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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/12/2025 has been entered.
Remarks
This action is in response to the Remarks filed in the RCE filed on 05/12/2025.
Claims 1-4, 6-18, and 20-28 are pending.
Response to Arguments
Applicant's arguments filed 05/12/2025 have been fully considered but they are not persuasive.
Rejection of claims 1-4, 6-18, and 20-28 under 35 U.S.C. 101
Independent claims 1 and 15 have been amended to focus the claims specifically on generating a patient-specific arrythmia localization and cardiac activation model. Withdrawn claims 29-31 have been canceled. Applicant argues (see Remarks, pages 9-12) that the amended features do not recite a mental process because the process cannot be performed in the mind or using generic computer components and further that the amended claims provide specific improvements to the technology. However, this is not found to be persuasive.
As recited, the claims recite a method and system for generating a patient-specific arrythmia localization and cardiac activation model, comprising using a patient specific 3D cardiac activation and arrythmia localization model to identify an electrophysiological area of interest, using a patient-specific 3D heart model to identify heart structures, recording patient electrocardiogram data during an arrythmia event, capturing a 3D image of a patient’s torso including a position of an ECG electrode and position of a fiducial marker, generating a cardiac activation map, adjusting a 3D reference model of the heart, determining a positional offset, adjusting the 3D model based on the positional offset, and generating a patient specific model that includes internal structures of the heart by merging the cardiac activation map, the adjusted 3D reference model, and the 3D image of the torso to form a patient specific model.
As best understood, the crux of the invention is the analysis performed to result in a patient specific model. The identifying, determining, generating, adjusting, capturing, and merging steps are merely techniques that may be performed by a human. These steps are merely analysis techniques for finding patterns and translating in the data, which may be performed in the human mind, or using pen and paper. Thus, the claims recite limitations which fall within the 'mental processes' grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
The additional elements of a 3D camera system, an electrocardiogram, and a memory and processor are recited at a high level of generality (i.e., as sensing components to gather data and as a generic computer to store and analyze data) such that they amount to no more than mere instructions to apply the exception using a generic computer component. The camera system and electrocardiogram are providing a generic structure for the insignificant, extra-solution activity of data gathering. Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
Therefore, there is no further description, in the claims or the specification, of any particular technology for performing the steps recited in the claim other than generic computer components used in their ordinary capacity as tools to apply the abstract idea. Nor does the claimed invention use a particular, or special, machine. In other words, the claims “are not tied to any particular novel machine or apparatus” capable of rescuing them from the realm of an abstract idea. Further, these components are being used to perform the extra-solution activity of data gathering and analysis (i.e. an insignificant extra-solution activity, see MPEP 2106.05(g)).
Therefore, the claims do not recite any additional elements that: (1) improve the functioning of a computer or other technology, (2) are applied with any particular machine, (3) effect a transformation of a particular article to a different state, and (4) are applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment or field of use. Please See MPEP § 2106.05(a)(c), (e)-(h). Therefore, the rejection of the claims under 35 U.S.C. 101 is maintained.
Rejection of claims 1-4, 6-18, and 20-28 under 35 U.S.C. 103
Independent claims 1 and 15 have been amended to focus the claims specifically on generating a patient-specific arrythmia localization and cardiac activation model. Withdrawn claims 29-31 have been canceled. Applicant argues (see Remarks, pages 14-18) that Passerini or Passerini in view of Rai and Adler does not disclose the amended limitations. Examiner respectfully disagrees.
First, Applicant argues (see page 14) that Passerini does not disclose capturing 3D torso images while recording ECG data during an arrythmia event or determining positional offsets through comparison of ECG signals and adjusting models based on these offsets. However, in the 02/13/2025 Final Rejection, Adler was used to disclose these limitations (e.g. Adler, Fig. 9: 3D camera 109; Par. [0063]: electrode positioning image; Par. [0140]: 3D model of heart; Par. [0115]: data recorded during the procedure; Par. [0133]; Fig. 12: step 804: merging the data). Therefore, Passerini is still eligible as prior art.
Next, Applicant argues (see pages 14-15) that Rai does not disclose the limitations of recording patient ECG data during an arrythmia event, capturing a 3D image of a patient's torso using a 3D camera system while the ECG data is recorded, determining positional offset of ECG electrode and fiducial marker based on comparison of detected ECG signals to reference ECG signals, and adjusting the patient-specific 3D heart model based on the determined positional offset. However, as explained above, Adler was used to disclose these limitations. Therefore, Rai is still eligible as prior art.
Applicant then argues (see pages 15-16) that Adler fails to disclose determining positional offsets specifically through comparison of detected ECG signals to reference ECG signals, or adjusting a 3D heart model based on such determined offsets. However, this is not persuasive. Adler discloses determining positional offsets specifically through comparison of detected ECG signals to reference ECG signals and adjusting a 3D heart model based on such determined offsets (e.g. Par. [0064]: comparing detected ECG signals to reference signals to determine an offset; Par. [0140]: 3D model of heart; Par. [0115]: data recorded during the procedure; Par. [0133]; Fig. 12: step 804: merging the data). Therefore, Adler is still eligible as prior art.
The claims are now rejected as explained in the office action below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-11 and 20-25 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.
Claim 6 recites the limitation "the prognostic indication" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the prognostic indication" in line 3. There is insufficient antecedent basis for this limitation in the claim. Additionally, claim 20 depends on claim 19, which is canceled.
Claim 21 depends on claim 19, which is canceled. Appropriate correction is required.
Claims 7-11 and 22-25 are rejected based on their dependency on claims 6 and 20.
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 1-4, 6-18, and 20-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method and system for generating a patient specific arrythmia localization and cardiac activation model. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed towards a method and claim 15 is directed towards a system, and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 1 recites a method and claim 15 recites a system for generating a patient-specific arrythmia localization and cardiac activation model, comprising using a patient specific 3D cardiac activation and arrythmia localization model to identify an electrophysiological area of interest, using a patient-specific 3D heart model to identify heart structures, recording patient electrocardiogram data during an arrythmia event, capturing a 3D image of a patient’s torso including a position of an ECG electrode and position of a fiducial marker, generating a cardiac activation map, adjusting a 3D reference model of the heart, determining a positional offset, adjusting the 3D model based on the positional offset, and generating a patient specific model that includes internal structures of the heart by merging the cardiac activation map, the adjusted 3D reference model, and the 3D image of the torso to form a patient specific model.
The limitation of generating a patient-specific arrythmia localization and cardiac activation model, as drafted in claims 1-4, 6-18, and 20-28, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper or using a generic computer. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
As claimed and understood, the crux of the invention is the data analysis performed in order to generate the patient specific arrythmia localization and cardiac activation model. The additional elements of a 3D camera system, an electrocardiogram, and a memory and processor are recited at a high level of generality (i.e., as sensing components to gather data and as a generic computer to store and analyze data) such that they amount to no more than mere instructions to apply the exception using a generic computer component. The camera system and electrocardiogram are providing a generic structure for the insignificant, extra-solution activity of data gathering.
Further, the memory and processor as described in the instant specification is described as being implemented in generic and well-known computing devices (e.g. Pars. [0102]-[0103]: generic computing systems; Pars. [0108]-[0109]: general purpose processor).
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of a 3D camera system, electrocardiogram, memory, and processor amounts to no more than mere instructions to apply the exception using generic computer components. The camera system and electrocardiogram are providing a generic structure for the insignificant, extra-solution activity of data gathering.
Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the additional element does not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 2-4, 6-14, 16-18, and 20-28 depend on claims 1 and 15 and recite the same abstract idea as claims 1 and 15 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2-4 and 16-18 (i.e. further defining the area of interest) are simply further defining the data that can be gathered during the data gathering and data analysis steps. The additional limitations recited in claims 6-8 and 20-22 (i.e. further defining the model and output) are further data analysis steps. The additional limitations recited in claims 9-12 and 23-26 (i.e. defining where the data is saved) are further data analysis steps. The additional limitations recited in claims 13, 14, 27, and 28 (i.e. further defining electrophysiological procedure) simply further define the procedure that can be used during the data gathering step. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-8, 10, 13, 14, 15, 20-22, 24, 27, and 28 rejected under 35 U.S.C. 103 as being unpatentable over Passerini et al. (US Patent Application Publication 2015/0294082 – of record), hereinafter Passerini, further in view of Rai et al. (US Patent 9,875,544 – of record), hereinafter Rai, and further in view of Adler (US Patent Application Publication 2019/0038363 – of record).
Regarding claim 1, Passerini discloses a method performed by a diagnostic apparatus for generating a patient-specific arrythmia localization and cardiac activation model (e.g. Abstract), comprising:
using a patient-specific three-dimensional (3D) cardiac activation and arrythmia localization model to identify an electrophysiological area of interest for performing an electrophysiology procedure to treat the arrythmia (e.g. Par. [0017]: patient specific heart model; Fig. 1: step 104);
using a patient-specific 3D heart model to identify heart structures near the identified area of electrophysiological interest (e.g. Par. [0022]: myocardium fibers are modeled);
recording patient electrocardiogram (ECG) data during an arrythmia event (e.g. Par. [0027]: measurements done during arrhythmia);
generating a cardiac activation map comprising a 3D heart model that shows propagation of electrical signals through the 3D heart model based on the recorded ECG data and a 3D heart model (e.g. Par. [0027]: measurements done during arrhythmia; Par. [0030]: cardiac EP model); and
adjusting a selected 3D reference model of the heart based on patient image data (e.g. Par. [0017]).
However, Passerini fails to specifically disclose the image data being Digital Imaging and Communications in Medicine (DICOM) image data, capturing, using a 3D camera system while the ECG data is recorded, a 3D image of a patient's torso that identifies a position of an ECG electrode and a position of a fiducial marker on the patient's torso, determining a positional offset of at least one of the ECG electrode and fiducial marker based on a comparison of detected ECG signals to reference ECG signals, adjusting the patent-specific 3D heart model based on the determined positional offset of the at least one ECG electrode and fiducial marker, and generating a patient-specific arrythmia localization and cardiac activation model that includes internal structures of the heart by merging the generated cardiac activation map, the adjusted 3D reference model of the heart, and the captured 3D image of the patient's torso.
Rai, in a similar field of endeavor, is directed towards registering 3D image data. Rai discloses receiving image data through DICOM (e.g. Col. 5, lines 54-58).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini to include using DICOM image data as taught by Rai to receive image data for further analysis.
However, Passerini in view of Rai fails to disclose capturing, using a 3D camera system while the ECG data is recorded, a 3D image of a patient's torso that identifies a position of an ECG electrode and a position of a fiducial marker on the patient's torso, determining a positional offset of at least one of the ECG electrode and fiducial marker based on a comparison of detected ECG signals to reference ECG signals, adjusting the patent-specific 3D heart model based on the determined positional offset of the at least one ECG electrode and fiducial marker, and generating a patient-specific arrythmia localization and cardiac activation model that includes internal structures of the heart by merging the generated cardiac activation map, the adjusted 3D reference model of the heart, and the captured 3D image of the patient's torso.
Adler, in a similar field of endeavor, is directed towards cardiac mapping. Adler discloses using a 3D camera system to capture a position of electrocardiogram (ECG) electrode and a position of a fiducial marker on the patient's torso (e.g. Fig. 9: 3D camera 109; Par. [0063]: electrode positioning image), determining a positional offset of at least one of the ECG electrode and fiducial marker based on a comparison of detected ECG signals to reference ECG signals (e.g. Par. [0064]: comparing detected ECG signals to reference signals to determine an offset), and adjusting the patent-specific 3D heart model based on the determined positional offset of the at least one ECG electrode and fiducial marker, and generating a patient-specific arrythmia localization and cardiac activation model that includes internal structures of the heart by merging the generated cardiac activation map, the adjusted 3D reference model of the heart, and the captured 3D image of the patient's torso (e.g. Par. [0140]: 3D model of heart; Par. [0115]: data recorded during the procedure; Par. [0133]; Fig. 12: step 804: merging the data).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini in view of Rai to include the 3D camera system and generating a patient-specific model as taught by Adler because doing so would result in an updated patient specific cardiac map.
Regarding claim 15, Passerini discloses a diagnostic system, comprising:
a memory, an electrocardiogram (ECG), and a processor coupled to the memory and the ECG and configured with processor-executable instructions to perform operations (e.g. Par. [0012]; Par. [0025]: ECG leads; Par. [0060]) comprising:
using a patient-specific three-dimensional (3D) cardiac activation and arrythmia localization model identifying an area of electrophysiological interest for performing an electrophysiology procedure to treat the arrythmia (e.g. Par. [0017]: patient specific heart model; Fig. 1: step 104);
using a patient-specific 3D heart model to identify heart structures near the identified area of electrophysiological interest (e.g. Par. [0022]: myocardium fibers are modeled);
recording, using the ECG, patient ECG data during an arrythmia event (e.g. Par. [0027]: measurements done during arrhythmia);
generating a cardiac activation map comprising a 3D heart model that shows propagation of electrical signals through the 3D heart model based on the recorded ECG data and a 3D heart model (e.g. Par. [0027]: measurements done during arrhythmia; Par. [0030]: cardiac EP model); and
adjusting a selected the 3D reference model of the heart based on patient image data (e.g. Par. [0017]).
However, Passerini fails to specifically disclose the image data being Digital Imaging and Communications in Medicine (DICOM) image data, capturing, using a 3D camera system while the ECG data is recorded, a 3D image of a patient's torso that identifies a position of an ECG electrode and a position of a fiducial marker on the patient's torso, determining a positional offset of at least one of the ECG electrode and fiducial marker based on a comparison of detected ECG signals to reference ECG signals, adjusting the patent-specific 3D heart model based on the determined positional offset of the at least one ECG electrode and fiducial marker, and generating a patient-specific arrythmia localization and cardiac activation model that includes internal structures of the heart by merging the generated cardiac activation map, the adjusted 3D reference model of the heart, and the captured 3D image of the patient's torso.
Rai, in a similar field of endeavor, is directed towards registering 3D image data. Rai discloses receiving image data through DICOM (e.g. Col. 5, lines 54-58).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini to include using DICOM image data as taught by Rai to receive image data for further analysis.
However, Passerini in view of Rai fails to disclose capturing, using a 3D camera system while the ECG data is recorded, a 3D image of a patient's torso that identifies a position of an ECG electrode and a position of a fiducial marker on the patient's torso, determining a positional offset of at least one of the ECG electrode and fiducial marker based on a comparison of detected ECG signals to reference ECG signals, adjusting the patent-specific 3D heart model based on the determined positional offset of the at least one ECG electrode and fiducial marker, and generating a patient-specific arrythmia localization and cardiac activation model that includes internal structures of the heart by merging the generated cardiac activation map, the adjusted 3D reference model of the heart, and the captured 3D image of the patient's torso.
Adler, in a similar field of endeavor, is directed towards cardiac mapping. Adler discloses using a 3D camera system to capture a position of electrocardiogram (ECG) electrode and a position of a fiducial marker on the patient's torso (e.g. Fig. 9: 3D camera 109; Par. [0063]: electrode positioning image), determining a positional offset of at least one of the ECG electrode and fiducial marker based on a comparison of detected ECG signals to reference ECG signals (e.g. Par. [0064]: comparing detected ECG signals to reference signals to determine an offset), and adjusting the patent-specific 3D heart model based on the determined positional offset of the at least one ECG electrode and fiducial marker, and generating a patient-specific arrythmia localization and cardiac activation model that includes internal structures of the heart by merging the generated cardiac activation map, the adjusted 3D reference model of the heart, and the captured 3D image of the patient's torso (e.g. Par. [0140]: 3D model of heart; Par. [0115]: data recorded during the procedure; Par. [0133]; Fig. 12: step 804: merging the data).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini in view of Rai to include the 3D camera system and generating a patient-specific model as taught by Adler because doing so would result in an updated patient specific cardiac map.
Regarding claims 6 and 20, Passerini further discloses wherein determining the prognostic indication of the electrophysiology procedure further comprises determining at least one of a likelihood of success or a likelihood of complications of the electrophysiology procedure at the identified area of electrophysiological interest based at least in part on one or more heart structures near the area of electrophysiological interest, and generating an output providing a prognostic indication of an electrophysiology procedure at the identified area of electrophysiological interest based at least in part on a determined likelihood of success (e.g. Pars. [0045]-[0046]: different procedures tested to determine if the therapy will be successful and the result is output).
Regarding claims 7 and 21, Passerini further discloses wherein determining at least one of a likelihood of success or a likelihood of complications comprises: applying the one or more heart structures near the area of electrophysiological interest as model inputs to a predictive model; and obtaining an output from the diagnostic predictive model (e.g. Par. [0047]).
Regarding claims 8 and 22, Passerini further discloses applying characteristics of the arrythmia to the diagnostic predictive model (e.g. Par. [0047]: patient specific model; Par. [0027]: measurements done during arrhythmia; Par. [0030]: cardiac EP model).
Regarding claims 10 and 24, Passerini further discloses wherein the diagnostic predictive model is stored in memory of the diagnostic apparatus (e.g. Par. [0012]; Par. [0060]).
Regarding claims 13 and 27, Passerini further discloses wherein the electrophysiology procedure comprises an ablation procedure (e.g. Par. [0048]: virtual ablations performed).
Regarding claims 14 and 28, Passerini further discloses wherein the electrophysiology procedure comprises a pacing procedure (e.g. Par. [0047]: virtual pacing performed).
Claims 2-4 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Passerini et al. (US Patent Application Publication 2015/0294082 – of record), hereinafter Passerini, further in view of Rai et al. (US Patent 9,875,544 – of record), hereinafter Rai, and further in view of Adler (US Patent Application Publication 2019/0038363 – of record), as applied to claims 1 and 15 above, and further in view of Branham et al. (US Patent 5,687,737 – of record), hereinafter Branham.
Regarding claims 2 and 16, Passerini fails to specifically disclose wherein the area of electrophysiological interest comprises an area of earliest activation within the heart. Branham, in a similar field of endeavor, discloses wherein the area of electrophysiological interest comprises an area of earliest activation within the heart (e.g. Col. 12, lines 42-58: data is gathered including the earliest moments of activation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini in view of Rai and Adler to include the area of electrophysiological as taught by Branham in order to provide the predictable results of being able to target specific sites of the arrhythmia for future treatment.
Regarding claims 3 and 17, Passerini fails to specifically disclose wherein the area of electrophysiological interest comprises an area of latest activation within the heart. Branham, in a similar field of endeavor, discloses wherein the area of electrophysiological interest comprises an area of latest activation within the heart (e.g. Col. 12, lines 42-58: data is gathered over the entire arrhythmia, which would include latest activation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini in view of Rai and Adler to include the area of electrophysiological as taught by Branham in order to provide the predictable results of being able to target specific sites of the arrhythmia for future treatment.
Regarding claims 4 and 18, Passerini fails to specifically disclose wherein the area of electrophysiological interest comprises an area within the heart between an area of earliest activation and an area of latest activation. Branham, in a similar field of endeavor, discloses wherein the area of electrophysiological interest comprises an area within the heart between an area of earliest activation and an area of latest activation (e.g. Col. 12, lines 42-58: data is gathered over the entire arrhythmia, which would include the area between earliest and latest activation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini in view of Rai and Adler to include the area of electrophysiological as taught by Branham in order to provide the predictable results of being able to target specific sites of the arrhythmia for future treatment.
Claims 9, 11, 12, 23, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Passerini et al. (US Patent Application Publication 2015/0294082 – of record), hereinafter Passerini, further in view of Rai et al. (US Patent 9,875,544 – of record), hereinafter Rai, and further in view of Adler (US Patent Application Publication 2019/0038363 – of record), as applied to claims 1 and 15 above, and further in view of Yang et al. (US Patent Application Publication 2019/0053728 – of record), hereinafter Yang.
Regarding claim 9, Passerini further discloses wherein: the diagnostic predictive model is maintained in processor (e.g. Par. [0012]; Par. [0060]); applying the one or more heart structures near the area of electrophysiological interest as model inputs to the diagnostic predictive model comprises uploading the one or more heart structures near the area of electrophysiological interest to the processor (e.g. Par. [0047]; Par. [0012]; Par. [0060]); and obtaining an output from the diagnostic predictive model comprises receiving the output from the processor (e.g. Par. [0047]).
However, Passerini fails to disclose using a remote server. Yang, in a similar field of endeavor, is directed towards determining cardiac activation. Yang discloses using a remote server (e.g. Par. [0054]: a server can be used; Fig. 6: server with mapping model in communication with the computing device and image source).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini in view of Rai and Adler to include using a server as taught by Yang in order to provide the predictable results of receiving and transmitting the required data.
Regarding claims 11 and 25, Passerini fails to disclose downloading the diagnostic predictive model or an update to the diagnostic predictive model to memory from a remote server. Yang, in a similar field of endeavor, is directed towards determining cardiac activation. Yang discloses downloading the diagnostic predictive model from a remote server (e.g. Par. [0054]: a server can be used; Fig. 6: server with mapping model in communication with the computing device and image source).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini in view of Rai and Adler to include using a server as taught by Yang in order to provide the predictable results of receiving and transmitting the required data.
Regarding claims 12 and 26, Passerini further discloses uploading to a memory information regarding characteristics of the arrythmia, information regarding the one or more heart structures near the area of electrophysiological interest, and an indication of one or both of an assessment of success or a summary of complications of a performed electrophysiology procedure performed at the identified area of electrophysiological interest (e.g. Par. [0012]; Par. [0060]).
However, Passerini fails to disclose using a remote server. Yang, in a similar field of endeavor, is directed towards determining cardiac activation. Yang discloses using a remote server (e.g. Par. [0054]: a server can be used; Fig. 6: server with mapping model in communication with the computing device and image source).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini in view of Rai and Adler to include using a server as taught by Yang in order to provide the predictable results of receiving and transmitting the required data.
Regarding claim 23, Passerini further discloses wherein the processor is further configured with processor-executable instructions to perform operations (e.g. Par. [0012]; Par. [0060]) such that: the diagnostic predictive model is maintained in processor (e.g. Par. [0012]; Par. [0060]); applying the one or more heart structures near the area of electrophysiological interest as model inputs to the diagnostic predictive model comprises receiving information regarding the one or more heart structures near the area of electrophysiological interest from a diagnostic system and applying the received information regarding the one or more heart structures near the area of electrophysiological interest as inputs to the diagnostic predictive model (e.g. Par. [0047]; Par. [0012]; Par. [0060]); and obtaining an output from the diagnostic predictive model comprises receiving the output from the processor (e.g. Par. [0047]).
However, Passerini fails to disclose using a remote server. Yang, in a similar field of endeavor, is directed towards determining cardiac activation. Yang discloses using a remote server (e.g. Par. [0054]: a server can be used; Fig. 6: server with mapping model in communication with the computing device and image source).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Passerini in view of Rai and Adler to include using a server as taught by Yang in order to provide the predictable results of receiving and transmitting the required data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kamen et al. (US 2016/0283687 – of record) is directed towards estimating electrophysiology maps.
Comaniciu et al. (US 2015/0042646 – of record) is directed towards patient specific planning of electrophysiology interventions.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796