FREESPIRA, INC.

Patent Trials and Appeals Board

Mar 14, 2022

2021004041 (P.T.A.B. Mar. 14, 2022)

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. 16/050,340 07/31/2018 Leslie E. MACE 12461-701.400 7629 66854 7590 03/14/2022 SHAY GLENN LLP 2929 CAMPUS DRIVE SUITE 225 SAN MATEO, CA 94403 EXAMINER KUHLMAN, CATHERINE BURK ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 03/14/2022 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): info@shayglenn.com shayglenn_pair@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LESLIE E. MACE, ELIZABETH K. SIEGELMAN, DEBRA L. REISENTHEL, and SIMON W. H. THOMAS Appeal 2021-004041 Application 16/050,340 Technology Center 3700 Before BENJAMIN D. M. WOOD, JEREMY M. PLENZLER, and CARL M. DEFRANCO, Administrative Patent Judges. PLENZLER, 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 1-4 and 6-16. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Freespira, Inc. Appeal Br. 2. Appeal 2021-004041 Application 16/050,340 2 CLAIMED SUBJECT MATTER The claims relate to breathing therapy. Claim 1 and 12, reproduced below, are illustrative of the claimed subject matter: 1. A breathing therapy method comprising: receiving at least a portion of a user’s exhaled air in a gas inlet of a quantitative colorimetric detection system; measuring a user’s end-tidal CO2 levels with the quantitative colorimetric detection system based on a color change resulting from exposure of the system to the user’s exhaled air; and outputting a set of visual and/or audio cues from the quantitative colorimetric system with instructions for the user to adjust their breathing pattern to coincide with the cues to thereby modify the user’s exhaled end-tidal CO2 levels to between about 37 mmHg and 43 mmHg. 12. A method for treating a user with a panic disorder or PTSD with a breathing therapy comprising: measuring a user’s baseline end-tidal CO2 and breathing rate, wherein the user’s CO2 is measured with a quantitative colorimetric CO2 detection system; providing a target end-tidal CO2 level and a target breathing rate for the user; and outputting a set of tone patterns with instructions to modify the user’s end-tidal CO2 levels and breathing rate from an audio device during a first time period and discontinuing the output of the set of tone patterns during a second time period, wherein the tone patterns are configured to guide the user’s breathing pattern to achieve the target end-tidal CO2 level and target breathing rate. Appeal 2021-004041 Application 16/050,340 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Mault US 2002/0026937 A1 Mar. 7, 2002 Anderson US 2003/0225324 A1 Dec. 4, 2003 Gavish US 2004/0116784 A1 Jun. 17, 2004 Schmeink US 2011/0046434 A1 Feb. 24, 2011 Freeman US 2012/0302910 A1 Nov. 29, 2012 Moretti US 2013/0236980 A1 Sep. 12, 2013 REJECTIONS Claims 1-4, 8, and 9 are rejected under 35 U.S.C. § 103 as being unpatentable over Gavish, Moretti, and Freeman. Claims 6 and 7 are rejected under 35 U.S.C. § 103 as being unpatentable over Gavish, Moretti, Freeman, and Schmeink. Claim 10 is rejected under 35 U.S.C. § 103 as being unpatentable over Gavish, Moretti, Freeman, and Mault. Claim 11 is rejected under 35 U.S.C. § 103 as being unpatentable over Gavish, Moretti, Freeman, and Anderson. Claims 12-16 are rejected under 35 U.S.C. § 103 as being unpatentable over Gavish and Moretti. OPINION Claim 1 Appellant argues claims 1-4, 8, and 9 as a group. Appeal Br. 4-6. We select claim 1 as representative. Claims 2-4, 8, and 9 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv). In the rejection of claim 1, the Examiner finds that Gavish teaches “receiving at least a portion of a user’s exhaled air in a gas inlet of a system Appeal 2021-004041 Application 16/050,340 4 including a capnometer.” Final Act. 4. The Examiner’s finding is based on “an inlet [being] considered to be inherent in any capnometer, since there must be an opening to receive the user’s exhaled gas.” Ans. 5 Appellant responds that “Gavish does not disclose any structure that could be characterized as an inlet that could receive a user’s exhaled air . . . without [the Examiner] explaining why Gavish’s capnometer necessarily includes an inlet as opposed to, e.g., an open structure lacking an inlet.” Appeal Br. 5. Appellant’s contention is not persuasive. Appellant does not dispute that there must be some sort of opening in Gavish’s capnometer to receive exhaled air. Claim 1 does not require, nor does Appellant even allege, that any particular structure is required for its “gas inlet.” We are apprised of no reason why an opening in a capnometer would not be a “gas inlet,” as broadly recited in claim 1. Appellant further contends that “Gavish never describes how end-tidal CO2 may be used by the device to help the user voluntarily modify the user’s breathing.” Appeal Br. 5. The Examiner responds that “Paragraphs [0071] and [0078] clearly teach end-tidal CO2 as a parameter that can be . . . used by the system as feedback for controlling a stimulus provided to the user.” Ans. 6. Appellant contends that “[n]either paragraph [0071] nor any other part of Gavish’s disclosure explicitly describes monitoring end-tidal CO2 and directing the user to change a breathing pattern to put the user's end-tidal CO2 into a particular range.” Reply Br. 4-5. The Examiner has the better position. Paragraph [0071] of Gavish explains that “the benefit-related variable is selected from the list consisting of . . . an end-tidal CO2 level of the user.” Appeal 2021-004041 Application 16/050,340 5 Paragraph [0078] of Gavish describes the voluntary parameter as being respiration. Both paragraphs follow Gavish’s explanation that “[t]he output signal directs the user to modify a parameter of the voluntary action, so as to cause an improvement in the benefit-related variable.” Gavish ¶ 31. That is, Gavish teaches modifying respiration to modify end-tidal CO2 level. Although Appellant additionally purports to dispute findings related to Moretti and Freeman in the Appeal Brief, it no longer appears to maintain that dispute in its Reply Brief. See Appeal Br. 5-8; Reply Br. 2-5 (not responding to the Examiner’s Answer). Appellant additionally presents contentions related to features allegedly not taught by Moretti or Freeman. See Appeal Br. 5-6. But these contentions are also unpersuasive because they do not relate to teachings relied on in the Examiner’s rejection. See, e.g., Ans. 6 (“Moretti is cited merely to teach the structure of a quantitative colorimetric.”), 7 (“Freeman is cited merely to teach a normal value for end- tidal CO2.”). The actual findings relied on in the rejection are not disputed by Appellant. For the reasons set forth above, we are not apprised of error in the rejection of claims 1-4, 8, and 9. Claims 6, 7, and 11 Although Appellant purports to dispute findings related to the rejection of claims 6, 7, and 11 in the Appeal Brief, it no longer appears to maintain that dispute in its Reply Brief. See Appeal Br. 6-8; Reply Br. 2-5 (not responding to the Examiner’s Answer). As the Examiner explains in the Answer, the Appeal Brief does not dispute the actual findings relied on in the rejections. See Ans. 7-9. Appeal 2021-004041 Application 16/050,340 6 For at least these reasons, we are not apprised of error in the rejection of claims 6, 7, and 11. Claim 10 Claim 10 depends from claim 1, and further recites “controlling a temperature of a colorimetric indicator in the quantitative colorimetric detection system while measuring the user’s end-tidal CO2 levels.” The Examiner finds that “Mault discloses a sensor 68 comprising a reactive material for detecting an analyte in a respiratory gas sample and further discloses controlling the temperature of the sensor with a temperature controller 54 operatively coupled to the sensor [0054-57].” Final Act. 7. The Examiner reasons that it would have been obvious “to control a temperature of a colorimetric indicator in the quantitative colorimetric detection system while measuring the user’s end-tidal CO2 levels in the method of Gavish . . . in order to avoid condensation forming on the sensor and maintain a generally constant temperature, as taught by Mault [0056].” Id. at 7-8. Appellant acknowledges that “Mault employs a heater to maintain a constant temperature on the optical sensing region to prevent condensation from forming,” but responds that there is no reason to avoid condensation in the recited arrangement. Appeal Br. 7-8. The Examiner does not respond with any reason to avoid condensation in the modified system of Gavish. See Ans. 8. Rather, the Examiner faults Appellant for framing its dispute relative to the claim. See id. (“The examiner notes that the question is not whether one would be motivated to modify the claimed method to avoid condensation, but whether one of ordinary skill in the art before the effective filing date of the claimed Appeal 2021-004041 Application 16/050,340 7 invention would have been motivated to modify the device of Gavish in view of Moretti and Freeman, to avoid condensation.”). Appellant has the better position. As Appellant explains, “[t]he device that the Examiner constructed from . . . Gavish, Moretti and Freeman is the device recited in the method of claim 1, from which claim 10 depends, and it includes a colorimetric CO2 indicator.” Reply Br. 5. Appellant’s dispute is not directed solely to the claim, in isolation, but, rather, that “there is no indication in Gavish, Moretti or Freeman that the device components (such as the colorimetric CO2 indicator) would benefit from heating to avoid condensation.” We are left with no explanation from the Examiner as to why one skilled in the art would want to avoid condensation in Gavish’s modified system. Accordingly, we do not sustain the Examiner’s decision to reject claim 10. Claim 12 Appellant argues claims 12-16 as a group. Appeal Br. 3-4. We select claim 12 as representative. Claims 13-16 stand or fall with claim 12. In the rejection of claim 12, the Examiner finds that Gavish teaches the features recited in claim 12, including “a capnometer[,] but is silent as to the user’s end-tidal CO2 being measured with a quantitative colorimetric CO2 detection system.” Final Act. 3. Appellant responds that “Gavish never describes a single embodiment using both breathing rate and end-tidal CO2 as measured parameters, and Gavish does not disclose the measurement of a baseline breathing rate or a baseline end-tidal CO2 measurement.” Appeal Br. 4. Appellant contends Appeal 2021-004041 Application 16/050,340 8 that “Gavish also does not provide a target end-tidal CO2 level for the user.” Id. The Examiner has the better position. As the Examiner explains (see Ans. 3), paragraphs [0071] and [0078] of Gavish describe using both breathing rate and end-tidal CO2 as measured parameters. Gavish describes using measured parameters to generate an “output signal [that] directs the user to modify a parameter of the voluntary action, so as to cause an improvement in the benefit-related variable.” Gavish ¶ 31. Paragraph [0078] of Gavish states using “at least one breathing parameter selected from: inspiration time and expiration time” and “alternatively or additionally . . . an end-tidal CO2 level of the user.” Emphasis added. Although maintaining its dispute in the Reply Brief, Appellant does not address this express disclosure in Gavish noted above. As for Gavish teaching the measurement of a baseline breathing rate and a baseline end-tidal CO2 measurement, again, the Examiner finds support in Gavish. See Ans. 4 (citing, e.g., Gavish ¶¶ 170-171). Paragraph [0171] of Gavish explains, for example, that “[a] comparator 42 receives values of BAP, BRP, and HSP, and compares these values with values that have been previously stored in data logger 41,” which “are also useful for identifying deviations in measured values of physiological variables from benchmark values.” According to Gavish, “[s]uch benchmark values include . . . the most probable values characteristic of the user, as determined by comparator 42 using statistical methods applied to the data stored in data logger 41.” Gavish ¶ 171. Appellant fails to apprise us of any persuasive reason as to why this disclosure in Gavish fails to teach the recited baseline Appeal 2021-004041 Application 16/050,340 9 measurements. Indeed, Appellant does not even appear to maintain this dispute in its Reply Brief. With respect to claim 12’s recitation of “providing a target end-tidal CO2 level . . . for the user,” the Examiner cites paragraph [0057] of Gavish. Ans. 4. Appellant contends that “Gavish [0057] . . . does not disclose the setting of a target end-tidal CO2 level for the user” because “Gavish describes the ‘first characteristic[]’ . . . as an aspect of the sensor signal ‘indicative of a voluntary action of the user, typically one aspect of the user’s biorhythmic activity.’” Reply Br. 3. Appellant contends that Gavish describes target end-tidal CO2 level, however, as “the ‘second characteristic[’] of the sensor signal as being ‘indicative of a physiologic variable of the user that is desired to be improved and over which most persons do not usually exert voluntary control.’” Id. (citing Gavish ¶ 31). Appellant’s contention is not persuasive. The first and second characteristics are related to sensor output in Gavish. While Gavish might describe some characteristics as being voluntary or involuntary, it also expressly states, as noted above and cited by the Examiner (see Final Act. 3), that “alternatively or additionally, the first characteristic includes an end-tidal CO2 level of the user, and the sensor is adapted to generate the sensor signal having the first characteristic.” Gavish ¶ 78 (emphasis added). Appellant does not address this disclosure in Gavish. For at least these reasons, Appellant does not apprise us of error in the rejection of claims 12-16. CONCLUSION The Examiner’s rejections of claims 1-4, 6-9, and 11-16 are affirmed. The Examiner’s rejection of claim 10 is reversed. Appeal 2021-004041 Application 16/050,340 10 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-4, 8, 9 103 Gavish, Moretti, Freeman 1-4, 8, 9 6, 7 103 Gavish, Moretti, Freeman, Schmeink 6, 7 10 103 Gavish, Moretti, Freeman, Mault 10 11 103 Gavish, Moretti, Freeman, Anderson 11 12-16 103 Gavish, Moretti 12-16 Overall Outcome 1-4, 6-9, 11-16 10 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED IN PART