DETAILED ACTION
This action is in response to communications filed 1/10/2025:
Claims 1-20 are pending
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12239478 in view of Migeotte et al (EP4254425, hereinafter Migeotte). For example:
Regarding claim 1, 12239478 teaches a wearable heart sound detection device (claim 1, a wearable heart sound detection system), comprising:
an acoustic sensing device for collecting heart sound signals of user's body, and outputting said heart sound signals (claim 1, an acoustic sensing device for collecting heart sound signals of user's body, performing signal amplification, filtering, digitization on said collected heart sound signals, and outputting preprocessed heart sound signals);
a wireless transmission device connected to transmit and receive data (claim 1, an external computing electronic device communicatively coupled to said acoustic sensing device for acquiring said preprocessed heart sound signals; claim 2, wherein said circuit assembly at least includes a wireless transmission device…to send the preprocessed first heart sound signals and the preprocessed second heart sound signals to said external computing electronic device via said wireless transmission device for further analysis);
wherein said acoustic sensing device includes a capacitive sound sensor, a piezoelectric sound sensor or the combination thereof (claim 1, wherein said acoustic device includes a capacitive sound sensor, a piezoelectric sound sensor and a circuit assembly);
a circuit assembly electrically connected with said capacitive sound sensor or said piezoelectric sound sensor (claim 1, said circuit assembly is respectively electrically connected with said capacitive sound sensor and said piezoelectric sound sensor); and
wherein said capacitive sound sensor and said piezoelectric sound sensor are integrated on a flexible substrate (claim 1, wherein said circuit assembly, said capacitive sound sensor and said piezoelectric sound sensor are integrated on a flexible substrate).
12239478 fails to explicitly teach e-SIM embedded in said wearable heart sound detection device;
Migeotte teaches e-SIM embedded in said wearable heart sound detection device (¶43, acoustic device comprising eSIM);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the heart sound detection system (as taught by 12239478) with the capabilities of wireless transmission via SIM or eSIM means (as taught by Migeotte). The rationale to do so is to combine prior art elements according to known methods to yield the predictable result of achieving wireless communication means through the use of a telephone network by using the well-known technology of SIM or eSIM (Migeotte, ¶43).
The remaining independent and/or dependent claims are similarly rejected using one or more claims of the patent and Migeotte (whether alone or in combination).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, it recites “wherein said acoustic sensing device includes a capacitive sound sensor, a piezoelectric sound sensor or the combination thereof;
a circuit assembly electrically connected with said capacitive sound sensor or said piezoelectric sound sensor; and
wherein said capacitive sound sensor and said piezoelectric sound sensor are integrated on a flexible substrate.”
There appears to be a constant change in scope between a capacitive sound sensor, a piezoelectric sound sensor, or a combination thereof. Applicant is advised to keep/choose a singular scope throughout the claim.
Claims 2-20 are dependent on claim 1 and thus also considered to be indefinite.
Regarding claim 14, it recites “extracting feature points of said heart sound signals by said external computing electronic device.” However, there is no antecedent basis for “said external computing electronic device”.
Claims 15-18 are considered indefinite as they depend upon an indefinite parent claim.
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.
Claim(s) 1-6, 11-17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Migeotte et al (EP4254425, hereinafter “Migeotte”) in view of Larson et al (US20160296159, hereinafter “Larson”) in further view of Gilland (US20100234706).
Regarding claim 1, Migeotte teaches a wearable heart sound detection device (¶15, an IMU such as a smartphone), comprising:
an acoustic sensing device for collecting heart sound signals of user's body, and outputting said heart sound signals (¶15, device capable of recognizing and collecting data related to the heart);
a wireless transmission device connected to transmit and receive data (¶41, device capable of wireless connection to transmit and receive data);
e-SIM embedded in said wearable heart sound detection device (¶43, device can comprise of a network communication module comprising of a SIM and/or eSIM);
Migeotte fails to explicitly teach wherein said acoustic sensing device includes a capacitive sound sensor, a piezoelectric sound sensor or the combination thereof;
a circuit assembly electrically connected with said capacitive sound sensor or said piezoelectric sound sensor; and
wherein said capacitive sound sensor and said piezoelectric sound sensor are integrated on a flexible substrate.
Larson teaches wherein said acoustic sensing device includes a capacitive sound sensor, a piezoelectric sound sensor or the combination thereof (Fig. 3, ¶176, acoustic sensors can comprise of capacitive and piezoelectric sensors);
a circuit assembly electrically connected with said capacitive sound sensor or said piezoelectric sound sensor (Fig. 3, various electrical components are in electrical connection with a processor on a circuit);
Larson fails to explicitly teach and wherein said capacitive sound sensor and said piezoelectric sound sensor are integrated on a flexible substrate.
Gilland teaches and wherein said capacitive sound sensor and said piezoelectric sound sensor are integrated on a flexible substrate (abstract, the use of flexible circuitry with various sensors attached).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the heart sound detection device (as taught by Migeotte) for the piezoelectric and capacitive sensors (as taught by Larson). The rationale to do so is to combine prior art elements according to known methods to yield the predictable result of using known sensors to achieve detection of known parameters using said known sensors (Larson, ¶176). It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the heart sound detection device (as taught by Migeotte in view of Larson) with the flexible circuitry (as taught by Gilland). The rationale to do so is to combine prior art elements according to known methods to yield the predictable result of achieving a device that is small and lightweight and easily bendable to improve the comfort of the patient (Gilland, abstract).
Regarding claim 2, Migeotte in view of Larson in further view of Gilland teaches wherein said e-SIM is compatible with a wireless transmission protocol selected from a group of WiFi, 4G, 5G, 6G or any combination thereof (Migeotte, ¶43, device can be a smartphone with 4G wireless communication means as well as Wi-Fi).
Regarding claim 3, Migeotte in view of Larson in further view of Gilland teaches wherein an external computing electronic device is communicatively coupled to said wearable heart sound detection device (Larson, Fig. 3, heart sensors can be in communication with an external terminal device).
Regarding claim 4, Migeotte in view of Larson in further view of Gilland teaches wherein a cloud database is communicatively coupled to said external computing electronic device (Migeotte, Fig. 5, cloud database (6) is communicatively coupled to an external computing device (5)).
Regarding claim 5, Migeotte in view of Larson in further view of Gilland teaches wherein a cloud database is communicatively coupled to said wearable heart sound detection device (Migeotte, Fig. 4, a cloud database (6) is communicatively coupled to said wearable heart detection device (5)).
Regarding claim 6, Migeotte in view of Larson in further view of Gilland teaches wherein said capacitive sound sensor is disposed on a surface of said circuit assembly (Gilland, Fig. 7, various electrical modules such as a capacitive sound sensor (as taught by Larson) can be disposed on a surface of a circuit assembly).
Regarding claim 11, it is rejected similarly as claim 1.
Regarding claim 12, Migeotte in view of Larson in further view of Gilland teaches wherein said flexible substrate is made of polyimide (PI), polyethylene terephthalate (PET), or textile (Gilland, ¶22, polyimide can be used to form the flexible substrate).
Regarding claim 13, Migeotte in view of Larson in further view of Gilland teaches further performing following steps:
establishing attachment confirmation between said user's body and said acoustic sensing device (Larson, ¶59, proper attachment of sensors can be confirmed);
collecting said user's biometric features by said acoustic sensing device (Migeotte, ¶63, collecting cardiac features using acoustic sensing device);
capturing said user's heartbeat signals by said acoustic sensing device (Migeotte, ¶63, capturing at least one heartbeat);
performing heart rhythm analysis on said heart sound signals by said acoustic sensing device (Migeotte, ¶63, detecting cardiac cycles/periods);
checking whether emergency situations existed after said heart rhythm analysis being performed (Migeotte, ¶3, 73, performing analysis of the captured heartbeat signal(s) to determine a health check of the patient and to inform the patient of irregularities).
Regarding claim 14, Migeotte in view of Larson in further view of Gilland teaches further performing following steps:
sending out an alarm if one of said emergency situations is justified, otherwise sending out said heart sound signals for signal processing and continuously capturing said user's heartbeat signals (Larson, ¶65, sending out an alarm upon detection of abnormal heart pattern);
extracting feature points of said heart sound signals by said external computing electronic device (Migeotte, Fig. 7, collecting heartbeat signals and identifying one or more features).
Regarding claim 15, Migeotte in view of Larson in further view of Gilland teaches further performing following steps:
performing artificial intelligence (AI) comparison and status classification between said extracted feature points and with previous stored data;
archiving results of said AI comparison and status classification for subsequent comparisons and offering said results to interpret and provide medical-related advices by medical specialists (MIgeotte, ¶72, AI is performed on the captured data and compared against an established model to determine if user’s health is in danger or normal; said captured results can subsequently be used as training data for refining of AI/ML models).
Regarding claim 16, Migeotte in view of Larson in further view of Gilland teaches wherein said AI comparison and said status classification are performed by an AI algorithm installed on said external computing electronic device to preliminarily classify normal heart sound signals and abnormal heart sound signals (Migeotte, ¶47-48, the AI algorithm can be stored both locally and in the cloud (i.e. on an external computing device)).
Regarding claim 17, Migeotte in view of Larson in further view of Gilland teaches wherein said AI algorithm includes performing steps of:
pre-filtering and normalizing said heart sound signals been input (Migeotte, ¶58, pre-filtering to remove signal components not related to the heart; Larson, ¶78, normalization can be applied to IMU data);
extracting time-domain and frequency-domain features of said heart sound signals been input (Migeotte, ¶58-59, extracting both time-based and frequency-based features of the collected signals);
outputting classification results by adopting convolutional neural networks (CNN) model (Migeotte, ¶72, AI engine can be a NN-based model).
Regarding claim 19, Migeotte in view of Larson in further view of Gilland teaches further comprising identifying user's identity by said collected biometric features (Larson, ¶59, detecting a user’s biometric parameters that can include a heart rate).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Migeotte et al (EP4254425, hereinafter “Migeotte”) in view of Larson et al (US20160296159, hereinafter “Larson”) in further view of Gilland (US20100234706) in further view of Sandler et al (US20110295127, hereinafter “Sandler”).
Regarding claim 18, Migeotte in view of Larson in further view of Gilland teaches wherein said signal processing includes performing filtering (Migeotte, ¶58, filtering)
Migeotte in view of Larson in further view of Gilland fail to explicitly teach wavelet analysis, and Fourier transform over said heart sound signals.
Sandler teaches wavelet analysis, and Fourier transform over said heart sound signals (¶82, performing wavelet analysis and Fourier transforms).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply known analysis techniques (as taught by Sandler) on the heart monitoring system (as taught by Migeotte in view of Larson in further view of Gilland). The rationale to do so is to apply a known technique to a known device ready for improvement to yield the predictable result of determining analysis results related to heartbeats using known techniques to better detect possible heart failure (Sandler, ¶3, 7).
Allowable Subject Matter
Claims 7-10 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to PTO-892, Notice of References Cited for a listing of analogous art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIN ZHU whose telephone number is (571)270-1304. The examiner can normally be reached Monday-Thursday 6AM-4PM EST.
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/QIN ZHU/Primary Examiner, Art Unit 2691
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