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 .
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.
Claim 10 is 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.
In re claim 10, the limitation “obtain a period” is unclear. The period could refer to a measurement of time when the signal-to-noise ratio is below the threshold value or the period could refer to the electrocardiogram waveform during which the signal-to-noise ratio is below a threshold value. For purposes of examination, the limitation “obtain a period” will be interpreted to mean obtain the electrocardiogram waveform and would then inform the later limitation “display that period” to mean displaying that waveform on a display device.
Claim Rejections - 35 USC § 101
Claims 9-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 14-18 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Step 1: Claim 14 is drawn to a method.
Step 2A – Prong 1: Claim 14 is drawn to an abstract idea, that under its broadest reasonable interpretation, covers a mental process but for the recitation of generic computer components to perform the methods and steps for selecting particular data.
In re claim 14, the claim recites the following limitations:
a first step of a first step of detecting R waves from an electrocardiogram waveform… obtaining an interval between adjacent R waves (mental process, detecting the R waves just requires receiving the data which can then be segmented into intervals);
a second step of obtaining an instantaneous heart rate for each beat indicated by an R wave from the interval obtained in the first step (mental process, data is being received and inverted);
a third step of obtaining a smoothed heart rate by smoothing the instantaneous heart rate for each beat calculated in the second step (mental process, data is being received and averaged);
a fourth step of obtaining a signal-to-noise ratio of the electrocardiogram waveform based on the instantaneous heart rate or the smoothed heart rate; and (mental process, data is being received and a ratio is calculated)
a fifth step of transmitting the signal-to-noise ratio to a set destination (mental process, presentation).
In re claim 9, see above (In re claim 14). Substantially, the same reasoning applies.
In re claim 19, see above (In re claim 14). Substantially, the same reasoning applies.
These limitations of claim 14 are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, are steps merely comprised of mental processes.
Step 2A – Prong Two:
In re claim 14, the claim recites the following emphasized (indicated in bold) additional elements that are beyond the judicial exception:
a first step of detecting R waves from an electrocardiogram waveform measured by electrocardiograph.
The additional elements do not integrate the exception into a practical application of the exception because the elements are directed to insignificant extra-solution activity. The electrocardiograph amounts to no more than pre-solution activity of data gathering to receive the electrocardiogram waveforms. Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Further, the judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field. The alleged improvement made by the claimed invention as argued by the application above sets forth the improvement in a conclusory manner and the claim does not include the components or steps of the invention that the improvement described.
In re claim 9, see above (In re claim 14). Substantially, the same reasoning applies.
In re claim 19, see above (In re claim 14). Substantially, the same reasoning applies.
Step 2B:
In re claim 14, the claim does not recite additional elements that amount to significantly more than the judicial exception itself. Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity. The electrocardiograph amounts to no more than pre-solution activity of data gathering. The pre-solution activity of data gathering using an electrocardiograph is well-understood, routine, and conventional in the field of cardiology: “There may be employed an output terminal of a conventional electrocardiograph, which detects a specific electrocardiographic signal, such as an R wave, and transmits the signal as output” (Kawada, US 20030009107). All uses of the recited abstract idea require the pre-solution data gathering.
In re claim 9, see above (In re claim 14). Substantially, the same reasoning applies.
In re claim 19, see above (In re claim 14). Substantially, the same reasoning applies.
Claims 10- 13, 15-18, and 20-23 recite the same abstract idea as their respective parent claims. Furthermore, these claims only contain recitations that further limit the abstract idea.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura (JP 2018011819) in view of Zhao (US 20200107786).
In re claim 9, Matsuura discloses a device (abstract), comprising:
a first arithmetic circuit ([0020]: Biological Signal Extraction Unit) configured to
detect R waves [0020] from an electrocardiogram waveform [0020] measured by electrocardiograph [0020] and
obtain an interval between adjacent R waves [0020];
a second arithmetic circuit ([0021]: part of Averaging Processing Unit) configured to obtain an instantaneous heart rate [0021] for each beat indicated by an R wave from the interval obtained by the first arithmetic circuit [0021];
a third arithmetic circuit ([0022]: part of Averaging Processing Unit) configured to obtain a smoothed heart rate ([0022]: “HRave”) by smoothing the instantaneous heart rate for each beat calculated by the second arithmetic circuit [0022];
a fourth arithmetic circuit ([0026]: “Abnormal Value Determination Unit”) configured to obtain an abnormal value measurement ([0027]: Difference between RRI and RRIave) based on the instantaneous heart rate or the smoothed heart rate ([0023], the value is based on the average interval between R waves which is based on the smoothed heart rate); and
Matsuura lacks:
a fourth arithmetic circuit configured to obtain a signal-to-noise ratio based on the instantaneous heart rate or the smoothed heart rate; and
a transmission circuit configured to transmit the signal-to-noise ratio to a set destination.
Zhao discloses a signal quality measurement device wherein noise is measured by a signal-to-noise ratio and the signal-to-noise ratio is transmitted for selection and evaluation of electrocardiograph events.
It would have been obvious before the effective filing date of the instant application to one of ordinary skill in the art to modify the device taught by Matsuura by utilizing the fourth circuit to calculate a signal-to-noise ratio and to transmit that ratio to a set destination as the signal-to-noise ratio is a known measurement for noise level and can be used to evaluate the quality of electrocardiograph data. Further, it would be obvious to transmit the signal-to-noise ratio to a set destination in order to present the data to a user or to conduct further selection and evaluation of electrocardiograph events.
In re claim 14, see above (In re claim 9).
In re claim 19, see above (In re claim 9).
Matsuura also discloses a non-transitory computer-readable storage device [0041] storing a program [0041] that when executed by one or more processors [0041], cause the one or more processors to execute [0041].
Claims 10 – 11, 17 - 18, and 22 - 23 are rejected under 35 U.S.C. 103 as being unpatentable over Mastuura (JP 2018011819) in view of Zhao (US 20200107786) in view of Hiromu (JP 2021079007).
In re claim 10, Matsuura lacks:
a fifth arithmetic circuit configured to:
obtain a period during which the signal-to-noise ratio is below a threshold value within a measurement period during which the electrocardiogram waveform is measured
display the period on a display device.
Hiromu discloses an electrocardiograph processing device wherein when a signal-to-noise ratio is below a threshold value [0042], the user is notified of low quality [0030], and the corresponding period is displayed on display device [0031].
It would have been obvious before the effective filing date of the instant application to one of ordinary skill in the art to modify the device taught by Matsuura by obtaining a period with a signal-to-noise ratio under a threshold value while the electrocardiogram was measured, and display that period on a display device as taught by Hiromu. This would allow the user to review if the period and determine if the quality was not suitable and if they want to remeasure their heart rate.
In re claim 17, see above (In re claim 10).
In re claim 22, see above (In re claim 10).
In re claim 11, Mastuura lacks:
a fifth arithmetic circuit configured to:
obtain a ratio between a measurement period during which the electrocardiogram waveform is measured and a period during which the signal-to-noise ratio is below a threshold in the measurement period, and
display the ratio on a display device.
Hiroma discloses measuring the quality of electrocardiographic data based on a ratio of noise to total measurement time [0045] and discloses utilizing a display to notify the user if the electrocardiogram data is suitable for analysis or not [0030].
It would have been obvious before the effective filing date of the instant application to one of ordinary skill in the art to modify the proposed invention by determining a ratio between the measurement period and a period when the signal-to-noise ratio is below a threshold, as taught by Hiroma, because it would allow the user to identify how often electrocardiogram is overwhelmed by noise and the data has low quality and to determine if any of the data is useable. Further, it would be obvious to try to use a display function, as taught by Hiroma, to present the ratio in order to notify the user that the data is not suitable for analysis.
In re claim 18, see above (In re claim 11).
In re claim 23, see above (In re claim 11).
Claims 12, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mastuura (JP 2018011819) in view of Zhao (US 20200107786) in view of Ji (CN 101828916).
In re claim 12, Matsuura discloses a sixth arithmetic circuit configured to determine adequacy of the smoothed heart rate [0040] obtained by the third arithmetic circuit.
Matsuura lacks:
wherein the fourth arithmetic circuit obtains the signal-to-noise ratio of the electrocardiogram waveform based on a determination result of the sixth arithmetic circuit.
Ji discloses an electrocardiograph processing system wherein a process determines if processed electrocardiograph data is detected (i.e. adequate), wherein the detection determines if processing continues or further detection is required [0080].
It would have been obvious before the effective filing date of the instant application to one of ordinary skill in the art to modify the proposed invention of finding a signal-to-noise ratio based on the smoothed heart rate by determining if the processed electrocardiograph data is adequate before progressing to further processing, as taught by Ji. This would help to ensure that there was no loss of signal prior to determining the level of noise in the data and allow a user to determine if the data is usable, before continuing to analyze the quality of the electrocardiogram.
In re claim 15, see above (In re claim 12).
In re claim 20, see above (In re claim 12).
Claims 13, 16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura (JP 2018011819) in view of Zhao (US 20200107786) in view of Nakayama (US 20140296681).
In re claim 13, Matsuura lacks:
a seventh arithmetic circuit configured to
generate a non-computable indication in response to the first arithmetic circuit not detecting a R wave for a set period of time,
wherein the transmission circuit is configured to transmit the non-computable indication.
Nakayama discloses a method for measuring an electrocardiogram wherein a user is notified, for example by display or alarm (i.e. non-computable indication), in response to R wave detection failure [0082] after a set period of time [0080].
It would have been obvious before the effective filing date of the instant application to one of ordinary skill in the art to modify the proposed invention by transmitting a non-computable indication in response to not detecting an R wave for a set period of time, as taught by Nakayama, as it would alert a user to a failure of the electrocardiograph or the measuring quality evaluating device and potentially alert to cardiac events, informing the user that the collected data is not usable to determine the quality of the electrocardiograph.
In re claim 16, see above (In re claim 13).
In re claim 21, see above (In re claim 13).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chao (US 20190099103) discloses an electrocardiogram processing method wherein quality of the electrocardiogram is determined by finding the signal-to-noise ratio based on an average heart rate and a quality level is relayed to the user.
Samuelsson (US 20200163575) discloses a device and method for analyzing electrocardiogram data wherein a signal-to-noise ratio is calculated to determine quality and a user is notified of the results of a quality examination.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 7:30 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796