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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/12/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 2A PRONG ONE: Claim 1 recite(s) specific limitations/method steps of: acquire audio data from a subject in need thereof; extract an audio feature from the audio data; and analyze the audio feature and output an abnormal classification corresponding to the audio data according to an analysis result of the audio feature. These limitations recite a mental process, because the claimed limitation describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). For example, a caregiver can determine audio data and determine abnormal classification corresponding to the audio data. Thus, the claims are drawn to a Mental Process, which is an Abstract Idea.
STEP 2A PRONG TWO: Claim 1 does not recite additional elements that integrates the judicial exception into a practical application. Claim 1 recites the following additional elements beyond the judicial exception: data acquisition module, and a feature analysis module. Accordingly, the combination of the additional element/step does not integrate the exception into a practical application of the exception because the use of processing modules is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)).
Accordingly, each of the additional elements or a combination of the additional elements do not integrate the abstract idea into a practical application as they fail to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
STEP 2B: Claim 1 does/do not include additional structural elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements, such as, data acquisition module, and a feature analysis module.
The combination of these elements of a processing modules does not amount to significantly more than the judicial exception because the use of processing modules is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)).
Accordingly, the additional elements individual or in co do not integrate the abstract idea into a practical application as they fail to recite additional element(s) or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
When viewed alone or in combination, the limitations of claims 2-19 merely instruct the practitioner to implement the concept of collecting data with routine, conventional activity specified at a high level of generality in a particular technological environment. The inventive concept cannot be furnished by the abstract idea; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity” (Genetic Technologies Limited v. Merial L.L.C.). The additional elements of independent claims when viewed alone or as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea and does not amount to significantly more than the abstract idea itself. In other words, this claim merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
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.
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 limitation(s) is/are:
Limitations “data acquisition module” in claims 1, 4, 6 and 9, “feature extraction module” in claims 1, 4, 7, 10 and 13, “feature analysis module” in claims 1, 7, 10 and 16, “data segmentation module” in claims 4 and 13, “recording site determination module” in claims 6, 7 and 15, and “model building module” in claims 7 and 16, the claims do not recite enough structure that corresponds to the claimed modules above. The specification does not disclose any structure that can be interpreted to correspond to the claimed modules.
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 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 7, 8, 16 ad 17 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 7, 8, 16 ad 17 recite the limitation “artificial intelligence model”, the current specification fails to disclose the artificial intelligence model in a manner to allow one of ordinary skill in the art to make or use the invention. Claimed artificial intelligence model must be disclosed as either a flowchart showing the process that is taken by the model to process the incoming data to provide the desired output, or the actual algorithm must be shown in order to allow one of ordinary skill in the art the ability to make or use the current invention without undue experimentation.
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 1-18 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.
Claims 1, 4, 6 and 9 recite limitation “data acquisition module”, claims 1, 4, 7, 10 and 13 recite limitation “feature extraction module”, claims 1, 7, 10 and 16 recite limitation “feature analysis module”, claims 4 and 13 recite limitation “data segmentation module”, claims 6, 7 and 15 recite limitation “recording site determination module”, and claims 7 and 16 recite limitation “model building module”, these limitations are not defined by the claims, which renders the claims indefinite. The specification does not disclose any structure that corresponds to the claimed modules above. One with ordinary skill in the art isn’t sure what structural elements the claimed “modules” must or must not include, or if the claimed modules constitute software, hardware or a combination of software and hardware. The scope of the claims remains indeterminate because of the claimed limitations above.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 9-13 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ota et al (Evaluation of Hemodialysis Arteriovenous Bruit by Deep Learning: NPL in IDS mailed on 05/12/2025).
As to claims 1, 9, 10 and 18, Ota teaches a computer readable medium storing a computer executable instruction which, when being executed, causes a system and method to analyze vascular sound (recording and analyzing arteriovenous sounds, abstract, sec.2.1, fig.1, page 3, sec.2.2.1, page 4), comprising:
a data acquisition module, configured to acquire audio data from a subject in need thereof (inherently the module/stethoscope that records arteriovenous fistula sounds, sec.2.1, fig.1, page 3);
a feature extraction module coupled with the data acquisition module, configured to extract an audio feature from the audio data (inherently the module that extracts sound patterns and converts arteriovenous fistula sounds to frequency spectrogram, sec.2.1, fig.1, page 3, sec.2.2.1, page 4); and
a feature analysis module coupled with the feature extraction module, configured to analyze the audio feature and output an abnormal classification corresponding to the audio data according to an analysis result of the audio feature (inherently the module that analyzes the sound pattern/spectrogram and classifies the sounds as normal, hard, high, or whistle and detects abnormal sounds, fig.1 in page 3, sec.2.2.1 and table 2 in page 4).
As to claims 2 and 11, Ota teaches the system and method, wherein: the audio data corresponds to the vascular sound of a vessel of the subject (recording and analyzing arteriovenous fistula sounds, abstract, sec.2.2.1, fig.1, page 3); and the abnormal classification corresponds to degree of stenosis of the vessel indicated in the vascular sound (indicating high risk of arteriovenous fistula stenosis, sec.3.3, end of page 8, and
As to claims 3 and 12, Ota teaches the system and method, wherein the vessel is an autologous arteriovenous fistula and/or an arteriovenous graft (recording and analyzing arteriovenous fistula sounds, abstract, sec.2.2.1, fig.1, page 3, constructing a model for arteriovenous fistula stenosis diagnosis, page 12).
As to claims 4 and 13, Ota teaches the system and method, further comprising:
a data segmentation module coupling to the data acquisition module and the feature extraction module, configured to segment the audio data into a segmented audio data corresponding to a predetermined length of time (inherently the module that extracts of a single beat of the arteriovenous fistula sound, sec.2.2.1, and single heartbeat, page 11), and
transmit the segmented audio data corresponding to the predetermined length of time to the feature extraction module, wherein the predetermined length of time corresponds to a length of time of at least one cardiac cycle of the subject (extracts of a single beat of the arteriovenous fistula sound, sec.2.2.1, and single heartbeat, page 11).
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) 5 and 14 is/are rejected under 35 U.S.C. 103 as being obvious over Ota et al (Evaluation of Hemodialysis Arteriovenous Bruit by Deep Learning: NPL in IDS mailed on 05/12/2025).
As to claims 5 and14, Ota teaches the audio feature is a Mel-frequency cepstral coefficient feature (feature extraction from spectrogram wad performed by Mel filter bank and/or Log Mel spectrogram, sec.2.2.2 and table 3, page 6, and using Mel-frequency log spectrogram as the input source, sec.3.1, page 7).
But failed to explicitly teach the Mel-frequency cepstral coefficient feature is a 26-dimensional feature. However, it would have been obvious to one having an ordinary skill in the art at the time the invention was made to have the Mel-frequency cepstral coefficient feature to be 26-dimensional feature, since it has been held that discovering the optimum value of a result of effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215(CCPA 1980).
Claim(s) 6 and 15 is/are rejected under 35 U.S.C. 103 as being obvious over Ota et al (Evaluation of Hemodialysis Arteriovenous Bruit by Deep Learning: NPL in IDS mailed on 05/12/2025), in view of Chen et al (US 2019/0320912).
As to claims, 6 and 15, Ota teaches the invention substantially as claimed above, wherein the recording site is a position on the subject corresponding to a stenosis site of a vessel of the subject (recording site is an arteriovenous fistula, abstract, sec.2.2.1, fig.1, page 3, constructing a model for arteriovenous fistula stenosis diagnosis, page 12), but failed to explicitly teach a recording site determination module coupled with the data acquisition module, configured to determine a recording site for acquiring the audio data of the subject according to an angiography image, wherein the recording site is a position on the subject corresponding to a stenosis site of a vessel of the subject presented in the angiography image.
However, Chen teaches an analogous system for arteriovenous fistula (AVF) stenosis detection (abstract), wherein a recording site determination module coupled with the data acquisition module, configured to determine a recording site for acquiring the audio data of the subject according to an angiography image (server receives angiography information of the patient body and determines a real stenosis percentage according to the angiography information, par.12, 39 and 47), wherein the recording site is a position on the subject corresponding to a stenosis site of a vessel of the subject presented in the angiography image (par.12, 39 and 47, fig.2).
Since using angiography images to determine recording/stenosis site is well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to use angiography imaged to determine stenosis/recording site in Ota’s invention, as taught by Chen’s invention, to aid the physician to accurately and precisely determine recording/stenosis artery site, as taught by Chen’s invention (par.12, 39 and 47).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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