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 .
Election/Restrictions
Claims 15-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 14 October 2025 of Invention I, directed to Claims 1-14 and 24.
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 9-10 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 9, the claim recites “the signal generator”. There is lack of antecedent basis for this limitation in the claim. For purposes of examination, the Examiner is interpreting this limitation as “a signal generator”. Claim 10 is rejected for depending on Claim 9.
.
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 1-14 and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-14 are directed to a method (process) and 24 a system (machine) which are within the four statutory categories.
Claims 1-14 and 24 are directed to an abstract idea as described below.
Step 2A, Prong One:
Claim 1 recites “a cardiac activation mapping method comprising:
using a localization system to determine a plurality of locations on endothelium and epithelium surfaces of a heart of a patient …;
using the plurality of locations on endothelium and epithelium surfaces of the heart to select a representative three-dimensional (3D) heart model of the patient's heart;
using the localization system to determine locations of electrocardiogram (ECG) electrodes disposed on the patient;
collecting ECG data from the patient using the ECG electrodes;
and generating a 3D activation map of the heart based on the selected 3D heart model, the ECG data, and the determined locations of the ECG electrodes on the patient”.
Claim 24 recites, “a medical system, comprising:
means for using a localization system to determine a plurality of locations on endothelium and epithelium surfaces of a heart of a patient…;
means for using the plurality of locations on endothelium and epithelium surfaces of the heart to select a representative three-dimensional (3D) heart model of the patient's heart;
means for using the localization system to determine locations of electrocardiogram (ECG) electrodes disposed on the patient;
means for collecting ECG data from the patient using the ECG electrodes;
and means for generating a 3D activation map of the heart based on the selected 3D heart model, the ECG data, and the determined locations of the ECG electrodes on the patient”.
However, these claims as drafted under their broadest reasonable interpretation, are merely a mental process than can be performed by a person using a pen and paper by viewing images/signal data, because these are steps are akin to having a doctor or other human actor performing a medical diagnosis of a patient and mathematically evaluating sensed data, and graphically “displaying” (drawing) the output. Therefore, these steps may be performed mentally by a human actor and implemented by drawing objects/graphs based on the evaluation by hand using a pen and paper.
Claims 2-14 depend from Claim 1. The dependent claims only recite additional features of mathematically evaluating, analyzing, and displaying sensed data, with generic treatment steps or output. These limitations and other limitations of the dependent claims are also merely processes to evaluate a sensed signal which may be performed mentally by a human actor, such as by visually comparing charts/plots/images, performing calculations, and/or simply by drawing objects using a pen and paper, and then performing generic treatment or diagnosis.
If claim limitations, under their broadest reasonable interpretation covers the performance of the limitations within the human mind or by a human using a pen and paper, then it falls within “mental processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Step 2A, Prong Two:
The judicial exception is not integrated into a practical application. Claims 1 and 24 only recites the additional limitations “electrodes”, “catheter”, “means for using a localization system”, “means for collecting ECG data”, and “means for generating a 3D activation map”. The dependent Claims 2-14 recite additionally, “sensors”, “magnetic sensors”, “electric field sensors”, “ultrasound transducers”, and “pacemaker or defibrillator lead”.
These additional elements are recited at a high-level of generality (i.e. most generic computer and cardiac mapping systems would be known to have these components for general computation, imaging/sensing, processing, and output of sensed data), and they amount to no more than mere pre-solution activity of data gathering from a known sensing or imaging device. This pre-solution activity of data gathering using electrodes/sensors and imaging devices is well-understood, routine, and conventional in the field of medical sensing and computing technology.
For example, see the Kalinin et al. reference (US Publication No. 2016/0338611) which discloses a known computing and electrophysiological mapping system (10, Fig. 1; Paragraph 0008, 0038-0041, 0044-0050), as well as Yomtov et al. (US Publication No. 2022/0007990) and Braido et al. (US Publication No. 2021/0369394), which also teaches these claimed structures. Additionally, Neuman (Neuman, M. R. “Biopotential Electrodes.” The Biomedical Engineering Handbook: Second Ed. Joseph D. Bronzino; Boca Raton: CRC Press LLC, 2000) describes known biosensor signal sensing and processing (Table 48.1, Sections 48.1 and 48.4) for further evaluation and diagnosis. Therefore, 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.
Thus the claims are directed to an abstract idea. As described above, Claims 1-14 and 24 are merely a mental process, because these are steps are akin to having a doctor or other human actor performing a medical diagnosis of a patient and mathematically evaluating sensed and image data, and drawing graphs/objects, which may be done mentally by a human actor and implemented by drawing objects/graphs based on the evaluated by hand using a pen and paper, and then performing generic treatment or diagnosis.
Furthermore, the limitations of “performing a cardiac treatment procedure” including “an ablation procedure” and “implanting a pacemaker lead or a defibrillator lead on the heart” in Claims 12-14 is not defining a “particular treatment” as required to be considered a practical application. According to MPEP 2106.04(d)(2), “The treatment or prophylaxis limitation must be “particular,” i.e., specifically identified so that it does not encompass all applications of the judicial exception(s).” Therefore, the “treatment” as defined by Claims 12-14 is considered generic and therefore does not integrate the 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 the integration of the judicial exception into a practical application (Step 2A - Prong Two), the additional elements of using “electrodes”, “catheter”, “means for using a localization system”, “means for collecting ECG data”, “means for generating a 3D activation map”, “sensors”, “magnetic sensors”, “electric field sensors”, “ultrasound transducers”, and “pacemaker or defibrillator lead” as recited in the claims to perform data analysis of sensed signals amounts to no more than mere instruction to apply the exception using known and generic elements, and then outputting the results using known computing elements (such as a display, screen, monitor, etc.) and providing generic and well-known “treatment”.
The only structural elements recited in the claims are “electrodes”, “catheter”, “means for using a localization system”, “means for collecting ECG data”, “means for generating a 3D activation map”, “sensors”, “magnetic sensors”, “electric field sensors”, “ultrasound transducers”, and “pacemaker or defibrillator lead”. These additional elements are recited at a high-level of generality (i.e. most generic computer and medical mapping systems would be known to have these components for general computation, sensing/imaging, processing, and output of sensed data), and only provide conventional, well-known sensing and computing functions that do not add meaningful limits to practicing the abstract idea.
The data collection and mapping steps amount to no more than mere pre-solution activity of data processing, and this pre-solution activity of processing data using known sensors is well-understood, routine, and conventional in the field of computing and medical technology. For example, see the Kalinin et al. reference (US Publication No. 2016/0338611) which discloses a known computing and electrophysiological mapping system (10, Fig. 1; Paragraph 0008, 0038-0041, 0044-0050), as well as Yomtov et al. (US Publication No. 2022/0007990) and Braido et al. (US Publication No. 2021/0369394), which also teaches these claimed structures. Additionally, Neuman (Neuman, M. R. “Biopotential Electrodes.” The Biomedical Engineering Handbook: Second Ed. Joseph D. Bronzino; Boca Raton: CRC Press LLC, 2000) describes known biosensor signal sensing and processing (Table 48.1, Sections 48.1 and 48.4) for further evaluation and diagnosis.
Furthermore, the measuring and data manipulation steps in the claims do not recite any additional structural elements or limitations on practical applications (e.g. explicitly applied non-generic treatment or explicit tangible output). Therefore, the claims are not patent eligible.
Therefore, Claims 1-14 and 24 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
It is recommended by the Examiner that explicit treatment steps based on the mapping/data analysis be added to independent Claims 1 and 24 in order to overcome the rejections under 35 USC 101.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
In Claim 24:
“means for using a localization system” will be interpreted as the computer system 100, processing unit 110, and associated components which are connected to the localization system 108 as described in Fig. 1, Pages 8-9 of the Specification
“means for using the plurality of locations on endothelium and epithelium surfaces of the heart” will be interpreted as the computer system 100, processing unit 110, and associated components as described in Fig. 1, Pages 8-9 of the Specification
“means for collecting ECG data” will be interpreted as the ECG electrodes/system 104, and the computer system 100, processing unit 110, and associated components which are connected to the localization system 108 as described in Fig. 1, Pages 8-11 of the Specification
“means for generating a 3D activation map of the heart” will be interpreted as the output unit 130, and the computer system 100, processing unit 110, and associated components which are connected to the localization system 108 as described in Fig. 1, Pages 8-9, 11 of the Specification
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.
Claims 1, 2, 12, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kalinin et al. (US Publication No. 2016/0338611) in view of Walzman (US Publication No. 2017/0333674).
Regarding Claim 1, Kalinin et al. discloses a cardiac activation mapping method (Abstract, Paragraph 0008-0011, 0046, 0058), comprising:
using a localization system (electrophysiological mapping system 10, Fig. 1; Paragraph 0038-0041) to determine a plurality of locations on epicardial and endocardial surfaces of a heart of a patient (Paragraph 0050, 0054, 0057, 0060) as the surfaces are touched with a tip or electrode of a catheter (invasive mapping EP catheter system 500, Figs. 1, 2; Paragraph 0038, 0041, 0043, 0045, 0052-0054);
using the plurality of locations on the surfaces of the heart to select a representative three-dimensional (3D) heart model of the patient's heart (geometric/mathematical modeling, Paragraph 0008, 0010, 0050, 0062, 0095, 0133, 0160-0162; See Figs. 11A-C);
using the localization system to determine locations of electrocardiogram (ECG) electrodes disposed on the patient (identifying electrode location/position data, Paragraph 0052, 0061, 0130, 0158, 0165);
collecting ECG data from the patient using the ECG electrodes (sensed ECG data with ECG electrodes, Paragraph 0044, 0045, 0049, 0081, 0085, 0130);
and generating a 3D activation map of the heart based on the selected 3D heart model, the ECG data, and the determined locations of the ECG electrodes on the patient (activation mapping, Paragraph 0009-0011, 0046, 0049, 0058; generating 3D electrical activity mapping, Paragraph 0059, 0061, 0064, 0070, 0161, 0162, 0165).
Although Kalinin et al. discloses determine a plurality of locations on epicardial and endocardial surfaces of a heart of a patient (Paragraph 0050) including other myocardial surfaces (Abstract; Paragraph 0008-0011), Kalinin et al. does not explicitly disclose these surfaces include endothelium and epithelium surfaces of a heart.
Walzman teaches a cardiac access method (Abstract) including using a catheter to obtain visualization of cardiac structures (Paragraph 0244-0250), wherein cardiac surfaces of interest include endothelium and epithelium surfaces of a heart (Paragraph 0006, 0014). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include endothelium and epithelium surfaces of a heart, as taught by Walzman, since these are known anatomical surface tissue structures of the heart proximal to the epicardial and endocardial surfaces of cardiac structures, as also taught by Walzman (Paragraph 0006, 0014), in the cardiac activation mapping method disclosed by Kalinin.
Regarding Claim 24, Kalinin et al. discloses a medical system comprising:
means for using (computing/processing system disclosed by Kalinin et al. to be functionally equivalent to structures described in the instant Specification, see 35 USC 112(f) section above; Paragraph 0008, 0038, 0044-0050) a localization system (electrophysiological mapping system 10, Fig. 1; Paragraph 0038-0041) to determine a plurality of locations on epicardial and endocardial surfaces of a heart of a patient (Paragraph 0050, 0054, 0057, 0060) as the surfaces are touched with a tip or electrode of a catheter (invasive mapping EP catheter system 500, Figs. 1, 2; Paragraph 0038, 0041, 0043, 0045, 0052-0054);
means for using (computing/processing system disclosed by Kalinin et al. to be functionally equivalent to structures described in the instant Specification, see 35 USC 112(f) section above; Paragraph 0008, 0038, 0044-0050) the plurality of locations on epicardial and endocardial surfaces of a heart (Paragraph 0050, 0054, 0057, 0060) to select a representative three-dimensional (3D) heart model of the patient's heart (geometric/mathematical modeling, Paragraph 0008, 0010, 0050, 0062, 0095, 0133, 0160-0162; See Figs. 11A-C);
means for using (computing/processing system disclosed by Kalinin et al. to be functionally equivalent to structures described in the instant Specification, see 35 USC 112(f) section above; Paragraph 0008, 0038, 0044-0050) the localization system to determine locations of electrocardiogram (ECG) electrodes disposed on the patient (identifying electrode location/position data, Paragraph 0052, 0061, 0130, 0158, 0165);
means for collecting ECG data (computing/processing system disclosed by Kalinin et al. to be functionally equivalent to structures described in the instant Specification, see 35 USC 112(f) section above; Paragraph 0008, 0038, 0044-0050) from the patient using the ECG electrodes (sensed ECG data with ECG electrodes, Paragraph 0044, 0045, 0049, 0081, 0085, 0130);
and means for generating a 3D activation map (computing/processing and display system disclosed by Kalinin et al. to be functionally equivalent to structures described in the instant Specification, see 35 USC 112(f) section above; Paragraph 0008, 0038, 0044-0050, 0070, 0085, 0088) of the heart based on the selected 3D heart model, the ECG data, and the determined locations of the ECG electrodes on the patient (activation mapping, Paragraph 0009-0011, 0046, 0049, 0058; generating 3D electrical activity mapping, Paragraph 0059, 0061, 0064, 0070, 0161, 0162, 0165).
Although Kalinin et al. discloses determine a plurality of locations on epicardial and endocardial surfaces of a heart of a patient (Paragraph 0050) including other myocardial surfaces (Abstract; Paragraph 0008-0011), Kalinin et al. does not explicitly disclose these surfaces include endothelium and epithelium surfaces of a heart.
Walzman teaches a cardiac access method (Abstract) including using a catheter to obtain visualization of cardiac structures (Paragraph 0244-0250), wherein cardiac surfaces of interest include endothelium and epithelium surfaces of a heart (Paragraph 0006, 0014). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include endothelium and epithelium surfaces of a heart, as taught by Walzman, since these are known anatomical surface tissue structures of the heart proximal to the epicardial and endocardial surfaces of cardiac structures, as also taught by Walzman (Paragraph 0006, 0014), in the cardiac activation mapping method disclosed by Kalinin.
Regarding Claim 2, Kalinin et al. discloses a cardiac activation mapping method (Abstract, Paragraph 0008-0011, 0046, 0058) further comprising: processing the plurality of locations on epicardial and endocardial surfaces of a heart of a patient (Paragraph 0050, 0054, 0057, 0060) and the determined locations of the ECG electrodes on the patient to determine distances between each ECG electrode and the heart (determining location/distance, Paragraph 0061, 0089, 0165; see distance/location calculations of Figs. 14b, 15b, Paragraph 00200-00204); and generating the 3D activation map of the heart further based on the distances between each ECG electrode and the heart (activation mapping, Paragraph 0009-0011, 0046, 0049, 0058; generating 3D electrical activity mapping, Paragraph 0059, 0061, 0064, 0070, 0161, 0162, 0165).
Although Kalinin et al. discloses determine a plurality of locations on epicardial and endocardial surfaces of a heart of a patient (Paragraph 0050) including other myocardial surfaces (Abstract; Paragraph 0008-0011), Kalinin et al. does not explicitly disclose these surfaces include endothelium and epithelium surfaces of a heart.
Walzman teaches a cardiac access method (Abstract) including using a catheter to obtain visualization of cardiac structures (Paragraph 0244-0250), wherein cardiac surfaces of interest include endothelium and epithelium surfaces of a heart (Paragraph 0006, 0014). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include endothelium and epithelium surfaces of a heart, as taught by Walzman, since these are known anatomical surface tissue structures of the heart proximal to the epicardial and endocardial surfaces of cardiac structures, as also taught by Walzman (Paragraph 0006, 0014), in the cardiac activation mapping method disclosed by Kalinin.
Regarding Claim 12, Kalinin et al. discloses a cardiac activation mapping method (Abstract, Paragraph 0008-0011, 0046, 0058) further comprising performing a cardiac treatment procedure while viewing the displayed generated 3D activation map of the heart (combining with treatment procedures, Paragraph 0079).
Claims 9, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kalinin et al. (US Publication No. 2016/0338611) in view of Walzman (US Publication No. 2017/0333674), further in view of Yomtov et al. (US Publication No. 2022/0007990).
Regarding Claims 9 and 10, Kalinin et al. discloses a cardiac activation mapping method (Abstract, Paragraph 0008-0011, 0046, 0058) further wherein using the plurality of locations on the surfaces of the heart to select the representative 3D heart model of the patient's heart comprises (geometric/mathematical modeling, Paragraph 0008, 0010, 0050, 0062, 0095, 0133, 0160-0162; See Figs. 11A-C) estimating size, shape and orientation of heart structures (volume/shape/position of anatomical structures, Paragraph 0089-0090, 0050, 0057, 0059, 0061-0062, 0079, 0096) from the plurality of locations on the surfaces of the heart determined based on distances from each of the three or more sensors (multiple sensors, see Figs. 3A-3E; 4A-4C; Paragraph 0039-0043, 0068, 0080) to a signal generator on the tip or electrode of the catheter when the tip or electrode of the catheter touches the surface of the heart (invasive mapping EP catheter system 500, Figs. 1, 2; Paragraph 0038, 0041, 0043, 0045, 0052-0054, 0064, 0068).
Although Kalinin et al. discloses determining a plurality of locations on epicardial and endocardial surfaces of a heart of a patient (Paragraph 0050) including other myocardial surfaces (Abstract; Paragraph 0008-0011), Kalinin et al. does not explicitly disclose these surfaces include endothelium and epithelium surfaces of a heart.
Walzman teaches a cardiac access method (Abstract) including using a catheter to obtain visualization of cardiac structures (Paragraph 0244-0250), wherein cardiac surfaces of interest include endothelium and epithelium surfaces of a heart (Paragraph 0006, 0014). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include endothelium and epithelium surfaces of a heart, as taught by Walzman, since these are known anatomical surface tissue structures of the heart proximal to the epicardial and endocardial surfaces of cardiac structures, as also taught by Walzman (Paragraph 0006, 0014), in the cardiac activation mapping method disclosed by Kalinin.
However, neither Kalinin et al. nor Walzman explicitly discloses selecting a 3D heart model from a database of 3D heart models that best matches the estimated size, shape and orientation of heart structures, and wherein the 3D heart model comprises at least one heart structure selected from an aorta, an aortic arch, coronary vascular structures, pulmonary vascular structures, or scar tissue indicative of ischemic heart disease.
Yomtov et al. teaches a system and method of generating a 3D activation map of the heart (Abstract, Paragraph 0006-0007, 0023) selecting a 3D heart model from a database of 3D heart models (selecting based upon 3D models within database, Paragraph 0027-0029) that best matches the estimated size, shape and orientation of heart structures (best-fitting heart model based upon anatomical structure/size/position data, Paragraph 0027-0029, 0031, 0035, 0036; Claims 1, 5), and wherein the 3D heart model comprises at least one heart structure selected from an aorta (Paragraph 0027, 0041), an aortic arch (Paragraph 0027, 0041), coronary vascular structures (Paragraph 0027, 0041, Claim 9), pulmonary vascular structures (Claim 9, 17), or scar tissue indicative of ischemic heart disease (Paragraph 0021, 0032, 0041, 0046).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select a 3D heart model from a database of 3D heart models that best matches the estimated size, shape and orientation of heart structures, and wherein the 3D heart model comprises at least one heart structure selected from an aorta, an aortic arch, coronary vascular structures, pulmonary vascular structures, or scar tissue indicative of ischemic heart disease, as taught by Yomtov et al., in the cardiac activation mapping method disclosed by Kalinin and Walzman in combination, in order to quickly and accurately visualize these anatomical structures during the mapping procedure based upon modifying pre-existing data (see Yomtov et al., Paragraph 0027-0028, 0031).
Regarding Claim 11, Kalinin et al. discloses generating and displaying a 3D activation map of the heart based on the selected 3D heart model, the ECG data, and the determined locations of the ECG electrodes on the patient (activation mapping, Paragraph 0009-0011, 0046, 0049, 0058; generating 3D electrical activity mapping, Paragraph 0059, 0061, 0064, 0070, 0161, 0162, 0165). However, neither Kalinin et al. nor Walzman explicitly discloses generating the 3D activation map of the heart to include one or more of an earliest activation site, a latest activation site, a PVC onset point, a VT entry point or a VT exit point based on the ECG data; and displaying the generated 3D activation map of the heart on a display device.
Yomtov et al. teaches a system and method of generating a 3D activation map of the heart (Abstract, Paragraph 0006-0007, 0023) which includes an earliest activation site (Paragraph 0006-0007, 0030; see Figs. 2A-B, 3-5), a latest activation site (Paragraph 0006-0007, 0030; see Figs. 2A-B, 3-5), a PVC onset point (Paragraph 0006-0007, 0030, 0038), a VT entry point (Paragraph 0038) or a VT exit point based (Paragraph 0006-0007, 0038, 0040) on the ECG data; and displaying the generated 3D activation map of the heart on a display device (Paragraph 0006-0007, 0030; see Figs. 2A-B, 3-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include one or more of an earliest activation site, a latest activation site, a PVC onset point, a VT entry point or a VT exit point based on the ECG data; and displaying the generated 3D activation map of the heart on a display device, as taught by Yomtov et al., in the in the cardiac activation mapping method disclosed by Kalinin and Walzman in combination, in order to quickly and accurately localize various arrhythmias to diagnose conduction disorders within the heart (see Yomtov et al., Paragraph 0002-0005).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kalinin et al. (US Publication No. 2016/0338611) in view of Walzman (US Publication No. 2017/0333674), further in view of Braido et al. (US Publication No. 2021/0369394).
Regarding Claims 13 and 14, Kalinin et al. discloses a cardiac activation mapping method (Abstract, Paragraph 0008-0011, 0046, 0058) further comprising performing a cardiac treatment procedure while viewing the displayed generated 3D activation map of the heart (combining with treatment procedures, Paragraph 0079). However, neither Kalinin et al. nor Walzman explicitly discloses wherein the cardiac treatment procedure comprises an ablation procedure or implanting a pacemaker lead or a defibrillator lead on the heart.
Braido et al. teaches a cardiac anatomical mapping system and method (Abstract; Paragraph 0031-0032; Figs. 7A-B) including performing a cardiac treatment procedure while viewing the displayed generated 3D mapping images of the heart (Paragraph 0030, 0039, 0041-0042, 0243, 0244), wherein the cardiac treatment procedure comprises an ablation procedure (Paragraph 0043, 0046, 0060, 0063, 0071) or implanting a pacemaker lead or a defibrillator lead on the heart (Paragraph 0043, 0046, 0060, 0063, 0069).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a ablation procedure or implanting a pacemaker lead or a defibrillator lead on the heart, as taught by Braido et al., in the cardiac activation mapping method including performing a cardiac treatment procedure while viewing the displayed generated 3D activation map of the heart as taught by Kalinin et al. and Walzman in combination, in order to allow for more successful outcomes of these specific treatment/implantation procedures by allowing for viewing of the 3D mapping images of the heart in real-time during the procedures (see Braido et al., Paragraph 0006, 0030-0031).
Allowable Subject Matter
Claims 3-8 would be allowable over the prior art if rewritten/ameded to overcome the rejections under 35 U.S.C. 101 set forth in this Office action above, and to include all of the limitations of the base claim and any intervening claims. It is recommended by the Examiner that explicit treatment steps based on the mapping/data analysis be added to the claims in order to overcome the rejections under 35 USC 101.
The prior art of record does not explicitly disclose, “the ECG electrodes and the tip or electrode of the catheter comprise signal generators; the localization system includes three or more sensors configured to receive signals from the signal generators; using the localization system to determine the plurality of locations on endothelium and epithelium surfaces of the heart of the patient as the surfaces aretouched with the tip or electrode of the catheter comprises determining distances from each of the three or more sensors to the signal generator on the tip or electrode of the catheter when the tip or an electrode of the catheter touches an endothelium and epithelium surface of the heart; and using the localization system to determine locations of the ECG electrodes disposed on the patient comprises determining distances from each of the three or more sensors to the signal generator on each of the ECG electrodes.” Claims 4-8 depend from and thus further limit Claim 3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796