DETAILED ACTION
Claims 1-20 are hereby under examination.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/30/2025 is being considered by the examiner.
Claim Objections
Claims 1, 13, and 20 are objected to because of the following informalities:
Regarding claim 1, line 11 recites “the received physiological state”, however it appears it should read --the physiological state-- to maintain consistent claim language.
Regarding claim 13, lines 15-16 recite “the received physiological state”, however it appears it should read --the physiological state-- to maintain consistent claim language.
Regarding claim 20, line 13 recites “the received physiological state”, however it appears it should read --the physiological state-- to maintain consistent claim language.
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.
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Claims 1-3, 7-14, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, 11-12, 15, and 17 of U.S. Patent No. 12,310,759 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application: 19/194,265 (claim set filed 04/30/2025)
Reference Patent: US 12,310,759 B2 (claim set published 05/27/2025)
1. A computer-implemented method comprising:
receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's tissue;
determining a blood flow demand of the portion of the patient's tissue modeled by the non-invasive patient-specific three dimensional anatomic model, based on a determined mass of the portion of the patient's tissue and a physiological state of the patient;
determining a blood flow characteristic of blood delivered to the portion of the patient's tissue using a fluid simulation of a blood flow in the received patient-specific three dimensional anatomic model, the determined blood flow demand, and a value of microvascular resistance based on the received physiological state;
determining adequacy of blood flow to the portion of the patient's tissue by comparing the determined blood flow characteristic with a threshold blood flow characteristic; and
generating and displaying (i) an assessment of blood supply adequacy based on the determined adequacy of blood flow, or (ii) a risk score defining a risk of disease of the patient's tissue, based on the comparison.
1. A computer-implemented method of assessment of ischemia and related disorders, the method comprising:
receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's bowel;
receiving a patient physiological state, the physiological state being a state different from a resting state;
determining a blood flow demand of the portion of the patient's bowel modeled by the non-invasive patient-specific three dimensional anatomic model, based on a determined mass of the portion of the patient's bowel and the received physiological state of the patient;
performing a fluid simulation of a blood flow in the received patient-specific three dimensional anatomic model;
determining a blood flow characteristic of blood delivered to the portion of the patient's bowel using the fluid simulation, the determined blood flow demand, and a value of microvascular resistance based on the received physiological state;
determining adequacy of blood flow to the portion of the patient's bowel by comparing the determined blood flow characteristic with a threshold blood flow characteristic; and
generating and displaying (i) an assessment of blood supply adequacy based on the determined adequacy of blood flow, or (ii) a risk score defining a risk of disease of the patient's bowel, based on the comparison.
2. The computer-implemented method of claim 1, wherein the physiological state is a state different from a resting state.
1. … receiving a patient physiological state, the physiological state being a state different from a resting state …
3. The computer-implemented method of claim 1, wherein the patient's tissue comprises visceral vasculature or bowel of the patient.
1. … receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's bowel …
7. The computer-implemented method of claim 1, wherein the blood flow characteristic includes one or more of blood pressure, flow rate, fractional flow reserve, or portal venous pressure.
2. The computer-implemented method of claim 1, wherein the blood flow characteristic includes one or more of blood pressure, flow rate, fractional flow reserve, or portal venous pressure.
8. The computer-implemented method of claim 1, further comprising: determining the blood flow demand based on an allometric relationship between blood flow and the determined mass of the portion of the patient's tissue.
3. The computer-implemented method of claim 1, further comprising:
determining the blood flow demand based on an allometric relationship between blood flow and the determined mass of the portion of the patient's bowel.
9. The computer-implemented method of claim 8, further including: subdividing the non-invasive patient-specific three dimensional anatomic model into one or more tissue regions; determining an association between a vessel of vasculature of the patient and at least one tissue region of the one or more tissue regions; and determining blood flow adequacy for one or more locations of the portion of the patient's tissue distal to the at least one tissue region, based on a determined blood flow adequacy for the at least one tissue region.
4. The computer-implemented method of claim 3, further including:
subdividing the non-invasive patient-specific three dimensional anatomic model into one or more bowel regions;
determining an association between a vessel of the patient's vasculature and at least one bowel region of the one or more bowel regions; and
determining blood flow adequacy for one or more locations of the portion of the patient's bowel distal to the at least one bowel region, based on a determined blood flow adequacy for the at least one bowel region.
10. The computer-implemented method of claim 1, wherein the value of microvascular resistance comprises resistance at a vessel outlet.
6. The computer-implemented method of claim 1, wherein the value of microvascular resistance comprises resistance at a vessel outlet.
11. The computer-implemented method of claim 10, further comprising: modifying a geometry of the non-invasive patient-specific three dimensional anatomic model; determining a modified blood flow characteristic at a location in the modified non- invasive patient-specific three dimensional anatomic model based on the modified non- invasive patient-specific three dimensional anatomic model; and generating an updated assessment or display of blood supply adequacy to the patient's tissue, or generating or displaying a risk score for risk of disease to one or more regions of the patient's tissue, based on the determined modified blood flow characteristic at the location in the modified non-invasive patient-specific three dimensional anatomic model.
7. The computer-implemented method of claim 6, further comprising:
modifying a geometry of the non-invasive patient-specific three dimensional anatomic model; determining a modified blood flow characteristic at a location in the modified non-invasive patient-specific three dimensional anatomic model based on the modified non-invasive patient-specific three dimensional anatomic model; and generating an updated assessment or display of blood supply adequacy to the patient's bowel, or generating or displaying a risk score for risk of disease to one or more regions of the patient's bowel, based on the determined modified blood flow characteristic at the location in the modified non-invasive patient-specific three dimensional anatomic model.
12. The computer-implemented method of claim 11, further comprising: determining the risk score for risk of disease to one or more regions of the patient's tissue based on the assessment of blood supply adequacy to the patient's tissue, wherein the risk of disease includes risk of one or more of mesenteric ischemia, intestinal ischemia, ischemic colitis, abdominal pain, gangrene, bowel perforation, sepsis, stricture, and inflammatory conditions.
8. The computer-implemented method of claim 1, further comprising:
determining the risk score for risk of disease to one or more regions of the patient's bowel based on the assessment of blood supply adequacy to the patient's bowel, wherein the risk of disease includes risk of one or more of mesenteric ischemia, intestinal ischemia, ischemic colitis, abdominal pain, gangrene, bowel perforation, sepsis, stricture, and inflammatory conditions.
13. A system comprising:
at least one data storage device storing instructions for assessment of ischemic colitis; and
at least one processor configured to execute the instructions to perform a method including:
receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's tissue;
determining a blood flow demand of the portion of the patient's tissue modeled by the non-invasive patient-specific three dimensional anatomic model, based on a determined mass of the portion of the patient's tissue and a physiological state of the patient;
determining a blood flow characteristic of blood delivered to the portion of the patient's tissue using a fluid simulation of a blood flow in the received patient- specific three dimensional anatomic model, the determined blood flow demand, and a value of microvascular resistance based on the received physiological state;
determining adequacy of blood flow to the portion of the patient's tissue by comparing the determined blood flow characteristic with a threshold blood flow characteristic; and
generating and displaying (i) an assessment of blood supply adequacy based on the determined adequacy of blood flow, or (ii) a risk score defining a risk of disease of the patient's tissue, based on the comparison.
9. A system for assessment of ischemia and related disorders, the system comprising:
at least one data storage device storing instructions for assessment of ischemic colitis; and
at least one processor configured to execute the instructions to perform a method including:
receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's bowel;
receiving a patient physiological state, the physiological state being a state different from a resting state;
determining a blood flow demand of the portion of the patient's bowel modeled by the non-invasive patient-specific three dimensional anatomic model, based on a determined mass of the portion of the patient's bowel and the received physiological state of the patient;
performing a fluid simulation of a blood flow in the received patient-specific three dimensional anatomic model;
determining a blood flow characteristic of blood delivered to the portion of the patient's bowel using the fluid simulation, the determined blood flow demand, and a value of microvascular resistance based on the received physiological state;
determining adequacy of blood flow to the portion of the patient's bowel by comparing the determined blood flow characteristic with a threshold blood flow characteristic; and
generating and displaying (i) an assessment of blood supply adequacy based on the determined adequacy of blood flow, or (ii) a risk score defining a risk of disease of the patient's bowel, based on the comparison.
14. The system of claim 13, wherein the patient's tissue comprises visceral vasculature or bowel of the patient.
9. … receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's bowel …
17. The system of claim 13, wherein the system is further configured for: determining the blood flow demand based on an allometric relationship between blood flow and the determined mass of the portion of the patient's tissue.
11. The system of claim 9, wherein the system is further configured for:
determining the blood flow demand based on an allometric relationship between blood flow and the determined mass of the portion of the patient's bowel.
18. The system of claim 17, wherein the system is further configured for: subdividing the non-invasive patient-specific three dimensional anatomic model into one or more tissue regions; determining an association between a vessel of vasculature of the patient and at least one tissue region of the one or more tissue regions; and determining blood flow adequacy for one or more locations of the portion of the patient's tissue distal to the at least one tissue region, based on a determined blood flow adequacy for the at least one tissue region.
12. The system of claim 11, wherein the system is further configured for:
subdividing the non-invasive patient-specific three dimensional anatomic model into one or more bowel regions; determining an association between a vessel of the patient's vasculature and at least one bowel region of the one or more bowel regions; and determining blood flow adequacy for one or more locations of the portion of the patient's bowel distal to the at least one bowel region, based on a determined blood flow adequacy for the at least one bowel region.
19. The system of claim 13, wherein the system is further configured for: modifying a geometry of the non-invasive patient-specific three dimensional anatomic model; determining a modified blood flow characteristic at a location in the modified non- invasive patient-specific three dimensional anatomic model based on the modified non- invasive patient-specific three dimensional anatomic model; and generating an updated assessment or display of blood supply adequacy to the patient's tissue, or generating or displaying a risk score for risk of disease to one or more regions of the patient's tissue, based on the determined modified blood flow characteristic at the location in the modified non-invasive patient-specific three dimensional anatomic model.
15. The system of claim 14, wherein the system is further configured for: modifying a geometry of the non-invasive patient-specific three dimensional anatomic model; determining a modified blood flow characteristic at a location in the modified non-invasive patient-specific three dimensional anatomic model based on the modified non-invasive patient-specific three dimensional anatomic model; and generating an updated assessment or display of blood supply adequacy to the patient's bowel, or generating or displaying a risk score for risk of disease to one or more regions of the patient's bowel, based on the determined modified blood flow characteristic at the location in the modified non-invasive patient-specific three dimensional anatomic model.
20. A non-transitory computer readable medium for use on a computer system containing computer-executable programming instructions for performing a method, the method comprising:
receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's tissue;
determining a blood flow demand of the portion of the patient's tissue modeled by the non-invasive patient-specific three dimensional anatomic model, based on a determined mass of the portion of the patient's tissue and a physiological state of the patient;
determining a blood flow characteristic of blood delivered to the portion of the patient's tissue using a fluid simulation of a blood flow in the received patient-specific three dimensional anatomic model, the determined blood flow demand, and a value of microvascular resistance based on the received physiological state;
determining adequacy of blood flow to the portion of the patient's tissue by comparing the determined blood flow characteristic with a threshold blood flow characteristic; and
generating and displaying (i) an assessment of blood supply adequacy based on the determined adequacy of blood flow, or (ii) a risk score defining a risk of disease of the patient's tissue based on the comparison.
17. A non-transitory computer readable medium for use on a computer system containing computer-executable programming instructions for performing a method of assessment of ischemia and related disorders, the method comprising:
receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's bowel;
receiving a patient physiological state, the physiological state being a state different from a resting state;
determining a blood flow demand of the portion of the patient's bowel modeled by the non-invasive patient-specific three dimensional anatomic model, based on a determined mass of the portion of the patient's bowel and the received physiological state of the patient;
performing a fluid simulation of a blood flow in the received patient-specific three dimensional anatomic model;
determining a blood flow characteristic of blood delivered to the portion of the patient's bowel using the fluid simulation, the determined blood flow demand, and a value of microvascular resistance based on the received physiological state;
determining adequacy of blood flow to the portion of the patient's bowel by comparing the determined blood flow characteristic with a threshold blood flow characteristic; and
generating and displaying (i) an assessment of blood supply adequacy based on the determined adequacy of blood flow, or (ii) a risk score defining a risk of disease of the patient's bowel based on the comparison.
Claims 4-6 and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 12,310,759 B2, hereinafter referred to as ‘759, in view of Charles Taylor (US 20120041318 A1), hereinafter referred to as Taylor.
Regarding claims 4-6, ‘759 discloses the computer-implemented method of claim 1.
However, ‘759 does not disclose determining boundary conditions at a blood flow input of the portion of the patient's tissue (claim 4), wherein the boundary conditions are determined by measuring aortic flow of the patient (claim 5), and wherein the fluid simulation of the blood flow is performed based on the boundary conditions (claim 6).
Taylor discloses an analogous computer-implemented method for modeling blood flow characteristics of a patient (Abstract, Fig. 2, para. [0010]). Taylor discloses receiving a non-invasive patient specific three dimensional anatomic model including a portion of a patient’s tissue (Fig. 2, para. [0111]) and determine blood flow information using the three-dimensional model (Fig. 2, para. [0114]). Taylor further discloses determining boundary conditions at a blood flow input of the portion of the patient's tissue (para. [0113], para. [0159-0164]). Taylor further discloses the boundary conditions are determined by measuring aortic flow of the patient (para. [0113]). Taylor further discloses the fluid simulation of the blood flow is performed based on the boundary conditions (para. [0113-0114]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computer-implemented method disclosed by ‘759 to additionally determine boundary conditions at a blood flow input of the portion of that patient’s tissue, specifically by measuring aortic flow, and utilize the boundary conditions in a fluid simulation, as disclosed by Taylor. This is because Taylor teaches the addition of boundary conditions provide insight into the blood flow characteristics outside of the portion of the patients tissue, allowing for upstream and downstream conditions, specifically at the aorta, to be accounted for in the blood flow analysis (para. [0113]).
Regarding claims 15-16, ‘759 discloses the system of claim 13.
However, ‘759 does not disclose determining boundary conditions at a blood flow input of the portion of the patient's tissue, wherein the boundary conditions are determined by measuring aortic flow of the patient (claim 15), and wherein the fluid simulation of the blood flow is performed based on the boundary conditions (claim 16).
Taylor discloses an system for modeling blood flow characteristics of a patient (Abstract, Fig. 2, para. [0010]). Taylor discloses receiving a non-invasive patient specific three dimensional anatomic model including a portion of a patient’s tissue (Fig. 2, para. [0111]) and determine blood flow information using the three-dimensional model (Fig. 2, para. [0114]). Taylor further discloses determining boundary conditions at a blood flow input of the portion of the patient's tissue (para. [0113], para. [0159-0164]). Taylor further discloses the boundary conditions are determined by measuring aortic flow of the patient (para. [0113]). Taylor further discloses the fluid simulation of the blood flow is performed based on the boundary conditions (para. [0113-0114]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by ‘759 to additionally determine boundary conditions at a blood flow input of the portion of that patient’s tissue, specifically by measuring aortic flow, and utilize the boundary conditions in a fluid simulation, as disclosed by Taylor. This is because Taylor teaches the addition of boundary conditions provide insight into the blood flow characteristics outside of the portion of the patients tissue, allowing for upstream and downstream conditions, specifically at the aorta, to be accounted for in the blood flow analysis (para. [0113]).
Prior Art Analysis
Claims 1-20 are rejected on the ground of nonstatutory double patenting as recited above. However, claims 1-20 are not rejected in view of prior art. The closest prior art made of record includes: Charles Taylor (US 20120041318 A1), hereinafter referred to as Taylor, Senzig et al. (US 20120243761 A1), hereinafter referred to as Senzig, and Patwardhan et al. (US 20160106347 A1), hereinafter referred to as Patwardhan.
Taylor teaches a computer-implemented method (Abstract) comprising: receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's tissue (Fig. 24, element 620, para. [0218-0220], “generating one or more models based on the inputs … medical imaging data of the patient’s aorta, coronary arteries, and heart …”); determining a blood flow characteristic of blood delivered to the portion of the patient's tissue using a fluid simulation of a blood flow in the received patient-specific three dimensional anatomic model, and a value of microvascular resistance based on the received physiological state (Fig. 24, para. [0222-0227], “generating one or more physics-based blood flow models … blood flow through the patient-specific geometric model … one or more conditions may be determined based on the inputs and/or the models … resistances for the individual coronary arteries …”); and generating a displaying assessments or risks of results (para. [0118], “three-dimensional model and/or the simulations may be displayed to the physician …”).
Taylor individually teaches that mass of the portion of the patient’s tissue may be used to estimate a baseline mean coronary flow (para. [0177]), and a physiological state of the patient, including levels of exercise, can be used to adjust boundary conditions (para. [0227]). However, Taylor does not disclose, teach, or reasonably suggest, “determining a blood flow demand of the portion of the patient’s tissue modeled by the non-invasive patient specific three dimensional anatomic model, based on a determined mass of the portion of the patient’s tissue and a physiological state of the patient; determining a blood flow characteristic of blood delivered to the portion of the patients tissue using … the determined blood flow demand …”, in combination with the other elements of the independent claims.
Senzig teaches computer-implemented method (Abstract) comprising: receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient's tissue (Fig. 3, para. [0025], “CT projection data … reconstruct an image volume …”); determining a blood flow demand of the portion of the patient's tissue modeled by the non-invasive patient-specific three dimensional anatomic model, based on a physiological state of the patient (Fig. 3, para. [0040], “imaging data acquired at multiple stress levels …”, para. [0049], “CFD analysis is performed and an hemodynamic information is generated …).
However, Senzig does not disclose, teach, or reasonably suggest “the blood flow demand is additionally based on a determined mass of the portion of the patient’s tissue”, and “determining a blood flow characteristic of blood delivered to the portion of the patient’s tissue using … the determined blood flow demand … determining adequacy of blood flow to the portion of the patent’s tissue by comparing the determined blood flow characteristic with a threshold blood flow characteristic …”, in combination with the other elements of the independent claims.
Patwardhan teaches receiving a non-invasive patient-specific three dimensional anatomic model including a portion of a patient’s tissue, specifically a bowel, and determining a blood flow characteristic from the images (Fig. 4, para. [0046], “receives a plurality of images of an abdominal region from an image capture device … determines a blood flow characteristics of the bowel tissue from the plurality of images”).
However, Patwardhan does not disclose, teach, or reasonable suggest at least “determining a blood flow demand of the potion of the patient’s tissue … based on a determined mass of the portion of the patient’s tissue and a physiological state of the patient …”.
Conclusion
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/KYLE W. KRETZER/Examiner, Art Unit 3791
