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) been submitted on 07/03/24 has been considered by the examiner
Claim Objections
Claims 3, 6, 10, 18 and 19 are objected to because of the following informalities:
Claims 3 and 6 recite “the determination”. Examiner notes it should read “a determination”.
Claim 10 recites “below the present value”. Examiner notes it should read “below the preset value”
Claims 18 and 19 recite “the one or more sound patterns”. Examiner notes it should read “the one or more abnormal/pathological sound patterns”
Appropriate correction is required.
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 1-20 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, 2, 4, 5, 16 and 17 recite the limitation “abnormal/pathological”. Examiner notes that the use of the “/” makes it unclear as to whether this it to be interpreted as “or” or “and” Claims 2, 5, 17 and 20 recite the limitation “health/physical/fitness-related/wellness-related condition”. Examiner notes that the use of the “/” makes it unclear as to whether this it to be interpreted as “or” or “and”
Claim 3 recites the limitation “the respective interaction” in line 7. Does this refer to “one or more iterations” recited previously in claim 3 or is it a new term?
Claim 6 recites the limitation “the respective interaction” in line 6. Does this refer to “one or more iterations” recited previously in claim 6 or is it a new term?
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 1-20 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 1, the claim recites a method of analyzing a signal indicative of sounds detected from within a subject's body. Thus, the claim is directed to a process, 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:
receiving an output signal, the output signal being indicative of sounds detected from within a subject's body
detecting repetitive portions in the output signal;
subtracting the repetitive portions from the output signal to provide non-repetitive portions
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 1 recites determining, based on the non-repetitive portions, one or more subsets of data values indicative of one or more abnormal/pathological sound patterns detected from within the subject's body, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The determining of data indicative of abnormal/pathological sound patterns 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. Claims 2, 4, 5 and 16-20 recite detecting one or more biomarkers indicative of a health/physical/fitness-related/wellness-related condition of the subject based on at least one of the averaged non- repetitive/repetitive portions and the one or more abnormal/pathological sound patterns, determining the one or more subsets of data values indicative of the one or more abnormal/pathological sound patterns based on the averaged non-repetitive/repetitive portions, generating and transmitting a notification indicative of the one or more sound patterns detected from within the subject's body to a remote device, and generating a notification indicative of the one or more biomarkers indicative of the health/physical/fitness-related/wellness-related condition of the subject, which also is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g), does not provide an improvement to the technological field, and the system does not effect a particular treatment or effect a particular change based on the model.
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 computing device operating a processor
a sensor
Additionally, claim 19 recites the additional limitation
a remote device
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 3 and 6-15 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-20 are not patent eligible under 35 USC 101.
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.
Claims 1, 2, 5, 6, 10, 11 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sham (US 2019/0046072) and in further view of Zia (US 9125574)
Regarding claim 1, Sham teaches a method of analyzing a signal indicative of sounds detected from within a subject's body, the method comprising, using a computing device [fig. 2, element 202] operating a processor [fig. 2, element 204; par. 26]: receiving an output signal generated by a sensor, the output signal being indicative of sounds detected from within a subject's body [par. 22]; detecting repetitive portions in the output signal [par. 29, 30; Examiner notes the matching patterns are the repetitive portions]; and determining one or more subsets of data values indicative of one or more abnormal/pathological sound patterns detected from within the subject's body [par. 27].
However, Sham does not teach subtracting the repetitive portions from the output signal to provide non-repetitive portions and determining, based on the non-repetitive portions, one or more subsets of data values indicative of one or more abnormal/pathological sound patterns detected from within the subject's body
Zia teaches subtracting the repetitive portions from the output signal to provide non-repetitive portions [col. 2: lines 39-47] and determining, based on the non-repetitive portions, one or more subsets of data values indicative of one or more abnormal/pathological sound patterns detected from within the subject's body [col. 7: lines 33-60]
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 Sham, to incorporate subtracting the repetitive portions from the output signal to provide non-repetitive portions and determining, based on the non-repetitive portions, one or more subsets of data values indicative of one or more abnormal/pathological sound patterns detected from within the subject's body, for removing noise from the signal, as evidence by Zia [col. 7: lines 33-60]
Regarding claim 2, Sham further teaches based on at least one of the non-repetitive portions and the one or more abnormal/pathological sound patterns, detecting one or more biomarkers indicative of a health/physical/fitness-related/wellness-related condition of the subject [par. 35, 44]
Regrading claim 5, Sham further teaches detecting the one or more biomarkers indicative of the health/physical/fitness- related/wellness-related condition of the subject based on at least one of the averaged non- repetitive portions and the one or more abnormal/pathological sound patterns [par. 40, 41]
Regarding claim 6, Zia further teaches applying one or more iterations of an average function on the repetitive portions to provide averaged repetitive portions [col. 14: lines 13-32]; determining, for each of the one or more iterations, based on the averaged repetitive portions, whether or not the averaged repetitive portions meet a condition [col. 14: lines 33-62]; and terminating the respective interaction upon the determination that the averaged repetitive portions meet the predefined condition [col. 14: lines 63-67]
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 Sham, to incorporate applying one or more iterations of an average function on the repetitive portions to provide averaged repetitive portions; determining, for each of the one or more iterations, based on the averaged repetitive portions, whether or not the averaged repetitive portions meet a condition; and terminating the respective interaction upon the determination that the averaged repetitive portions meet the predefined condition, for classifying true noisy segments, as evidence by Zia [col. 14: lines 33-62]
Regarding claim 10, Zia further teaches determining, for each of the one or more iterations, a cross-correlation value between the averaged repetitive portions and a reference signal [col. 14: lines 33-62], and terminating the respective iteration if the cross-correlation value has reached a specified cross-correlation value [col. 14: lines 63-67]
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 Sham, to incorporate determining, for each of the one or more iterations, a cross-correlation value between the averaged repetitive portions and a reference signal, and terminating the respective iteration if the cross-correlation value has reached a specified cross-correlation value, for classifying true noisy segments, as evidence by Zia [col. 14: lines 33-62]
Regarding claim 11, Zia further teaches wherein the specified cross-correlation value is preset or determined based on an average cross-correlation value in the output signal over a specified time interval [col. 14: lines 33-62]
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 Sham, to incorporate wherein the specified cross-correlation value is preset or determined based on an average cross-correlation value in the output signal over a specified time interval, for classifying true noisy segments, as evidence by Zia [col. 14: lines 33-62]
Regarding claim 16, Zia further teaches at least one of: determining the one or more subsets of data values indicative of the one or more abnormal/pathological sound patterns based on the averaged repetitive portions [col. 14: lines 63-67]
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 Sham, to incorporate at least one of: determining the one or more subsets of data values indicative of the one or more abnormal/pathological sound patterns based on the averaged repetitive portions, for identifying noisy segments in order for the signal processing algorithms to ignore them for detection of CAD, as evidence by Zia [col. 14: lines 63-67]
Regarding claim 17, Zia further teaches detecting one or more abnormal/pathological biomarkers indicative of a health/physical/fitness-related/wellness-related condition of the subject based on at least one of the averaged repetitive portions and the one or more abnormal/pathological sound patterns [col. 3: lines 33-49, col. 14: lines 63-67]
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 Sham, to incorporate detecting one or more abnormal/pathological biomarkers indicative of a health/physical/fitness-related/wellness-related condition of the subject based on at least one of the averaged repetitive portions and the one or more abnormal/pathological sound patterns, for identifying noisy segments in order for the signal processing algorithms to ignore them for detection of CAD, as evidence by Zia [col. 14: lines 63-67]
Regarding claim 18, Sham further teaches generating a notification indicative of the one or more sound patterns detected from within the subject's body [par. 35]
Regarding claim 19, Sham further teaches transmitting a notification indicative of the one or more sound patterns detected from within the subject's body to a remote device [par. 36]
Regarding claim 20, Sham further teaches generating a notification indicative of the one or more biomarkers indicative of the health/physical/fitness-related/wellness-related condition of the subject [par. 35, 44]
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Sham and Zia and in further view of Vernalis (US 2022/0061797)
Regarding claim 3, Sham and Zia teach a method of analyzing a signal indicative of sounds detected from within a subject's body as disclosed above.
However, Sham and Zia do not teach applying one or more iterations of an average function on the non-repetitive portions to provide averaged non-repetitive portions; determining, for each of the one or more iterations, based on the averaged non- repetitive portions, whether or not the averaged non-repetitive portions meet a predefined condition; and terminating the respective interaction upon the determination that the averaged non- repetitive portions meet the predefined condition
Vernalis teaches applying one or more iterations of an average function on the non-repetitive portions to provide averaged non-repetitive portions [par, 263]; determining, for each of the one or more iterations, based on the averaged non- repetitive portions, whether or not the averaged non-repetitive portions meet a predefined condition; and terminating the respective interaction upon the determination that the averaged non- repetitive portions meet the predefined condition [par. 263, 264; Examiner notes the averaged unexpected signals allow for distinguishing between non-obstructive CAD and obstructive CAD]
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 Sham and Zia, to incorporate applying one or more iterations of an average function on the non-repetitive portions to provide averaged non-repetitive portions; determining, for each of the one or more iterations, based on the averaged non- repetitive portions, whether or not the averaged non-repetitive portions meet a predefined condition; and terminating the respective interaction upon the determination that the averaged non- repetitive portions meet the predefined condition, for allowing a clinician to distinguish low-energy noise (which may or may not be a sign of non-obstructive CAD) from high-energy noise (which is a likely indicator of obstructive CAD), as evidence by Vernalis [par. 264]
Regarding claim 4, Vernalis further teaches determining the one or more subsets of data values indicative of the one or more abnormal/pathological sound patterns based on the averaged non-repetitive portions [par. 263, 264]
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 Sham and Zia, to incorporate determining the one or more subsets of data values indicative of the one or more abnormal/pathological sound patterns based on the averaged non-repetitive portions, for allowing a clinician to distinguish low-energy noise (which may or may not be a sign of non-obstructive CAD) from high-energy noise (which is a likely indicator of obstructive CAD), as evidence by Vernalis [par. 264]
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sham and Zia and in further view of Mhajna (US 2021/0236046)
Regarding claim 7, Sham and Zia teach a method of analyzing a signal indicative of sounds detected from within a subject's body as disclosed above.
However, Sham and Zia do not teach determining, for each of the one or more iterations, a signal to noise ratio (SNR) value in the averaged repetitive portions of the output signal and terminating the respective iteration if the SNR value has reached a specified SNR value
Mhajna teaches determining, for each of the one or more iterations, a signal to noise ratio (SNR) value in the averaged repetitive portions of the output signal and terminating the respective iteration if the SNR value has reached a specified SNR value [par. 149]
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 Sham and Zia, to incorporate determining, for each of the one or more iterations, a signal to noise ratio (SNR) value in the averaged repetitive portions of the output signal and terminating the respective iteration if the SNR value has reached a specified SNR value, as the data becomes corrupted at a certain threshold, as evidence by Mhajna [par. 149]
Regarding claim 12, Zia further teaches each of the averaged repetitive portions includes a first section having data values that are above a preset value and a second section having data values that are below the present value [col. 14: lines 13-32]
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 Sham, to incorporate each of the averaged repetitive portions includes a first section having data values that are above a preset value and a second section having data values that are below the present value, for separating noisy segments and noisy-free segments, as evidence by Zia [col. 14: lines 13-32]
However, Sham and Zia do not teach determining, for each of the one or more iterations, a SNR value of the second sections of the averaged repetitive portions, and terminating the respective iteration if the SNR value of the second sections of the averaged repetitive portions has reached a specified SNR value
Mhajna further teaches determining, for each of the one or more iterations, a SNR value of the second sections of the averaged repetitive portions, and terminating the respective iteration if the SNR value of the second sections of the averaged repetitive portions has reached a specified SNR value [par. 149]
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 Sham and Zia, to incorporate determining, for each of the one or more iterations, a SNR value of the second sections of the averaged repetitive portions, and terminating the respective iteration if the SNR value of the second sections of the averaged repetitive portions has reached a specified SNR value, as the data becomes corrupted at a certain threshold, as evidence by Mhajna [par. 149]
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sham and Zia and in further view of Boyd (US 2016/0286974)
Regarding claim 8, Sham and Zia teach a method of analyzing a signal indicative of sounds detected from within a subject's body, as disclosed above.
However, Sham and Zia do not teach determining, for each of the one or more iterations, a number of the repetitive portions or the averaged repetitive portions in the output signal, and terminating the respective iteration if the number of the repetitive portions or the averaged repetitive portions has reached a specified number of repetitive portions
Boyd teaches determining, for each of the one or more iterations, a number of the repetitive portions or the averaged repetitive portions in the output signal, and terminating the respective iteration if the number of the repetitive portions or the averaged repetitive portions has reached a specified number of repetitive portions [par. 27]
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 Sham and Zia, to incorporate determining, for each of the one or more iterations, a number of the repetitive portions or the averaged repetitive portions in the output signal, and terminating the respective iteration if the number of the repetitive portions or the averaged repetitive portions has reached a specified number of repetitive portions, so the processor can distinguish between different events, as evidence by Boyd [par. 36]
Regarding claim 9, Boyd further teaches the specified number of repetitive portions is preset or determined based on an average number of repetitive portions in the output signal over a specified time interval [par. 27, 36, 37]
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 Sham and Zia, to incorporate the specified number of repetitive portions is preset or determined based on an average number of repetitive portions in the output signal over a specified time interval, to reduce the number of false identifications of events, as evidence by Boyd [par. 37]
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sham and Zia and in further view of Turcott (US 6527729)
Regarding claim 14, Sham and Zia teach a method of analyzing a signal indicative of sounds detected from within a subject's body, as disclosed above.
However, Sham and Zia do not teach applying the average function on a specified number of the repetitive portions of the output signal
Turcott teaches applying the average function on a specified number of the repetitive portions of the output signal [col. 23: lines 53-67-col. 24: lines 1-29]
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 Sham and Zia, to incorporate applying the average function on a specified number of the repetitive portions of the output signal, for allowing subsequent analysis to recognize specific criteria of the signal, as evidence by Turcott [col. 23: lines 53-67]
Regarding claim 15, Turcott further teaches the specified number of the repetitive portions is preset or determined based on a preset SNR value [col. 23: lines 53-67-col. 24: lines 1-29]
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 Sham and Zia, to incorporate the specified number of the repetitive portions is preset or determined based on a preset SNR value, for allowing subsequent analysis to recognize specific criteria of the signal, as evidence by Turcott [col. 23: lines 53-67]
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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