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 .
Claim Status
Claims 1-20 have been cancelled by preliminary amendment.
Claims 21-40 are currently pending and examined herein.
Priority
This application is a continuation U.S. Patent Application No. 16/691,134, filed November21, 2019, (now US Patent No. 12,336,769), which is a continuation of U.S. Patent Application No. 15/185,618, filed June 17, 2016, (now U.S. Patent No. 10,517,677, issued December 31, 2019), which is a continuation of U.S. Patent Application No. 14/962,348, filed December 8, 2015, (now U.S. Patent No. 9,649,171, issued May 16, 2017), which is a continuation of U.S. Application No. 14/621,129, filed February 12, 2015, (now U.S. Patent No. 9,239,905, issued January 19, 2016), which is a continuation of U.S. Patent Application No. 14/522,343 filed October 23, 2014 (now U.S. Patent No. 9,195,801, issued November 24, 2015), which claims priority to U.S. Provisional Application No. 62/033,446, filed August 5, 2014. Priority to each of claims 21-40 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements filed 21 March 2022; 12 April 2023; and 24 March 2025 are in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. Signed copies of the IDS documents are included with this Office Action.
It is noted that reference 6 to Koskinas in the IDS dated 21 March 2022 is lined through as including improper page numbers. Said citation is a duplicate of reference 7, which does include the proper page number for the reference.
Drawings
The Drawings submitted 21 March 2022 are accepted.
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; and calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based on the characteristics of the one or more systems of interest”. 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. Measurements of hemodynamics are mathematical operations using observed changes in vessel dynamics.
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; estimation of a characteristic and calculation of hemodynamic measurements (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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1. Claims 21-27, 31-35 and 39-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor et al. (Journal of the American College of Cardiology (2013) Vol. 61:2233-2241)
Claim 21 is directed to:
A computer-implemented method for processing images for quantitative hemodynamic flow analysis, comprising [Taylor et al. disclose CTA visualization of coronary artery disease using CT scan images, computational fluid dynamics and image based modeling to determine rest and hyperemic coronary flow and pressure from CTA scans (p.2233 at abstract)]:
retrieving patient specific image data [Taylor et al. disclose getting CT scan patient images (page. 2233 at abstract) and (page 2234, cols. 1-2)];
creating a 3D reconstruction of a vessel of interest from the patient specific image data [Taylor et al. disclose getting CT scan patient images (page. 2233 at abstract) and construction of an anatomic model of the coronary arteries; a mathematical model of coronary physiology to derive boundary conditions representing cardiac output, aortic pressure, and microcirculatory resistance; and a numerical solution of the laws of physics governing fluid dynamics. (page 2234, cols. 1-2);
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 [Taylor et al. disclose the determination of diseased areas of a vessel based on said representation at Figure 1];
determining a location of the diseased segment [Taylor et al. disclose the determination of diseased location of a vessel at Figure 1];
estimating characteristics of the one or more systems of interest [Taylor et al. disclose determining characteristics of said vessel representation (system) wherein CTA indicates stenosis in the LAD and a FFR derived from said CTA demonstrates that there is no ischemia as indicated by a computed value (0.91)-Figure 1]; and
calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based on the characteristics of the one or more systems of interest [Taylor et al. disclose determining characteristics of said vessel representation (system) wherein CTA indicates stenosis in the LAD and a FFR derived from said CTA demonstrates that there is no ischemia as indicated by a computed value (0.91)-Figure 1; FFR is fractional flow reserve which is a hemodynamic measurements of a ratio of upstream to downstream blood flow].
With respect to claim 32 to the system, Taylor et al. disclose computer implementation as indicated by the 3D representations depicted in at least Figure 1-2 and 4-8. The system operates the method steps as disclosed above and therefore claim 32 is rejected under 35 USC 102(a)(1) for the same reasons as above.
With respect to claim 22 to the system, Taylor et al. disclose computer implementation as indicated by the 3D representations depicted in at least Figure 1-2 and 4-8. The system operates the method steps as disclosed above and therefore claim 22 is rejected under 35 USC 102(a)(1) for the same reasons as above.
With respect to claims 23 and 40, Taylor et al. disclose, “this segmentation process involves extracting the topology of the coronary artery tree; identifying, analyzing, and segmenting coronary plaques in each vessel; and extracting the luminal boundary” [Taylor et al.-p. 2237].
With respect to claim 24, Taylor et al. disclose disease as based on vessel narrowing [Figure 5 (B)].
With respect to claims 25 and 33, Taylor et al. disclose the system that includes coronary arteries and calculations based on a condition of said arteries at least at [Figure 5].
With respect to claims 26 and 34, Taylor et al. disclose determinations of geometries at disease segment and calculation of hemodynamic quantities based on geometry, including computations of pressure and velocity [Figure 3; Figure 5; Figure 6].
With respect to claims 27 and 35, Taylor et al. disclose pressure calculations based on proximal and distal ends of a lesion at [Figure 3; Figure 5].
With respect to claims 31 and 39, Taylor et al. disclose patient-specific hemodynamic velocity based on patient geometry and characteristics of the diseased segment [Figure 8].
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 28-30 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (Journal of the American College of Cardiology (2013) Vol. 61:2233-2241), as applied to claims 21 and 32 above and in view of Wannarong et al. (Stroke (2013) Vol. 44:1859-1865).
With respect to claims 21 and 32, Taylor et al. disclose the limitations as provided above.
With respect to claims 28-29 and 36- 37 the prior art to Taylor et al. does not, however, specifically disclose the elements for the calculation of progression and/or regression of disease. With respect to claims 30 and 38 the prior art to Taylor et al. does not specifically disclose the elements of determining a characteristic curve and calculations of hemodynamic quantity based on the curve.
However, the prior art to Wannarong et al. disclose calculations for evaluation of intima-media thickness and plaque burden for progression/regression as predictors for cardiovascular outcomes, including progression/regression analysis calculations (abstract; p.1862, col. 1-p.1863).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have assessed progression and/or regression using the teachings of Taylor et al. in combination with Wannarong et al. teaching the techniques of progression/regression analysis. One would have found motivation to do so, as Taylor et al. disclose, “importantly, these methods may also enable prediction of changes in coronary flow and pressure from therapeutic interventions (e.g., percutaneous coronary intervention, coronary artery bypass graft)…” thus providing motivation for using said methods for assessment of progression and/or regression of CAD [Taylor et al. at p. 2240, col. 2]. Further the art to Wannarong et al. disclose advantages, such as “quantification of plaque burden is superior to IMT for several reasons: it is a stronger predictor of cardiovascular events, 6–8 change can be reliably measured within individuals in months, 9–11 and progression of total plaque area (TPA) strongly predicts stroke, death, and myocardial infarction (MI).12 Measurement of TPA has been used to treat arteries rather than risk factors,10 and doing so markedly reduces cardiovascular events” [p. 1859, col. 2].
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; and calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based on the characteristics of the one or more systems of interest.
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; and calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based on the characteristics of the one or more systems of interest.
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; and calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based on the characteristics of the one or more systems of interest.
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; and calculating one or more hemodynamic measurements of a change in the lesion in the diseased segment based on the characteristics of the one or more systems of interest.
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.
Conclusion
No claims are allowed.
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