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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/09/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 11/07/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Preliminary Amendment
The preliminary amendment filed 01/08/2025 have been entered and considered.
Claim 1 was cancelled.
Claims 2-21 were added.
Claims 2-21 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,558,048 B2 in view of common knowledge in the art.
As per claim 2, ‘048 patent discloses a computer-implemented method of facilitating risk assessment of coronary artery disease (CAD) for a subject by generating a CAD risk stage for the subject based on multivariable information derived from medical image analysis (claim 1: “A computer-implemented method of facilitating risk assessment of coronary artery disease (CAD) for a subject by generating a CAD risk stage for the subject based on multivariable information derived from medical image analysis”), the computer-implemented method comprising: accessing, by a computer system, a first medical image of the subject comprising one or more regions of one or more coronary arteries of a subject, the first medical image obtained at a first point in time (claim 1: “accessing, by a computer system, one or more medical images comprising one or more regions of one or more coronary arteries of a subject”); identifying, by the computer system, one or more segments of coronary arteries within the first medical image (claim 1: “identifying, by the computer system, one or more segments of coronary arteries within the one or more medical images”); determining, by the computer system, a total plaque volume present in the one or more segments of coronary arteries in the first medical image, wherein the total plaque volume is determined based at least in part by applying a first machine learning algorithm to the accessed first medical image to identify one or more regions of plaque within the one or more segments of coronary arteries in the first medical image (claim 1: “determining, by the computer system, for the identified one or more segments of coronary arteries, one or more plaque parameters and one or more vascular parameters, wherein the one or more plaque parameters are determined automatically based at least in part by applying a machine learning algorithm to the accessed one or more medical images, wherein the one or more plaque parameters comprise one or more of total plaque volume, calcified plaque volume, non-calcified plaque volume, or low density non-calcified plaque volume”); generating, by the computer system, a baseline CAD risk stage for the subject based at least in part on the determined total plaque volume present in the one or more segments of coronary arteries in the first medical image (claim 1: “generating, by the computer system, a combined measure of the determined one or more plaque parameters and the one or more vascular parameters to generate the CAD risk stage for the subject”); determining, by the computer system, presence or absence of one or more risk modifying factors by further analyzing the accessed first medical image, the one or more risk modifying factors comprising a likelihood or presence of ischemia (claim 1: “wherein the one or more vascular parameters comprise one or more of stenosis severity or likelihood of presence of ischemia”); modifying, by the computer system, the baseline CAD risk stage for the subject when one or more risk modifying factors are determined to be present; causing, by the computer system, generation of a first graphical representation of the baseline CAD risk stage or modified baseline CAD risk stage for the subject to facilitate risk assessment of CAD for the subject for determining a CAD treatment for the subject (claim 1: “generating, by the computer system, a combined measure of the determined one or more plaque parameters and the one or more vascular parameters to generate the CAD risk stage for the subject; and generating, by the computer system, a graphical representation of the CAD risk stage for the subject, wherein the graphical representation of the CAD risk stage for the subject is configured to facilitate risk assessment of CAD for the subject for determining a CAD treatment for the subject”); wherein the computer system comprises a computer processor and an electronic storage medium (claim 1: “wherein the computer system comprises a computer processor and an electronic storage medium”).
Although ‘048 patent does not explicitly teach “accessing, by the computer system, a second medical image of the subject comprising the one or more regions of one or more coronary arteries of the subject, the second medical image obtained at a second point in time after applying CAD treatment for the subject; identifying, by the computer system, one or more segments of coronary arteries within the second medical image; determining, by the computer system, a total plaque volume present in the one or more segments of coronary arteries in the second medical image, wherein the total plaque volume is determined based at least in part by applying the first machine learning algorithm to the accessed second medical image to identify one or more regions of plaque within the one or more segments of coronary arteries in the second medical image; generating, by the computer system, a post-treatment CAD risk stage for the subject based at least in part on the determined total plaque volume present in the one or more segments of coronary arteries in the second medical image; determining, by the computer system, presence or absence of one or more risk modifying factors by further analyzing the accessed second medical image, the one or more risk modifying factors comprising a likelihood or presence of ischemia; modifying, by the computer system, the post-treatment CAD risk stage for the subject when one or more risk modifying factors are determined to be present; and causing, by the computer system, generation of a second graphical representation of the post-treatment CAD risk stage or modified post-treatment CAD risk stage for the subject to facilitate a post-treatment risk assessment of CAD for the subject for determining continued CAD treatment for the subject”, nonetheless, it is common knowledge in the art to repeat the same procedures as above for a post treatment CAD risk assessment. At the time of the invention, it would have been obvious to a person of ordinary skill in the art to modify ‘048 patent in view of common knowledge in the art to repeat same CAD risk assessment procedures for images taken before and after a proposed treatment plan to access the effectiveness of the treatment plan.
As per claim 3, ‘048 patent discloses wherein the baseline CAD risk stage comprises a number of predetermined risk stages determined based on one or more ranges of total plaque volume (see claim 2 of ‘048 patent).
As per claim 4, ‘048 patent discloses wherein the one or more ranges of total plaque volume comprises 0 mm3, 1-250 mm3, 251-750 mm3, or more than 750 mm3 (see claim 4 of ‘048 patent).
As per claim 5, ‘048 patent discloses wherein modification of the CAD risk stage comprises increasing the CAD risk stage by one stage (see claim 6 of ‘048 patent).
As per claim 6, ‘048 patent discloses wherein the one or more risk modifying factors further comprises one or more of a presence of stenosis above a first predetermined threshold in a left main coronary artery, a presence of stenosis above a second predetermined threshold in a left anterior descending (LAD) coronary artery, or presence of high-risk plaque (see claims 6 and 7 of ‘048 patent).
As per claim 7, ‘048 patent discloses wherein the first predetermined threshold comprises 30 percent stenosis (see claim 6 of ‘048 patent).
As per claim 8, ‘048 patent discloses wherein the second predetermined threshold comprises 50 percent stenosis (see claim 7 of ‘048 patent).
As per claim 9, ‘048 patent discloses wherein high-risk plaque is determined to be present when at least one region of low density non-calcified plaque larger than 2 mm3 is identified from analyzing the one or more medical images (see claim 11 of ‘048 patent).
As per claim 10, ‘048 patent discloses wherein the likelihood of presence of ischemia is determined using a second machine learning algorithm configured to determine the likelihood of presence of ischemia based at least in part on a plurality of plaque or vascular variables derived from analyzing the one or more medical images (see claims 8 and 9 of ‘048 patent).
As per claim 11, ‘048 patent discloses wherein high-risk plaque is determined to be present when at least one region of low density non-calcified plaque larger than 2 mm3 and with a positive remodeling index of more than 1.1 is identified from analyzing the one or more medical images (see claim 12 of ‘048 patent).
As per claim 12, see explanation in claim 2 above and see claim 21 of ‘048 patent for a system.
As per claim 13, see explanation in claim 3 above.
As per claim 14, see explanation in claim 4 above.
As per claim 15, see explanation in claim 5 above.
As per claim 16, see explanation in claim 6 above.
As per claim 17, see explanation in claim 7 above.
As per claim 18, see explanation in claim 8 above.
As per claim 19, see explanation in claim 9 above.
As per claim 20, see explanation in claim 10 above.
As per claim 21, see explanation in claim 11 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOM Y LU whose telephone number is (571)272-7393. The examiner can normally be reached Monday - Friday, 9AM - 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached at (571) 272 - 7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOM Y LU/Primary Examiner, Art Unit 2667
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