DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's response filed 4/13/2026 has been fully considered. The following rejections
and/or objections are either reiterated or newly applied.
Status of Claims
Claims 1-2, 5-6, and 8-10 pending and examined on the merits.
Claims 3-4 and 7 canceled.
Priority
The instant application filed on 4/18/2022 claims the benefit of foreign priority to Patent Application No. EP21169042.5 filed on 4/18/2021. Thus, the effective filing date of the claims is 4/18/2021.
The applicant is reminded that amendments to the claims and specification must comply with 35 U.S.C. § 120 and 37 C.F.R. § 1.121 to maintain priority to an earlier-filed application. Claim amendments may impact the effective filing date if new subject matter is introduced that lacks support in the originally filed disclosure. If an amendment adds limitations that were not adequately described in the parent application, the claim may no longer be entitled to the priority date of the earlier filing.
Specification
The objections to the abstract and specification withdrawn in view of Applicant's claim amendments filed on 4/13/2026.
Claim Objections
The objection to claims 1, 3-4, and 7 withdrawn in view of Applicant's claim amendments filed on 4/13/2026.
Withdrawn Rejections
35 USC § 112(b)
The rejection of claims 5-6 and 8-9 under 35 USC 112(b) withdrawn in view of Applicant's claim amendments filed on 4/13/2026.
Double Patenting
The rejection of claims 1-2, 5-6, and 8-10 on the ground of nonstatutory double patenting over US Patent 11626211 and US Patent 12051511 withdrawn in view of Applicant's Terminal Disclaimer filed 4/13/2026 and approved 4/17/2026.
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 1-2, 5-6, and 8-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 1 and 10: “generating a personalized model of the blood vessels, wherein the personalized model is three-dimensional, based on the medical imaging data; generating a reconstructed model of the blood vessels, wherein the reconstructed model is three-dimensional, that reflects a state of healthy blood vessels that lack lesions, based on a numerical reconstruction of the personalized model, by eliminating stenoses existing in the personalized model, resulting from atherosclerosis lesions, by numerical modification of the blood vessel geometry in areas of said stenoses to obtain a hypothetically healthy model as the reconstructed model prior to the onset of the lesions” provides a mathematical calculation (generating a model based on images, or by numerical modification of geometry, involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
“generating, in the personalized model and in the reconstructed model, a volumetric calculation grid, for which the equation of blood flow dynamics is solved in each node to determine local velocity and pressure values” provides a mathematical calculation (solving blood flow dynamics equations involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
“performing a pre-simulation of the reconstructed model, establishing boundary conditions and initial conditions for both models for a steady flow of blood; performing a numerical simulation of the steady flow of blood, for the same physical and boundary conditions, for the personalized model and the reconstructed model of transitional or turbulent flow, the simulation comprising initial conditions of blood flow determined during the pre-simulation under fixed inlet pressure and outlet flow rate conditions” provides a mathematical calculation (performing numerical simulations involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
“determining at least one of a relative fractional flow reserve index (FFRVCAST) or an energy flow reference index (EFR), for the steady flow, by comparing pressure or total pressure between the personalized model and the reconstructed model” provides a mathematical calculation (determining an FFRVCAST or EFR index involves mathematical calculations (based on page 8 of the instant specification)) that is considered a mathematical concept, which is an abstract idea, as well as a comparison (comparing values between models involves a comparison) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 5: “the relative fractional flow reserve index (FFRVCAST) is determined as a ratio of an average pressure measured in the personalized model to the average pressure measured in the reconstructed model, for the steady flow under fixed inlet pressure and outlet flow rate conditions” provides a mathematical calculation (determining an FFRVCAST index involves mathematical calculations (based on page 8 of the instant specification)) that is considered a mathematical concept, which is an abstract idea.
Claim 6: “the energy flow reference index (EFR) is determined as a ratio of an average total pressure measured in the personalized model to an average pressure measured in the reconstructed model, for the steady flow under fixed inlet pressure and outlet flow rate conditions” provides a mathematical calculation (determining an EFR index involves mathematical calculations (based on page 8 of the instant specification)) that is considered a mathematical concept, which is an abstract idea.
Claim 8: “determining a patient-specific coronary inlet flow rate for the steady flow test based on a flow-mass relationship as a function of diameter of an inlet coronary artery” provides a mathematical calculation (determining a flow rate based on a flow-mass relationship as a function of diameter involves performing numerical simulations which involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
Claim 9: “determining at least one other absolute index or relative index of hemodynamics parameters [. . .] as a function of a pressure and a flow rate of the personalized model and the reconstructed model” provides a mathematical calculation (determining an index as a function of pressure and flow rate involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
These recitations are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in 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 or are mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Additionally, while claim 10 recites performing some aspects of the analysis on “A computer-implemented system, comprising: at least one non-transitory processor-readable storage medium that stores at least one of processor-executable instructions or data; and at least one processor communicably coupled to at least one non-transitory processor-readable storage medium, wherein at least one processor is configured to perform the steps of the method of claim 1”, there are no additional limitations that indicate that this requires anything other than carrying out the recited mental processes or mathematical concepts in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental processes” grouping of abstract ideas. As such, claims 1-2, 5-6, and 8-10 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exceptions listed above are not integrated into a practical application because the claims do not recite an additional element or elements that reflects an improvement to technology. Specifically, the claims recite the following additional elements:
Claims 1 and 10: “obtaining medical imaging data of the blood vessels” provides insignificant extra-solution activities (obtaining image data is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
The steps for obtaining image data are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre-solution activities involving data gathering steps (see MPEP 2106.04(d)(2)). Furthermore, the limitations regarding implementing program instructions do not indicate that they require anything other than mere instructions to implement the abstract idea in a generic way or in a generic computing environment. As such, this limitation equates to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. Therefore, claims 1-2, 5-6, and 8-10 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application, or equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
As discussed above, there are no additional elements to indicate that the claimed “A computer-implemented system, comprising: at least one non-transitory processor-readable storage medium that stores at least one of processor-executable instructions or data; and at least one processor communicably coupled to at least one non-transitory processor-readable storage medium, wherein at least one processor is configured to perform the steps of the method of claim 1” requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. Additionally, the limitations for obtaining image data are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Furthermore, no inventive concept is claimed by these limitations as they are well-understood, routine, and conventional.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-2, 5-6, and 8-10 are not patent eligible.
Response to Arguments under 35 USC § 101
Applicant’s arguments filed 4/13/2026 are fully considered but they are not persuasive.
Applicant asserts that because of the amendments, specifically that "independent claim 1 no longer recites the explicit blood-flow-energy equation", "[t]he rejection should be withdrawn" (Remarks 4/13/2026 pages 3-4). Applicant further argues that "claim [1] recites specific technical operations on patient-specific and reconstructed vascular models, ending in determination of named hemodynamic indices" (Remarks 4/13/20216 page 4). Applicant also asserts that "[t]he amended claims are directed to a particular technical solution to a particular technical problem [. . .] rather than an over-broad mixture of every disclosed mode" of 'evaluating blood flow' (Remarks 4/13/2026 pages 4-5). Examiner notes above that amended claim 1 has been identified as still reciting several judicial exceptions in the form of mathematical calculations and comparisons that are not integrated into a practical application by any identified additional element.
Applicant also asserts that "the ordered combination" of the steps of amended claim 1 are a "concrete ordered combination and not in any equation viewed in isolation" (Remarks 4/13/2026 page 5). Examiner notes that MPEP 2106(I) states that if the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). In the “search for an ‘inventive concept’” (the second part of the Alice/Mayo test), the additional elements identified do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception because obtaining image data (data gathering and manipulation steps) are all well-understood, routine, and conventional techniques that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Therefore, combining insignificant extra-solution activities with any of the identified judicial exceptions would not result in patent eligible subject matter because integrating well-understood, routine, and conventional techniques does not yield “significantly more” to a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon.
Therefore, the rejection of claims 1-2, 5-6, and 8-10 under 35 USC 101 is maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 5-6, and 8-10 rejected under 35 U.S.C. 103 as being unpatentable over Zilberstien et al. (US-20190355118) in view of Kato et al. (US-20170095221).
Regarding claims 1 and 10, Zilberstien teaches a computer-implemented method for modelling blood vessels, the method comprising steps of: obtaining medical imaging data of the blood vessels; generating a personalized model of the blood vessels, wherein the personalized model is three-dimensional, based on the medical imaging data; generating a reconstructed model of the blood vessels, wherein the reconstructed model is three-dimensional, that reflects a state of healthy blood vessels that lack lesions, based on a numerical reconstruction of the personalized model, by eliminating stenoses existing in the personalized model, resulting from atherosclerosis lesions, by numerical modification of the blood vessel geometry in areas of said stenoses to obtain a hypothetically healthy model as the reconstructed model prior to the onset of the lesions; and performing a pre-simulation of the reconstructed model, establishing boundary conditions and initial conditions for both models for a steady flow of blood (Para.0051 "An aspect of some embodiments of the present invention relate to systems and/or methods (e.g. code stored in a storage device, executed by processor(s)) that calculate one or more values for one or more functional index parameters associated with blood vessel(s) (which may have a stenotic lesion) using functional imaging data, optionally nuclear medicine image data (optionally obtained from a nuclear medicine device, for example, from a single-photon emission computed tomography (SPECT) machine, optionally a dynamic SPECT machine, and/or positron emission tomography (PET) systems), and/or data obtained from magnetic resonance imaging (MRI) based systems that is registered with anatomical imaging data. Exemplary functional index parameters include: tissue perfusion, viability, reversibility, wall motion, wall thickening, flow, and flow reserve. The functional index parameter(s) are computed, for example, per blood vessel with or without stenotic lesion, across the stenotic lesion, per tissue territory (e.g., myocardium) fed by the blood vessel having the stenotic lesion, and/or globally for the organ (e.g., the heart). The functional index parameter(s) may be used to compute values based on blood flow and/or pressure changes within the blood vessel that occur across the stenotic lesion, optionally corresponding to a fractional flow reserve (FFR) parameter (e.g., correlated with an invasively measured FFR according to a correlation requirement). The functional index parameter(s) may serve as boundary conditions into mathematical model(s) that compute parameters for evaluation of the stenotic lesion, for example, imaged based FFR values. The boundary conditions obtained using functional index parameters represent actual patient specific data" and para.0058 "Optionally, the blood flow calculated with modified value of microvascular resistance provides an estimation of the effect of treatment of CMD for the patient, for example, using medications (e.g., rather than stenting). When abnormal microvascular resistance is detected based on the identified mismatch, the effects of the therapy of CMD for the patient may be evaluated. The value of the microvascular resistance may be artificially set within normal values (e.g., range) in the mathematical model. The flow in the vessel(s) (e.g., coronary arteries, other larger non-microvascular vessels) may be recalculated using the normal values (e.g., range) of the microvascular resistance" suggests comparison of abnormal to normal models).
Zilberstien also teaches performing a numerical simulation of the steady flow of blood, for the same physical and boundary conditions, for the personalized model and the reconstructed model of transitional or turbulent flow, the simulation comprising initial conditions of blood flow determined during the pre-simulation under fixed inlet pressure and outlet flow rate conditions (Para.0106 "The functional index parameter may be used to compute a relationship between a first state of a patient and a second (or more) state of the patient. The functional index parameter may be used to compute the effects of increased blood flow relative to the rest state. The first state may represent blood flow through the anatomical territory of the blood vessel at rest. The second state may represent hyperemic blood flow through the anatomical territory of the blood vessel, for example, after and/or during administration of a vasodilator. Alternatively or additionally, the second state may represent an increase in blood flow during stress, such as when the patient is exercising").
Zilberstien also teaches determining at least one of a relative fractional flow reserve index (FFRVCAST) or an energy flow reference index (EFR), for the steady flow, by comparing pressure or total pressure between the personalized model and the reconstructed model (para.0051 "The functional index parameter(s) may be used to compute values based on blood flow and/or pressure changes within the blood vessel that occur across the stenotic lesion, optionally corresponding to a fractional flow reserve (FFR) parameter" and "The functional index parameter(s) are computed, for example, per blood vessel with or without stenotic lesion").
Zilberstien does not explicitly teach generating, in the personalized model and in the reconstructed model, a volumetric calculation grid, for which the equation of blood flow dynamics is solved in each node to determine local velocity and pressure values.
However, Kato suggests a grid scheme for volumetric calculations (Para.0204 "the image generation function 162 reconstructs three-dimensional CT image data (volume data) by the Feldkamp method or cone-beam reconstruction", para.0206 "With the configuration described above, the storage circuitry 130 in the sixth embodiment stores therein correlation information and fluid resistance data similarly to the storage circuitry 320 described in the first or the second embodiment", and Figure 8 (top left)).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Zilberstien as taught by Kato in order to determine a blood circulation state in a blood vessel or vessels (abstract "The processing circuitry performs fluid analysis based on the vascular shape data and the blood flow rate and the pressure loss that correspond to the vascular shape data and that are correlated by the fluid resistance data to derive a functional index related to a blood circulation state in the blood vessel of the subject"). One skilled in the art would have a reasonable expectation of success because both methods utilize image data to model blood vessels.
Regarding claim 2, Zilberstien in view of Kato teach the methods of Claim 1 on which this claim depends/these claims depend, respectively. Kato also teaches the numerical modification of the geometry of the blood vessel is made on the basis of an approximation of the cross-sectional area in front of and behind the stenoses and curvature of the center line of the vessel (Para.0095 "The region to be eliminated is determined by starting a search from the downstream end of the coronary artery and determining the range from a point with a threshold radius therefrom to the downstream end of the blood vessel as the region to be eliminated" suggests modeling downstream of a target, therefore upstream modeling would be obvious even without hindsight reasoning).
Regarding claim 5, Zilberstien in view of Kato teach the methods of Claim 1 on which this claim depends/these claims depend, respectively. Zilberstien also teaches the relative fractional flow reserve index (FFRVCAST) is determined as a ratio of an average pressure measured in the personalized model to the average pressure measured in the reconstructed model, for the steady flow under fixed inlet pressure and outlet flow rate conditions (Para.0055 "scores representing the association between functional index parameters before and after the stenotic lesion may be computed, for example, FFR", and for claim 5, applying simple mathematical manipulations for calculating a ratio of variables previously determined).
Regarding claim 6, Zilberstien in view of Kato teach the methods of Claim 1 on which this claim depends/these claims depend, respectively. Zilberstien combined with Kato also teaches the energy flow reference index (EFR) is determined as a ratio of an average total pressure measured in the personalized model to an average pressure measured in the reconstructed model, for the steady flow under fixed inlet pressure and outlet flow rate conditions (combining Zilberstien's para.0055 "scores representing the association between functional index parameters before and after the stenotic lesion may be computed, for example, FFR" and Kato's para.0103 "K is kinetic energy and [expression 11] represents the source term of momentum acting in response to vascular deformation" suggests an "energy flow reference" index would be an obvious index to calculate and would require a minimum of mathematical manipulations of previously available data, and for claim 6, applying simple mathematical manipulations for calculating a ratio of variables previously determined).
Regarding claim 8, Zilberstien in view of Kato teach the methods of Claim 1 on which this claim depends/these claims depend, respectively. Kato also teaches determining a patient-specific coronary inlet flow rate for the steady flow test based on a flow-mass relationship as a function of diameter of an inlet coronary artery (Para.0059 "For another example, as illustrated in FIG. 3, the vascular shape is represented by an element shape of an expanding or constricted vessel. In this case, for example, the element shape of the expanding or constricted vessel includes the diameter of the inlet, the diameter of the outlet, the expanding or constricted angle, and the Reynolds number as the fluid resistance parameters" and para.0071 "The use of values at points in the radial direction and the angular direction with each point on the core line in an inlet cross-section and an outlet cross-section of the blood vessel as the origin enables an input and output relation of the distribution of the flow velocity, the pressure, the contrast agent, or the like to be saved").
Regarding claim 9, Zilberstien in view of Kato teach the methods of Claim 1 on which this claim depends/these claims depend, respectively. Zilberstien combined with Kato also teaches determining at least one other absolute index or relative index of hemodynamics parameters, including a vascular resistance (R), a pressure drop (dP), a turbulence kinetic energy (TKE), a wall shear stress (WSS), an oscillatory shear (OSI) and a residence time (RRT), as a function of a pressure and a flow rate of the personalized model and the reconstructed model (Para.0058 "the blood flow calculated with modified value of microvascular resistance provides an estimation of the effect of treatment of CMD for the patient, for example, using medications (e.g., rather than stenting)" and para.0066 "For example, the fluid resistance data includes, as the vascular shape, at least one of the cross-sectional area, the flow rate, the flow velocity, the static pressure, the dynamic pressure, the contrast agent concentration, the vorticity, the turbulent intensity, the mean value of shear stress, and coordinates in three-dimensional space for each point on the core line of the blood vessel").
Response to Arguments under 35 USC § 103
Applicant’s arguments filed 4/13/2026 are fully considered but they are not persuasive.
Applicant asserts "[t]he amended claims are no longer captured by the present obviousness rejection" because "Zilberstien does not teach the newly claimed reconstructed-model limitation", and "neither Zilberstien nor Kato teaches the newly added volumetric-grid / node-wise solution limitation" of claim 1 (Remarks 4/13/2026 page 6). Examiner notes above that Zilberstien does in fact teach the limitation of reconstructing a model (excerpt of para.0051 "The functional index parameter(s) may serve as boundary conditions into mathematical model(s) that compute parameters for evaluation of the stenotic lesion, for example, imaged based FFR values"), and that Kato does in fact suggest calculating metrics based on volumetric data (para.0204-206 and figure 8). Applicant also asserts that the citations from Zilberstien do "not correspond to pre-simulation of a lesion-free reconstructed model establishing conditions for both the personalized and reconstructed models, followed by same-condition steady-flow comparison of those paired models in amended claim 1" (Remarks 4/13/2026 page 7). Examiner notes that newly cited para.0058 combined with para.0051 ("The functional index parameter(s) are computed, for example, per blood vessel with or without stenotic lesion") do in fact teach these amended limitations (see above).
Applicant also asserts that Zilberstien nor Kato teach the specific reconstruction process of amended claim 2, that of modeling cross-section area in front of and behind the stenoses and curvature of the center line of the vessel (Remarks 4/13/2026 page 7). Examiner notes that Kato does suggest modeling downstream of a target, therefore upstream modeling would be obvious even without hindsight reasoning (Para.0095 above).
Applicant argues that "claims 5 and 6 remain patentable for essentially the same reason as claim 2" in that the "steady-flow indices determined between the personalized model and the reconstructed model under fixed inlet-pressure and outlet-flow-rate conditions" are not taught (Remarks 4/13/2026 page 7). Examiner notes above that it is Zilberstien who suggests comparison of abnormal to normal models, and Kato suggests modeling over fixed conditions (Para.0158 "Various methods are conceivable for the application of the flow rate, such as a method of fixing the flow rate in a highly reliable blood vessel and a method of using the flow rate as an initial value for fluid analysis").
Applicant asserts that claim 8 is not taught by Kato because it does not teach a "determination of a patient-specific coronary inlet flow rate for the steady-flow test based on a flow-mass relationship as a function of inlet diameter". Examiner notes that Kato does in fact teach these limitations in para.0059 and 71 as cited above, and that similar to claims 5 and 6 also suggests modeling over fixed conditions.
Applicant asserts that the cited references do not teach the limitations of claim 9 of "determining the recited hemodynamic parameters as functions of pressure/stress and flow rate of the compared personalized and reconstructed models in the claimed workflow" (Remarks 4/13/2026). Examiner notes that Zilberstien does in fact teach the limitations of claim 9 (para.0051 "The functional index parameter(s) may be used to compute values based on blood flow and/or pressure changes within the blood vessel that occur across the stenotic lesion, optionally corresponding to a fractional flow reserve (FFR) parameter" and "The functional index parameter(s) are computed, for example, per blood vessel with or without stenotic lesion").
Applicant also asserts that the Examiners rationale "does not track the claim language that is actually now being prosecuted" and that it "does not provide adequate reasonable-expectation-of-success analysis for the amended claims" (Remarks 4/13/2026 page 8). Examiner notes that the stated motivation to combine and reasonable expectation of success are as applicable to the amended claims as they are to the original claims. Both pieces of prior art are in extremely close proximity with the field of the instant application, and any person having ordinary skill in the art would reasonably identify their application to the instant modeling "problem".
Therefore, the rejection of claims 1-2, 5-6, and 8-10 under 35 USC 103 is maintained. All other claims depend from these independent claims; therefore, their rejection is likewise maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-6, and 8-10rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent Application 17/955,688 in view of Zilberstien et al. (US-20190355118) and Kato et al. (US-20170095221). Although the claims at issue are not identical, they are not patentably distinct from each other because both involve obtaining medical imaging data of blood vessels, generating a personalized and reconstructed model with and without lesions, performing a pre-simulation step for establishing boundary conditions, a volumetric calculation grid, and performing numerical simulation of blood flow using both models and calculating blood flow energies.
While 17/955,688 does not explicitly teach calculating blood flow energies, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Kato as described above for claims 1 and 10 of the instant application, in order to determine a blood circulation state in a blood vessel or vessels (abstract "The processing circuitry performs fluid analysis based on the vascular shape data and the blood flow rate and the pressure loss that correspond to the vascular shape data and that are correlated by the fluid resistance data to derive a functional index related to a blood circulation state in the blood vessel of the subject"). One skilled in the art would have a reasonable expectation of success because both methods utilize image data to model blood vessels.
While 17/955,688 does not explicitly teach determining a flow energy change index between models, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Zilberstien as described above for claims 1 and 10 of the instant application, in order to improve accuracy of image based calculation of a functional index parameter (para.0008 "improving accuracy of image based calculations of a functional index parameter (e.g., FFR) for an anatomical territory of a blood vessel (e.g., stenotic lesion, optionally of a coronary artery) of a certain patient"). One skilled in the art would have a reasonable expectation of success because both methods utilize image data to model blood vessels.
Response to Double Patenting
Applicant’s arguments filed 4/13/2026 are fully considered but they are not persuasive.
Applicant asserts that the amended claims are directed to different subject matter that is "patentably distinct" from US Patent Application 17/955,688, that of "comparative hemodynamic assessment of stenosis in patient-specific and reconstructed vessel models" (Remarks 4/13/2026 page 9). Examiner notes above the mapping of claims as well as those limitations taught in view of Zilberstien and Kato, together rendering the amended claims obvious and not patentably distinct from 17/955,688. Therefore, the rejection of claims 1-2, 5-6, and 8-10 on the ground of nonstatutory double patenting over US Patent Application 17/955,688 is maintained.
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 TH REE-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 finaI action.
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/R.A.P./Examiner, Art Unit 1686
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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