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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 13, 17, and 20, the limitations “wherein the treatment trajectory has an organ entry location for entering the patient’s soft tissue organ and an organ exit location for exiting the patient’s soft tissue organ” are not mentioned in the specification and are considered new matter. The specification is silent as to any “organ entry location” or “organ exit location”. While the surgical procedure may encompass entering and exiting the organ, the specification fails to describe a computer processing system/algorithm in which the organ entry location and organ exit location are defined within the computer processing system/algorithm.
Claim Rejections - 35 USC § 103
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.
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) 1-2 and 4-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshinaka et al. (US 2021/0169576; hereinafter Yoshinaka) in view of Thomas et al. (US 2016/0070436; hereinafter Thomas).
Yoshinaka shows a system and method for evaluating treatment of a surgical target of a patient's soft tissue organ ([0043]-[0044]), comprising: an imaging system configured to obtain images of the patient's soft tissue organ ([0047]-[0048]); and at least one controller configured to: receive a user input of a treatment trajectory on the images to resect a portion of the patient's soft tissue organ ([0049]-[0051], [0062], [0066], [0077]-[0079]); and determine a score related to a function of the patient's soft tissue organ based on the treatment trajectory ([0052], [0064], [0070]).
Yoshinaka also shows wherein the treatment trajectory comprises a cutting trajectory (surgical approaches; [0062], [0065]); wherein the score is a percentage of the organ being removed (different surgical techniques removing different percentages of the kidney, [0065]); wherein the at least one controller is further configured to identify a vasculature within the patient's organ within the treatment trajectory, and wherein the score is a function of the portion of the vasculature being removed within the treatment trajectory (identify vessels; [0051], [0057], [0064]-[0065]); wherein the score is a percentage of organ function loss based on the treatment trajectory (different surgical techniques removing different percentages of the kidney, [0065]; [0070]); wherein the at least one controller is further configured to modify the treatment trajectory based on the determined score (recommend surgical approach; [0063, [0070]-[0071]); wherein the at least one controller comprises a trained machine learning system configured to receive the treatment trajectory input by the user and to output the score ([0067], [0070]-[0071], [0074], [0077]); wherein the trained machine learning system is trained with data comprising treatment trajectories and corresponding surgical outcomes of historical surgical treatments ([0070]-[0071]); wherein the score is indicative of expected post-operative function of the organ (long-term renal function; [0070]); wherein determining the score includes determining long-term blood flow through the organ (planning accounts for blood vessels and amount of resected tissue, accounts for amount of blood loss; [0069]-[0070]); wherein the organ is a kidney, and determining the score includes determining a post-operative percentage of active nephrons in the kidney (where the surgical techniques encompass partial nephrectomy and radical nephrectomy each corresponding with a different percentage of active nephrons; [0065); wherein receiving at least one proposed treatment trajectory includes receiving two or more proposed treatment trajectories, and the method further comprises: providing a recommended treatment trajectory based on scores for each of the two or more proposed treatment trajectories ([0062]-[0063], [0066]).
Yoshinaka fails to show each proposed treatment trajectory being one of a plurality of possible treatment trajectories for a surgical approach.
Thomas discloses planning navigation and simulation systems for minimally invasive therapy. Thomas teaches each proposed treatment trajectory being one of a plurality of possible treatment trajectories for a surgical approach (determining optimal path and score encompasses both different entry points and different trajectories, [0102]-[0103], [0105]; [0081], [0085], [0093]-[0101]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Yoshinaka to plan for both different surgical approaches and different treatment trajectories as taught by Thomas, in order to increase the accuracy of the system by accounting for additional variables related to the surgical procedure, and to determine an optimal path from the surface of the patient to the desired target within the patient while avoiding damage to critical structures such as organs as described by Thomas ([0150], [0203]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshinaka et al. (US 2021/0169576; hereinafter Yoshinaka) in view of Thomas et al. (US 2016/0070436; hereinafter Thomas) as applied to claim 1 above, and further in view of Golijanin et al. (US 2008/0161662; hereinafter Golijanin).
Yoshinaka fails to show wherein the images are real time intraoperative images.
Golijanin disclose intraoperative imaging techniques for renal cortical tumors. Golijanin teaches wherein the images are real time intraoperative images (known in the art to utilize real-time ultrasound techniques [0013]; real-time fluorescent techniques, [0024]-[0025]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the combined invention of Yoshinaka and Thomas to additionally utilize real time intraoperative imaging as taught by Golijanin, as Golijanin teaches that intraoperative imaging provides numerous benefits such as providing the surgeon with a real time view of the tumor ensuring that no tumor tissue remains by clearly delineating the margin in real time ([0024]-[0025]). This provides advantages over only utilizing preoperative imaging data, such as identifying additional tumors that could not be seen in preoperative imaging techniques ([0024]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshinaka et al. (US 2021/0169576; hereinafter Yoshinaka) in view of Thomas et al. (US 2016/0070436; hereinafter Thomas) as applied to claim 1 above, and further in view of and Zhang et al. (US 2019/0298277; hereinafter Zhang) and Golijanin et al. (US 2008/0161662; hereinafter Golijanin).
Yoshinaka fails to show wherein the treatment trajectory has an organ entry location and an organ exit location for exiting the patient’s soft tissue organ.
Yoshinaka fails to show wherein the images are real time intraoperative images.
Zhang discloses surgical positioning systems and methods. Zhang teaches wherein the treatment trajectory has an organ entry location and an organ exit location for exiting the patient’s soft tissue organ ([0027]).
Golijanin disclose intraoperative imaging techniques for renal cortical tumors. Golijanin teaches wherein the images are real time intraoperative images (known in the art to utilize real-time ultrasound techniques [0013]; real-time fluorescent techniques, [0024]-[0025]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Yoshinaka, Thomas to utilize an organ entry location and an organ exit location as taught by Zhang, in order to define features of the patient’s tissue within the images so that the device may be accurately guided to the target along an optimal path while accounting for the position of various tissue/organs/critical structures in the path of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the combined invention of Yoshinaka, Thomas, and Zhang to additionally utilize real time intraoperative imaging as taught by Golijanin, as Golijanin teaches that intraoperative imaging provides numerous benefits such as providing the surgeon with a real time view of the tumor ensuring that no tumor tissue remains by clearly delineating the margin in real time ([0024]-[0025]). This provides advantages over only utilizing preoperative imaging data, such as identifying additional tumors that could not be seen in preoperative imaging techniques ([0024]).
Claim(s) 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshinaka et al. (US 2021/0169576; hereinafter Yoshinaka) in view of Thomas et al. (US 2016/0070436; hereinafter Thomas) and Zhang et al. (US 2019/0298277; hereinafter Zhang).
Yoshinaka shows a system and method for evaluating treatment of a surgical target of a patient's soft tissue organ ([0043]-[0044]), comprising: an imaging system configured to obtain images of the patient's soft tissue organ ([0047]-[0048]); and at least one controller configured to: receive a user input of a treatment trajectory on the images to resect a portion of the patient's soft tissue organ ([0049]-[0051], [0062], [0066], [0077]-[0079]); and determine a score related to a function of the patient's soft tissue organ based on the treatment trajectory ([0052], [0064], [0070]).
Yoshinaka also shows wherein the treatment trajectory comprises a cutting trajectory (surgical approaches; [0062], [0065]); wherein the score is a percentage of the organ being removed (different surgical techniques removing different percentages of the kidney, [0065]); wherein the at least one controller is further configured to identify a vasculature within the patient's organ within the treatment trajectory, and wherein the score is a function of the portion of the vasculature being removed within the treatment trajectory (identify vessels; [0051], [0057], [0064]-[0065]); wherein the score is a percentage of organ function loss based on the treatment trajectory (different surgical techniques removing different percentages of the kidney, [0065]; [0070]); wherein the at least one controller is further configured to modify the treatment trajectory based on the determined score (recommend surgical approach; [0063, [0070]-[0071]); wherein the at least one controller comprises a trained machine learning system configured to receive the treatment trajectory input by the user and to output the score ([0067], [0070]-[0071], [0074], [0077]); wherein the trained machine learning system is trained with data comprising treatment trajectories and corresponding surgical outcomes of historical surgical treatments ([0070]-[0071]); wherein the score is indicative of expected post-operative function of the organ (long-term renal function; [0070]); wherein determining the score includes determining long-term blood flow through the organ (planning accounts for blood vessels and amount of resected tissue, accounts for amount of blood loss; [0069]-[0070]); wherein the organ is a kidney, and determining the score includes determining a post-operative percentage of active nephrons in the kidney (where the surgical techniques encompass partial nephrectomy and radical nephrectomy each corresponding with a different percentage of active nephrons; [0065); wherein receiving at least one proposed treatment trajectory includes receiving two or more proposed treatment trajectories, and the method further comprises: providing a recommended treatment trajectory based on scores for each of the two or more proposed treatment trajectories ([0062]-[0063], [0066]).
Yoshinaka fails to show each proposed treatment trajectory being one of a plurality of possible treatment trajectories for a surgical approach.
Yoshinaka fails to show wherein the treatment trajectory has an organ entry location and an organ exit location for exiting the patient’s soft tissue organ.
Thomas discloses planning navigation and simulation systems for minimally invasive therapy. Thomas teaches each proposed treatment trajectory being one of a plurality of possible treatment trajectories for a surgical approach (determining optimal path and score encompasses both different entry points and different trajectories, [0102]-[0103], [0105]; [0081], [0085], [0093]-[0101]).
Zhang discloses surgical positioning systems and methods. Zhang teaches wherein the treatment trajectory has an organ entry location and an organ exit location for exiting the patient’s soft tissue organ ([0027]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Yoshinaka to plan for both different surgical approaches and different treatment trajectories as taught by Thomas, in order to increase the accuracy of the system by accounting for additional variables related to the surgical procedure, and to determine an optimal path from the surface of the patient to the desired target within the patient while avoiding damage to critical structures such as organs as described by Thomas ([0150], [0203]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Yoshinaka and Thomas to utilize an organ entry location and an organ exit location as taught by Zhang, in order to define features of the patient’s tissue within the images so that the device may be accurately guided to the target along an optimal path while accounting for the position of various tissue/organs/critical structures in the path of the device.
Response to Arguments
Applicant's arguments filed 9/18/25 have been fully considered but they are not persuasive.
In response to applicant’s arguments regarding the combination of Yoshinaka and Thomas fails to teach receiving a proposed “treatment trajectory on the image”, examiner respectfully disagrees. The examiner maintains that in the broadest reasonable interpretation of the claim language, the computer planning technique described by Yoshinaka receives a user input of a “treatment trajectory on the image”, where the treatment trajectory corresponds with the type of surgical approach as described by Yoshinaka, and where the treatment trajectory corresponds with the particular image ([0051], [0062]-[0063]). The defined optimal trajectories are based on the obtained medical images. The surgical planning system may process the images automatically or with some degree of human intervention ([0055]).
Furthermore, the claims are not limited to any specific manner of “user input”. The claims are not limited for example to drawing a line on the patient’s soft tissue organ within the image. Notably, the claims are not limited to “display” of any images, or “display” of any treatment trajectory on the images. The claim language does not preclude display of text or numerical information to represent the treatment trajectory on the image. The broadest reasonable interpretation of the claim language “receive a user input of a treatment trajectory on the images” is encompassed by the user input described by Yoshinaka.
Applicant’s arguments with respect to claim(s) 13-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797