SERVICES MEDICAUX ARNOLD ET JOAN ZIDULKA INC.Download PDFPatent Trials and Appeals BoardOct 25, 20212021001149 (P.T.A.B. Oct. 25, 2021) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/798,866 10/31/2017 Arnold ZIDULKA P1610US00 9220 39500 7590 10/25/2021 Anglehart et al. 1939 de Maisonneuve Ouest Montreal, QUEBEC H3H 1K3 CANADA EXAMINER STANIS, TIMOTHY A ART UNIT PAPER NUMBER 3785 NOTIFICATION DATE DELIVERY MODE 10/25/2021 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): james.anglehart@anglehart.et-al.ca martine@anglehart.et-al.ca PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ARNOLD ZIDULKA Appeal 2021-001149 Application 15/798,866 Technology Center 3700 Before CHARLES N. GREENHUT, ANNETTE R. REIMERS, and WILLIAM A. CAPP, Administrative Patent Judges. GREENHUT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 9–21, 23, and 25–29. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Services Medicaux Arnold Et Joan Zidulka Inc. Appeal Br. 2. Appeal 2021-001149 Application 15/798,866 2 CLAIMED SUBJECT MATTER The claims are directed to a device and method of delivering particles in the upper respiratory tract. Claim 1, reproduced below, with emphasis added, is illustrative of the claimed subject matter: 1. A method of delivering a dose of a substance to the pharynx and nasal passages of a person, the method comprising: a) the person placing a mouthpiece of a device in a mouth of the person for orally administering said substance in aerosol form or in powder form; b) spraying said dose of said substance into a chamber in communication with the mouthpiece, wherein the chamber is configured to maintain particles of said substance in suspension within the chamber until the person inhales the particles through the mouthpiece; c) the person inhaling said substance by oral inhalation into the pharynx and the larynx of the person; d) the device impeding said oral inhalation by the person before any substantial amount of said substance reaches the trachea, lower airways and lungs of the person; e) in response to said impeding, the person arresting oral inhalation; f) the person preventing oral exhalation by closing a soft palate of a roof of a mouth of the person against a tongue of the person; g) the person nasally exhaling said substance; and h) repeating steps (c) through (g) a number of times within one minute to deliver said dose. Appeal 2021-001149 Application 15/798,866 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Schuster US 5,906,202 May 25, 1999 Puderbaugh US 6,026,807 Feb. 22, 2000 Bethke US 8,371,292 B2 Feb. 12, 2013 Longest WO 2015/042352 A1 Mar. 26, 2015 Fattah, “The Frenzel Technique, Step-by-Step” (2001) http://www.ericfattah.com/equalizing.html (last visited Oct. 15, 2021) REJECTIONS Claims 1, 9, 16–18, 20, 25, and 26 are rejected under 35 U.S.C. § 103 as unpatentable over Longest, Puderbaugh, or in the alternative Longest, Puderbaugh, and Fattah. Final Act. 2. Claims 27–29 are rejected under 35 U.S.C. § 103 as unpatentable over Longest and Puderbaugh. Final Act. 7. Claims 10–15, 21, and 23 are rejected under 35 U.S.C. § 103 as being unpatentable over Longest, Puderbaugh (or Longest, Puderbaugh and Fattah), and Schuster. Final Act. 9. Claim 19 is rejected under 35 U.S.C. § 103 as being unpatentable over Longest, Puderbaugh (or Longest, Puderbaugh and Fattah), and Bethke. Final Act. 12. OPINION Concerning the disputed chamber limitation emphasized above and appearing in each of the independent claims before us (claims 1 and 27) the Examiner clarifies the position taken by the Examiner in the final rejection by stating in the Examiner’s Answer: Appeal 2021-001149 Application 15/798,866 4 the primary reference of Longest already includes a chamber in communication with the mouthpiece, whereby it is likely that Longest already maintains aerosolized particles in suspension until the person inhales (Longest, [0094]-[0095] discloses an air space or air chamber that is configured to minimize the deposition of the aerosol). Longest does not explicitly state that aerosolized particles are kept in suspension until inhalation by the patient. Insofar as addressing the chamber limitation, the secondary reference of Puderbaugh is only being applied to explicitly show that aerosolized particles in a spacer/chamber can be held in suspension until the patient inhales. This position is explained in the Final Rejection of 2/12/20 on Pages 3-4. Puderbaugh is not being used to teach in the general concept of a cloud chamber/spacer (the primary reference of Longest already has this), but rather the concept of using the existing spacer of Longest as a chamber that suspends particles until the person inhales through the mouthpiece. Ans. 14; see also Final Act 4 (“it is noted that the air spacer of Longest is configured to minimize the deposition of the aerosol ([0095]), which implies that the spacer of Longest is configured to maintain the particles in suspension within the spacer until the person inhales the particles.”) Facts upon which a rejection is predicated must be supported by a preponderance of the evidence during prosecution before the PTO. In re Caveney, 761 F.2d 671, 674, (Fed. Cir. 1985). Although this is a very close case, the cited portions of Longest ultimately do not provide sufficient evidence to support the Examiner’s findings concerning the purported structure and function of Longest’s spacer or chamber by a preponderance of the evidence. Longest does not provide detailed structural or functional details of either the spacer or chamber.2 It appears, but is not entirely clear 2 At times Longest uses the terms “chamber” and “spacer” interchangeably. See, e.g., paras. 95–98 (“Figs. 8A-8B illustrate actuation of an exemplary embodiment of a chamber . . . In the embodiments of Figs. 8A-8B and Fig. Appeal 2021-001149 Application 15/798,866 5 from Longest, that the term “spacer” is sometimes used to refer to a structure that seems to take the form of a simple passageway having an exit placed in the patient’s mouth, in order to place the aerosol generator in fluidic communication with the patient’s mouth. Paras. 95, 76. It appears, but is again not entirely clear, that the term “chamber” is used, sometimes interchangeably with the term “spacer,” to refer to what may take the form of a slidable housing 88, or bag 108, used to store a volume of air or gas (e.g., 88a), that is inhaled after the aerosol generator is fired. Paras. 76, 95– 96. The preferred location for Longest’s chamber or spacer is “behind the aerosol generator.” Para. 95; Figs 8A, 8B, 9. In such arrangements, it would seem that the aerosol generator would not spray its contents “into [the] chamber” as required by claims 1 and 27. See Figs 8A, 8B, 9 (illustrating the aerosol spray being directed away from the chambers). It is noted that, in paragraph 98, which was not cited by the Examiner, Longest does indicate that “one of skill in the art will appreciate that the air spacer could be disposed in front of the aerosol generator.” Such an arrangement is not illustrated or discussed in detail and, as the Examiner recognizes, there is no express indication that, even in such an arrangement, Longest’s spacer can 9, the air spacer is positioned behind the aerosol generator”; “Fig. 9 illustrates another exemplary embodiment of an air spacer . . . A flexible chamber, such as a bag 108 is coupled to the inhaler 102”). At times Longest suggests the “chamber” and “spacer” may be discrete structures. See, e.g., para. 94 (“the exemplary methods employed the use of an air chamber or a chamber and a spacer”). The Examiner and Puderbaugh use the terms “spacer” and “chamber” interchangeably. Final Act. 3; Puderbaugh col. 1, ll. 19, 22. Appeal 2021-001149 Application 15/798,866 6 “maintain particles of said substance in suspension within the chamber until the person inhales the particles through the mouthpiece.” Reply Br. 2. The minimization of deposition, cited by the Examiner to support the Examiner’s determination that the particles in Longest must therefore be in suspension (Final Act. 4 (citing Longest para. 95)), is discussed in greater detail in Longest with reference to Figures 4A–7F. Longest para. 76 et seq. Those figures illustrate computational fluid dynamic (CFD) modeling of an arrangement wherein a “spacer” 242 does seem to be located “in front of the aerosol generator.” However, this appears to be a situation wherein the “spacer” is used to refer to a simple passageway with an exit placed in the patient’s mouth. The CFD model does not detail the structure of the spacer. As Appellant points out (Reply Br. 2), just because the aerosol is fired into the spacer and minimal deposition occurs, it does not necessarily mean the particles are maintained in suspension in the spacer until the patient inhales: the aerosol could simply pass through the chamber while, or prior to, being combined with air or gas from the spacer or chamber. Longest’s descriptions of the inhalation processes (Longest para. 76 et seq.) do not make this clear, and are, in any case, not cited or discussed by the Examiner. The possibility that the aerosol could simply pass through the chamber while, or prior to, being combined with air or gas from the spacer or chamber not only undermines the Examiner’s conclusion with regard to Longest implicitly or inherently teaching a “chamber [that] is configured to maintain particles of a substance in suspension within the chamber until the person inhales,” it also undermines the Examiner’s determination of the purported similarities of the Longest and Puderbaugh chambers upon which the Examiner’s proposed combination is based. Appeal 2021-001149 Application 15/798,866 7 The Examiner does not make clear how, in light of Puderbaugh, effectiveness and efficiency would be improved by maintaining particles in suspension in Longest’s chamber. See Final Act. 4 (“would have been obvious . . . in order to deliver the medication in an effective and efficient means with little unwanted deposition on the tongue or inside the mouth (due to the use of the cloud chamber)”). Appellant argues Longest already has a system of using hygroscopic expedients to discourage unwanted deposition on the tongue or inside the mouth. App. Br. 11. The embodiments of Longest utilizing pressurized, or mechanically advanced, air or gas would also seem to be a mechanism for discouraging such unwanted deposition on the tongue or inside the mouth without requiring the use of a cloud chamber for maintaining particles in suspension. Appellant asserts that Longest would therefore not further benefit, and may actually suffer, from the use of a cloud chamber maintaining particles in suspension. App. Br. 12. Appellant also sets forth other reasons why a cloud chamber of the type disclosed in Puderbaugh would not be appropriate or effective in Longest. App. Br. 10– 13. The Examiner’s only rebuttal to all of Appellant’s arguments along these lines is based on the insufficiently supported assertion that “Longest already uses a spacer (Longest, [0095]), which is a cloud chamber.” Ans. 14–16. In light of the arguments presented and the Examiner’s response, we cannot say that, on the totality of the record before us, the Examiner has demonstrated that the evidence of obviousness outweighs the evidence against. For the foregoing reasons, we do not sustain the Examiner’s rejections on the record presently before us for review. CONCLUSION The Examiner’s rejections are REVERSED. Appeal 2021-001149 Application 15/798,866 8 DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 9, 16–18, 20, 25, 26 103 Longest, Puderbaugh, with or without Fattah 1, 9, 16–18, 20, 25, 26 27–29 103 Longest, Puderbaugh 27–29 10–15, 21, 23 103 Longest, Puderbaugh, with or without Fattah, Schuster 10–15, 21, 23 19 103 Longest, Puderbaugh, with or without Fattah, Bethke 19 Overall Outcome 1, 9–21, 23, 25–29 REVERSED Copy with citationCopy as parenthetical citation