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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/01/24 has been considered by the examiner.
Election/Restrictions
Applicant’s election with traverse of Invention II (claims 3-12) in the reply filed on May 8, 2026 is acknowledged. The traversal is on the ground(s) that Applicant
notes the subject matter of each of the claim Groups is linked by a common inventive
concept, and there is no serious burden on the Examiner to examine the different claim
Groups. This is not found persuasive because the apparatus of Invention I
can be used for detection of a blood pressure level, which is not required by Invention II or Invention III. Invention II uses a non-pressurized module, and Invention III uses a network processor to determine long-term hypertension, neither which are not required by Invention I. Further, Invention II recites a non-pressurized module, which is not required by Invention III, and Invention III uses a network processor to determine long-term hypertension, which is not required by Invention II. Invention I (claims 1 and 2) and Invention III (Claims 13-20) have been withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
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 3-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 3, the claim recites an apparatus for quick detection, for detecting hypertension. Thus, the claim is directed to a machine, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
capturing data of a second heart sound
transforming the data into a plurality of time-frequency spectrograms having a plurality of image features
These limitations set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element 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. Claim 3 recites a convolutional neural network trained to analyze the image features of the time-frequency spectrograms, by focusing on the second heart sound, for detecting hypertension, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The analyzing of the image to detect hypertension does not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change based on the model, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a non-pressurized module
a device for transforming the data
a network processor
The providing and recording steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the providing and recording steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Dependent claims 4-12 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 3-12 are not patent eligible under 35 USC 101.
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 3-12 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 limitations:
“the data” in line. Does this refer to “data of a second heart sound” recited previously?
“the image features” in line. Does this refer to “plurality of image features” mentioned previously?
“the time-frequency spectrograms” in line. Does this refer to “plurality of time-frequency spectrograms” mentioned previously?
Claim 4 recites the limitation “the time-frequency spectrograms” in line. Does this
refer to “plurality of time-frequency spectrograms” mentioned previously?
Claim 5 recites the limitations:
“the image features” in line. Does this refer to “plurality of image features” mentioned previously?
“the time-frequency spectrograms” in line. Does this refer to “plurality of time-frequency spectrograms” mentioned previously?
Claim 6 recites the term “about 0Hz to about 200Hz”. This is a relative term which renders the claim indefinite. The term “about 0Hz to about 200Hz” 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. Examiner notes it is unclear how close to this range the frequency must be to meet the requirements of the claim.
Claim 7 recites the term “about 400Hz to about 600Hz”. This is a relative term which renders the claim indefinite. The term “about 400Hz to about 600Hz” 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. Examiner notes it is unclear how close to this range the frequency must be to meet the requirements of the claim.
Claim 8 recites the term “about 20 to about 30 seconds”. This is a relative term which renders the claim indefinite. The term “about 20 to about 30 seconds” 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. Examiner notes it is unclear how close to this range the recording time must be to meet the requirements of the claim.
Claim 10 recites the term “about five minutes”. This is a relative term which renders the claim indefinite. The term “about five minutes” 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. Examiner notes it is unclear how close to this time the individual must be sitting to meet the requirements of the claim.
Claim 12 recites the term “about 120 beats per minute”. This is a relative term which renders the claim indefinite. The term “about 120 beats per minute” 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. Examiner notes it is unclear how close the individual’s heart rate must be to 120 BPM to meet the requirements of the 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Singh (US 2021/0090734) and in further view of Zhou (US 2023/0329646)
Regarding claim 3, Singh teaches an apparatus for quick detection, comprising: a non-pressurized module for capturing data of a second heart sound [fig. 4; par. 20, 63];
a device for transforming the data into a plurality of time-frequency spectrograms having a plurality of image features [par. 20, 21, 77, 80];
and a network processor equipped with a convolutional neural network trained to analyze the image features of the time-frequency spectrograms, by focusing on the second heart sound, for detecting heart disorders [fig. 4; par. 20, 63, 109]
However, Singh does not teach focusing on the second heart sound, for detecting hypertension
Zhou teaches focusing on the second heart sound, for detecting hypertension [par. 296]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh, to incorporate focusing on the second heart sound, for detecting hypertension, as the second heart sound is where defects can be heard, as evidence by Zhou [par. 296].
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Singh and Zhou and in further view of Vernalis (US 2022/0061797)
Regarding claim 4, Singh and Zhou teach an apparatus for quick detection, as disclosed above
However, Singh and Zhou do not teach each of the time-frequency spectrograms comprises a first frequency band and a second frequency band
Vernalis teaches each of the time-frequency spectrograms comprises a first frequency band and a second frequency band [par. 146 “frequency ranges 20 Hz to 200 Hz, 200 Hz to 800 Hz,”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh and Zhou, to incorporate each of the time-frequency spectrograms comprises a first frequency band and a second frequency band, for determining if the signal is corrupted by noise, as evidence by Vernalis [par. 146].
Regarding claim 5, Vernalis further teaches the network processor trained to analyze the image features of the time-frequency spectrograms within the first frequency band and the second frequency band [par. 146, 221]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh and Zhou, to incorporate the network processor trained to analyze the image features of the time-frequency spectrograms within the first frequency band and the second frequency band, to provide for binary classification of the associated heart sounds, as evidence by Vernalis [par. 221].
Regarding claim 6, Vernalis further teaches the first frequency band is about 0Hz to about 200Hz [par. 146]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh and Zhou, to incorporate the first frequency band is about 0Hz to about 200Hz, for determining if the signal is corrupted by noise, as evidence by Vernalis [par. 146].
Regarding claim 7, Vernalis further teaches the second frequency band is about 400Hz to about 600Hz [par. 146]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh and Zhou, to incorporate the second frequency band is about 400Hz to about 600Hz, t for determining if the signal is corrupted by noise, as evidence by Vernalis [par. 146].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Singh and Zhou and in further view of Thakur (US 2020/0037887)
Regarding claim 9, Singh and Zhou teach an apparatus for quick detection, as disclosed above
However, Singh and Zhou do not teach the non-pressurized module captures the data by recording the second heart sound for about 20 to about 30 seconds
Thakur teaches the non-pressurized module captures the data by recording the second heart sound for about 20 to about 30 seconds [par. 63]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh and Zhou, to incorporate the non-pressurized module captures the data by recording the second heart sound for about 20 to about 30 seconds, for detecting a VM session, as evidence by Thakur [par. 63].
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Singh and Zhou and in further view of Thakur (US 2020/0178850), herein Thakur ‘850
Regarding claim 9, Singh and Zhou teach an apparatus for quick detection, as disclosed above
However, Singh and Zhou do not teach the second heart sound is recorded from an individual who has been sitting down for a plurality of minutes
Thakur ‘850 teaches the second heart sound is recorded from an individual who has been sitting down for a plurality of minutes [par. 83, 84]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh and Zhou, to incorporate the second heart sound is recorded from an individual who has been sitting down for a plurality of minutes, for allowing the patient physiologic information to reach a resting baseline, as evidence by Thakur ‘850 [par. 84].
Regarding claim 10, Thakur ‘850 further teaches the second heart sound is recorded from the individual who has been sitting down for about five minutes [par. 83, 84]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh and Zhou, to incorporate the second heart sound is recorded from the individual who has been sitting down for about five minutes, for allowing the patient physiologic information to reach a resting baseline, as evidence by Thakur ‘850 [par. 84].
Regarding claim 11, Thakur ‘850 further teaches the second heart sound is recorded from the individual who has exercised [par. 84]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh and Zhou, to incorporate the second heart sound is recorded from the individual who has exercised, for obtaining exertion information, as evidence by Thakur ‘850 [par. 84].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Singh, Zhou and Thakur ‘850 and in further view of Goftari (US 2025/0160665)
Regarding claim 9, Singh, Zhou and Thakur ‘850 teach an apparatus for quick detection, as disclosed above
However, Singh, Zhou and Thakur ‘850 do not teach the second heart sound is recorded from the individual who has exercised to have a heart rate of about 120 beats per minute.
Goftari teaches the second heart sound is recorded from the individual who has exercised to have a heart rate of about 120 beats per minute [par. 71]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Singh, Zhou and Thakur ‘850, to incorporate the second heart sound is recorded from the individual who has exercised to have a heart rate of about 120 beats per minute, for selecting a subset of the heart sound segments that meet specific criteria to form a heart sound ensemble, as evidence by Goftari [par. 71].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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