DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 10th, 2024 is being considered by the examiner.
Priority
The current application claims benefit of provisional application 63541443, filed on September 29th, 2023. Examiner acknowledges the applicant’s claim for priority.
Claim Objections
Claim 13 is objected to because of the following informalities: “characteristics incudes” is misspelled and contains in improper plurality. The Examiner suggests “characteristics include” as a correction. Appropriate correction is required.
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 3, 6, 8, 11, 13, 17, and 20 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.
Claims 3 and 17 recites “T1/T2 maps” as an improper alternative expression that can be interpreted in multiple formats. Appropriate correction is required. Examiner will interpret this writing to comprise any MRI that could contain T1 or T2 relaxation times.
Claim 8 recites the limitation “wherein processor also predicts”. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction by writing “wherein the processor” is required.
Claim 11 recites the limitation "the oxidate stress levels" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction by writing “the oxidative stress levels” is required.
Claims 6 and 20 recite the term “optimal” in “optimal treatment plan”. The term “optimal” is a relative term which renders the claim indefinite. The term “optimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. An optimal treatment plan must contain an objective criterion. Appropriate correction is required. Examiner will interpret any optimal treatment as any output of a treatment protocol.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1
The claims recite subject matter within a statutory category as a process, machine, and/or article of manufacture. However, it will be shown in the following steps, that claims 1-20 are nonetheless unpatentable under 35 U.S.C. 101.
Step 2A Prong One
Claim 1 states:
A system to identify and predict atrial fibrillation, the system comprising: a memory configured to store one or more electrograms and one or more nerve recordings of a patient; and a processor operatively coupled to the memory and configured to:
identify one or more atrial fibrillation characteristics based on the one or more electrograms and the one or more nerve recordings, wherein the one or more atrial fibrillation characteristics include oxidative stress and fibrosis;
and identify a progression state of the atrial fibrillation based on the one or more atrial fibrillation characteristics.
The broadest reasonable interpretation of these steps includes mental processes because each bolded component can practically be performed by the human mind or with pen and paper. Other than reciting generic computer terms like “memory” or “processor”, nothing in the claims precludes the bold-font portions from practically being performed in the mind. For example, but for the “processor” language, “identify a progression state of the atrial fibrillation based on the one or more atrial fibrillation characteristics” in the context of this claim encompasses a mental process of the user diagnosing a patient based on a patient’s symptoms. 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 claim recites an abstract idea.
Independent claim 16’s method claim covers similar steps of storing patient information and identifying a progression state of the atrial fibrillation based on the one or more atrial fibrillation characteristics. These claims fall under the same category of an abstract idea and follows the same rationale as claim 1.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim 5, reciting particular aspects of how “the processor predicts a survival rate for the patient over a period of time, wherein the survival rate is based on the indication of whether the patient plans to pursue treatment and the identified progression state” may be performed in the mind but for recitation of generic computer components).
Dependent claims 3, 5, 10, and 17 add additional elements to their parent claims which will be further inspected in the following steps for a practical application to their abstract idea.
Step 2A Prong Two
This judicial exception of “Mental Processes” is not integrated into a practical application. Independent claim 1’s system recites additional elements such as memory, electrogram, and a processor. Additionally, Claim 16’s method recites the additional element of a computing system. The memory, processor, and computing system will be treated as a generic computer component. It will be shown in step 2B that the electrogram is well understood in the art, These additional elements do not integrate the abstract idea into a practical application because the additional elements:
amount to mere instructions to apply an exception (such as recitation of “a processor operatively coupled to the memory” amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0066-0067], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of “a memory configured to store one or more electrograms and one or more nerve recordings of a patient” amounts to mere data gathering, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For instance, claims 10, “the processor uses telemetry to obtain and analyze the one or more nerve recordings” amount to invoking computers as a tool to perform the abstract idea, and claim’s 3 and 17 “wherein the memory is further configured to store one or more T1/T2 maps obtained through imaging, and wherein the one or more atrial fibrillation characteristics are identified based at least in part on the one or more T1/T2 maps” and claim 5 “wherein the memory stores an indication of whether the patient plans to pursue treatment of the atrial fibrillation” add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering, see MPEP 2106.05(g)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The remaining dependent claims 2, 4, 6-9, 11-15, and 19-20 do not recite additional elements or activity but further narrow or define the abstract idea embodied in the claims and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
To elaborate “a memory configured to store one or more electrograms and one or more nerve recordings of a patient”, is equivalently, storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv);
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. These additional limitations amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As previously noted, the claim recites an additional element of an electrogram. Panescu (US20030078509) demonstrates “conventional electrogram” were conventional long before the priority data of the claimed invention. As such, this additional element, individually and in combination with the prior additional element, does not amount to significantly more.
To elaborate:
claim’s 3 and 17 “wherein the memory is further configured to store one or more T1/T2 maps obtained through imaging, and wherein the one or more atrial fibrillation characteristics are identified based at least in part on the one or more T1/T2 maps” , is equivalently, storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv);
claim 5 “wherein the memory stores an indication of whether the patient plans to pursue treatment of the atrial fibrillation” , is equivalently, storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv);
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rottmann et al. (US20210345958) in view of Narayan et al. (US20210236053).
Regarding claims 1 and 16, Rottmann teaches a method ([0005] “method of treating atrial fibrillation includes storing, in a memory of a computing system”) and system to identify and predict atrial fibrillation, the system comprising ([Abstract] “A system for treating atrial fibrillation includes… a baseline measurement of an atrial fibrillation… configured to determine a change… of the atrial fibrillation”): a memory configured to store ([0004] “a memory configured to store a baseline measurement of an atrial fibrillation characteristic of a patient”) one or more electrograms ([0041] “store baseline electrogram signals”) …of a patient ([0047] “algorithms, software, and operations described herein can be stored in the computer memory”); and a processor operatively coupled to the memory ([0046] “a computing device that includes a processor 110, a computer memory”) and configured to: identify one or more atrial fibrillation characteristics based on the one or more electrograms ([0041] “system involve use of an electrogram to monitor a patient's heart characteristics” and [0048])…, wherein the one or more atrial fibrillation characteristics include oxidative stress ([0039] “systems detect Oxidative Stress”) … and identify a progression state of the atrial fibrillation based on the one or more atrial fibrillation characteristics ([0049] “a schematic illustration of hotspots of atrial fibrillation characteristic changes in the atrium”).
Regarding claim 1, Rottmann does not explicitly teach, as taught by Narayan, a memory configured to store… one or more nerve recordings of a patient ([0121] “personal stored data 420” and [0116] “Nerve activity is an example of another sensed signal”);… identify one or more atrial fibrillation characteristics based on the… one or more nerve recordings of a patient ([0116] “electrodes on the chest may measure nerve activity”; see also [0103])… wherein the one or more atrial fibrillation characteristics include …fibrosis ([0122] “Stored data 420 may include … fibrosis”; see also [0129]).
Rottmann and Narayan are both in the same field of cardiac rhythm management and disclose features for the purposes of predicting and treating atrial fibrillation and other cardiac disease states. It would have been prima facie obvious to a person having ordinary skill in the art, before the effective filing date, to modify Rottmann’s system to analyze nerve recordings, as taught and suggested by Narayan, with a reasonable expectation of success. “A key problem in the prior art is that... multiple comorbidities … may represent some of the different types of AF” ([0178]). Thus, including nerve recordings would allow for more precise prediction of autonomic remodeling, a driver of atrial fibrillation.
Regarding claim 2, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Rottmann also teaches wherein the one or more atrial fibrillation characteristics include autonomic remodeling. ([0048] “mechanisms of oxidative stress on atrial fibrillation… including continued electrical, structural, and autonomic remodeling”)
Regarding claim 3, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. claim 17, Rottmann - Narayan as a combination teaches all of the limitations of claim 16. Rottmann also teaches wherein the memory is further configured to store one or more T1/T2 maps obtained through imaging, and wherein the one or more atrial fibrillation characteristics are identified based at least in part on the one or more T1/T2 maps. ([0046] “the electrogram system 105 includes or is connected to an imaging system such that a user is able to perform directed navigation to identified hotspots and other regions of interest. The imaging system can be a magnetic resonance imaging (MRI) system”)
Regarding claim 4, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. claim 18, Rottmann - Narayan as a combination teaches all of the limitations of claim 16. Rottmann also teaches wherein the processor predicts a subsequent progression state of the atrial fibrillation based on the identified progression state and the one or more atrial fibrillation characteristics. ([0048] “ AF typically develops in several steps” and [0044] “the system can repeat the process of ROS scavenger administration, electrogram monitoring, determination of percentage changes, determination of hotspot regions, and visualization to determine the effectiveness of the treatment and to determine the best approach for subsequent treatments”)
Regarding claim 5, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Regarding claim 19, Rottmann - Narayan as a combination teaches all of the limitations of claim 16. Rottmann also teaches wherein the memory stores an indication of whether the patient plans to pursue treatment of the atrial fibrillation, and wherein the processor predicts a survival rate for the patient over a period of time, wherein the survival rate is based on the indication of whether the patient plans to pursue treatment and the identified progression state. ([0054] “The mappings are used to determine areas to target with the treatment, and also to determine the effectiveness of prior treatments and to make determinations regarding subsequent treatments.” Where effectiveness of prior treatment comprises the patients successful pursuit of treatment)
Regarding claim 6, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Rottmann also teaches wherein the processor is configured to identify an optimal treatment plan for the atrial fibrillation based on the identified progression state and the one or more atrial fibrillation characteristics. ([0054] “The mappings are used to determine areas to target with the treatment, and also to determine the effectiveness of prior treatments and to make determinations regarding subsequent treatments.”)
Regarding claim 9, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Rottmann also teaches wherein the one or more atrial fibrillation characteristics include cycle length, organization index, dominant frequency, and voltage. ([0041] “patient's heart characteristics… can include dominant frequency (DF), cycle length (CL), organization index (OI)… and voltage”)
Regarding claim 11, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Rottmann also teaches wherein the one or more atrial fibrillation characteristics include oxidative stress levels in right and left atrial sub-regions of the patient, and wherein the progression state is identified based at least in part on the oxidate stress levels. ([0041] “electrogram signals to generate high resolution maps in multiple atrial regions of the patient… atrial regions of the heart can include posterior left atrium (PLA), left atrial free wall (LAFW), left atrial appendage (LAA), posterior right atrium (PRA), right atrial free wall (RAFW), right atrial appendage (RAA), etc.”)
Regarding claim 7, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Regarding claim 7, Rottmann does not explicitly teach, as taught by Narayan, wherein the processor predicts a time at which the atrial fibrillation will terminate and a normal sinus rhythm will commence for the patient, wherein the prediction is based on the identified progression state. ([0029] “system has the ability to update the personal phenotype using repeated measurements over time, to tailor therapy in changing conditions, or to predict worsening or improvement in cardiac state [0199] “Personal digital data 1445 shows electrograms at termination of AF to sinus rhythm.”). It would have been prima facie obvious to a person having ordinary skill in the art, before the effective filing date, to modify Rottmann’s system to indicate the atrial fibrillation termination time and therapy progression, as taught and suggested by Narayan, with a reasonable expectation of success. This would allow for identifying critical sites for personalized therapy, see [0199].
Regarding claim 8, Rottmann - Narayan as a combination teaches all of the limitations of claim 7. Regarding claim 8, Rottmann does not explicitly teach, as taught by Narayan, wherein processor also predicts a duration of the normal sinus rhythm. ([0010] “simple rhythms may be considered to have a well-defined circuit that is stable over time, with agreement by most methods of analysis (mapping). Examples include sinus rhythm (SR)” and [0029] “system has the ability to update the personal phenotype using repeated measurements over time, to tailor therapy in changing conditions, or to predict worsening or improvement in cardiac state”). It would have been prima facie obvious to a person having ordinary skill in the art, before the effective filing date, to modify Rottmann’s system to indicate the atrial fibrillation duration and therapy progression, as taught and suggested by Narayan, with a reasonable expectation of success. This would allow for more precise prediction of treatment, as the long term success “atrial fibrillation recurrence on long-term follow-up” would help reduce the generic an impersonalized nature of atrial fibrillation treatment [0004].
Regarding claim 10, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Regarding claim 10, Rottmann also teaches wherein the processor uses telemetry ([0046] “the computing device can include additional or different components such as a transceiver (transmitter and/or receiver)”). Regarding claim 10, Narayan also teaches telemetry to obtain and analyze the one or more nerve recordings. ([0116] “Nerve activity is an example of another sensed signal”).
Regarding claim 13, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Regarding claim 13 Narayan teaches wherein one or more atrial fibrillation characteristics incudes nerve frequency, and wherein the processor quantifies nerve frequency based at least in part on a time between nerve peaks assessed with zero-crossings based on the one or more nerve recordings. ([0129] “feature extraction techniques are well known in the art. Possible operations … include time domain analyses such as averaging, integration, area analysis… Frequency analysis can be performed using a selected parameter associated with the plurality of coordinate pairs (or loops) to generate a frequency spectrum” where integrating zero-crossings may result in a peak that can be assessed using time derivatives).
Regarding claim 14, Rottmann - Narayan as a combination teaches all of the limitations of claim 13. Regarding claim 14, Narayan teaches wherein the nerve frequency is based at least in part on an area under a nerve signal. ([0129] “feature extraction techniques are well known in the art. Possible operations … include time domain analyses such as averaging, integration, area analysis”)
Regarding claim 15, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Regarding claim 15, Narayan teaches wherein the one or more electrograms include an intracardiac electrogram of the patient and a body surface electrogram of the patient. ([0103] “electrodes 230 in the right atrium 230, electrodes 220 in the septum or left atrium… ECG electrodes can be applied to the body surface”)
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rottmann et al. (US20210345958) in view of Narayan et al. (US20210236053) as applied to claim 1 above, and further in view or Arora et al. (US20130324869).
Regarding claim 12, Rottmann - Narayan as a combination teaches all of the limitations of claim 1. Regarding claim 12, Rottmann does not explicitly teach, as taught by Arora, wherein the one or more atrial fibrillation characteristics include a fat percentage in heart tissue of the patient, and wherein the progression state is identified based at least in part on the fat percentage. ([0044] “the characteristics of AF EGMs in HF and the underlying distribution of myocardium, fibrosis, fat, and autonomic ganglia in the failing left atrium was also systematically assessed”; see also [Fig. 6a] measuring percentages of fat)
Rottmann and Arora are both in the same field of cardiac rhythm measurement and disclose features for the purposes of predicting and treating atrial fibrillation and other cardiac disease states. It would have been prima facie obvious to a person having ordinary skill in the art, before the effective filing date, to modify Rottmann’s system to analyze fat percentage, as taught and suggested by Arora, with a reasonable expectation of success. This would allow for improved indication of disease progression and treatment of atrial fibrillation, see [0006].
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Trayanova et al. (US20210085399) describes a computer-assisted way to plan atrial fibrillation (AF) ablation for patients who have atrial fibrosis using patient-specific imaging plus electrophysiology simulation to map how fibrosis affects AF behavior in that individual heart.
Ng et al. (US20160262643) discloses tools for finding spots in the atria of the heart that may help sustain atrial fibrillation or other arrhythmias. It looks at electrical recordings from inside the atrium from multiple locations, breaks each recording into individual activations and compares their wave shapes to see how often the same shape repeats.
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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