CYBERONICS, INC.

Patent Trials and Appeals Board

Apr 1, 2022

2021001502 (P.T.A.B. Apr. 1, 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. 14/884,021 10/15/2015 Stephen L. BOLEA 104292-1677 8475 138270 7590 04/01/2022 FOLEY & LARDNER LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER SO, ELIZABETH K ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 04/01/2022 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): ipdocketing@foley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEPHEN L. BOLEA Appeal 2021-001502 Application 14/884,021 Technology Center 3700 Before JOHN C. KERINS, DANIEL S. SONG, and BRANDON J. WARNER, Administrative Patent Judges. SONG, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s decision to reject claims 1-20. 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). The Appellant identifies the real party in interest as Cyberonics, Inc. Appeal Br. 2. Appeal 2021-001502 Application 14/884,021 2 CLAIMED SUBJECT MATTER The claims are directed to obstructive sleep apnea treatment devices, systems, and methods. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method of treating a patient, comprising: sensing, by circuitry, a biological parameter indicative of respiration; analyzing, by the circuitry, the biological parameter to identify a respiratory cycle; identifying, by the circuitry, an inspiratory phase of the respiratory cycle; determining, by the circuitry, that a duration of the inspiratory phase of the respiratory cycle is at least a predetermined percentage of a duration of the entire respiratory cycle; and delivering, by the circuitry, stimulation generated by a generator to a hypoglossal nerve of the patient via a lead coupled to the generator in response to determining the duration of the inspiratory phase of the respiratory cycle is at least the predetermined percentage of the duration of the entire respiratory cycle. Appeal Br. 18 (Claims App.). Claims 6 and 11 are also independent, and include limitations that are similar to those of claim 1, but are each directed to an implantable medical device including circuitry configured to perform steps of the method reproduced above. Appeal Br. 19, 20 (Claims App.). Appeal 2021-001502 Application 14/884,021 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Bolea US 9,186,511 B2 Nov. 17, 2015 Tehrani ’815 US 2006/0142815 A1 June 29, 2006 Tehrani ’341 US 2006/0155341 A1 July 13, 2006 REJECTIONS 1. Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of Bolea. Final Act. 5. 2. Claims 1-20 are rejected under 35 U.S.C. § 103 as being unpatentable under Tehrani ’341 in view of Tehrani ’815. Final Act. 6. OPINION Rejection 1: Nonstatutory Double Patenting The Examiner rejects claims 1-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of Bolea. Final Act. 5. The Appellant states that, “[w]ithout acquiescing to these rejections, Appellant has requested that these rejections be held in abeyance until such time that the claims are indicated to otherwise be in condition for allowance.” Appeal Br. 6. Thus, no argument having been presented against this double patenting rejection, we summarily affirm the same. Rejection 2: Obviousness The Examiner rejects claims 1-20 as being unpatentable under Tehrani ’341 in view of Tehrani ’815. Final Act. 6-9. The Examiner rejects independent claims 1, 6, and 11, finding that Tehrani ’341 discloses the method and device substantially as claimed, including “determining . . . a Appeal 2021-001502 Application 14/884,021 4 duration of the inspiratory phase of the respiratory cycle,” and “delivering stimulation to control the duration of the inspiratory phase in order to control breathing to prevent or mitigate obstructive sleep apnea.” Final Act. 6 (citing Tehrani ’341 ¶¶ 69-73, 103; Figs. 6A-12C). The Examiner also finds that Tehrani ’815 discloses: a same device and similar method of using to determining a duration of inspiratory phase out of a respiratory cycle, including monitoring when a duration of the inspiratory phase of the respiratory cycle is at least a predetermined percentage of a duration of the entire respiratory cycle . . . and also delivering stimulation to the hypoglossal nerve if an obstruction is determined . . . to induce a breathing pattern. Final Act. 7 (citing Tehrani ’815 ¶¶ 8, 59-61, 104-105, 116-117; Fig. 12A). Based on the above findings, the Examiner concludes that it would have been obvious to one of ordinary skill in the art to have “modified Tehrani ’341 in view of Tehrani ’815 to provide additional identification and determining means for the purpose of more effectively preventing or mitigating obstructive sleep apnea or other breathing disorder events,” thereby resulting in the invention claimed. Final Act. 7. The Appellant argues that the rejection is flawed because, contrary to the Examiner’s finding, neither Tehrani ’341 alone, or in combination with, Tehrani ’815, discloses “determining . . . that a duration of the inspiratory phase of the respiratory cycle is at least a predetermined percentage of a duration of the entire respiratory cycle,” and “delivering . . . stimulation . . . in response” based thereon. Appeal Br. 8-9. We agree with the Appellant. As the Appellant points out, Tehrani ’341 discloses that a first comparator “determines when respiration has been detected based on when an integrated signal waveform amplitude has been detected that is greater Appeal 2021-001502 Application 14/884,021 5 than a percentage value of the peak of an intrinsic respiratory cycle or another predetermined amount (comp 1),” and a second comparator that “determines a value of the waveform amplitude (comp 2) when an integrated signal waveform amplitude has been detected that is at a predetermined percentage value of the peak of an intrinsic respiratory cycle or another predetermined amount.” Appeal Br. 9-102; Tehrani ’341 ¶¶ 69-70, 72. Accordingly, the Appellant is correct that, contrary to the rejected claims, Tehrani ’341 discloses determination of the start of respiration and end of inspiration based on a predetermined percentage of the peak amplitude of an integrated signal waveform, instead of a predetermined percentage of a duration of the entire respiratory cycle as claimed. Appeal Br. 10. In addition, the disclosed thresholds or triggers in Tehrani ’341 are also based on “integrated signal waveform amplitude” instead of a predetermined percentage of a duration of the entire respiratory cycle. Tehrani ’341 ¶ 68. Thus, the Appellant is also correct that Tehrani ’341 likewise fails to disclose, teach, or suggest delivering stimulation “in response to” the recited determination, as the claims require. Appeal Br. 11. We also agree with the Appellant that Tehrani ’815 does not cure the above-noted deficiencies of Tehrani ’341 because it also discloses determinations as to the respiratory parameters and applied threshold or triggers based on “integrated signal waveform amplitude” instead of a predetermined percentage of a duration of the entire respiratory cycle. Appeal Br. 12; Tehrani ’815 ¶¶ 68-70. 2 We omit the underlining in all references to the Appellant’s Appeal Brief and Reply Brief. Appeal 2021-001502 Application 14/884,021 6 The Examiner responds that: under the broadest reasonable interpretation, a “percentage” is a part of a whole, wherein the part is the duration of the inspiratory phase and the whole is the duration of the entire respiratory cycle. Therefore, when there is a part of a duration out of a whole of a duration, mathematically speaking this gives a percentage of a duration. Ans. 8. The Examiner also points to Figure 16B of Tehrani ’341 for showing “an inspiration period 171 out of a whole respiratory cycle 180, thereby showing determination of a part out of a whole, thereby showing determination of a percentage of a duration of the entire respiratory cycle.” Ans. 8. However, the bare fact that there exists a mathematical relationship between a part of a duration and the whole, which may be expressed as a percentage, does not establish that such percentage is, in fact, determined, or that an action, such as stimulation, is delivered “in response to” such determination. Moreover, mere illustration of an inspiration part and the entire respiratory duration does not constitute “determining” any predetermined percentage. Tehrani ’341, Fig. 16A; see also Reply Br. 3 (“merely identifying an inspiration period, which happens to be a portion of an entire respiratory cycle, does not disclose, teach, or suggest determining that the duration of the inspiratory phase is at least a predetermined percentage of a duration of the entire respiratory cycle and delivering stimulation in response to this determination.”). The Examiner further responds that, “[r]egarding a ‘predetermined percentage’, Examiner interprets this to be equivalent to a predetermined threshold of some sort that triggers stimulation to be delivered,” and that “Tehrani ’341 shows in para. [0069] determining when an amount of Appeal 2021-001502 Application 14/884,021 7 inspiration has crossed a predetermined threshold, which Examiner considers is a predetermined percentage.” Ans. 8. We disagree that this identified disclosure is sufficient because the claim specifically recites “a predetermined percentage of a duration of the entire respiratory cycle,” not “a predetermined threshold of some sort,” and as noted, the Tehrani references disclose a threshold or trigger based on an integrated signal waveform amplitude. See also Reply Br. 4. Therefore, in view of the above considerations, we reverse the Examiner’s rejection of independent claims 1, 6, and 11, as being based on an incorrect factfinding. We also reverse the rejection as to the remaining claims 2-5, 7-10, and 12-20 ultimately depending from one of the independent claims. The Appellant’s arguments directed to dependent claims 2, 7, 12, and 16-20 are moot. CONCLUSION The Examiner’s rejections are affirmed in part. More specifically, the nonstatutory double patenting rejection of claims 1-15 is summarily affirmed, and the obviousness rejection of claims 1-20 is reversed. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-15 Nonstatutory Double Patenting US 9,186,511 1-15 1-20 103 Tehrani ’341, Tehrani ’815 1-20 Overall Outcome 1-15 16-20 Appeal 2021-001502 Application 14/884,021 8 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