DETAILED ACTION
This action is in response to communications filed 11/20/2024:
Claims 21-39 are pending
Claims 1-20 are cancelled
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 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12178634. Although the claims at issue are not identical, they are not patentably distinct from each other. For example:
Regarding claim 1, 12178634 teaches a method for diagnosing heart and/or lung conditions (claim 1, a method of positioning a stethoscope at one or more heart and/or lung listening locations) comprising:
providing an electronic stethoscope comprising a chest piece with a bell comprising a concave face, a light-emitting device on a side opposite the concave face, a microphone, an analog-to-digital converter, and an electronic connection (claim 12, an electronic stethoscope comprising: a hollow bell portion; claim 15, wherein the hollow bell portion comprises a concave face; claim 7, wherein the one or more variably switching light-emitting devices comprise one or more light-emitting diodes; claim 12, a microphone disposed in the microphone compartment; claim 13, wherein the electronic stethoscope further comprises a microprocessor and an analog-to-digital converter; claim 12, an electronic data connection from the microphone);
providing an electronic device comprising at least one input mechanism and a digital display, and comprising or coupled to a digital video camera (claim 1, providing a live video feed…displaying the live video feed on a video screen);
connecting the electronic stethoscope to the electronic device via the electronic connection;
using a visual localization algorithm to guide a user to position the electronic stethoscope at heart valve and/or lung listening locations on the chest and/or back of the user (claim 1, rendering, on the live video feed displayed on the video screen, a shape overlapping with a live location of the visual indicator of the electronic stethoscope, the shape changing in color and/or shape to indicate when the electronic stethoscope is positioned correctly at one of the one or more heart and/or lung listening locations);
recording a duration of heart and/or lung sounds at each of the heart valve and/or lung listening locations (claim 5, recording a duration of heart and/or lung sounds at each of the heart valve and/or lung listening locations);
providing the heart and/or lung sound recordings to a trained audio classification algorithm (claim 5, providing the sound recordings to a trained audio classification algorithm);
outputting, by the trained audio classification algorithm, a classification of each of the heart and/or lung sound recordings corresponding to at least one of normal heart and/or lung function or one or more of a plurality of heart and/or lung conditions (claim 5, outputting, by the trained audio classification algorithm, a classification of each of the sound recordings corresponding to at least one of normal heart function, normal lung function, one or more of a plurality of heart conditions, or one or more of a plurality of lung conditions).
The remaining independent and/or dependent claims are rejected using one or more claims of the patent (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 22-25, 29, and 33-37 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.
The term “about” in claim 22 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “about” in claim 23 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “about” in claim 33 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 22 further recites “…the set of matched pairs comprising a ‘sufficient’ number of data points….” The term “sufficient” is also understood to be a relative term and does not provide adequate metes and bounds to concretely define “sufficient”.
Claims 24-25 and 29 are considered as being indefinite because they depend upon an indefinite parent claim.
Claims 34-37 are considered as being indefinite because 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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randall et al (US20230270389, hereinafter “Randall”) in view of Blair et al (US20230096006, hereinafter “Blair”).
Regarding claim 21, Randall teaches a method for diagnosing heart and/or lung conditions comprising:
providing an electronic stethoscope comprising a chest piece with a bell comprising a concave face, a light-emitting device on a side opposite the concave face, a microphone, an analog-to-digital converter, and an electronic connection (Fig. 1, electronic stethoscope with chest piece as shown and bell with diaphragm, LEDs, microphone, AD converter (¶305) and electronic connection (Fig. 3, USB));
providing an electronic device comprising at least one input mechanism and a digital display, and comprising or coupled to a digital video camera (¶196, connecting the stethoscope to an electronic device to display the self-exam guide);
connecting the electronic stethoscope to the electronic device via the electronic connection (¶106, connecting stethoscope to a patient’s smart device);
using a visual localization algorithm to guide a user to position the electronic stethoscope at heart valve and/or lung listening locations on the chest and/or back of the user (Fig. 12, 14, ¶196, using a GUI to guide the user to place the stethoscope at the appropriate positions);
recording a duration of heart and/or lung sounds at each of the heart valve and/or lung listening locations (¶197, placing the stethoscope at the auscultation position for a specific duration and recording the sounds);
Randall fails to explicitly teach providing the heart and/or lung sound recordings to a trained audio classification algorithm;
outputting, by the trained audio classification algorithm, a classification of each of the heart and/or lung sound recordings corresponding to at least one of normal heart and/or lung function or one or more of a plurality of heart and/or lung conditions.
Blair teaches providing the heart and/or lung sound recordings to a trained audio classification algorithm (¶66, physiological data can be provided to rule-based system and to a deep neural network so the data can be classified);
outputting, by the trained audio classification algorithm, a classification of each of the heart and/or lung sound recordings corresponding to at least one of normal heart and/or lung function or one or more of a plurality of heart and/or lung conditions (¶66-68, Fig. 5, data is input into rule-based system and deep neural network in order to classify the data as well as make a decision on whether the recordings are clinically relevant).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the technique of machine learning (as taught by Blair) to the electronic stethoscope (as taught by Randall). The rationale to do so is to apply a known technique to a known device ready for improvement to yield the predictable result of improving self-guided auscultation.
Claim(s) 26-28 and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randall et al (US20230270389, hereinafter “Randall”) in view of Blair et al (US20230096006, hereinafter “Blair”) in further view of Mong et al (US20210338631, hereinafter “Mong”).
Regarding claim 26, Randall in view of Blair teaches wherein providing the heart and/or lung sound recordings comprises providing heart recordings (Randall, ¶76, heart and lung recordings); and
Randall in view of Blair fail to explicitly teach wherein the plurality of heart and/or lung conditions comprises heart conditions comprising at least one of aortic valve stenosis, mitral valve regurgitation, aortic valve regurgitation, mitral valve stenosis, patent ductus arteriosus, pulmonary valve stenosis, tricuspid valve regurgitation, and hypertrophic obstructive cardiomyopathy.
Mong teaches wherein the plurality of heart and/or lung conditions comprises heart conditions comprising at least one of aortic valve stenosis, mitral valve regurgitation, aortic valve regurgitation, mitral valve stenosis, patent ductus arteriosus, pulmonary valve stenosis, tricuspid valve regurgitation, and hypertrophic obstructive cardiomyopathy (¶294, the system can distinguish aortic stenosis conditions from others).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the technique of distinguishing heart/lung conditions (as taught by Mong) to the electronic stethoscope (as taught by Randall in view of Blair). The rationale to do so is to apply a known method to a known device ready for improvement to yield the predictable result of improving the parameterization of heart sound signals (Mong, ¶296).
Regarding claim 27, Randall in view of Blair in further view of Mong teaches wherein providing the heart and/or lung sound recordings comprises providing heart recordings (Randall, ¶76, heart and lung recordings); and
wherein the plurality of heart and/or lung conditions comprises heart conditions comprising at least one of an innocent murmur, an aortic stenosis, and a mitral valve prolapse (Mong, ¶294, the system can distinguish aortic stenosis conditions from others).
Regarding claim 28, Randall in view of Blair in further view of Mong teaches wherein providing the heart and/or lung sound recordings comprises providing lung recordings (Randall, ¶76, heart and lung recordings); and
wherein the plurality of heart and/or lung conditions comprises lung conditions comprising at least one of an egophony, bronchophony, and whispered pectoriloquy (Mong, ¶282, lung sounds can be auscultated including egophony, bronchophony and whispered pectoriloquy).
Regarding claim 30, Randall in view of Blair in further view of Mong teaches wherein using a visual localization algorithm to guide a user to position the electronic stethoscope comprises:
bringing the electronic stethoscope and at least the torso of the user into a field of view of the digital video camera (Blair, Fig. 6, guided usage of the stethoscope includes bringing the device and user into view of the camera).
Regarding claim 31, Randall in view of Blair in further view of Mong teaches further comprising:
capturing, via the digital video camera, light from the light-emitting device; and
transmitting the video image(s) and/or digital video to the electronic device (Randall, Fig. 16, the LEDs on top of the stethoscope are captured by the camera).
Regarding claim 32, Randall in view of Blair in further view of Mong teaches wherein using a visual localization algorithm to guide a user to position the electronic stethoscope comprises using a pose estimation algorithm, which outputs key points of a pose of the user, the key points including the locations of at least the left shoulder and the right shoulder of the user (Randall, Fig. 17, key auscultation points include the left and right shoulders).
Allowable Subject Matter
Claims 22-25 and 29 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.
Claims 33-39 are allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Duc Nguyen can be reached on 571-272-7503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QIN ZHU/Primary Examiner, Art Unit 2691
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