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 .
DETAILED ACTION
The amendment filed on August 07, 2026 is acknowledged and entered. Claims 1, 6-12, 15 and 17-18 are amended. Claim 14 is cancelled. Claims 1-3 and 15-18 are pending and under examination in this Office action.
Response to Amendment
The objection to claims 1, 6-8, 11, 12, 15 and 17-18 are now withdrawn in view of the claim amendment.
The rejections to claims 1-18 under 35 U.S.C. 112(b) are now withdrawn in view of the claim amendment. A new ground of rejection to claim 15 and 17 under 35 U.S.C. 112(b) is now made due to the cancellation of claim 14.
In regard to claim 9, upon incorporating the previously identified patent eligible and patentable claim 14 (not the patent eligible claim 10 as asserted in p.7 of the Remarks), the rejections to claims 9, 11-13 and 18 under 35 U.S.C. 101 and 35 U.S.C. 102(a)(1) are now withdrawn. Claims 9-18 are allowed.
The rejection to claim 1 under 35 U.S.C. 102(a)(1) is maintained but modified to address the amendment, hence is considered a new ground of rejection necessitated by the claim amendment. The rejections to claims 2-5 and 6-8 are also maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 15 and 17 depend on claim 14 that has been cancelled. The dependency of claims 15 and 17 hence is unclear.
The dependent claims of the above rejected claims are rejected due to their dependency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ollila et al., US 2018/0078789 A1, hereinafter Ollila.
Claim 1. Ollila teaches a method to facilitate optimizing a radiation treatment plan for a particular patient using a particular radiation treatment platform having a source of radiation ([0004]: the present disclosure relates generally to treatment planning for radiation therapy; and [0010]: in a radiation treatment plan that includes a plurality of treatment fields of multiple treatment modalities, an optimized spatial point sequence is determined that optimizes the total treatment time), the method comprising:
by a control circuit (560) ([0050]: FIG.5: the radiation treatment system 500 includes a control circuitry 560 for controlling the operation of the beam source, the beam aperture, the gantry, the couch, and the image acquisition system…The control circuitry is configured to carry out one or more steps, actions and other functions described herein):
accessing treatment arc information that identifies a treatment arc to be used ([0089]: FIG.11, at 1102, a radiation treatment plan is received. The radiation treatment plan has a first treatment field of an IMRT modality and a second treatment field of a dynamic treatment path modality… the start spatial point and the end spatial point of the second treatment field may define a start gantry angle and an end gantry angle of a VMAT arc) with the particular radiation treatment platform while administering radiation to the particular patient while the source of radiation is moving according to the treatment arc ([0057]: volumetric modulated art therapy (VMAT). A VMAT treatment involves one or multiple appropriately optimized intensity-modulated arcs in which radiation is administered with simultaneous gantry rotation and MLC motion);
accessing position information that identifies at least one specific location along the treatment arc ([0089]: FIG.11, at 1102, a radiation treatment plan is received. The radiation treatment plan has a first treatment field of an IMRT modality and a second treatment field of a dynamic treatment path modality. The first treatment field has a first spatial point associated with a first set of values for treatment axes of the radiation treatment system…the first spatial point of the first treatment field may define a first gantry angle for administering an IMRT field) where the source of radiation will halt to administer radiation to the particular patient while the source of radiation is halted ([0053]: intensity modulated radiotherapy (IMRT). In an IMRT modality, only the MLC leaves and collimator jaws move, while other treatment axes are fixed during beam on);
optimizing a radiation treatment plan for the particular patient as a simultaneous function of both the treatment arc information and the position information, and as a simultaneous function of using both volumetric modulated arc therapy and intensity-modulated radiation therapy, to provide an optimized radiation treatment plan that provides both for administering radiation while the source of radiation is moving along the treatment arc and while the source of radiation is halted at the at least one specific location along the treatment arc ([0083]: B. Interleaving and Intermixing Treatment Modalities; [0084]: the result of the optimization is a patient-specific and time-ordered treatment field trajectory of spatial points that includes a combination of interleaved and intermixed modalities with non-radiative transitions therebetween; [0085]: FIG.10 illustrates schematically an example optimized treatment field trajectory of a radiation treatment plan…this radiation treatment plan include a first IMRT field 1010 at a first spatial point 1040 and a second IMRT field 1020 at a second spatial point 1070, and a VMAT arc 1030 from a start spatial point 1050 to an end spatial point 1060).
In regard to the term of “a simultaneous function”, it is interpreted such that in a multi-component system, the components are considered together when performing the optimization. In Ollila, the treatment field trajectory of the entire radiation treatment plan is optimized. As illustrated in FIG.10, the radiation treatment plan is composed of sub-arcs of the VMAT arc and multiple IMRT fields interleaved with each other. To optimize a multi-component system requires interactive consideration among the components, i.e., a simultaneous consideration of the sub-components rather than focusing on the individual parts. Hence, the optimization of Ollila refers to a simultaneous function of both the treatment arc information and the position information, and as a simultaneous function of using both volumetric modulated arc therapy and intensity-modulated radiation therapy.
Claim 2. Ollila further teaches that
the treatment arc comprises only a single direction of rotation (FIG.10 illustrated that the treatment arc of VMAT rotates in a single direction only).
Claim 3. Ollila further teaches
optimizing the radiation treatment plan as a function of an arc field type that can permissibly contain temporary gantry rotation stops during traversal of the treatment arc while simultaneously modulating radiation emitted by the source of radiation ([0090]: At 1104, a plurality of intermediate spatial points along the path of the second treatment field are identified. Each intermediate spatial point divides the path into a first section and a second section. Each intermediate spatial point is associated with a respective intermediate set of values for the treatment axes).
Claim 4. Ollila further teaches
optimizing the radiation treatment plan as a function of a plurality of the arc field types ([0095] It should be appreciated that the optimal intermediate spatial point may correspond to a first intermediate control point and a second intermediate control point).
Claim 5. Ollila further teaches
modulating the radiation using at least one of a multi-leaf collimator, collimator jaws, and dose rate control ([0046]: FIG.3 shows schematically a photon collimation system 300 with upper jaws 310, lower jaws 320, and a multileaf collimator 330).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ollila et al., US 2018/0078789 A1, hereinafter Ollila, in view of Vojan et al., US 2022/0208365 A1, hereinafter Vojan.
Claim 6. Ollila teaches all the limitations of claim 1.
Ollila does not teach providing a user with an opportunity to select the at least one specific location; and receiving input from the user that selects the at least one specific location.
However, in an analogous IMRT and VMAT-based radiotherapy optimization field of endeavor, Vojan teaches
providing a user with an opportunity to select the at least one location; and receiving input from the user that selects the at least one location ([0316]: The alignment angles and corresponding satisfactory position for treatment may be determined by users and/or system administrators and retrieved by the analytics served, for example, from the radiation RT file, and/or received by the analytics server as an input from the user and/or system administrators).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Ollila employ such features associated with providing a user with an opportunity to select the at least one specific location; and receiving input from the user that selects the at least one specific location as taught in Vojan for the advantage of an alternative means for providing parameter input for the treatment planning optimization.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ollila et al., US 2018/0078789 A1, hereinafter Ollila.
Claim 7. Ollila teaches all the limitations of claim 1, including having a plurality of spatial points for each of the IMRT and VMAT treatment modalities ([0095] It should be appreciated that the optimal intermediate spatial point may correspond to a first intermediate control point and a second intermediate control point).
In regard to the claimed feature of accommodating a greater number of control points for when the source of radiation is halted at the at least one location along the treatment arc as compared to when the source of radiation is moving along the treatment arc, Ollila teaches in [0123]: In some embodiments, the optimization algorithm may make decisions regarding selections of different treatment fields and number of fields, e.g., IMRT fields and dynamic treatment path fields, according to how different treatment fields fit within the given time constraint. During the optimization process, multiple plan candidates using different field geometries may be evaluated. Since different field geometries might have different trade-offs between plan quality and required treatment time, the optimization algorithm considers which field geometry provides the best plan quality in the given time constraint. In one embodiment, the algorithm evaluates each candidate with the same time constraint and selects the plan that has the best plan quality. In another embodiment, the algorithm evaluates each candidate without time constraint and selects the most promising field geometry in terms of plan quality based on the required treatment time.
Hence, as the number of spatial points is among the parameters to be optimized, it would be obvious to one of ordinary skill in the art to obtain a greater number of control points for when the source of radiation is halted at the at least one specific location along the treatment arc as compared to when the source of radiation is moving along the treatment arc through routine experimentation with reasonable expectation of success when optimizing the treatment plan for the purpose of “achieving a desired plan quality with an optimized treatment time”, as suggested in Ollila, [0123].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ollila et al., US 2018/0078789 A1, hereinafter Ollila, in view of Ollila et al., US 2018/0078785 A1, hereinafter Ollila ‘785.
Claim 8. Ollila teaches all the limitations of claim 1.
Ollila does not teach optimizing the radiation treatment plan for the particular patient as a further function of an aggregate effect of both treatment arc information and position information over a plurality of treatment sessions.
However, in an analogous IMRT and VMAT-based radiation treatment planning optimization field of endeavor, Ollila ‘785 teaches
optimizing the radiation treatment plan for the patient as a further function of an aggregate effect of both the treatment arc information and the position information over a plurality of treatment sessions ([0128]: the initial radiation treatment plan includes one or more imaging sessions, and each of the plurality of candidate radiation treatment plans includes a respective imaging setup for performing the one or more imaging sessions; and [0129]: one or more imaging sessions may be programmed into the treatment field trajectory by interleaving and intermixing the plurality of treatment fields with the one or more imaging sessions. The imaging geometries of the one or more imaging sessions, such as the imaging directions, may be optimized together with the optimization of treatment trajectories).
To have the imaging sessions and the trajectories interleaving indicating that there are a plurality of treatment sessions. To perform optimization of both the imaging directions and the trajectories upon interleaving and intermixing them together indicating that the optimization is performed as a function of an aggregate effect over a plurality of treatment sessions.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Ollila employ such features associated with optimizing the radiation treatment plan for the particular patient as a further function of an aggregate effect of both treatment arc information and position information over a plurality of treatment sessions as taught in Ollila ‘785 for the advantage of obtaining an optimized radiation treatment plan for optimal treatment time, as suggested in Ollila ‘785, [0004].
Allowable Subject Matter
Claims 9-18 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The limitations recited in claim 9 in regard to the features of “pre-populating treatment fields with initial radiation treatment platform control points; and optimizing control point properties for the control points as a function, at least in part, of at least one cost function", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
Th dependent claims 10-18 are allowable at least by virtue of their dependency to claim 9.
Response to Arguments
Applicant’s arguments in regard to the teaching of Ollila on the claim limitations associated with the simultaneous function have been fully considered but they are not persuasive. The rejection to claim 1 is maintained, and Ollila is also considered reading on the amended feature of the optimization being a simultaneous function of using both VMAT and IMRT.
In the Remarks (pp. 8-9), Applicant asserted that claim 1 recites “optimizing a radiation treatment plan for the patient…as a simultaneous function of using both volumetric modulated arc therapy and intensity-modulated radiation therapy”…As noted by the Examiner, Ollila describes providing a radiation treatment plan that includes both VMAT and IMRT approaches to therapy. The ordinarily-skilled person who reads Ollila in its entirety, however, will find no explicit description of optimizing such a plan as a “simultaneous” function of both such approaches”. Examiner respectfully disagrees.
In regard to the consideration of the optimization being “a simultaneous function”, as considered in the rejection to claim 1, it is interpreted such that in a multi-component system, the components are considered altogether during optimization. In other words, when optimizing a multi-component system, not only the effect of the variation of each individual components but also the correlation, the interaction and the dependency among them are considered. When these factors are considered altogether, it is a “simultaneous function”. Ollila teaches an optimized treatment plan that is composed of multiple sub-arc of the VMAT arc and multiple IMRT fields at various spatial locations interleaving with the VMAT sub-arcs, and the optimization refers to the overall treatment field trajectory of such a radiation treatment plan. Hence, Ollila is considered providing appropriate and sufficient teaching of the asserted claim limitation of the above asserted claim limitation.
Since the interleaving and intermixing treatment modalities of Ollila taught in [0083]-[0100]) appears to provide no teaching to further details in regard to how the interleaved sessions are optimized other than minimizing the total beam-off transition time ([0084]) and minimizing the travel distance between the spatial points ([0087]) so to minimize the total treatment time ([0092]), By further incorporating into claim 1 the features associated with the optimization such as a simultaneous gantry rotation and radiation modulation as disclosed in [0031], would be sufficient to overcome Ollila.
Based on the above considerations, claims 1-8 remain rejected.
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 YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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