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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/10/26 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: acoustic sensing unit and data capture and processing unit in claims 1-7 and 9-20 which are interpreted as electronic stethoscope and mobile display device, phone or tablet, respectively.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3 and any claims that depend from it 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. Claim 3 recites “the plurality of acoustic signals” but there is no antecedent basis for a plurality of signals.
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.
Claim(s) 1-7, 9-18 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randall et al. US 2023/0270389 in view of Kushnir et al. US 2003/0139679.
Regarding claims 1 and 10, Randall discloses an image based lung auscultation system comprising
an acoustic sensing unit positionable on a patient and having a controller and an acoustic sensor to capture and communicate an acoustic signal from a respiratory cycle of the patient ([¶69,72] the sensing unit or electronic stethoscope has a controller and sensor), and
a data capture and processing unit including ([¶114] mobile platform or web portal):
a camera operable by a user to identify a target position of the acoustic sensing unit on the patient ([¶141,178,195] mobile platform has a camera for detecting the sensing unit and positioning),
a user interface including user inputs to operate the data capture and processing unit, a display, and a processor and a memory device storing instructions that ([¶114] the computer or mobile phone has an input a processor and memory), when executed by the processor, receive the user inputs, display an image generated by the camera on the display, display real-time information of the acoustic signal on the display, and display an output representing the patient's lungs on the display ([FIG28][¶198-201] the images, signal information and anatomical model can be displayed), and
a controller including a processor and a memory device storing instructions that, when executed by the processor, receive and store the acoustic signal from the acoustic sensing unit, generate real-time information of the acoustic signal, generate the image representing the lung function of the patient, and communicate the real-time information and the image to the user interface ([¶197,304,374] collected signals can be displayed and observed in the real-time).
Randall does not specifically disclose processing the acoustic signal through an interpolation algorithm and displaying an acoustic image representing the lung function of the patient based on the captured acoustic signal on the display. Kushnir teaches a similar acoustic based lung assessment device that displays an acoustic image as part of its output ([¶8,47] the calculated average acoustic energy is transformed into a gray scale image). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the device of Randall with the display of Kushnir in order to visualize in moving images the absence of airflow ([¶51]).
Regarding claims 2, 14 and 21, Randall discloses the acoustic signal includes more than one acoustic signal ([¶307] both microphones can record signals at the same time).
Regarding claim 3, Randall discloses an image based lung auscultation system comprising
an acoustic sensing unit positionable on a patient and having a controller and an acoustic sensor to capture and communicate an acoustic signal from a respiratory cycle of the patient ([¶69,72] the sensing unit or electronic stethoscope has a controller and sensor), and
a data capture and processing unit including ([¶114] mobile platform or web portal):
a camera operable by a user to identify a target position of the acoustic sensing unit on the patient ([¶141,178,195] mobile platform has a camera for detecting the sensing unit and positioning),
a user interface including user inputs to operate the data capture and processing unit, a display, and a processor and a memory device storing instructions that ([¶114] the computer or mobile phone has an input a processor and memory), when executed by the processor, receive the user inputs, display an image generated by the camera on the display, display real-time information of the acoustic signal on the display, and display an output representing the patient's lungs on the display ([FIG28][¶198-201] the images, signal information and anatomical model can be displayed), and
a controller including a processor and a memory device storing instructions that, when executed by the processor, receive and store the acoustic signal from the acoustic sensing unit, generate real-time information of the acoustic signal, generate the image representing the lung function of the patient, and communicate the real-time information and the image to the user interface ([¶197,304,374] collected signals can be displayed and observed in the real-time)
wherein the memory device of the controller further stores instructions that, when executed by the processor, synchronizes the more than one acoustic signal with each other based on a timing parameter of the respiratory cycle ([¶306,307] the signals are recorded simultaneously and processed in parallel to synchronize and compensating for timing differences in the signals).
Randall does not specifically disclose processing the acoustic signal through an interpolation algorithm and displaying an acoustic image representing the lung function of the patient based on the captured acoustic signal on the display. Kushnir teaches a similar acoustic based lung assessment device that displays an acoustic image as part of its output ([¶8,47] the calculated average acoustic energy is transformed into a gray scale image). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to combine the device of Randall with the display of Kushnir in order to visualize the absence of airflow ([¶51]).
Regarding claims 15 and 22, Randall discloses the memory device of the controller further stores instructions that, when executed by the processor, synchronizes the more than one acoustic signal with each other based on a timing parameter of the respiratory cycle ([¶306,307] the signals are recorded simultaneously and processed in parallel to synchronize and compensating for timing differences in the signals).
Regarding claims 4 and 16, Randall discloses the acoustic sensing unit is an electronic stethoscope ([¶69,72] the sensing unit or electronic stethoscope has a controller and sensor).
Regarding claims 5 and 17, Randall discloses the acoustic sensing unit includes an acoustic sensor and a controller, wherein the controller includes a processor and a memory device storing instructions that, when executed by the processor, cause the acoustic sensor to capture the acoustic signal of the patient and communicate the acoustic signal to the controller of the data capture and processing unit ([¶69,72] the sensing unit or electronic stethoscope has a controller and sensor. [¶141,178,195] mobile platform has a processor for analyzing the signals).
Regarding claims 6 and 18, Randall discloses the data capture and processing unit is a mobile device ([¶144] the sensing device is connected to a computing platform or mobile phone).
Regarding claims 7 and 11, Randall discloses the memory device of the user interface further includes instructions, that, when executed by the processor, displays a guide on the display ( [¶106,140,188] the device guides the user through positioning and testing).
Regarding claims 9 and 20, Randall discloses the acoustic sensing unit and the data capture and processing unit are wirelessly connected ([¶125,137]).
Regarding claim 12, Randall discloses the method further comprising the step of depicting real-time information of the acoustic signal on a display of the data capture and processing unit ([¶197,304,374] collected signals can be displayed and observed in the real-time).
Regarding claim 13, Randall discloses the step of depicting the output representing the patient’s lungs on a display of the data capture and processing device ([¶197,304,374] collected signals can be displayed and observed in the real-time).
Response to Arguments
Applicant’s arguments, see pgs. 6-9, filed 8/18/26, with respect to the 35 USC 101 rejection have been fully considered and are persuasive. The rejection has has been withdrawn.
Applicant's remaining arguments filed 8/18/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 103 rejection, Examiner respectfully disagrees. Kushnir teaches a acoustic device that uses multiple acoustic sensors to form its acoustic image. However, the claim language does not require that only one sensor is used. Similarly, combining Kushnir with Randall would not require modification of Randall. Kushnir teaches processing acoustic signals of the same type as Randall and creating an acoustic image. Kushnir uses multiple transducers to get an image of the entirety of the lungs but the claim does not require this limitation so using the acoustic signal interpolation algorithm of Kushnir with the sensor of Randall would provide an acoustic image that is indicative of lung function it would just be for limited regions.
Regarding Applicant’s argument that there is no motivation to combine Kushnir with Randall, Examiner respectfully disagrees. Kushnir provides the advantage of showing in a series of moving images based on the acoustic signal visual representation of lung function and air flow. Applicant also argues that the combination would not lead to the claimed structure or method but using a single sensor and capturing signals at different locations that are then synchronized is not actually in the current claim language. The claims do not recite that the device uses only one sensor and creates a combined image just that the signals are synchronized.
Regarding the Hindsight arguments, Examiner respectfully disagrees. Examiner’s combination of Randall and Kushnir does not have to teach using one sensor are multiple locations to generate one combined image because that is not claimed. The motivation for one of ordinary skill in the art at the time of filing to combine Kushnir with Randall is to provide the advantage of showing in a series of moving images based on the acoustic signal visual representation of lung function.
Regarding Applicant’s arguments against claim 3, Examiner respectfully disagrees. The claim does not require synchronizing signals that were captured sequentially at different positions as this is not claimed. Randall synchronizes the signals for parallel processing and compensating for sound travel. Additionally, Kushnir synchronizes its signal as well to each other based on the time series interval for the breath ([¶47-50]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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