DETAILED ACTION
Response to Arguments
Rejections under 35 U.S.C. §103
Applicant's arguments filed 11/26/2025 with respect to the rejections under 35 USC 103 have been fully considered. The arguments are not persuasive because there is a reason to combine the cited art.
Mansfield and Abel are both directed to radiation therapy treatment methods utilizing ionizing radiation. Mansfield taught most of the limitations of claim 1 but failed to teach range compensators for each field of ionizing radiation. Abel modified Mansfield by providing range compensators, which are well known in the art, for each field of radiation with the stated benefit and motivation that a range compensator shapes a distribution of a dose delivered to the patient by the beam and advantageously allows the treatment to apply the compensated beam fields without requiring machine changes between treatments.
Applicant’s arguments regarding the uniformity of the beam are not relevant to the manner in which Mansfield and Abel are being combined in the previous 103 rejection of claim 1, because in the prior rejection under 35 USC 103, Abel is primarily concerned with providing the range compensators lacking by Mansfield. Additionally, the prior claims did not require “concentrated energy administration to a specific spot”, (see page 8 of the remarks filed 11/26/2025). Range compensators have the effect of shaping a distribution of the dose delivery and would be expected by one of ordinary art to perform as such in the invention of Mansfield. Consequently, there is a reason to combine the cited art in the manner claimed.
Furthermore, note that under the broadest reasonable interpretation of the claims as written, a Bragg peak (broad) still includes a spread out Bragg peak (narrow) because a spread out Bragg peak is a type of Bragg peak, and prior art including such is relevant and applicable to the claims, as written. Further and along the same lines, note that the prior claims did not require “concentrated energy administration to a specific spot.”
Regarding the arguments on pgs. 8-13 directed to amended subject matter, a new ground(s) of rejection is made in view of Carabe-Fernandez, et. al. (US 20210101027 A1) is presented 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 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 factual inquiries 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.
Claims 1, 7, 11-14, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield (US 20180133514) in view of Abel, et. al. (US 20200269068 A1), hereinafter Abel, and Carabe-Fernandez, et. al. (US 20210101027 A1), hereinafter Carabe.
Regarding claim 1, Mansfield teaches a method for supplying at least two fields of ionizing radiation to a target tissue (intended use) comprising:
providing an ionizing radiation (The radiation therapy system directs “a beam of high energy particles such as electrons, protons, or heavy ions into a target volume,” [0002]);
forming at least two fields (Paragraph [0035] teaches that “The nozzle 106 is used to aim the beam toward various locations within an object (e.g., a patient) supported on the supporting device 108 (e.g., a chair or table) in a treatment room. The nozzle 106 may be mounted on or a part of a gantry (not shown) so that it can be moved relative to the supporting device 108” Since the nozzle is moved via the gantry to aim the beam toward various locations, the nozzle via the gantry forms at least two fields (i.e. “various locations” which the beam is aimed)) of shifted ionizing radiation (Paragraph [0009] teaches a beam energy adjuster including a range shifter and range modulator placed in the nozzle to adjust the beam of ionizing radiation) by:
shifting the range of the ionizing radiation by passing the ionizing radiation through an adjustable range shifter (range shifter 214, where the components of the range shifter, wedges 502 and 504 can be adjusted [0065-0067]), said adjustable range shifter comprising at least three plates ([0068] teaches range shifter 214 can be implemented using more than two wedges or blocks), so that the Bragg peak of the ionizing radiation coincides with a spot within tissue ([0046] teaches that “the range shifter 214 provides a rapid means of varying the range of the Bragg peak so that the Bragg peak occurs at the distal edge of the planning target volume for each shot.”);
directing the at least two fields of the shifted ionizing radiation to the spot within the target tissue (Paragraph [0010]-[0011] teaches “In an embodiment, a shot can be adjusted in energy (intensity) or range and delivered to the target volume with a Spread Out Bragg Peak (SOBP) that provides a uniform and otherwise suitably modified dose to an entire target line segment”).
Mansfield does not teach receiving a spot map comprising a set of spots within the target tissue, then successively for each spot in the spot map.
Carabe teaches receiving a spot map comprising a set of spots within the target tissue (Abstract, [0041]), then successively for each spot in the spot map providing an ionizing radiation ([0035]); forming at least two fields of ionizing radiation ([0035]); and directing the at least two fields of the ionizing radiation to the spot within the target tissue ([0035], [0041]).
Carabe modifies Mansfield by suggesting the organization process by which the irradiation occurs. In particular, Carbe suggests that the process for irradiating the target can be organized by first forming a spot map and then irradiating the target spot by spot within the map based on the plan.
Since both inventions are directed towards radiation therapy, 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 Carabe because a spot map and successively delivering to each spot allows for delivering a desired dosage to a target according to a plan, (Carabe, [0041], [0046]).
Mansfield and Carabe do not teach compensating the range of the ionizing radiation by passing each of the at least two fields of 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.
Abel teaches compensating the range of the ionizing radiation by passing each of the at least two fields of ionizing radiation (Fig. 13, [0104, [0082]-[0083], where each beam is a field of ionizing radiation) through a respective separate range compensator ([0079], [0082]-[0083], [0104] Figs. 8A-8C, 9, 10, 13), said range compensators each comprising a three-dimensional topography to conform the beam to the target tissue shape (Figs. 5A-5B, [0064]-[0065], [0080]).
Abel modifies the combination by suggesting respective separate range compensators for each of two or more fields of ionizing radiation in addition to the range shifter of Mansfield, resulting in at least two fields of shifted and compensated ionizing radiation.
Since both inventions are directed towards radiation therapy, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have a range compensator in addition to the range shifter in order to “shape a distribution of a dose delivered to the patient 804 by the beam,” (Abel, [0080]). Further, utilizing a respective range compensator for each beam of a plurality of beams advantageously limits movement of the patient, (Abel, [0100]), and advantageously allows the treatment to apply the beam fields without requiring machine changes between treatments, (Abel, [0104]).
Regarding claim 7, Mansfield teaches wherein said adjustable range shifter (range shifter 214, where the components of the range shifter, wedges 502 and 504 can be adjusted [0065-0067]) comprises multiple plates through which the ionizing radiation is transmitted (Paragraph [0068] teaches that the range shifter includes wedges 502 and 504, however the range shifter 214 may be made with components that are non-wedged shaped, such as block-shaped. Additionally, there may be more than two components. Paragraph [0008] teaches that “the range shifter is configured to place different thicknesses of material in the path of the beam to affect the distance that the particles penetrate into the object.”).
Regarding claims 11-13, Mansfield does not specifically teach comprises three (claim 11), four (claim 12), or five fields (claim 13) of the shifted and compensated ionizing radiation.
However, Mansfield teaches various fields (Paragraph [0035] teaches that “The nozzle 106 is used to aim the beam toward various locations within an object (e.g., a patient) supported on the supporting device 108 (e.g., a chair or table) in a treatment room. The nozzle 106 may be mounted on or a part of a gantry (not shown) so that it can be moved relative to the supporting device 108”
Since the nozzle is moved via the gantry to aim the beam toward various locations, the nozzle via the gantry forms various fields (i.e. “various locations” which the beam is aimed), the device of Mansfield is capable of three, four, five, or any number of fields. Therefore, it would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed to use various fields such that the various fields comprise three, four, or five fields of the shifted and compensated ionizing radiation to cover situations when the treatment plan requires three, four, or five fields in order to effectively irradiate the disease site. As per, paragraph [0081] “Some disease sites may not require a rotating gantry in order to be effectively treated with IMPT”, suggesting that in some instances a rotating gantry may be required to effectively treat disease sites. Again since a rotating gantry is capable of any number of irradiating fields, it would be obvious to select three, four, or five fields when three, four, or five fields are the number of fields necessary to effectively treat the disease site.
Regarding claim 14, Mansfield teaches a system for administering at least two fields of shifted and compensated ionizing radiation to a target tissue (intended use) comprising:
an ionizing radiation source configured to produce a charged particle beam ( [0002], [0069]);
a universal range shifter (range shifter 214, [0065-0067]) adjusted to shift the range of the charged particle beam so that the Bragg peak of the charged particle beam coincides with the spot within the target tissue ([0046] teaches that “the range shifter 214 provides a rapid means of varying the range of the Bragg peak so that the Bragg peak occurs at the distal edge of the planning target volume for each shot.”), said universal range shifter comprising at least three plates ([0068] teaches range shifter 214 can be implemented using more than two wedges or blocks).
Mansfield does not teach a spot map comprising a set of points within the target tissue.
Carabe teaches a spot map comprising a set of points within the target tissue (Abstract, [0041]).
Carabe modifies Mansfield by suggesting a spot map specifying particular points within the target.
Since both inventions are directed towards radiation therapy, 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 Carabe because a spot map allows for delivering a desired dosage to a target according to a plan, (Carabe, [0041]).
Mansfield and Carabe fail to teach 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.
Abel teaches at least two range compensators adjusted to compensate the range of the charged particle beam ([0079], [0082]) so that the Bragg peak of the ionizing radiation coincides with the contour of the target tissue ([0010], [0065]), said range compensators each comprising a unique three- dimensional topography to conform the beam to the target shape ([0065], [0080]).
Abel modifies the combination by suggesting at least two range compensators.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have a range compensator in addition to the range shifter in order to “shape a distribution of a dose delivered to the patient 804 by the beam,” (Abel, [0080]).
Regarding claim 27, Mansfield teaches wherein said method provides a uniform dose distribution across the target tissue (Paragraph [0010]-[0011] teaches “In an embodiment, a shot can be adjusted in energy (intensity) or range and delivered to the target volume with a Spread Out Bragg Peak (SOBP) that provides a uniform and otherwise suitably modified dose to an entire target line segment” Subsequent shots of the same nature are administered until the entire target volume is irradiated.).
Claims 2-6 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield (US 20180133514), Abel (US 20200269068 A1), and Carabe (US 20210101027 A1), further in view of Lansonneur, et. al. (US 20210393982 A1, note that this application claims priority to US provisional application 63,043,027 filed on 06/23/2020)).
Regarding claims 2 and 15, Mansfield fails to explicitly teach 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.
Since all inventions are directed towards ion beam radiation therapy, 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 claims 3 and 16, Mansfield teaches the fields do not substantially extend proximally beyond a distal edge of the target location (Mansfield, planning target volume 304, Fig. 3, Paragraph [0051] teaches that “the SOBP delivers a uniform dose in the direction along the target line segment 302 from the proximal edge to the distal edge,” and Fig. 3 shows how the target line segment 302 stays within the bounds (distal edge) of the target volume 304).
Regarding claim 4, Mansfield teaches comprises protons, helium, carbon, argon or neon (Mansfield, Paragraph [0033] teaches that “The accelerator and beam transport system 104 generates and accelerates a beam of charged particles, such as electrons, protons, and heavy ions, and contains the particles in a well-defined beam.”).
Regarding claim 5, Mansfield teaches comprises protons (Mansfield, Paragraph [0033] teaches that “The accelerator and beam transport system 104 generates and accelerates a beam of charged particles, such as electrons, protons, and heavy ions, and contains the particles in a well-defined beam.”).
Regarding claims 6 and 17, Mansfield teaches wherein said target tissue (Mansfield, planning target volume 304, [0051]) comprises cancerous tissue (Mansfield, Paragraph [0051] teaches that “The planning target volume refers to the size of the volume to be irradiated, and encompasses the clinical target volume 306, which refers to size of the actual tumor to be treated,” where a tumor can be a neoplasm or benign tumor, aligning with the definition disclosed by applicant).
Claims 18, 20-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield (US 20180133514), Abel (US 20200269068 A1), and Carabe (US 20210101027 A1), further in view of Yasushi, et. al. (JP 4282198 B2), hereinafter Yasushi.
Regarding claim 18, Mansfield teaches wherein said adjustable range shifter comprises more than two plates ([0068] teaches range shifter 214 can be implemented using more than two wedges or blocks. This would include the possibility of at least four plates, however, see Yasushi for explicit disclosure.).
Mansfield in view of Abel 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 the combination 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 20, Mansfield in view of Abel does not specifically teach wherein said at least two fields of the shifted and compensated ionizing radiation comprises three fields.
However, Mansfield teaches various fields (Paragraph [0035] teaches that “The nozzle 106 is used to aim the beam toward various locations within an object (e.g., a patient) supported on the supporting device 108 (e.g., a chair or table) in a treatment room. The nozzle 106 may be mounted on or a part of a gantry (not shown) so that it can be moved relative to the supporting device 108”
Since the nozzle is moved via the gantry to aim the beam toward various locations, the nozzle via the gantry forms various fields (i.e. “various locations” which the beam is aimed), the device of Mansfield is capable of three, four, five, or any number of fields. Therefore, it would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed to use various fields such that the various fields comprise three, four, or five fields of the shifted and compensated ionizing radiation to cover situations when the treatment plan requires three, four, or five fields in order to effectively irradiate the disease site. As per, paragraph [0081] “Some disease sites may not require a rotating gantry in order to be effectively treated with IMPT”, suggesting that in some instances a rotating gantry may be required to effectively treat disease sites. Again since a rotating gantry is capable of any number of irradiating fields, it would be obvious to select three, four, or five fields when three, four, or five fields are the number of fields necessary to effectively treat the disease site.
Regarding claims 21 and 24, Mansfield teaches wherein said adjustable range shifter comprises more than two plates ([0068] teaches range shifter 214 can be implemented using more than two wedges or blocks. This would include the possibility of at least five plates, however, see Yasushi for explicit disclosure.).
Mansfield in view of Abel 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 the combination 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]).
Claims 22-23 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Mansfield (US 20180133514), Abel (US 20200269068 A1), Carabe (US 20210101027 A1), and Yasushi (JP 4282198 B2), further in view of Schulte, et. al. (US 20120273665 A1), hereinafter Schulte.
Regarding claims 22 and 25, Mansfield in view of Abel 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, (Schulte, [0095], [0098])
Regarding claims 23 and 26, Mansfield in view of Abel 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 “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.
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, (Schulte, [0095], [0098])
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 LAURA E TANDY whose telephone number is (703)756-1720. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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LAURA E TANDY
Examiner
Art Unit 2881
/DAVID E SMITH/Examiner, Art Unit 2881