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 .
Status of Claims
Claims 1-10 are pending and examined on the merits.
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.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 5/2/2022 has been entered and considered. A signed copy of the corresponding 1449 form has been included with this Office action.
Specification
The disclosure is objected to because of the following informalities:
Abstract line 11, "that compares at least on of pressure, velocity" should read "that compares at least one of pressure, velocity".
Specification page 7, lines 15-16, "that compares at least on of pressure, velocity" should read "that compares at least one of pressure, velocity".
Appropriate correction is required.
Claim Objections
Claims 1, 3-4, and 7 objected to because of the following informalities:
Claim 1 line 31, "compares at least on of pressure, velocity" should read "compares at least one of pressure, velocity".
Claim 1 lines 6 and 8 recite "a three-dimensional personalized model of the blood vessels" and "a three-dimensional reconstructed model of the blood vessels", but the models are referred to as simply "the personalized model" or "the reconstructed model" later in the claim(s), respectively. Therefore, the claim should read "a personalized model of three-dimensional blood vessels" and "a reconstructed model of three-dimensional blood vessels".
Claim 3 line 10, "transient flow simulation;" should read "transient flow simulation."
Claim 4 line 15, "transient flow simulation;" should read "transient flow simulation."
Claim 7 lines 30-31, "and a Energy Flow Reference" should read "and an Energy Flow Reference".
Appropriate correction is required.
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.
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 5-6 and 8-9 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites "the personalized model (1) to the average pressure (P)rec in the reconstructed model (6)" on lines 18-19. It is not clear what purpose the "(1)" or "(6)" are intended to have here and is unnecessary as there is already antecedent basis for a personalized model and a reconstructed model in claim 1, from which this claim depends. To further prosecution, the limitation is interpreted as "the personalized model to the average pressure (P)rec in the reconstructed model".
Claim 6 recites "the personalized model (1) to the average pressure (Ptotal)rec in the reconstructed model (6)" on lines 18-19. It is not clear what purpose the "(1)" or "(6)" are intended to have here and is unnecessary as there is already antecedent basis for a personalized model and a reconstructed model in claim 1, from which this claim depends. To further prosecution, the limitation is interpreted as "the personalized model to the average pressure (Ptotal)rec in the reconstructed model".
Claim 8 recites "n - power number, in our example n=2". It is not clear if n=2 is being claimed here, or any number indicated by the variable "n". Additionally, it is not clear what two variables form the "correlation coefficient". The instant specification is silent on this matter, therefore the limitation is interpreted as "determining a coronary inlet flow rate for the steady flow test".
Claim 9 recites "as a function of a pressure (stress) and a flow rate of the compared personalized model (1) and the reference model (6)" on lines 14-15. There is a lack of antecedent basis for "the compared personalized model", as there is only "a personalized model" in claim 1 (after appropriate action is taken on the objection), and it is not clear what purpose the "(1)" is intended to have and is unnecessary as there is already antecedent basis for a personalized model in claim 1, from which this claim depends. Additionally, there is a lack of antecedent basis for "the reference model", as there is only "a reconstructed model" in claim 1 (after appropriate action is taken on the objection), and it is not clear what purpose the "(6)" is intended to have and is unnecessary as there is already antecedent basis for a reconstructed model in claim 1, from which this claim depends. To further prosecution, the limitation is interpreted as "as a function of a pressure (stress) and a flow rate of the personalized model and the reconstructed model".
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 1-10 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 three-dimensional personalized model of the blood vessels, based on the medical imaging data; generating a three-dimensional reconstructed model of the blood vessels that reflects a state of healthy blood vessels that lack lesions, based on the medical imaging data or based on a numerical reconstruction of the personalized model” 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.
“performing a pre-simulation of the reconstructed model, establishing boundary conditions and initial conditions for both models for a steady flow of blood and a transient flow of blood; performing a numerical simulation of the transient flow of blood, for the same physical and boundary conditions, for the personalized model and the reconstructed model for an increasing blood flow rate that increases from a laminar flow to a developed turbulent flow, the simulation comprising, determined during the pre- simulation, initial conditions of blood flow; 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, determined during the pre-simulation, initial conditions of blood flow” provides a mathematical calculation (performing numerical simulations involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
“calculating a blood flow energy Ef for the personalized model and for the reconstructed model” provides a mathematical calculation (calculating a blood flow energy using the function detailed in claim 1 involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
“determining absolute or relative indexes of blood flow as a function that compares at least on[e] of pressure, velocity or energy flow between the personalized model and the reconstructed model for at least one of a steady flow or a transient flow” provides a comparison (comparing variables in such a way as to return a ratio or index) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 2: “generating the reconstructed model based on 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 by numerical modification of geometry involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
Claim 3: “determining a relative fractional flow reserve index (FFRvcast), from curve slope of function of average pressure of personalized model and average pressure of reconstructed model” provides a mathematical relationship (determining an index based on the slope of a function involves calculating a mathematical relationship) that is considered a mathematical concept, which is an abstract idea.
Claim 4: “determining a flow energy reference index (EFR), from a curve slope of function of an average total pressure of the personalized model and an average total pressure of the reconstructed model” provides a mathematical relationship (determining an index based on the slope of a function involves calculating a mathematical relationship) that is considered a mathematical concept, which is an abstract idea.
Claim 5: “determining a relative fractional flow reserve index (FFRvcast), as a ratio” provides a mathematical calculation (determining a ratio involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
Claim 6: “determining a reference flow energy reference index (EFR) as a ratio” provides a mathematical calculation (determining a ratio involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
Claim 7: “determining a relative Fractional Flow Reserve (FFRvcast) index and a Energy Flow Reference (EFR) index” provides a mathematical calculation (determining a ratio involves mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
Claim 8: “determining a coronary inlet flow rate for the steady flow test” provides a mathematical calculation (determining a flow rate 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 (stress) and a flow rate” provides a mathematical calculation (determining an index as a function is 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 1-10 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 1-10 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 1-10 are not patent eligible.
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 1-10 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 three-dimensional personalized model of the blood vessels, based on the medical imaging data; generating a three-dimensional reconstructed model of the blood vessels that reflects a state of healthy blood vessels that lack lesions, based on the medical imaging data or based on a numerical reconstruction of the personalized model; performing a pre-simulation of the reconstructed model, establishing boundary conditions and initial conditions for both models for a steady flow of blood and a transient flow of blood; and determining absolute or relative indexes of blood flow as a function that compares at least one of pressure, velocity or energy flow between the personalized model and the reconstructed model for at least one of a steady flow or a transient flow (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").
Zilberstien also teaches performing a numerical simulation of the transient flow of blood, for the same physical and boundary conditions, for the personalized model and the reconstructed model for an increasing blood flow rate that increases from a laminar flow to a developed turbulent flow, the simulation comprising, determined during the pre- simulation, initial conditions of blood flow; and 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, determined during the pre-simulation, initial conditions of blood flow (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 does not explicitly teach calculating a blood flow energy Ef for the personalized model and for the reconstructed model, for at least one of every time step of the transient flow or for fixed values of the inlet pressure and the outlet flow rate conditions, wherein the blood flow energy Ef is defined as the product of the total pressure and the mass flow rate:
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wherein (1/2)u^2 is a dynamic pressure, P/p is a static pressure, Ptotal is total pressure, and Q is the flow rate through a surface perpendicular to an axis of the blood vessel.
However, Kato teaches calculation, using time-series data, of energy with respect to various blood flow parameters, combining conservation of energy, pressure, and flow rates (para.0103 "K is kinetic energy and [expression 11] represents the source term of momentum acting in response to vascular deformation" and para.0104 "In the expression, P is pressure, P.sub.0 is the pressure at a flow rate of 0, E is the elastic modulus, h is the thickness of the vascular wall, r.sub.0 is the blood vessel radius at a flow rate of 0, A.sub.0 is the vascular cross-sectional area at a flow rate of 0, and A is the vascular cross-sectional area" demonstrate calculation of energy with respect to blood flow parameters because combining conservation of energy, pressure, and flow rates are all captured in the expressions defined. Additionally, para.0077 teaches performing functions on time-series data "The extraction function 352 extracts time-series vascular shape data representing the shape of the blood vessel from the time-series three-dimensional CT image data acquired by the acquisition function").
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. Zilberstien also teaches generating the reconstructed model based on 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 (Para.0051 "The functional index parameter(s) are computed, for example, per blood vessel with or without stenotic lesion").
Regarding claims 3 and 5, Zilberstien in view of Kato teach the methods of Claim 1 on which this claim depends/these claims depend, respectively. Zilberstien also teaches determining a relative fractional flow reserve index (FFRvcast), from curve slope of function of average pressure of personalized model and average pressure of reconstructed model Psten(Prec), for a linearly increased flow rate, in each time step of transient flow simulation; and determining a relative fractional flow reserve index (FFRvcast), as a ratio of an average pressure (P)sten measured in the personalized model to the average pressure (P)rec in the reconstructed model, for the steady flow, under fixed value of the inlet pressure and the 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 claims 4 and 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 determining a flow energy reference index (EFR), from a curve slope of function of an average total pressure of the personalized model and an average total pressure of the reconstructed model Ptotal sten(Ptotal rec), for a linearly increased flow rate, in each time step of the transient flow simulation; and determining a reference flow energy reference index (EFR) as a ratio of an average total pressure (Ptotal)sten Measured in the personalized model to the average pressure (Ptotal)rec in the reconstructed model, for a steady flow, under a fixed value of the inlet pressure and the 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 7, Zilberstien in view of Kato teach the methods of Claim 1 on which this claim depends/these claims depend, respectively. Kato also teaches taking into account zero-flow pressure (P0), determining a relative Fractional Flow Reserve (FFRvcast) index and a Energy Flow Reference (EFR) index (para.0104 "In the expression, P is pressure, P.sub.0 is the pressure at a flow rate of 0" takes into account zero-flow pressure, and 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 coronary inlet flow rate for the steady flow test (as interpreted above) (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 (stress) 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").
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 1-10 rejected 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, 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.
Claims 1-10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of US Patent US-11626211 in view of Zilberstien et al. (US-20190355118). 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 numerical simulation of blood flow using both models and calculating blood flow energies, and determining a flow energy change index between models.
While US-11626211 does not explicitly teach the pre-simulation step for establishing boundary conditions, 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.
Claims 1-10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of US Patent US-12051511 in view of Zilberstien et al. (US-20190355118). 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 numerical simulation of blood flow using both models and calculating blood flow energies, and determining a flow energy change index between models.
While US-12051511 does not explicitly teach the pre-simulation step for establishing boundary conditions, 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.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Huo et al. "Flow patterns in three-dimensional porcine epicardial coronary arterial tree." American Journal of Physiology-Heart and Circulatory Physiology 293.5 (2007): H2959-H2970.
Kopernik et al. "Development of multi-phase models of blood flow for medium-sized vessels with stenosis." Acta of bioengineering and biomechanics 21.2 (2019): 63-70.
Vito et al. "Blood vessel constitutive models—1995–2002." Annual review of biomedical engineering 5.1 (2003): 413-439.
Conclusion
No claims are allowed.
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/R.A.P./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686