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 Statement (IDS) filed on 09/12/2022 has been considered by the Examiner.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/10/2025 has been entered.
Response to Arguments
Rejections under 35 USC 101
Applicant's arguments filed 11/25/2025 with regards to the rejection of claims 1-14 under 35 USC 101 have been fully considered but they are not persuasive.
On pages 7-8 of the Remarks, Applicant argues that the claimed invention is directed to significantly more than an abstract idea on the basis that the claims recite an improvement to a physiological monitoring and processing device because the claimed invention addresses the problem of fusion beats by utilizing a pulse wave signal and an electrocardiogram signal in tandem.
Applicant cites MPEP section 2106.05(a) stating that the improvement may be provided by the additional elements in combination with the recited judicial exception.
Applicant also cites MPEP section 2106.05(I)(A)(i) stating that significantly more is found when the claims include an improvement to the functioning part of a computer, and that the improvement of the claimed invention lies, at least in part, in the functioning of the processor and memories based on their claimed capabilities.
Examiner respectfully disagrees and points to MPEP section 2106.05(a)(I), which specifies that in order for a method to claim to improve computer functionality, the broadest reasonable interpretation of the claim must be limited to computer implementation. That is, a claim whose entire scope can be performed mentally cannot be said to improve computer technology. In the case of the claimed invention, a person of ordinary skill in the art could perform the scope of the claim without computer implementation. Acquiring electrocardiogram and pulse wave data of a subject is extra-solution activity of data gathering. A person of ordinary skill in the art could look at the two signals, line up the timeframes based on QRS/pulse wave peaks, and identify a period in which a QRS complex appears to be missing, look at the corresponding period in the pulse wave signal, and determine based on the presence of a pulse wave, that a QRS complex was present in the time period.
The computer implementation of the processes is claimed generically, to link the claimed invention to a technological environment or field of use. The computer elements of a processor, memory, and computer readable command executed by the processor, are all generic, and although they are directed to a machine which carries out the claimed process, the process does not result in any improvement to the computer functionality itself. With this in consideration, the rejection of the claims under 35 USC 101 is maintained.
Rejections under 35 USC 103
Applicant’s arguments, see Remarks filed 11/25/2025, with respect to the rejection of claims 1-14 under 35 USC 103 have been fully considered and are persuasive. The rejection of claims 1-14 under 35 USC 103 has been withdrawn.
On pages 8-9 of the Remarks, Applicant argues that the cited prior art does not teach or suggest the limitation of determining that the QRS complex is actually present in the predetermined time period in which the pulse wave is detected. Examiner has found the arguments persuasive and agrees that the claims teach features which are not taught or suggested in the prior art as taken alone or combined. The rejection of the claims under 35 USC 103 is thereby withdrawn. Further reasons for allowance over prior art detailed below.
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 1-14 rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more.
Step 1
Claims 1-8 and 14 are directed to a machine and claims 9-13 are directed to a method.
Step 2A, Prong 1
Claims 1 and 9 recite the limitations of determining that a QRS complex is present in a time period in which the QRS complex was not detected based on pulse wave data and notifying that the QRS complex was present in said time period. These steps, given their broadest reasonable interpretation can be practically performed in the human mind. Namely, a human is capable of identifying peaks corresponding to QRS complexes or pacing pulses in electrocardiogram data representing a given time period. Therefore, the claims recite a mental process (including an observation, evaluation, judgement, and/or opinion).
Claim 14 recites the limitation of determining that a QRS complex is present in a time period in which the QRS complex was not detected based on pulse wave data and updating the time period in which the QRS complex was not detected based on the determination that the QRS complex was present. These steps, given their broadest reasonable interpretation can be practically performed in the human mind. Namely, a human is capable of identifying peaks corresponding to QRS complexes or pacing pulses in electrocardiogram data representing a given time period. Therefore, the claims recite a mental process (including an observation, evaluation, judgement, and/or opinion).
Step 2A, Prong 2
Claims 1, 9, and 14 do not recite any additional elements that integrate the abstract idea into practical application.
Claim 1 includes the additional elements of one or more processors, one or more memories, and ‘acquiring electrocardiogram data from a subject; detecting a QRS complex from the electrocardiogram data; acquiring pulse wave data of the subject; detecting a pacing pulse output from an apparatus implanted in a body of the subject.’ The one or more processors and memories are claimed as generic computer implementation of the mental process. Acquiring electrocardiogram data, detecting a QRS complex in the data, acquiring pulse wave data, and detecting a pacing pulse output amount to extra-solution activity of data gathering. Therefore, none of these elements amount to integrating the mental process into a practical application.
Claim 9 includes the additional elements of claim 1 above, and a computer. The computer only amounts to generic computer implementation of the mental process. None of these elements amount to integrating the mental process into a practical application.
Claim 14 includes the additional elements of claim 1 above, and an electrocardiogram sensor, a pacing pulse detection circuit, an electrocardiogram detection circuit, and a pulse wave sensor. These additional elements amount to generally linking the mental process or abstract idea to a particular technological environment or field of use. Therefore, none of these elements amount to integrating the mental process into a practical application.
Step 2B
Claims 1, 9, and 14 do not recite any additional elements that amount to significantly more than the mental process.
Claim 1 includes the additional elements of one or more processors, one or more memories, and ‘acquiring electrocardiogram data from a subject; detecting a QRS complex from the electrocardiogram data; acquiring pulse wave data of the subject; detecting a pacing pulse output from an apparatus implanted in a body of the subject.’ The one or more processors and memories are claimed as generic computer implementation of the mental process. Acquiring electrocardiogram data, detecting a QRS complex in the data, acquiring pulse wave data, and detecting a pacing pulse output amount to extra-solution activity of data gathering. Therefore, none of these elements amount to significantly more than the mental process.
Claim 9 includes the additional elements of claim 1 above, and a computer. The computer only amounts to generic computer implementation of the mental process. None of these elements amount to significantly more than the mental process.
Claim 14 includes the additional elements of claim 1 above, and an electrocardiogram sensor, a pacing pulse detection circuit, an electrocardiogram detection circuit, and a pulse wave sensor. These additional elements amount to generally linking the mental process or abstract idea to a particular technological environment or field of use. Therefore, none of these elements amount to significantly more than the mental process.
Claims 2-8 and 10-13 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations merely include limitations that either further define the abstract idea (and thus do not make the abstract idea any less abstract), only add insignificant extra-solution activity, or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use.
Subject Matter Allowable Over Prior Art
Claims 1-14 allowable over the prior art. However, claims 1-14 are not patentable at this time due to the pending rejection under 35 USC 101.
The claims have been found to be allowable over the closest prior art of Hahn et al (US 20180056075) in view of Spencer et al (US 20210007621) and Takayanagi (US 20200029846 A1) as previously presented in the Non-Final Office Action filed 07/29/2025.
Hahn teaches a physiological information processing method executed by a computer (see Hahn [0169]; computer-implemented), and a physiological information processing apparatus (see Hahn Fig. 2; device 50) comprising:
one or more processors (see Hahn Fig. 2; processing block 52); and
one or more memories configured to store a computer readable command (see Hahn Fig. 2; memory 54),
wherein in a case where the computer readable command is executed by the processor (see Hahn Fig. 2; device 50), the physiological information processing apparatus is configured to:
acquire electrocardiogram data of a subject (see Hahn [0097], Fig. 8; cardiac signal shown at 400);
detect a QRS complex from the electrocardiogram data (see Hahn Fig. 8; QRS complex 410 and 424);
detect a pacing pulse (see Hahn Fig. 8; pace pulse 422) output from an apparatus worn by/implanted in the subject (see Hahn [0037-0040]; pace pulse delivered by the LCP in cooperation with an extracardiac device).
Spencer teaches a system and method for monitoring cardiac data comprising determining whether the pacing pulse is detected in a time period in which the QRS complex is not detected when the time period is equal to or longer than a predetermined time width (see Spencer [0088]; apparent R-wave on the ECG trace which is not accompanies by a pulse as measured by a peripheral pulse oximeter might be classified as a false-positive, see Spencer [0112]; reducing false negatives or false positives); and determining, based on the pulse wave data, that a pulse wave is present within a predetermined time after the pacing pulse is detected (see Spencer [0093]; pulse wave data can be used to create a 'blanking period' around the time of each trace, denoting a time frame in which an ECG trace corresponding to ventricular contraction is expected).
Takayanagi teaches a physiological information processing method that is configured to determine, that the QRS complex is actually present in the time period (see Takayanagi Fig. 3, [0045-0048]; classification correction system determines the validity of waveform W3 after the time period was previously classified as missing a QRS complex); and
notify that the QRS complex was present in the time period in which the QRS complex was not detected (see Takayanagi [0048]; the classification result has been corrected in accordance with the determination of the presence of the QRS complex at W3 and the classification is stored in the memory).
None of the previously cited prior art teaches determining that a QRS complex is actually present in a predetermined time period based on a pulse wave, where the pulse wave is present in the predetermined time period after a pacing pulse was delivered.
The claims are also allowable over the closest prior art of Thakur et al (US 20150216433 A1). Thakur teaches a system where impedance waveforms, which may be considered to represent a pulse wave, are used to define a window for searching for an R-wave (Thakur [0068]). A derivative of an impedance signal is taken and the slopes or other features of the derived signal indicate a relationship to a concurrent portion of the ECG feature.
The prior art however does not teach using this method for determining a period in which an R-wave is expected for use with a pacing device in order to reduce the fusion of QRS complexes with pacing pulses and validate the presence of a previously missed QRS complex.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./
Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792