DETAILED ACTION
The Applicant’s response, received 29 August 2025 has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 29 August 2025 has been entered.
Status of the Claims
Claims 14 and 17-21 are pending.
Claims 14 and 17-21 are rejected.
Claim 19 is objected to.
Priority
The effective filing date of the claimed invention is 14 August 2018.
Claim Interpretation
The amendment received 29 August 2025 has been fully considered, however after further consideration, the claim limitations noted below are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph in view of the amendment.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitations are:
an input unit, in claim 14; and
an output unit, in claims 14 and 21.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The written description does not disclose a corresponding structure for:
an input unit, in claim 14; and
an output unit, in claims 14 and 21.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
The objections to claims 11 and 14 in the Office action mailed 20 May 2025 are withdrawn in view of the amendment received 29 August 2025.
The amendment received 29 August 2025 has been fully considered, however after further consideration, new grounds of objection are raised in view of the amendment.
Claim 19 is objected to because of the following informalities: The word “wherein” should be inserted after the comma and before the word “the” in line one.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 1-5, 7, 8, 10-14, and 17-21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in the Office action mailed 20 May 2025 is withdrawn in view of the amendment received 29 August 2025.
The rejection of claim 2 under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, in the Office action mailed 20 May 2025 is withdrawn in view of the amendment received 29 August 2025.
The amendment received 29 August 2025 has been fully considered, however after further consideration new grounds of rejection are raised in view of the amendment.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14 and 17-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 14 recites “an input unit configured to…” and “an output unit configured to…” and claim 21 further recites “the output unit is further configured to…” however the disclosure does not clearly link any structure for the “input unit” or the “output unit” as required by MPEP 2181. For example, FIG.27 as described at paragraphs [00290] – [00292] in the Specification describes functions for the “input unit” or the “output unit” but do not link any structure to the functions.
Claims 17-21 are rejected for depending from claim 14 and failing to remedy the failure to comply with the written description requirement.
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 14 and 17-21 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 14 is indefinite for reciting an “information acquisition system having a heart and lung sounds acquisition device and a computer, using heart and lung sounds, the system comprising” (emphasis added), because the claim recites a system as well as method steps of using the system, i.e., “analyze an amplitude variation and an amplitude of each of a first heart sound and a second heart sound, based on the received electrical signals corresponding to the collected heart sound and/or the collected lung sound” and “determine a target measurement position of the probe based on a result of comparing of the analyzed amplitude variation and amplitude of the first heart sound and the analyzed amplitude variation and amplitude of the second heart sound” (see MPEP 2173.05(p) II.).
Claims 17-21 are indefinite for depending from claim 14 and for failing to remedy the indefiniteness of claim 14.
Claim 14 is further indefinite for reciting “wherein the processor is further configured to guide the probe to the determined target measurement position” because it is not clear as to whether the processor is configured to have direct control of the probe, or if the processor is configured to process and output data (e.g., information regarding the position of the probe) that would be used by an operator (e.g., medical staff) to manually guide the insertion of the device to a specific position in the patient’s airway. This limitation is interpreted to mean that the processor is configured to output data (with an intended use of an operator (e.g., medical staff) using the data to manually guide the probe to the target position).
Claims 17-21 are indefinite for depending from claim 14 and for failing to remedy the indefiniteness of claim 14.
Claim 19 is indefinite for reciting “the processor is further configured to: analyze the received electrical signals…” because the processor analyzes digital data (1s and 0s) and not electrical signals, therefore requiring that the electrical signals be converted from an analog signal to a digital signal prior to being analyzed by a computer.
Claim 20 is indefinite for depending from claim 19 and for failing to remedy the indefiniteness of claim 19.
Claim 19 is further indefinite for reciting “based on the analysis result” in line six, because it is not clear as to whether this limitation is referring to result of the analysis step in lines 3-5 of claim 19, or the results of the analysis step in lines 15-17 of claim 14.
Claim 20 is indefinite for depending from claim 19 and for failing to remedy the indefiniteness of claim 19.
Claim 20 is indefinite for reciting “wherein the processor is further configured to…wherein the training data is created by collecting, by the computer, the electrical signals…and training, by the computer, a learning model by using the collected electrical signals…” because the computer collects digital data (1s and 0s) and not electrical signals, and further, training a learning model requires that the computer use digital data and not electrical signals, and therefore the electrical signals would not be utilizable for creating training data or training a learning model without first having been converted from an analog signal to a digital signal prior to being collected and processed by a computer.
Claim Rejections - 35 USC § 101
The amendment received 29 August 2025 has been fully considered, however after further consideration, the rejection of claims 1-5, 7, 8, 10-14, and 17-21 in the Office action mailed 20 May 2025 is maintained with modification in view of the amendment.
The rejection of claims 1-5, 7, 8, and 10-13 under 35 U.S.C. 101 in the Office action mailed 20 May 2025 has been withdrawn in view of the cancellation of these claims in the amendment received 29 August 2025.
Claim Interpretation
Claim 14 recites the limitation “wherein the processor is further configured to guide the probe to the determined target measurement position.” This limitation is interpreted to mean that the processor is configured to output data (with an intended use of an operator (e.g., medical staff) using the data to manually guide the probe to the target position).
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14 and 17-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite both: (a) mathematical concepts (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Subject matter eligibility evaluation in accordance with MPEP 2106.
Eligibility Step 1: Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter?
Claims 14 and 17-21 are directed to an information acquisition system (machine or manufacture).
Therefore, these claims are encompassed by the categories of statutory subject matter, i.e., each claim as a whole falls within one or more statutory categories.
[Step 1: YES]
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claim 14 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
analyze an amplitude variation and an amplitude of each of a first heart sound and a second heart sound, based on the received electrical signals corresponding to the collected heart sound and/or the collected lung sound (i.e., mental processes); and
determine a target measurement position of the probe based on a result of comparing of the analyzed amplitude variation and amplitude of the first heart sound and the analyzed amplitude variation and amplitude of the second heart sound (i.e., mental processes and mathematical concepts).
Dependent claims 17-21 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claim 17 further recites:
separate the collected heart sound into the first heart sound and the second heart sound, based on the amplitude or the amplitude variation of a signal waveform of each of the collected heart sound and/or the collected lung sound; or (i.e., mental processes); or
separate the collected lung sound into a left lung sound and a right lung sound, based on a frequency band of the collected heart sound and/or the collected lung sound (i.e., mental processes).
Dependent claim 18 further recites:
wherein the target measurement position includes information on a target position of the microphone (i.e., mental processes).
Dependent claim 19 further recites:
analyze the received electrical signals corresponding to the collected heart sound and/or the collected lung sound, and determine whether an abnormal region is contained therein, based on the analysis result (i.e., mental processes); and
when the received electrical signals corresponding to the collected heart sound and/or the collected lung sound contain the abnormal region, correct a signal waveform of the abnormal region based on a predefined normal signal waveform (i.e., mental processes).
Dependent claim 20 further recites:
generate training data learned from a plurality of patients (i.e., mental processes);
determine whether the abnormal region is contained therein, based on the training data (i.e., mental processes), and
training a learning model by using the collected electrical signals corresponding to the collected heart sound and/or the collected lung sound containing the abnormal region (i.e., mental processes and mathematical concepts).
Dependent claim 21 further recites:
construct a new data set, and construct a new learning model (i.e., mental processes and mathematical concepts).
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pen and paper (e.g., analyze an amplitude variation and an amplitude of each of a first heart sound and a second heart sound, based on the received electrical signals corresponding to the collected heart sound and/or the collected lung sound), and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas (e.g., construct a new learning model) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Heart and/or lung sounds, after having been picked up and converted to analog electrical signals (e.g., by a microphone), converted to a digital signal (e.g., by an analog-to-digital converter), and then decomposed into waveform data, are data (i.e., information) that can be practically analyzed in the human mind with or without a physical aid and/or operated on mathematically (see MPEP 2106.04(a)(2)).
Therefore, claims 14 and 17-21 recite an abstract idea.
[Step 2A Prong One: YES]
Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
The judicial exceptions identified in Eligibility Step 2A: Prong One are not integrated into a practical application because of the reasons noted below.
Dependent claim 18 does not recite any elements in addition to the judicial exception, and thus is part of the judicial exception.
The additional elements in independent claim 14 include:
a heart and lung sounds acquisition device comprising:
a probe configured to be inserted into a patient's esophagus to acquire a heart sound and/or a lung sound at a measurement position;
a microphone configured to collect the heart sound and/or the lung sound at the measurement position; and
a connector configured to transmit electrical signals corresponding to the collected heart sound and/or the collected lung sound to the computer;
a computer comprising:
an input unit configured to receive the electrical signals corresponding to the collected heart sound and/or the collected lung sound; and
an output unit configured to output the determined target measurement position of the probe,
wherein the processor is further configured to guide the probe to the determined target measurement position.
The additional elements in dependent claims 17, 19, 20, and 21 include:
a computer (claims 20 and 21);
a processor (claims 19 and 20);
the heart and lung sounds acquisition device is further configured to filter the collected heart sound and/or the collected lung sound based on a difference between frequency bands of the collected heart sound and/or the collected lung sound, and separate the collected heart sound and/or the collected lung sound from each other (claim 17);
collecting, by the computer, the electrical signals corresponding to the collected heart sound and/or the collected lung sound containing the abnormal region from the plurality of patients (claim 20);
the output unit is further configured to output the target measurement position of the probe on a screen, and output guiding information for the probe to the target measurement position (claim 21);
the heart and lung sounds acquisition device is further configured to acquire a new heart sound and/or a new lung sound from the probe at the target measurement position (claim 21); and
the computer is further configured to collect the new heart sound and/or the new lung sound (claim 21).
The additional elements of a computer (claims 14, 20, and 21) comprising an input unit configured to receive data; and an output unit configured to output data (claim 14); and a processor (claims 19 and 20); invoke a computer and/or computer-related components merely as tools for use in the claimed process, and therefore are not an improvement to computer functionality itself, or an improvement to any other technology or technical field (see MPEP 2106.04(d)(1)).
The additional elements of wherein the processor is further configured to guide the probe to the determined target measurement position (i.e., output data) (claim 14); collecting data using a computer (claims 20 and 21); and outputting data to a screen (claim 21); are insignificant extra-solution activities that are part of the data gathering process (pre-solution) and/or data outputting process (post-solution) used in the recited judicial exceptions (see MPEP 2106.05(g)).
The additional elements of a heart and lung sounds acquisition device comprising a probe configured to be inserted into a patient's esophagus to acquire a heart sound and/or a lung sound at a measurement position (claim 14); a microphone configured to collect the heart sound and/or the lung sound at the measurement position (claim 14); and a connector configured to transmit electrical signals corresponding to the collected heart sound and/or the collected lung sound to the computer (claim 14); the heart and lung sounds acquisition device is further configured to filter the collected heart sound and/or the collected lung sound based on a difference between frequency bands of the collected heart sound and/or the collected lung sound, and separate the collected heart sound and/or the collected lung sound from each other (claim 17); and the heart and lung sounds acquisition device is further configured to acquire a new heart sound and/or a new lung sound from the probe at the target measurement position (claim 21); are insignificant extra-solution activities that are part of the data gathering process used in the recited judicial exceptions (MPEP 2106.05(g)), and also do not amount to more than generally linking the use of a judicial exception to a particular technological environment (MPEP 2106.05(h)).
Thus, the additionally recited elements merely invoke a computer as a tool, and/or amount to merely indicating a field of use or technological environment in which to apply a judicial exception, and/or amount to insignificant extra-solution activity, and as such, when all limitations in claims 14 and 17-21 have been considered as a whole, the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 14 and 17-21 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
Dependent claim 18 does not recite any elements in addition to the judicial exception.
The additional elements recited in independent claim 14 and dependent claims 17, 19, 20, and 21 are identified above, and carried over from Step 2A: Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A: Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional elements of a computer and computer-related components (i.e., a processor; an input unit configured to receive data; an output unit configured to output data; and a processor further configured for collecting and outputting data); are conventional computer components and/or functions (see MPEP at 2106.05(b) and 2106.05(d)(II) regarding conventionality of computer components and computer processes).
The additional elements of a heart and lung sounds acquisition device comprising a probe configured to be inserted into a patient's esophagus to acquire a heart sound and/or a lung sound at a measurement position (claim 14); a microphone configured to collect the heart sound and/or the lung sound at the measurement position (claim 14); and a connector configured to transmit electrical signals corresponding to the collected heart sound and/or the collected lung sound to the computer (claim 14); and the heart and lung sounds acquisition device is further configured to acquire a new heart sound and/or a new lung sound from the probe at the target measurement position (claim 21); are conventional. Evidence for the conventionality is shown by Manecke et al. (Anesthesia & Analgesia, 1998, Vol. 86(6), p. 1276-1279, as cited in the Office action mailed 21 November 2024), Linder (U.S. Patent No.: 4,475,555, as cited in the Office action mailed 21 November 2024), and Priemer (U.S. Patent Application Publication No.: US 2005/0043643, as cited in the Office action mailed 21 November 2024).
Manecke et al. shows analysis of heart and lung sounds obtained from an esophageal stethoscope at various placement depths (Title; and Abstract); and further shows the esophageal stethoscope was advanced to 40 cm measured at the upper incisors (or gums), and with the patient in the supine position and the head in neutral position, the stethoscope was progressively withdrawn while sound recordings were made at 2-cm intervals until the stethoscope had been withdrawn to 20 cm (page 126, column 2, para. 1).
Linder shows a universal measuring attachment for esophageal stethoscopes (Title; and Abstract) and shows a reusable measuring attachment having an adjustably-positionable sensing probe for use with a variety of sizes and types of esophageal stethoscopes (column 1, lines 9-13); for monitoring heart and respiration sounds (column 4, lines 63-66; and Figure 8); the stethoscope may be positioned at varying depths to monitor the patient’s body sounds at different locations in the esophageal region (column 1, lines 30-35); the sensing probe can be placed at any desired position within the stethoscope (column 5, lines 66-67) to different depths of penetration (column 6, lines 1-3); and sensing probes can include microphones (column 6, lines 10-11).
Priemer shows an esophageal stethoscope with a sensor head comprising a plurality of microphones that may pass down an esophagus of a patient so that the plurality of microphones are able to get closer to the heart of the patient to capture heart sounds (¶¶ [0062] & [0063]; and Figure 11).
The additional elements of the heart and lung sounds acquisition device is further configured to filter the collected heart sound and/or the collected lung sound based on a difference between frequency bands of the collected heart sound and/or the collected lung sound, and separate the collected heart sound and/or the collected lung sound from each other (claim 17); are conventional. Evidence for the conventionality is shown by Kim et al. (U.S. Patent Application Publication No.: US 2016/0120416, as cited in the Office action mailed 21 November 2024), and Uphold et al. (U.S. Patent No.: 4,763,663, as cited in the Office action mailed 21 November 2024).
Kim et al. shows filtering heart and lung sounds according to a frequency band (¶¶ [0102], [0118], & [0119]).
Uphold et al. shows signals from the microphone are transmitted to an audio amplifier and band pass filter for filtering and selecting the desired sounds such as heart beat and breathing (column 4, lines 7-10); and a proportional heart/lung sound filter for separating the heart and lung sounds (column 5, lines 10-14; and Figure 3: Vital Signs Monitor/Transmitter section at lower right).
Therefore, when taken alone, all additional elements in claims 14 and 17-21 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as a combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 14 and 17-21 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
Response to Arguments
The Applicant's arguments/remarks received 29 August 2025 have been fully considered, but they are not persuasive.
The Applicant states on page 8 (para. 1) of the Remarks that amended independent claim 14 explicitly recites particular hardware elements and their interworking operations. The Applicant points to the MPEP at § 2164.04(a)(1), and further states (para. 2) that amended claim 14 does not fall into a judicial exception, such as an abstract idea because the features recited in amended claim 14 cannot be practically be performed in the human mind, hence, amended claim 14 as a whole is not directed to an abstract idea.
These arguments are not persuasive, because the MPEP at 2106.04(a) states that examiners should determine whether a claim recites an abstract idea by (1) identifying the specific limitation(s) in the claim under examination that the examiners believes recites an abstract idea, and (2) determining whether the identified limitation(s) fall within at last one of the groupings of abstract ideas. If the identified limitation(s) falls within at least one of the groupings of abstract ideas, it is reasonable to conclude that the claim recites an abstract idea in Step 2A Prong One. As noted in the rejection above at Eligibility Step 2A Prong One, claim limitations are identified that recite abstract ideas from one or both of the judicial exception groupings of mathematical concepts and mental processes. Furthermore, claim limitations that recite elements in addition to judicial exceptions (e.g., particular hardware elements) are identified at Eligibility Step 2A Prong Two, as noted in the rejection above.
The Applicant states on page 8 (para. 3) of the Remarks that even if amended claim 14 is considered to be directed to an abstract idea, the claim integrates the alleged abstract idea into a practical application by demonstrating a technical improvement in an existing technology, such as acquiring the heart and lung sounds with improved signal quality for each patient to accurately determine the patient’s health status and disease diagnosis more effectively. The Applicant further states (para. 4) that in particular, amended claim 14 specifically recites, inter alia, that the features of “analyze an amplitude variation and an amplitude of each of a first heart sound and a second heart sound, based on the received electrical signals corresponding to the collected heart sound and/or the collected lung sound; and determine a target measurement position of the probe based on a result of comparing of the analyzed amplitude variation and amplitude of the first heart sound and the analyzed amplitude variation and amplitude of the second heart sound” demonstrate the technical improvement mentioned above. The Applicant points to the MPEP at § 2106.04(d), and further states (para. 5) that accordingly, amended claim 14 specifically and practically sets forth the features that demonstrate how the alleged abstract idea is applied in a way that provides concrete benefits or solves specific problems in the relevant field, and hence, amended claim 14 as a whole integrates the alleged abstract idea into a practical application.
These arguments are not persuasive, because first, the particular limitations asserted in the foregoing arguments to provide the technical improvement are the limitations identified as judicial exceptions at Eligibility Step 2A Prong One in the above rejection. Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. However, the way in which the additional elements use or interact with the exception may integrate it into a practical application (MPEP at § 2106.04(d) III.). As noted in the rejection above, when all limitations in claims 14 and 17-21 have been considered as a whole (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), they are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, i.e., a claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception (MPEP 2106.04(d)). Amended claim 14, however, does not recite any additional elements that apply, rely on, or use the judicial exceptions in a manner that imposes a meaningful limit on the judicial exception, because the claim merely outputs the data of the determined target measurement position, as opposed to, e.g., an active step of positioning a device at a target position determined by the recited judicial exceptions.
The Applicant points to the MPEP at § 2106.05(a), and states (para. 6) that additionally, amended claim 14 provides a technical improvement in the relevant field and that the specification as filed identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim or identifies technical improvements realized by the claim over the prior art, thereby adding inventive concepts to the alleged abstract idea, and therefore amended claim 14 recites significantly more than a judicial exception.
These arguments are not persuasive, because first, and as discussed in the foregoing responses to arguments, the particular limitations asserted in the foregoing arguments to provide the technical improvement are the limitations identified as judicial exceptions at Eligibility Step 2A Prong One in the above rejection. Second, Eligibility Step 2B asks “Does the claim recite additional elements that amount to significantly more than the judicial exception?” Examiners should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)). As noted in the rejection above, when all additional elements in claims 14 and 17-21 have been evaluated individually and in combination at Eligibility Step 2B, they are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exceptions (MPEP 2106.05(II)). Third, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology (MPEP 2106.05(a) II.). Therefore, the instant claimed technical improvements are a purported improvement to the abstract idea (data analysis), and not an improvement to computer functionality itself, or an improvement to another technology or technical field.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 2, 4, 5, and 7 under 35 U.S.C. 102 as being anticipated by Kim et al. in the Office action mailed 20 May 2025 has been withdrawn in view of the cancellation of these claims in the amendment received 29 August 2025.
Response to Arguments
The Applicant's arguments/remarks received 29 August 2025 have been fully considered, and are persuasive.
The Applicant states on page 9 (para. 5) of the Remarks that in particular, the cited references fail to disclose the claimed combination of features presently set forth in amended independent claim 14, including the combination of features of: “a processor configured to: analyze an amplitude variation and an amplitude of each of a first heart sound and a second heart sound, based on the received electrical signals corresponding to the collected heart sound and/or the collected lung sound; and determine a target measurement position of the probe based on a result of comparing of the analyzed amplitude variation and amplitude of the first heart sound and the analyzed amplitude variation and amplitude of the second heart sound; and an output unit configured to output the determined target measurement position of the probe, wherein the processor is further configured to guide the probe to the determined target measurement position.”
These arguments are persuasive.
Claim Rejections - 35 USC § 103
The rejection of claims 8 and 10-13 under 35 U.S.C. 103 as being unpatentable over Kim et al. in the Office action mailed 20 May 2025 is withdrawn in view of the amendment received 29 August 2025.
The rejection of claim 3 under 35 U.S.C. 103 as being unpatentable over Kim et al. as applied to claims 1, 2, 4, 5, and 7 under 35 U.S.C. 102, and further in view of Manecke et al. in the Office action mailed 20 May 2025 is withdrawn in view of the amendment received 29 August 2025.
The rejection of claims 14, 17, 18, and 19 under 35 U.S.C. 103 as being unpatentable over Kim et al. in view of Manecke et al. in the Office action mailed 20 May 2025 is withdrawn in view of the amendment received 29 August 2025.
The rejection of claims 20 and 21 under 35 U.S.C. 103 as being unpatentable over Kim et al. in view of Manecke et al. as applied to claims 14, 17, 18, and 19 above, and further in view of Goldman in the Office action mailed 20 May 2025 is withdrawn in view of the amendment received 29 August 2025.
The amendment received 29 August 2025 has been fully considered, however after further consideration, new grounds of rejection are raised in view of the amendment.
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.
Claims 14, 17, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2016/0120416, as cited in the Office action mailed 21 November 2024) in view of Manecke et al. (Anesthesia & Analgesia, 1998, Vol. 86(6), p. 1276-1279, as cited in the Office action mailed 21 November 2024).
Claim Interpretation
Claims 14 and 21 recite the limitation “probe.” This limitation is interpreted to comprise a device for measuring the heart sound and/or lung sound from a patient, and may be a stethoscope, e.g., the probe (e.g., the stethoscope) may be inserted to acquire the heart sound and/or the lung sound at the inserted position (Specification, para. [00248]).
Regarding independent claim 14, Kim et al. discloses that the initialism “HS” can be interpreted to mean either heart sound or heart lung sound (para. [0068]).
Kim et al. further shows the heart sound receiving means may be a microphone and can be inserted in the body of a patient using another device such as a catheter type of esophageal stethoscope which is previously inserted and mounted into the esophagus of a patient (para. [0095]); a digital signal processor (DSP) (para. [0079]) and an analog to digital converter (ADC) (para. [0080]) for converting the analog signals of the heart sounds to a digital signal (paras. [0096] – [0101]) and that can be associated with the computer using a USB standard (i.e., “a connector”) (para. [0104]); comparing an amplitude of the first heart sound (S1) with an amplitude of the second heart sound (S2) (para. [0122]); and using the amplitude variation of the heart sound during a particular period of time for information comparative analysis (para. [0150]).
Regarding independent claim 14, Kim et al. does not show the limitations determine a target measurement position of the probe based on a result of comparing of the analyzed amplitude variation and amplitude of the first heart sound and the analyzed amplitude variation and amplitude of the second heart sound; and an output unit configured to output the determined target measurement position of the probe, wherein the processor is further configured to guide the probe to the determined target measurement position.
Regarding independent claim 14, Manecke et al. shows analysis of heart and lung sounds obtained from an esophageal stethoscope at various placement depths (Title; & Abstract); and further shows the esophageal stethoscope was advanced to 40 cm measured at the upper incisors (or gums), and with the patient in the supine position and the head in neutral position, the stethoscope was progressively withdrawn while sound recordings were made at 2-cm intervals until the stethoscope had been withdrawn to 20 cm (page 126, col. 2, para. 1); and determining a recommended placement depth of 28-32 cm in clinical use based on a high amplitude of S1, S2 (heart) sounds, and inspiratory and expiratory (lung) sounds (Abstract; & FIG. 2); for each sample a representative example of the first heart sound (S1), second heart sound (S2), inspiratory breath sound (insp), and expiratory breath sound (exp) were selected by visual inspection of the characteristic waveforms and root mean squared (RMS) amplitude and peak frequency was calculated, and the relationship between stethoscope depth and the RMS amplitudes and peak frequencies of the four different types of sounds (S1, S2, insp, and exp) were analyzed (page 1277, col. 1, paras. 3-4). Manecke et al. further shows using a continuous visual display and an amplified audio signal which allows precise determination of amplitude of each sound at varying depths (page 1279, col. 1, para. 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method shown by Kim et al. by incorporating the methods for acquiring and analyzing heart and lung sound data based on the positioning of the acquisition device as disclosed by Menecke et al. (pp. 1276-1277: Methods). One of ordinary skill in the art would have been motivated to combine the method of Kim et al. with Menecke et al. because Menecke et al. discloses that esophageal stethoscope placement depth greatly affects the sounds, and discloses a recommended placement depth for acquiring high amplitude sounds (Abstract). This modification would have had a reasonable expectation of success given that Kim et al. discloses the acquisition of heart sounds using an esophageal stethoscope (para. [0095]) and Menecke et al. discloses a method for analysis of sound from an esophageal stethoscope at various insertion depths (Abstract).
Regarding dependent claim 17, Kim et al. further shows a band pass filter (BDF) (para. [0081]); receiving a heart sound that is then amplified (HS; para. [0117]); the amplified heart sound (HS) is a digital signal that undergoes band pass filtering using a desirable frequency band (para. [0118]); noises such as a lung sound in digital signals are removed by such filtering (para. [0119]); the signal from which noise has been removed is transmitted to Hilbert transformer (para. [0119]); the digital signal is transformed thus calculating a phonocardiogram (PCG) showing the time and amplitude of the first heart sound (S1) and the time and amplitude of the second heart sound (S2; para. [0120]).
Regarding dependent claim 19, Kim et al. further shows a series of Figures depicting a verification process using a phonocardiogram to identify deviations from normal ranges (each of A, B, C and D in FIGS. 10(a) and 10(b); paras. [0153] – [0157]) and the result of the measurement of the patients in which the deviation has been removed and the phonocardiogram returned to normal (FIG. 10(c); para. [0158]).
Kim et al. further does not show wherein the target measurement position includes information on a target position of the microphone (claim 18).
Regarding dependent claim 18, Manecke et al. further shows data points and regression curves for depth of maximal amplitude versus patient height for S1 and S2 heart sounds (FIG. 2).
Therefore,