CTNF 17/995,148 CTNF 91226 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 14-17 and 29-31 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. 07-34-03 AIA The term “ about ” in claim s 14 and 29 is a relative term which renders the claim indefinite. The term “ about ” 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. Examiner suggests removing the term to resolve the issue . Claims 15-17 and 30-31 inherit this issue and do not correct it . Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-3 and 5-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental processes and mathematical relationships) without significantly more. Claim 1 recites: A computer implemented clinical method for guiding ablation of atrial or ventricular arrhythmia in a patient's heart, comprising: (this falls within the statutory categories of invention. Computer implementation is equivalent to mere instructions to apply an exception with generic computer components as per MPEP 2106.05(f).) generating a digital representation of the electrical functioning of atria or ventricles of the patient's heart based on imaging data of the patient's heart based on imaging data of the patient's heart that reveals the presence of adipose tissue; (This is done with physics equations and represents a serious of mathematical relationships that are merely generally linked to the technical field of cardiac surgery. The imaging data is analyzed numerically and the digital representation is in the form of numerical geometry models constructed according to a mathematical algorithm, explicitly noted as finite element modeling in later claims. Alternatively, but for the requirement of generic computer components implied by “digital”, this could be accomplished by a person mentally by performing observations and using their professional expertise to evaluate and judge the condition of a patient based on the imaging data. Note that gathering the imaging data is never claimed, only its use, but even obtaining generic imaging data would be insignificant extra-solution activity in the form of mere data gathering as per MPEP 2106.05(g)) determining the arrhythmias arising in the presence of the adipose tissue in the digital representation of the patient's atria or ventricles; (a person can do this mentally via observation and evaluation of the data based on professional expertise. Alternatively, this is done via numerical analysis according to mathematical equations to determine mathematical features of the numerical data, and falls within the scope of mathematical relationships) identifying, in the digital representation, ablation targets that need to be ablated to terminate determined arrhythmias; (a person can do this mentally via observation and evaluation of the data based on professional expertise, then making judgements to set targets) executing, in the digital representation, a mock-up of a clinical ablation procedure of the patient to determine the electrical response of the patient's heart to ablating the ablation targets, and to determine whether the heart continues to generate new arrhythmias post-procedure; and (This is done with physics equations and represents a serious of mathematical relationships that are merely generally linked to the technical field of cardiac surgery. The potential results of the ablation are analyzed numerically and the digital representation is in the form of numerical geometry models constructed according to a mathematical algorithm, explicitly noted as finite element modeling in later claims. Alternatively, but for the requirement of generic computer components implied by “digital”, this could be accomplished by a person mentally by performing observations and using their professional expertise to evaluate and judge the condition of a patient. Note that actually performing an ablation procedure is not claimed or recited here, only simulating its effects in an abstract manner.) generating a final set of ablation targets based on the mock-up of the clinical ablation procedure. (a person can do this mentally via observation and evaluation of the data based on professional expertise, then making judgements to set targets) This judicial exception is not integrated into a practical application. In particular, the claim only recites the following additional elements: 1) mere instructions to apply the exception using generic computer components (the computer implementation), 2) generally linking the use of the exception to the technical field of cardiac surgery, and 3) insignificant extra-solution activity in the form of mere data gathering (if the implied obtaining of imaging data is read as being required by the claim). The computer implementation is recited at a high-level of generality (i.e., as a generic computer with implied processor/memory performing a generic computer function of executing instructions and storing data) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception cannot integrate a judicial exception into a practical application. The specification that image data is used, and implication that it is obtained is only tangentially linked to the calculation and analysis steps, and does not meaningfully limit the claim. The claim is directed to an abstract idea. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer with processor/memory to perform the claimed steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself. The addition of insignificant extra-solution activity does not amount to an inventive concept. The claim is not patent eligible. The dependent claims 2, 3, and 5-17 recite only further features that fall within the scope of the above analysis, namely in terms of generally linking the use of the exception to the technical field of cardiac surgery, and further defining features within the scope of mental processes and mathematical relationships. They remain ineligible for the above reasons. Claims 18-31 are substantively similar to claims 1-2 and 5-16 respectively, and are rejected under the same grounds as those set forth for claims 1-2 and 5-16 above. Claim 4 is patent eligible and is not rejected under 35 USC 101. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 1-3, 5-7, 9-22, and 24-31 are rejected under 35 U.S.C. 103 as being unpatentable over Nazarian (US 20140023256 A1) in view of Zipse (Zipse, M. M., Edward, J. A., Zheng, L., Tzou, W. S., Borne, R. T., Sauer, W. H., & Nguyen, D. T. (2020). Impact of epicardial adipose tissue and catheter ablation strategy on biophysical parameters and ablation lesion characteristics. Journal of cardiovascular electrophysiology, 31(5), 1114-1124.) and Boyle (Boyle, P. M., Zghaib, T., Zahid, S., Ali, R. L., Deng, D., Franceschi, W. H., ... & Trayanova, N. A. (2019). Computationally guided personalized targeted ablation of persistent atrial fibrillation. Nature biomedical engineering, 3(11), 870-879.) . Note that when specific elements of a limitation are not disclosed by the primary reference, but are later rendered obvious in combination with a secondary reference, double brackets ‘[[‘ and ‘]]’ will be used to indicate they are not disclosed by the primary reference in that limitation. Regarding Claim 1: Nazarian teaches: generating a digital representation of the electrical functioning of atria or ventricles of the patient's heart based on imaging data of the patient's heart [[that reveals the presence of adipose tissue]]; (¶29 receiving at least left ventricle three-dimensional image data of a patient's heart ... provide the structural information that is used in the modeling and mapping.; ¶31 predetermined data that associates a value of at least one electrogram characteristic to each scar tissue thickness and each normal myocardium tissue thickness for the plurality of portions of the left ventricle image of the patient's heart is received. The predetermined data can be model data for example. The model data can be an empirical model according to some embodiments of the current invention.; ¶32 generating the three-dimensional cardiac electrogram characteristic map of the at least one electrogram characteristic corresponding to the left ventricle image of the patient's heart based on the predetermined data. For example, one or more such three-dimensional cardiac electrogram characteristic maps can be displayed on a display screen along with an image indicating the location of the ablation catheter during an ablation procedure.) determining the arrhythmias arising in the presence of the [[adipose]] tissue in the digital representation of the patient's atria or ventricles; (¶22 To identify such candidate areas, catheter ablation of ischemic VT begins by an attempt to map the myocardial substrate by creation of an endocardial voltage map.; ¶23 selection and ablation of critical VT sites; ¶24 The entire map can be created based upon cardiac MRI imaging) identifying, in the digital representation, ablation targets that need to be ablated to terminate determined arrhythmias; (¶41 Ablation targets were principally determined by pace mapping during sinus rhythm and entrainment mapping during sustained monomorphic VT. Additional radiofrequency applications were also performed targeting fractionated and isolated potentials within scar) Nazarian does not teach in particular, but Zipse teaches: based on imaging data of the patient's heart that reveals the presence of adipose tissue; (Section 4.3, The findings of our study would also support a possible role for preprocedural imaging before epicardial VT ablation to evaluate for overlying EA at putative ablation target sites. ) determining the arrhythmias arising in the presence of the adipose tissue in the digital representation of the patient's atria or ventricles; (Section 1, Epicardial catheter ablation for ventricular tachycardia (VT) is often required when critical elements of VT circuits are epicardial in origin. Unfortunately, anatomic locations of epicardial adipose (EA) sometimes coincide with desired targets for ablation. The presence of EA interposed between an ablation catheter and underlying epicardium may result in ineffective delivery of radiofrequency (RF) and inadequate lesion formation; Section 4.3, The findings of our study would also support a possible role for preprocedural imaging before epicardial VT ablation to evaluate for overlying EA at putative ablation target sites. ) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to utilize the pre-procedural epicardial adipose (EA) tissue analysis and consideration of Zipse for an ablation guidance system including the modeling of Nazarian, as Zipse explicitly says this is a useful application for its methodology and can result in better treatment outcomes (Zipse, Section 4.3, The findings of our study would also support a possible role for preprocedural imaging before epicardial VT ablation to evaluate for overlying EA at putative ablation target sites ... thus, knowing the thickness of fat in the planning of an epicardial mapping and ablation procedure is important) Nazarian does not teach in particular, but Boyle teaches: executing, in the digital representation, a mock-up of a clinical ablation procedure of the patient to determine the electrical response of the patient's heart to ablating the ablation targets, and to determine whether the heart continues to generate new arrhythmias post-procedure; and (p.3, personalized simulations are conducted to determine all the atrial arrhythmias that could arise from the fibrotic substrate; this is done by analysing model responses following rapid pacing from 40 uniformly distributed bi-atrial sites. Based on the model responses, an optimal (minimum size) set of ablation lesions is determined that fully eliminates the arrhythmogenic propensity of the atrial substrate – these are the OPTIMA ablation targets. ; p.10 each personalized 3D atrial electrophysiological model was used in simulations to determine all the possible arrhythmias that could arise in the given fibrotic substrate ... the results of all 40 distinct simulations (conducted in parallel on a high-performance computing system, as described below) were analysed. ; p.11-12 Determining the OPTIMA ablation targets. ... This process was repeated iteratively until each model was rendered non-inducible for reentrant atrial arrhythmias.) generating a final set of ablation targets based on the mock-up of the clinical ablation procedure. (p.11-12 Determining the OPTIMA ablation targets. ... This process was repeated iteratively until each model was rendered non-inducible for reentrant atrial arrhythmias. To complete the personalized OPTIMA ablation target set …) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claim 2: Nazarian does not teach in particular, but Boyle teaches: importing, as part of an ablation procedure of the patient, the final set of ablation targets together with a number of anatomical landmarks from the digital representation into a clinical three-dimensional electroanatomical mapping system in a procedure room of an ablation procedure. (p.13 Prior to the procedure, movies displaying OPTIMA targets with nearby anatomical landmarks annotated were made available to physicians for review and planning.) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claim 3: Nazarian does not teach in particular, but Boyle teaches: registering the imported final set of ablation targets and the imported landmarks to a heart coordinate system of the patient in the clinical three-dimensional electroanatomical mapping system in the operating room during the ablation procedure. (p.13 ¶2 describes the ablation procedure, see p.22 Fig.3 for illustration of targets; see also ¶42 of Nazarian regarding coordinates " based on the registration coordinates for EAM merge with the LV CMR".) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claim 5: Nazarian teaches: wherein the patient imaging data comprises computed tomography (CT) data. (¶29 the image data can be x-ray computed tomography (CT) data. In some embodiments, the CT data can be late enhanced or perfusion CT data) Regarding Claim 6: Nazarian teaches: wherein the CT data comprises three-dimensional CT data. (¶29-30 the image data can be x-ray computed tomography (CT) data. In some embodiments, the CT data can be late enhanced or perfusion CT data … three-dimensional image data) Regarding Claim 7: Nazarian does not teach in particular, but Zipse teaches: wherein the adipose tissue is one of infiltrating the atrial or ventricular wall, or is epicardial, or pericardial tissue. (Abstract, Epicardial adipose (EA) tissue) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to utilize the pre-procedural epicardial adipose (EA) tissue analysis and consideration of Zipse for an ablation guidance system including the modeling of Nazarian, as Zipse explicitly says this is a useful application for its methodology and can result in better treatment outcomes (Zipse, Section 4.3, The findings of our study would also support a possible role for preprocedural imaging before epicardial VT ablation to evaluate for overlying EA at putative ablation target sites ... thus, knowing the thickness of fat in the planning of an epicardial mapping and ablation procedure is important) Regarding Claim 9: Nazarian does not teach in particular, but Zipse teaches: wherein the generating a digital representation of electrical functioning of atria or ventricles of the patient's heart is further based on clinical or experimental data for a regional electrical behavior of cardiac tissue in the presence of adipose tissue. (Examiner notes that virtually the entire document is focused on providing clinical/experimental data for behavior of cardiac tissue with epicardial adipose tissue present, and the effect of this on ablation; Section 1, Epicardial catheter ablation for ventricular tachycardia (VT) is often required when critical elements of VT circuits are epicardial in origin. Unfortunately, anatomic locations of epicardial adipose (EA) sometimes coincide with desired targets for ablation. The presence of EA interposed between an ablation catheter and underlying epicardium may result in ineffective delivery of radiofrequency (RF) and inadequate lesion formation; Section 4.3, The findings of our study would also support a possible role for preprocedural imaging before epicardial VT ablation to evaluate for overlying EA at putative ablation target sites. ) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to utilize the pre-procedural epicardial adipose (EA) tissue analysis and consideration of Zipse for an ablation guidance system including the modeling of Nazarian, as Zipse explicitly says this is a useful application for its methodology and can result in better treatment outcomes (Zipse, Section 4.3, The findings of our study would also support a possible role for preprocedural imaging before epicardial VT ablation to evaluate for overlying EA at putative ablation target sites ... thus, knowing the thickness of fat in the planning of an epicardial mapping and ablation procedure is important) Regarding Claim 10: Nazarian teaches: wherein the ablation procedure comprises one of endocardial, epicardial or intramural needle ablation to access endocardial, epicardial or intramyocardial ablation targets. (¶22 To identify such candidate areas, catheter ablation of ischemic VT begins by an attempt to map the myocardial substrate by creation of an endocardial voltage map.; ¶23 selection and ablation of critical VT sites; ¶24 The entire map can be created based upon cardiac MRI imaging) Regarding Claim 11: Nazarian does not teach in particular, but Boyle teaches: wherein when the digital representation continues to generate arrhythmias after ablation of predicted ablation targets in the mock-up of the clinical procedure, (p.3, personalized simulations are conducted to determine all the atrial arrhythmias that could arise from the fibrotic substrate; this is done by analysing model responses following rapid pacing from 40 uniformly distributed bi-atrial sites. Based on the model responses, an optimal (minimum size) set of ablation lesions is determined that fully eliminates the arrhythmogenic propensity of the atrial substrate – these are the OPTIMA ablation targets. ; p.10 each personalized 3D atrial electrophysiological model was used in simulations to determine all the possible arrhythmias that could arise in the given fibrotic substrate ... the results of all 40 distinct simulations (conducted in parallel on a high-performance computing system, as described below) were analysed. ; p.11-12 Determining the OPTIMA ablation targets. ... This process was repeated iteratively until each model was rendered non-inducible for reentrant atrial arrhythmias.) determining any new arrhythmias which arise in the ablated digital representation of the patient's atria or ventricles with adipose tissue, and (p.3, personalized simulations are conducted to determine all the atrial arrhythmias that could arise from the fibrotic substrate; this is done by analysing model responses following rapid pacing from 40 uniformly distributed bi-atrial sites. Based on the model responses, an optimal (minimum size) set of ablation lesions is determined that fully eliminates the arrhythmogenic propensity of the atrial substrate – these are the OPTIMA ablation targets. ; p.10 each personalized 3D atrial electrophysiological model was used in simulations to determine all the possible arrhythmias that could arise in the given fibrotic substrate ... the results of all 40 distinct simulations (conducted in parallel on a high-performance computing system, as described below) were analysed. ; p.11-12 Determining the OPTIMA ablation targets. ... This process was repeated iteratively until each model was rendered non-inducible for reentrant atrial arrhythmias.) wherein when the new arrhythmias arise, generating additional ablation targets, and adding the additional ablation targets to a set of initial ablation targets. (p.3, personalized simulations are conducted to determine all the atrial arrhythmias that could arise from the fibrotic substrate; this is done by analysing model responses following rapid pacing from 40 uniformly distributed bi-atrial sites. Based on the model responses, an optimal (minimum size) set of ablation lesions is determined that fully eliminates the arrhythmogenic propensity of the atrial substrate – these are the OPTIMA ablation targets. ; p.10 each personalized 3D atrial electrophysiological model was used in simulations to determine all the possible arrhythmias that could arise in the given fibrotic substrate ... the results of all 40 distinct simulations (conducted in parallel on a high-performance computing system, as described below) were analysed. ; p.11-12 Determining the OPTIMA ablation targets. ... This process was repeated iteratively until each model was rendered non-inducible for reentrant atrial arrhythmias.) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claim 12: Nazarian does not teach in particular, but Boyle teaches: wherein the determining whether any new arrhythmias arise, and the generating additional ablation targets is repeated, until no new arrhythmias are generated, and the final set of ablation targets is then generated. (p.3, personalized simulations are conducted to determine all the atrial arrhythmias that could arise from the fibrotic substrate; this is done by analysing model responses following rapid pacing from 40 uniformly distributed bi-atrial sites. Based on the model responses, an optimal (minimum size) set of ablation lesions is determined that fully eliminates the arrhythmogenic propensity of the atrial substrate – these are the OPTIMA ablation targets. ; p.10 each personalized 3D atrial electrophysiological model was used in simulations to determine all the possible arrhythmias that could arise in the given fibrotic substrate ... the results of all 40 distinct simulations (conducted in parallel on a high-performance computing system, as described below) were analysed. ; p.11-12 Determining the OPTIMA ablation targets. ... This process was repeated iteratively until each model was rendered non-inducible for reentrant atrial arrhythmias.) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claim 13: Nazarian does not teach in particular, but Boyle teaches: wherein the determining whether any new arrhythmias arise comprises delivering pacing to a number of pacing locations of the digital representation of the patient's atria or ventricles. (p.3, personalized simulations are conducted to determine all the atrial arrhythmias that could arise from the fibrotic substrate; this is done by analysing model responses following rapid pacing from 40 uniformly distributed bi-atrial sites. Based on the model responses, an optimal (minimum size) set of ablation lesions is determined that fully eliminates the arrhythmogenic propensity of the atrial substrate – these are the OPTIMA ablation targets. ; p.10 each personalized 3D atrial electrophysiological model was used in simulations to determine all the possible arrhythmias that could arise in the given fibrotic substrate ... the results of all 40 distinct simulations (conducted in parallel on a high-performance computing system, as described below) were analysed. ; p.11-12 Determining the OPTIMA ablation targets. ... This process was repeated iteratively until each model was rendered non-inducible for reentrant atrial arrhythmias.) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claim 14: Nazarian does not teach in particular, but Zipse teaches: imaging data of the patient's heart that reveals the presence of adipose tissue, (Section 4.3, The findings of our study would also support a possible role for preprocedural imaging before epicardial VT ablation to evaluate for overlying EA at putative ablation target sites. ) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to utilize the pre-procedural epicardial adipose (EA) tissue analysis and consideration of Zipse for an ablation guidance system including the modeling of Nazarian, as Zipse explicitly says this is a useful application for its methodology and can result in better treatment outcomes (Zipse, Section 4.3, The findings of our study would also support a possible role for preprocedural imaging before epicardial VT ablation to evaluate for overlying EA at putative ablation target sites ... thus, knowing the thickness of fat in the planning of an epicardial mapping and ablation procedure is important) Nazarian does not teach in particular, but Boyle teaches: wherein the generating a digital representation comprises creating a finite element mesh using the imaging data of the patient's heart [[that reveals the presence of adipose tissue,]] (p.8, high-resolution tetrahedral meshes were generated using an established automated approach33. These volumetric meshes were 3D, and included atrial wall thickness and the 3D distribution of fibrotic remodelling reconstructed from LGE-MRI. Across all 10 finite-element atrial meshes, average element edge length was 428.4±24.3 μm and the number of nodes ranged from ~1 million to ~2.6 million. ) the finite element mesh comprising a plurality of volume elements, wherein the volume elements each represent a volume having an edge length in a range of about 300-400 microns. (p.8, high-resolution tetrahedral meshes were generated using an established automated approach33. These volumetric meshes were 3D, and included atrial wall thickness and the 3D distribution of fibrotic remodelling reconstructed from LGE-MRI. Across all 10 finite-element atrial meshes, average element edge length was 428.4±24.3 μm and the number of nodes ranged from ~1 million to ~2.6 million; examiner notes that the difference in range from the reference to the claim is so small that it is negligible, and an obvious difference per MPEP 2144.05, "a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.") It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claim 15: Nazarian does not teach in particular, but Boyle teaches: wherein a number of the volume elements is greater than one million. (p.8, high-resolution tetrahedral meshes were generated using an established automated approach33. These volumetric meshes were 3D, and included atrial wall thickness and the 3D distribution of fibrotic remodelling reconstructed from LGE-MRI. Across all 10 finite-element atrial meshes, average element edge length was 428.4±24.3 μm and the number of nodes ranged from ~1 million to ~2.6 million) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claim 16: Nazarian does not teach in particular, but Boyle teaches: wherein the number of the volume elements is greater than two million. (p.8, high-resolution tetrahedral meshes were generated using an established automated approach33. These volumetric meshes were 3D, and included atrial wall thickness and the 3D distribution of fibrotic remodelling reconstructed from LGE-MRI. Across all 10 finite-element atrial meshes, average element edge length was 428.4±24.3 μm and the number of nodes ranged from ~1 million to ~2.6 million) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claim 17: Nazarian does not teach in particular, but Boyle teaches: where simulations performed with the heart model involve solving a differential equation representing electrical current propagation, together with the system of equations representing cell electrical activity, at each node at the finite element mesh. (p.8, high-resolution tetrahedral meshes were generated using an established automated approach33. These volumetric meshes were 3D, and included atrial wall thickness and the 3D distribution of fibrotic remodelling reconstructed from LGE-MRI. Across all 10 finite-element atrial meshes, average element edge length was 428.4±24.3 μm and the number of nodes ranged from ~1 million to ~2.6 million; p.10, This system was coupled with ordinary differential and algebraic equations representing myocyte membrane dynamics at each node in the mesh.) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the iterative target simulation and OPTIMA methodology for ablation targeting and guidance of Boyle to the ablation mapping and guidance of Nazarian as modified by Zipse, in order to improve the accuracy and efficacy of targeted AF ablation in patients whilst eliminating the need for repeat procedures. (Boyle, Abstract). Regarding Claims 18-22 and 24-31: claims 18-22 and 24-31 are substantively similar to claims 1-2, 5-7, and 9-16 respectively, and are rejected under the same grounds as those set forth for claims 1-2, 5-7, and 9-16 above . 07-21-aia AIA Claim s 4, 8, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Nazarian (US 20140023256 A1) in view of Zipse (Zipse, M. M., Edward, J. A., Zheng, L., Tzou, W. S., Borne, R. T., Sauer, W. H., & Nguyen, D. T. (2020). Impact of epicardial adipose tissue and catheter ablation strategy on biophysical parameters and ablation lesion characteristics. Journal of cardiovascular electrophysiology, 31(5), 1114-1124.) and Boyle (Boyle, P. M., Zghaib, T., Zahid, S., Ali, R. L., Deng, D., Franceschi, W. H., ... & Trayanova, N. A. (2019). Computationally guided personalized targeted ablation of persistent atrial fibrillation. Nature biomedical engineering, 3(11), 870-879.), and further in view of Soto (US 20180318013 A1) . Regarding Claim 4: Nazarian does not teach in particular, but Soto teaches: displaying the generated final set of ablation targets overlaid over an image of the patient's heart in a clinical electroanatomical mapping system in an operating room during an ablation procedure, and navigating an ablation catheter to the final ablation targets. (¶33 FIG. 1 shows a schematic diagram of an exemplary electroanatomical mapping system 8 for conducting cardiac electrophysiology studies by navigating a cardiac catheter and measuring electrical activity occurring in a heart 10 of a patient 11 and three-dimensionally mapping the electrical activity and/or information related to or representative of the electrical activity so measured. System 8 can be used, for example, to create an anatomical model of the patient's heart 10 using one or more electrodes; ¶50 In some embodiments, system 8 is the EnSite™ Velocity™ or EnSite Precision™ cardiac mapping and visualization system of Abbott Laboratories. Other localization systems, however, may be used in connection with the present teachings, including for example the CARTO navigation and location system of Biosense Webster, Inc., the AURORA® system of Northern Digital Inc., Sterotaxis' NIOBE® Magnetic Navigation System, as well as MediGuide™ Technology from Abbott Laboratories.) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the navigation and guidance system of Soto in the ablation mapping and guidance of Nazarian as modified by Zipse and Boyle, in order to provide a specific guidance implementation that is well-suited to the treatment of ventricular arrhythmias by ablation (Soto ¶5). Regarding Claim 8: Nazarian does not teach in particular, but Soto teaches: wherein the adipose tissue is in combination with fibrosis tissue. (¶70 The instant disclosure provides methods, apparatuses, and systems to express LSI as a function of tissue biological attributes or properties, such as fiber orientation, tissue thickness, fat (adipose) content, scar content, fibrosis, and the like. This is referred to herein as a “transmurality index”) It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include the navigation and guidance system of Soto in the ablation mapping and guidance of Nazarian as modified by Zipse and Boyle, in order to provide a specific guidance implementation that is well-suited to the treatment of ventricular arrhythmias by ablation (Soto ¶5). Regarding Claim 23: Claim 23 is substantially similar to claim 8, and is rejected under the same grounds as those set forth above for claim 8. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to BIJAN MAPAR whose telephone number is (571)270-3674. The examiner can normally be reached Monday - Thursday, 11:00-8:30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BIJAN MAPAR/ Primary Examiner, Art Unit 2189 Application/Control Number: 17/995,148 Page 2 Art Unit: 2189 Application/Control Number: 17/995,148 Page 3 Art Unit: 2189 Application/Control Number: 17/995,148 Page 4 Art Unit: 2189 Application/Control Number: 17/995,148 Page 5 Art Unit: 2189 Application/Control Number: 17/995,148 Page 6 Art Unit: 2189 Application/Control Number: 17/995,148 Page 7 Art Unit: 2189 Application/Control Number: 17/995,148 Page 8 Art Unit: 2189 Application/Control Number: 17/995,148 Page 9 Art Unit: 2189 Application/Control Number: 17/995,148 Page 10 Art Unit: 2189 Application/Control Number: 17/995,148 Page 11 Art Unit: 2189 Application/Control Number: 17/995,148 Page 12 Art Unit: 2189 Application/Control Number: 17/995,148 Page 13 Art Unit: 2189
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