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 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.
Claim(s) 1-26 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brynolffson et al. (WO 2022/008374 A1, Jan. 13, 2022) (hereinafter “Brynolffson”) in view of Vogel, Marco ME, et al. "Prognostic risk classification for biochemical relapse-free survival in patients with oligorecurrent prostate cancer after [68Ga] PSMA-PET-guided metastasis-directed therapy." European journal of nuclear medicine and molecular imaging 47.10 (2020): 2328-2338 (hereinafter “Vogel”).
Regarding claim 1: Brynolffson discloses a method for processing one or more images of a prostate cancer patient to automatically determine a patient risk index that correlates with biochemical progression free survival (bPFS) in the patient, the method comprising: (a) receiving, by a processor of a computing device, an image of the subject obtained using a functional imaging modality (claim 1; figs. 1C, 2C; [0214]-[0215]; [0228]); (b) determining, by the processor, based on the image, values of one or more patient risk index/indices that correlate with bPFS in the patient (claims 18 and 22; figs. 1C, 2C; [0220]-[0222], [0229]; [0233]-[0236], table 1); and generating a report with the results of the analysis ([0260]-[0264], figs. 16A-16E).
Brynolffson is silent on generating, by the processor, based on the values of the one or more patient risk index/indices, an estimate of bPFS and including the estimate of bPFS in the generated report.
Vogel, in the same field of endeavor, teaches generating survival estimates based on various risk indices and characteristics (fig. 3, table 5).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to generate a survival estimate as taught by Vogel based on the calculated indices of Brynolffson and include the information, with the other assorted results, in the report of Brynolffson in order to provide a practitioner with a reasonable estimate of a patient’s prognosis to inform further treatment decisions.
Regarding claim 13: Brynolffson discloses a system for processing one or more images of a prostate cancer patient to automatically determine a patient risk index that correlates with biochemical progression free survival (bPFS) in the patient, the system comprising: a processor of a computing device (claim 48, fig. 31); and memory having instructions stored thereon, wherein the instructions, when executed by the processor (claim 48, fig. 31), cause the processor to: (a) receive an image of the subject obtained using a functional imaging modality (figs. 1C, 2C; [0214]-[0215]; [0228]); (b) determine, based on the image, values of one or more patient risk index/indices that correlate with bPFS in the patient (claims 65 and 69; figs. 1C, 2C; [0220]-[0221], [0229; [0233]-[0236], table 1); and generate a report with the results of the analysis ([0260]-[0264], figs. 16A-16E).
Brynolffson is silent on generating, based on the values of the one or more patient risk index/indices, an estimate of bPFS and including the estimate of bPFS in the generated report.
Vogel, in the same field of endeavor, teaches generating survival estimates based on various risk indices and characteristics (fig. 3, table 5).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to generate a survival estimate as taught by Vogel based on the calculated indices of Brynolffson and include the information, with the other assorted results, in the report of Brynolffson in order to provide a practitioner with a reasonable estimate of a patient’s prognosis to inform further treatment decisions.
Regarding claims 2 and 14: Brynolffson and Vogel disclose the method of claim 1 and system of claim 13. Brynolffson further discloses wherein the image of the subject is or comprises a 3D PET/CT image ([0214]-[0215]; [0280).
Regarding claims 3 and 15: Brynolffson and Vogel disclose the method of claim 1 and system of claim 13. Brynolffson further discloses wherein the image is a composite image comprising a CT image and a PET image, wherein the determining step comprises using deep learning to segment anatomical information from the CT image and use the anatomical information in combination with the PET image to detect and quantify candidates for prostate cancer lesions ([0279], [0280] - composite PET/CT image, [0291]).
Regarding claims 4 and 16: Brynolffson and Vogel disclose the method of claim 1 and the system of claim 13. Brynolffson further discloses wherein the one or more determined patient risk index/indices that correlate with bPFS in the patient include one or more members selected from the group consisting of (i) SUVmean, (ii) SUVmax, (iii) PSMA positive total tumor volume (PSMAttv), and (iv) aPSMA scores ([0264], [0284]).
Regarding claims 5 and 17: Brynolffson and Vogel disclose the method of claim 4 and system of claim 16. Brynolffson further discloses wherein the PSMAttv is a measure of a total lesion volume for the subject and/or over a subset of lesions within one or more tissue regions and/or prostate cancer staging classes ([0263], [0325], table 6 - volume, which is the lesion volume).
Regarding claims 6 and 18: Brynolffson and Vogel disclose the method of claim 4 and the system of claim 16. Brynolffson further discloses wherein the aPSMA score is a quantitative score for tumor burden measuring the interaction of tumor volume and uptake ([0263]-[0264], [0343], table 6 - tissue type ITLV; where the instant disclosure indicates that ITLV may be the aPSMA index in at least [0019]).
Regarding claim 7: Brynolffson and Vogel disclose the method of claim 1. Brynolffson further discloses wherein step (b) comprises: detecting, by the processor, one or more hotspots within the functional image, each hotspot determined to represent a potential underlying lesion ([0217]-[0221], [0233]; claims 1-2 and 18); and determining, by the processor, the one or more patient risk indices based on the one or more detected hotspots ([0217]-[0221], [0233]; claims 1-2 and 18).
Regarding claim 19: Brynolffson and Vogel disclose the system of claim 13. Brynolffson further discloses wherein, at step (b), the instructions cause the processor to: detect one or more hotspots within the functional image, each hotspot determined to represent a potential underlying lesion ([0217]-[0221], [0233]; claims 48-50 and 65); and determine the one or more patient risk indices based on the one or more detected hotspots ([0217]-[0221], [0233]; claims 48-50 and 65).
Regarding claims 8 and 20: Brynolffson and Vogel disclose the method of claim 7 and system of claim 19. Brynolffson further discloses wherein detecting the one or more hotspots comprises using a deep learning model ([0279], [0291]).
Regarding claims 9 and 21: Brynolffson and Vogel disclose the method of claim 1 and system of claim 13. Brynolffson further discloses wherein the image of the subject is a nuclear medicine image obtained following administration to the subject of a PSMA binding agent ([0193]-[0197]).
Regarding claims 10 and 22: Brynolffson and Vogel disclose the method of claim 9 and system of claim 21. Brynolffson further discloses wherein the PSMA binding agent is or comprises [18F]DCFPyL (PyL) ([0293], [0370]).
Regarding claims 11 and 23: Brynolffson and Vogel disclose the method of claim 1 and system of claim 13. Brynolffson further discloses causing, by the processor, display of the one or more patient risk indices within a graphical user interface (GUI) ([0237]).
Regarding claims 12 and 24: Brynolffson and Vogel disclose the method of claim 1 and system of claim 13. Brynolffson further discloses wherein the processor is a processor of a cloud-based system ([0079], claims 33 and 80).
Regarding claim 25: Brynolffson as modified by Vogel discloses the method of claim 1, wherein the estimate of bPFS is a time estimate of biochemical progression free survival (Vogel - fig. 3, table 5).
Regarding claim 26: Brynolffson as modified by Vogel discloses the system of claim 13, wherein the estimate of bPFS is a time estimate of biochemical progression free survival (Vogel - fig. 3, table 5).
Regarding claim 28: Brynolffson as modified by Vogel discloses the method of claim 1, wherein the report is a portion of a graphical user interface (GUI) ([0260]-[0264], figs. 16A-16E).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brynolffson and Vogel as applied to claim 1 above, and further in view of Zimmermann et al. (US 2019/0316184 A1, Oct. 17, 2019) (hereinafter “Zimmermann”).
Regarding claim 27: Brynolffson as modified by Vogel disclose the method of claim 1, but are silent on wherein the report is an electronic document.
Zimmermann, in the same field of endeavor, discloses generating a report on patient cancer detection and monitoring where the report may be an electronic document ([0788]). Zimmermann further teaches that such an electronic document may be sent to a physician to review ([0788]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the report of Brynolffson and Vogel as an electronic document as taught by Zimmermann so that the information can be sent to a physician for review, e.g. at a remote location or via a mobile device.
Response to Arguments
Rejection of claims 3 and 15 under 35 U.S.C. §112(b) is withdrawn in light of the amendments to the claims.
Applicant’s arguments with respect to prior art rejection of claims 1-24, filed 12/17/2025, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799