DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 15-18, 28-31, 34, 42-47, 58, 60 and 63-69 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2019/0358464 A1 to Volosin et al. (hereinafter “Volosin ‘464”).
Regarding Claims 1, 34 and 63, Volosin ‘464 teaches an ambulatory externally worn cardiac device (see e.g. 100 in FIG. 1; see e.g. Para. 2: “The present disclosure is directed to wearable cardiac devices, systems, and methods for monitoring physiological status of patients during periods of patient activity”) configured to automatically assess an ambulatory patient's physical condition (see e.g. Paras. 175, 192, 195), the device comprising:
one or more externally worn ECG sensing electrodes (see e.g. 114 in FIG. 1) configured to detect at least one cardiac electric signal of the ambulatory patient (see e.g. “ECG signal” throughout the disclosure, e.g. in Para. 194);
one or more motion detectors (see e.g. 110 and/or 118 in FIG. 1) configured to detect at least one motion signal indicative of patient movement (see e.g. “cardio-vibrational signal, accelerometer data” throughout the disclosure, e.g. in Para. 194); and
at least one processor (see e.g. 104 in FIG. 1) operably coupled to the one or more externally worn sensing electrodes and the one or more motion detectors (see e.g. FIG. 1), the at least one processor being configured to
receive, for the ambulatory patient wearing the device, an initiating criterion corresponding to an ambulatory exertion test (see e.g. Para. 195), wherein the initiating criterion specifies heartrate-dependent parameter requirements (see e.g. Para. 175) and/or activity level- dependent parameter requirements (see e.g. Para. 195),
continuously monitor a current heartrate-dependent parameter (see e.g. Paras. 175-176) and/or a current activity level-dependent parameter of the ambulatory patient (see e.g. Paras. 177 and 195),
periodically determine whether the monitored current heartrate-dependent parameter and/or the current activity level-dependent parameter satisfies the initiating criterion for the ambulatory exertion test (see e.g. Paras. 174-177 and 195),
invite, via a user interface prompt, the ambulatory patient to participate in the ambulatory exertion test (see e.g. FIGS. 13A-C, Para. 195), and
initiate, upon receiving patient input indicating acceptance of the invitation, the ambulatory exertion test (see e.g. Para. 195).
Regarding Claim 2, see e.g. Paras. 175-176.
Regarding Claim 3, see e.g. Para. 138.
Regarding Claim 4, see e.g. Para. 193.
Regarding Claims 15-17 and 64-66, see e.g. Para. 195 and FIGS. 13D-E.
Regarding Claims 18 and 67, see e.g. FIGS. 14A-C, 15 and Paras. 196-200.
Regarding Claim 28, see e.g. Para. 197.
Regarding Claims 29 and 68, see e.g. Para. 138 and 195.
Regarding Claim 30, see e.g. Para. 137.
Regarding Claim 31, see e.g. Para. 177.
Regarding Claims 42-44, see e.g. Para. 177.
Regarding Claims 45-46, see e.g. Paras. 138, 174.
Regarding Claim 47, see e.g. Para. 177.
Regarding Claim 58¸see e.g. Paras. 176 and 179.
Regarding Claim 60, see e.g. FIGS. 14A-C, 15 and Paras. 196-200.
Regarding Claim 69, see e.g. Para. 194 and 825 in FIG. 8.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Volosin ‘464.
Regarding Claim 32, Volosin ‘464 teaches a multi-axis accelerometer as noted in portions cited above (see e.g. Paras. 123, 135, 137). Regarding the specific motion amplitude and/or duration thresholds used, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal motion thresholds for various activity classifications. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). One skilled in the art would understand the effects of different thresholds, e.g. higher thresholds equate to less sensitivity which reduces the chance of false positives, but increases the change of false negatives (and vice versa for lower thresholds). As such, one skilled in the art would understand how to experiment with different motion thresholds to find optimal threshold(s) which best categorize the patient’s motion.
Claims 31-32 and 70-73 are rejected under 35 U.S.C. 103 as being unpatentable over Volosin ‘464 in view of US 2021/0035674 A1 to Volosin et al. (hereinafter “Volosin ‘674”).
Regarding Claim 31, Volosin ‘464 implicitly teaches the limitations of this claim as noted above. As further evidence, Volosin ‘674 provides a more explicit teaching of comparing motion to thresholds for activity classification (see e.g. Para. 306). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Volosin ‘464 to utilize motion thresholds for motion activity classification because it would predictably provide a more accurate classification of the patient’s movements.
Regarding Claim 32, Volosin ‘464 teaches a multi-axis accelerometer as noted in portions cited above (see e.g. Paras. 123, 135, 137). Regarding the specific motion amplitude and/or duration thresholds used, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal motion thresholds for various activity classifications. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). One skilled in the art would understand the effects of different thresholds, e.g. higher thresholds equate to less sensitivity which reduces the chance of false positives, but increases the change of false negatives (and vice versa for lower thresholds). As such, one skilled in the art would understand how to experiment with different motion thresholds to find optimal threshold(s) which best categorize the patient’s motion.
Regarding Claims 70-71, Volosin ‘464 fails to specifically teach “outputting a performance message to the ambulatory patient during the ambulatory exertion test, the performance message comprising one or more of an indication to increase pace, an indication to decrease pace, an indication to maintain current pace, an indication of time remaining, or an indication of elapsed time … outputting at least a portion of the patient performance information to the ambulatory patient during the ambulatory exertion test, the patient performance information comprising one or more of total steps taken during the ambulatory exertion test, total distance covered during the ambulatory exertion test, total stairs climbed or descended during the ambulatory exertion test, average heartrate during the ambulatory exertion test, maximum heartrate during the ambulatory exertion test, or minimum heartrate during the ambulatory exertion test.” However, it was known in the art in a similar context to output such data to the patient. Volosin ‘674 shows this in e.g. Paras. 282-289 and Table 16. It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Volosin ‘464 to output this information, as seen in Volosin ‘674, because it would advantageously provide the patient with additional useful information.
Regarding Claim 72, Volosin ‘464 fails to specifically teach “determining that the ambulatory patient is experiencing or has experienced cardiac arrhythmia during the ambulatory exertion test; and terminating the ambulatory exertion test upon determining that the ambulatory patient is experiencing or has experienced cardiac arrhythmia during the ambulatory exertion test.” However, Volosin ‘674 teaches this limitation in a similar context (see e.g. Para. 83 and Table 1). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Volosin ‘464 to monitor for arrhythmia and terminate the test upon detecting arrhythmia because it would predictably enhance patient safety.
Regarding Claim 73, Volosin ‘464 fails to specifically teach “determining that the ambulatory patient is experiencing or has experienced a fall event during the ambulatory exertion test; and terminating the ambulatory exertion test upon determining that the ambulatory patient is experiencing or has experienced the fall event during the ambulatory exertion test” However, Volosin ‘674 teaches monitoring for a fall event (see e.g. Para. 94) and further teaches that the exertion test can be terminated based on a variety of criteria, including signs and symptoms of exercise intolerance (see e.g. Para. 83 and Table 1). One of ordinary skill in the art would have recognized that falling down during an exercise is a sign of intolerance of that exercise. As such, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Volosin ‘464 to monitor for a patient fall and terminate the test upon detecting a fall because it would predictably enhance patient safety.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at (571)-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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