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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 27 Mar 2025. As directed by the amendment: claims 1, 5-11, 45, 20-26 have been amended, claims 2-3, 12-17, and 27-106 have been canceled, and claims 107-110 have been added. Thus, claims 1, 4-11, 18-26, and 107-110 are presently pending in this application.
Specification
The amendment filed 27 Mar 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The amended portions of the specification describing Figs. 15A and B (page 40, line 10-page 41, line 8) describe predicting two lead locations, but the original descriptions of Figs. 10 and 12 (page 47, lines 2-12; page 48, line 28-page 49, line 2) only appear to disclose predicting one location at a time. Thus, the disclosure of predicting two lead locations is new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Drawings
The drawings were received on 27 Mar 2025. Newly added Figures 15A and 15B are objected to because they add new matter that was not part of the original disclosure.
Response to Arguments
VI. CLAIMS 1, 4-26, AND 107-110 ARE PATENTABLE SUBJECT MATTER UNDER 35 U.S.C. § 101 BECAUSE THE CLAIMED INVENTION IS NOT DIRECTED TOWARD AN ABSTRACT IDEA
Applicant’s arguments, see Remarks, filed 27 Mar 2025, with respect to rejections of claims 8, 20, and 23 under 35 U.S.C. 101 for encompassing a human organism have been fully considered and are persuasive in light of the claim amendments. The rejections of claims 8, 20, and 23 under 35 U.S.C. 101 for encompassing a human organism have been withdrawn.
Applicant's arguments filed 27 Mar 2025 regarding subject matter eligibility under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant argues
Even if the claimed limitations were directed to an abstract idea, the claimed limitations nevertheless "recite additional elements that integrate the judicial exception into a practical application." Id If such abstract ideas exist in the claim language, the claimed surgical method places "meaningful limits" on them by integrating them into the method of "placing a first pacemaker lead and a second pacemaker lead on a patient during cardiac resynchronization therapy (CRT)." Thus, the claimed surgical method is a real-world process that cannot logically be characterized as failing to integrate any alleged abstract ideas within it.
(Remarks, page 16)
Examiner respectfully disagrees. The limitations of “using a compartmental model”, “calibrating said compartmental model”, “tuning hemodynamic parameters of the compartmental model”, “simulating said placement of said first pacemaker lead and said second pacemaker lead on the patient”, and “predicting a cardiac response”, as drafted, under their broadest reasonable interpretations, are merely mental processes, because these steps are akin to having a doctor or other human actor performing these operations with pen and paper. For example, “calibrating said compartmental model” encompasses nothing more than a human actor evaluating formulas of the compartmental model using a pen and paper. “Predicting a cardiac response” encompasses nothing more than a human actor mentally evaluating the treatment strategy and calibrated model, and drawing a conclusion based on these pieces of information. Furthermore, the claims omit any details as to how the method solves a technical problem, and instead recites only the idea of a solution or outcome.
Claim 1 recites “placing said first pacemaker lead and second pacemaker lead on the patient during the cardiac resynchronization therapy (CRT) in accordance to said simulated placement during the surgical method”, which encompasses post-solution activity analogous to the example of cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016), per MPEP § 2106.05(g).
Therefore, the rejections of claims 1, 4-11, 18-26, and 107-110 under 35 U.S.C. 101 are maintained.
VII. CLAIMS 1, 4-26, AND 107-110 ARE NONOBVIOUS UNDER 35 U.S.C. § 103 BECAUSE THE APPLIED REFERENCES AS A WHOLE FAIL TO TEACH OR SUGGEST THE APPLICANT'S INVENTION
Applicant’s arguments, see Remarks, filed 27 Mar 2025, with respect to the rejection(s) of claims 1, 4-11, 18-26, and 107-110 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Panthee et al. (Tailor-made heart simulation predicts the effect of cardiac resynchronization therapy in a canine model of heart failure, 2016), hereinafter Panthee, as explained in further detail below.
X. CLAIMS 1, 4-11, 18-26, AND 107-108 ARE ALLOWABLE UNDER 35 U.S.C. § 112
Applicant’s arguments, see Remarks, filed 27 Mar 2025, with respect to objections to claims 1-26, 33-63, and 70-100 have been fully considered and are persuasive in light of the claim amendments. The objections to claims 1-26, 33-63, and 70-100 have been withdrawn.
However, new rejections of the claims are made below.
XI. OBJECTIONS TO CLAIMS HAVE BEEN REMEDIED
Applicant’s arguments, see Remarks, filed 27 Mar 2025, with respect to objections to claims 1, 25, 47-48, 62-63, 85, and 99-100 have been fully considered and are persuasive in light of the claim amendments. The objections to claims 1, 25, 47-48, 62-63, 85, and 99-100 have been withdrawn.
However, new objections to the claims are made below.
Claim Objections
Claims 1, 10, and 107 are objected to because of the following informalities:
Claim 1:
“and treatment strategy” in line 4 should read “and a treatment strategy”
“16-segments” in line 15 should read “16 segments”
“during cardiac resynchronization therapy” in lines 29-30 should read “during the cardiac resynchronization therapy”
Claim 10: “patient-specific data;” in line 4 should read “patient-specific data.”
Claim 107: “greater than and less than 30 minutes” in line 13 appears to be missing a time value after “greater than”
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, 4-11, 18-26, and 107-110 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.
As explained above, the amendments to the specification add new matter regarding the surgical method of predicting the locations of two pacemaker leads. Similarly, the amendments to claim 1 contain new matter regarding predicting the locations of two pacemaker leads, whereas the specification previously only described predicting the location of one pacemaker lead.
Claims 4-11, 18-26, and 107-110 are also rejected because they are dependent on claim 1.
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 1, 4-11, 18-26, and 107-110 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 phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear as to whether the compartmental model requires the chambers of the heart to be represented as any “simple geometric shape” or specifically as spheres of assemblies of spheres. For the purposes of examination, claim 1 will be interpreted such that the compartmental model comprises chambers of the heart represented as simple geometric shapes.
Claims 4-11, 18-26, and 107-110 are also rejected because they are dependent on claim 1.
Claim 8 recites the limitation "said subject" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “said subject” will be interpreted as “she patient”.
Claim 20 recites “wherein said patient-specific prognostic data configured for said use on the patient determines the placement of said first pacemaker lead and second pacemaker lead on the patient”. It has not been established that the prognostic data is configured for said use on the patient. For the purposes of examination, this limitation will be interpreted as “wherein said patient-specific prognostic data is configured for said use on the patient and determines the placement of said first pacemaker lead and second pacemaker lead on the patient”.
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, 4-11, 18-26, and 107-110 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Determination as to whether a claim satisfies the criteria for subject matter eligibility is a stepwise process (MPEP 2016).
Step 1: Does the claim fall within a statutory category of invention?
Claim 1 recites a process (method), which is within the four statutory categories. Therefore, claim 1 is directed to a statutory category of invention.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 1 is directed to an abstract idea.
Claim 1 is directed to a surgical method of placing a first pacemaker lead and a second pacemaker lead on a patient during cardiac resynchronization therapy (CRT) that is achieved by predicting a cardiac response to a heart condition of the patient and a treatment strategy.
The limitations of “using a compartmental model”, “calibrating said compartmental model”, “tuning hemodynamic parameters of the compartmental model”, “simulating said placement of said first pacemaker lead and said second pacemaker lead on the patient”, and “predicting a cardiac response”, as drafted, under their broadest reasonable interpretations, are merely mental processes, because these steps are akin to having a doctor or other human actor performing these operations with pen and paper. For example, “calibrating said compartmental model” encompasses nothing more than a human actor evaluating formulas of the compartmental model using a pen and paper. “Predicting a cardiac response” encompasses nothing more than a human actor mentally evaluating the treatment strategy and calibrated model, and drawing a conclusion based on these pieces of information.
The limitations of “receiving disease-specific data” and “receiving patient-specific data” encompass nothing more than a human actor collecting these pieces of information by hand.
Therefore, claim 1 recites an abstract idea.
Claims 4-11, 18-26, and 107-110 depend on claim 1. These dependent claims only recite additional features of the analysis described in claim 1, which may also be performed by a human actor mentally and using a pen and paper. For example, claim 6 recites “evaluating said predicted cardiac response to said simulated placement of said first pacemaker lead and said second pacemaker lead on the patient”, which encompasses nothing more than a human actor mentally evaluating a prediction and drawing a conclusion.
Therefore, claims 1, 4-11, 18-26, and 107-110 recite an abstract idea.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application.
Claim 1 recites the additional limitations “receiving disease-specific data” and “receiving patient-specific data”, which amounts to no more than mere pre-solution activity of data gathering. Therefore these elements do not integrate the judicial exception into a practical application.
Claim 1 recites “placing said first pacemaker lead and second pacemaker lead on the patient during the cardiac resynchronization therapy (CRT) in accordance to said simulated placement during the surgical method”, which encompasses post-solution activity analogous to the example of cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016), per MPEP § 2106.05(g).
Thus, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea. As described above, dependent claims 4-11, 18-26, and 107-110 only recite other limitations of calibrating, tuning, and predicting a cardiac response using the compartmental model, which may be done mentally by a human actor and/or with a pen and paper.
Step 2B: Does the claim include additional elements that are sufficient to amount to significantly more than the judicial exception?
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 recites the additional limitation “receiving disease-specific data” and “receiving patient-specific data”. As discussed above with respect to integration of the abstract idea into a practical application (Step 2A, Prong 2), the additional element of receiving data amounts to no more than mere pre-solution activity of data gathering. This pre-solution activity of data gathering is well-understood, routine, and conventional in the field of cardiac modeling technology. For example, see Taylor et al. (“Patient-Specific Modeling of Cardiovascular Mechanics.” Annual Review of Biomedical Engineering, vol. 11, no. 1, Annual Reviews, 1 Aug. 2009, pp. 109–134.), which describes known methods of predicting outcomes on a patient-specific level. Therefore, the claimed “receiving data” steps and computer processing elements are all well-understood, routine, and conventional in the first of cardiac modeling technology.
Claim 1 recites “placing said first pacemaker lead and second pacemaker lead on the patient during the cardiac resynchronization therapy (CRT) in accordance to said simulated placement during the surgical method”, which encompasses post-solution activity analogous to the example of cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016), per MPEP § 2106.05(g).
Therefore, claims 1, 4-11, 18-26, and 107-110 are not patent-eligible under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 4-8, 18-23, and 108-110 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Panthee et al. (Tailor-made heart simulation predicts the effect of cardiac resynchronization therapy in a canine model of heart failure, 2016), hereinafter Panthee.
Regarding claim 1, Panthee discloses a surgical method of placing a first pacemaker lead and a second pacemaker lead on a patient during cardiac resynchronization therapy (CRT) that is achieved by predicting a cardiac response to a heart condition of the patient and a treatment strategy, wherein the treatment strategy is defined as strategic placement of said first pacemaker lead and said second pacemaker lear on the patient (Section 2.7. Pacing simulation, "we performed simulations of triple-lead pacing for 25 lead positions and determined the best and worst cases in terms of improvement in EF"), wherein said method comprises:
using a compartmental model (Section 2.4. Multi-scale simulation model of the canine heart) comprising:
receiving disease-specific data (Section 2.5.1. ECG personalization, left bundle branch block);
wherein said compartmental model comprises systemic and pulmonary circulations that are represented as a system of resistors and capacitors (Section 2.4.5. Circulatory model) together with chambers of the heart represented as simple geometric shapes (Section 2.6. Virtual tissue tracking, tetrahedral mesh) or other analytic equations that relate pressure and volume to stress and strain (Section 2.4.3. Sarcomere model, Strain energy function; Section 2.4.4. Mechanics, Cauchy stress tensor, Piola–Kirchoff stress, active stress tensor, hydrostatic pressure, diastolic pressure-volume relation; Section 2.6. Virtual tissue tracking, radial strain, strain of deformed tetrahedral element); and
wherein each of said chambers are represented as a compartment wherein said compartment is configured into 16 segments (Section 2.7. Pacing simulation, 16-segment model);
calibrating said compartmental model based on said disease-specific data to create a disease-specific calibrated model (Section 2.5.1. ECG personalization);
receiving patient-specific data (Section 2.2. Canine model of left ventricular dysfunction with left bunch branch block);
tuning hemodynamic parameters of the compartmental model using said patient-specific data (Section 2.4.5. Circulatory model, Section 2.5.3. Personalization of systemic and pulmonary circulation);
simulating said placement of said first pacemaker lead and said second pacemaker lead on the patient using said tuned hemodynamic parameters with patient-specific data (Section 2.7. Pacing simulation, "In each canine heart model, we performed simulations of triple-lead pacing for 25 lead positions and determined the best and worst cases in terms of improvement in EF"); and
predicting a cardiac response, configured for use on the patient, using said simulated placement of said first pacemaker lead and said second pacemaker lead on the patient and said disease-specific-calibrated model (Section 2.7. Pacing simulation, "improvement in EF");
outputting said predicted cardiac response for said use on the patient during the surgical method (Section 2.7. Pacing simulation, "determined the best and worst cases in terms of improvement in EF");
placing said first pacemaker lead and second pacemaker lead on the patient during cardiac resynchronization therapy (CRT) in accordance to said simulated placement during the surgical method (Section 2.3. Acute pacing experiment, "the right ventricular lead and two custom-made platinum epicardial leads that were sutured to the left ventricular surface were placed at the positions predicted to yield the best or worst performance by simulation").
Regarding claim 4, Panthee discloses the method of claim 1, as explained above. Panthee further discloses that said patient-specific data includes anatomical imaging data from CT (Section 2.4.1. Mesh generation, "Segmentations and three-dimensional reconstruction of the multi-detector CT scan data at end-diastole were performed in each animal").
Regarding claim 5, Panthee discloses the method of claim 1, as explained above. Panthee further discloses that said predicted cardiac response includes changes in cavity volumes (Section 3.2 Simulation of resynchronization therapy, Fig. 12 shows changes in pressure-volume loops with and without simulated pacing, ejection fraction is a measure of change in heart volume between systolic and diastolic stages).
Regarding claim 6, Panthee discloses the method of claim 1, as explained above. Panthee further discloses evaluating said predicted cardiac response to said simulated placement of said first pacemaker lead and said second pacemaker lead on the patient (Section 2.7. Pacing simulation, "determined the best and worst cases in terms of improvement in EF").
Regarding claim 7, Panthee discloses the method of claim 6, as explained above. Panthee further discloses outputting said evaluated predicted cardiac response configured for said use on the patient (Section 2.7. Pacing simulation, "determined the best and worst cases in terms of improvement in EF").
Regarding claim 8, Panthee discloses the method of claim 7, as explained above. Panthee further discloses wherein said use on the patient of said evaluated predicted cardiac response determines the placement of said first pacemaker lead and second pacemaker lead on the patient (Section 2.3. Acute pacing experiment, "the right ventricular lead and two custom-made platinum epicardial leads that were sutured to the left ventricular surface were placed at the positions predicted to yield the best or worst performance by simulation").
Regarding claim 18, Panthee discloses the method of claim 1, as explained above. Panthee further discloses generating patient-specific prognostic data from said tuned hemodynamic parameters (Section 2.5.3. Personalization of systemic and pulmonary circulation, "we evaluated sensitivities of EF to changes in parameters values (either 50% or 200% of the estimated values) using the simple simulation model used for parameter estimation").
Regarding claim 19, Panthee discloses the method of claim 18, as explained above. Panthee further discloses outputting said generated patient-specific prognostic data (Table 2, Fig. 3).
Regarding claim 20, Panthee discloses the method of claim 19, as explained above. Panthee further discloses that said patient-specific prognostic data configured for said use on the patient determines the placement of said first pacemaker lead and second pacemaker lead on the patient (Section 2.3. Acute pacing experiment, "the right ventricular lead and two custom-made platinum epicardial leads that were sutured to the left ventricular surface were placed at the positions predicted to yield the best or worst performance by simulation").
Regarding claim 21, Panthee discloses the method of claim 18, as explained above. Panthee further discloses evaluating said predicted cardiac response to said simulated placement of said first pacemaker lead and said second pacemaker lead on the patient (Section 2.7. Pacing simulation, "determined the best and worst cases in terms of improvement in EF").
Regarding claim 22, Panthee discloses the method of claim 21, as explained above. Panthee further discloses outputting said evaluated predicted cardiac response configured for said use on the patient (Section 2.7. Pacing simulation, "determined the best and worst cases in terms of improvement in EF").
Regarding claim 23, Panthee discloses the method of claim 22, as explained above. Panthee further discloses that said patient-specific prognostic data configured for said use on the patient determines the placement of said first pacemaker lead and second pacemaker lead on the patient (Section 2.3. Acute pacing experiment, "the right ventricular lead and two custom-made platinum epicardial leads that were sutured to the left ventricular surface were placed at the positions predicted to yield the best or worst performance by simulation").
Regarding claim 108, Panthee discloses the method of claim 1, as explained above. Panthee further discloses that the predicting a cardiac response to a heart condition of the patient and the simulated placement of said first pacemaker lead and said second pacemaker lead on the patient takes "0.3 h for electrophysiology and 2.7 h for mechanics simulations" (Section 2.8. Computation), which is within the claimed range of 2 hours to 4 hours.
Regarding claim 109, Panthee discloses the method of claim 1, as explained above. Panthee further discloses that said cardiac response includes changes in ejection fraction (Section 2.7. Pacing simulation, "determined the best and worst cases in terms of improvement in EF").
Regarding claim 110, Panthee discloses the method of claim 5, as explained above. Panthee further discloses that said cardiac response includes changes in ejection fraction (Section 2.7. Pacing simulation, "determined the best and worst cases in terms of improvement in EF").
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.
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.
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 9 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Panthee et al. (Tailor-made heart simulation predicts the effect of cardiac resynchronization therapy in a canine model of heart failure, 2016), hereinafter Panthee, in view of Rosenberg et al. (US 20090254140 A1), hereinafter Rosenberg.
Regarding claim 9, Panthee discloses the method of claim 6, as explained above. Panthee does not explicitly disclose modifying said simulated placement of said first pacemaker lead and said second pacemaker lead on the patient based on said evaluated predicted cardiac response.
However, Rosenberg teaches a method for selecting a configuration for delivering a cardiac pacing therapy (Abstract), wherein a configuration includes electrode location (paragraph [0029]), and wherein the method comprises evaluating the predicted cardiac response (Fig. 15, paragraph [0165], decision block 1535), and modifying the configuration based on said evaluated predicted cardiac response (Fig. 15, paragraph [0166], step 1510; paragraph [0167], "the method 1500 the decision block 1535 and other portions may be modified accordingly").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panthee with the teachings of Rosenberg so that the method further comprises modifying said simulated placement of said first pacemaker lead and said second pacemaker lead on the patient based on said evaluated predicted cardiac response, because doing so optimizes the lead placement in a manner that avoids a need to test all configurations, shortening optimization time (Rosenberg, paragraphs [0164], [0167]).
Regarding claim 24, Panthee discloses the method of claim 21, as explained above. Panthee does not explicitly disclose modifying said simulated placement of said first pacemaker lead and said second pacemaker lead on the patient based on said evaluated predicted cardiac response.
However, Rosenberg teaches a method for selecting a configuration for delivering a cardiac pacing therapy (Abstract), wherein a configuration includes electrode location (paragraph [0029]), and wherein the method comprises evaluating the predicted cardiac response (Fig. 15, paragraph [0165], decision block 1535), and modifying the configuration based on said evaluated predicted cardiac response (Fig. 15, paragraph [0166], step 1510).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panthee with the teachings of Rosenberg so that the method further comprises modifying said simulated placement of said first pacemaker lead and said second pacemaker lead on the patient based on said evaluated predicted cardiac response, because doing so optimizes the lead placement in a manner that avoids a need to test all configurations, shortening optimization time (Rosenberg, paragraphs [0164], [0167]).
Claims 10-11 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Panthee et al. (Tailor-made heart simulation predicts the effect of cardiac resynchronization therapy in a canine model of heart failure, 2016), hereinafter Panthee, in view of Rosenberg et al. (US 20090254140 A1), hereinafter Rosenberg, and further in view of Kadooka (US 20170032095 A1).
Regarding claim 10, the method of claim 9 is obvious over Panthee and Rosenberg, as explained above. Although Panthee discloses simulating placement of said first pacemaker lead and said second pacemaker lead on the patient using said tuned hemodynamic parameters with patient-specific data (Section 2.7. Pacing simulation, "In each canine heart model, we performed simulations of triple-lead pacing for 25 lead positions and determined the best and worst cases in terms of improvement in EF"), Panthee does not explicitly disclose simulating a modified simulated placement of said first pacemaker lead and said second pacemaker lead on the patient using said tuned hemodynamic parameters with patient-specific data. Rosenberg teaches modifying the simulated placement of pacemaker leads (Fig. 15, paragraph [0166], step 1510), and testing the placement of pacemaker leads on the patient (Fig. 15, paragraph [0165], step 1520), but does not explicitly disclose simulating the modified placement of the pacemaker leads.
However, Kadooka teaches a technique for investigating the effectiveness of an operation by running biomedical simulation using a biomedical model of a patient's organ (paragraph [0055]), comprising simulating a plurality of electrode disposition patterns (analogous to placements of first pacemaker lead and second pacemaker lead) using tuned hemodynamic parameters with patient-specific data (paragraph [0067]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panthee and Rosenberg with the teachings of Kadooka to simulate said modified simulated placement of said first pacemaker lead and said second pacemaker lead on the patient using said tuned hemodynamic parameters with patient-specific data, because doing so reduces the surgical time and alleviates the physical burden on the patient (Kadooka, paragraph [0067]), and increases the certainty of the CRT implantation (Kadooka, paragraph [0068]).
Regarding claim 25, the method of claim 24 is obvious over Panthee and Rosenberg, as explained above. Although Panthee discloses simulating placement of said first pacemaker lead and said second pacemaker lead on the patient using said tuned hemodynamic parameters with patient-specific data (Section 2.7. Pacing simulation, "In each canine heart model, we performed simulations of triple-lead pacing for 25 lead positions and determined the best and worst cases in terms of improvement in EF"), Panthee does not explicitly disclose simulating a modified simulated placement of said first pacemaker lead and said second pacemaker lead on the patient using said tuned hemodynamic parameters with patient-specific data. Rosenberg teaches modifying the simulated placement of pacemaker leads (Fig. 15, paragraph [0166], step 1510), and testing the placement of pacemaker leads on the patient (Fig. 15, paragraph [0165], step 1520), but does not explicitly disclose simulating the modified placement of the pacemaker leads.
However, Kadooka teaches a technique for investigating the effectiveness of an operation by running biomedical simulation using a biomedical model of a patient's organ (paragraph [0055]), comprising simulating a plurality of electrode disposition patterns (analogous to placements of first pacemaker lead and second pacemaker lead) using tuned hemodynamic parameters with patient-specific data (paragraph [0067]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panthee and Rosenberg with the teachings of Kadooka to simulate said modified simulated placement of said first pacemaker lead and said second pacemaker lead on the patient using said tuned hemodynamic parameters with patient-specific data, because doing so reduces the surgical time and alleviates the physical burden on the patient (Kadooka, paragraph [0067]), and increases the certainty of the CRT implantation (Kadooka, paragraph [0068]).
Regarding claim 26, the method of claim 25 is obvious over Panthee, Rosenberg, and Kadooka, as explained above. Kadooka further teaches predicting a cardiac response (paragraph [0058], "The heart simulation outputs, for example, ECG data and an ejection fraction value as its simulation results.") using said modified simulated placement of said first pacemaker lead and second pacemaker lead on the patient and said disease-specific-calibrated model (paragraph [0058], "the simulation executing unit 12b runs the simulation to predict post-operative heartbeat conditions following an operation of disposing electrodes of the CRT device based on the input electrode disposition pattern") to determine the placement of said first pacemaker lead and second pacemaker lead on the patient (paragraph [0067], "by running simulation for each of a plurality of electrode disposition patterns associated with CRT device implementation, the optimal electrode disposition pattern is determined").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panthee and Rosenberg with the teachings of Kadooka to predict a cardiac response, configured for use on the patient, using said modified simulated placement of said first pacemaker lead and said second pacemaker lead on the patient and said disease-specific-calibrated model to determine the placement of said first pacemaker lead and second pacemaker lead on the patient, because doing so reduces the surgical time and alleviates the physical burden on the patient (Kadooka, paragraph [0067]), and increases the certainty of the CRT implantation (Kadooka, paragraph [0068]).
Claim 107 is rejected under 35 U.S.C. 103 as being unpatentable over Panthee et al. (Tailor-made heart simulation predicts the effect of cardiac resynchronization therapy in a canine model of heart failure, 2016), hereinafter Panthee, in view of Niederer et al. (Simulating Human Cardiac Electrophysiology on Clinical Time-Scales, 2011).
Regarding claim 107, Panthee discloses the method of claim 1, as explained above. Panthee does not explicitly disclose that the predicting a cardiac response to a heart condition of the patient and the simulated palcement of said first pacemaker lead and said second pacemaker lead on the patient occurs in one of the claimed time ranges.
However, Niederer teaches a method of conducting computer simulations of human cardiac electrophysiology (Abstract) in under 5 minutes (page 2, "This improvement in the speed of cardiac simulations allows the simulation of a 1000-ms human heart beat in under 5 min and an activation sequence to be simulated in approximately 1 min"; page 5, "We have demonstrated that the introduction of customized I/O and efficient mesh partitioning strategies combined with efficient code enable the simulation of a single human heart beat within 4 min and the simulation of activation time in 1 min.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panthee with the teachings of Niederer so that the predicting a cardiac response to a heart condition of the patient and the simulated placement of said first pacemaker lead and said second pacemaker lead on the patient occurs in a time range greater than 1 minute and less than 5 minutes, because doing so assists in treatment planning and patient selection, improves the fidelity of the models representation of the patients data, and increases the number of treatment scenarios able to be evaluated (Niederer, page 1). Reducing the amount of time needed to predict a cardiac response to a heart condition and the simulated placement of the pacemaker leads would also enable the simulations to be performed during surgical procedures for ease of use and to minimize the risk to the patient and the economic cost of prolonged procedures (Niederer, page 1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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