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 .
Response to Amendment
Applicant’s arguments filed on 1/07/2025 have been fully considered but they are not persuasive.
Applicant argues that Cooley fails to describe modulating the particle beam, particularly in cases where the energy is the same before modulation. This is not persuasive. Cooley describes a series of variously shaped and composed plates that modulate an energy of the particle beam to correspond to the requirements of a treatment plan after the beam has been generated at a particular, and stable, energy by a synchrocyclotron.
Applicant argues that Colley fails to disclose a quality assurance process. This is not persuasive. Cooley describes an encoder that measures the movement of energy degrading plates into the particle beam. These measurements are a quality assurance process since they measure the quality of the actual movement of the energy degrader plates.
Applicant argues that Cooley fails to teach the generation of a particle beam at same energy levels for different parts of a scan pattern. Once more, this is not persuasive. Cooley demonstrates a synchrocyclotron generating a particle beam at one energy level, and an energy degrader being used to modify the energy of said beam for various portions of the scan pattern.
Applicant argues that Cooley fails to teach a pin cell. This is not persuasive. Cooley specifically teaches that the energy degrader plates may be shaped as polyhedra or curved three- dimensional shapes. Such shapes are understood to be pin cells since they fulfil both requirements of a pin cell from the instant application, i.e., a depth shifting part/portion and b) a distal widening part/portion.
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.
(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.
Claim(s) 1-14, 16-19, 22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cooley et al. WO 2020/185544A1.
Re. Claim 1 Cooley discloses a system comprising:
a particle generation component that generates a particle beam (Fig. 1 (421));
a modulation scanning component that controls movement of the particle beam in a scan
pattern (scanning magnet 424, para 104) and modulation of the particle beam resulting in modulated treatment particle beam (energy degrader 426, para 104); and
a treatment and configuration control component that directs configuration of the modulation scanning component and directs delivery of the modulated treatment particle beam (claim 21),
wherein the configuration of the modulation scanning component and delivery of the modulated treatment particle beam are based upon a treatment plan (para 40),
the particle generation component generates a treatment particle beam at a same energy level
for a first portion of the scan pattern and a second portion of the scan pattern (para 91-92, 95), and
the modulation of the treatment particle beam by the modulation scanning component is different for the first portion of the scan pattern than the second portion of the scan pattern (para 95).
Re. claim 2 Cooley discloses a range of the treatment particle beam is different for the first
portion of the scan pattern and the second portion of the scan pattern. (Strategy for regulating
doses of radiation, claim 48)
Re. claim 3 Cooley discloses an adjustment of the modulation scanning component of a
treatment particle beam includes shifting a deposition depth of the treatment particle beam to a
lower depth. (Determine whether a voxel among the voxels contains targeted tissue, non-
targeted tissue, or both, claim 53)
Re. claim 4 Cooley discloses an adjustment of the modulation scanning component of a
treatment particle beam includes generating a determined dose profile from a largest
penetration depth to a smallest penetration depth. (Determining the dose rate of radiation to the
voxel, claim 56)
Re. claim 5 Cooley discloses that the determined dose profile is homogenous from the largest
penetration depth to the smallest penetration depth. (Dose regiment specifies doses and dose
rates, claim 42)
Re. claim 6 Cooley discloses an adjustment of the modulation scanning component (control
system, claim 21) of the treatment particle beam applies fields with multiple Iso-Energy-Slices
(IES) (multiple paths, claim 21) and the treatment particle beam is at the same energy level for
the first portion of the scan pattern and the second portion of the scan pattern. (Delivers a dose
of radiation to the target, claim 21)
Re. claim 7 Cooley discloses treatment fields that are irradiated as single Iso- Energy-Slice
(IES) fields by the treatment particle beam. (The particle beam is directed along each of the
multiple paths, claim 21)
Re. claim 8 Cooley discloses the modulation scanning component (control system, claim 21)
includes homogenous and field individual modulation components that allow a conformal
irradiation using the treatment particle beam at the same energy level. (Control system is
configured to control the energy of the particle, claim 23)
Re. claim 9 Cooley discloses the treatment and configuration control component develops an
optimized version of the treatment plan (dose calculation engine, claim 41), and adjustment of
the treatment particle beam by the modulation scanning component in accordance with
information from the treatment and configuration control component optimizes radiation
treatment in a target tissue. (Optimize effective doses determined by the dose calculation
engine, claim 42)
Re. claim 10 Cooley discloses the treatment and configuration control component (non-
transitory machine-readable storage media, claim 42) comprises adjustment of the treatment
particle beam and radiation (specifies doses and dose rates, claim 42) in optimization of the
treatment plan. (Optimize effective doses, claim 42)
Re. claim 11 Cooley discloses an adjustment of the treatment particle beam by the modulation
scanning component optimizes (calculation engine is configured, claim 53) on a scan point
location and depth granularity basis. (Determine whether a voxel among the voxels contains
target tissue, claim 53)
Re. claim 12 Cooley discloses an adjustment of the treatment particle beam by the modulation
scanning component optimizes dose distribution. (Determine a dose regimen, claim 41)
Re. claim 13 Cooley discloses an adjustment of the treatment particle beam by the modulation
scanning component optimizes dose rate. (Prediction model characterizes the particle therapy
system based on a structure of pulses of a particle beam, claim 43)
Re. claim 14 Cooley discloses a method comprising:
performing a treatment plan creation process in which a treatment plan is created (claim 41);
performing a modulation component configuration process, wherein a modulation component is configured based on the treatment plan (claim 47);
performing a quality assurance process, including a quality assurance process on the modulation component (para 126 – the quality of the energy modulation plate movement is evaluated, i.e., assured, by the encoders’ detection) ; and
performing a treatment process in accordance with the treatment plan (para 40).
Re. claim 16 Cooley discloses the treatment plan creation process includes determining a dose
prescription and developing a remainder of the treatment plan to achieve the dose prescription.
(Generate instructions for sequencing delivery of doses, claim 41)
Re. claim 17 Cooley discloses a creation process of the treatment plan includes utilizing laterally
distributed scan spot positions (voxels, claim 53) corresponding to modulator pin cells of a
modulator component, wherein the modulator pin cells receive a particle beam at a similar
energy level across a plurality of the modulator pin cells. (Dose rate of radiation to the voxel,
claim 53)
Re. claim 18 Cooley discloses the similar energy level is a highest available energy of a
treatment system. (ultra-high dose rate radiation, claim 58)
Re. claim 19 Cooley discloses the treatment plan creation process includes laterally distributed
scan spot positions which are arranged in a scan pattern. (Dose calculation engine is configured
to determine whether a voxel among the voxels contains targeted tissue, non-targeted tissue, or
both, clam 53)
Re. claim 22 Cooley discloses a system comprising:
a particle generation component that generates a particle beam (Fig. 1 (421));
a modulation scanning component that controls movement of the particle beam in a scan pattern (scanning magnet 424, para 104) and modulation of the particle beam resulting in a modulated treatment particle beam (energy degrader 426, para 104); and
a treatment and configuration control component that directs configuration of the modulation scanning component and directs delivery of a treatment particle beam (claim 21),
wherein the configuration of the modulation scanning component and delivery of the modulated particle treatment beam are based upon a treatment plan (para 40),
wherein the particle generation component generates the particle beam at a same energy level for a first portion of the scan pattern and a second portion of the scan pattern (para 91-92, 95), and
the modulation scanning component is partitioned into a plurality of pin cells (Figs. 12-16 (500a-c) are energy absorbing plates that are the claimed pin cells, particularly as described in para 173 as having polyhedral or three-dimensional shapes) in which a first one of the plurality of pin cells and a second one of the plurality of pin cells have different configurations that result in different modulation of the treatment particle beam (para 112).
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.
Claims 15,20-21,23 are rejected under 35 U.S.C. 103 as being unpatentable over Cooley et al (‘544) in view of Chiu et al (WO 2018156693A1).
In Re. to claims 15, 20, 21, Cooley does not specifically mention the use of a CT scan on the patient for the uses of the treatment plan creation, the verification of the modulation component, and the comparison of a simulated CT scan.
However, Chiu teaches a radiation treatment, where at least one parameter of the plan comprises one or more computed tomography (CT) scan image. For the creation of a 3-dimensional
representation of a bolus for radiotherapy.
Someone with ordinary skill in the pertinent art would be aware of the uses of a CT scan
and would require that these images would need to be taken as part of the treatment plan
process, as taught by Chiu. Furthermore, the CT scan would also be used to verify the target area which is a common use of the CT scan, SO the targeted plan would not intentionally affect healthy
structures. It is also obvious to someone in the pertinent art to conduct a follow-up scan to the
original to observe the targeted area to see the results of the treatment plan, and to compare
these scans to ideal simulated or healthy CT scan images of the same region. Thus, it would have been an obvious to implement Cooley device with CT use/analysis of Chiu.
Re. claim 23, it would have been obvious to one of ordinary skill in the art to recognize that the method of claim 14 is performed by some form of processing means.
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.
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/ROBERT H KIM/ Supervisory Patent Examiner, Art Unit 2881