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 7/6/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2 and 4-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Core (US 2012/0069968 A1).
Regarding claim 1, Core discloses a method for a radiation therapy system (Figs.2-5), including:
a) based on x-ray images of an anatomical region of a patient that includes a target volume, reconstructing a digital volume of the anatomical region (step 202; par.0018);
b) based on a location of a patient origin in the digital volume, determining one or more shift values for repositioning the patient origin at an isocenter of the radiation therapy system with respect to a coordinate system (step 204 and Fig.5, step 504);
c) based on the one or more shift values, determining whether a movable couch is capable of repositioning the patient origin at the isocenter prior to obtaining a treatment plan that is based on the location of the patient origin and is associated with the target volume (step 504);
d) obtaining the treatment plan (Fig.2, step 206);
e) in response to a determination that the movable couch is capable of repositioning the patient origin at the isocenter, based on the treatment plan, repositioning the movable couch so that the patient origin is disposed at the isocenter (Fig.5, step 510); and
f) while the patient origin is disposed at the isocenter, directing a treatment beam to the patient origin in accordance with the treatment plan associated with the target volume (Fig.5, step 512).
With respect to claim 2, Core further discloses, prior to obtaining the treatment plan, transmitting the location of the patient origin in the digital volume to a treatment planning system external to the radiation therapy system for generation of the treatment plan (Fig.2, step 202, par.0018; also see Fig.8; it is additionally inherent that the locations and corresponding delineated target(s) and organs-at-risk, along with dose prescriptions for each, are provided to the treatment planning system as is routine in the art for establishing the optimization parameters).
With respect to claim 4, Core further discloses, in response to a determination that the movable couch cannot reposition the patient origin at the isocenter, halting movement of the movable couch (step 504, “no”).
With respect to claim 5, Core further discloses that repositioning the movable couch further includes moving the movable couch to a marking position that ensures the patient origin is disposed at the isocenter (step 506).
With respect to claim 6, Core further discloses that repositioning the movable couch includes generating one or more prompts in a user interface to the radiation therapy system to apply the one or more shift values (Fig. 1).
With respect to claim 7, Core further discloses that, prior to the determining the one or more shift values for repositioning the patient origin, displaying a portion of the digital volume that includes the target volume (Figs.1 and 6A-7).
With respect to claim 8, Core further discloses that the portion of the digital volume includes at least one of a sagittal slice, a transversal slice, and a coronal slice of the digital volume (Figs.1 and 6A-7).
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 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.
Claims 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Core (US 2012/0069968 A1) in view of Xu (US 2020/0390406 A1).
Regarding claims 9 and 19, Core discloses a radiation therapy system and a method therefore (Figs.1-9), including a movable couch and a processor (Figs.4, 8 and 9), the method (Figs.1-7) including:
a) based on x-ray images of an anatomical region of a patient disposed on a movable couch, where the anatomical region includes a target volume, reconstructing a digital volume of the anatomical region (step 502);
b) based on a location of a patient origin in the digital volume, determining one or more shift values for repositioning the patient origin at an isocenter of the radiation therapy system prior to obtaining a treatment plan that is based on the location of the patient origin and is associated with the target volume (step 504); and
c) based on the one or more shift values, determining whether the movable couch is capable of repositioning the patient at the isocenter (step 504).
Further regarding claim 9, Core further discloses making a determination whether the couch may be repositioned (Fig.5); however, Core does not specifically disclose the following details of the user interface:
d) generating one or more prompts in a user interface of the radiation therapy system associated with repositioning the movable couch so that the patient origin is disposed at the isocenter when it is determined that the couch can move the patient origin to the isocenter; and
e) generating an alert when it is determined that the couch cannot move the patient origin to the isocenter.
Xu teaches the practice of generating one or more prompts when it is determined that the desired couch movement is permissible (Fig.9, “Safe”; also see Fig.8, steps 804 and 806), and further teaches generating an alert when it is determined that the desired couch movement is not permissible (Fig.10, “Danger”; also see Fig.8, steps 804 and 805). In this manner, the operator is consistently and accurately apprised of whether the couch is capable of aligning the patient origin to the isocenter.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Core to prompt the operator with an alert and one or more prompts associated with repositioning the movable couch based on the determination, as taught by Xu, in order to intuitively and reliably apprise the operator of the repositioning status of the movable couch.
With respect to claim 10, Xu further teaches that the one or more prompts include applying the one or more shift values (Fig.9, “Confirm”).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Core to prompt the operator associated with repositioning the movable couch based on the determination, as taught by Xu, in order to intuitively and reliably apprise the operator of the repositioning status of the movable couch.
With respect to claims 11 and 20, Xu further teaches that the one or more prompts correspond to moving the movable couch to a marking position (Fig.9, “Automatic movement”).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Core to prompt the operator associated with repositioning the movable couch based on the determination, as taught by Xu, in order to intuitively and reliably apprise the operator of the repositioning status of the movable couch.
With respect to claims 12 and 13, Xu further discloses, when it is determined that the movable couch cannot move the patient origin to the isocenter, disabling a function associated with selecting the one or more shift values by disabling one or more user interface elements of the user interface that are being displayed (Fig.10, “confirm” and “automatic movement” are both grayed out).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Core to prompt the operator associated with repositioning the movable couch based on the determination, as taught by Xu, in order to intuitively and reliably apprise the operator of the repositioning status of the movable couch.
With respect to claim 14, Xu further teaches that generating the alert includes at least one of modifying a user interface element of the user interface (grayed out buttons, Fig.10), adding a user interface element of the user interface (“Danger”, Fig.10), and causing a visual indicator of the radiation therapy system to be activated (Fig.10 being different from Fig.9).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Core to prompt the operator associated with repositioning the movable couch based on the determination, as taught by Xu, in order to intuitively and reliably apprise the operator of the repositioning status of the movable couch.
With respect to claim 15, Core further discloses that each of the one or more shift values for repositioning the patient origin at the isocenter references a location in a coordinate system associated with the movable couch (Figs.1 and 4).
With respect to claim 16, Core further discloses, in response to a determination that the movable couch cannot reposition the patient origin at the isocenter, halting movement of the movable couch (step 504, “no”).
With respect to claim 17, Core further discloses, prior to the determining whether the movable couch can reposition the patient origin at the isocenter, displaying a portion of the digital volume that includes the target volume (Figs.1 and 6A-7).
With respect to claim 18, Core further discloses that the patient origin is disposed within the target volume (Figs.1 and 6A-7).
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art neither teaches nor reasonably suggests the additional limitation of performing the determining of whether the movable couch is capable of repositioning the patient origin to the isocenter prior to transmitting the location of the patient origin in the digital volume to the treatment planning system, where intervening claim 2 specifies that the step of transmitting the location of the patient origin to the treatment planning system includes generating the treatment plan with the determined patient origin, as required by the combination of features as claimed.
Core, like most of the prior art, generates the shift values for moving the couch based on comparing the acquired x-ray image(s) with DRRs from a treatment plan that has already been generated. Therefore, it makes no sense to make the determination of whether the couch is able to move the patient origin to the isocenter without first generating the radiation treatment plan to which the comparison may be made.
Others, as exemplified by Nord (US 2018/0243584 A1), teach that the treatment plan is developed with taking into the account the permissible movement range of the patient couch and other components (Figs.1, 2, 14 and 15; pars.0004-0005). Nord does not, however, generate the shift values for repositioning the patient origin at the isocenter, from which it is determined whether the couch is capable of repositioning the patient, until after the treatment plan has been developed and the operator is positioning the patient for a treatment session (Fig.17).
Response to Arguments
Applicant's arguments with respect to amended claims 1, 9 and 19 have been fully considered but they are not persuasive. Applicant argues that Core does not teach performing the shift value determination prior to acquiring the radiation treatment plan. The Examiner respectfully disagrees.
As currently claimed in the independent claims, the radiation treatment plan is generated in the same manner as the prior art, where the radiation treatment plan is generated using the location of the patient origin without regard to whether the movable couch is capable of moving the patient origin to the isocenter. That is why the 102 and 103 rejections based on Core still apply. Shift values are determined based on image comparisons between the current images and the DRRs from the already-generated treatment plan, and then the treatment plan is retrieved and applied once the patient origin is aligned with the isocenter. This is still the same as the known prior art teachings, including those of Core and of Nord, previously discussed.
The indication of allowable subject matter attempted to emphasize that the novelty of the claimed invention lies in generating the treatment plan using the patient origin AFTER the ability to move the patient origin to the isocenter has been determined. Specifically, intervening claim 2 specifies that the treatment plan is generated with the transmitted patient origin, and then claim 3 further requires that the determination of whether the patient origin may be located at the isocenter takes place prior to sending the patient origin to the planning system.
This is a significant departure from the prior art. Precise treatment and collision avoidance through shift value calculations for aligning the patient origin to the isocenter in the prior art all take place after the radiation treatment plan is generated. Even in Nord, an allowable range of values are fed to the treatment planning system; however, patient table shift values are not determined until after the treatment plan has been generated, and errors may still be incurred.
By contrast, the claimed combination of features, as incorporated by dependent claim 3 (which includes intervening claim 2), requires, in essence, that the allowable patient origin is determined based on the calculated shift values first, then fed into the planning system in order to generate the radiation treatment plan. In this situation, the potential errors are substantially reduced due to having the treatment plan being created by using the patient origin that has been determined as being suitable based on the patient table shift values.
For at least these reasons, Applicant’s arguments are not persuasive, and the rejections have been maintained.
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 THOMAS R ARTMAN whose telephone number is (571)272-2485. The examiner can normally be reached Monday-Thursday 10am-6:30pm.
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THOMAS R. ARTMAN
Primary Examiner
Art Unit 2884
/THOMAS R ARTMAN/ Primary Examiner, Art Unit 2884
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