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 Objections
Claim 1-15 are objected to because of the following informalities: For all claims an article (“a,” “an,” or “the”) is needed at the start of a claim. For example, claim 1 should be written as “A method…”. Appropriate correction is required.
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 1-15 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. Claim 1 recites the limitations “verifying the event at least in part based on a heart episode associated with the event; wherein the verifying is based at least in part a type of event.” The instant specification does not provide adequate support for the claimed event as recited. The event is claimed so broadly that one of ordinary skill in the art would interpret the scope as encompassing any type of event. An event and event type, as recited, could include a great number of events (i.e., heart attack, arrythmias, heart failure, cardiomyopathy, stroke, poisoning, overdose, panic attacks, seizures, etc.). The instant specification only describes a limited number of cardiac events (pg. 3, ln. 14-15). However, the examples of species “event type[s]” are insufficient to describe the genus of “an event.”
Citing the MPEP 2163(3)(a)(ii): The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted)."). A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Claims 2-15 are rejected due to their dependency from claim 1.
Claim 8 also 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. Claim 8 recites the limitations “if the type comprises an asystole, high ventricular rate, and/or a bradycardia, the verifying comprises eliminating, from the heart episode, RR intervals associated with a clipping of an amplitude, and preferably also RR intervals adjacent to at least one RR interval associated with a clipping of an amplitude.” The instant specification does not provide support for the claimed invention as cited. It is not clear how eliminating RR intervals associated with a clipping amplitude is used to verify asystole, high ventricular rate, and/or bradycardia. The instant specification describes that amplitudes are clipped when a threshold amplitude is met for a period of time (pg. 8, ln. 5-16). However, it is unclear how the eliminating RR intervals associated with a clipping verifies asystole, high ventricular rate, or bradycardia. Asystole is a term of the art that describes flat-lining on an ECG. It is unclear based on the instant specification how the removal of RR intervals verifies the occurrence of a true flat-lining, asystole ECG signals. Further, ventricular rate and bradycardia are both events defined by time intervals between successive peaks in the ECG. Based on the inadequate description provided in the instant specification, one of ordinary skill in the art would not know how eliminating amplitudes associated with clippings is used to verify high ventricular rate or bradycardia. There is a gap between the elimination of intervals associated with clippings and the verification of event types that requires more detailed 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 1-15 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.
Regarding claim 1, the claim recites “verifying the event” (ln. 3) and “wherein the verifying is based at least in part on a type of event” (ln. 4). It is unclear from the claim language what subject matter of the broad, unspecific species (“a type of event”) can be used to verify the broad genus (“the event”) of events. Further, the number of possible events is so broad that one of ordinary skill in the art would not understand what is considered an event. Lastly, the limitation of verifying an event is recited so broadly that one of ordinary skill in the art would not understand what can be considered to be included as an action of verifying.
Claims 1-15 are rejected due to their dependency from claim 1.
Regarding claim 4, the applicant recites “receiving information associated with the event from the implantable device.” However, it is unclear who or what is receiving information, as well as what the information might include. As claimed, the limitation is so broad that the information could include anything associated with an event from an implantable device. Further, the device (or person) receiving the information could include anything (or anyone) since the claim does not specify what does the receiving. The metes and bounds of the claim are not clear for this reason, and the scope is therefore indefinite.
Regarding claim 5, the claim recites “determining a sliding linear regression in a vicinity of a predetermined QRS peak” (ln. 3-4). The use of “vicinity” is so broad that it is unclear what is considered to be in the vicinity. More specificity is required to understand the metes and bounds of the limitation.
Regarding claim 8, the claim recites "RR intervals" in line 3. There is insufficient antecedent basis for this limitation in the claim. No recitation of “RR intervals” is made prior to claim 8, line 1, nor in claim 1.
Regarding claim 9, the claim recites “a pause associated with the asystole.” (line 3). However, claim 8 recites the option for event types as being “an asystole, high ventricular rate, and/or a bradycardia”. There is insufficient antecedent basis for “the asystole” since it is referred to in the optional case in claim 8 (by reciting the option “and/or”).
Regarding claim 8 and 9, the phrase "preferably" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. For examination purposes, the limitations following “preferably” will be interpreted as optional steps in the claimed method.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The claim recites “the verifying comprises eliminating, from the heart episode, RR intervals associated with a clipping of an amplitude…”. The claim fails to recite a step of clipping an amplitude of an ECG signal, and therefore, it is unclear how RR intervals associated with clippings can be removed. Necessary steps involving clipping the signal amplitude should be recited before referencing the elimination of RR intervals associated with clipped signals.
Regarding claim 10, the claim recites “If a pause is detected determining that the event is a true positive otherwise determining that the event is a false positive.” It is unclear, as the claim is written, if the term “otherwise” is referring to a scenario where a false positive is determined, or if the term “otherwise” is referring to a case where no pause is detected. It is not clear if the lack of a pause is directly correlated to the determination that the event is a false positive.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Independent claim 1 is directed to a method, and dependent claims 13 and 14 are directed to an apparatus and system (i.e., a machine) for performing the method. Thus, the claims meet the requirements for step 1. However, regarding dependent claim 15, the claim is directed towards a computer program, which is not patent eligible subject matter and is therefore rejected under 35 USC § 101 step 1. See MPEP 2106.03 regarding signals per se.
Step 2A, prong 1
Claim 1 recites a “verifying the event at least in part based on a heart episode associated with the event; wherein the verifying is based at least in part on a type of the event.” The recited limitations of claim 1 is directed to an abstract idea mental process. The claim is a mental process in that one of ordinary skill in the art, such as a physician, could observe the recordings from an implantable device, and verify the event. The action of verifying an event is a human process that is often performed by a medical professional (i.e., a physician providing an opinion) in their head.
Step 2A, prong 2
Claim 1 recites a “method for analyzing an event determined by an implantable device, the method comprising...” The recited limitation does not amount to integration of the abstract idea mental process into a practical application. The recited limitation does nothing more than define the field of use for the method.
Step 2B
Claim 1 recites a “method for analyzing an event determined by an implantable device, the method comprising...” The recited limitation does not amount to significantly more than the abstract idea mental process. The recited limitation does nothing more than define the field of use for the method.
Dependent claims
Claims 2, 3, 5, 6, 7, 8, 9, 10, 11, and 12 further define the abstract idea mental process of verifying.
Claim 4 recites extra-solution activity data gathering (“receiving information from the device”).
Claims 13 and 14 recite structures that are defined by the abstract ideas of claims 1-12 (an apparatus “configured to perform the methods of claim 1”).
Claim 15 recites subject matter that is not patent eligible (a computer program).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 3, 4, 11, 12, 13, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dawoud et al. (US 20190336026 A1, “Dawoud”).
Regarding claim 1, Dawoud teaches a method for analyzing an event (abstract; “Computer implemented methods and systems for detecting arrhythmias in cardiac activity are provided.”) determined by an implantable device (Fig. 1; para. [0076]; “FIG. 1 illustrates an implantable cardiac monitoring device (ICM) 100 intended for subcutaneous implantation at a site near the heart”), the method comprising: verifying the event at least in part based on a heart episode associated with the event (para. [0109]; “The process may initiate the operations of FIG. 3 in an attempt to verify whether one or more episodes in a CA data set, are in fact an AF episode or a normal rhythmic/sinus episode.”); wherein the verifying is based at least in part on a type of the event (para. [109]; atrial fibrillation (AF) is the cardiac event type).
Regarding claim 2, Dawoud teaches the method according to claim 1 (see rejection above), wherein the type comprises at least one of the following: an atrial fibrillation onset, an asystole, a high ventricular rate, a bradycardia (para. [0018]; “The first pass arrhythmia detection algorithm may declare the arrhythmia episode to be one of a bradycardia, asystole or atrial fibrillation episode.”; para. [0086]; “The arrhythmia detector 134 of the microcontroller 121 includes an on-board R-R interval irregularity (ORI) process 136 that detects AF episodes using an automatic detection algorithm that monitors for irregular ventricular rhythms that are commonly known to occur during AF.”)
Regarding claim 3, Dawoud teaches the method according to claim 1 (see above), wherein the verifying comprises determining whether the event is true positive and/or whether the event is false positive. (para. [0160]; “The adaptive sensitivity threshold changes between events and/or episodes. The detection algorithm 813 provides a reduction in false declaration of bradycardia and asystole episodes by the ORI process 809, while maintaining the sensitivity in detecting true bradycardia and asystole episodes.”; para. [0108]; “For example, a 30-45 second strip of EGM signals may include one or more PVC events that cause the AF detection algorithm of an IMD to designate a false R-wave marker. Based on the number of false R-wave markers in the EGM strip, the AF detection algorithm may determine that no arrhythmia episode is present or a false arrhythmia episode is present.”)
Regarding claim 4, Dawoud teaches the method according to any of claims 1, further comprising receiving information associated with the event from the implantable device (para. [0082]; “The ICM 100 is further equipped with a communication modem (modulator/demodulator) 140 to enable wireless communication…The modem 140 facilitates data retrieval from a remote monitoring network. The modem 140 enables timely and accurate data transfer directly from the patient to an electronic device utilized by a physician.”).
Regarding claim 11, Dawoud teaches a method according to any of claims 1 (see above), wherein, if the type comprises a high ventricular rate and/or a bradycardia, the verifying comprises a calculation of a heart rate based on the heart episode. (para. [0101]; “The ICM 100 may provide comprehensive safe diagnostic data reports including a summary of heart rate, in order to assist physicians in diagnosis and treatment of patient conditions. By way of example, reports may include episodal diagnostics for auto trigger events, episode duration, episode count, episode date/time stamp and heart rate histograms.”)
Regarding claim 12, Dawoud teaches a method according to claim 11 (see above), wherein the verifying is based at least in part on comparing the calculated heart rate with a predetermined threshold (para. [0187]; “the processors may maintain a running count of a number of beats having RR intervals that are sufficiently long (exceed a bradycardia RR interval threshold) to be indicative of a bradycardia episode.”)
Regarding claim 13, Dawoud teaches an apparatus (abstract; “Computer implemented methods and systems for detecting arrhythmias in cardiac activity are provided. The method is under control of one or more processors configured with specific executable instructions.”) for analyzing an event determined by an implantable device (Fig. 1; para. [0076]; “implantable cardiac monitoring device (ICM) 100.”), wherein the apparatus is configured to perform a method of claim 1 (see above).
Regarding claim 14, Dawoud teaches a system (abstract; “Computer implemented methods and systems for detecting arrhythmias in cardiac activity are provided”) for analyzing an event determined by an implantable device comprising: an apparatus according to claim 13 (see above); and the implantable device (Fig. 1; para. [0076]; “implantable cardiac monitoring device (ICM) 100.”).
Regarding claim 15, Dawoud teaches a computer program comprising instructions to perform a method of any of claim 1 when the instructions are executed (Abstract; “The method is under control of one or more processors configured with specific executable instructions.”)
Claim(s) 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakar (US 20170273589 A1, “Sakar”).
Regarding claim 1, Sakar teaches a method for analyzing an event (abstract; “A system and method for detecting and verifying bradycardia/asystole episodes…”) determined by an implantable device (Fig. 1; implantable device 100), the method comprising: verifying the event at least in part based on a heart episode (para. [0033]; “A subcutaneous device may be coupled to a lead tunneled subcutaneously or submuscularly for delivering transthoracic pacing pulses and/or sensing ECG signals.”) associated with the event; wherein the verifying is based at least in part on a type of the event (para. [0028] FIG. 1 is a schematic diagram of an exemplary medical device for detecting an arrhythmia according to an embodiment of the present disclosure”).
Regarding claim 8, Sakar teaches wherein, if the type comprises an asystole, high ventricular rate, and/or a bradycardia (para. [0059]; “FIG. 5 describes a method and system for verifying bradycardia and/or asystole episodes based on the detection of under-sensed events.”) the verifying comprises eliminating, from the heart episode, RR intervals associated with a clipping of an amplitude, and preferably also RR intervals adjacent to at least one RR interval associated with a clipping of an amplitude (para. [0066]; “In the embodiment shown in FIG. 6, a plurality of parameters defines the behavior of the secondary auto-adjusting threshold 612. These parameters may be programmable and may be stored in hardware and/or software. In one embodiment these parameters include the maximum value of the auto-adjust threshold (e.g., 30% of previously sense R-wave amplitude), duration of the blanking period following an R-wave sense before the threshold begins to decrease or decay (e.g., 500 ms), the rate at which the threshold decreases or decays, and the minimum threshold value or floor. In one embodiment, the maximum value is not allowed to exceed a maximum value (i.e., is clipped to a maximum value), which may also be programmable.”)
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.
Claim(s) 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Dawoud et al. (US 20190336026 A1, “Dawoud”), Aspuru et al. (“Segmentation of the ECG Signal by Means of a Linear Regression Algorithm”; Pub. Feb. 14, 2019, “Aspuru”), and Mena et al. (“Mobile Personal Health Monitoring for Automated Classification of Electrocardiogram Signals in Elderly”; Pub. May 29, 2018, “Mena”).
Regarding claim 5, Dawoud teaches a method according to claim 1 (see 102 rejection above). However, Dawoud does not teach wherein, if the type comprises an atrial fibrillation onset, the verifying comprises detecting, in the heart episode, a P wave peak by determining a sliding linear regression in a vicinity of a predetermined QRS peak.
Aspuru, in the same field of endeavor of detecting cardiac events and anomalies from ECG signals, discloses a method for performing a linear regression to a segment of an ECG signal to detect a peak. Aspuru discloses wherein, if the type comprises an atrial fibrillation onset, the verifying comprises detecting, in the heart episode, a P wave peak by determining a sliding linear regression in a vicinity of a predetermined QRS peak (Abstract; “Our approach is based on the use of linear regression to segment the signal, with the goal of detecting the R point of the ECG wave and later, to separate the signal in periods for detecting P, Q, S, and T peaks. After pre-processing of ECG signal to reduce the noise, the algorithm was able to efficiently detect fiducial points, information that is transcendental for diagnosis of heart conditions using machine learning classifiers.”; In the case of Aspuru, sliding is not used to describe the linear regression. However, sliding linear regression is considered performing linear regression to data in a window that is changing over time (as opposed to a set number of data points). Thus, Aspuru discloses an example of a sliding linear regression in that it is performed on a window of ECG data recorded over time.)
Aspuru does not specifically disclose performing the linear regression for the atrial fibrillation event type. However, Aspuru discloses that the method is used to detect each section of an ECG signal for diagnosis of several heart conditions (introduction; para. 1), and references Mena et al. (“Mobile Personal Health Monitoring for Automated Classification of Electrocardiogram Signals in Elderly”). Mena discloses classifying ECG signals for specificity in detecting atrial fibrillation (Discussion; para. 1). Thus, atrial fibrillation is considered one of the heart conditions where the sliding linear regression method can be used to detect P waves.
It would have been obvious to one of ordinary skill in the art before the effective filing date to combine the methods of claim 1, as disclosed by Dawoud, with the technique of identifying P-wave peaks with a sliding linear regression as disclosed by Aspuru. Aspuru discloses the known technique of performing a sliding linear regression on segments of an ECG, and uses this technique to diagnose heart conditions. It would have been obvious to incorporate this into the method of claim 1, which is directed towards a method of diagnosing heart conditions, since it would improve the method of detecting P-wave peaks. In doing so, the technique would have yielded predictable results of improved accuracy in verifying heart conditions.
Regarding claim 6, Dawould, in combination with Aspuru, disclose the method according to claim 5 (see above). Dawoud further discloses wherein the verifying is further based at least in part on one of the following: an RR interval, a PP interval, an RP interval, a correlation of a QRS complex morphology and/or on an ectopy probability, in the heart episode (para. [0078]; “The ICM 100 includes one or more processors and memory that stores program instructions directing the processors to implement AF detection utilizing an on-board R-R interval irregularity (ORI) process that analyzes cardiac activity signals collected over one or more sensing channels.”; para. [0125]; “For example, at 318, the one or more processors may implement the QRS complex morphology based PVC detection process described in one or more of the Co-Pending Related Applications referred to above, and filed concurrently on the same day as the present application. The processors determine whether a QRS complex morphology has varied beyond a morphology variation threshold. Variation in the R-wave morphology beyond the morphology variation threshold provides a good indicator that the cardiac events include one or more PVC. When the cardiac events include a sufficient number of PVCs, the process may attribute an R-R interval variation to (and indicative of) PVCs or non-atrial originated beats that lead to significantly different R-R intervals, and not due to (or indicative of) an AF episode.”; The morphological differences are indicative of a PVC episode and are used to detect false positives.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to further include the intervals and components of the heart episode as disclosed by Dawoud with the methods of claim 5, as disclosed by the combination of Dawoud and Aspuru. The intervals mentioned are common intervals and components of an ECG signal, and the information from these signals can be used to verify events and abnormalities in the heart, such as atrial fibrillation, as is shown in the case of Dawoud’s methods. Therefore, including these specific intervals and components would have been obvious to use in the methods of claim 5, which are directed to verifying atrial fibrillation onset.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Dawoud et al. (US 20190336026 A1, “Dawoud”), Aspuru et al. (“Segmentation of the ECG Signal by Means of a Linear Regression Algorithm”; Pub. Feb. 14, 2019, “Aspuru”), Mena et al. (“Mobile Personal Health Monitoring for Automated Classification of Electrocardiogram Signals in Elderly”; Pub. May 29, 2018, “Mena”), and Cao et al. (US 20200305799 A1, Cao).
Regarding claim 7, Dawoud, in combination with Aspuru and Mena, disclose the method according to claim 5 (see 102 rejection). However, neither Dawoud nor Aspuru disclose wherein the verifying is performed by an artificial intelligence system and/or a machine learning system that has been trained with events that were verified via manual inspection of heart episodes.
Cao, in the same field of processing ECG data to diagnose cardiac events, discloses a method based on machine learning artificial intelligence. Cao discloses wherein the verifying is performed by an artificial intelligence system and/or a machine learning system (para. [0043]; " The ECG automatic analysis method based on artificial intelligence self-learning according to the embodiments of the present disclosure includes data preprocessing, heart beat feature detection, interference signal detection and heart beat classification based on deep learning methods, signal quality evaluation and lead combination, heart beat verifying, and analysis and calculation of ECG events and parameters.") that has been trained with events that were verified via manual inspection of heart episodes (para. [0005]; "Specifically, training data came from 64,121 samples of 29,163 patients. Each sample was single-lead data with a length of 30 seconds and a sample rate of 200 Hz. Each second of data corresponds to the Rhythm Type labeled and reviewed by qualified ECG experts, with a total of 14 labeled types, including 12 common arrhythmia events, a normal sinus rhythm and a noise type. The trained model labeled data by using a single-lead gold standard with a same sample rate to perform 14 types of events identification on each second of input data").
It would have been obvious to one of ordinary skill in the art before the effective filing date to combine the method of claim 5, as disclosed by the Dawoud and Aspuru combination, with the method of using artificial intelligence as disclosed by Cao. Doing so would have been an obvious improvement of the ECG analysis for detecting cardiac events that would yield the predictable result of further increasing the accuracy of detecting cardiac events. Further, it would have been obvious to train the AI algorithm with confirmed events labeled by ECG experts since doing so would provide a baseline accuracy for the algorithm to compare with the output calculations. Using this known technique would have yielded predictable results for an improving the accuracy of verifying heart events.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sakar (US 20170273589 A1, “Sakar”), in view of Ghanem et al. (US 7734336 B2, “Ghanem”).
Regarding claim 9, Sakar discloses a method according to claim 8 (see 102 rejection above). However, Sakar does not disclose wherein the verifying further comprises: detecting, in the heart episode, whether a pause associated with the asystole is present between subsequent QRS peaks, preferably corresponds to a (prolonged) RR interval that has not been eliminated.
Ghanem, in the same field of endeavor of detecting arrythmia, discloses a method for detecting cardiac events from an ECG. Ghanem discloses wherein the verifying further comprises: detecting, in the heart episode, whether a pause associated with the asystole is present between subsequent QRS peaks (para. (63); “Once the heart rate estimate is obtained using the heart rate metric, a determination is made as to whether asystole is detected for either channel, ECG1 or ECG 2, Block 324. According to an embodiment of the present invention, asystole is detected for the channel, for example, either by determining whether one of the 12 R-R intervals is greater than a predetermined time period, such as three seconds, for example, or if the time since the most recently sensed R wave exceeds a predetermined time period, such as three seconds, for example.”), preferably corresponds to a (prolonged) RR interval that has not been eliminated. Ghanem does not explicitly disclose the limitation as a “pause” between peaks. However, as described, a prolonged interval, or an “interval longer than a time period”, can be considered to be a pause.
It would have been obvious to combine the method of claim 8, as disclosed by Sakar, with the methods of detecting a pause associated with asystole between QRS peaks as disclosed by Ghanem. Detecting a pause between peaks is a technique for indicating asystole, as disclosed in Ghanem. It would have been obvious to include this technique with the method of claim 8 since it improves the process of verifying asystole events.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sakar (US 20170273589 A1, “Sakar”), Ghanem et al. (US 7734336 B2, “Ghanem”), and Dawoud et al. (US 20190336026 A1, “Dawoud”).
Regarding claim 10, Sakar, in combination with Ghanem, disclose the method according to claim 9 (see above). However, the combination does not disclose wherein the verifying further comprises: if a pause is detected determining that the event (E) is true positive (TP) otherwise determining that the event is false positive.
Dawoud discloses wherein the verifying further comprises: if a pause is detected determining that the event (E) is true positive (TP) otherwise determining that the event is false positive (Fig. 3; 316 and 320 show “Declare False Arrythmia Detection” (False Positive) and “Confirm Original Arrythmia Detection” (True positive), respectively.)
It would have been obvious for one of ordinary skill in the art before the effective filing date to combine the methods of claim 9 with Dawoud’s methods of labeling an event as a false or true positive. Doing so would clearly indicate to the user that the event is a true or false positive based on the detection of a pause, which is a technique disclosed by Dawoud for verifying an event. It would have been obvious to combine this with Sakar and Ghanem’s method.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th) and 8am – 12pm (F).
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/OWEN LEWIS MARSH/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796