Valencell, Inc.

Patent Trials and Appeals BoardMar 11, 2021

2020004350 (P.T.A.B. Mar. 11, 2021)

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. 14/511,692 10/10/2014 Steven Francis LeBoeuf 9653-11TSCT 3369 20792 7590 03/11/2021 MYERS BIGEL, P.A. PO BOX 37428 RALEIGH, NC 27627 EXAMINER BALDWIN, NATHAN AARON ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 03/11/2021 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): myersbigel_pair@firsttofile.com uspto@myersbigel.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte STEVEN FRANCIS LEBOEUF, JESSE BERKLEY TUCKER, MICHAEL EDWARD AUMER, ERIC DOUGLAS ROMESBURG, and JOSEPH NORMAN MORRIS __________ Appeal 2020-004350 Application 14/511,692 Technology Center 3700 __________ Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and ANNETTE R. REIMERS, Administrative Patent Judges. HOELTER, 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 8–12, 21, 22, 24, 27, and 28.2 Non- Final Act. 1 (Office Action Summary). We have jurisdiction under 35 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Valencell, Inc.” Appeal Br. 2. 2 Claims 1–7, 14–18, 23, 25, and 26 are withdrawn from consideration and claims 13, 19, and 20 are canceled. Appeal Br. 2, 17, 19 (Claims App.). Appeal 2020-004350 Application 14/511,692 2 U.S.C. § 6(b). For the reasons explained below, we AFFIRM the Examiner’s rejections of these claims. CLAIMED SUBJECT MATTER The disclosed subject matter “relates generally to monitoring apparatus and methods and, more particularly, to physiological monitoring apparatus and methods.” Spec. 1:9–11. Claims 8, 21, and 28 are independent. Appeal Br. 3–4. Claim 8 is illustrative of the claims on appeal and is reproduced below. 8. A method of monitoring at least one physiological property of a subject, comprising: directing modulated energy at a target region of the subject via an energy emitter; obtaining a first energy response signal from the subject when the emitter is on; obtaining a second energy response signal from the subject when the emitter is off; detecting step rate of the subject via a motion sensor; and processing the first and second energy response signals via an interference filter to produce a processed energy response signal that is associated with a physiological condition of the subject, and removing time-varying environmental interference caused by one or more of the following: sunlight, ambient light, airflow, and temperature, comprising determining frequencies of interference to ignore from a desired-information spectrum of the processed energy response signal using harmonics of the detected step rate, and setting the determined frequencies of interference within the desired-information spectrum to zero. Appeal 2020-004350 Application 14/511,692 3 REFERENCES Name Reference Date Kronberg et al. (“Kronberg”) US 5,273,036 Dec. 28, 1993 Amano et al. (“Amano”) US 6,095,984 Aug. 1, 2000 Cinbis et al. (“Cinbis”) US 2008/0208020 A1 Aug. 28, 2008 Yang et al. (“Yang”) US 2010/0113948 A1 May 6, 2010 Vetter et al. (“Vetter”) US 2012/0190948 A1 July 26, 2012 THE REJECTIONS ON APPEAL Claims 8–11, 21, 22, and 28 are rejected under 35 U.S.C. § 103(a) as unpatentable over Cinbis, Vetter, and Amano. Non-Final Act. 3. Claim 12 is rejected under 35 U.S.C. § 103(a) as unpatentable over Cinbis, Vetter, Amano, and Yang. Non-Final Act. 6. Claims 24 and 27 are rejected under 35 U.S.C. § 103(a) as unpatentable over Cinbis, Vetter, Amano, and Kronberg. Non-Final Act. 6. ANALYSIS The rejection of claims 8–11, 21, 22, and 28 as obvious over Cinbis, Vetter, and Amano Appellant argues claims 8–11 together. See Appeal Br. 6–12. Appellant also argues claims 21 and 22 together. See Appeal Br. 12. Finally, Appellant argues claim 28 separately. See Appeal Br. 13. We select claims 8, 21, and 28 for review, with the remaining claims standing or falling with their respectively grouped claim. See 37 C.F.R. § 41.37(c)(1)(iv)(2019). Appeal 2020-004350 Application 14/511,692 4 Claim 8 Claim 8 recites a method of monitoring at least one physiological property of a subject, and relies primarily on Cinbis for disclosing this claimed subject matter. Non-Final Act. 3; see also Ans. 7. Claim 8 further recites the steps of “detecting step rate of the subject via a motion sensor” and “determining frequencies of interference to ignore from a desired- information spectrum . . . and setting the determined frequencies of interference within the desired-information spectrum to zero.” The Examiner relies on Vetter and Amano for such teaching (the latter for teaching that “the frequency components taught by Vetter includes step motion from activities such as running and walking”). Non-Final Act. 3–4; see also Ans. 7–8. According to Appellant, “the Examiner puts forth a conclusion of obviousness that is only supported by conclusory statements instead of the required articulated reasoning having some rational underpinning.” Appeal Br. 6. As support, Appellant states that: (1) Vetter “uses an ECG ‘cardiosynchronous’ signal as a condition for measuring the PPG signals and in projecting the PPG signals onto a frequency component of the instantaneous heart rate from the ECG signal,” and (2) Vetter’s ECG signal is also used “to determine whether the difference between the heart rate and the motion frequency is ‘very small.’” Appeal Br. 10 (citing Vetter ¶¶ 71, 79). Appellant contends that “[t]hese usages of an ECG signal from Vetter are incompatible with the purpose and principle of operation of the Cinbis system, which provides optical sensors of tissue perfusion as an alternative to ECG-based monitoring of the patient’s cardiac system.” Appeal Br. 10; see also Reply Br. 2. “In other words, the motion filtering of Vetter uses an Appeal 2020-004350 Application 14/511,692 5 ECG-based heart rate, which if available renders the entirety of the Cinbis optical-based tissue perfusion system redundant: a processor need only monitor the instantaneous heart rate to monitor cardiac activity, in accordance with the prior art discussed in Cinbis.” Appeal Br. 10; see also Reply Br. 2–5. Appellant further contends that “the fact that Cinbis already contemplates different types of motion filtering can be used [as] an argument against combining the references: the combination only provides redundant advantages” and thus, providing “only redundant advantages is the result of impermissible hindsight.” Appeal Br. 10; see also Reply Br. 3. These arguments are unpersuasive because they do not address the Examiner’s basis for the rejection. The Examiner relies on Vetter for “determining frequencies of interference to ignore . . . and setting [them] to zero.” Non-Final Act. 3, Ans. 7 (both referencing Vetter ¶ 76); see also Vetter ¶¶ 78, 79. To be clear, Vetter discloses the method further comprises a step of extracting a motion frequency of the motion artifacts of the user (shown by numeral 17 in FIG. 3), and determining an activity of the user, by using motion signals measured by the motion sensor 6. Motion artifacts of the user can comprise regular periodical movement artifact related to activities like, for example, running, cycling, walking, etc., or voluntary and involuntary (respiration) subject movements. Vetter ¶ 76. Vetter takes into consideration “the frequency of harmful regular noise contributions due to regular movement artifacts, or central motion frequency” and setting their values to zero. Vetter ¶ 79. Vetter is relied upon since, as per the Examiner, “Cinbis does teach filtering out motion noise [0140] but not specifically removing frequencies.” Non-Final Act. 3; see also Ans. 7. Thus, the Examiner relies on Vetter for identifying certain frequencies and setting them to zero rather than, as asserted by Appeal 2020-004350 Application 14/511,692 6 Appellant, for teaching an ECG signal for monitoring tissue perfusion or adding additional layers of motion filtering. See Appeal Br. 10. In other words, as expressed by the Examiner, “the key teaching being [relied upon] in Vetter is the uses of the motion sensor 6 to extract the frequency of the motion and using these motion frequency components to filter the PPG signal by setting these frequency values to zero using a windowing function.” Ans. 9 (citing Vetter ¶¶ 19, 76–79; Fig. 3 (referring to “step[s] 18 and 20” of the figure)). Thus, Appellant incorrectly presumes that the Examiner’s modification combines or incorporates other Vetter teachings with Cinbis in an effort to distinguish Vetter, which is not persuasive the Examiner erred when relying on Vetter for the teachings actually employed. Moreover, even if Vetter uses an ECG signal for monitoring tissue perfusion, Appellant does not sufficiently explain why Vetter’s motion sensor 6 and Vetter’s methodology of removing frequencies relating to motion noise, are incompatible with the purpose and principle of operation of the Cinbis system, or would render the entirety of the Cinbis optical-based tissue perfusion system redundant. As the Examiner explains, “the filtering method taught by Vetter utilizes the activity sensor/accelerometer that is already taught by Cinbis . . . and therefore would only require the additional programming of the processor of Cinbis.” Ans. 9–10 (citing Vetter ¶¶ 43, 44, 76; Cinbis ¶ 38). The Examiner also correctly states that “even if Cinbis taught against using ECG signals, the PPG filtering technique using the motion/activity sensor signal taught by Vetter would not require the ECG signal to implement.” Ans. 9. Indeed, Vetter discloses that “for the motion artifacts being larger than large-band background noise, the window function yields an equivalent frequency response having zeros at the motion Appeal 2020-004350 Application 14/511,692 7 frequency and its harmonics, and the window function is a rectangular window.” Vetter ¶ 19. Appellant does not explain why Vetter’s methodology of filtering motion artifacts, i.e., by “yield[ing] an equivalent frequency response having zeros at the motion frequency and its harmonics,” cannot be applied to or conflicts with Cinbis’ system. Vetter ¶ 19. Appellant further argues that the motion filtering of Vetter, which discards unreliable PPG signals, can do so because there are eight (i.e., a plurality) different PPG emitter/detector groups within the multichannel sensor. This significantly differs from the Cinbis device, in which only one emitter/detector is present; discarding the PPG signals therefrom due to motion artifacts would result in no information about the cardiac condition of the subject, an unacceptable result. Appeal Br. 10. However, the Examiner correctly responds that “[n]owhere, does Vetter indicate that more than one PPG signal is required to implement this motion filtering technique and further this motion filtering technique utilizing motion sensor does not involve the discarding of the different PPG groups.” Ans. 10. Instead, “the PPG filtering technique [of Vetter] using the motion/activity sensor signal can be implemented on the system of Cinbis without . . . adding additional PPG channels.” Ans. 10. Once again, Appellant would have us believe that the Examiner is incorporating much more of Vetter’s disclosure than simply teaching adjustments to motion noise by filtering out particular frequencies. See Vetter ¶ 19. Appellant also contends that “Amano fails to teach or suggest the recitations of Claim 8” because “Amano describes a low or high pass filter in which all frequencies below or above a certain value are excluded.” Appeal Br. 11 (citing Amano 12:19–40). Appellant argues that claim 8 requires “frequencies of interference within a spectrum are ignored by Appeal 2020-004350 Application 14/511,692 8 setting them to zero” but “[r]emoving all frequencies above or below a certain value, as taught by Amano, is not the same, nor does it suggest, ignoring frequencies within a spectrum by setting them to zero.” Appeal Br. 11. As Appellant points out, Amano, indeed, discloses that certain frequencies “are excluded.” Amano 12:19–40. However, by excluding those frequencies, Amano effectively sets those frequencies to zero or otherwise gives them no weight. As such, Appellant is not persuasive that Amano’s exclusion of certain frequencies can be distinguished from their being set to zero or ignored. Further, Appellant does not explain any discrepancy between the claimed subject matter and Amano’s disclosure. Also, and of great importance, the Examiner relies on Amano for evidencing that the periodic harmonic motion related to walking and running taught by Vetter corresponds to the frequency and/or rate of steps. See Non-Final Act. 4; Ans. 8; Vetter ¶ 76.3 For these reasons, we sustain the Examiner’s rejection of claims 8–11 as being unpatentable over the combination of Cinbis, Vetter, and Amano. Claims 21 and 28 Appellant repeats the above argument that the combination of Cinbis, Vetter, and Amano “is only supported by conclusory statements instead of the required articulated reasoning having some rational underpinning.” See Appeal Br. 6, 12, 13. For similar reasons as already discussed, Appellant’s 3 We also note that the claimed subject matter, which Appellant is arguing here, appears to be disclosed in Vetter’s paragraph 19 as replicated above. See Vetter ¶ 19; see also Ans. 10. Appeal 2020-004350 Application 14/511,692 9 contention is not persuasive. We sustain the Examiner’s rejection of claims 21, 22, and 28. The rejection of claim 12 as obvious over Cinbis, Vetter, Amano, and Yang The rejection of claims 24 and 27 as obvious over Cinbis, Vetter, Amano, and Kronberg With respect to these claims, Appellant relies on the same arguments presented above regarding independent claim 8. See Appeal Br. 6–13. Consequently, for similar reasons as already discussed, we likewise sustain the Examiner’s rejection of claims 12, 24, and 27 as being unpatentable over the various combinations of cited prior art. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 8–11, 21, 22, 28 103(a) Cinbis, Vetter, Amano 8–11, 21, 22, 28 12 103(a) Cinbis, Vetter, Amano, Yang 12 24, 27 103(a) Cinbis, Vetter, Amano, Kronberg 24, 27 Overall Outcome 8–12, 21, 22, 24, 27, 28 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED