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 .
Response to Arguments
Applicant's arguments filed 8/31/2025 on p. 11 are persuasive in that Jumbe does not disclose a soundproof ring. New grounds for rejection are presented under 35 U.S.C. § 103 in view of Kline et al. (U.S. Patent Application Publication No. 2019/0125196).
With respect to the rejections under 35 U.S.C. § 103, on p. 10, Applicant firstly states that “none of (the cited prior art) discloses the integrated design of packaged resonance and skin-mounted sensing” alleging the prior art of record does not teach the structure of the device as claimed.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “integrated design of packaged resonance and skin-mounted sensing”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Jumbe reference appears to teach an integrated design of packaged resonance in the embodiment of Fig. 13C as cited, for example, as these elements form an integral assembly that includes a resonant chamber formed between the membrane element 1324 and the frame element 1322, with walls formed by the support ring element 1326. The support ring 1326 acts as an isolation ring, maintaining acoustic isolation of sensor element 1332 located above the resonant cavity when the assembly is complete, away from the flexible printed circuit board, element 1340.
The Jumbe reference teaches, for example, skin-mounted sensing in ¶[0356]:
“In some variations, the sensing device may include a wearable housing. The wearable housing may, for example, be coupled to an adhesive patch configured for attachment to a surface (e.g., skin) of a subject in a suitable body location (e.g., chest, stomach, etc.). As another example, the wearable housing may be coupled to a suitable garment (e.g., clothing such as a shirt or jacket, a chest strap, a belly band, arm band, etc.) for detecting vibroacoustic signals from a subject wearing the garment. Accordingly, in such variations the sensing device may enable continuous monitoring of the subject for one or more bodily conditions.”
With respect to the rejections under 35 U.S.C. § 103, on p. 10, Applicant further states that the prior art does not disclose a sound sensing module that incorporates the piezoelectric sensor, adhering directly to the user’s skin and providing isolation from external noise and converting the heart’s mechanical vibrations and sounds into signals.
As noted above, the Jumbe reference does teach this arrangement and the sensor coupled directly to a user’s skin.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 103
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.
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(s) 1-2, 5, 7-8, 11-12, 15, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jumbe et al. (U.S. Patent Application Publication No. 2021/0345939) hereinafter referred to as Jumbe; in view of Kline et al. (U.S. Patent Application Publication No. 2019/0125196) hereinafter referred to as Kline.
Regarding claim 1, Jumbe teaches a wearable stethoscope (¶[0087] wearable housing applied to the subject or coupled to clothing or other garments) comprising:
a sound sensor (¶[0357], sensing device, vibroacoustic sensor module, which may be any of the disclosed embodiments of the vibroacoustic sensor module, including Fig. 13A-C, e.g.) configured to collect heart sound signals of a user (¶[0485] heart sounds), said sound sensor including a diaphragm (¶[0152] membrane extends over a cavity formed by membrane and sidewalls, such as element 1325 in Fig. 13B), a piezoelectric sensor (¶[0126] piezoelectric transducer elements, ¶[0149] any of the disclosed sensors may comprise additional piezo electric transducer), and a circuit board (Fig. 13B, element 1340 flexible PCB, ¶[0151]);
wherein said circuit board is electrically connected to said sound sensor and said piezoelectric sensor (¶¶[0283-0284] electronics system connected to sensors as a microcontroller unit, and performing signal processing) to preprocess said collected heart sound signals (¶[0292] at least a portion of the signal processing system may occur in the electronics systems, outside the sensor itself); and
wherein said diaphragm is disposed on a surface of said circuit board (Fig. 13C, e.g. although many arrangements of the vibroacoustic sensor module are disclosed, and the embodiment of Fig. 29 as cited above may include any of them, element 1324 membrane is attached to flexible PCB 1340 via a contacting ring 1344 on one side of flexible PCB 1340), a support ring (Fig. 13B, element 1326) disposed on said surface and enclosed said diaphragm to form a resonant cavity (¶[0152] membrane extends over a cavity formed by membrane and sidewalls, such as element 1325 in Fig. 13B) wherein said piezoelectric sensor is arranged on a side of said support ring that is not in contact with said circuit board (Fig. 13B, sensors 1332 are not in contact with 1340 and can comprise the piezoelectric transducer, ¶[0149]).
Jumbe does not teach the support ring is soundproof.
Attention is brought to the Kline reference, which teaches sound barriers and dampening material (¶[0286]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the support ring of Jumbe to be soundproof, as taught by Kline, because Kline teaches that soundproof material eliminates unwanted noise (Kline ¶[0286]).
Regarding claim 2, Jumbe as modified teaches the wearable stethoscope of claim 1.
Jumbe further teaches wherein said piezoelectric sensor is directly attached to user's skin (¶[0158], ¶[0442]), or through a clothing body attached to said user's skin (¶[0357] aligned openings allow sound sensor direct attachment to skin or through clothing, ¶[0358], ¶[0158]).
Regarding claim 5, Jumbe as modified teaches the wearable stethoscope of claim 2.
Jumbe further teaches wherein said sound sensor is detachably integrated with said clothing body through a connecting piece (¶[0356], ¶[0358]).
Regarding claim 6, Jumbe as modified teaches the wearable stethoscope of claim 5.
Jumbe further teaches wherein said connecting piece is a buckle (¶[0358] interlocking parts, latch).
Regarding claim 7, Jumbe as modified teaches the wearable stethoscope of claim 2.
Jumbe further teaches wherein said clothing body is a tight-fitting clothing that fits said user's body (¶[0356]), to facilitate said piezoelectric sensor of said stethoscope sensing said user's body sounds, especially for sensing said user's heart sound signals (¶¶[0357-0358]).
Regarding claim 8, Jumbe as modified teaches the wearable stethoscope of claim 1.
Jumbe further teaches wherein said circuit board at least includes: a signal preprocessing module comprising a filter (¶[0440] filter), a signal amplifier electrically connected to said filter (¶[0440] amplifier) and an analog to digital converter electrically connected to said signal amplifier (¶[0440] digitizing), for sequentially filtering, amplifying and digitizing said heart sound signals (¶[0440] filter, amplifier, digitizer);
a microprocessor, electrically connected to said analog to digital converter, used to receive and process said digitalized heart sound signals to obtain preprocessed heart sound signals with background noise been removed (Fig. 24, ¶[0128] noise cancellation performed in postprocessing).
Regarding claims 11-12 and 15-18, the claims are directed to a wearable stethoscope integrated with a clothing body comprising substantially the same subject matter as claims 1-2 and 5-8, and are rejected under substantially the same sections of Jumbe and Kline.
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jumbe and Kline as applied to claim 1 above, and further in view of Lanzo et al. (U.S. Patent No. 6,661,161) hereinafter referred to as Lanzo.
Regarding claim 3/13, Jumbe as modified teaches the wearable stethoscope (integrated into a clothing body) of claim 2/12.
Jumbe does not teach wherein said piezoelectric sensor includes a piezoelectric layer, and upper and lower surfaces of said piezoelectric layer have conductive electrodes.
Attention is brought to the Lanzo reference, which teaches wherein a piezoelectric sensor (element 4, Fig. 1) includes a piezoelectric layer (element 13, Fig. 1), and upper and lower surfaces (elements 12 and 14 comprise electrode coatings, Fig. 1) of said piezoelectric layer have conductive electrodes (col. 4, lines 10-16, Fig. 1).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the piezoelectric transducer of Jumbe as modified to include electrode coatings, as taught by Lanzo, because Lanzo teaches that piezoelectric membrane transduces are particularly suited for the capture of acoustic waves, and converting them to electrical signals via the electrode surface coatings (Lanzo, col. 1, lines 34-51).
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jumbe and Kline as applied to claim 1 above, and further in view of Longinotti-Buitoni et al. (U.S. Patent Application Publication No. 2021/0195732) hereinafter referred to as L-B.
Regarding claim 4/14, Jumbe as modified teaches the wearable stethoscope (integrated into a clothing body) of claim 2/12.
Jumbe does not teach wherein said sound sensor is integrated with said clothing body through a storage bag.
Attention is brought to the L-B reference, which teaches wherein a sound sensor is integrated with said clothing body through a storage bag (Fig. 1B, pouch, element 9, ¶[0265] may hold sensor elements and situated in, on, and/or around any portion of the internal surface or external surface of a clothing body).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the attachment of the clothing body and sensor module of Jumbe as modified to include a storage bag, as taught by L-B, because it can be weatherproof and/or waterproof for protecting sensitive electronic and sensor elements (L-B ¶[0265]).
Claim(s) 9-10 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jumbe and Kline as applied to claim 1 above, and further in view of Stevens et al. (U.S. Patent Application Publication No. 2018/0108440) hereinafter referred to as Stevens.
Regarding claim 9, Jumbe as modified teaches the wearable stethoscope of claim 8.
Jumbe does not teach wherein said preprocessed heart sound signals are analyzed and cross-referenced with an existing database through an external electronic computing device communicatively coupled with said wearable stethoscope.
Attention is drawn to the Stevens reference, which teaches wherein said preprocessed heart sound signals (¶[0080]) are analyzed and cross-referenced with an existing database (¶[0028] stored biomarkers across multiple patients) through an external electronic computing device (¶[0028]) communicatively coupled with a wearable stethoscope (¶[0080]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the analysis of Jumbe as modified to include a database for cross-referencing heart sounds, as taught by Stevens, because population based patterns of heart sound data can enable the prediction of disease and give care teams the ability to escalate care (Stevens ¶[0084]).
Regarding claim 10/20, Jumbe as modified teaches the wearable stethoscope (integrated into a clothing body) of claim 9/19.
Jumbe further teaches wherein said external electronic computing device is a smart phone (¶[0092] parsed data may be stored on a smartphone gateway, ¶[0093] computing device may be a smartphone).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792