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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 78, 150, 422, and 1110. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 76, 1010, 1012, 1014, 1016, 1111. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "422" and "424" have both been used to designate applications. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2, 18, 21, and 26-28 are objected to because of the following informalities:
In claim 2, line 4, “in the cardiac electrogram data…” should read “in the cardiac electrogram data…”
In claim 18, lines 2-3, “during the episode of bradycardia or pause of bradycardia or pause…” should read “during the episode of bradycardia or pause…”
In claim 21, line 1, “wherein the one or more cardiac features…” should read “wherein one or more cardiac features…”
In claim 26, line 3, “data of the patient…” should read “data of a patient…”
In claim 26, line 13, “one of the R-R intervals or P-R intervals…” should read “one of R-R intervals or P-R intervals…”
In claim 27, line 13, “one of the R-R intervals or P-R intervals…” should read “one of R-R intervals or P-R intervals…”
In claim 28, lines 6-7, “determining, by the computing device a P-R interval” should read “determining, by the computing device, a P-R interval”
Appropriate correction is required.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-6 and 17-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas of mental processes without significantly more.
Step 1:
Claims 1-6 and 17-25 recite a system and therefore is a product.
Claim 26 recites a non-transitory computer-readable storage medium and therefore is a product.
Claims 27-30 recite a method and therefore a process.
Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claims 1, 26, and 27 recite the following limitations:
“receive, from the medical device, the cardiac electrogram data of the patient…recorded by the medical device”
“identify a plurality of heartbeats within the cardiac electrogram data”
“determine, based on the cardiac electrogram data, whether atrioventricular block has occurred”
“responsive to determining that atrioventricular block has occurred…output a report”
The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, include performance of the limitations in the mind. The above limitations disclose that “the computing device” is receiving data, identifying a plurality of heartbeats from the data, making a determination based on the data, and outputting a report of the data. Therefore, “the computing device” performing the receiving step, identification step, determination step, and output step is nothing more than a generic computer function of processing data. Nothing in the claims precludes the steps from practically being performed in the human mind or being considered as methods of organizing human activity. MPEP 2106.04(a)(2)(II) states that the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions and MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, aside from the recitations of “the computing device” language, the claim encompasses receiving data and identifying a plurality of heartbeats within the data (mental process) to determine whether atrioventricular block has occurred and display/communicate said results (organizing human activity).
Step 2A, Prong 2:
The claims recite “a computing device”, “processing circuitry”, and “a non-transitory computer-readable storage medium” to perform the abstract steps. These components read on a computer implemented system and method and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
As discussed with respect to Step 2A, Prong 2, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in Step 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
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 in the field. The specification in ¶[0025] and ¶[0028] does not provide any indication that the computing device is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 2-6, 17-25, and 28-30 further limit the abstract idea already indicated in independent claims 1 and 27, and they are ineligible for the same reasons provided for claims 1 and 27 above.
For example, claim 18 further limits the abstract idea already indicated in independent claim 1 with the recitation “applying a machine learning system to the cardiac electrogram data”. This limitation’s recitation of “a machine learning system” reads on a computer implemented system and is recited at a high level of generality, thus reciting an abstract idea that includes a mental process.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
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.
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 1-3, 18-21, and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Pedalty et al. (U.S. PGPub No. 2020/0352462) in view of Chen et al. (U.S. PGPub No. 2022/0202344).
Regarding claim 1, Pedalty teaches a system (Fig. 1, Paragraph 0029, line 2, 2)
comprising: a medical device (Fig. 1, Paragraph 0029, line 4, 10) configured to sense cardiac electrogram data (Fig. 2, Paragraph 0047, lines 4-7) of a patient (Fig. 1, Paragraph 0029, line 4, 4); and a computing device (Fig. 1, Paragraph 0030, lines 4-9, 12/24) comprising processing circuitry (Paragraph 0033, lines 15-16, “processor”) configured to: receive, from the medical device, the cardiac electrogram data of the patient (Paragraph 0036, lines 1-4) for an episode of bradycardia recorded by the medical device (Paragraph 0036, lines 4-9); identify a plurality of heartbeats within the cardiac electrogram data for the episode of bradycardia (Paragraph 0072, lines 1-14); determine, based on the cardiac electrogram data, whether atrioventricular block has occurred during the episode of bradycardia (Paragraph 0073, lines 1-5, Paragraph 0077, lines 1-8, and Paragraph 0078, lines 2-5); and responsive to determining that atrioventricular block has occurred during the episode of bradycardia or pause, output a report (Fig. 7, Paragraph 0099, lines 1-6) comprising: an indication that atrioventricular block has occurred during the episode of bradycardia (Fig. 7, Paragraph 0101, lines 3-7); and R-R intervals that coincide with the atrioventricular block that has occurred during the episode of bradycardia (Fig. 7, Paragraph 0101, lines 23-24).
Pedalty does teach that the medical device uses electrocardiogram data to determine that a patient is undergoing an episode of cardiac arrhythmia such as bradycardia, tachycardia, atrial fibrillation, ventricular fibrillation, or AV block (Paragraph 0036, lines 1-9). Pedalty does not teach that the computing device is configured to receive cardiac electrogram data for a pause recorded by the medical device.
Chen, however, teaches an analogous system (Fig. 1, Paragraph 0026, lines 1-2) that comprises: a medical device (Fig. 1, Paragraph 0027, line 4, 17) configured to sense cardiac electrogram data (Paragraph 0027, lines 10-13) of a patient (Fig. 1, Paragraph 0027, line 3, 1); and a computing device (Fig. 1, Paragraph 0033, lines 2-4, 7) containing processing circuitry (Fig. 1, Paragraph 0027, line 5, 3). Chen teaches that the system can generate heart-rate related alarms for bradycardia or pauses to identify heart block events (Paragraph 0010, lines 9-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the computing device is configured to receive cardiac electrogram data for a pause recorded by the medical device. Doing so would ensure that the system can identify pauses in an accurate and timely manner, and that clinicians can provide patients with treatment as needed (Paragraph 0010, lines 9-18), as recognized by Chen.
Pedalty does teach that a P-wave of the patient can be determined during an episode of arrhythmia (Paragraph 0101, line 26). Pedalty does not explicitly teach that the computing device outputs a report comprising P-R intervals that coincide with the atrioventricular block that has occurred during the episode of bradycardia.
Chen, however, teaches in an exemplary embodiment that a processor (Fig. 6, Paragraph 0069, line 4, 306), which may be the same as the components found in the medical device (Paragraph 0043, lines 1-6), is configured to determine P-R intervals during an episode of arrhythmia (Paragraph 0069, lines 8-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the system is configured to determine P-R intervals that coincide with the AV block that has occurred during an episode of arrhythmia. Doing so would ensure that different types of heart block events can be identified (Paragraph 0069, lines 8-12), as recognized by Chen.
Regarding claim 2, Pedalty teaches the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 1, wherein the processing circuitry (Paragraph 0033, lines 15-16, “processor”) is further configured to: for each of the plurality of heartbeats: determine a R-R interval (Fig. 7, Paragraph 0101, lines 23-24, “mean”); a P-wave during the episode of arrhythmia (Fig. 7, Paragraph 0101, line 26).
Pedalty does not teach that the processing circuitry is further configured to: for each of the plurality of heartbeats: determine whether a P-wave is detectable in the cardiac electrogram data; and responsive to determining that the P-wave is detectable, determine a P-R interval.
Chen, however, teaches an analogous system (Fig. 1, Paragraph 0026, lines 1-2) that comprises a medical device (Fig. 1, Paragraph 0027, line 4, 17) and a computing device (Fig. 1, Paragraph 0033, lines 2-4, 7). Chen teaches that the processor (Fig. 6, Paragraph 0069, line 4, 306), which may be the same as the components found in the medical device (Paragraph 0043, lines 1-6), is configured to determine whether a P-wave is detectable in the cardiac electrogram data (Paragraph 0058, lines 1-14). Chen teaches that once it is determined that the P-wave is detectable, a P-R interval is determined (Paragraph 0068, lines 6-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the processing circuitry is further configured to: for each of the plurality of heartbeats: determine whether a P-wave is detectable in the cardiac electrogram data; and responsive to determining that the P-wave is detectable, determine a P-R interval. Doing so would ensure that large P-waves are not mistakenly detected as valid ventricular R-waves, and consequently that heart rate related alarms aren’t missed (Paragraph 0057, lines 7-11), as recognized by Chen.
Regarding claim 3, Pedalty teaches the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 2 that includes the processing circuitry (Paragraph 0033, lines 15-16, “processor”). Pedalty does not teach that the processing circuitry is further configured to, responsive to determining that one or more P-waves are not detectable in the cardiac electrogram data for the episode of bradycardia or pause, output a report comprising an indication that whether atrioventricular block has occurred during the episode of bradycardia or pause is indeterminate.
Chen, however, teaches an analogous system (Fig. 1, Paragraph 0026, lines 1-2) that comprises a medical device (Fig. 1, Paragraph 0027, line 4, 17) and a computing device (Fig. 1, Paragraph 0033, lines 2-4, 7). Chen teaches that the processor (Fig. 6, Paragraph 0069, line 4, 306), which may be the same as the components found in the medical device (Paragraph 0043, lines 1-6), is configured to determine whether a P-wave is detectable in the cardiac electrogram data (Paragraph 0058, lines 1-14).
Chen also teaches that the processor detects a heart block, such as AV block (Paragraph 0002, lines 1-2), when P-waves are detected (Paragraph 0058, lines 11-14). Furthermore, Chen teaches that heart block events can be output on a display (Fig. 6, Paragraph 0069, line 6, 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that, in response to determining that one or more P-waves are not detectable in the cardiac electrogram data for the episode of bradycardia or pause, output a report comprising an indication that whether atrioventricular block has occurred during the episode of bradycardia or pause is indeterminate. Doing so would ensure that the patient and a clinician can be notified that an indication that atrioventricular block has occurred cannot be determined (Paragraph 0069, lines 6-8 and Paragraph 0088, lines 5-9), as recognized by Chen.
Regarding claim 18, Pedalty in view of Chen discloses the claimed invention of claim 1. Pedalty further discloses the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 1, wherein the processing circuitry (Paragraph 0033, lines 15-16, “processor”) is configured to determine whether atrioventricular block has occurred during the episode of bradycardia (Paragraph 0073, lines 1-5, Paragraph 0077, lines 1-8, and Paragraph 0078, lines 2-5) by applying a machine learning system (Fig. 1, Paragraph 0033, lines 7-8, 150) to the cardiac electrogram data (Paragraph 0039, lines 1-6).
Regarding claim 19, Pedalty in view of Chen discloses the claimed invention of claim 18. Pedalty further discloses the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 18, wherein the processing circuitry (Paragraph 0033, lines 15-16, “processor”) is configured to apply the machine learning system (Fig. 1, Paragraph 0033, lines 7-8, 150) by performing feature-based delineation of the cardiac electrogram data to obtain (Paragraph 0070, lines 16-19), in addition to the R-R intervals (Fig. 7, Paragraph 0101, lines 23-24), one or more cardiac features present in the cardiac electrogram data (Paragraph 0072, lines 1-6), wherein the report further comprises the one or more cardiac features (Paragraph 0085, lines 1-6).
Regarding claim 20, Pedalty in view of Chen discloses the claimed invention of claim 19. Pedalty further discloses the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 19, wherein the processing circuitry (Paragraph 0033, lines 15-16, “processor”) is configured to perform feature-based delineation of the cardiac electrogram data (Paragraph 0070, lines 16-19) to obtain the one or more cardiac features present in the cardiac electrogram data (Paragraph 0072, lines 1-6) by performing at least one of QRS detection (Paragraph 0077, line 21), refractory processing (Paragraph 0053, line 15), noise processing (Paragraph 0076, line 6), or delineation of the cardiac electrogram data (Paragraph 0070, lines 16-19).
Regarding claim 21, Pedalty in view of Chen discloses the claimed invention of claim 18. Pedalty further discloses the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 18, wherein the one or more cardiac features present in the cardiac electrogram data (Paragraph 0072, lines 2-3) comprise one or more of a mean heartrate of the patient (Paragraph 0072, lines 6-7), a minimum heartrate of the patient (Paragraph 0072, lines 7-8), a maximum heartrate of the patient (Paragraph 0072, line 8), a variability of heartrate of the patient (Paragraph 0072, lines 9-10), one or more amplitudes of one or more features of an electrocardiogram of the patient (Paragraph 0072, lines 10-11), or an interval between the one or more features of the electrocardiogram of the patient (Paragraph 0072, lines 11-12).
Regarding claim 24, Pedalty teaches the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 1, wherein the episode of bradycardia is recorded by the medical device (Paragraph 0036, lines 4-9). Pedalty does not teach that the episode of bradycardia is recorded by the medical device in response to the R-R intervals coinciding with the atrioventricular block that has occurred during the episode of bradycardia satisfying a duration condition.
Chen, however, teaches an analogous system (Fig. 1, Paragraph 0026, lines 1-2) that comprises a medical device (Fig. 1, Paragraph 0027, line 4, 17) and a computing device (Fig. 1, Paragraph 0033, lines 2-4, 7). Chen teaches that R-R intervals may be calculated and compared to identify different types of heart blocks (Paragraph 0069, lines 10-12), such as bradycardia or pauses (Paragraph 0010, lines 9-12). Chen further teaches that R-R intervals that satisfy a duration condition (Paragraph 0073, lines 1-2) indicate when atrioventricular block has occurred (Paragraph 0073, lines 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the episode of bradycardia is recorded by the medical device in response to the R-R intervals coinciding with the atrioventricular block that has occurred during the episode of bradycardia satisfying a duration condition. Doing so would ensure that a variety of different types of heart blocks can be identified based on recorded R-R intervals (Paragraphs 0073-0076), as recognized by Chen.
Regarding claim 25, Pedalty teaches the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 1, wherein the computing device (Fig. 1, Paragraph 0030, lines 4-9, 12/24) determines whether atrioventricular block has occurred during the episode of bradycardia (Paragraph 0073, lines 1-5, Paragraph 0077, lines 1-8, and Paragraph 0078, lines 2-5). Pedalty does not teach that the computing device determines atrioventricular block has occurred during the episode of bradycardia based on the P-R intervals coinciding with the atrioventricular block that has occurred during the episode of bradycardia or pause.
Chen, however, teaches an analogous system (Fig. 1, Paragraph 0026, lines 1-2) that comprises a medical device (Fig. 1, Paragraph 0027, line 4, 17) and a computing device (Fig. 1, Paragraph 0033, lines 2-4, 7). Chen teaches that the P-R intervals may be calculated and compared to identify different types of heart blocks (Paragraph 0069, lines 10-12), such as bradycardia or pauses (Paragraph 0010, lines 9-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the computing device determines atrioventricular block has occurred during the episode of bradycardia based on the P-R intervals coinciding with the atrioventricular block that has occurred during the episode of bradycardia or pause. Doing so would ensure that a variety of different types of heart blocks can be identified based on recorded P-R intervals (Paragraphs 0072 and 0075), as recognized by Chen.
Regarding claim 26, Pedalty teaches a non-transitory computer-readable storage medium (Paragraph 0063, lines 1-7 and Paragraph 0151, lines 6-7) having instructions stored thereon (Paragraph 0062, lines 14-15 and Paragraph 0151, lines 6-12) that, when executed, cause processing circuitry (Paragraph 0033, lines 15-16, “processor”) of a computing device (Fig. 1, Paragraph 0030, lines 4-9, 12/24) to: receive, from a medical device (Fig. 1, Paragraph 0029, line 4, 10), cardiac electrogram data of the patient (Paragraph 0036, lines 1-4) for an episode of bradycardia recorded by the medical device (Paragraph 0036, lines 4-9); identify a plurality of heartbeats within the cardiac electrogram data for the episode of bradycardia (Paragraph 0072, lines 1-14); determine, based on the cardiac electrogram data, whether atrioventricular block has occurred during the episode of bradycardia (Paragraph 0073, lines 1-5, Paragraph 0077, lines 1-8, and Paragraph 0078, lines 2-5); and responsive to determining that atrioventricular block has occurred during the episode of bradycardia, output a report (Fig. 7, Paragraph 0099, lines 1-6) comprising: an indication that atrioventricular block has occurred during the episode of bradycardia (Fig. 7, Paragraph 0101, lines 3-7); and R-R intervals that coincide with the atrioventricular block that has occurred during the episode of bradycardia (Fig. 7, Paragraph 0101, lines 23-24).
Pedalty does teach that the medical device uses electrocardiogram data to determine that a patient is undergoing an episode of cardiac arrhythmia such as bradycardia, tachycardia, atrial fibrillation, ventricular fibrillation, or AV block (Paragraph 0036, lines 1-9). Pedalty does not teach that the computing device is configured to receive cardiac electrogram data for a pause recorded by the medical device.
Chen, however, teaches an analogous system (Fig. 1, Paragraph 0026, lines 1-2) that comprises: a medical device (Fig. 1, Paragraph 0027, line 4, 17) configured to sense cardiac electrogram data (Paragraph 0027, lines 10-13) of a patient (Fig. 1, Paragraph 0027, line 3, 1); and a computing device (Fig. 1, Paragraph 0033, lines 2-4, 7) containing processing circuitry (Fig. 1, Paragraph 0027, line 5, 3). Chen teaches that the system can generate heart-rate related alarms for bradycardia or pauses to identify heart block events (Paragraph 0010, lines 9-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the computing device is configured to receive cardiac electrogram data for a pause recorded by the medical device. Doing so would ensure that the system can identify pauses in an accurate and timely manner, and that clinicians can provide patients with treatment as needed (Paragraph 0010, lines 9-18), as recognized by Chen.
Pedalty does teach that a P-wave of the patient can be determined during an episode of arrhythmia (Paragraph 0101, line 26). Pedalty does not explicitly teach that the computing device outputs a report comprising P-R intervals that coincide with the atrioventricular block that has occurred during the episode of bradycardia.
Chen, however, teaches in an exemplary embodiment that a processor (Fig. 6, Paragraph 0069, line 4, 306), which may be the same as the components found in the medical device (Paragraph 0043, lines 1-6), is configured to determine P-R intervals during an episode of arrhythmia (Paragraph 0069, lines 8-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the system is configured to determine P-R intervals that coincide with the AV block that has occurred during an episode of arrhythmia. Doing so would ensure that different types of heart block events can be identified (Paragraph 0069, lines 8-12), as recognized by Chen.
Regarding claim 27, Pedalty teaches a method (Paragraph 0010, line 1) comprising: receiving, by a computing device (Fig. 1, Paragraph 0030, lines 4-9, 12/24) and from a medical device (Fig. 1, Paragraph 0029, line 4, 10), cardiac electrogram data (Paragraph 0036, lines 1-4) of a patient (Fig. 1, Paragraph 0029, line 4, 4) sensed by the medical device (Fig. 2, Paragraph 0047, lines 4-7) for an episode of bradycardia recorded by the medical device (Paragraph 0036, lines 4-9); identifying, by the computing device, a plurality of heartbeats within the cardiac electrogram data for the episode of bradycardia (Paragraph 0072, lines 1-14); determining, based on the cardiac electrogram data, whether atrioventricular block has occurred during the episode of bradycardia (Paragraph 0073, lines 1-5, Paragraph 0077, lines 1-8, and Paragraph 0078, lines 2-5); and responsive to determining that atrioventricular block has occurred during the episode of bradycardia or pause, outputting a report (Fig. 7, Paragraph 0099, lines 1-6) comprising: an indication that atrioventricular block has occurred during the episode of bradycardia (Fig. 7, Paragraph 0101, lines 3-7); and R-R intervals that coincide with the atrioventricular block that has occurred during the episode of bradycardia (Fig. 7, Paragraph 0101, lines 23-24).
Pedalty does teach that the medical device uses electrocardiogram data to determine that a patient is undergoing an episode of cardiac arrhythmia such as bradycardia, tachycardia, atrial fibrillation, ventricular fibrillation, or AV block (Paragraph 0036, lines 1-9). Pedalty does not teach that the computing device is configured to receive cardiac electrogram data for a pause recorded by the medical device.
Chen, however, teaches an analogous system (Fig. 1, Paragraph 0026, lines 1-2) and method (Paragraph 0008, lines 1-2) that comprises: a medical device (Fig. 1, Paragraph 0027, line 4, 17) configured to sense cardiac electrogram data (Paragraph 0027, lines 10-13) of a patient (Fig. 1, Paragraph 0027, line 3, 1); and a computing device (Fig. 1, Paragraph 0033, lines 2-4, 7) containing processing circuitry (Fig. 1, Paragraph 0027, line 5, 3). Chen teaches that the system can generate heart-rate related alarms for bradycardia or pauses to identify heart block events (Paragraph 0010, lines 9-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the computing device is configured to receive cardiac electrogram data for a pause recorded by the medical device. Doing so would ensure that the system can identify pauses in an accurate and timely manner, and that clinicians can provide patients with treatment as needed (Paragraph 0010, lines 9-18), as recognized by Chen.
Pedalty does teach that a P-wave of the patient can be determined during an episode of arrhythmia (Paragraph 0101, line 26). Pedalty does not explicitly teach that the computing device outputs a report comprising P-R intervals that coincide with the atrioventricular block that has occurred during the episode of bradycardia.
Chen, however, teaches in an exemplary embodiment that a processor (Fig. 6, Paragraph 0069, line 4, 306), which may be the same as the components found in the medical device (Paragraph 0043, lines 1-6), is configured to determine P-R intervals during an episode of arrhythmia (Paragraph 0069, lines 8-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the system is configured to determine P-R intervals that coincide with the AV block that has occurred during an episode of arrhythmia. Doing so would ensure that different types of heart block events can be identified (Paragraph 0069, lines 8-12), as recognized by Chen.
Regarding claim 28, Pedalty teaches the method (Paragraph 0010, line 1) of claim 27, further comprising: for each of the plurality of heartbeats: determining, by the computing device (Fig. 1, Paragraph 0030, lines 4-9, 12/24), a R-R interval (Fig. 7, Paragraph 0101, lines 23-24, “mean”); and determining, by the computing device, a P-wave during the episode of arrhythmia (Fig. 7, Paragraph 0101, line 26).
Pedalty does not teach that the method further comprises, for each of the plurality of heartbeats: determining, by the computing device, whether a P-wave is detectable in the cardiac electrogram data; and responsive to determining the P-wave is detectable, determining, by the computing device a P-R interval.
Chen, however, teaches an analogous system (Fig. 1, Paragraph 0026, lines 1-2) and method (Paragraph 0008, lines 1-2) that comprises a medical device (Fig. 1, Paragraph 0027, line 4, 17) and a computing device (Fig. 1, Paragraph 0033, lines 2-4, 7). Chen teaches that the processor (Fig. 6, Paragraph 0069, line 4, 306), which may be the same as the components found in the medical device (Paragraph 0043, lines 1-6), is configured to determine whether a P-wave is detectable in the cardiac electrogram data (Paragraph 0058, lines 1-14). Chen teaches that once it is determined that the P-wave is detectable, a P-R interval is determined (Paragraph 0068, lines 6-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that the processing circuitry is further configured to: for each of the plurality of heartbeats: determine whether a P-wave is detectable in the cardiac electrogram data; and responsive to determining that the P-wave is detectable, determine a P-R interval. Doing so would ensure that large P-waves are not mistakenly detected as valid ventricular R-waves, and consequently that heart rate related alarms aren’t missed (Paragraph 0057, lines 7-11), as recognized by Chen.
Regarding claim 29, Pedalty teaches the method (Paragraph 0010, line 1) of claim 28 that includes using the computing device (Fig. 1, Paragraph 0030, lines 4-9, 12/24). Pedalty does not teach that the method further comprises, responsive to determining that one or more P-waves are not detectable in the cardiac electrogram data for the episode of bradycardia or pause, outputting, by the computing device, a report comprising an indication that whether atrioventricular block has occurred during the episode of bradycardia or pause is indeterminate.
Chen, however, teaches an analogous system (Fig. 1, Paragraph 0026, lines 1-2) and method (Paragraph 0008, lines 1-2) that comprises a medical device (Fig. 1, Paragraph 0027, line 4, 17) and a computing device (Fig. 1, Paragraph 0033, lines 2-4, 7). Chen teaches that the processor (Fig. 6, Paragraph 0069, line 4, 306), which may be the same as the components found in the medical device (Paragraph 0043, lines 1-6), is configured to determine whether a P-wave is detectable in the cardiac electrogram data (Paragraph 0058, lines 1-14).
Chen also teaches that the processor detects a heart block, such as AV block (Paragraph 0002, lines 1-2), when P-waves are detected (Paragraph 0058, lines 11-14). Furthermore, Chen teaches that heart block events can be output on a display (Fig. 6, Paragraph 0069, line 6, 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Chen to include that, in response to determining that one or more P-waves are not detectable in the cardiac electrogram data for the episode of bradycardia or pause, output a report comprising an indication that whether atrioventricular block has occurred during the episode of bradycardia or pause is indeterminate. Doing so would ensure that the patient and a clinician can be notified that an indication that atrioventricular block has occurred cannot be determined (Paragraph 0069, lines 6-8 and Paragraph 0088, lines 5-9), as recognized by Chen.
Claims 4-6, 17, 22-23, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Pedalty et al. (U.S. PGPub No. 2020/0352462) in view of Chen et al. (U.S. PGPub No. 2022/0202344) as applied to claims 1, 2, and 28 above, and further in view of Farazi (U.S. Patent No. 8,600,503).
Regarding claim 4, Pedalty teaches the system (Fig. 1, Paragraph 0029, line 2, 2)
of claim 2, wherein the processing circuitry (Paragraph 0033, lines 15-16, “processor”) outputs the report (Fig. 7, Paragraph 0099, lines 1-6). Pedalty does not teach that the processing circuitry is further configured to determine, for each of the plurality of heartbeats, whether the R-R interval satisfies an R-R interval threshold, wherein the processing circuitry is configured to output the report comprising P-R intervals by excluding P-R intervals for heartbeats for which the R-R interval threshold is not satisfied.
Farazi, however, teaches a system (Fig. 1-2, Col. 3, line 22, 10) that comprises: a medical device (Fig. 2, Col. 5, lines 41-42, 82/84) configured to sense cardiac electrogram data (Fig. 2, Col. 5, lines 41-45 and Col. 6, lines 34-37) of a patient (Col. 3, line 23, “patient’s”); and a computing device (Fig. 1-2, Col. 4, lines 50-51, 60) comprising processing circuitry (Col. 4, lines 52-53), and that is configured to receive cardiac electrogram data from the medical device (Col. 7, lines 15-19). Farazi teaches that the computing device (60) can identify and classify arrhythmias (Col. 6, lines 22-23).
Furthermore, Farazi teaches that, in accordance with embodiments of the present invention (Col. 11, lines 4-10), R-R intervals and P-R intervals can be measured to supplement one another (Col. 12, lines 2-4). Farazi teaches that R-R intervals can be compared to an R-R interval threshold (Col. 12, lines 14-17 and Col. 15, lines 51-55). Farazi then teaches that cardiac intervals corresponding to some beats can be excluded (Col. 11, lines 41-42).
It would have been obvious to one of ordinary skill in the art, in light of the disclosure of Farazi, to specify that the processing circuitry is further configured to determine, for each of the plurality of heartbeats, whether the R-R interval satisfies an R-R interval threshold, wherein the processing circuitry is configured to output the report comprising P-R intervals by excluding P-R intervals for heartbeats for which the R-R interval threshold is not satisfied. One of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success of correctly identifying whether atrioventricular block has occurred, in order to provide a patient with appropriate therapy (Col. 6, lines 22-24), as recognized by Farazi.
Regarding claim 5, Pedalty teaches the system (Fig. 1, Paragraph 0029, line 2, 2)
of claim 4, wherein the processing circuitry (Paragraph 0033, lines 15-16, “processor”) outputs the report (Fig. 7, Paragraph 0099, lines 1-6). Pedalty does not teach that the processing circuitry is configured to output the report comprising P-R intervals by excluding P-R intervals for heartbeats that adjacently follow a respective premature ventricular contraction heartbeat.
Farazi, however, teaches a system (Fig. 1-2, Col. 3, line 22, 10) that comprises: a medical device (Fig. 2, Col. 5, lines 41-42, 82/84) and a computing device (Fig. 1-2, Col. 4, lines 50-51, 60). Farazi also teaches that in accordance with embodiments of the present invention (Col. 11, lines 4-10), P-R intervals can be measured (Col. 12, lines 2-3). Farazi teaches that cardiac intervals that both precede and follow each premature ventricular contraction can be monitored (Col. 11, lines 42-44). Farazi then teaches that cardiac intervals corresponding to some beats can be excluded (Col. 11, lines 41-42).
It would have been obvious to one of ordinary skill in the art, in light of the disclosure of Farazi, to specify that the processing circuitry is configured to output the report comprising P-R intervals by excluding P-R intervals for heartbeats that adjacently follow a respective premature ventricular contraction heartbeat. One of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success of correctly identifying whether atrioventricular block has occurred, in order to provide a patient with appropriate therapy (Col. 6, lines 22-24), as recognized by Farazi.
Regarding claim 6, Pedalty teaches the system (Fig. 1, Paragraph 0029, line 2, 2)
of claim 1, wherein the processing circuitry (Paragraph 0033, lines 15-16, “processor”) is
configured to determine whether an atrioventricular block has occurred during the episode of bradycardia (Paragraph 0073, lines 1-5, Paragraph 0077, lines 1-8, and Paragraph 0078, lines 2-5).
Pedalty does not teach that the processing circuitry is further configured to, for each of the plurality of heartbeats, determine whether a R-R interval satisfies an R-R interval threshold, wherein the processing circuitry is configured to determine whether atrioventricular block has occurred during the episode of bradycardia or pause by excluding P-R intervals for heartbeats for which the R-R interval threshold is not satisfied.
Farazi, however, teaches a system (Fig. 1-2, Col. 3, line 22, 10) that comprises: a medical device (Fig. 2, Col. 5, lines 41-42, 82/84) and a computing device (Fig. 1-2, Col. 4, lines 50-51, 60). Farazi also teaches that in accordance with embodiments of the present invention (Col. 11, lines 4-10), R-R intervals and P-R intervals can be measured to supplement one another (Col. 12, lines 2-4). Farazi teaches that R-R intervals can be compared to an R-R interval threshold (Col. 12, lines 14-17 and Col. 15, lines 51-55). Farazi then teaches that cardiac intervals corresponding to some beats can be excluded (Col. 11, lines 41-42).
It would have been obvious to one of ordinary skill in the art, in light of the disclosure of Farazi, to specify that the processing circuitry is further configured to, for each of the plurality of heartbeats, determine whether a R-R interval satisfies an R-R interval threshold, wherein the processing circuitry is configured to determine whether atrioventricular block has occurred during the episode of bradycardia or pause by excluding P-R intervals for heartbeats for which the R-R interval threshold is not satisfied. One of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success of correctly identifying whether atrioventricular block has occurred, in order to provide a patient with appropriate therapy (Col. 6, lines 22-24), as recognized by Farazi.
Regarding claim 17, Pedalty teaches the system (Fig. 1, Paragraph 0029, line 2,
2) of claim 6, wherein the processing circuitry (Paragraph 0033, lines 15-16, “processor”) is configured to determine whether an atrioventricular block has occurred during the episode of bradycardia (Paragraph 0073, lines 1-5, Paragraph 0077, lines 1-8, and Paragraph 0078, lines 2-5).
Pedalty does not teach that the processing circuitry is configured to determine whether atrioventricular block has occurred during the episode of bradycardia or pause by excluding P-R intervals for heartbeats that adjacently follow a premature ventricular contraction heartbeat.
Farazi, however, teaches a system (Fig. 1-2, Col. 3, line 22, 10) that comprises: a medical device (Fig. 2, Col. 5, lines 41-42, 82/84) and a computing device (Fig. 1-2, Col. 4, lines 50-51, 60). Farazi also teaches that in accordance with embodiments of the present invention (Col. 11, lines 4-10), P-R intervals can be measured (Col. 12, lines 2-3). Farazi teaches that cardiac intervals that both precede and follow each premature ventricular contraction can be monitored (Col. 11, lines 42-44). Farazi then teaches that cardiac intervals corresponding to some beats can be excluded (Col. 11, lines 41-42).
It would have been obvious to one of ordinary skill in the art, in light of the disclosure of Farazi, to specify that the processing circuitry is configured to determine whether atrioventricular block has occurred during the episode of bradycardia or pause by excluding P-R intervals for heartbeats that adjacently follow a premature ventricular contraction heartbeat. One of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success of correctly identifying whether atrioventricular block has occurred, in order to provide a patient with appropriate therapy (Col. 6, lines 22-24), as recognized by Farazi.
Regarding claim 22, Pedalty in view of Chen and Farazi discloses the claimed invention of claim 17. Pedalty further discloses the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 17, wherein a machine learning model (Paragraph 0042, lines 4-5) of the machine learning system (Fig. 1, Paragraph 0033, lines 7-8, 150 and Paragraph 0069, lines 5-7, 450) is trained using cardiac electrogram data for a plurality of patients (Paragraph 0042, lines 5-6), wherein the cardiac electrogram data for the plurality of patients comprises a plurality of electrocardiogram waveforms (Paragraph 0070, lines 1-6), and wherein at least some of the electrocardiogram waveforms are labeled with atrioventricular block (Paragraph 0070, lines 8-14).
Regarding claim 23, Pedalty teaches the system (Fig. 1, Paragraph 0029, line 2, 2) of claim 1 that includes the computing device (Fig. 1, Paragraph 0030, lines 4-9, 12/24). Pedalty does not teach that the system further comprises selecting, by the computing device, a medical device sensitivity based on user input.
Farazi, however, teaches a system (Fig. 1-2, Col. 3, line 22, 10) that comprises: a medical device (Fig. 2, Col. 5, lines 41-42, 82/84) and a computing device (Fig. 1-2, Col. 4, lines 50-51, 60). Farazi teaches that the computing device can select a sensitivity of the medical device (Col. 7, lines 1-7). Furthermore, Farazi teaches that the operating parameters of the medical device may be programmed via communication between the computing device (Col. 7, lines 11-13) and an external device (Fig. 1-2, Col. 7, line 13, 102) based on user input (Col. 7, lines 4-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pedalty to incorporate the teachings of Farazi to include that the computing device selects a medical device sensitivity based on user input. Doing so would ensure that operating parameters, such as sensitivity, can be selected and modified as required to meet the needs of individual patients (Col. 7, lines 1-10), as recognized by Farazi.
Regarding claim 30, Pedalty teaches the method (Paragraph 0010, line 1) of claim 28 that includes outputting the report (Fig. 7, Paragraph 0099, lines 1-6). Pedalty does not teach that the method further comprises, determining, for each of the plurality of heartbeats, whether the R-R interval satisfies an R-R interval threshold, wherein outputting the report comprising P-R intervals comprises excluding P-R intervals for heartbeats for which the R-R interval threshold is not satisfied.
Farazi, however, teaches a system (Fig. 1-2, Col. 3, line 22, 10) and method of using said system (Col. 1, lines 52-53) that comprises: a medical device (Fig. 2, Col. 5, lines 41-42, 82/84) configured to sense cardiac electrogram data (Fig. 2, Col. 5, lines 41-45 and Col. 6, lines 34-37) of a patient (Col. 3, line 23, “patient’s”); and a computing device (Fig. 1-2, Col. 4, lines 50-51, 60) comprising processing circuitry (Col. 4, lines 52-53), and that is configured to receive cardiac electrogram data from the medical device (Col. 7, lines 15-19). Farazi teaches that the computing device (60) can identify and classify arrhythmias (Col. 6, lines 22-23).
Furthermore, Farazi teaches that, in accordance with embodiments of the present invention (Col. 11, lines 4-10), R-R intervals and P-R intervals can be measured to supplement one another (Col. 12, lines 2-4). Farazi teaches that R-R intervals can be compared to an R-R interval threshold (Col. 12, lines 14-17 and Col. 15, lines 51-55). Farazi then teaches that cardiac intervals corresponding to some beats can be excluded (Col. 11, lines 41-42).
It would have been obvious to one of ordinary skill in the art, in light of the disclosure of Farazi, to specify that the method further comprises, determining, for each of the plurality of heartbeats, whether the R-R interval satisfies an R-R interval threshold, wherein outputting the report comprising P-R intervals comprises excluding P-R intervals for heartbeats for which the R-R interval threshold is not satisfied. One of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success of correctly identifying whether atrioventricular block has occurred, in order to provide a patient with appropriate therapy (Col. 6, lines 22-24), as recognized by Farazi.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chakravarthy et al. (U.S. PGPub No. 2020/0352466) discloses techniques for using both feature delineation and machine learning to detect and classify cardiac arrhythmias, wherein a computing device outputs a report indicating that an episode of arrhythmia occurred (Abstract).
Chakravarthy et al. (U.S. PGPub No. 2020/0352521) discloses techniques for using category-based reviews and machine learning models to detect and classify arrhythmia episodes (Abstract).
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/H.A.H./Patent Examiner , Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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