op. at 18

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

      “Like the database in Lister, the University of Sheffield’s University Library database allowed members of the public, at least as early as 2004, to “electronically search[] the University Library index” via the internet or the library’s computer terminals, and using any of the author, department, date, and, most importantly, title. See Ex. 1010 ¶ 7. Indeed, Ms. Abbs states that, once a thesis such as Oraby is received by the library, “at least the title, author, related department, and date of completion are recorded in the University Library’s records.” Id. ¶ 3 (emphasis added). Furthermore, like the manuscript in Lister, Oraby has a title that is descriptive of its subject matter—“Mathematical Modelling and In-Process Monitoring Techniques for Cutting Tools” (Ex. 1004, 1)—as Oraby indeed covers “mathematical models which describe the cutting tool-workpiece interaction” and “accurate on-line monitoring of tool-state” (see id. at 3). Thus, a reasonably diligent researcher in the field of CNC machining interested in ways to improve the 11 The court ultimately held, however, that the manuscript did not qualify as prior art because there was insufficient evidence that the aforementioned “date that [the manuscript] was included in either [of the two] databases that permitted keyword searching of titles” had actually antedated the patent’s critical date. Lister, 583 F.3d at 1316–17. library’s database by title for references disclosing such improvements. Furthermore, given Oraby’s title that describes its subject matter covering particular improvements in the CNC machining process, Oraby would have been discovered through such an electronic search. As such, Ms. Abbs’ declaration is sufficient evidence to establish by a preponderance of the evidence that Oraby was publicly available before the ’432 patent’s critical date and therefore qualifies as a printed publication.” slip op. at 21

    Patent outcomesUS 8,136,432 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,136,432
  • 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
  • PTAB · Apr 28, 2022 · IPR2021-00088 · APJ James A Worth · IPR · Final written decision

    Claims 1, 2, 6, 8, and 9 were not shown unpatentable because Simonnet disclosed split sample streams, and Petitioner did not adequately show a reason to modify it to form a single stream.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “focused split sample typically would not allow two cells to arrive at the inspection region at once, because there is not enough space for two 10-μm cells to travel side by side.” See Ex. 1054 ¶ 21 (citing Ex. 1005, 5662) (emphasis added). The qualifier “typically” for two cells not arriving at the same time does not indicate that there would be no split stream. And Dr. Issadore seems to concede there could be a split sample. Id. Further, Dr. Issadore does not state which dimensions of which of Simonnet’s channels that he is using as a reference.27 We determine that Dr. Issadore provides insufficient evidence and reasoning for an understanding that there would be a single stream if mammalian cells were used, in addition to making a statement that stops short of that conclusion. Although not argued by Petitioner nor discussed by Dr. Issadore, Simonnet does state: “we expect the HTD to be compatible with cells up to ~15 µm in size.” Ex. 1005, 5662. Simonnet also states: “We expect that with the improvements in optics and detection electronics, a cytometry system based on the HTD would match the throughput, sensitivity, and accuracy of commercial flow cytometers and would be an adequate tool for assaying fluorescently marked live cells.” Id. These statements can be fairly read as a statement of reasonable expectation of success of using mammalian cells in the device. However, Simonnet is silent as to whether the mammalian cells would be in a single stream, and if anything, Simonnet appears to be inviting further experimentation. Accordingly, Petitioner has not provided adequate reasoning to modify Simonnet to form a single sample stream.” slip op. at 52

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In the Decision on Institution, we set forth our preliminary determination that a person of ordinary skill in the art at the relevant time would have had a bachelor’s or master’s degree in the field of bioengineering, mechanical engineering, chemical engineering, or analytical chemistry, or a related field and at least three years of experience in designing or developing microfluidic systems. See Dec. 10–11. Patent Owner does not dispute this definition. See PO Resp. 4. 6 The parties do not present or address objective evidence of non-obviousness in this proceeding. After considering all evidence and arguments anew, we determine that it is proper to maintain our definition of the level of skill in the art.” slip op. at 11

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner

      “sheath flow does not mean that “focusing” requires sheath flow. In other words, the Specification does not contain a definition of “focusing” that defines “focusing” as requiring “sheath flow.” As discussed above, the Specification does state “focusing (e.g., constricting).” See also Tr. 41:22– 42:8 (discussing the Specification of the ’439 patent). Whether or not this disclosure rises to the level of a definition, it indicates that focusing is understood to be constricting and does not mention “sheath flow.” Although sheath flow may, in certain cases, be a natural result of having multiple fluid focusing features (see Ex. 1001, 14:6), the claim itself does not require that focusing include sheath flow.11 11 In terms of resolving the dispute between the parties, the real question appears to be whether the sample stream that exits the focusing region must be a single sample stream or whether it may encompass split sample streams, a question that we address in the next subsection. Patent Owner’s ultimate argument appears to be that “focusing” requires a single sample stream because “focusing” requires sheath flow and sheath flow requires a single sample stream. However, we agree with Petitioner that persons of ordinary skill could still refer to split streams as having “sheath flow” (see Ex. 1054 ¶ 11; Ex. 1043, 2215, Fig. 10 and caption (“separated two-sample 3D sheath flow”); Ex. 1044, 2 (“multiple core-sheath flow”), and therefore, even if we agreed with Patent Owner that focusing requires sheath flow, that would not clarify whether “focusing” precludes split sample streams. In any event, we conclude that focusing does not require sheath flow. We recognize that there are examples in the Specification where there is sheath flow. E.g., Ex. 1001, 5:30–32 (“Certain embodiments described herein relate [to] systems and methods for producing a sheath flow . . .”), 10:35–37 (“The illustrated core stream forming geometry 400 provides improved sheath flow capabilities and thus improved sample focusing capabilities.”). However, case law generally counsels against importing limitations from the Specification into the claims. See, e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1323 (“To avoid importing limitations from the specification into the claims, it is important to keep in mind that the purposes of the specification are to teach and enable those of skill in the art to make and use the invention and to provide a best mode for doing so.”).12 We, therefore, do not import “sheath flow” into the definition of focusing.” slip op. at 16

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

      “Therefore, we construe “the sample stream” in the claim phrase “configured to focus the sample stream” to refer to a singular stream. c) Conclusion as to “focusing” and “configured to focus the sample stream” We maintain our construction of “focusing” as “pinching, confining, squeezing, or constricting” and decline to import additional requirements such as sheath flow into the term “focusing.” Nevertheless, we construe “the sample stream” in the claim phrase “configured to focus the sample stream” to refer to a singular stream.” slip op. at 28

    Patent outcomesUS 10,583,439 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 10,583,439
  • PTAB · Apr 20, 2022 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Institution

    The Board instituted IPR on claims 1–15 over all asserted grounds, finding a reasonable likelihood that Petitioner would show at least one challenged claim unpatentable.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information presented shows a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we authorize an inter partes review to be instituted as to the Challenged Claims of the ’176 patent on the grounds raised in the Petition. Our factual findings and conclusions at this stage of the proceeding are based on the evidentiary record developed thus far (prior to Patent Owner’s Response). This is not a final decision as to patentability of claims for which inter partes review is instituted. Any final decision will be based on the record, as fully developed during trial.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Pet. 15 (citing Ex. 1007 ¶¶ 19–24). Patent Owner does not comment on the characterization offered by Petitioner or offer one of its own. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’176 patent and the cited prior art. 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)Term construed patent owner constructionOther

      “Prelim. Resp. 16. Patent Owner cites Ex. 1001 6:32–34, noting that the patent specification “expressly defines ‘isolated cell’ as ‘[referring] to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.’” Id. As neither party references any prosecution history related to interpretation of this claim term, we look only to the claim itself and the specification as intrinsic evidence. DePuy Spine, 469 F.3d at 1014. Claim 1 recites “an isolated cell prepared by a process comprising . . . ” Ex. 1001 at 19:6. As Patent Owner notes, the patent specification states “the term ‘isolated cell’ refers to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.” Id. at 6:32–34. The remainder of the citations Petitioner cites relate to additional steps for isolating the cell, or characteristics of the cell, such as the markers expressed or not expressed, but do not further elucidate the meaning of “an isolated cell” itself. Dr. Olsen’s testimony reiterates the content of these citations but does not add any additional information or explanation. Ex. 1007 ¶¶ 67–68. Given the definition provided in the specification, we interpret “an isolated cell,” consistent with Patent Owner’s definition, to mean “one or more cells isolated from the subepithelial layer of a mammalian umbilical cord.”” slip op. at 13

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInstituted

      “the Wharton’s Jelly, epithelium, etc.” and that, without evidence that the recited markers are expressed/not expressed as recited, there is no inherent disclosure. Prelim. Resp. 22, 25, 28–29 (citing Ex. 2022 ¶ 162). Patent Owner is correct that an ultimate finding of anticipation requires such confirmation, but, for purposes of institution, our standard is a reasonable likelihood. 35 U.S.C. § 314(a). Due to the breadth of claim 1, Majore’s method must produce only one cell having the recited limitations to anticipate. Petitioner’s expert testifies that production of such cells would be inherent by Majore. See Ex. 1007 ¶ 97 (“Majore’s protocol would produce a population of adherent cells that necessarily and inevitably comprise the cells of the subepithelial layer.”). And, although we recognize that the burden of persuasion does not rest on Patent Owner, Dr. Burger’s testimony, which focuses heavily on the differences in methodology between Majore and the ’176 patent disclosure and Petitioner’s alleged failure of proof, is not persuasive at this stage to overcome the evidence presented by Petitioner. See Ex. 2002 ¶¶ 137–163. Indeed, both Majore and the ’176 patent disclose umbilical cord tissue cut into sections and placed into environments fostering cell culture and replication. Ex. 1011 at 18, Ex. 1001 at 13:57–14:5. Both methods encourage and result in adherent cells growing on a plastic growth surface awash in culture media. Id. On this record, Petitioner has provided sufficient factual basis to establish a reasonable likelihood that Majore’s explant method of dissecting umbilical cord, culturing cells, and growing adherent cells would have produced (or did produce) at least one cell with the recited limitations. In this regard, we credit the testimony of Dr. Olsen that the isolated cells disclosed in Majore are MSCs cultured from umbilical cord tissues including the subepithelial layer, which have migrated to the periphery of the cut tissue and adhered to the tissue culture vessel. Ex. 1007 ¶¶ 95–97. That Majore discloses genetic markers with similar expression/non-expression to the markers recited in claim 1 is further evidence that at least some cells were cultured from the subepithelial layer. Id. ¶ 99. Moreover, even if we gave weight to the process limitations construed as requested by Patent Owner (Prelim. Resp. 13–20), the limitations are sufficiently broad as to read on Majore with the exception of the express/non-expressed markers. With regard to markers not examined by Majore, we credit Dr. Olson’s statement that “the cells obtained by Majore’s protocol necessarily and inevitably comprise the same cells produced by the process steps of claim 1[A] and 1[B]” and that the skilled artisan would have understood that the marker expression pattern would be identical for those cells. Id. ¶ 101.16 The evidence on this issue is subject to final determination on a more complete record developed through trial.” slip op. at 21

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,803,176
  • PTAB · Apr 20, 2022 · IPR2021-00017 · APJ James A Tartal · IPR · Final written decision

    Claims 1–3, 6, 9, and 10 are unpatentable as anticipated by Quintana; claims 4, 5, 7, 8, and 11 are unpatentable as obvious over Quintana.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “have had either “a medical degree and at least two years’ experience with treating glaucoma and performing glaucoma surgery,” or “an undergraduate or graduate degree in biomedical or mechanical engineering and at least five years of work experience in the area of ophthalmology, including familiarity with ophthalmic anatomy and glaucoma surgery.” Pet. 26 (citing Ex. 1003 ¶ 24). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill in the art. Resp. 10 n.5. We adopt Petitioner’s definition as we find it is undisputed and consistent with the level of skill in the art at the time of the invention, as reflected by the prior art and the ’885 patent. 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 13

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

      “Neither Petitioner nor Patent Owner propose any express construction for a claim term. See Pet. 27; Resp. 10. We find that no express construction of any claim term is necessary for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 14

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “Quintana’s disclosure expressly states that “[o]nly the tip of the instrument is introduced into Schlemm’s canal, and the [trabecular meshwork] is stripped slowly, gently and easily from the canal’s lumen towards the anterior chamber as the needle progresses,” which informs one of ordinary skill in the art that the beveled edges of the needle cut and remove a strip of trabecular meshwork tissue. See Ex. 1004, 4; see also id. at 8 (“[f]urther studies are necessary to disclose the ‘in vivo’ behaviour of the sectioned trabecular meshwork”), caption to Figure 2 (“[t]he tip of the needle stripping the trabecular meshwork”); see also Ex. 1030 ¶¶ 7–10 (Dr. Netland discussing Quintana from the perspective of one of ordinary skill in the art).” slip op. at 34

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

      “Reasons Supporting Obviousness Over Quintana We find for the reasons provided below that Petitioner has shown by a preponderance of the evidence persuasive reasons the subject matter of the Challenged Claims, as a whole, was taught by Quintana, in light of the knowledge of a person of ordinary skill in the art. We further find that, to the extent a feature of Quintana relied upon by Petitioner would have required modification to correspond to a feature of a Challenged Claim, Petitioner has shown by a preponderance of the evidence a person of ordinary skill not only could have made the modification, but would have had reason to do so in light of the knowledge of a person of ordinary skill in the art. Patent Owner argues a lack of motivation to modify Quintana “to create first and second spaced-apart cutting edges.” Resp. 31–32. As explained above, we find Quintana discloses this feature without modification. See supra Section II.E.1. Patent Owner also broadly argues no motivation for any of the proposed modifications because Quintana “never describes creating and removing a strip of [trabecular meshwork],” and that Petitioner does not show how the asserted modification “would have been advantageous” and are “the product of speculation, conjecture and hindsight.” Resp 33–34. As explained above, we find Quintana discloses cutting a strip of trabecular meshwork and Patent Owner’s argument fails to address the reasons Petitioner identifies for each proposed modification. See supra Section II.E.1. We likewise find no persuasive evidence to support Patent Owner’s undeveloped arguments that any modification proposed by Petitioner of Quintana based on the knowledge in the art would have rendered Quintana’s device “unfit for its intended purpose” or that Quintana “would have taught away . . . for fear of reducing the effectiveness of the device.” Resp. 33–34. We find persuasive Petitioner’s argument in its Reply that Patent Owner “fails to explain how modifying Quintana’s needle as proposed by [Petitioner] would have increased the risk of injury to [Schlemm’s Canal], and no disclosure in Quintana that criticizes, discredits, or discourages “investigation into the modifications proposed by [Petitioner]. Reply 24 (citing Ex. 1004, 4). We further focus our discussion below on any additional determinative issues in dispute.” slip op. at 51

    Patent outcomesUS 9,820,885 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,820,885

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.