DETAILED ACTION
Response to Arguments
Rejections under 35 USC 112(b)
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive. Claim 14 has been amended but the amendment fails to correct the antecedent basis issue because it remains unclear if “the discrete spot within the target tissue” refers to one of the discrete points within the “a set of discrete points” or some other limitation. Consequently, the claim remains indefinite.
Rejections under 35 U.S.C. §103
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive. The arguments beginning pg. 7 are not persuasive because the claim language does not preclude a spread out Bragg peak. In view of the amendments to the independent claims, a new grounds of rejection is made in view of Snider, III, et. al. See below.
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 .
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 14-18, 20, and 24-26 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.
Claim 14 recites the limitation "the discrete spot within the target tissue". There is insufficient antecedent basis for this limitation in the claim.
Claims 15-18, 20, and 24-26 are rejected by virtue of their dependence on claim 14.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-7, 11-14, 16-18, 20-21, 24, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Snider, III, et. al. (US 20200001118 A1), hereinafter Snider, in view of Yasushi, et. al. (JP 4282198 B2; previously cited), hereinafter Yasushi.
Regarding claim 1, Snider teaches a method for supplying at least two fields of ionizing radiation at discrete spots in a target tissue (Fig. 4, Fig. 5, [0055]), the method comprising:
receiving a spot map comprising a set of discrete spots within the target tissue, then successively for each discrete spot in the spot map ([0023], Fig. 4, Fig. 5, Figs. 6A-6C);
providing an ionizing radiation ([0055]);
forming at least two fields of shifted and compensated ionizing radiation (beamlets [0037], [0055], Fig. 4) by:
shifting the range of the ionizing radiation by passing the ionizing radiation through a range shifter (range-shifters/preabsorbers, [0037]) so that the Bragg peak of the ionizing radiation coincides with a respective one of the discrete spots within the target tissue (Abstract, [0007], [0055]), said Bragg peak comprising a pronounced peak on the Bragg curve of the ionizing radiation ([0002]);
compensating the range of the ionizing radiation by passing each field of the ionizing radiation through a respective separate range compensator, said range compensators each comprising a three-dimensional topography to conform the beam to the target tissue shape ([0037], compensators); and
directing the at least two fields of the shifted and compensated ionizing radiation to the respective, discrete spots within the target tissue, so that the majority of the ionizing raditation is limited to the target tissue (Fig. 4, [0037], [0007]).
Snider does not explicitly teach wherein said adjustable range shifter comprising at least three plates.
Yasushi teaches wherein said adjustable range shifter comprises at least three plates ([0010] teaches range shifter 7 (adjustable, see [0010] and [0047]) composed of a plurality of acrylic plates, Fig. 9 and Fig. 10 show range shifters with 6 plates).
Yasushi modifies Snider by suggesting the adjustable range shifter comprises at least three plates.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate the teachings of Yasushi because having a range shifter composed of a plurality of acrylic plates allows for them to be appropriately combined to achieve the desired range, (Yasushi, [0010]).
Regarding claim 14, Snider teaches a system for administering at least two fields of shifted and compensated ionizing radiation to a target tissue( Fig. 4, Fig. 5, [0055]), comprising:
a spot map comprising a set of discrete points within the target tissue ([0023], Fig. 4, Fig. 5, Figs. 6A-6C);
an ionizing radiation source configured to produce a charged particle beam (radiation source origin [0055]);
a universal range shifter adjusted to shift the range of the charged particle beam (range-shifters/preabsorbers, [0037]) so that the Bragg peak of the charged particle beam coincides with the discrete spot within the target tissue (Abstract, [0007], [0055]), said Bragg peak comprising a pronounced peak on the Bragg curve of the ionizing radiation ([0002]);
at least two range compensators adjusted to compensate the range of the charged particle beam so that the Bragg peak of the ionizing radiation coincides with the contour of the target tissue, said range compensators each comprising a unique three- dimensional topography to conform the beam to the target shape ([0037], compensators (plural indicates at least two));
wherein the majority of the ionizing radiation is limited to the target tissue by the range shifter and range compensators (Fig. 4, [0037], [0007]).
Snider does not explicitly teach said range shifter comprising at least three plates.
Yasushi teaches wherein said range shifter comprises at least three plates ([0010] teaches range shifter 7 (adjustable, see [0010] and [0047]) composed of a plurality of acrylic plates, Fig. 9 and Fig. 10 show range shifters with 6 plates).
Yasushi modifies Snider by suggesting the adjustable range shifter comprises at least three plates.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate the teachings of Yasushi because having a range shifter composed of a plurality of acrylic plates allows for them to be appropriately combined to achieve the desired range, (Yasushi, [0010]).
Regarding claim 3, Snider teaches wherein said at least two fields of the shifted and compensated ionizing radiation does not substantially extend beyond a distal edge of the target location ([0037], [0055], [0056], Figs. 4-5 the radiation is contained substantially within the target region/volume 192/500).
Regarding claim 16, Snider teaches wherein said fields do not substantially extend beyond a distal edge of the target tissue ([0037], [0055], [0056], Figs. 4-5 the radiation is contained substantially within the target region/volume 192/500).
Regarding claim 4, Snider teaches wherein said at least two fields of the shifted and compensated ionizing radiation comprises protons, helium, carbon, argon or neon (proton therapy [0036], [0037]).
Regarding claim 28, Snider teaches wherein said at least two fields of the shifted and compensated ionizing radiation comprises protons, helium, carbon, argon or neon (proton therapy [0036], [0037]).
Regarding claim 5, Snider teaches wherein said at least two fields of the shifted and compensated ionizing radiation comprises protons (proton therapy [0036]).
Regarding claim 29, Snider teaches wherein said at least two fields of the shifted and compensated ionizing radiation comprises protons (proton therapy, [0036]).
Regarding claim 6, Snider teaches wherein said target tissue location comprises cancerous tissue ([0002], [0037] target region 192 includes tumor cells).
Regarding claim 17, Snider teaches wherein said target tissue comprises a neoplasm or benign tumor ([0002], [0037] target region 192 includes tumor cells).
Regarding claim 7, Snider does not explicitly teach wherein said adjustable range shifter comprises at least four plates.
Yasushi teaches wherein said adjustable range shifter comprises at least four plates ([0010] teaches range shifter 7 (adjustable, see [0010] and [0047]) composed of a plurality of acrylic plates, Fig. 9 and Fig. 10 show range shifters with 6 plates).
Yasushi modifies Snider by suggesting the adjustable range shifter comprises at least four plates.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate the teachings of Yasushi because having a range shifter composed of a plurality of acrylic plates allows for them to be appropriately combined to achieve the desired range, (Yasushi, [0010]).
Regarding claim 18, Snider does not explicitly teach wherein said range shifter comprises at least four plates.
Yasushi teaches wherein said range shifter comprises at least four plates ([0010] teaches range shifter 7 composed of a plurality of acrylic plates, Fig. 9 and Fig. 10 show range shifters with 6 plates).
Yasushi modifies Snider by suggesting the adjustable range shifter comprises at least four plates.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate the teachings of Yasushi because having a range shifter composed of a plurality of acrylic plates allows for them to be appropriately combined to achieve the desired range, (Yasushi, [0010]).
Regarding claim 11, Snider teaches wherein said at least two fields of the shifted and compensated ionizing radiation comprises three fields of the shifted and compensated ionizing radiation (Fig. 4, [0037], [0055] two or more beamlets. This is an overlapping range—see 2144.05, which states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”).
Regarding claim 20, Snider teaches wherein said at least two fields of the shifted and compensated ionizing radiation comprises three fields (Fig. 4, [0037], [0055] two or more beamlets. This is an overlapping range—see 2144.05, which states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”).
Regarding claim 12, Snider teaches wherein said at least two fields of the shifted and compensated ionizing radiation comprises four fields of the shifted and compensated ionizing radiation (Fig. 4, [0037], [0055] two or more beamlets. This is an overlapping range—see 2144.05, which states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”).
Regarding claim 13, Snider teaches wherein said at least two fields of the shifted and compensated ionizing radiation comprises five fields of the shifted and compensated ionizing radiation (Fig. 4, [0037], [0055] two or more beamlets. This is an overlapping range—see 2144.05, which states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”).
Regarding claim 21, Snider does not explicitly teach wherein said adjustable range shifter comprises at least five plates.
Yasushi teaches wherein said adjustable range shifter comprises at least five plates ([0010] teaches range shifter 7 (adjustable, see [0010] and [0047]) composed of a plurality of acrylic plates, Fig. 9 and Fig. 10 show range shifters with 6 plates).
Yasushi modifies Snider by suggesting the adjustable range shifter comprises at least five plates.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate the teachings of Yasushi because having a range shifter composed of a plurality of acrylic plates allows for them to be appropriately combined to achieve the desired range, (Yasushi, [0010]).
Regarding claim 24, Snider does not explicitly teach wherein said adjustable range shifter comprises at least five plates.
Yasushi teaches wherein said adjustable range shifter comprises at least five plates ([0010] teaches range shifter 7 (adjustable, see [0010] and [0047]) composed of a plurality of acrylic plates, Fig. 9 and Fig. 10 show range shifters with 6 plates).
Yasushi modifies Snider by suggesting the adjustable range shifter comprises at least five plates.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate the teachings of Yasushi because having a range shifter composed of a plurality of acrylic plates allows for them to be appropriately combined to achieve the desired range, (Yasushi, [0010]).
Regarding claim 27, Snider teaches wherein said method provides a uniform dose distribution across the target tissue ([0092], [0093]).
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Snider (US 20200001118 A1) and Yasushi (JP 4282198 B2; previously cited) in view of Lansonneur, et. al. (US 20210393982 A1; previously cited).
Regarding claim 2, Snider in view of Yasushi fails to explicitly teach said fields are applied in a dose rate of at least 40 Gy/s.
Lansonneur, et. al. teaches a dose rate of at least 40 Gy/s (Paragraph [0057] teaches a dose rate of as much as 120 Gy per second or more).
Lansonneur, et. al. modifies the radiotherapy system of Mansfield and Abel by suggesting a dose rate of at least 40 Gy/s.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have each of the fields delivered at a dose rate of at least 40 Gy/s because “FLASH RT advantageously spares normal, healthy tissue from damage when that tissue is exposed to a high radiation dose for only a very short period of time” (Lansonneur, et. al., [0005]).
Regarding claim 15, Snider in view of Yasushi fails to explicitly teach said fields are applied in a dose rate of at least 40 Gy/s.
Lansonneur, et. al. teaches a dose rate of at least 40 Gy/s (Paragraph [0057] teaches a dose rate of as much as 120 Gy per second or more).
Lansonneur, et. al. modifies the radiotherapy system of Mansfield and Abel by suggesting a dose rate of at least 40 Gy/s.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have each of the fields delivered at a dose rate of at least 40 Gy/s because “FLASH RT advantageously spares normal, healthy tissue from damage when that tissue is exposed to a high radiation dose for only a very short period of time” (Lansonneur, et. al., [0005]).
Claims 22-23 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Snider (US 20200001118 A1) and Yasushi (JP 4282198 B2; previously cited) in view of Schulte, et. al. (US 20120273665 A1), hereinafter Schulte.
Regarding claim 22, Snider in view of Yasushi does not teach wherein said at least five plates comprise plates of 1, 2, 3, 7, or 14 cm water equivalent thickness (WET).
Schulte teaches wherein said at least five plates comprise plates of 1, 2, 3, 7, or 14 cm water equivalent thickness (WET) (Table 1, [0095], [0098], where [0094] teaches that d0 is approximately 0.3175 cm. [0095] teaches that in terms of WET values, such plates can provide different effective water-equivalent thicknesses between about 0 cm and 36 cm. The range disclosed by Schulte includes the values claimed.).
Schulte modifies the combination by suggesting plates with water-equivalent thicknesses between 0 cm and 36 cm, which include water-equivalent thicknesses of 1, 2, 3, 7, or 14 cm.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate the teachings of Schulte because the water equivalent thicknesses of the degrader plate combinations are appropriate for 200 MeV protons or 100 MeV protons, and different combination of plates allow introduction of different ranges of WET values for calibrating different proton energies as desired, (Schulte, [0095], [0098])
Regarding claim 25, Snider in view of Yasushi does not teach wherein said at least five plates comprise plates of 1, 2, 3, 7, or 14 cm water equivalent thickness (WET).
Schulte teaches wherein said at least five plates comprise plates of 1, 2, 3, 7, or 14 cm water equivalent thickness (WET) (Table 1, [0095], [0098], where [0094] teaches that d0 is approximately 0.3175 cm. [0095] teaches that in terms of WET values, such plates can provide different effective water-equivalent thicknesses between about 0 cm and 36 cm. The range disclosed by Schulte includes the values claimed.).
Schulte modifies the combination by suggesting plates with water-equivalent thicknesses between 0 cm and 36 cm, which include water-equivalent thicknesses of 1, 2, 3, 7, or 14 cm.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate the teachings of Schulte because the water equivalent thicknesses of the degrader plate combinations are appropriate for 200 MeV protons or 100 MeV protons, and different combination of plates allow introduction of different ranges of WET values for calibrating different proton energies as desired, (Schulte, [0095], [0098])
Regarding claims 23 and 26, Snider in view of Yasushi does not explicitly teach wherein said adjustable range shifter can generate 35 discrete range pulling-backs with a depth resolution of 1 cm.
Schulte teaches wherein said adjustable range shifter can generate 35 discrete range pulling-backs with a depth resolution of 1 cm. (Table 1, [0094]-[0095], [0098], where [0094] teaches that d0 is approximately 0.3175 cm. [0095] teaches that various combinations of the example plates 282a-282h can be made to produce different effective thicknesses which will result in various corresponding discrete range pulling-backs. With the 8 plates shown in table 1, which includes 5 unique effective thicknesses, by permutation there are 120 ways to combine the 5 effective thicknesses to achieve different depth combination and corresponding discrete range pulling-backs. Consequently, these 120 combinations include 35 combinations resulting in 35 discrete range pulling-backs. The thicknesses in Table 1 are on the order of centimeters. [0095] and Table 1 teaches increments (depth resolution) of d0 = 0.3175 cm, which is similar to 1 cm. See MPEP 2144.05 I., which states that “[i]n the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists” and “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”)
Additionally, optimizing the discrete range pulling-backs and the depth resolution is well within the bounds of normal experimentation. See MPEP 2144.05 II (A). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, “[a] particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.” In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In the case at hand, Schulte teaches the number of discrete range pulling-backs and the depth resolution as a variable which achieves a recognized result. In paragraphs [0094]-[0095] and the abstract, Schulte teaches that energy degrader plates of various thicknesses can be introduced to an ion beam in various controlled combinations in order to introduce different energy degradations settings. Therefore, the prior art identifies the depth resolution (thickness unit d0) and discrete range pulling-backs as result-effective variables because adjusting these values will affect the energy degradation settings. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective time of filing to optimize both the number of discrete range pulling-backs and the depth resolution to meet the claimed values since it is not inventive to dis-cover the optimum or workable ranges/amounts by routine experimentation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wu, et. al. (US 20140194667 A1)
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LAURA E TANDY
Examiner
Art Unit 2881
/DAVID E SMITH/Examiner, Art Unit 2881
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