DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 19 August 2025 has been entered. Claims 16-20, 22-25, 28, 29, and 33-36 are now pending. The Examiner acknowledges the amendments to claims 16, 18, 19, 23-25 and 33. Claims 34-36 remain withdrawn from consideration.
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 Objections
Claim 24 is objected to because of the following informalities: in claim 24, “the particle beams” should apparently read --the one or more particle beams--. Appropriate correction is required.
Claim Rejections - 35 USC § 101
3. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
4. Claims 16-20, 22-25, 28, 29 and 33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a method of generating a treatment plan. This judicial exception is not integrated into a practical application because as currently written, the step of determining a dose distribution using a non-Gaussian model configured to estimate depth dose distribution and energy distribution of particles in a medium, the model comprising a combination of error functions, can simply amount to determining the dose distribution by looking at values/results of the model on printed information (wherein “using” the model would amount to looking at the model on paper as the model/equation itself is described in claims 22 and 23 and could be solved by hand on paper); the step of “generating a treatment plan based on the determined dose distribution, the treatment plan including an irradiation plan and additional information, the additional information including desired radiation dose within the medium, and particle angles and particle energies needed to provide the desired radiation dose…” simply amounts to looking at the printed paper of the previous step and writing down an irradiation plan and information regarding a desired radiation dose, and particle angles and particle energies needed to provide the desired dose; and the step of “generating instructions for the particle therapy system to effect the irradiation plan based on the additional information” could amount to a practitioner writing down instructions on a separate piece of paper for an operator/surgeon of the particle therapy system to input data/information/parameters into the therapy system for delivering a subsequent dose to a patient (as the clause is written as an intended use of the instructions).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because irradiation of a patient with a particle beam comprising protons, ions or other charged particles is a well-understood and routine step/component in particle therapy treatment as evidenced by Gattiker et al. (U.S. Pub. No. 2015/0352374) and Brand et al. (U.S. Pub. No. 2015/0202464). The additional element of a computer processor/processing system for determining a dose distribution; generating a treatment plan (that includes information regarding an irradiation plan and particle energies); and generating instructions is merely recited as a generic computer processor/processing system for implementing a generic step of determining a dose distribution as addressed above, in addition to generating a treatment plan based on the determinized dose distribution and “additional information”, which is likewise disclosed by Brand. Moreover, the additional element of a degrader or energy defining slit is likewise a well-understood and routine, and conventional component in particle therapy systems as disclosed by Ma (U.S. Patent No. 7,317,192).
With respect to the dependent claims, calculating a radiation dose and employing certain functions/models as claimed can be implemented with pen/paper as recited, and the non-Gaussian model comprising error functions as claimed can be solved via pen/paper. Further, the generation of a treatment plan is recited at such a high level of generality that one could perform such a step in the mind by looking at a dose distribution printed on a piece of paper.
Claim Rejections - 35 USC § 112
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 16-20, 22-25, 28, 29 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 16 and 25 (at lines 10-12) recite that the additional information includes “…particle angles…needed to provide the desired radiation dose”. However, the disclosure, as originally filed, only appears to provide support for “angles” with respect to the gantry/nozzle ([0044] and [0049] of the instant publication) and not “particle angles” as claimed. Therefore, claims 16 and 25 constitute new matter.
7. 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.
8. Claims 17-20, 25, 28, 29 and 33 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.
9. Claim 17 at line 3 recites the limitation "the determined energy distribution". There is insufficient antecedent basis for this limitation in the claim.
10. Claim 25 at line 8 recites the limitation "the determined radiation dose". There is insufficient antecedent basis for this limitation in the claim.
11. Claim 33 at line 2 recites the limitation "the determining of the radiation dose distribution". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
12. 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.
13. 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.
14. Claims 16-19, 24, 25, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Gattiker et al. (U.S. Pub. No. 2015/0352374) in view of Schulte et al. (U.S. Patent No. 8,632,448). Regarding claim 16, Gattiker et al. (hereinafter Gattiker) discloses a method for generating a treatment plan, the method comprising executing by a computer processor the following steps:
determining an energy distribution for one or more particle beams, or portions thereof, from a particle therapy system, using a non-Gaussian model ([0086]-[0089] and Fig. 16) configured to estimate energy distribution of particles within a medium (scatter within a particular material such as water - [0084]), the non-Gaussian model comprising a combination of error functions ([0064] and [0088]);
generating a treatment plan based on the determined energy distribution [0090], the treatment plan including an irradiation plan and additional information ([0090] and [0092]), the additional information including particle angles and particle energies [0086]; and
generating instructions for the particle therapy system to effect the irradiation plan based on the additional information ([0090] and [0092]).
While Gattiker does not explicitly disclose that the non-Gauusian model is configured to estimate depth dose distribution in addition to the energy distribution, the “additional information” further including “desired radiation dose within the medium,” Gattiker does teach that the aforementioned set of simulations can include results on the dose distribution in a water phantom, namely the amount of dose accumulated in the target tumor and in regions to avoid such as organs-at-risk, and that generally a higher dose would be desired in the former and a low dose in the latter [0090], obviating an estimation of depth dose distribution within a medium and the desired radiation dose within the medium. Gattiker further obviates such as Gattiker states that the fluctuation model looks at radiation dosage versus depth [0076]-[0078]).
However, Gattiker fails to disclose that the additional information includes information regarding particle energies needed to provide the desired radiation dose within the medium. Schulte et al. (hereinafter Schulte) likewise utilizes modeling simulations in order to estimate/determine the passage of charged particles of a particle beam through tissue in order to facilitate more accurate planning and monitoring of proton-based therapy (see Abstract and col. 2, lines 41-57; and col. 10, lines 59-67), wherein a treatment plan is generated which includes additional information including information regarding particle energies needed to provide a desired radiation dose within a medium (col. 21, lines 46-67 – col. 22, lines 1-26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include information regarding particle energies needed to provide a desired radiation dose within a medium as taught by Schulte (col. 21, lines 52-61), in a method for generating a treatment plan based on determination of an energy distribution of particles of a particle beam as suggested by Gattiker, as Gattiker recognizes the importance of energy fluctuation in modeling for treatment planning ([0088]-[0090]), and Schulte teaches that energies of a therapeutic proton beam are factored in to generating a particular treatment plan (col. 21, lines 56-60).
Regarding claim 17, the method further comprises irradiating a patient with the one or more particle beams, or portions thereof, based at least in part on the determined energy distribution (Fig. 16 and [0092] of Gattiker).
Regarding claim 18, the method further comprises calculating a radiation dose from the one or more particle beams, or portions thereof, within the patient based on the determined energy distribution (Fig. 16 and [0107] of Gattiker).
Regarding claim 19, the calculating of the radiation dose employs an analytical function or a stochastic algorithm ([0106]-[0107] of Gattiker).
Regarding claim 24, the one or more particle beams comprise protons, ions, or other charged particles ([0092] of Gattiker).
Regarding claim 25, Gattiker discloses a non-transitory computer readable medium upon which is embodied a sequence of programmed instructions, which when executed a computer processing system, causes the computer processing system to:
determine an energy distribution for one or more particle beams, or portions thereof, from a particle therapy system, using a non-Gaussian model ([0086]-[0089] and Fig. 16) configured to estimate energy distribution of particles within a medium (scatter within a particular material such as water - [0084]), the non-Gaussian model comprising a combination of error functions ([0064] and [0088]);
generate a treatment plan based on the determined energy distribution [0090], the treatment plan including an irradiation plan and additional information ([0090] and [0092]), the additional information including particle angles and particle energies [0086]; and
generate instructions for the particle therapy system to effect the irradiation plan based on the additional information ([0090] and [0092]).
While Gattiker does not explicitly disclose that the non-Gauusian model is configured to estimate depth dose distribution in addition to the energy distribution, the “additional information” further including “desired radiation dose within the medium,” Gattiker does teach that the aforementioned set of simulations can include results on the dose distribution in a water phantom, namely the amount of dose accumulated in the target tumor and in regions to avoid such as organs-at-risk, and that generally a higher dose would be desired in the former and a low dose in the latter [0090], obviating an estimation of depth dose distribution within a medium and the desired radiation dose within the medium. Gattiker further obviates such as Gattiker states that the fluctuation model looks at radiation dosage versus depth [0076]-[0078]).
However, Gattiker fails to disclose that the additional information includes information regarding particle energies needed to provide the desired radiation dose within the medium. Schulte et al. (hereinafter Schulte) likewise utilizes modeling simulations in order to estimate/determine the passage of charged particles of a particle beam through tissue in order to facilitate more accurate planning and monitoring of proton-based therapy (see Abstract and col. 2, lines 41-57; and col. 10, lines 59-67), wherein a treatment plan is generated which includes additional information including information regarding particle energies needed to provide a desired radiation dose within a medium (col. 21, lines 46-67 – col. 22, lines 1-26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include information regarding particle energies needed to provide a desired radiation dose within a medium as taught by Schulte (col. 21, lines 52-61), in a method for generating a treatment plan based on determination of an energy distribution of particles of a particle beam as suggested by Gattiker, as Gattiker recognizes the importance of energy fluctuation in modeling for treatment planning ([0088]-[0090]), and Schulte teaches that energies of a therapeutic proton beam are factored in to generating a particular treatment plan (col. 21, lines 56-60).
Regarding claim 33, the determining of the radiation dose distribution further employs an analytical function or a stochastic algorithm ([0106]-[0107] of Gattiker).
16. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gattiker et al. (U.S. Pub. No. 2015/0352374) in view of Schulte et al. (U.S. Patent No. 8,632,448) and further in view of Jongen (U.S. Pub. No. 2014/0005463). Regarding claim 20, Gattiker and Schulte fails to disclose wherein the irradiating includes adjusting an energy of the one or more particle beams, or portions thereof, from a particle accelerator using at least one of a degrader and an energy defining slit. Jongen discloses a particle therapy system for providing a dose to a moving target, such as a patient (see Abstract), via a particle beam generator, wherein the particle beam generator includes a fixed energy cyclotron and an energy degrader for degrading the fixed energy such that a particle beam of a selected energy can be delivered [0021]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an energy degrader as taught Jongen, into a particle delivery system as suggested by Gattiker and Schulte, as Gattiker discloses the necessity to provide the desired radiation energy or dosage [0047] and Jorgen teaches the use of a degrader for providing selection of such desired energy to be delivered [0021].
Response to Arguments
17. Applicant’s arguments filed 19 August 2025 with respect to the rejection of claims 16-20, 22-25, 28, 29 and 33 under 35 U.S.C. 101 have been fully considered and are not persuasive. Applicant contends that the “combination of features recited in Claim 16 integrates the alleged judicial exception into a practical application because the features recited in the claim, namely, the use of a non-Gaussian model configured to estimate depth dose distribution and energy distribution of particles within a medium to determine a dose distribution for one or more particle beams, or portions thereof, from a particle therapy system, improves the model, which then improves the functionality of the computer using this model, as well as the technology/technical field in which the model is used”; and that the added features of “generating a treatment plan based on the determined dose distribution” and “the generating of instructions for the particle therapy system to effect the irradiation plan” further add a meaningful limitation. However, this argument is not persuasive as such limitations/teachings are not imparted to the claim(s). As indicated above, at least the clause of “generating instructions for the particle therapy system to effect the irradiation plan…” is written as intended use and is construed as instructions (on printed matter) that an operator could use for inputting data/control functions to the particle therapy system to implement the plan. Additionally, the most recent recitation of “using a non-Gaussian model configured to estimate depth dose distribution and energy distribution of particles within a medium, the non-Gaussian model comprising a combination of error functions,” is not a positive recitation of the recited steps of estimating depth dose distribution and energy distribution of particles (which the claim recites that the model is configured to do). Further, “using a non-Gaussian model” can simply amount to determining the dose distribution by looking at values/results of the model computations on printed information (wherein “using” the model would amount to looking at the model on paper as the model/equation itself is described in claims 22 and 23 and could be solved by hand on paper). The equation(s) for the non-Gaussian model, as disclosed and claimed, would not require a specialized computer/processor as those equations can be solved by hand on paper. In view of the foregoing, the rejection of claims 16-20, 22-25, 28, 29 and 33 under 35 U.S.C. 101 has been maintained.
18. Applicant’s arguments filed 19 August 2025 with respect to the rejection of claims 16-20, 22-25, 28, 29 and 33 under 35 U.S.C. 112(b) have been fully considered and are persuasive, however new grounds of rejection are presented above (to some of the claims) in light of the amendments.
19. Applicant’s arguments filed 19 August 2025 with respect to the rejection of claims 16-19, 24, 25 and 33 under 35 U.S.C. 103 citing Gattiker in view of Schulte (‘448) have been fully considered and are not persuasive. Applicant has amended the independent claims to include new limitations not previously recited, however such limitations were found obvious in light of Gattiker as outlined about. Regarding Gattiker in view of Schulte, Applicant contends that Schulte fails to teach or suggest a treatment plan generated using a non-Gaussian model that includes particle energies needed to provide the desired radiation dose as the additional information as the information regarding the particle energies and angles needed to provide the desired radiation dose within a medium is not obtained using a non-Gaussian model. However, this argument is not persuasive. Gattiker teaches the non-Gaussian model as indicated in the rejection above, and Schulte is incorporated for the teaching of the additional information regarding particle energies, which is not claimed as requiring use of the non-Gaussian model.
Conclusion
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791