DETAILED ACTION
Applicant's response, filed 30 September 2025, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 33-35, 37-39, and 48-59 are currently pending and under exam herein.
Claims 48-59 are newly presented.
Claims 1-32, 36, and 40-47 have been cancelled.
Information Disclosure Statement
The Information Disclosure Statement filed 12 August 2025 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
Claim Objections
The outstanding claim objections are hereby withdrawn in view of the amendments filed.
Claim Rejections - 35 USC § 112, 1st paragraph
The outstanding claim rejections under 35 USC 112(a) are hereby withdrawn in view of the claim amendments filed and in view of cancellation of claims 36 and 40-47.
Claim Rejections - 35 USC § 112, 2nd paragraph
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 33-35, 37-39, and 48-59 are rejected under 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 applicant regards as the invention.
Claims 33, 48, and 54 recite, “simulating, by a processor, a plurality of different treatments with a physiological model personalized to the organ based on the segmented data, the different treatments;”, wherein the claim language fails to make sense with respect to what is being modified by “, the different treatments;”. The claim construction presents an incomplete step. Clarification is requested through clearer claim language.
Claims 33, 48, and 54 recite, “using the generated blood flow characteristic value to determine statistical variation of the blood flow characteristic value as a result of adjustment of the uncertainties”, wherein there is no “adjustment” to any uncertainties claimed in earlier steps, rendering said recitation unclear. Clarification is requested through clearer claim language.
Claims 35, 50, and 56 recite, “wherein simulating comprises identifying past patients similar to the first patient and using past patient blood flow characteristics for the different treatments as the results of the simulation for the first patient”, wherein the “results” recited are not clear as no such “results” are claimed in claims 33, 48, and 54 from which said claims depend. Clarification is requested.
Claims 38, 52, and 58 recite, “wherein presenting comprises presenting the simulated outcomes and respective estimated uncertainties in a ranked order”, wherein the step of “presenting” lacks antecedent basis in the claims as no such “presenting” is claimed in previous recitations. Rather, the claims 33, 48, and 54 (from which said claims depend), recite, “providing”. Clarification is requested.
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 33-35, 37-39, and 48-59 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Directed to process, machine, manufacture/composition of matter Assessment
With respect to step (1): yes, the claims are directed to a method, system, and computer-readable medium for decision support therapy.
Step 2A, Prong 1: Do Claims Recite Abstract Idea Assessment
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and/or mathematical concepts (in particular mathematical relationships and formulas).
The claim steps to abstract ideas are as follows:
Claims 33, 48, 54: simulating a plurality of different treatments with a physiological model personalized to the organ based on the segmented data, the different treatments, wherein steps of “simulating” under the broadest reasonable interpretation (BRI) and given the plain meaning of said term are interpreted as steps that can be performed via mathematical operation and directed to mathematical concepts wherein “simulations” include steps implemented via, for example, computational fluid dynamic calculations for collocation points (instant Specification at [0052]; [0053]); estimating uncertainties in simulated outcomes of the different treatments, wherein an uncertainty variable is a mathematical operations. The instant Specification indicates that uncertainty calculations as pertain to FFR, for example may be performed [0049]; [0051]. As such, the claims include steps directed to abstract ideas; generating a blood flow characteristic value using the physiological model, the uncertainties, and the different treatments, wherein under the broadest reasonable interpretation (BRI) and given the plain meaning of said term are interpreted as steps that can be performed via mental operations of value generation. No particular steps beyond said plain meaning are claimed; using the generated blood flow characteristic value to determine statistical variation of the blood flow characteristic value as a result of adjustment of the uncertainties, wherein operations of statistical variation determination are those that can be reasonably performed using mental operation (pen and paper calculations) as no steps beyond said plain meaning are claimed.
Claims 34: simulating comprises…wherein steps of “simulating” are further limiting to the mathematical operations discussed above and are directed to abstract ideas.
Claim 35: simulating comprises identifying past patients similar to the first patient and using past patient blood flow characteristics for the different treastments as the results of the simulation for the first patient, wherein steps of “simulating” and steps of “identifying” are further limiting to the mathematical operations (simulate) and mental operations (identify) discussed above and are directed to abstract ideas.
Claim 37: estimating comprises estimating the uncertainties in the simulated outcomes of the simulating based on variability of the simulated outcomes, wherein said operations are mathematical concepts of assessing an estimation of data as per the instant Specification at least at [0046]-FFR value estimations.
Claim 38: presenting comprises presenting the simulated outcomes and respective estimated uncertainties in a ranked order, wherein “ranking” is, under its plain meaning, a mathematical operation and/or mental operation of placing items in a particular hierarchical order.
Claim 39: simulating comprises simulating with the physiological model providing biomechanical parameters with inverse modeling or computation fluid dynamics and the different therapies comprising variation in stent properties in a stent model, the simulating being interaction of the stent model with the physiological model, wherein operations of “simulation” include steps implemented via, for example, computational fluid dynamic calculations for collocation points (instant Specification at [0052]; [0053]).
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined as similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts 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" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); 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").
Further, to the instant claims reciting “mathematical concepts” (see MPEP § 2106.04(a)(2), subsection I: including a mathematical relationship between enhanced directional radio activity and antenna conductor arrangement (i.e., the length of the conductors with respect to the operating wave length and the angle between the conductors), Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86, 91, 40 USPQ 199, 201 (1939): while the litigated claims 15 and 16 of U.S. Patent No. 1,974,387 expressed this mathematical relationship using a formula that described the angle between the conductors, other claims in the patent (e.g., claim 1) expressed the mathematical relationship in words); as well as organizing information and manipulating information through mathematical correlations (in Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). The patentee in Digitech claimed methods of generating first and second data by taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form. The court explained that such claims were directed to an abstract idea because they described a process of organizing information through mathematical correlations, like Flook's method of calculating using a mathematical formula. 758 F.3d at 1350, 111 USPQ2d at 1721).
Step 2A, Prong 2:Integration to a Practical Application Assessment
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claim 33, 48, 54: segmenting organ data representing an organ of a patient; processor; providing a display
Further with respect to the additional elements in the instant claims, those steps directed to data gathering, such as “segmenting image data” and “inputting patient information” perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further steps herein directed to additional non-abstract elements of “processor” do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)).
None of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application.
Step 2B: Do Claims Provide an Inventive Concept Assessment
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to steps directed to “segmenting data” in an image, said operations are steps that, as described in the prior art to, for example Patil et al. (International Journal of Computer Science and Mobile Computing (2013) Vol. 2:22-27) disclosing that image segmentation is a critical function in image analysis techniques and that automated algorithms are key to facilitating such steps (abstract). Patil et al. disclose segmenting anatomical structures or regions of interest as detailed (pages 22-27). As such, said operations are routine and well-known in the art of image acquisition for data analysis.
With respect to the instant claims the computer-related elements and data input or the general purpose computer do not rise to the level of significantly more than the judicial exception. Further the specification also notes that computer processors and systems, as example, are commercially available or widely used [0048]. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
1. Applicant states that claim 33 has been amended and that “these elements require significantly more than an abstract idea, and integrate the any alleged abstract idea into the practical application”.
This is not persuasive for the rationales provided and outlined above in the framework analysis. Applicant has provided no specifics as to what elements provide for integration herein.
Claim Rejections - 35 USC § 102/103
With respect to the outstanding rejections under 35 USC 102 over 7,912,528 to Krishnan et al., said rejections are withdrawn in view of the claim amendments to claims 33 (and newly presented claims 48 and 54) including steps directed to “generating blood flow characteristics value using the physiological model, the uncertainties and the different treatments” and “using the generated blood flow characteristic value to determine statistical variation of the blood flow characteristic value as a result of adjustment of the uncertainties” as now claimed.
With respect to the outstanding rejections under 35 USC 103 over 7,912,528 to Krishnan et al. in view of Hammer et al. and 7,912,528 to Krishnan et al. in view of Grbic et al., said rejections are withdrawn in view of the claim amendments to claim 33 (and newly presented claims 48 and 54) for the same reasons as above pertaining to Krishnan.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-273-8300): PTO/SB/439. Applicant is encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/Lori A. Clow/Primary Examiner, Art Unit 1687