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 12/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-30 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. Although the claims at issue are not identical, they are not patentably distinct from each other because:
As per claim 1, ‘048 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, one or more medical images comprising one or more regions of one or more coronary arteries of a subject (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 one or more medical images (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, wherein the total plaque volume is determined based at least in part by applying a first machine learning algorithm to the accessed one or more medical images to identify one or more regions of plaque within the one or more segments of coronary arteries (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”); determining, by the computer system, a presence or absence of one or more additional risk factors by further analyzing the accessed one or more medical images, the one or more additional risk factors comprising 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, a presence of high-risk plaque, or a likelihood of presence of ischemia (see claims 5-7 in ‘048 patent); generating, by the computer system, a CAD risk stage for the subject based at least in part on the determined total plaque volume and the presence or absence of one or more additional risk factors (see claims 8-9); 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 (claim 1: “ 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”).
As per claim 2, ‘048 patent discloses wherein the CAD risk stage comprises a number of predetermined stages (see claim 2 of ‘048 patent).
As per claim 3, ‘048 patent discloses wherein the number of predetermined stages comprises four (see claim 3, of ‘048 patent).
As per claim 4, ‘048 patent discloses wherein one or more ranges of total plaque volume is used to generate the CAD risk stage, the one or more ranges comprising 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 the generated CAD risk stage is configured to be higher when one or more additional risk factors is present compared to when one or more additional risk factors is absent (see claims 5 and 8, the presence or absence of ischemia).
As per claim 6, ‘048 patent discloses wherein the first predetermined threshold comprises 30 percent stenosis (see claim 6 of ‘048 patent).
As per claim 7, ‘048 patent discloses wherein the second predetermined threshold comprises 50 percent stenosis (see claim 7 of ‘048 patent).
As per claim 8, ‘048 patent discloses wherein ischemia is determined to be likely present based on one or more of the one or more segments of the coronary arteries (see claim 8 of ‘048 patent).
As per claim 9, ‘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 claim 9 of ‘048 patent).
As per claim 10, ‘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 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, ‘048 patent discloses wherein low density non-calcified plaque comprises radiodensity values between -189 and 30 Hounsfield units (see claim 13 of ‘048 patent).
As per claim 13, ‘048 patent discloses wherein the presence of high-risk plaque is determined using a third machine learning algorithm configured to determine the presence of high-risk plaque by analyzing the one or more medical images (see claim 14 of ‘048 patent).
As per claim 14, ‘048 patent discloses wherein the graphical representation comprises a report displaying the CAD stage for the subject (see claim 15 of ‘048 patent).
As per claim 15, ‘048 patent discloses wherein the report comprises the CAD risk stage, a risk characterization, and a non-calcified plaque volume (see claim 16 of ‘048 patent).
As per claim 16, ‘048 patent discloses wherein the CAD treatment for the subject is determined based at least in part on the CAD risk stage for the subject, wherein a higher CAD risk stage is reflective of more intensive treatment for the subject (see claim 17 of ‘048 patent).
As per claim 17, ‘048 patent discloses wherein the CAD treatment comprises one or more of lifestyle changes, medication, or intervention (see claim 18 of ‘048 patent).
As per claim 18, ‘048 patent discloses wherein the CAD treatment comprises at least one of more aggressive therapy goals or greater number of medications for higher CAD risk stages (see claim 19 of ‘048 patent).
As per claim 19, ‘048 patent discloses wherein the CAD risk stage is configured to be used as an indication of a risk of major adverse cardiovascular event (MACE) (see claim 20 of ‘048 patent).
As per claim 20, ‘048 patent discloses wherein the CAD risk stage is generated using a fourth machine learning algorithm (see claim 10 of ‘048 patent).
As per claim 21, see explanation in claim 1 above, and claim 21 of ‘048 patent for system.
As per claim 22, see explanation in claim 2 above.
As per claim 23, see explanation in claim 4 above.
As per claim 24, see explanation in claim 5 above.
As per claim 25, see explanation in claim 6 above.
As per claim 26, see explanation in claim 7 above.
As per claim 27, see explanation in claim 9 above.
As per claim 28, see explanation in claim 10 above.
As per claim 29, see explanation in claim 20 above.
As per claim 30, 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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