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 .
Status of Application, Amendments and Claims
Applicant’s submission filed 11 August 2025 is entered. Claims 1, 3-5, 7-8, 10-12 and 14-19 are pending; claims 1, 3-5, 7-8, 10-12 and 14-16 are amended; and claims 17-19 are newly added.
Response to Arguments
Applicant's arguments filed 11 August 2025 with respect to the written description rejections under 35 U.S.C. 112 (a) have been fully considered but they are not persuasive.
The applicant argues paragraph [67] – [69] sufficiently disclose the machine learning-based algorithm because the a paragraphs discuss using a correlation between the characteristics of the biosignal and the desired estimated signal quality level. The use of a correlation in a machine-learning algorithm without disclosing the correlation does not sufficiently describe the algorithm. What is the correlation the applicant possessed at the time of filing?
The applicant further argues paragraph [70] discloses the signal analysis processor may determine whether the biosignals correspond to atrial fibrillation (abnormal) or normal sinus rhythm (NSR). This not convincing as this does not disclose how the abnormal signal is determined by the applicant. As stated in the rejection, this amounts to functional claiming without disclosing how the function is performed.
The applicant argues paragraph [68] defines “good.” However, the paragraph states “As the similarity between the characteristics of a biosignal and a reference signal provided based on a machine learning-based algorithm generated based on correlation with signal quality to be estimated increases, signal quality may be estimated to be good.” This is not a definition of good because it does not define the level of similarity between 0 and 1 that constitutes good.
The applicant argues paragraphs [39], [42], [75], [86]-[89] and [103]-[110] sufficiently describe a minimum number of consecutive times units and minimum unit. The cited paragraphs provide specific examples of minimum units but these examples do not cover any minimum unit and do not fully disclose how the machine learning algorithm defines/determines minimum units for analysis. These specific examples of minimum units could be integrated into the claims to avoid a written description rejection.
Applicant's arguments filed 11 August 2025 with respect to the rejections under 35 U.S.C. 112 (b) have been fully considered but they are not persuasive.
The applicant argues “good” and “poor” are defined by the specification. The examiner respectfully disagrees. The amendment to claim recites “wherein the good signal quality is when the estimated signal quality of the one or more biosignals is greater than or equal to a preset threshold in a range of signal quality level between 0 and 1, and the signal quality increases to the good signal quality as a value of the signal quality level approaches 1, and wherein a poor signal quality is when the estimated signal quality of the one or more biosignals is less than the preset threshold in the range of signal quality level between 0 and 1, and the signal quality decreases to the poor signal quality as the value of the signal quality level approaches 0.” However, this fails to provide a definition for the relative terms “good” and “poor.” While the respective values must be between 0 and 1, the disclosure does not provide a specific definition of “good” or “poor” within the range of 0 and 1.
Applicant's arguments filed 11 August 2025 with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The amendments to claims change the various processing elements to “processors” from “units” and newly added dependent claims 17-18 recite generic PPG sensors. These “processors” and “sensors” are recited at a high-level of generality. A processor is generic computer structure and the sensors represent well-known devices (Official Notice is taken of this fact) for mere data gathering. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. It is important to keep in mind that an improvement in the abstract idea itself is not an improvement in technology. Similarly, the inventive concept cannot be furnished by the abstract idea itself.
The applicant further argues the prediction and prevention of AF constitutes a particular prophylaxis under In re Vanda. The examiner respectfully disagrees. The diagnosis of a condition itself is not a particular prophylaxis or treatment.
Applicant’s arguments, see remarks, filed 11 August 2025, with respect to the rejection(s) of claim(s) 1 and 8 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
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 1, 3-5, 7-8, 10-12 and 14-19 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.
Regarding claim 1, the limitation “estimating , by a signal quality estimation processor, a signal quality of one or more biosignals” lacks sufficient description in the disclosure. In paragraph [68], the specification indicates signal quality estimation unit 130 operates based on a machine learning-based algorithm for quality estimation. However, the specification does not describe the machine learning-based algorithm. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. In the instant application, the skilled artisan is not provided with the steps of the machine learning-based algorithm for determining signal quality, and would not know how the applicant intended signal quality to be evaluated.
Regarding claim 1, the limitation “determining, by a signal analysis processor, whether the one or more biosignals of the preset unit time correspond to an abnormal signal or a normal signal” lacks sufficient description in the disclosure. In paragraph [71], the specification indicates the signal analysis unit 140 operates based on a machine learning-based algorithm for classifying abnormal signals. However, the specification does not describe the machine learning-based algorithm. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. In the instant application, the skilled artisan is not provided with the steps of the machine learning-based algorithm for determining abnormal versus normal signal, and would not know how the applicant intended the signal to be analyzed. For instance, paragraph [27] indicates various abnormal signals could be determined.
Regarding claim 1, the limitation “determining, by an episode determination processor, whether at least one abnormal condition episode has occurred” lacks sufficient description in the disclosure. In paragraph [23], the specification indicates the episode determination unit determines that an AF episode has occurred when each of biosignals of consecutive unit times of more than a preset minimum number is classified as atrial fibrillation. However, the specification does not identify the minimum number nor describe how this minimum number could be determined. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. In the instant application, the skilled artisan is not provided with the steps of episode determination.
Regarding claims 3-4, the limitations of the claims are not sufficiently described. The applicant does not define good, the minimum number of consecutive time units, or the minimum unit required to perform the claimed analysis. While a person of skill in the art could set these values, the applicant does not provide the specific parameters the used. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved.
Regarding claim 8, the limitation “a signal quality estimation processor configured to estimate a signal quality of the one or more biosignals” lacks sufficient description in the disclosure. In paragraph [68], the specification indicates signal quality estimation unit 130 operates based on a machine learning-based algorithm for quality estimation. However, the specification does not describe the machine learning-based algorithm. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. In the instant application, the skilled artisan is not provided with the steps of the machine learning-based algorithm for determining signal quality, and would not know how the applicant intended signal quality to be evaluated.
Regarding claim 8, the limitation “a signal analysis processor to determine whether the one or more biosignals of the preset unit time correspond to an abnormal signal or a normal signal” lacks sufficient description in the disclosure. In paragraph [71], the specification indicates the signal analysis unit 140 operates based on a machine learning-based algorithm for classifying abnormal signals. However, the specification does not describe the machine learning-based algorithm. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. In the instant application, the skilled artisan is not provided with the steps of the machine learning-based algorithm for determining abnormal versus normal signal, and would not know how the applicant intended the signal to be analyzed. For instance, paragraph [27] indicates various abnormal signals could be determined.
Regarding claim 8, the limitation “an episode determination processor configured to determine whether an at least one abnormal condition episode has occurred” lacks sufficient description in the disclosure. In paragraph [23], the specification indicates the episode determination unit determines that an AF episode has occurred when each of biosignals of consecutive unit times of more than a preset minimum number is classified as atrial fibrillation. However, the specification does not identify the minimum number nor describe how this minimum number could be determined. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. In the instant application, the skilled artisan is not provided with the steps of episode determination.
Regarding claims 10-11, the limitations of the claims are not sufficiently described. The applicant does not define good, the minimum number of consecutive time units, or the minimum unit required to perform the claimed analysis. While a person of skill in the art could set these values, the applicant does not provide the specific parameters the used. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved.
All remaining claims are rejected for depending from a claim lacking sufficient written description.
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.
Claim 3-5, 10-12 and 15-16 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.
The term “good” in claims 3-5, 10-12 and 15-16 is a relative term which renders the claims indefinite. The term “good” is not defined by the claims, 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. Paragraph [69] of the specification states “signal quality estimation unit 130 determines that the signal quality is good (SQ Good) when the estimated signal quality level is equal to or greater than a preset threshold.” However, the preset threshold is not disclosed rendering unclear what applicant believes to be a “good” signal.
The term “poor” in claims 3-5, 10-12 and 15-16 is a relative term which renders the claims indefinite. The term “poor” is not defined by the claims, 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. Paragraph [69] of the specification states “determines that the signal quality is poor (SQ Poor) when the estimated signal quality level is less than a preset threshold..” However, the preset threshold is not disclosed rendering unclear what applicant believes to be a “poor” signal.
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, 3-5, 7-8, 10-12 and 14-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea, specifically a mental/mathematical process, without significantly more. The claims recite a method and device for analyzing abnormal physiological signals to determine abnormal condition burden. A physician can receive the signals on a display or print out and perform the generic steps of estimating quality, classifying as normal or abnormal, determining when an abnormal condition episode has occurred, and calculating an abnormal condition burden. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Regarding claim 1, the judicial exception is not integrated into a practical application. That is, nothing in the claim precludes the method steps from being performed in the mind. The claim recites two elements: a device for analyzing and a sensor. These elements are recited at a high-level of generality and the specification discloses a processor and a variety of sensors may be used. Thus, the processor is generic computer structure and the sensor represents mere data gathering. Accordingly, these additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above the recitation of the device for analyzing and sensor for obtaining data is mere data gathering. Therefore, the limitations remain insignificant extra-solution activity, even upon reconsideration, and do not amount to significantly more. The claim is not patent eligible.
Regarding claim 8, the judicial exception is not integrated into a practical application. That is, nothing in the claim precludes the method steps from being performed in the mind. The claim recites addition processing elements: a biosignal collection unit, preprocessing unit, signal quality estimation unit, signal analysis unit, episode determination unit, and abnormal signal burden estimation unit. These elements are recited at a high-level of generality and the specification discloses a processor and a variety of biosignals may be used. Thus, the processor is generic computer structure. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they does not impose any meaningful limits on practicing the abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above the recitation of the various processing units does not add anything significant to the abstract idea, and do not amount to significantly more. The claim is not patent eligible.
Regarding claims 3-5, 7, 10-12 and 14-19, the dependent claims do not add any additional elements that can be considered to constitute a practical application or to be significantly more as they merely attempt to further limit the mental process/abstract idea itself. Claim 14 recites an output unit which is a generic device that does not add anything more to the abstract idea.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 10 October 2025