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 .
Claims status: claims are unchanged from presented last.
Response to Arguments
Applicant's arguments filed 07/23/2025 with respect to Filiberti et al. have been fully considered but they are not persuasive. Applicant argues in last para. of pg.7 of the remarks to 1st two para. of pg.8 of remarks that it would not be obvious to one of ordinary skill in the art to modify the combined method of Owens et al. and Maltz et al. with the teachings Filiberti et al. Additionally, applicant argues that the “claimed predetermined condition” is absent in Filiberti et al. The examiner respectfully disagrees because Filiberti et al. is directed to controlling a dose applied to a target while the target is moving and preventing healthy tissues from being overexposed (para. [0005], [0104]). Para. [0008]-[0009] of Filiberti et al. teach a predetermined condition for the movement of the target. Therefore, the rejection is maintained and made final.
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.
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.
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.
Claims 1-2, 5-12, 14-15, 18-24 are rejected under 35 U.S.C. 103 as being unpatentable over Owens et al. (US 2018/0369611 A1; pub. Dec. 27, 2018) in view of Maltz et al. (US 2023/0241419 A1; pub. Aug. 3, 2023) and further in view of Filiberti et al. (US 2018/0185671 A1; pub. Jul. 5, 2018).
Regarding claim 1, Owens et al. disclose: a method for controlling a radiotherapy apparatus, the method (para. [0065]) comprising: obtaining a first treatment plan comprising positioning information of a beam shaping apparatus of the radiotherapy apparatus (para. [0045] “The position of the leaves at a particular firing location (e.g., location around a patient area where the therapeutic radiation source may be positioned when firing radiation beams) may be determined based on a treatment plan. A treatment plan may be calculated in a treatment planning session and may be updated just prior or during a treatment session based on the biological activity data and/or physiological data and/or anatomical data extracted from imaging data acquired on the day of treatment (e.g., in real-time). In some variations, the processor of the controller may generate a set of multi-leaf collimator commands that drive the movement and location of each leaf at each firing location so that the radiation beam has an irradiation shape that adheres to the treatment plan. This computation may also be referred to as segmentation of the treatment plan (and/or generating a fluence map of the treatment plan) to generate a sinogram or radiation-firing matrix “, “the configuration of the multi-leaf collimator (e.g., the positions of the leaves at various firing locations) may be updated as the treatment plan is updated based on imaging data acquired on the day of treatment (e.g., at the time of treatment, during treatment)”, para. [0065]); receiving, during delivery of a radiation therapeutic beam to a target on a patient, information indicating a positional shift of the target (para. [0065]); generating a revised treatment plan based on the first treatment plan (para. [0065]), the generating of the revised treatment plan comprising determining an updated configuration of the beam shaping apparatus from the positioning information of the first treatment plan based on the positional shift of the target ((para. [0045], [0065], para. [0087]).
Owens et al. are silent about: determining whether the positional shift meets a predetermined condition, wherein generating the revised treatment plan is performed when the positional shift meets the predetermined condition; and when the positional shift does not meet the predetermined condition, terminating the delivery of the radiation therapeutic beam, wherein the predetermined condition is based on a maximum positional shift that is compensatable by adjusting the beam shaping apparatus.
In a similar field of endeavor, Maltz et al. disclose: determining whether the positional shift meets a predetermined condition, wherein generating the revised treatment plan is performed when the positional shift meets the predetermined condition; and when the positional shift does not meet the predetermined condition, terminating the delivery of the radiation therapeutic beam (para. [0211], [0213]) motivated by the benefits for saving healthy tissues.
In light of the benefits for saving healthy tissues, 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 method of Owens et al. with the teachings Maltz et al.
Maltz et al. are silent about: the predetermined condition is based on a maximum positional shift that is compensatable by adjusting the beam shaping apparatus.
In a similar field of endeavor, Filiberti et al. disclose: the predetermined condition is based on a maximum positional shift that is compensatable by adjusting the beam shaping apparatus (para. [0038], [0072], [0104]) motivated by the benefits for effective treatment.
In light of the benefits for effective treatment, 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 method of Owens et al. and Maltz et al. with the teachings Filiberti et al.
Regarding claim 2, Owens et al. disclose: the beam shaping apparatus comprises a multi-leaf collimator (MLC), and wherein the updated configuration of the beam shaping apparatus comprises an updated position of the MLC (the claim is rejected on the same basis as claim 1).
Regarding claim 5, Maltz et al. disclose the predetermined condition comprises the positional shift being less than or equal to a threshold shift amplitude (para. [0213]) motivated by the benefits for saving healthy tissues.
Regarding claim 6, Owens et al. disclose: adjusting the beam shaping apparatus according to the determined updated configuration of the beam shaping apparatus (the claim is rejected on the same basis as claim 1).
Regarding claim 7, Owens et al. disclose: evaluating a dosimetric property based at least in part on the updated configuration of the beam shaping apparatus and the positional shift of the target (the claim is rejected on the same basis as claim 1).
Regarding claim 8, Owens et al. disclose: the dosimetric property comprises a radiation dose (Abstract).
Regarding claim 9, Owens et al. disclose: in response to the evaluated dosimetric property meeting a predetermined dosimetric criterion, adjusting the beam shaping apparatus in accordance with the updated configuration of the beam shaping apparatus (para. [0070], [0102]).
Regarding claim 10, Owens et al. disclose: outputting a result of the evaluation of the dosimetric property to a user; and prompting the user to confirm whether to proceed with adjusting the beam shaping apparatus in accordance with the updated configuration of the beam shaping apparatus (para. [0053]).
Regarding claim 11, Owens et al. disclose: the first treatment plan is generated before delivery of the radiation therapeutic beam based on a reference plan (para. [0071 “Offline adaptive treatment planning may refer to calculating and/or simulating treatment plans in between treatment sessions using biological activity and/or physiological data acquired during a previous treatment session. Optionally, treatment plans generated during a treatment session and/or offline may be stored in a treatment plan database. Treatment plans in a database may be used in future treatment sessions, as may be desirable”).
Regarding claim 12, Owens et al. disclose: the information indicating the positional shift of the target comprises a longitudinal displacement, a vertical displacement and a transverse displacement of the target (para. [0065]).
Regarding claim 14, Owens et al. disclose: determining the updated configuration of the beam shaping apparatus comprises determining at least one of an updated configuration of one or more leaves of a multi-leaf collimator of the beam shaping apparatus or an updated configuration of a diaphragm of the beam shaping apparatus (the claim is rejected on the same basis as claim 1).
Regarding claim 15, Owens et al., Maltz et al. and Filiberti et al. disclose: A non-transitory computer-readable medium comprising computer-executable instructions which, when executed by one or more processors of a computer device, cause the one or more processors to: obtain a first treatment plan comprising positioning information of a beam shaping apparatus of a radiotherapy apparatus; receive, during delivery of a radiation therapeutic beam to a target on a patient, information indicating a positional shift of the target; and generate a revised treatment plan based on the first treatment plan, wherein to generate the revised treatment plan comprises determining an updated configuration of the beam shaping apparatus from the positioning information of the first treatment plan based on the positional shift of the target; determine whether the positional shift meets a predetermined condition, wherein generating the revised treatment plan is performed when the positional shift meets the predetermined condition; and when the positional shift does not meet the predetermined condition, terminate the delivery of the radiation therapeutic beam wherein the predetermined condition is based on a maximum positional shift that is compensatable by adjusting the beam shaping apparatus. (the claim is rejected on the same basis as claim 1).
Regarding claim 18, Owens et al., Maltz et al. and Filiberti et al. disclose: A system comprising: a controller to control a radiotherapy apparatus, the controller configured to: obtain a first treatment plan comprising positioning information of a beam shaping apparatus of the radiotherapy apparatus; receive, during delivery of a radiation therapeutic beam to a target on a patient, information indicating a positional shift of the target; and generate a revised treatment plan based on the first treatment plan, wherein to generate the revised treatment plan comprises determining an updated configuration of the beam shaping apparatus from the positioning information of the first treatment plan based on the positional shift of the target, determine whether the positional shift meets a predetermined condition, wherein generating the revised treatment plan is performed when the positional shift meets the predetermined condition, and when the positional shift does not meet the predetermined condition, terminate the delivery of the radiation therapeutic beam wherein the predetermined condition is based on a maximum positional shift that is compensatable by adjusting the beam shaping apparatus (the claim is rejected on the same basis as claim 1).
Regarding claim 19, Owens et al. disclose: a radiotherapy apparatus; and the beam shaping apparatus (the claim is rejected on the same basis as claim 1, + Abstract).
Regarding claim 20, Owens et al. disclose: the beam shaping apparatus comprises a multi-leaf collimator, and wherein the updated configuration of the beam shaping apparatus comprises an updated position of the multi-leaf collimator (the claim is rejected on the same basis as claim 1).
Regarding claim 21, Owens et al. disclose: the computer- executable instructions further cause the one or more processors to: evaluate a dosimetric property based at least in part on the updated configuration of the beam shaping apparatus and the positional shift of the target (the claim is rejected on the same basis as claim 1).
Regarding claim 22, Owens et al. disclose: the dosimetric property comprises a radiation dose (Abstract).
Regarding claim 23, Owens et al. disclose: the computer- executable instructions further cause the one or more processors to: in response to the evaluated dosimetric property meeting a predetermined dosimetric criterion, adjust the beam shaping apparatus in accordance with the updated configuration of the beam shaping apparatus (para. [0070], [0102]).
Regarding claim 24, Owens et al. disclose: the beam shaping apparatus comprises a multi-leaf collimator (MLC), and wherein the updated configuration of the beam shaping apparatus comprises an updated position of the MLC (the claim is rejected on the same basis as claim 1).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Owens et al. (US 2018/0369611 A1; pub. Dec. 27, 2018) in view of Maltz et al. (US 2023/0241419 A1; pub. Aug. 3, 2023) in view of Filiberti et al. (US 2018/0185671 A1; pub. Jul. 5, 2018) and further in view of Han et al. (US 2016/0213947 A1; pub. Jul. 28, 2016).
Regarding claim 13, the combined references are silent about: the information indicating the positional shift of the target is based on one or more 2-dimensional slice images.
In a similar field of endeavor, Han et al. disclose: the information indicating the positional shift of the target is based on one or more 2-dimensional slice images (para. [0009]-[0010]) motivated by the benefits for minimizing damage to the surrounding healthy tissue (Han et al. para. [0003]).
In light of the benefits for minimizing damage to the surrounding healthy tissue as taught by Han et al., 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 method of Owens et al., Maltz et al. and Filiberti et al. with the teachings Han et al.
Conclusion
THIS ACTION IS MADE FINAL. 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 MAMADOU FAYE whose telephone number is (571)270-0371. The examiner can normally be reached Mon – Fri 9AM-6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Makiya can be reached at 571-272-2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MAMADOU FAYE/Examiner, Art Unit 2884
/EDWIN C GUNBERG/Primary Examiner, Art Unit 2884
Prosecution Insights