DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Herein, “the previous Office action” refers to the Non-Final Rejection filed 8/11/2025.
Amendments Received
Amendments to the claims were received on 10/21/2025.
Priority
As detailed on the Filing Receipt filed 8/13/2025, the instant application claims priority to as early as 5/29/2019. At this point in prosecution, all claims are accorded the earliest claimed priority date.
Claim Status
Claims 6-8 are canceled.
Claims 1-5 and 9-11 are pending, and under examination.
Withdrawn Objections/Rejections
The objection to claim 10 is hereby withdrawn in view of Applicant’s amendment of the claim to remove an extraneous number.
The rejection of claim 8 under 35 USC § 112(b), as being indefinite, is hereby withdrawn in view of Applicant’s cancelation of the claim.
The rejection of claims 6-8 under 35 USC § 101, as being directed to nonstatutory subject matter, is hereby withdrawn in view of Applicant’s cancelation of the claims.
The rejection of claims 6-8 under 35 USC § 103, as being unpatentable over Niederer, in view of Matthews, is hereby withdrawn in view of Applicant’s cancelation of the claims.
Claim Interpretation
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. This section documents the Examiner’s interpretation of
certain claim elements under this standard.
“The broadest reasonable interpretation of a method (or process) claim having
contingent limitations requires only those steps that must be performed and does not include
steps that are not required to be performed because the condition(s) precedent are not met”
(MPEP 2111.04 § II).
Claim 1 is directed to a method, and recites the limitation of “wherein when a user selects an arbitrary coordinate on the heart model, the maximum slope at the coordinate is numerically output… together with a stimulation cycle… and a location” (lines 30-34). This limitation requires output of the maximum slope, stimulation cycle and location when a user selects a coordinate.
The claim does not appear to affirmatively require that a user selects a coordinate, rather, the cited limitation indicates user selection of a coordinate as a condition precedent for output of the recited information. It is therefore considered as a contingent limitation. For purposes of prosecution, contingent limitations are not included in the broadest reasonable interpretation of the claims (MPEP 2111.04 § II).
Response to Arguments - Claim Rejections Under 35 USC § 112
In the Remarks filed 10/21/2025, Applicant traverses the rejection under 35 USC § 112 and presents supporting arguments.
Applicant notes that claims 10-11 have been amended as suggested in the previous Office action (pg. 8, para. 2). Applicant’s amendment of the claims has removed certain statutory issues under § 112(b) that were previously presented by the claims, but has not wholly rendered claims 10-11 as definite (see rejection for details). Thus, the rejection of these claims under § 112(b) is maintained.
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.
Claims 10-11 are rejected under 35 U.S.C. 112(b), as being indefinite, for failing to particularly point out and distinctly claim the subject matter which the inventor, or a joint inventor, regards as the invention. This rejection is maintained from the previous Office action, and has been revised to address the amended claims (filed 10/21/2025).
With respect to claims 10-11, there is uncertainty regarding scope of the recited limitation of “wherein when a user selects an arbitrary coordinate on the heart model, the maximum slope at the coordinate is numerically output… together with a stimulation cycle… and a location” (claim 10, lines 35-39; claim 11, lines 29-33). This wherein clause requires that the claimed device, and claimed storage medium, be capable of implementing the function of outputting recited information (e.g., the maximum slope) upon user performance of recited activity (i.e., selection of a coordinate).
A claim to a product (i.e., a device, apparatus, manufacture, or composition of matter) may contain reference to the process in which it is intended to be used, or capabilities of the product, so long as it is clear that the claim is directed to the product and not the process of use. Claims reciting limitations directed to both a product and steps of using the product (i.e., user activity) are indefinite (MPEP 2173.05(p) §§ I-II).
The recited limitation appears directed to both product capabilities and particular user activity. Thus, the limitation is indefinite. The Examiner suggests amendment to clarify reference to product capabilities, e.g., amendment to “wherein, for any selected arbitrary coordinate on the heart model, the maximum slope is numerically output… together with a stimulation cycle… and a location”.
With respect to claim 11, there is uncertainty regarding scope of the recited limitation of “to execute, in combination with a computing device, performs the steps of” (claim 11, lines 1-2).
A claim to a product (i.e., a device, apparatus, manufacture, or composition of matter) may contain reference to the process in which it is intended to be used, or capabilities of the product, so long as it is clear that the claim is directed to the product and not the process. Claims reciting limitations directed to both a product and steps of using the product (i.e., user activity) are indefinite (MPEP 2173.05(p) §§ I-II).
It is unclear if the recited limitation merely describes product capabilities, or actively requires user employment of the claimed product to perform particular process steps (e.g., loading, calculating). Hence, the recited limitation is indefinite. See MPEP 2113-4 and 2173.05(p) §§ I-II.
The Examiner suggests amendment to clarify reference to product capabilities, e.g., amendment to “which, when executed by a computing device, causes the computing device to perform steps of”.
For the above reasons, the claims are indefinite. For purposes of further prosecution herein, the claims are interpreted in accordance with the Examiner’s suggestions.
Response to Arguments - Claim Rejections Under 35 USC § 101
In the Remarks filed 10/21/2025, Applicant traverses the rejection under 35 USC § 101 and presents supporting arguments.
Applicant alleges that the claims are directed to a specific and practical technological process that improves the functioning of computational electrophysiological/cardiac modeling systems and/or the technical field of cardiac modeling (pg. 9, para. 2; pg. 10, paras. 1 and 3).
Additional elements may constitute an inventive concept, sufficient to render claims as significantly more than judicial exceptions, by virtue of providing improvement to technology. However, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing a technical improvement (see MPEP 2106.05(a) and 2106.04(d)(1)).
The following excerpts of the specification uniquely concern potential ‘improvements’:
“it is preferable to improve the accuracy by setting N to a high number… although the calculation speed may increase when N is small, the accuracy may be lowered, and although the accuracy may be improved when N is large, the calculation speed may decrease. Therefore, it will be most preferable to set N to 450,000 in consideration of both the calculation speed and accuracy ” (pp. 20-21, para. 59);
“steps… may be simultaneously performed through parallel processing, and in this case, the calculation speed may be dramatically improved” (pg. 28, para. 78).
These excerpts concern desirable model performance (i.e., efficiency and accuracy) respectively stemming from selection of model parameters, and conventional computer implementation, rather than technological improvements over prior art. Thus, the instant specification does not describe the invention such that a realized technical improvement over the prior art would be apparent to one of ordinary skill in the art, e.g., by identifying a technical problem in the field of the invention and explaining the details of an unconventional solution expressed in the claims. In the absence of requisite technical description in the specification of the provision of improvement by recited additional elements, Applicant’s assertion of such improvement is considered conclusory. See Simio, LLC v. FlexSim Software Prods., Inc., 983 F.3d at 1353 (Fed. Cir. 2020).
Furthermore, the specification describes exemplary components of the claimed device as general-purpose computer hardware having conventional functionality. In describing components of the claimed device, the instant specification states: “The processor may be any one among a central processing unit (CPU)… and a type of processor widely known in the art… The network interface supports wired/wireless Internet communication… The memory may store various data, commands and/or information… RAM… [and other] various storage media may be used as the memory…. The storage may be any one among non-volatile memory such as read only memory (ROM)… and computer-readable recording media of an arbitrary form widely known in the technical field to which the present invention belongs” (pg. 15, para. 46 – pg. 17, para. 49).
In this way, the specification underscores the inclusion of general-purpose computer hardware within the scope of the claimed device. It is unclear how the claimed technical components, encompassing general-purpose computer hardware, improve the functioning of computational modeling systems (i.e., computers) and/or other technology employed in the field of cardiac modeling. The invention does not appear, by virtue of including the cited features, to provide technical improvement. Thus, the argument is found unpersuasive.
In particular, Applicant notes that the claimed invention produces a color image which visualizes risk of atrial fibrillation and alleges that this feature provides a technological solution to a medical imaging problem by improving preoperative visualization for cardiac ablation (pg. 9, para. 3).
The specification does not describe the referenced medical imaging problem, nor its solution by technical features of the claimed invention. In the absence of requisite technical description it is unclear how claimed additional elements, encompassing well-known technology, provide solution to a previously-recognized technological problem. See TLI Comms. LLC v. AV Auto. LLC, 823 F.3d 607 (Fed. Cir. 2016, hereafter “TLI”), in which the court ruled that steps of analyzing particular data, and visualizing results, using conventional or generic technology were insufficient to show an improvement in technical functionality (Id. at 611-13). Thus, the argument of technical solution is found unpersuasive.
Applicant notes that the claimed invention provides a diagnostic tool having real world clinical applications, producing a tangible medical image that helps doctors determine where atrial fibrillation may happen and decide where the ablative signal should be applied (pg. 9, para. 3; pg. 10, para. 1).
The claims do not require that results of the recited data analysis are tangibly (i.e., physically) rendered, instead requiring their “visual[] output”. In Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350 (Fed. Cir. 2016, hereafter “Electric Power”), the court held that computer-implemented steps drawn to visualizing results of particular data analysis were abstract (Id. at 1353-54). The potential clinical usefulness of the output is not germane to subject matter eligibility of the claims, as its clinical application is not claimed. Thus, the argument to clinical utility is found unpersuasive.
Applicant alleges that the asserted technological improvement integrates any recited mathematical concept in the manner described in MPEP 2106.04(d), and points to the court decisions in McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir 2016; hereafter “McRO”) and CardioNet, LLC v. Infobionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020; hereafter, “CardioNet”) (pg. 9, para. 4 – pg. 10, para. 1).
The claims considered for eligibility in McRO were directed to a method of defining and applying a derived function to timed phoneme subsequences to automatically render a synchronous 3D animation of facial expressions (837 F.3d at 1307-1308). The court found that the considered invention provided an improvement rooted in the application of an unconventional set of specific mathematical rules (i.e., a ‘specific means or method’), wherein an analogous process for rendering 3d animation of facial expressions was not known in the art prior to the filing of the considered claims. Accordingly, the claims were held eligible under § 101. See McRO at 1314.
The mere fact that the considered claims provided a computerized method of performing a technological process did not render the considered claims as eligible in the eyes of the McRO court. Unlike the fact pattern considered in McRO, there is no evidence in the instant specification that the claimed invention newly enables technical performance of recited tasks, via a computerized method distinct from mere computer implementation of abstract ideas. The instant claims are not considered to be eligible under similar reasoning to that provided by the McRO court.
The claims considered for eligibility in CardioNet were directed to a device, including a ventricular beat detector, which detects beat-to-beat timing of cardiac activity and correlates variance in timing to heart conditions. The court found that the considered invention provided an improvement rooted in said particular device (i.e., in a ‘specific means or method’), a finding suggested by the record as a whole and corroborated by the considered specification. Accordingly, the claims were found eligible under § 101. See CardioNet at 1365-70.
Unlike the particular device considered in CardioNet, the claimed invention does not include specialized hardware components (e.g., a ventricular beat detector). Claim 10, for example, recites a device comprising: one or more processors; a network interface; a memory for loading a computer program; and a storage for storing the computer program, wherein the computer program, when executed by the processor(s), cause the processor(s) to perform various data processing and output functions. The courts have held that processing and visually outputting data are conventional functions of general-purpose computer hardware (see, e.g., In re Katz , 639 F.3d 1303, 1316 (Fed. Cir. 2011); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 612-13 (Fed. Cir. 2016)), thus the recited functional limitations are not considered to require the inclusion of specialized hardware components. The fact pattern of the instant application is therefore considered non-analogous to that considered in CardioNet.
Applicant has not provided evidence for provision of improvement to technology by a specific means or method claimed, such as those provided by the claims considered in CardioNet or McRO. Hence, argument of analogy to these decisions is unpersuasive.
Applicant alleges that particular claimed elements represent meaningful limitations that are neither routine nor conventional, each contributing to diagnostic improvement, and points to the inclusion of real patient voltage data, 3D spatial coordinates, time series analysis, exponential correlation modeling, and slope-based color visualization (pg. 10, para. 2).
The claims are drawn to performance of analytical functions using voltage values associated with spatial coordinates and time intervals. Requiring performance using real patient voltage data, and 3D spatial coordinates, further limits the nature of the utilized data (i.e., its origin and representative significance) but does not significantly alter the recited functions themselves. Time series analysis refers broadly to statistical analysis of temporally-indexed data, i.e., a mathematical operation defined by the temporal nature of the analyzed data. The performed exponential correlation modeling is likewise a mathematical operation, while the performed slope-based color visualization is output of resulting data in particular form.
An inventive concept cannot be furnished by a judicial exception itself (Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376 (Fed. Cir. 2016)). Neither can an inventive concept be furnished by a combination of judicial exceptions albeit unconventional (RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327-28 (Fed. Cir. 2017)), limitation of a process to performance using particular data (Electric Power at 1353-54; SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161 (Fed. Cir. 2018); Recentive v. Fox, 134 F.4th 1205, 1213-14 (Fed. Cir. 2025)), or visualizing a result of particular data analysis (TLI at 612-13). A finding that recited additional elements are not well-understood, routine and conventional within a particular field is, by itself, not sufficient to render claims as patent eligible (Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315 (Fed. Cir. 2016); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151 (Fed. Cir. 2016)). As detailed above, Applicant’s assertion of technical improvement is considered conclusory. Thus, in the absence of further substantive rationale, the presented argument is found unpersuasive.
For the above reasons, the arguments are found unpersuasive and the rejection is maintained.
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 1-5 and 9-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more (i.e., non-statutory subject matter). This rejection is maintained from the previous Office action, and has been revised to address the amended claims (filed 10/21/2025).
"Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I).
Abstract ideas include mathematical concepts (including formulas, equations and calculations), and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)).
The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea.
Step 1: The Four Categories of Statutory Subject Matter (MPEP 2106.03)
Claims 1-5 and 9 are directed to a method, which falls under the ‘process’ category of statutory subject matter; and claim 10 is directed to a device, which falls under the ‘apparatus’ category of statutory subject matter.
Claim 11 is directed to “[a] processor-executable computer program stored in a medium”. The claimed subject matter encompasses transitory embodiments (e.g., propagating signals) which do not fall under any category of statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007); Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, 1294 (Fed. Cir. 2017).
The specification states that “the present invention may be implemented as a computer program stored in a storage medium to be executed by a computer” (para. 93). The Examiner suggests amendment to, e.g., “[a] non-transitory computer readable medium storing a processor-executable computer program”. Direction of the claim to non-transitory embodiments of the recited storage medium, rather than to the computer program itself, would cause the claim to fall under a category of statutory subject matter and overcome this portion of the rejection.
However, this amendment alone would likely not overcome rejection for recitation of judicial exceptions without significantly more. In the interest of compact prosecution, the recited subject matter has been interpreted according to the Examiner’s suggestion for further analysis below regarding recitation of judicial exceptions without significantly more.
Step 2A, Prong One: Whether the Claims Set Forth or Describe a Judicial Exception (MPEP 2106.04 § II.A.1)
‘Mathematical concepts’ are relationships between variables and numbers, numerical formulas or equations, or acts of calculation, which need not be expressed in mathematical symbols (MPEP 2106.04(a)(2) § I). The claims recite elements which encompass mathematical concepts, at least under their broadest reasonable interpretation, including:
“calculating a relaxation period… from a point… included in a first predetermined time interval to… [a] point included in a next first predetermined time interval at specific coordinates included in [a] heart model using… time-specific voltage data” (claims 1 and 10-11), i.e., calculating a value;
“calculating an action potential duration… from a point… included in a first predetermined time interval to… [a] point included in a next first predetermined time interval at specific coordinates included in [a] heart model using… time-specific voltage data” (claim 1 and 10-11), i.e., calculating a value;
“calculating a correlation between the relaxation period and the action potential duration at specific coordinates in the calculated heart model” (claims 1 and 10-11), i.e., calculating a similarity metric, wherein:
“the correlation between the relaxation period and the action potential duration… is calculated through… [the] formula… y (action potential duration) = y0 – A1(1 – e–relaxation period / τ1), where y0 and A1 are free-fitting variables, and τ1 is a time constant” (claim 5), i.e., a particular equation; and
“calculating a maximum slope using the calculated correlation” (claims 1 and 10-11), i.e., calculating a value, wherein:
“the maximum slope is calculated by differentiating the correlation calculation formula with respect to the relaxation duration” (claim 6), i.e., solving an equation; and
“applying an interpolation method to the maximum slope calculated… for areas… in the heart model” (claims 1 and 10-11), i.e., applying a mathematical technique to numeric data.
The recited acts of calculation constitute mathematical concepts.
The following claim elements delimit embodiments of the above mathematical concepts, but do not alter their characterization as mathematical concepts:
“the heart model is a three-dimensional atrium model generated for each patient” (claim 2);
“the… coordinates are 450,000 coordinates” (claim 3);
“the first predetermined time interval is any one among 1ms, 2ms, and 3ms” (claim 4); and
“a range of a magnitude of the calculated maximum slope is 0.3 to 2.3” (claim 9).
‘Mental processes’ are processes that can be performed in the human mind at least with use of a physical aid, e.g., a slide rule or pen and paper (MPEP 2106.04(a)(2) § III). The claims recite the following contingent element that encompasses a process that is practicably performable in the human mind, at least under the broadest reasonable interpretation:
“a user selects an arbitrary coordinate on the heart model” (claim 1), i.e. selecting a data point.
As this element is currently recited in contingent form, it is not considered to fall
within the broadest reasonable interpretation of the claims (see ‘Claim Interpretation’
section). Were said element required under the broadest reasonable interpretation of
the claims (i.e., were it rendered non-contingent by appropriate amendment), it
would be considered as encompassing a mental process.
Mathematical concepts and mental processes constitute enumerated groupings of abstract ideas (MPEP 2106.04(a)(2) §§ I and III). Hence, the claims recite elements that, individually and in combination, constitute an abstract idea. The claims must therefore be examined further to determine whether they integrate this abstract idea into a practical application (MPEP 2106.04(d)).
Step 2A, Prong Two: Whether the Claims Contain Additional Elements that Integrate the Judicial Exception(s) into a Practical Application (MPEP 2106.04 § II.A.2)
The claims recite the following additional element that gathers data necessary for performance of claimed method steps:
“loading a heart model including… coordinates, and… time-specific voltage data including voltage values measured at… coordinates included in the heart model at first predetermined time intervals” (claims 1 and 10-11).
Necessary data gathering is considered to be insignificant pre-solution activity, and as such insufficient to integrate an abstract idea into a practical application (MPEP 2106.05(g)). Additionally, the claimed process of loading data, i.e., loading electronic data into computer memory, requires performance using computer hardware. The claims recite further additional elements that require performance of claimed functions using computer hardware and/or software, or constitute computer hardware and/or software for performing the claimed functions, including:
“[a] device comprising: one or more processors; a network interface; a memory… and a storage… wherein [a stored] computer program, when executed by the one or more processors, causes the one or more processors to perform” steps of the claimed method (claim 10); and
“[a] non-transitory computer readable medium storing a processor-executable computer program which, when executed by a computing device, causes the computing device to perform steps of” the claimed method (claim 11, see ‘Claim Rejections - 35 USC § 112’ section and Step 1 analysis).
The claims do not describe any specific computational steps by which a computer performs or carries out functions drawn to the abstract idea, nor do they provide any details of how specific structures of a computer are used to implement these functions. The claims state nothing more than that a generic computer performs functions drawn to the abstract idea, and are therefore mere instructions to apply the abstract idea using a computer. As such, the claims do not integrate the abstract idea into a practical application (see MPEP 2106.04(d) § I and 2106.05(f)).
The claims recite further additional elements directed to outputting results of claimed method steps in particular form, including:
“visually outputting an image of the calculated maximum slope by reflecting the maximum slope to specific coordinates included in the heart model” (claims 1 and 10-11), i.e., visualizing a calculated number, including “outputting the maximum slope in a different color according to the magnitude of the calculated maximum slope” (claims 1 and 10-11);
“the heart model is configured to be visually output with the entire heart model colored according to the magnitude of the maximum slope” (claims 1 and 10-11);
“for any selected arbitrary coordinate on the heart model, the maximum slope is numerically output… together with a stimulation cycle… and a location” (claims 10-11, see ‘Claim Rejections - 35 USC § 112’ section);
“the maximum slope at the coordinate is numerically output, together with a stimulation cycle of an electrical signal which was applied to the heart model… and a location where the electrical signal was applied” (claims 1 and 10-11);
The claims further recite “repeatedly perform[ing]” the above-indexed acts of calculation and visual output for additional coordinates included in the heart model (claims 1 and 10-11). Mere repetition of abstract and insignificant extra-solution activity does not materially alter the abstract nature of recited abstract ideas, does not integrate recited abstract ideas into a practical application, and does not provide an inventive concept.
No further additional elements are recited.
When the claims are considered as a whole: they do not improve the functioning of a computer, other technology, or technical field (MPEP 2106.04(d)(1) and 2106.05(a)); they do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition (MPEP 2106.04(d)(2)); they do not implement the abstract idea with, or in conjunction with, a particular machine (MPEP 2106.05(b)); they do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)); and they do not apply or use the abstract idea in some other meaningful way beyond linking the use of the abstract idea to a particular technological environment and/or field of use (e.g., cardiac pathology; MPEP 2106.05(e) and 2106.05(h)).
Therefore, the claims do not integrate the abstract idea into a practical application. See MPEP 2106.04(d) § I.
Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are directed to the abstract idea. Claims that are directed to an abstract idea must be examined further to determine whether the additional elements besides the abstract idea render the claims significantly more than the abstract idea. Additional elements besides the abstract idea may constitute inventive concepts that are sufficient to render the claims significantly more (MPEP 2106.05).
Step 2B: Whether the Claims Contain Additional Elements that Amount to an Inventive Concept (MPEP 2106.05)
As noted above, several recited additional elements amount to insignificant extra-solution activity. Mere addition of insignificant extra-solution activity does not amount to an inventive concept that would render the claims significantly more than the recited abstract idea, particularly when the activities are well-understood or conventional (MPEP 2106.05(g)). The conventionality of recited additional elements that amount to insignificant extra-solution activity must be further considered.
Recited additional elements amounting to insignificant extra-solution activity encompass the following computer-implemented functions, which the courts have held as coextensive with a general-purpose computer and/or well-understood, routine and conventional:
Receiving, storing, and processing data (In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1316 (Fed. Cir. 2011); EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 622 (Fed. Cir. 2015)), including:
Receiving data over a network (buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015)), and
Storing and retrieving information in memory (OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015); Versata Dev. Group, Inc. v. SAP America, Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015));
Selecting information for display (Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55 (Fed. Cir. 2016));
Displaying the result of data analysis (TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 612-13 (Fed. Cir. 2016)); and
Displaying electronic data (Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1344-45 (Fed. Cir. 2018)).
Hence, the encompassed extra-solution activity is considered well-understood, routine and conventional. Well-understood, routine and conventional activity is insufficient to constitute an inventive concept that would render the claims significantly more than judicial exceptions (MPEP 2106.05(d)).
Mere instructions to implement judicial exceptions using a computer are, when considered individually, similarly insufficient to constitute an inventive concept that would render the claims significantly more than said judicial exceptions (see MPEP 2106.05(f)).
When the claims are considered as a whole, they do not integrate the judicial exceptions into a practical application; they do not confine the use of the judicial exceptions to a particular technology; they do not solve a problem rooted in or arising from the use of a
particular technology; they do not improve a technology by allowing the technology to
perform a function that it previously was not capable of performing; and they do not
provide any limitations beyond generally linking the use of the judicial exceptions to a particular technological environment and/or field of use (e.g., cardiac pathology; MPEP 2106.05(e) and 2106.05(h)).
Therefore, the claims do not provide an inventive concept and/or significantly more than the judicial exceptions themselves. See MPEP 2106.05.
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not constitute significantly more than the abstract idea, so the claims are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Response to Arguments - Claim Rejections Under 35 USC § 103
In the Remarks filed 10/21/2025, Applicant traverses the rejections under 35 USC § 103 and presents supporting arguments.
Applicant notes that the technique of Niederer utilizes conduction velocity (CV) and effective refractory period (ERP) values as key model parameters, and alleges that one of ordinary skill in the art would have attempted to improve the relevant technology by exploring other techniques related to said parameters rather than being motivated to import an entirely different approach, e.g., modeling based on APD repolarization slope as discussed by Matthews (pg. 11, para. 2).
A conclusion of obviousness may take into account "the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)), considering that “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton” (Id. at 421). The Examiner considers that one of ordinary skill in the art would be of sufficient creativity to experiment with known alternative model parameters (e.g., APD restitution) beyond those utilized by Niederer. Thus, the argument is found unpersuasive.
Applicant notes that Matthews discusses superior performance of the wavelength repolarization method to the APD repolarization method for arrythmia prediction, and alleges that Matthews thus teaches away from adoption of maximum slope of APD repolarization as a core diagnostic parameter (pg. 11, para. 3).
Matthews discusses predictive modeling of cardiac arrythmia based on restitution slopes of three different metrics: APD, conduction velocity (θ’), and wavelength (λ’, the product of APD and θ’). Matthews teaches that APD restitution “has previously been extensively studied for arrythmia prediction” (pg. 4168, l. column), and “has been successful in some studies at predicting arrhythmogenesis” although “others do not confirm a clear-cut relationship” (pg. 4168, r. column). Matthews thus characterizes APD restitution-based modeling as a well-established technique in the art with recognized, albeit mixed, predictive utility.
Matthews evaluates the predictive performance of each restitution metric, and presents findings that “when plotted over a physiological range between restitution slopes of 0 to mmax, the λ’ restitution relationship showed a closer adherence and converged towards the line of equality. In contrast, APD restitution significantly underestimated the magnitude of alternans and diverged from equality, suggesting that a function which includes θ is superior to one employing APD alone” (pg. 4180, l. column). Matthews thus describes predictive modeling based on wavelength restitution (i.e., a combination of APD and CV restitution) as more effective than predictive modeling based on either of APD restitution or CV restitution alone.
Noting findings that APD restitution is less effective than a preferred metric (λ’) does not negate its presentation as a known alternative to CV restitution, and does not amount to teaching away from its use in predictive modeling of cardiac arrythmia. Moreover, said preferred metric mathematically incorporates APD. A reference does not teach away from experimentation with elements that its preferred alternative relies upon.
Given that the preferred modeling technique disclosed by Matthews resulted from the authors’ experimentation with APD restitution as a core model parameter, the argument that Matthews teaches away is found unpersuasive. See In re Fulton, 391 F.3d 1195, 1200-01 (Fed. Cir. 2004).
Applicant alleges that the rejection appears to rely on improper hindsight reconstruction (pg. 11, para. 4). A judgment of obviousness is proper, albeit in a sense necessarily a hindsight
reconstruction, so long only relies upon knowledge which was within the level of ordinary
skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure (In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971)). Relevant teachings from the applied combination of references are outlined in the rejections under 35 USC § 103, and Applicant’s own disclosure is not relied upon as a source of knowledge therein. Thus, the argument of improper hindsight reconstruction is found unpersuasive.
For the above reasons, the arguments are found unpersuasive and the rejections are maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 USC §§ 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, 4-5 and 9-11 are rejected under 35 USC § 103 as being unpatentable over Niederer et al (WO 2017/203250; published 11/30/2017; on IDS filed 10/18/2021), in view of Matthews et al (J Physiol 591(17): 4167-4188; published 7/13/2013). This rejection is maintained from the previous Office action, and has been revised to address the amended claims (filed 10/21/2025).
Claim 1 recites a device-executed heart model generation method comprising steps of: loading a heart model including N (≥ 1) coordinate(s) and time-specific voltage data including voltage values measured at the N coordinates at first predetermined time intervals; calculating a relaxation period from an ‘APD90’ point to an electrically stimulated point; calculating an action potential duration (APD) from an electrically stimulated point to an ‘APD90’ point; calculating a correlation between the relaxation period and the APD, and calculating a maximum slope using the correlation; visually outputting the calculated maximum slope by reflecting the maximum slope to specific coordinates in the heart model; repeatedly performing the calculating and outputting steps for all the N coordinates included in the heart model except the specific coordinates; applying an interpolation method to the maximum slope calculated for the N coordinates; and visually outputting an image of the maximum slope for areas of the heart model located between the N coordinates.
The claim further specifies that: the APD90 point is a point showing a voltage value dropped 90% from the highest point of the voltage value included in a first predetermined time interval; the electrically stimulated point is a point included in a next predetermined time interval; the visual output is outputting the maximum slope in a different color according to the magnitude of the calculated maximum slope; the heart model is configured by the interpolation step to be visually output with the entire heart model colored according to the magnitude of the maximum slope; and when a user selects an arbitrary coordinate on the heart model, the maximum slope at the coordinate is numerically output together with a stimulation cycle of an electrical signal which was applied to the heart model to measure the voltage values and a location where the electrical signal was applied.
With respect to claim 1, Niederer discloses a method for personalized heart tissue model generation (Abstract), comprising: recording electrocardiographic measurements including effective refractory period (ERP), i.e., relaxation period, and conduction velocity (CV) and generating a personalized heart tissue model therefrom (pg. 2, para. 2; pg. 3, para. 5), wherein the electrophysiology measurements are scaled to produce a voltage variable (pg. 28, para. 4), discretized over fixed spatial and time intervals (pg. 16, para. 4; pg. 31, paras. 2-3), and modeled for every discrete node (pg. 31, paras. 5-7), i.e., interpolated for every coordinate; fitting ERP and CV restitution curves as a function of activation times (pg. 18, para. 4 – pg. 19, para. 1; Fig. 6), i.e., calculating a correlation between relaxation period and activation; plotting activation patterns to a 3D image map of localized heart tissue, and displaying the map to a user (pg. 3, para. 2; pg. 4, para. 2), i.e., visually outputting results by reflecting results to specific coordinates included in the heart model, wherein pacing protocol information is stored (pg. 13, para. 1) and the location of the patterns on the image corresponds to the location of the patterns within the tissue (pg. 15, para. 1).
Niederer mentions APD restitution analysis (pg. 24, para. 3), but does not further describe the technique and does not specifically disclose calculating APD; calculating a correlation between relaxation period and APD; calculating a maximum slope using the correlation; or reflecting the maximum slope to specific coordinates of the output heart model.
Niederer presents a visualization of statistical results wherein color represents time (pg. 7, para. 2; Figure 9), i.e., visual representation of a parameter in different colors according to its numeric magnitude. However, Niederer does not disclose coloring output according to magnitude of the maximum slope.
Matthews discusses analysis of cardiac electrophysiological measurements and assessment of arrythmia, and teaches: calculating diastolic interval (pg. 4171, abbreviated as ‘DI’), i.e., relaxation period; detecting time to peak following stimulation and 90% repolarization to baseline, i.e., action potential duration (APD); calculating wavelength restitution parameters that relate resting and active wavelengths, using exponential decay functions, and calculating maximum restitution gradients (pg. 4170, r. column - pg. 4171, r. column), i.e., maximum slopes. Matthews further teaches plotting and processing data for individual hearts (pg. 4171, l. column), characterizing their employed methodology as personalized modeling of heart tissue.
Matthews does note findings that calculated slopes of wavelength restitution functions showed greater adherence to alternans magnitude than APD restitution, i.e., greater prediction of arrhythmia than direct correlation of DI to APD (pg. 4167, ‘Key points’ and Abstract; pg. 4180, l. column; see description of APD restitution at pg. 4168, l. column). However, Matthews explicitly characterizes wavelength restitution as a statistical extension of APD restitution (pg. 4173, l. column), noting the mathematical relationships between DI/APD and resting/active wavelengths, and teaching that wavelength restitution similarly correlates DI and APD with the inclusion of a latency term (pg. 4169, Figure 1B; pg. 4173, l. column). Thus, the disclosed wavelength restitution technique is considered to be a special case (i.e., a species) of the claimed APD restitution technique.
Furthermore, Matthews notes that APD restitution has been extensively studied for arrythmia prediction (pg. 4168, l. column) and found successful at predicting arrhythmogenesis in some studies (pg. 4168, r. column). Thus, Matthews is considered to teach calculating a correlation between relaxation period and APD as claimed.
With respect to claim 2, Niederer discloses performing a 3D simulation using the personalized heart tissue model, by simulating a stimulation pacing protocol and calculating tissue activation results across a simulated 3D region of heart tissue (pg. 4, para. 2).
Niederer further discloses collecting activation measurements from the atrium of the heart (pg. 9, para. 2; pg. 10, para. 3), and characterizes their method as generating local ionic models for patient-specific simulations of atrial function (pg. 25, paras. 2). Niederer thus discloses implementation of the electrophysiology model as a three-dimensional atrium model generated for each patient.
With respect to claim 4, Niederer discloses discretizing measured data according to a fixed time interval of 0.1 ms (pg. 31, para. 3).
With respect to claim 5, Matthews teaches exponential decay functions that are equivalent to the claimed equation (pg. 4171, l. column, see Equations 1 and 12).
With respect to claim 9, Matthews teaches calculating maximum restitution gradients (pg. 4170, r. column - pg. 4171, r. column), i.e. maximum slopes, and discusses study findings that a calculated maximum active wavelength restitution gradient typically took a value of 1.7 (pg. 4179, r. column). Where prior art discloses a value which occurs within a claimed range, the prior art disclosure renders the claimed range as obvious (MPEP 2144.05 § I). Thus, Matthews makes obvious the claimed range of between 0.3 – 2.3.
Claim 10 is directed to a device comprising processor(s), a network interface, a memory, and storage, wherein a stored computer program implements recited functions. The functional limitations of the claim are of substantive similarity to the process limitations of claim 1.
With respect to claim 10, Niederer discloses a tissue model generation and simulation apparatus, comprising: a central processing unit; a storage medium, such as a hard disk or flash drive, on which is stored programs that control operation of the apparatus; an input/output port; and a visual display (pg. 12, para. 2 – pg. 13, para. 1; Figure 11).
Computer processing units contain embedded caches, which are a form of computer memory. Niederer also discloses that activation data may be received at the apparatus by email, or other file transfer mechanism (pg. 14, para. 1), which requires that the disclosed apparatus include a network interface. Thus, Niederer is considered to inherently disclose the claimed components of memory and a network interface.
The combined teachings of Niederer and Matthews are considered to apply to the functional limitations of the claim in the same manner as detailed above regarding the process limitations of claim 1.
Claim 11 is directed to a computer program stored in a medium to execute, in combination with a computing device, recited functions. The functional limitations of the claim are of substantive similarity to the process limitations of claim 1.
With respect to claim 11, Niederer discloses a computer readable storage medium on which is stored programs that control operation of an apparatus (pg. 12, para. 3; Figure 11). The combined teachings of Niederer and Matthews are considered to apply to the functional limitations of the claim in the same manner as detailed above regarding the process limitations of claim 1.
An invention would have been obvious to one of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, said practitioner would have combined APD restitution analysis, as taught by Matthews, with the personalized heart tissue model generation method taught by Niederer, because Matthews teaches that APD restitution has been conventionally employed and experimentally validated for arrythmia prediction (pg. 4168, l. column). Said practitioner would have had a reasonable expectation of success because Niederer and Matthews both discuss modeling of electrophysiological data measured from the heart of a patient and simulation of atrial stimulation.
In this way the disclosure of Niederer, in view of Matthews, makes obvious the limitations of claims 1-2, 4-5 and 9-11. Thus, the invention is prima facie obvious.
Claim 3 is rejected under 35 USC § 103 as being unpatentable over Niederer, in view of Matthews, as applied to claim 1 above, and further in view of Garny et al (Prog Biophys Mol Biol 87(1): 47-66; published 7/30/2004; previously cited). This rejection is maintained from the previous Office action.
With respect to claim 3, Niederer discloses discretizing measured data over a fixed spatial domain, having a length of 20 cm, according to a fixed spatial interval of 200 μm (pg. 31, para. 2). Discretizing the exemplified domain length over the exemplified interval renders 1001 discrete spatial nodes, i.e., coordinates. Niederer does not disclose modeling 450,000 coordinates.
Matthews teaches dimensioning of DI in terms of time (pg. 4183, l. column). Matthews does not teach modeling 450,000 coordinates.
Garny discusses cardiac modelling, and teaches that three-dimensional cardiac simulations consisting of ~500,000 nodes, i.e., including 450,000 coordinates, can be run on personal desktop computers (pg. 48, Introduction). In this way Garny provides evidence that modeling ~450,000 coordinates was both technologically enabled, and contemplated in the field of cardiac modeling, before the effective filing date of the claimed invention.
An invention would have been obvious to one of ordinary skill in the art if it simply
applies known techniques to a known method. Before the effective filing date of the claimed invention, said practitioner would have utilized a heart model including 450,000 coordinates, as discussed by Garny, in combination with the personalized heart tissue model generation method taught by Niederer, in view of Matthews, because Garny teaches that modeling including 450,000 coordinates was known in the art. Said practitioner would have had a reasonable expectation of success because Niederer and Garny both discuss cardiac modeling.
In this way the disclosure of Niederer, in view of Matthews and Garny, makes obvious the limitations of claim 3. Thus, the claimed invention is prima facie obvious.
Conclusion
At this point is prosecution, no claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/T.C.S./Examiner, Art Unit 1685
/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 January 9, 2026