DETAILED ACTION
Applicant's response, filed 15 July 2026, 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 Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 21-40 are currently pending and examined herein.
Claims 1-20 have been cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 21-40 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
This rejection is newly cited and based on claim amendment herein.
Claims 21 and 32, as amended, recite, “determining a location of the diseased segment; estimating characteristics of the one or more systems of interest based on plaque vulnerability at the location, plaque composition at the location, inflammatory status at the location, or a combination thereof; computing a plaque remodeling index based on a relationship between plaque progression and one or more of patient risk factors, medications used by a patient, hemodynamic forces, structural composition of plaque, or a combination thereof; calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based on the plaque remodeling index; and classifying the lesion based on the plaque remodeling index and the calculated hemodynamic measurements to predict a propensity of the lesion to remodel”, wherein the step recited for “computing a plaque remodeling index based on a relationship between plaque progression and one or more patient risk factors, medications used by a patient, hemodynamic forces, structural composition of plaque or a combination thereof” is not clear with respect to the steps prior (claim elements 1-5). The characteristic for the “system of interest” (the diseased segment related to a lesion) as estimated in the claim element 5 does not appear to be used in any of the steps that follow including the “computing a plaque remodeling index” or in “calculating one or more hemodynamic measurements of change in the lesion”. The final step of “classifying the lesion” is based solely on the “plaque remodeling index” and the “hemodynamic measurements”. Thus, the recitation of the estimation of characteristics in the claim is not clear with respect to the relationship with the claim elements that follow. Dependent claims fail to remedy the above are also rejected herein. Clarification is requested through clearer claim language.
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 21-40 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:
With respect to step (1): yes, the claims are directed to a computer-implemented method and a system for processing images for quantitative hemodynamic flow analysis.
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 mathematical concepts (in particular mathematical relationships and formulas).
The claim steps to abstract ideas are as follows:
Claims 21 and 32: “determining one or more systems of interest based on the 3D reconstruction, the one or more systems of interest includes a diseased segment related to a lesion; determining a location of the diseased segment; estimating characteristics of the one or more systems of interest…; computing a plaque remodeling index based on relationship between plaque progression and one or more patient risk factors… calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based on the plaque remodeling index; and classifying the lesion based on the plaque remodeling index and the calculated hemodynamic measurements…”. Said operations are directed to mental operations whereby one may assess data by making determinations of said data that equates to mere observation in the case of looking at and determining a location in a 3D representation. Computing remodeling indices are mathematical operations that may be done using pen and paper or with the aid of a computer for said calculations. Index calculation, for example, is provided in the Specification, wherein plaque remodeling may be assessed using “statistical methods” [0031]; [0074]. Measurements of hemodynamics are mathematical operations using observed changes in vessel dynamics, also elucidated in the Specification at least at [0031]; [0032].
The dependent claims recite additional steps that further limit the judicial exceptions in independent claims 21 and 32 and as such, are further directed to abstract ideas. The dependent claims that further limit the judicial exception are:
Claims 23 and 24 further limit the judicial exception to “determining of the diseased segment location”, wherein the disease is defined based on a presence of vessel narrowing, of which equate to mental operations of deciding given data location and mental defining what it means to be “narrow” in terms of the vessel.
Claims 25 and 33 further define calculating parameters, in part.
Claims 26 and 34 recite, “determining a geometry of the system of interest of the diseased segment; and calculating a hemodynamic quantity based on the geometry of the system of interest, wherein the hemodynamic quantity includes one of a computed blood pressure or a computer blood velocity, which further limits the judicial exceptions as recited above to determining and calculating.
Claims 27 and 35 recite, “calculating a pressure gradient based on proximal and distal ends of the lesion, wherein the one or more hemodynamic measurements are calculated in part based on the pressure gradient, further limiting the recited judicial exceptions above that include mathematic processes.
Claim 28 and 36 recite, “calculating the one or more hemodynamic measurements within the system of interest includes calculating at least one of i) hemodynamic measurements based on progression or ii) hemodynamic measurements based on regression.”, further limiting the recited judicial exceptions above that include mathematic processes.
Claim 29 and 37: “wherein the progression and regression are calculated based on the characteristics of the one or more systems of interest, limiting claims 28 and 36 above which further include limits the recited judicial exceptions in the independent claims.
Claim 30 and 38 further limiting the calculations (mathematical concepts) including “calculating further comprises: determining a characteristic curve for the system of interest; and calculating a hemodynamic quantity of interest based on the characteristic curve..”
Claims 31 and 39 recite, “calculating further comprises: determining a patient specific hemodynamic velocity based on a patient specific geometry and the characteristics of the one or more systems of interest”, also further limiting the calculations (mathematical concepts) in the claims.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind and/or performance by mathematical operation because the steps involve nothing more than instructions for a user to manually compile data in the form of the received data to create a vessel reconstruction (additional elements), determine systems of interest in the reconstruction; location of said segment; computing a plaque remodeling index; calculation of hemodynamic measurements; classifying a lesion…(italicized judicial exceptions). However, there are no specifics as to the methodology involved in said operations and thus, under the BRI, one could simply receive the appropriate image data of a patient and create a model, for example, by employing a computer as a tool by which to render a 3D representation of said vessel data and performing determinations and calculations using said presentation.
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:
Claims 21: “computer-implemented”; “retrieving patient-specific image data” and “creating a 3D representation of a vessel of interest from the patient-specific image data”.
Claim 32: “system”; “processor”; “retrieving patient-specific image data” and “creating a 3D representation of a vessel of interest from the patient-specific image data”.
Dependent claims recite steps that further limit the recited additional elements in the claims as follows:
Claims 22 further limit the method as performed by processors executing program instructions.
The additional elements in the instant claims directed to data gathering, such as “retrieving patient-specific image data” 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).
The additional elements in the instant claims directed to data gathering, such as “creating a 3D reconstruction of a vessel of interest from patient specific image data” perform functions of collecting the data needed to carry out the abstract idea by way of using data to generate a representation of said image as a vessel. 3D representation includes imaging tools such as those that are routinely used in the art. 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).
The additional non-abstract elements of “processor; programs; system; instructions etc…” 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.
As such, 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 the instant claims, the prior art to Parodi et al. (IEEE Transactions on Information Technology in Biomedicine (2012) Vol. 16, No. 5:952-965; IDS reference) discloses that receiving patient data for modeling purposes is a data gathering element that is routine, well-understood and conventional in the art. See Parodi et al. at page 962; abstract and 954, col. 1 describing the model generation using data. As such, activities such as data gathering do not improve the functioning of a computer, or comprise an improvement to any other technical field; they do not require or set forth a particular machine; they do not effect a transformation of matter; nor do they provide a non-conventional or unconventional step. Rather, the data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to claims 21-40, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. Further exemplified prior art to, for example, Parodi teaches that computing elements are routine, well-understood and conventional in the art. 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).
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, “independent claim 21 of the instant application does not explicitly recite the abstract idea of a mathematical formula. Rather, claim 21 recites, in part, "estimating characteristics of the one or more systems of interest based on plaque vulnerability at the location, plaque composition at the location, inflammatory status at the location, or a combination thereof," "computing a plaque remodeling index," and "calculating one or more hemodynamic measurements to predict a change in the lesion in the diseased segment based on the plaque remodeling index." While the estimation of characteristics and the calculation of hemodynamic measurements may involve the application of mathematical concepts, the claims do not recite a mathematical concept, and thus the claims pass Step 2A, prong 1.”
It is respectfully submitted that this is not persuasive. As set forth above, the instant Specification specifically states that these operations are mathematical, including the calculation of plaque remodeling as per [0030]-[0032]. Measurements of hemodynamics may also be done via calculations including FFR calculations [0040]. Further to classifications, said operations are based on calculation and armed with calculation data, one may assess the lesion based on values, which is a mathematical procedure and mental in nature [0034].
2. Applicant states that, “even if claim 21 does involve an abstract idea (a point that Applicant does not concede), aspects of the present disclosure integrate the exception into a practical application, and thus the claim passes Step 2A, prong 2. In particular, the claimed method provides a specific, non-invasive technique for assessing coronary artery disease and predicting changes in lesions - a technique that represents a concrete improvement over prior art approaches that required invasive catheterization procedures to obtain hemodynamic measurements such as fractional flow reserve (FFR). As described in the as-filed application, the functional significance of changes in arterial plaque geometry has traditionally been assessed using FFR, which requires invasive measurement of pressure at a distal location in the coronary artery relative to aortic pressure. See, e.g., Specification at paragraph [028]. The claimed method improves upon this invasive approach by non-invasively estimating characteristics of the diseased segment - including plaque vulnerability, plaque composition, and inflammatory status - and using those characteristics to predict changes in the lesion. This non-invasive approach provides a technological improvement to the field of cardiovascular diagnostics by enabling physicians to assess the functional significance of lesions and predict disease progression or regression without subjecting the patient to invasive catheterization…”.
It is respectfully submitted that this is not persuasive. The instant claims fail to include any use of the estimated characteristics, as asserted herein (see 112b rejections above) and the claim is thus unclear with respect to the estimation of said characteristics and relationship to the computation of plaque remodeling index and calculation of hemodynamics that would lead to classification herein. Further, the classification is only intended to “predict” a propensity of a “lesion to remodel” wherein the claims fall short to any actual prediction of such. Therefore the claim does not appear to provide for improvement as stated.
3. Applicant states that “claim 21 of the instant application does not recite a mental process, at least because amended claim 21 recites several steps that cannot be practically performed in the human mind. For example, claim 21 recites "creating a 3D reconstruction of a vessel of interest from the patient specific image data,"- a task that cannot be performed in the human mind. Further, claim 21 recites "estimating characteristics of the one or more systems of interest based on plaque vulnerability at the location, plaque composition at the location, inflammatory status at the location, or a combination thereof," which requires analysis of multiple patient-specific plaque parameters that cannot be practically performed as a mental process. Still further, claim 21 recites "calculating one or more hemodynamic measurements to predict a change in the lesion in the diseased segment based on the plaque remodeling index," - a task that is well beyond the capability of the human mind. Thus, independent claim 21 passes Step 2A, prong 1”.
It is respectfully submitted that this is not persuasive. First, the claim step directed to “creating a 3D reconstruction of a vessel of interest from the patient specific image data” is not asserted herein to be one that is an abstract idea (see the above rejection). It is, as step “in addition”. However, that step is one that is routine in the art of cardiac imaging as per the prior art teachings in Parodi et al. and to Wannarong et al. (each previously cited in the Non-Final Office Action dated 18 February 2026). Parodi et al., for example, disclose the use of computational fluid dynamics methods based on in vivo 3-D vessel reconstructions (abstract; and p. 954, col. 2). Wannarong et al. disclose prediction of cardiac events using 3-D models (p. 1861, col. 2). Thus the use of 3-D models for further assessment using computational strategies was not novel at the time of the invention. Thus, the 3-D model as an additional element is one that was routinely in use.
With respect to estimations and computations, calculations and classification, said operations have been discussed above.
Prior Art under 35 USC 102 and 103
With respect to the prior art cited in the Non-final Office Action of 18 February 2026 over Taylor et al. and Taylor et al. in view of Wannarong et al., the rejections are hereby withdrawn in view of the claim amendments herein which include, “estimating characteristics of the one or more systems of interest based on plaque vulnerability at the location, plaque composition at the location, inflammatory status at the location, or a combination thereof;; computing a plaque remodeling index based on a relationship between plaque progression and one or more of patient risk factors, medications used by a patient, hemodynamic forces, structural composition of plaque, or a combination thereof calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based on the plaque remodeling index; and classifying the lesion based on the plaque remodeling index and the calculated hemodynamic measurements to predict a propensity of the lesion to remodel”, as now recited.
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.
1. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,517,677, in view of Taylor et al. (Journal of the American College of Cardiology (2013) Vol. 61:2233-2241). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to (Claim 21 (instant) and Claim 1 (patent) as exemplary):
Claim 21: A computer-implemented method for processing images for quantitative hemodynamic flow analysis, comprising: retrieving patient specific image data; creating a 3D reconstruction of a vessel of interest from the patient specific image data; determining one or more systems of interest based on the 3D reconstruction, the one or more systems of interest includes a diseased segment related to a lesion; determining a location of the diseased segment; estimating characteristics of the one or more systems of interest based on plaque vulnerability at the location, plaque composition at the location, inflammatory status at the location, or a combination thereof; computing a plaque remodeling index based on a relationship between plaque progression and one or more of patient risk factors, medications used by a patient, hemodynamic forces, structural composition of plaque, or a combination thereof; and calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based plaque remodeling index; and classifying the lesion based on the plaque remodeling index and the calculated hemodynamic measurements to predict a propensity of the lesion to remodel.
Claims of the ‘677 patent are directed to the overlapping subject matter as:
Claim 1: A computer-implemented method of evaluating a patient with vascular disease, the method comprising: receiving patient-specific image data regarding a geometry of the patient's vasculature; creating, based on the received patient-specific image data, a patient-specific anatomic model representing a diseased region of the patient's vasculature at a first point of time; computing a plaque type using one or more image features of the received patient-specific image data; predicting, using the computed plaque type, a change to a geometric parameter of the diseased region of the patient's vasculature at a second point of time; modifying a geometry of the patient-specific anatomic model to include the predicted change to the geometric parameter of the diseased region at the second point in time; and computing a value of a blood flow characteristic using the modified patient-specific anatomic model.
Performing assessment at two time points as in the ‘677 patent is obvious in view of the art to Taylor et al. (citation above) disclosing assessment of blood velocity over time, at least at [Figure 8].
2. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,649,171, in view of Taylor et al. (Journal of the American College of Cardiology (2013) Vol. 61:2233-2241), in view of Wannarong et al. (Stroke (2013) Vol. 44:1859-1865). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to (Claim 21 (instant) and Claim 1 (patent) as exemplary):
Claim 21: A computer-implemented method for processing images for quantitative hemodynamic flow analysis, comprising: retrieving patient specific image data; creating a 3D reconstruction of a vessel of interest from the patient specific image data; determining one or more systems of interest based on the 3D reconstruction, the one or more systems of interest includes a diseased segment related to a lesion; determining a location of the diseased segment; estimating characteristics of the one or more systems of interest based on plaque vulnerability at the location, plaque composition at the location, inflammatory status at the location, or a combination thereof; computing a plaque remodeling index based on a relationship between plaque progression and one or more of patient risk factors, medications used by a patient, hemodynamic forces, structural composition of plaque, or a combination thereof; and calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based plaque remodeling index; and classifying the lesion based on the plaque remodeling index and the calculated hemodynamic measurements to predict a propensity of the lesion to remodel.
Dependent claims are directed to assessment of progression/regression and locations of disease.
Claims of the ‘171 patent are directed to the overlapping subject matter as:
Claim 1: A computer-implemented method of evaluating a patient with vascular disease, the method comprising: receiving or determining patient-specific data representing at least a portion of a location of disease in the patient's vasculature; receiving or determining, from the patient-specific data, values of one or more plaque remodeling characteristics at the location of disease, the one or more plaque remodeling characteristics including at least one of: plaque composition, plaque location, plaque vulnerability, hemodynamic forces, intramural stress, and/or plaque inflammatory status; calculating, based on the received or determined values of the one or more plaque remodeling characteristics, a propensity of the disease in the patient's vasculature to progress or regress; generating, using the calculated propensity, an anatomic model of the location of disease at a first point of time; identifying, based on the calculated propensity, a progression or regression of the disease in the patient's vasculature by modeling the progression or the regression of the disease using the generated anatomic model; identifying a second point of time different from the first point of time, the second point of time being associated with the progression or regression of the disease in the patient's vasculature; and generating a display including the identified progression or regression of the disease at the location of disease at the second point of time or generating a display including recommending assessment of the progression or regression of disease at the location of disease at the second point of time.
Performing assessment at two time points as in the ‘171 patent is obvious in view of the art to Taylor et al. (citation above) disclosing assessment of blood velocity over time, at least at [Figure 8], while the art to Wannarong et al. teach the techniques of progression and regression analysis. As such the claims are obvious herein.
3. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,239,905, in view of Taylor et al. (Journal of the American College of Cardiology (2013) Vol. 61:2233-2241), in view of Wannarong et al. (Stroke (2013) Vol. 44:1859-1865). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to (Claim 21 (instant) and Claim 1 (patent) as exemplary):
Claim 21: A computer-implemented method for processing images for quantitative hemodynamic flow analysis, comprising: retrieving patient specific image data; creating a 3D reconstruction of a vessel of interest from the patient specific image data; determining one or more systems of interest based on the 3D reconstruction, the one or more systems of interest includes a diseased segment related to a lesion; determining a location of the diseased segment; estimating characteristics of the one or more systems of interest based on plaque vulnerability at the location, plaque composition at the location, inflammatory status at the location, or a combination thereof; computing a plaque remodeling index based on a relationship between plaque progression and one or more of patient risk factors, medications used by a patient, hemodynamic forces, structural composition of plaque, or a combination thereof; and calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based plaque remodeling index; and classifying the lesion based on the plaque remodeling index and the calculated hemodynamic measurements to predict a propensity of the lesion to remodel.
Dependent claims are directed to assessment of progression/regression and locations of disease.
Claims of the ‘905 patent are directed to the overlapping subject matter as:
Claim 1: A computer-implemented method of evaluating a patient with vascular disease, the method comprising: receiving patient-specific data regarding a geometry of the patient's vasculature; determining a plaque remodeling characteristic characterizing a propensity of the disease in the patient's vasculature to progress or regress; determining, using the received patient-specific data and the determined plaque remodeling characteristic, a geometric model of a progression or regression of disease at a location in the patient's vasculature; calculating a value of a blood flow characteristic within the patient's vasculature using a blood flow model determined based on the received patient-specific data and the determined plaque remodeling characteristic; and generating a treatment recommendation or risk assessment based on the value of the blood flow characteristic calculated using the blood flow model based on the received patient-specific data and the determined plaque remodeling characteristic.
Performing assessment at two time points as in the ‘905 patent is obvious in view of the art to Taylor et al. (citation above) disclosing assessment of blood velocity over time, at least at [Figure 8], for patient CAD diagnoses and treatment, while the art to Wannarong et al. teach the techniques of progression and regression analysis. As such the claims are obvious herein.
4. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,195,801, in view of Taylor et al. (Journal of the American College of Cardiology (2013) Vol. 61:2233-2241), in view of Wannarong et al. (Stroke (2013) Vol. 44:1859-1865). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to (Claim 21 (instant) and Claim 1 (patent) as exemplary):
Claim 21: A computer-implemented method for processing images for quantitative hemodynamic flow analysis, comprising: retrieving patient specific image data; creating a 3D reconstruction of a vessel of interest from the patient specific image data; determining one or more systems of interest based on the 3D reconstruction, the one or more systems of interest includes a diseased segment related to a lesion; determining a location of the diseased segment; estimating characteristics of the one or more systems of interest based on plaque vulnerability at the location, plaque composition at the location, inflammatory status at the location, or a combination thereof; computing a plaque remodeling index based on a relationship between plaque progression and one or more of patient risk factors, medications used by a patient, hemodynamic forces, structural composition of plaque, or a combination thereof; and calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based plaque remodeling index; and classifying the lesion based on the plaque remodeling index and the calculated hemodynamic measurements to predict a propensity of the lesion to remodel.
Dependent claims are directed to assessment of progression/regression and locations of disease.
Claims of the ‘801 patent are directed to the overlapping subject matter as:
Claim 1: A computer-implemented method of evaluating a patient with vascular disease, the method comprising: receiving patient-specific data regarding a geometry of the patient's vasculature; determining an anatomic model representing at least a portion of a location of disease in the patient's vasculature based on the received patient-specific data; determining a plaque remodeling characteristic characterizing a propensity of the disease in the patient's vasculature to progress or regress; modeling, using the determined plaque remodeling characteristic, one or more changes in the geometry of the anatomic model at the location of disease due to the progression or regression of the disease; calculating one or more values of a blood flow characteristic within the patient's vasculature using a computational model of blood flow through the anatomical model, taking into account the one or more modeled changes in geometry of the anatomic model; and generating a display including a plot of the one or more values of the calculated blood flow characteristic versus the one or more modeled changes in geometry of the anatomic model due to the progression or regression of disease according to the determined plaque remodeling characteristic.
Performing assessment at two time points as in the ‘905 patent is obvious in view of the art to Taylor et al. (citation above) disclosing assessment of blood velocity over time, at least at [Figure 8], for patient CAD diagnoses and treatment, while the art to Wannarong et al. teach the techniques of progression and regression analysis. As such the claims are obvious herein.
Response to Applicant’s Arguments
1. Applicant’s arguments are considered but not deemed persuasive, as no particular arguments are set forth. As such, the rejections are 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 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.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 11:00AM to 9:00PM ET.
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/Lori A. Clow/ Primary Examiner, Art Unit 1687
