Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statements
The information disclosure statements filed February 2, 2024, February 14, 2024, March 29, 2024 and June 27, 2025 have been entered and the references cited therein have been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of claims 1-20 recites at least one step or instruction for identifying an ablation site, which is grouped as a mental process in MPEP 2106.04(a)(2)(III).
The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675. See also Mortgage Grader, 811 F.3d at 1324, 117 USPQ2d at 1699 (concluding that concept of "anonymous loan shopping" recited in a computer system claim is an abstract idea because it could be "performed by humans without a computer").
Because both product and process claims may recite a "mental process", the phrase "mental processes" should be understood as referring to the type of abstract idea, and not to the statutory category of the claim. The courts have identified numerous product claims as reciting mental process-type abstract ideas, for instance the product claims to computer systems and computer-readable media in Versata Dev. Group. v. SAP Am., Inc., 793 F.3d 1306, 115 USPQ2d 1681 (Fed. Cir. 2015). Both product claims (e.g., computer system, computer-readable medium, etc.) and process claims may recite mental processes. For example, in Mortgage Grader, the patentee claimed a computer-implemented system and a method for enabling borrowers to anonymously shop for loan packages offered by a plurality of lenders, comprising a database that stores loan package data from the lenders, and a computer system providing an interface and a grading module. The Federal Circuit determined that both the computer-implemented system and method claims were directed to "anonymous loan shopping", which was an abstract idea because it could be "performed by humans without a computer." 811 F.3d. at 1318, 1324-25, 117 USPQ2d at 1695, 1699-1700. See also FairWarning IP, 839 F.3d at 1092, 120 USPQ2d at 1294 (identifying both system and process claims for detecting improper access of a patient's protected health information in a health-care system computer environment as directed to abstract idea of detecting fraud); Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1345, 113 USPQ2d 1354, 1356 (Fed. Cir. 2014) (system and method claims of inputting information from a hard copy document into a computer program). Accordingly, the phrase "mental processes" should be understood as referring to the type of abstract idea, and not to the statutory category of the claim.
Specifically, independent claims 1 and 11 recite generating a model of at least one ventricle, simulating, in the model, pacing in the ventricle, recording an activation time and a repolarization time at a plurality of nodes, determining a reentry susceptibility quantification at each of the plurality of nodes, identifying a candidate ablation site, simulating, in the model, an ablation at the ablation site and determining, using the model, that simulating the ablation prevents a simulated pacing from inducing simulated reentrant ventricular tachycardia. which is grouped as a mental process in MPEP 2106.04(a)(2)(III)). Further, dependent claims 2-10 and 12-20 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in independent claims 1 and 11 (and dependent claims 2-10 and 12-20) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h). Claims 1-10 do not contain any additional structural elements. However, in claims 11-20, the additional elements of an electronic processor and computer readable instructions are generically recited computer elements in independent claim 11 (and dependent claims 12-20) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent claims 1 and 11 (and dependent claims 2-10 and 12-20) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., a control unit as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 1 (and dependent claims 2-15) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent claims 1 and 11 (and dependent claims 2-10 and 12-20) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of claims 1-20 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
Claims 11-20 require the additional elements of an electronic processor and computer readable instructions. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
In light of Applicant’s specification, the claimed terms an electronic processor and computer readable instructions are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for an electronic processor and computer readable instructions. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in claims 11-20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and system of claims 1-20 is directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent claim 1 (and dependent claims 2-15) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the claims 1-20 amounts to significantly more than the abstract idea itself. Accordingly, claims 1-20 are not patent eligible and rejected under 35 U.S.C. 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: an electronic processor and computer readable instructions in claims 11-20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1 and 11 is/are rejected under 35 U.S.C. 102(a)(a) as being anticipated by Campos, Fernando O. et al., “Characterizing the clinical implementation of a novel activation-repolarization metric to identify targets for catheter ablation of ventricular tachycardiac using computational models”, Computers in Biology and Medicine, 108 (2019), pp. 263-275 (hereinafter “Campos et al.”).
In regard to claims 1 and 11, Campos et al. teaches a method of utilizing an RVI mapping algorithm using a computational model to optimize the RVI mapping algorithm (see page 264) which inherently includes the use of a processor and computer readable instructions. Campos et al. teach generating a model of at least one ventricle of a patient (see Fig. 3) and simulating pacing in the model in the at least one ventricle wherein the simulating pacing induces a simulated premature heartbeat in the model (see section 2.4). Campos et al. also teach recording an activation time and a repolarization time resulting from the simulated pacing at each of a plurality of nodes in the model (see section 3.1 and Fig. 4). A plurality of activation times and repolarization times are recorded (see section 3.3, spatial RVI maps). Campos et al. also teach determining, based on the plurality of activation times and repolarization times, a reentry susceptibility quantification at each of a plurality of nodes in the model, wherein a plurality of reentry susceptibility quantifications are determined (see RVI in Fig. 1, section 2.1.1 and equation 1). Campos et al. also teach identifying a candidate ablation site based on the plurality of reentry susceptibility quantifications (see Fig. 6 and section 4) and simulating in the model an ablation at the candidate ablation site (see section 3.6). Campos et al. also teach determining, using the model, that simulating the ablation prevents a simulated pacing from inducing simulated reentrant ventricular tachycardia (see sections 3.6, 4.2 and Figs. 10 and 11).
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 1, 2, 4-12 and 14-20 is/are rejected under 35 U.S.C. 103 as being obvious over Trayanova et al. (U.S. Patent Application Publication No. 2021/0085399) in view of Child et al., “An activation-repolarization time metric to predict localized regions of high susceptibility to re-entry”, Heart Rhythm, 12(7), July 2015 (hereinafter “Child et al.”).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 1 and 11, Trayanova et al. teach a method, system and media (see paras. 0008-0010) for identifying an ablation site, comprised of generating a model of at least one heart chamber of a patient (see paras. 0018 and 0024), simulating pacing, in the model, in the at least one heart chamber of the patient, wherein the simulated pacing induces a simulated premature heartbeat in the model (see paras. 0008 and 0029). Trayanova et al. also teach recording electrical impulse data resulting from the simulated pacing at each of a plurality of nodes in the model whereby a plurality of impulse data are recorded (see para. 0034). Trayanova et al. also teach determining, based on the plurality of electrical impulse data, a reentry susceptibility quantification at each of a plurality of nodes in the model, wherein a plurality of reentry susceptibility quantifications are determined (see paras. 0008, 0019, 0029-0030, 0038 and 0046). Trayanova et al. also teach identifying a candidate ablation site based on the plurality of reentry susceptibility quantifications (see paras. 0008 and 0047) and simulating, in the model, an ablation at the candidate ablation site (see paras. 0047 and 0056). Trayanova et al. also teach determining, using the model, that the simulating the ablation prevents a simulated pacing from inducing simulated reentrant arrhythmias (see paras. 0047 and 0056). Trayanova et al. do not specifically teach that the heart chamber is a ventricle, the electrical impulse data is an activation time and a repolarization time or the reentrant arrhythmias prevented by ablation is ventricular tachycardia. However, Child et al. teach generating a model of at least one ventricle of a mammal, simulating pacing, in the model in the at least one ventricle, wherein the simulated pacing induces a simulated premature heartbeat in the model (see page 4, para. 3, Fig. 1 and page 6, para. 2). Child et al. also teach recording an activation time and a repolarization (RVI) time resulting from simulating pacing at each of the plurality of nodes in the model (see page 3, para. 4). Child et al. also teach determining, based on an activation time and a repolarization time, reentry susceptibility quantification at each of a plurality of nodes in the model (see page 2, para. 2), wherein the simulated pacing induces simulated reentrant ventricular tachycardia (see page 8, para. 4). Since Child et al. further suggest that use of the RVI mapping for ventricular tachycardia reentry susceptibility determination as an aid to identify ablation sites in a ventricle (see page 8, para. 4), it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to have applied to models and methods to determine reentry susceptibility of Child et al. to the models and methods of Trayanova et al. in order to determine ventricular tachycardia reentry susceptibility to identify ablation sites in patients in need thereof. In regard to claims 2 and 12, see paras. 0019 and 0054 of Trayanova et al. In regard to claims 4, 5, 14 and 15, see page 12, Fig. 2 and page 3, para. 4 to page 4, para. 1 of Child et al. In regard to claims 6 and 16, see page 4, lines 1-6 and page 12, Fig. 2 of Child et al. In regard to claims 7 and 17, see para. 0029 of Trayanova et al. In regard to claims 8 and 18, see para. 0102 of Trayanova et al. In regard to claims 9 and 19, see page 6, para. 3 of Child et al. In regard to claims 10 and 20, see paras. 0019 and 0100 of Trayanova et al.
Claims 3 and 13 is/are rejected under 35 U.S.C. 103 as being obvious over Trayanova et al. (U.S. Patent Application Publication No. 2021/0085399) in view of Child et al., “An activation-repolarization time metric to predict localized regions of high susceptibility to re-entry”, Heart Rhythm, 12(7), July 2015 (hereinafter “Child et al.”) and further in view of Schmidt et al., “Genetic ablation of TASK-1 (Tandem of P domains in a weak inward rectifying K+ channel-related acid-sensitive K+ channel-1), Circ Arrhythm Eletrophysiol, 2019 (hereinafter “Schmidt et al.”).
In regard to claims 3 and 13, Schmidt et al. are silent as to genetically ablating the location in the patient’s ventricle. However, Schmidt et al. teach targeted genetic ablation as an effective therapy for atrial fibrillation (see abstract). Since Schmidt et al. further teach that the targeted therapy acts to correct electrophysiological pathology (see abstract), it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to have applied the genetic ablation taught by Schmidt et al. to locations identified by the methods of Trayanova et al. and Child et al. in order to treat patients in need thereof in a less invasive manner.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794