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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
-Fig. 1 contains element 106 which is not found within the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 13 is objected to because of the following informalities:
-Claim 13 recites “time, output” in lines 5-6. Examiner recommends amending to –time, and output—
Appropriate correction is required.
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 (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 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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meltsner (WO 2011154853).
Regarding Claim 1, Meltsner teaches a proton therapy system [Pg. 10, lines 5-9] comprising:
a memory storing computer executable instructions [Fig. 1, element 22 (local memory)]; and
at least one processor configured to execute the computer executable instructions [Fig. 1, elements 12 (system processor)] and [Pg. 4, lines 7-8] to cause the proton therapy system to selectively adjust a treatment plan for proton therapy treatment of a target volume based on a treatment delivery time for the treatment plan and a threshold maximum treatment delivery time [Pg. 5, lines 18-25] and [Pg. 9, lines 9-11], the treatment plan at least prescribing proton therapy field characteristics for treatment of the target volume [Fig. 4] and [Pg. 11, lines 21-29].
Regarding Claim 2, Meltsner teaches wherein selective adjustment of the treatment plan includes selectively adjusting at least one proton therapy field characteristic among the proton therapy field characteristics for the treatment of the target volume [Fig. 4, step 204 (optimization parameters)].
Regarding Claim 3, Meltsner teaches wherein the at least one proton therapy field characteristic includes at least one of a number of energy layers or a spot spacing for the treatment of the target volume [Pg. 9, lines 19-22] and [Pg. 11-13].
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meltsner (WO 2011154853) in view of Kang (U.S. 20220323791).
Regarding Claim 4, Meltsner is silent on wherein the at least one proton therapy field characteristic includes at least one of a number of energy layers or a spot spacing for the treatment of the target volume, and the at least one proton therapy field characteristic is selectively adjusted by at least one of (i) removing an energy layer from the number of energy layers or (ii) increasing the spot spacing. Kang teaches wherein the at least one proton therapy field characteristic includes at least one of a number of energy layers or a spot spacing for the treatment of the target volume [0080], and the at least one proton therapy field characteristic is selectively adjusted by at least one of (i) removing an energy layer from the number of energy layers or (ii) increasing the spot spacing [0130].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selectively adjust spot spacing and size as taught by Kang to adjust treatment characteristics of the treatment plan as suggested by Meltsner, as Meltsner discusses adjusting spots of dose including weights and positions [Pg. 10, lines 11-13] with Kang because Kang teaches the criticality of spot and air gap spacing on Bragg peak treatment planning [0130].
Claim(s) 5, 6, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meltsner (WO 2011154853) in view of Pfeiler (U.S. 20230001233).
Regarding Claim 5, Meltsner is silent on wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to determine that the treatment delivery time is greater than the threshold maximum treatment delivery time, and adjust the treatment plan in response to determining that the treatment delivery time is greater than the threshold maximum treatment delivery time. Pfeiler teaches wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to determine that the treatment delivery time is greater than the threshold maximum treatment delivery time [0089],
and adjust the treatment plan in response to determining that the treatment delivery time is greater than the threshold maximum treatment delivery time [0088].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor when delivery times are exceeded as taught by Pfeiler to adjust treatment characteristics of the treatment plan as suggested by Meltsner, as Meltsner discusses optimizing delivery duration [Pg. 10, lines 7-11] with Pfeiler because Pfeiler teaches the use of these limits to minimize the amount of time that normal tissue is irradiated [0089].
Regarding Claim 6, Meltsner further teaches wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to adjust the treatment plan by adjusting at least one proton therapy field characteristic among the proton therapy field characteristics for the treatment of the target volume [Pg. 5, lines 18-25], and
generating an adjusted treatment plan based on the adjusted at least one proton therapy field characteristic [Fig. 4] and [Pg. 11, lines 21-29].
Regarding Claim 7, Meltsner further teaches wherein the at least one proton therapy field characteristic includes at least one of a number of energy layers or a spot spacing for the treatment of the target volume [Pg. 9, lines 19-22] and [Pg. 11-13].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meltsner (WO 2011154853) in view of Pfeiler (U.S. 20230001233) and in further view of Kang (U.S. 20220323791).
Regarding Claim 8, Meltsner and Pfeiler are silent on wherein the adjusting at least one proton therapy field characteristic includes at least one of (i) removing an energy layer from the number of energy layers or (ii) increasing the spot spacing. Kang teaches wherein the adjusting at least one proton therapy field characteristic includes at least one of (i) removing an energy layer from the number of energy layers or (ii) increasing the spot spacing [0130].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selectively adjust spot spacing and size as taught by Kang to adjust treatment characteristics of the treatment plan as suggested by Meltsner and Pfeiler, as Meltsner discusses adjusting spots of dose including weights and positions [Pg. 10, lines 11-13] and Pfeiler discusses variations is spot distances [0072] with Kang because Kang teaches the criticality of spot and air gap spacing on Bragg peak treatment planning [0130].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meltsner (WO 2011154853) in view of Ranganathan (DE 112019003476).
Regarding Claim 9, Meltsner teaches wherein the proton therapy field characteristics include at least a number of energy layers [Pg. 8, lines 11-13] and a spot spacing for the treatment of the target volume [Pg. 9, lines 19-22] and [Pg. 11-13], Meltsner is silent on and the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to determine that the treatment delivery time is greater than the threshold maximum treatment delivery time, adjust at least one of the number of energy layers or the spot spacing in response to determining that the treatment delivery time is greater than the threshold maximum treatment delivery time, and generate an adjusted treatment plan based on the adjusted at least one of the number of energy layers or the spot spacing.
Ranganathan teaches the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to determine that the treatment delivery time is greater than the threshold maximum treatment delivery time [0062],
adjust at least one of the number of energy layers or the spot spacing in response to determining that the treatment delivery time is greater than the threshold maximum treatment delivery time [0063], and
generate an adjusted treatment plan based on the adjusted at least one of the number of energy layers or the spot spacing [0039].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize feedback such as timing, spot, and energy layer radiation information as taught by Ranganathan to generate adjusted treatment plans as suggested by Meltsner, as Meltsner discusses real time adjustment of treatment parameters [Pg. 10, lines 28-30] with Ranganathan because Ranganathan teaches adjusting clinical goals until dose distribution is acceptable [0039].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meltsner (WO 2011154853) in view of Ranganathan (DE 112019003476) and in further view of Kang (U.S. 20220323791).
Regarding Claim 10, Meltsner and Ranganathan are silent on wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to adjust at least one of the number of energy layers or the spot spacing by at least one of (i) removing an energy layer from the number of energy layers or (ii) increasing the spot spacing. Kang teaches wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to adjust at least one of the number of energy layers or the spot spacing by at least one of (i) removing an energy layer from the number of energy layers or (ii) increasing the spot spacing [0130].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selectively adjust spot spacing and size as taught by Kang to adjust treatment characteristics of the treatment plan as suggested by Meltsner and Ranganathan, as Meltsner discusses adjusting spots of dose including weights and positions [Pg. 10, lines 11-13] and Ranganathan which discloses adjustment of critical proton spot in reference to uncertainty values [0064] with Kang because Kang teaches the criticality of spot and air gap spacing on Bragg peak treatment planning [0130].
Claim(s) 11, 12, 13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meltsner (WO 2011154853) in view of Engwall (U.S. 2021/0154492).
Regarding Claim 11, Meltsner is silent on wherein the proton therapy field characteristics include a number of energy layers for the treatment of the target volume, and the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to determine that the treatment delivery time is greater than the threshold maximum treatment delivery time, adjust the number of energy layers in response to determining that the treatment delivery time is greater than the threshold maximum treatment delivery time, and generate a first adjusted treatment plan based on the adjusted number of energy layers.
Engwall teaches wherein the proton therapy field characteristics include a number of energy layers for the treatment of the target volume [0014],
and the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to determine that the treatment delivery time is greater than the threshold maximum treatment delivery time [0053], [0069], and [0074],
adjust the number of energy layers in response to determining that the treatment delivery time is greater than the threshold maximum treatment delivery time [0069],
and generate a first adjusted treatment plan based on the adjusted number of energy layers [0034]—discussion of applying different energy levels based on sub-beams.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust energy layers as taught by Engwall to generate adjusted treatment plans as suggested by Meltsner, as Meltsner discusses energy layers involved in therapy planning [Pg. 8, lines 12-13] with Engwall because Engwall teaches controlling dose fall-off [0002].
Regarding Claim 12, Meltsner is silent on wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to adjust the number of energy layers by removing an energy layer from the number of energy layers. Engwall teaches wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to adjust the number of energy layers by removing an energy layer from the number of energy layers [0014].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to remove energy layers as taught by Engwall as a method to alter energy layers as suggested by Meltsner, as Meltsner discusses the use of a compensator [Pg. 8, lines 13-16] with Engwall because Engwall teaches controlling energy levels [0003].
Regarding Claim 13, Meltsner is silent on wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to compute a first adjusted treatment delivery time for the first adjusted treatment plan, determine whether the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time, output the first adjusted treatment plan for the treatment of the target volume in response to determining that the first adjusted treatment delivery time is less than or equal to the threshold maximum treatment delivery time. Engwall teaches wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to compute a first adjusted treatment delivery time for the first adjusted treatment plan [0034]—discussion of applying different energy levels based on sub-beams, and [0016],
determine whether the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time [0053], [0069], and [0074],
output the first adjusted treatment plan for the treatment of the target volume in response to determining that the first adjusted treatment delivery time is less than or equal to the threshold maximum treatment delivery time [0019]—discussion on reduced total treatment time.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reduce treatment time as taught by Engwall as a means to allow for user input in treatment parameters as suggested by Meltsner, as Meltsner discusses treatment duration being a user entered goal [Pg. 9, lines 7-11] with Engwall because Engwall teaches factors that cause a total reduction in treatment time [0005].
Regarding Claim 14, Meltsner further teaches further comprising: a radiation therapy machine configured to perform the treatment based on the first adjusted treatment plan [Fig. 1, element 28 (Multimodal Radiation Therapy Module)].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meltsner (WO 2011154853) in view of Engwall (U.S. 2021/0154492) and in further view of Prieels (U.S. 20180099155).
Regarding Claim 15, Meltsner teaches wherein the proton therapy field characteristics further include a spot spacing for the treatment of the target volume [Pg. 9, lines 19-22] and [Pg. 11-13], Meltsner is silent on the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to determine that the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time, adjust the spot spacing in response to determining that the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time. Engwall teaches the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to determine that the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time [0053], [0069], and [0074],
adjust the spot spacing in response to determining that the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time [0039].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust energy layers as taught by Engwall to generate adjusted treatment plans as suggested by Meltsner, as Meltsner discusses energy layers involved in therapy planning [Pg. 8, lines 12-13] with Engwall because Engwall teaches controlling dose fall-off [0002].
Meltsner and Engwall are silent on and generate a second adjusted treatment plan based on the adjusted spot spacing. Prieels teaches and generate a second adjusted treatment plan based on the adjusted spot spacing [0040]—describing reference to t0 and t1 with further reference to target spot changes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a second treatment plan as taught by Prieels to allow for modifications of spot spacing as suggested by Meltsner, and Engwall, as Meltsner discusses energy layers involved in therapy planning [Pg. 8, lines 12-13] and Engwall which discloses transforming spots within energy layers [0039] with Prieels because Prieels teaches assessing validity of treatment plans through this method step [0040].
Claim(s) 16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meltsner (WO 2011154853) in view of Engwall (U.S. 2021/0154492) and in further view of Kang (U.S. 20220323791).
Regarding Claim 16, Meltsner teaches wherein the proton therapy field characteristics further include a spot spacing for the treatment of the target volume, Meltsner is silent on and the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to compute a first adjusted treatment delivery time for the first adjusted treatment plan, determine that the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time, adjust the spot spacing in response to determining that the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time,
Engwall teaches the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to compute a first adjusted treatment delivery time for the first adjusted treatment plan [0034]—discussion of applying different energy levels based on sub-beams, and [0016],
determine that the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time [0053], [0069], and [0074],
adjust the spot spacing in response to determining that the first adjusted treatment delivery time is greater than the threshold maximum treatment delivery time [0039].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust energy layers as taught by Engwall to generate adjusted treatment plans as suggested by Meltsner, as Meltsner discusses energy layers involved in therapy planning [Pg. 8, lines 12-13] with Engwall because Engwall teaches controlling dose fall-off [0002].
Meltsner and Engwall are silent on and generate a second adjusted treatment plan based on the adjusted spot spacing. Kang teaches and generate a second adjusted treatment plan based on the adjusted spot spacing [0210] a universal range shifter adjusted to shift the range of the proton/particle beam so that the Bragg peak of the particle beam coincides with the target tissue; with reference to the original treatment plan in [0207].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a second treatment plan as taught by Kang to allow for modifications of spot spacing as suggested by Meltsner, and Engwall, as Meltsner discusses energy layers involved in therapy planning [Pg. 8, lines 12-13] and Engwall which discloses transforming spots within energy layers [0039] with Kang because Kang teaches considerations for spot sizing [0066].
Regarding Claim 17, Meltsner and Engwall are silent on wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to adjust the spot spacing by increasing the spot spacing. Kang teaches wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to adjust the spot spacing by increasing the spot spacing [0080].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selectively adjust spot spacing and size as taught by Kang to adjust treatment characteristics of the treatment plan as suggested by Meltsner and Engwall, as Meltsner discusses adjusting spots of dose including weights and positions [Pg. 10, lines 11-13] and Engwall which discloses increasing spot weight [0074] with Kang because Kang teaches the criticality of spot and air gap spacing on Bragg peak treatment planning [0130].
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meltsner (WO 2011154853) in view of Engwall (U.S. 2021/0154492) and in further view of Kang (U.S. 20220323791) and in even further view of Prieels (U.S. 20180099155).
Regarding Claim 18, Meltsner, Engwall and Kang are silent on wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to compute a second adjusted treatment delivery time for the second adjusted treatment plan, determine whether the second adjusted treatment delivery time is greater than the threshold maximum treatment delivery time, and selectively output the second adjusted treatment plan for the treatment of the target volume based on whether the second adjusted treatment delivery time is greater than the threshold maximum treatment delivery time.
Prieels teaches wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to compute a second adjusted treatment delivery time for the second adjusted treatment plan [0040],
determine whether the second adjusted treatment delivery time is greater than the threshold maximum treatment delivery time [0040; “t1>t0”], and
selectively output the second adjusted treatment plan for the treatment of the target volume based on whether the second adjusted treatment delivery time is greater than the threshold maximum treatment delivery time [0040-0044].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include secondary planning and treatment timing as taught by Prieels to allow for treatment adjustment and optimization as suggested by Meltsner, Engwall, and Kang, as Meltsner discusses the use of an optimizer [Abstract] and Engwall which discloses optimizing through the use of filtering settings [Abstract] and Kang which references multiple field-optimization [0060] with Prieels because Prieels teaches correcting target spot positioning through adjustment [0040].
Regarding Claim 19, Meltsner, Engwall, and Kang are silent on wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to output the second adjusted treatment plan for the treatment of the target volume in response to determining that the second adjusted treatment delivery time is less than or equal to the threshold maximum treatment delivery time. Prieels teaches wherein the at least one processor is configured to execute the computer executable instructions to cause the proton therapy system to output the second adjusted treatment plan for the treatment of the target volume in response to determining that the second adjusted treatment delivery time is less than or equal to the threshold maximum treatment delivery time [0122]—reference to discussion of scanning times between successive target spots where each time for each spot is interpreted to be the second adjusted treatment plan and second adjusted treatment delivery time.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include secondary planning and treatment timing as taught by Prieels to allow for treatment adjustment and optimization as suggested by Meltsner, Engwall, and Kang, as Meltsner discusses the use of an optimizer [Abstract] and Engwall which discloses optimizing through the use of filtering settings [Abstract] and Kang which references multiple field-optimization [0060] with Prieels because Prieels teaches correcting target spot positioning through adjustment [0040].
Regarding Claim 20, Meltsner further teaches further comprising: a radiation therapy machine configured to perform the treatment based on the second adjusted treatment plan [Fig. 1, element 28 (Multimodal Radiation Therapy Module)].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Abel (U.S. 11590364)—includes reference to identifying a multi-step treatment process for delivering beams to target locations in a patient
-Folkerts (U.S. 11541252)—discusses exceeding dose rates in treatment delivery plans
-Smith (U.S. 11554271)—discloses identification of dose rate thresholds and irradiation timing
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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