DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-6, 8-15, 18-21, and 45-46 are presented for examination based on the claims in the application filed on October 15, 2025. Claims 7, 16-17, and 22-44 have been cancelled by the applicant.
Claims 1-6, 8-11, 18, 45-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 19 of U.S. Patent No. 11,213,699.
Claims 12-15 and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,213,699 in view of US 2006/0285640 A1, Nizin et al. [herein “Nizin”].
Claims 1-6, 8-15, 18-21, and 45-46 are rejected under 35 USC § 101 because the claimed invention is directed to judicial exception, an abstract idea, it has not been integrated into practical application.
Claims 1-6, 8, 10-15, 18-21, and 45-46 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2006/0285640 A1, Nizin et al. [herein “Nizin”].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nizin in view of Lindborg, Lennart, et al. Microdosimetry: Experimental Methods and Applications. CRC Press, 2017 [herein “Lindborg”].
This action is made Final.
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
The amendment filed October 15, 2025 has been entered. Claims 1-6, 8-15, 18-21, and 45-46 remain pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on September 11, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8-11, 18, 45-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 19 of U.S. Patent No. 11,213,699. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent No 11,213,699 teaches:
1. “A method comprising: determining volumetric data associated with an object of interest, wherein the volumetric data comprise a plurality of domains”, (Claim 1, A method comprising: determining data indicative of a particle beam to apply to an object of interest; determining imaging data associated with the object of interest, wherein the imaging data comprises a plurality of voxels of data.)
“determining, for each of the plurality of domains, a plurality of distributions for characterizing interactions of particles of a particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution indicative of energy imparted in a corresponding domain due to a particle traveling in the domain”, (Claim 1, determining, for each of a plurality of domains in a first voxel of the plurality of voxels, a plurality of distributions for characterizing interactions of particles of the particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution comprising an energy value imparted in a corresponding domain due to a particle traveling in the domain.)
“determining an analytical function based on one or more of the plurality of distributions”, (Claim 1, determining, based on at least the first distribution, an analytical function that models at least the first distribution.)
“determining, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain”, (Claim 1, determining, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain.)
and “outputting, based on the first data, data associated with treatment of the object of interest by the particle beam”. (Claim 1, outputting, based on the first data, data associated with treatment of the object of interest by the particle beam.)
2. The method of claim 1, “wherein the data associated with treatment comprises one or more of (1) a three-dimensional distribution of dose or (2) a segment-averaged, restricted, dose averaged linear energy transfer for the particle beam, and further comprising adjusting a treatment plan based on one or more of the first data or the data associated with the treatment”. (Claim 2, wherein the data associated with treatment comprises one or more of (1) a three-dimensional distribution of dose or (2) a segment-averaged, restricted, dose averaged linear energy transfer for the particle beam, and further comprising adjusting a treatment plan based on one or more of the first data or the data associated with the treatment.)
3. The method of claim 1, “wherein the first data comprises one or more of a linear energy transfer imparted by the particle beam to the corresponding domain or a dose imparted by the particle beam to the corresponding domain”. (Claim 3, wherein the first data comprises one or more of a linear energy transfer imparted by the particle beam to the corresponding domain or a dose imparted by the particle beam to the corresponding domain.)
4. The method of claim 1, “wherein the particle beam comprises a beam of one or more of protons, neutrons, positive ions, electrons, or alpha particles”. (Claim 4, wherein the particle beam comprises a plurality of protons at a plurality of corresponding energies.)
5. The method of claim 1, “wherein determining the plurality of distributions comprises using one or more simulations to generate the plurality of distributions”. (Claim 5, wherein determining the plurality of distributions comprises using one or more simulations to generate the plurality of distributions.)
6. The method of claim 1, “wherein the plurality of distributions comprises a second distribution indicative of segment length of a particle path in the domain and a third distribution indicative of energy imparted in the domain due to a collision of a particle, wherein the segment length comprises a distance a particle of the particle beam is predicted to travel after entering the domain before coming to rest”. (Claim 6, wherein the plurality of distributions comprise a second distribution indicative of segment length of a particle path in the domain and a third distribution indicative of energy imparted in the domain due to a collision of a particle, and Claim 7, wherein the segment length comprises the distance a particle of the particle beam is predicted to travel after entering the domain before coming to rest.)
8. The method of claim 1, further comprising “determining, for a particle energy of the particle beam and based on the plurality of distributions, an energetic kernel, wherein the energetic kernel comprises a first average of at least one of the plurality of distributions and a first variance of the at least one of the plurality of distributions”. (Claim 8, wherein determining the analytical function comprises determining, for a proton energy of the particle beam and based on the plurality of distributions, an energetic kernel, wherein the energetic kernel comprises a first average of at least one of the plurality of distributions and a first variance of the at least one of the plurality of distributions.)
9. The method of claim 8, further comprising “performing a first convolution of an energy fluence of the particle beam with the first average and a performing a second convolution of the energy fluence of the particle beam with the first variance, wherein the first data is determined based on a result of the first convolution and the second convolution”. (Claim 9, further comprising performing a first convolution of an energy fluence of the particle beam with the first average and a performing a second convolution of the energy fluence of the particle beam with the first variance, wherein the first data is determined based on the results of the first convolution and the second convolution.)
10. The method of claim 1, “wherein the data associated with treatment plan is based on a model that accounts for one or more of variations of linear energy transfer in a domain, variations of dose in a domain, variations of segment length of paths of particles entering a domain, variations of whether particles come to rest in a domain, variations in a number of collisions of a particle in a domain, or variations in an amount of energy imparted in a collision of a particle in a domain”. (Claim 10, wherein the data associated with treatment plan is based on a model that accounts for one or more of variations of linear energy transfer in a domain, variations of dose in a domain, variations of segment length of paths of particles entering a domain, or variations of whether particles come to rest in a domain, or variations in the number of collisions of a particle in a domain, or variations in an amount of energy imparted in a collision of a particle in a domain.)
11. The method of claim 1, “wherein the volumetric data comprises one or more of geometric data associated with the object of interest, data comprising a plurality of voxels, data associated with a cell of the object of interest, data associated with a tissue of the object of interest, or data associated with a macroscopic structure of the object of interest”. (Claim 1, determining imaging data associated with the object of interest, wherein the imaging data comprises a plurality of voxels of data.)
18. The method of claim 1, “wherein determining the analytical function comprises determining the analytical function based on the first distribution”. (Claim 1, determining, based on at least the first distribution, an analytical function that models at least the first distribution.)
45. “A device comprising: one or more processors; and memory storing instructions that, when executed by the one or more processors, cause the device to: determine volumetric data associated with an object of interest, wherein the volumetric data comprise a plurality of domains”, (Claim 11, A device comprising: one or more processors; and memory storing instructions that, when executed by the one or more processors, cause the device to: determine imaging data associated with the object of interest, wherein the imaging data comprises a plurality of voxels of data.)
“determine, for each of the plurality of domains, a plurality of distributions for characterizing interactions of particles of a particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution indicative of energy imparted in a corresponding domain due to a particle traveling in the domain”, (Claim 11, determine, for each of a plurality of domains in a first voxel of the plurality of voxels, a plurality of distributions for characterizing interactions of particles of the particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution comprising an energy value imparted in a corresponding domain due to a particle traveling in the domain.)
“determine an analytical function based on one or more of the plurality of distributions”, (Claim 11, determine, based on at least the first distribution, an analytical function that models at least the first distribution.)
“determine, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain”, (Claim 11, determine, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain.)
and “output, based on the first data, data associated with treatment of the object of interest by the particle beam”. (Claim 11, output, based on the first data, data associated with treatment of the object of interest by the particle beam.)
46. “A system comprising: a particle beam generator”, (Claim 19, A system comprising: a particle beam generator.)
“and at least one processor communicatively coupled to the particle beam generator and configured to: determine volumetric data associated with an object of interest, wherein the volumetric data comprise a plurality of domains”, (Claim 19, at least one processor communicatively coupled to the particle beam generator and configured to: determine imaging data associated with the object of interest, wherein the imaging data comprises a plurality of voxels of data.)
“determine, for each of the plurality of domains, a plurality of distributions for characterizing interactions of particles of a particle beam from the particle beam generator with the corresponding domain, wherein the plurality of distributions comprises a first distribution indicative of energy imparted in a corresponding domain due to a particle traveling in the domain”, (Claim 19, determine, for each of a plurality of domains in a first voxel of the plurality of voxels, a plurality of distributions for characterizing interactions of particles of the particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution comprising an energy value imparted in a corresponding domain due to a particle traveling in the domain.)
“determine an analytical function based on one or more of the plurality of distributions”, (Claim 19, determine, based on at least the first distribution, an analytical function that models at least the first distribution.)
“determine, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain”, (Claim 19, determine, based on the analytical function and for each of the plurality of domains, first data comprising an energy imparted by the particle beam to the corresponding domain.)
and “output, based on the first data, data associated with treatment of the object of interest by the particle beam”. (Claim 19, output, based on the first data, data associated with treatment of the object of interest by the particle beam.)
Claims 12-15 and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,213,699 in view of US 2006/0285640 A1, Nizin et al. [herein “Nizin”].
As per Claim 12, Patent No. 11,213,699 fails to distinctly point out “wherein the volumetric data comprises one or more of a geometrical model or a spatial distribution indicative of the object of interest”.
However, in the same field of endeavor namely simulating radiation particles for radiation therapy, Nizin teaches the method of Claim 12, “wherein the volumetric data comprises one or more of a geometrical model or a spatial distribution indicative of the object of interest”. (Para. 55, “an image gathering device 41, e.g., computed tomography (CT) scanner or other imaging device known to those skilled in the art, accessible to a communication network 43 to provide stacks of two-dimensional image slices or a three-dimensional image tumor target volume and an adjacent structure volume in a patient or phantom” [geometrical model of the object of interest] “used to develop the treatment plan.” Para. 24, “The simulated dose calculation program product can include instructions that, when executed by at least one of the plurality of processors, can perform the operation of modeling the tumor target volume and adjacent structure volume to define the absorbing medium” [model of the object of interest].)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the volumetric data comprises one or more of a geometrical model or a spatial distribution indicative of the object of interest” as conceptually seen from the teaching of Nizin, into that of Patent No. 11,213,699 because this modification of obtaining the patient’s tumor as a geometrical model for the advantageous purpose of generating a treatment plan that is representative of the patient’s specific structure (Nizin, Para. 55). Further motivation to combine be that Patent No. 11,213,699 and Nizin are analogous art to the current claim and are directed to simulating radiation particles for radiation therapy.
As per Claim 13, Patent No. 11,213,699 fails to distinctly point out “wherein the volumetric data is generated based on imaging data associated with the object of interest”.
However, Nizin teaches the method of Claim 13, “wherein the volumetric data is generated based on imaging data associated with the object of interest”. (Para. 55, “an image gathering device 41, e.g., computed tomography (CT) scanner or other imaging device known to those skilled in the art, accessible to a communication network 43 to provide stacks of two-dimensional image slices or a three-dimensional image of a tumor target volume and an adjacent structure volume in a patient or phantom” [generated based on imaging data associated with the object of interest].)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the volumetric data is generated based on imaging data associated with the object of interest” as conceptually seen from the teaching of Nizin, into that of Patent No. 11,213,699 because this modification of obtaining imaging data of the patient’s tumor for the advantageous purpose of generating a treatment plan that is representative of the patient’s specific structure (Nizin, Para. 55). Further motivation to combine be that Patent No. 11,213,699 and Nizin are analogous art to the current claim and are directed to simulating radiation particles for radiation therapy.
As per Claim 14, Patent No. 11,213,699 fails to distinctly point out “wherein the domains comprise subdivisions of a biological structure”.
However, Nizin teaches the method of Claim 14, “wherein the domains comprise subdivisions of a biological structure”. (Para. 27, “the number of particles being tracked can instead be adjusted upon transition of a boundary or interface between adjacent regions of the heterogeneous medium” [subdivisions of a biological structure] “to account for differences in density and/or the associated particle mean free path length between the adjacent regions”.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the domains comprise subdivisions of a biological structure” as conceptually seen from the teaching of Nizin, into that of Patent No. 11,213,699 because this modification of obtaining dividing up the domains for the advantageous purpose of generating a treatment plan that is representative of the patient’s specific structure by breaking down the model to show the different material types in the domain (Nizin, Para. 27). Further motivation to combine be that Patent No. 11,213,699 and Nizin are analogous art to the current claim and are directed to simulating radiation particles for radiation therapy.
As per Claim 15, Patent No. 11,213,699 fails to distinctly point out “wherein one or more of the plurality of domains vary in one or more of shape, size, or arrangement to represent corresponding biological features of the object of interest”.
However, Nizin teaches the method of Claim 15, “wherein one or more of the plurality of domains vary in one or more of shape, size, or arrangement to represent corresponding biological features of the object of interest”. (Para. 62, “z is a variable representing the depth in the phantom”. Para. 64, “The attenuation coefficient μi within each step length zi is calculated using the photon mean free path, which is a function of the photon energy and the average material density within zi. A fixed step length of zi 0.l cm that is smaller than the resolution of a typical patient CT scan has been chosen for the illustration. This step size should be adjusted for different applications” [depth of the domain of the phantom can be adjusted (e.g., vary in one or more of shape or size or to represent corresponding biological features of the object of interest)].)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein one or more of the plurality of domains vary in one or more of shape, size, or arrangement to represent corresponding biological features of the object of interest” as conceptually seen from the teaching of Nizin, into that of Patent No. 11,213,699 because this modification of altering the domains for the advantageous purpose of generating a treatment plan that is representative of the patient’s specific structure (Nizin, Para. 27). Further motivation to combine be that Patent No. 11,213,699 and Nizin are analogous art to the current claim and are directed to simulating radiation particles for radiation therapy.
As per Claim 19, Patent No. 11,213,699 fails to distinctly point out “wherein determining the analytical function comprises determining the analytical function based on fitting the one or more of the plurality of distributions to the analytical function”.
However, Nizin teaches the method of Claim 19, “wherein determining the analytical function comprises determining the analytical function based on fitting the one or more of the plurality of distributions to the analytical function”. (Para. 15, “In a first collisions method, the time-consuming simulations of the primary photon interactions can be replaced with the analytically calculated collision density” [based on fitting the one or more of the plurality of distributions]. “This technique depends on the accuracy of pre-calculated attenuation rate of primary photons tissue” [determining an analytical function].)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein determining the analytical function comprises determining the analytical function based on fitting the one or more of the plurality of distributions to the analytical function” as conceptually seen from the teaching of Nizin, into that of Patent No. 11,213,699 because this modification of basing the function on a distribution for the advantageous purpose of generating a treatment plan and simulating the model in an efficient and variance-reducing manner (Nizin, Para. 59). Further motivation to combine be that Patent No. 11,213,699 and Nizin are analogous art to the current claim and are directed to simulating radiation particles for radiation therapy.
As per Claim 20, Patent No. 11,213,699 fails to distinctly point out “wherein the plurality of domains of the volumetric data indicate a shape of one or more of a cell, a nucleus of a cell, or a tissue of the object of interest”.
However, Nizin teaches the method of Claim 20, “wherein the plurality of domains of the volumetric data indicate a shape of one or more of a cell, a nucleus of a cell, or a tissue of the object of interest”. (Para. 58, “the simulated dose calculation computer 61 having simulated dose calculation program product 71, simulation data administrator server 51, and interactive database 53 are readily applicable to other areas which deal with particle transport through an absorbing medium including but not exclusively: nuclear reactor design and radiation shielding; x-ray imaging simulations involving low energy (KeV) photons hence large attenuations in tissue” [the plurality of domains of the volumetric data indicate a shape of a tissue of the object of interest].)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the plurality of domains of the volumetric data indicate a shape of one or more of a cell, a nucleus of a cell, or a tissue of the object of interest” as conceptually seen from the teaching of Nizin, into that of Patent No. 11,213,699 because this modification of obtaining the shape of the patient’s tissue for the advantageous purpose of generating a treatment plan that is representative of the patient’s specific structure (Nizin, Para. 55).Further motivation to combine be that Patent No. 11,213,699 and Nizin are analogous art to the current claim and are directed to simulating radiation particles for radiation therapy.
As per Claim 21, Patent No. 11,213,699 fails to distinctly point out “wherein the plurality of domains of the volumetric data indicate an arrangement of one or more of a cell, a nucleus of a cell, or a tissue within the object of interest”.
However, Nizin teaches the method of Claim 21, “wherein the plurality of domains of the volumetric data indicate an arrangement of one or more of a cell, a nucleus of a cell, or a tissue within the object of interest”. (Para. 58, “the simulated dose calculation computer 61 having simulated dose calculation program product 71, simulation data administrator server 51, and interactive database 53 are readily applicable to other areas which deal with particle transport through an absorbing medium including but not exclusively: nuclear reactor design and radiation shielding; x-ray imaging simulations involving low energy (KeV) photons hence large attenuations in tissue” [the plurality of domains of the volumetric data indicate an arrangement of a tissue within the object of interest].)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the plurality of domains of the volumetric data indicate an arrangement of one or more of a cell, a nucleus of a cell, or a tissue within the object of interest” as conceptually seen from the teaching of Nizin, into that of Patent No. 11,213,699 because this modification of arranging the tissue of the patient for the advantageous purpose of generating a treatment plan that is representative of the patient’s specific structure (Nizin, Para. 55). Further motivation to combine be that Patent No. 11,213,699 and Nizin are analogous art to the current claim and are directed to simulating radiation particles for radiation therapy.
Claim Rejections - 35 USC § 101
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.
Claims 1-6, 8-15, 18-21, and 45-46 are rejected under 35 USC § 101 because the claimed invention is directed to judicial exception, an abstract idea, it has not been integrated into practical application and the claims further do not recite significantly more than the judicial exception. Examiner has evaluated the claims under the framework provided in the 2019 Patent Eligibility Guidance published in the Federal Register 01/07/2019 and has provided such analysis below.
Step 1:
Claims 1-6, 8-15, and 18-21, are directed to a method and fall within the statutory category of a process; Claims 45 is directed to a system and falls within the statutory category of a machine; and Claims 46 is directed to system and falls within the statutory category of a machine. Therefore, “Are the claims to a process, machine, manufacture or composition of matter?” Yes.
In order to evaluate the Step 2A inquiry “Is the claim directed to a law of nature, a natural phenomenon or an abstract idea?” we must determine, at Step 2A Prong 1, whether the claim recites a law of nature, a natural phenomenon or an abstract idea and further whether the claim recites additional elements that integrate the judicial exception into a practical application.
Step 2A Prong 1:
Claims 1, 45, and 46: The limitations of “determining volumetric data associated with an object of interest, wherein the volumetric data comprise a plurality of domains” and “determining an analytical function based on one or more of the plurality of distributions”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper parameters for a model for a plurality of cells associated with specified object such as the length of the segment, object/segment shape, and material properties of the segment and can mentally determine or draw with pen and paper a relationship or algorithm based on the results on the energy imparted by a particle beam on the different cells.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Furthermore, Regarding Claims 1, 45, and 46: The limitation of “determining, for each of the plurality of domains, a plurality of distributions for characterizing interactions of particles of a particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution indicative of energy imparted in a corresponding domain due to a particle traveling in the domain” and “determining, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain”, as drafted, is an operation that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation of mathematical evaluations. For example, calculating the energy imparted on a cell by a particle beam traveling through a cell can be conducted using Kellerer’s equation (see Para. 52 and Fig. 1D) for the different domains, and calculating the energy imparted on a cell by a particle beam traveling through the cell can be conducted for a specific cell using an algorithm based on the results on the energy imparted by a particle beam on the different cells (see Para. 58-61 and 86-89).
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation of mathematic operation but for the recitation of generic computer components, then it falls within the “Mathematical Operation” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Therefore, yes, Claims 1, 45, and 46 recite judicial exceptions. The claims have been identified to recite judicial exceptions, Step 2A Prong 2 will evaluate whether the claims are directed to the judicial exception.
Step 2A Prong 2:
Claims 1, 45, and 46: The judicial exception is not integrated into a practical application. In particular, the claims recite the following additional elements: “A device comprising: one or more processors; and memory storing instructions that, when executed by the one or more processors” and “A system comprising: a particle beam generator; and at least one processor communicatively coupled to the particle beam generator” which is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) with the broad reasonable interpretation, which does not integrate a judicial exception into elements. Further, the following additional element “outputting, based on the first data, data associated with treatment of the object of interest by the particle beam”. which is merely a recitation of insignificant extra-solution data outputting activity (see MPEP § 2106.05(g)) which does not integrate a judicial exception into practical application. The insignificant extra-solution activities are further addressed below under step 2B as also being Well-Understood, Routine, and Conventional (WURC).
Therefore, “Do the claims recite additional elements that integrate the judicial exception into a practical application?” No, these additional elements do not integrate the abstract idea into a practical application and they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
After having evaluated the inquires set forth in Steps 2A Prong 1 and 2, it has been concluded that Claims 1, 45, and 46 not only recite a judicial exception but that the claims are directed to the judicial exception as the judicial exception has not been integrated into practical application.
Step 2B:
Claims 1, 45, and 46: The claims do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than generic computing components which do not amount to significantly more than the abstract idea. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”).
Therefore, “Do the claims recite additional elements that amount to significantly more than the judicial exception?” No, these additional elements, alone or in combination, do not amount to significantly more than the judicial exception. Having concluded the analysis within the provided framework, Claims 1, 45, and 46 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding Claim 2, it recites an additional element recitation of “wherein the data associated with treatment comprises one or more of (1) a three-dimensional distribution of dose or (2) a segment-averaged, restricted, dose averaged linear energy transfer for the particle beam, and further comprising adjusting a treatment plan based on one or more of the first data or the data associated with the treatment” which is merely an insignificant extra-solution data outputting activity (see MPEP § 2106.05(g))] which does not integrate a judicial exception into practical application. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”). Further, this claim does not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether the additional element amounts to significantly more, this claim also fails both Step 2A prong 2, thus this claim is directed to the judicial exception as it has not been integrated into practical application, and fails Step 2B as not amounting to significantly more. Therefore, Claim 2 does not recite patent eligible subject matter under 35 U.S.C. §101.
Regarding Claim 3, it recites an additional element recitation of “wherein the first data comprises one or more of a linear energy transfer imparted by the particle beam to the corresponding domain or a dose imparted by the particle beam to the corresponding domain” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation of mathematical evaluations. For example, calculating the linear energy transfer imparted on a cell by a particle beam traveling through the cell can be conducted using an algorithm based on the results on the energy imparted by a particle beam on the different cell for a specific cell (see Para. 58-61).
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation of mathematic evaluations but for the recitation of generic computer components, then it falls within the “Mathematical Operation” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 4, it recites an additional element recitation of “wherein the particle beam comprises a beam of one or more of protons, neutrons, positive ions, electrons, or alpha particles” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation of mathematical evaluations. For example, calculating the energy imparted on a domain by a particle beam of protons traveling through the cell can be conducted using Kellerer’s equation (see Para. 52 and Fig. 1D) for the different cell.)
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation of mathematic evaluations but for the recitation of generic computer components, then it falls within the “Mathematical Operation” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 5, it recites an additional element recitation of “wherein determining the plurality of distributions comprises using one or more simulations to generate the plurality of distributions” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation of mathematical evaluations. For example, calculating the interactions of a particle beam traveling through a cell can be conducted using Kellerer’s equation (see Para. 52 and Fig. 1D) and Monte Carlo simulations for the different domains (see Para. 57, the Monte Carlo simulation equations can be found at Ripley, Brian D. Stochastic simulation. John Wiley & Sons, 2009).)
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation of mathematic evaluations but for the recitation of generic computer components, then it falls within the “Mathematical Operation” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 6, it recites an additional element recitation of “wherein the plurality of distributions comprises a second distribution indicative of segment length of a particle path in the domain and a third distribution indicative of energy imparted in the domain due to a collision of a particle, wherein the segment length comprises a distance a particle of the particle beam is predicted to travel after entering the domain before coming to rest” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation of mathematical evaluations. For example, calculating the distance a particle of the particle beam travels through a cell can be conducted by the linear difference of the path of the particle (i.e., the stop position minus the start position) (see Para. 69). Additionally, calculating the energy imparted on a cell due to a collision of a particle can be conducted using the relationship between mass and energy (see Para. 82).)
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation of mathematic evaluations but for the recitation of generic computer components, then it falls within the “Mathematical Operation” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 8, it recites an additional element recitation of “determining, for a particle energy of the particle beam and based on the plurality of distributions, an energetic kernel, wherein the energetic kernel comprises a first average of at least one of the plurality of distributions and a first variance of the at least one of the plurality of distributions” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation of mathematical evaluations. For example, calculating an average and variance energy distributions of a particle beam traveling through a cell can be conducted by an integral of the product of the input (e.g., average or variance) and the energy fluence over the particle energy imparted (see Para. 59 and 81).)
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation of mathematic evaluations but for the recitation of generic computer components, then it falls within the “Mathematical Operation” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 9, it recites an additional element recitation of “performing a first convolution of an energy fluence of the particle beam with the first average and a performing a second convolution of the energy fluence of the particle beam with the first variance, wherein the first data is determined based on a result of the first convolution and the second convolution” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation of mathematical evaluations. For example, calculating a first convolution of the energy fluence of the particle beam can by conducted by an integral of the energy influence with the average energy distribution, and calculating a second convolution of the energy fluence of the particle beam can by conducted by an integral of the energy influence with the total energy distribution to obtain the variance (see Para. 81).)
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation of mathematic evaluations but for the recitation of generic computer components, then it falls within the “Mathematical Operation” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 10, it recites an additional element recitation of “wherein the data associated with treatment plan is based on a model that accounts for one or more of variations of linear energy transfer in a domain, variations of dose in a domain, variations of segment length of paths of particles entering a domain, variations of whether particles come to rest in a domain, variations in a number of collisions of a particle in a domain, or variations in an amount of energy imparted in a collision of a particle in a domain” which is merely an insignificant extra-solution data outputting activity (see MPEP § 2106.05(g))] which does not integrate a judicial exception into practical application. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”). Further, this claim does not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether the additional element amounts to significantly more, this claim also fails both Step 2A prong 2, thus this claim is directed to the judicial exception as it has not been integrated into practical application, and fails Step 2B as not amounting to significantly more. Therefore, claim 10 does not recite patent eligible subject matter under 35 U.S.C. §101.
Regarding Claim 11, it recites an additional element recitation of “wherein the volumetric data comprises one or more of geometric data associated with the object of interest, data comprising a plurality of voxels, data associated with a cell of the object of interest, data associated with a tissue of the object of interest, or data associated with a macroscopic structure of the object of interest”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper parameters for a model for a specified object such as object’s shape and material properties.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 12, it recites an additional element recitation of “wherein the volumetric data comprises one or more of a geometrical model or a spatial distribution indicative of the object of interest”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper parameters for a model for a specified object such as with object’s geometric properties.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 13, it recites an additional element recitation of “wherein the volumetric data is generated based on imaging data associated with the object of interest”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper parameters for a model for a specified object by referencing an image of the specified object.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 14, it recites an additional element recitation of “wherein the domains comprise subdivisions of a biological structure”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper parameters for a model for the cells of a specified object by dividing the cells into sub-cells.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 15, it recites an additional element recitation of “wherein one or more of the plurality of domains vary in one or more of shape, size, or arrangement to represent corresponding biological features of the object of interest”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper parameters for a model for the cells of a specified object having different shapes and sizes.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 18, it recites an additional element recitation of “wherein determining the analytical function comprises determining the analytical function based on the first distribution”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper a relationship or algorithm based on the results on the energy imparted by a particle beam on the different cells.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 19, it recites an additional element recitation of “wherein determining the analytical function comprises determining the analytical function based on fitting the one or more of the plurality of distributions to the analytical function”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper a relationship or algorithm to best fit on the results on the energy imparted by a particle beam on the different cells.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 20, it recites an additional element recitation of “wherein the plurality of domains of the volumetric data indicate a shape of one or more of a cell, a nucleus of a cell, or a tissue of the object of interest”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper parameters for a model for the cells of a specified object having a certain shape based on the specified object.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding Claim 21, it recites an additional element recitation of “wherein the plurality of domains of the volumetric data indicate an arrangement of one or more of a cell, a nucleus of a cell, or a tissue within the object of interest”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper parameters for a model for the cells of a specified object having a certain arrangement based on the specified object.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Therefore, having concluded the analysis within the provided framework, Claims 1-6, 8-15, 18-21, and 45-46 do not recite patent eligible subject matter and are rejected under 35 USC § 101 because the claimed invention is directed to judicial exception, an abstract idea, that has not been integrated into a practical application. The claims further do not recite significantly more than the judicial exception. Claims 2-6, 8-15, and 18-21 are also rejected for incorporating the deficiency of their independent Claim 1.
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)(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 1-6, 8, 10-15, 18-21, and 45-46 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2006/0285640 A1, Nizin et al. [herein “Nizin”].
As per Claim 1, Nizin teaches “A method comprising: determining volumetric data associated with an object of interest, wherein the volumetric data comprise a plurality of domains”, (Para. 26, “Embodiments of the present invention also include methods of increasing efficiency in a simulation of particle transport through a medium.” Para. 55, “an image gathering device 41, e.g., computed tomography (CT) scanner or other imaging device known to those skilled in the art, accessible to a communication network 43 to provide stacks of two-dimensional image slices or a three-dimensional image” [determining volumetric data] “of a tumor target volume and an adjacent structure volume in a patient or phantom” [associated with an object of interest] “used to develop the treatment plan. The system 30 also includes a radiation beam source 45, e.g., linear accelerator or other delivery device known to those skilled in the art, to deliver radiation to the tumor target according to the radiation treatment plan.” Para. 32, “Further, advantageously such systems, program product, and methods can also be incorporated in nuclear engineering and radiation safety, medical imaging, radiation therapy, and other applications involved with particles or radiation traversing various media” [a plurality of domains]. The examiner has interpreted that a method of providing stacks of two-dimensional image slices or a three-dimensional image of a patient’s tumor target volume and an adjacent structure volume for simulation of particles traversing through various media as a method comprising determining volumetric data associated with an object of interest, wherein the volumetric data comprise a plurality of domains.)
“determining, for each of the plurality of domains, a plurality of distributions for characterizing interactions of particles of a particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution indicative of energy imparted in a corresponding domain due to a particle traveling in the domain”, (Para. 32, “Further, advantageously such systems, program product, and methods can also be incorporated in nuclear engineering and radiation safety, medical imaging, radiation therapy, and other applications involved with particles or radiation traversing various media” [a plurality of domains]. Para. 63, “Once the delivery simulation is initiated (block 103), each photon from the radiation beam source 45 is labeled as a primary photon (block 105). Each photon is transported and tracked through the medium (block 107), e.g., patient or phantom, until each photon, if at all, is deemed to encounter a collision event, e.g., Compton scattering, pair production, photo-electric effect, or coherent scattering” [interactions of particles of a particle beam with the corresponding domain]. Para. 63, “When such a collision event, e.g., scattering event is deemed to happen (block 109), the interaction database 53 can be used to describe the effect of the collision event (block 111)” [a distribution for characterizing interactions]. “Referring to scattering for illustrative purposes, energy deposited from the scattering event is recorded (block 113)” [a first distribution indicative of energy imparted in a corresponding domain due to a particle traveling in the domain]. Para. 63, “the scattered photons will not be restored in further scattering events” [plurality of distributions]. The examiner has interpreted that tracking photons traversing through various media, identifying a number of different collision events, and recording the energy depositing from the collision event (e.g., scatting) as determining, for each of the plurality of domains, a plurality of distributions for characterizing interactions of particles of a particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution indicative of energy imparted in a corresponding domain due to a particle traveling in the domain.)
“determining an analytical function based on one or more of the plurality of distributions”, (Para. 15, “In a first collisions method, the time-consuming simulations of the primary photon interactions” [based on a plurality of distributions] “can be replaced with the analytically calculated collision density. This technique depends on the accuracy of pre-calculated attenuation rate of primary photons tissue” [determining an analytical function]. The examiner has interpreted that calculated the collision density of primary phonon interactions with the pre-calculated attenuation rate of primary photons tissue as determining an analytical function based on one or more of the plurality of distributions.)
“determining, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain”, (Para. 59, “In general, an incident particle, e.g., photon for illustration, passing through the medium may interact, and thus be absorbed or scattered resulting in an exponential attenuation in primary photon flux with the depth z” [determining first data comprising energy imparted by the particle beam to the corresponding domain]. Para. 81, “retrieving data on the colliding particle and each secondary particle resulting from each collision event, and recording energy deposited from each collision event” [first data comprising energy imparted by the particle beam to the corresponding domain]. Para. 59, “As the primary photon flux attenuates, statistical uncertainty of absorbed dose increases with z as (Nz)-1/2, where Nz = N0 exp(-μz) is the number of photons available at depth z, N0 is the number of initial number of photons, and μ is the linear attenuation coefficient for primary radiation” [based on the analytical function]. Para. 63, “According to embodiments of the simulated dose calculation program product 71 implemented in a Monte Carlo simulation of radiation dose deliverable according to a radiation treatment plan, in order to produce the simulation, the tumor target volume and adjacent structure volume is first modeled to define the absorbing medium (block 101)” [for each of the plurality of domains]. The examiner has interpreted that calculating the exponential attenuation in primary photon flux with the depth and the linear attenuation coefficient as a photon passes through the tumor target volume and adjacent structure volume with its energy that is absorbed being recorded as determining, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain.)
“outputting, based on the first data, data associated with treatment of the object of interest by the particle beam”. (Para. 55, “The system 30 also includes a radiation beam source” [particle beam]. Para. 56, “the simulated dose calculation computer 61 includes memory 63 and at least one but preferably a plurality of processors 65 coupled to the memory 63 forming a computer array to calculate a simulated absorbed dose in the absorbing medium deliverable according to the radiation treatment plan” [based on the first data]. Para. 64, “Upon completion of the transport portion of the simulation, a three-dimensional map of simulated absorbed dose delivered to the phantom or patient can be displayed to a user (block 123)” [outing the data associated with treatment of the object of interest]. The examiner has interpreted that displaying a three-dimensional map of simulated absorbed dose in the absorbing medium delivered to the patient as outputting, based on the first data, data associated with treatment of the object of interest by the particle beam.)
As per Claim 2, Nizin teaches “wherein the data associated with treatment comprises one or more of (1) a three-dimensional distribution of dose or (2) a segment-averaged, restricted, dose averaged linear energy transfer for the particle beam, and further comprising adjusting a treatment plan based on one or more of the first data or the data associated with the treatment”. (Para. 64, “Upon completion of the transport portion of the simulation, a three-dimensional map of simulated absorbed dose delivered to the phantom or patient can be displayed to a user (block 123)” [data associated with treatment comprises one or more of a three-dimensional distribution of dose]. Para. 23, “the system can include an image gathering device, e.g., CT scanner, accessible to a communication network to provide an at least two-dimensional image slice of a tumor target volume and an adjacent structure volume in a patient, a radiation beam source to deliver radiation to the tumor target according to a radiation treatment plan, and a radiation treatment planning computer in communication with the image gathering device and having memory, a processor coupled to the memory, and radiation treatment planning program product stored in the memory adapted to produce an optimized radiation treatment plan for delivering radiation to the tumor target volume” [adjusting a treatment plan]. Para. 64, “The attenuation coefficient μi within each step length zi is calculated using the photon mean free path,” [first data] “which is a function of the photon energy and the average material density within zi. A fixed step length of zi = 0.1 cm that is smaller than the resolution of a typical patient CT scan has been chosen for the illustration. This step size should be adjusted for different applications. Following the weight factor Wh assigned to the newly restored virtual photon, the offspring particles and hence their dose contributions, can be provided the same weight factor Wh (block 121). If the restored virtual photon is scattered again, it is further restored with the new weight factor Wh, but having parameters associated with the new temporal and spatial location. Upon completion of the transport portion of the simulation,” [e.g., using first data] “a three-dimensional map of simulated absorbed dose delivered to the phantom or patient can be displayed to a user (block 123)” [e.g., for the updated treatment plan]. The examiner has interpreted that delivering a three-dimensional map of simulated absorbed dose of the transport portion of the simulation where the attenuation coefficient within each step length is calculated using the photon mean free path as wherein the data associated with treatment comprises one or more of (1) a three-dimensional distribution of dose or (2) a segment-averaged, restricted, dose averaged linear energy transfer for the particle beam, and further comprising adjusting a treatment plan based on one or more of the first data or the data associated with the treatment.)
As per Claim 3, Nizin teaches “wherein the first data comprises one or more of a linear energy transfer imparted by the particle beam to the corresponding domain or a dose imparted by the particle beam to the corresponding domain”. (Para. 63, “According to embodiments of the simulated dose calculation program product 71 implemented in a Monte Carlo simulation of radiation dose deliverable according to a radiation treatment plan, in order to produce the simulation, the tumor target volume and adjacent structure volume is first modeled to define the absorbing medium (block 101). Once the delivery simulation is initiated (block 103), each photon from the radiation beam source 45” [by the particle beam] “is labeled as a primary photon (block 105). Each photon is transported and tracked through the medium (block 107)” [the corresponding domain]. Para. 63, “When such a collision event, e.g., scattering event is deemed to happen (block 109), the interaction database 53 can be used to describe the effect of the collision event (block 111). Referring to scattering for illustrative purposes, energy deposited from the scattering event is recorded (block 113)” [imparted by the beam]. Para. 64, “The attenuation coefficient μi within each step length zi is calculated using the photon mean free path, which is a function of the photon energy and the average material density within zi” [first data]. The examiner has interpreted that calculating the attenuation coefficient within each step length using the photon mean free path for a radiation dose that travels through a medium and deposits energy due to a scattering event as wherein the first data comprises one or more of a linear energy transfer imparted by the particle beam to the corresponding domain or a dose imparted by the particle beam to the corresponding domain.)
As per Claim 4, Nizin teaches “wherein the particle beam comprises a beam of one or more of protons, neutrons, positive ions, electrons, or alpha particles”. (Para. 55, “The system 30 also includes a radiation beam source 45, e.g., linear accelerator or other delivery device known to those skilled in the art, to deliver radiation to the tumor target according to the radiation treatment plan. The radiation can be in the form of photons, neutrons, electrons, protons, or other particles”. The examiner has interpreted that a radiation beam in the form of photons, neutrons, electrons, protons, or other particles as wherein the particle beam comprises a beam of one or more of protons, neutrons, positive ions, electrons, or alpha particles.)
As per Claim 5, Nizin teaches “wherein determining the plurality of distributions comprises using one or more simulations to generate the plurality of distributions”. (Para. 63, “According to embodiments of the simulated dose calculation program product 71 implemented in a Monte Carlo simulation of radiation dose” [using one or more simulations]. Para. 63, “Referring to scattering for illustrative purposes, energy deposited from the scattering event is recorded (block 113)” [distribution]. Para. 63, “the scattered photons will not be restored in further scattering events” [plurality of distributions]. The examiner has interpreted that recording the energy deposited from the scattering events through the implementation of Monte Carlo simulation as wherein determining the plurality of distributions comprises using one or more simulations to generate the plurality of distributions.)
As per Claim 6, Nizin teaches “wherein the plurality of distributions comprises a second distribution indicative of segment length of a particle path in the domain and a third distribution indicative of energy imparted in the domain due to a collision of a particle, wherein the segment length comprises a distance a particle of the particle beam is predicted to travel after entering the domain before coming to rest”. (Para. 64, “Each restored virtual photon can inherit or otherwise be provided the properties from the respective previous primary photon (block 117), except that it is assigned a new weight factor: Wh= Wh-1 exp(-R), where Wh-1 is the weight factor of the photon before the scattering event, and R is the radiological path length between the current location and the previous location” [a second distribution indicative of segment length of a particle path in the domain]. Para. 64, “Following the weight factor Wh assigned to the newly restored virtual photon, the offspring particles and hence their dose contributions, can be provided the same weight factor Wh (block 121). If the restored virtual photon is scattered again, it is further restored with the new weight factor Wh, but having parameters associated with the new temporal and spatial location. Upon completion of the transport portion of the simulation,” [e.g., once the particle has stopped traveling (i.e., a distance a particle of the particle beam is predicted to travel after entering the domain before coming to rest)] “a three-dimensional map of simulated absorbed dose delivered to the phantom or patient can be displayed to a user (block 123).” Para. 66, “For example, according to an embodiment of the simulated dose calculation program product 71, rather than restore scattered primary photons at a ratio of one-to-one, when a collision occurs in a second medium type of the heterogeneous medium, an average number of photons are instead restored according to a scaling factor approximately equaling a ratio approximately equal to a second density p2 of a second medium type of the heterogeneous medium to a first density pl of a first medium type and/or a ratio of a first photon mean free path to a second photon mean free path associated with the different medium types” [third distribution indicative of energy imparted in the domain due to a collision of a particle]. The examiner has interpret that the radiological path length between the current location and the previous location of the simulation until the transportation of the particle has completed in addition to restoring the number of photons based on the density of photons when the collision occurs in a medium as wherein the plurality of distributions comprises a second distribution indicative of segment length of a particle path in the domain and a third distribution indicative of energy imparted in the domain due to a collision of a particle, wherein the segment length comprises a distance a particle of the particle beam is predicted to travel after entering the domain before coming to rest.)
As per Claim 8, Nizin teaches “determining, for a particle energy of the particle beam and based on the plurality of distributions, an energetic kernel, wherein the energetic kernel comprises a first average of at least one of the plurality of distributions and a first variance of the at least one of the plurality of distributions”. (Para. 69, “As illustrated, NVR can beneficially maintain a constant primary photon fluence throughout the phantom with a slight modification from that used with respect to a purely heterogeneous medium. Because the photon mean free path is larger in the lung, for example, there are fewer scattering events per unit volume; hence the variance increases in the lung” [a first variance of the at least one of the plurality of distributions]. Para. 75, “That is, according to a first configuration, when a photon travels from a material with a density p1 to another material with a density p2” [distribution], “and if p2<p1, instead of restoring one particle, e.g., photon, as in the original NVR, described and illustrated above, p/p2 photons are instead restored on average” [a first average of at least one of the plurality of distributions]. The examiner had interpreted that calculating scattering events per unit volume to obtain variance and averaging the restored photons from collisions as determining, for a particle energy of the particle beam and based on the plurality of distributions, an energetic kernel, wherein the energetic kernel comprises a first average of at least one of the plurality of distributions and a first variance of the at least one of the plurality of distribution.)
As per Claim 10, “wherein the data associated with treatment plan is based on a model that accounts for one or more of variations of linear energy transfer in a domain, variations of dose in a domain, variations of segment length of paths of particles entering a domain, variations of whether particles come to rest in a domain, variations in a number of collisions of a particle in a domain, or variations in an amount of energy imparted in a collision of a particle in a domain”. (Para. 64, “Upon completion of the transport portion of the simulation, a three-dimensional map of simulated absorbed dose delivered to the phantom or patient can be displayed to a user (block 123)” [data associated with treatment plan]. Para. 66, “Note that variations in restoration ratio can be incorporated in the process to account for differences between homogeneous and heterogeneous media. That is, when performing a simulation on a heterogeneous medium, the average number of new virtual particles created as a result of collision events throughout the medium can be adjusted for each collision event according to a ratio proportional to variations between, for example, density or particle mean free path of adjacent medium types” [based on a model that accounts for variations of segment length of paths of particles entering a domain]. The examiner has interpreted that the three-dimensional map of simulated absorbed dose that adjusts to account for the variations in the particle mean free path as wherein the data associated with treatment plan is based on a model that accounts for one or more of variations of linear energy transfer in a domain, variations of dose in a domain, variations of segment length of paths of particles entering a domain, variations of whether particles come to rest in a domain, variations in a number of collisions of a particle in a domain, or variations in an amount of energy imparted in a collision of a particle in a domain.)
As per Claim 11, Nizin teaches “wherein the volumetric data comprises one or more of geometric data associated with the object of interest, data comprising a plurality of voxels, data associated with a cell of the object of interest, data associated with a tissue of the object of interest, or data associated with a macroscopic structure of the object of interest”. (Para. 55, “an image gathering device 41, e.g., computed tomography (CT) scanner or other imaging device known to those skilled in the art, accessible to a communication network 43 to provide stacks of two-dimensional image slices or a three-dimensional image” [volumetric data] “of a tumor target volume and an adjacent structure volume in a patient or phantom” [object of interest] “used to develop the treatment plan.” Para. 69, “Similarly, FIG. 8 shows that NVR is unbiased in the case of a 6 MV X-ray beam with a field size of 7 cmx7 cm in a heterogeneous phantom of layered geometry,” [geometric data associated with the object of interest]. The examiner has interpreted that heterogeneous phantom of layered geometry of the two-dimensional image slices or a three-dimensional image as wherein the volumetric data comprises one or more of geometric data associated with the object of interest, data comprising a plurality of voxels, data associated with a cell of the object of interest, data associated with a tissue of the object of interest, or data associated with a macroscopic structure of the object of interest.)
As per Claim 12, Nizin teaches “wherein the volumetric data comprises one or more of a geometrical model or a spatial distribution indicative of the object of interest”. (Para. 55, “an image gathering device 41, e.g., computed tomography (CT) scanner or other imaging device known to those skilled in the art, accessible to a communication network 43 to provide stacks of two-dimensional image slices or a three-dimensional image tumor target volume and an adjacent structure volume in a patient or phantom” [geometrical model of the object of interest] “used to develop the treatment plan.” Para. 24, “The simulated dose calculation program product can include instructions that, when executed by at least one of the plurality of processors, can perform the operation of modeling the tumor target volume and adjacent structure volume to define the absorbing medium” [model of the object of interest]. The examiner has interpreted that providing stacks of two-dimensional image slices or a three-dimensional image of a patient’s tumor target volume and an adjacent structure volume for modeling as wherein the volumetric data comprises one or more of a geometrical model or a spatial distribution indicative of the object of interest.)
As per Claim 13, Nizin teaches “wherein the volumetric data is generated based on imaging data associated with the object of interest”. (Para. 55, “an image gathering device 41, e.g., computed tomography (CT) scanner or other imaging device known to those skilled in the art, accessible to a communication network 43 to provide stacks of two-dimensional image slices or a three-dimensional image of a tumor target volume and an adjacent structure volume in a patient or phantom used to develop the treatment plan.” The examiner has interpreted that providing a stacks of two-dimensional image slices or a three-dimensional image of a tumor target volume and an adjacent structure volume in a patient or phantom through an imaging gathering device as wherein the volumetric data is generated based on imaging data associated with the object of interest.)
As per Claim 14, Nizin teaches “wherein the domains comprise subdivisions of a biological structure”. (Para. 66, “the number of particles being tracked can instead be adjusted upon transition of a boundary or interface between adjacent regions of the heterogeneous medium to account for differences in density and/or the associated particle mean free path length between the adjacent regions”. The examiner has interpreted that a heterogeneous medium which contains adjacent regions as wherein the domains comprise subdivisions of a biological structure.)
As per Claim 15, Nizin teaches “wherein one or more of the plurality of domains vary in one or more of shape, size, or arrangement to represent corresponding biological features of the object of interest”. (Para. 62, “z is a variable representing the depth in the phantom”. Para. 64, “The attenuation coefficient μi within each step length zi is calculated using the photon mean free path, which is a function of the photon energy and the average material density within zi. A fixed step length of zi 0.l cm that is smaller than the resolution of a typical patient CT scan has been chosen for the illustration. This step size should be adjusted for different applications” [depth of the domain of the phantom can be adjusted (e.g., vary in one or more of shape or size or to represent corresponding biological features of the object of interest)]. The examiner has interpreted that adjusting the step size of the depth in the phantom (e.g., domain of the phantom) as wherein one or more of the plurality of domains vary in one or more of shape, size, or arrangement to represent corresponding biological features of the object of interest.)
As per Claim 18, Nizin teaches “wherein determining the analytical function comprises determining the analytical function based on the first distribution”. (Para. 15, “In a first collisions method, the time-consuming simulations of the primary photon interactions can be replaced with the analytically calculated collision density” [based on the first distribution]. “This technique depends on the accuracy of pre-calculated attenuation rate of primary photons tissue”. [determining an analytical function]. The examiner has interpreted that calculated the collision density of primary phonon interactions as wherein determining the analytical function comprises determining the analytical function based on the first distribution.)
As per Claim 19, Nizin teaches “wherein determining the analytical function comprises determining the analytical function based on fitting the one or more of the plurality of distributions to the analytical function”. (Para. 15, “In a first collisions method, the time-consuming simulations of the primary photon interactions can be replaced with the analytically calculated collision density” [based on fitting the one or more of the plurality of distributions] “This technique depends on the accuracy of pre-calculated attenuation rate of primary photons tissue” [determining an analytical function]. The examiner has interpreted that calculated the collision density of primary phonon interactions as wherein determining the analytical function comprises determining the analytical function based on fitting the one or more of the plurality of distributions to the analytical function.)
As per Claim 20, Nizin teaches, “wherein the plurality of domains of the volumetric data indicate a shape of one or more of a cell, a nucleus of a cell, or a tissue of the object of interest”. (Para. 58, “the simulated dose calculation computer 61 having simulated dose calculation program product 71, simulation data administrator server 51, and interactive database 53 are readily applicable to other areas which deal with particle transport through an absorbing medium including but not exclusively: nuclear reactor design and radiation shielding; x-ray imaging simulations involving low energy (KeV) photons hence large attenuations in tissue”. The examiner has interpreted that modeling and simulating a particle that transports through an absorbing medium with large attenuations in tissue as wherein the plurality of domains of the volumetric data indicate a shape of one or more of a cell, a nucleus of a cell, or a tissue of the object of interest.)
As per Claim 21, Nizin teaches “wherein the plurality of domains of the volumetric data indicate an arrangement of one or more of a cell, a nucleus of a cell, or a tissue within the object of interest”. (Para. 58, “the simulated dose calculation computer 61 having simulated dose calculation program product 71, simulation data administrator server 51, and interactive database 53 are readily applicable to other areas which deal with particle transport through an absorbing medium including but not exclusively: nuclear reactor design and radiation shielding; x-ray imaging simulations involving low energy (KeV) photons hence large attenuations in tissue”. The examiner has interpreted that modeling and simulating a particle that transports through an absorbing medium with large attenuations in tissue as wherein the plurality of domains of the volumetric data indicate an arrangement of one or more of a cell, a nucleus of a cell, or a tissue within the object of interest.)
Re Claim 45, it is a system claim, having similar limitations of claim 1. Thus, claim 45 is also rejected under the similar rationale as cited in the rejection of claim 1.
Re Claim 46, it is a system claim, having similar limitations of claim 1. Thus, claim 45 is also rejected under the similar rationale as cited in the rejection of claim 1.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nizin in view of Lindborg, Lennart, et al. Microdosimetry: Experimental Methods and Applications. CRC Press, 2017 [herein “Lindborg”].
As per claim 9, Nizin does not specifically teach “performing a first convolution of an energy fluence of the particle beam with the first average and a performing a second convolution of the energy fluence of the particle beam with the first variance, wherein the first data is determined based on a result of the first convolution and the second convolution”.
However, in the same field of endeavor namely simulating radiation particles for radiation therapy, Lindborg teaches “performing a first convolution of an energy fluence of the particle beam with the first average and a performing a second convolution of the energy fluence of the particle beam with the first variance, wherein the first data is determined based on a result of the first convolution and the second convolution”. (Pg. 37, “This technique can also be used in calculations of y̅D at any specific point in a radiation field. It requires that the dose fraction for each of the different particles, dis, as well as their energy distributions, φi(E), and mass stopping power at a specific point in a radiation field are known. The dose fraction of the particle i is then given by” [Equation 2.55]. “If for each particle, i, and energy, E, y̅D,i is known at this is” [Equation 2.56]. Equation 2.56 shows the convolutional relation between the energy distribution, φi(E), and the dose-mean linear energy, y̅D.. Pg. 80, “The relative variance of a multi-event distribution,” [first variance] “decreases in proportion to the number of events (Equation 2.28 in Chapter 2). At a given fluence, φ,” [energy fluence] “the number of events is larger in the detector gas volume than in the microscopic tissue volume and this number is proportional to the cross sectional area of the volume (Equation 3.6). The relative variances observed in the detector and in the tissue volume are thus related as” [Equation 3.28]. Equation 3.28 shows the relation between the energy fluence and the variance. Pg. 81, “ln practice a measurement consists of repeated integrations of εi during equally long time intervals and from this series Vn, rel,det and εdet are calculated. Equation 2.27 in Chapter 2 is equivalent to” [Equation 3.30]. Equations 3.30-3.33 show the convolution of the fluent-dependent variance. The examiner had interpreted by integrating the dose-mean linear energy with the energy distribution in addition to integrating the variance with the energy distribution as performing a first convolution of an energy fluence of the particle beam with the first average and a performing a second convolution of the energy fluence of the particle beam with the first variance, wherein the first data is determined based on a result of the first convolution and the second convolution.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “performing a first convolution of an energy fluence of the particle beam with the first average and a performing a second convolution of the energy fluence of the particle beam with the first variance, wherein the first data is determined based on a result of the first convolution and the second convolution” as conceptually seen from the teaching of Lindborg, into that of Nizin because this modification of calculating convolutions of the energy fluence for the advantageous purpose of developing a radiation treatment that determines characterizing radiation quality of charged particles through simulation (Lindborg, Pg. 1, 22, & 40). Further motivation to combine be that Nizin and Lindborg are analogous art to the current claim and are directed to simulating radiation particles for radiation therapy.
Response to Arguments
Applicant's arguments filed on October 15, 2025 have been fully considered but they are not persuasive.
Applicant argues that the claims are patent eligible under 35 U.S.C. § 101 since the nonstatutory double patenting rejection on claims 1-6, 8-11, 18, 45-46 over claims 1-11 and 19 of U.S. Patent No. 11,213,699 in addition to the nonstatutory double patenting rejection on claims 12-15 and 19-21 over claim 1 of U.S. Patent No. 11,213,699 in view of US 2006/0285640 A1, Nizin et al. should be considered moot in regards to a terminal disclaimer over U.S. Patent No. 11,213,699 that has been filed (See Applicant’s response, Pg. 7).
The Applicant has stated in the remarks that a terminal disclaimer has been filed; however, no terminal disclaimer has been filed.
Therefore, for at least the reasons set forth in the Office Action mailed April 15, 2025 and replicated above in this Office Action, the claims are rejected on the ground(s) of nonstatutory double patenting.
Applicant argues that claim 1 features are patent eligible under 35 U.S.C. § 101 because the claims do not recite mental processes as they cannot be performed practically in the mind. (See Applicant’s response, Pg. 7-8).
MPEP § 2106.04(a)(2)(III)(A) recites “claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions”, “claims can recite a mental process even if they are claimed as being performed on a computer”, and “in evaluating whether a claim that requires a computer recites a mental process, examiners should carefully consider the broadest reasonable interpretation of the claim in light of the specification. For instance, examiners should review the specification to determine if the claimed invention is described as a concept that is performed in the human mind and applicant is merely claiming that concept performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept. In these situations, the claim is considered to recite a mental process.”
The examiner has provided the rational for the claim limitations that are being directed to a mental process in the rejection above. For example, the limitation of claim 1 “determining volumetric data associated with an object of interest, wherein the volumetric data comprise a plurality of domains” and “determining an analytical function based on one or more of the plurality of distributions”, can be conducted as person can mentally determining or drawing with pen and paper parameters for a model for a plurality of cells associated with specified object such as object’s shape and material properties and can mentally determine or draw with pen and paper a relationship or algorithm based on the results on the energy imparted by a particle beam on the different cell, respectively. For example, a person mentally take or draw with a pen and paper a 2-D object that has been segmented into a number of segments and designated the length of the segment, object/segment shape, and material properties of the segment as parameters for the model (see Para. 0050 and 0133, “An object of interest may be scanned and/or imaged to produce imaging data (e.g., or scanning data). The imaging data may be two-dimensional or three-dimensional. The imaging data may comprise a plurality of voxels (e.g., each voxel as a single unit of data). A single voxel may be subdivided into a plurality of domains (e.g., or sites). A domain (e.g., or site) may be a geometrically defined volume in a voxel” and “wherein the volumetric data comprises one or more of geometric data associated with the object of interest, data comprising a plurality of voxels, data associated with a cell of the object of interest, data associated with a tissue of the object of interest, or data associated with a macroscopic structure of the object of interest”), and a person can mentally determine or draw with pen and paper a relationship or algorithm between the energy impacted by a particle beam on the segments such as amount of energy loss as a function of number of segments traveled by the particle (see mathematical steps to determine an equation for this relationship Para. 0058-0061 and 0086-0089).
The examiner has properly identified that the claims recite a mental concept as provided in the rejection above is proper under the framework provided in the 2019 Patent Eligibility Guidance and MPEP § 2106.04(a)(2)(III)(C). The claims are directed to judicial exception, an abstract idea.
Applicant argues that the claim 1 features are patent eligible under 35 U.S.C. § 101 because the claims do not recite mathematical relations, formulas, or calculations (See Applicant’s response, Pg. 8-9).
MPEP 2106.04(a)(2)(I)(C) recites that a “claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the ‘mathematical concepts’ grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number”.
The examiner has provided the rational for the claim limitations that are being directed to a mathematical concept in the rejection above. For example, the claim 1 limitation “determining, for each of the plurality of domains, a plurality of distributions for characterizing interactions of particles of a particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution indicative of energy imparted in a corresponding domain due to a particle traveling in the domain”, involves calculating the energy imparted on a cell by a particle beam traveling through a cell through different segments of the cell or the average of the energy imparted on the cells, which is not only a known mathematical calculation, but the steps and formula have been provided in Para. 0052 specification and Fig. 1D (also see Para. 0058-0061 and 0086-0089) showing a known mathematical operation with the use of a known equation to determine a variable.
As such, this limitation would fall under a mathematical concept in step 2A Prong 1 of analysis above. The examiner has properly identified that the claims recite a mathematical concept as provided in the rejection above under the framework provided in the 2019 Patent Eligibility Guidance and MPEP 2106.04(a)(2)(I)(C). The claims are directed to judicial exception, an abstract idea.
Applicant argues that the claim 1 features are patent eligible under 35 U.S.C. § 101 because the features are not insignificant extra-solution or well-understood routine activities and since the examiner has not provided evidence that the claim features are well-understood, routine, or conventional in the art (See Applicant’s response, Pg. 9-10).
MPEP § 2106.05(d)(II) recites “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); … ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”. MPEP § 2106.05(g) recites “Whether the limitation amounts to necessary data gathering and outputting…Below are examples of activities that the courts have found to be insignificant extra-solution activity: … Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)”.
With regards to claim 1, the additional element of “outputting, based on the first data, data associated with treatment of the object of interest by the particle beam” has been interpreted as outputting data from the results of the analysis, i.e., outputting analysis data to a display or over the internet, which has been defined by MPEP § 2106.05(d)(II) and 2106.05(g) as an insignificant extra-solution activity that is well-understood, routine, or conventional. Therefore, this additional element is an insignificant extra-solution activity as defined and as such evidence is provide in MPEP § 2106.05(d)(II).
Therefore, the examiner has properly identified that the claims recite a feature that is well-understood,
routine, or conventional in the art and does not integrate the abstract idea into a practical application since the
feature is an insignificant extra-solution activity.
Applicant argues that reference does not teach each and every limitation in claim 1 because cited reference fails to teach “determining an analytical function based on one or more of the plurality of distributions” and “determining, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain” (See Applicant’s response, Pg. 10-12).
MPEP § 2143.03 that “All words in a claim must be considered in judging the patentability of that claim against the prior art” and “Examiners must consider all claim limitations when determining patentability of an invention over the prior art.”
As original mapped in the previous Office Action and above in this Office Action in claim 1, Nizin discloses “determining an analytical function based on one or more of the plurality of distributions” as calculating the collision density of primary phonon interactions with the pre-calculated attenuation rate of primary photons tissue. As seen in the mapping of the previous limitation of “determining, for each of the plurality of domains, a plurality of distributions for characterizing interactions of particles of a particle beam with the corresponding domain, wherein the plurality of distributions comprises a first distribution indicative of energy imparted in a corresponding domain due to a particle traveling in the domain”, Para. 63 discloses that tracked photos that are deemed to encounter a collision event cause energy deposited from the event, which has been mapped to the first distribution as claimed. Therefore, in light of this, the analytic function, which is the calculated attenuation rate of primary photons tissues for calculating the collision density of primary phonon interactions, is based on one or more of the plurality of distributions. Nizin also discloses “determining, based on the analytical function and for each of the plurality of domains, first data comprising energy imparted by the particle beam to the corresponding domain” as calculating the exponential attenuation in primary photon flux with the depth and the linear attenuation coefficient as a photon passes through the tumor target volume and adjacent structure volume with its energy that is absorbed being recorded. The examiner would like to emphasize that the number of photos available being a function of the attenuation of photon, the analytical function, as a result of the particle being absorbed or scatting and this data is retrieved, e.g., first data. Additional emphasis and further clarification has been added to this mapping in the rejection above to the limitation.
Therefore, all of the limitations of the claim 1 are disclosed in Nizin. Therefore, applicant’s arguments are not persuasive and the rejection of claim 1 as anticipate by Nizin is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20170252577 A1 Dempsey, James et al. teaches a method for utilizing the radiation therapy prescription information and the patient MRI data to account for interaction properties of soft tissues in the patient through which the particle beam passes. The MRI data acquired during treatment may also be utilized to modify or optimize the particle radiation therapy treatment.
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.
Examiner’s Note: The examiner has cited particular columns and line numbers in the reference that applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. In the case of amending the claimed invention, the applicant is respectfully requested to indicate the portion(s) of the specification which dictate(s) the structure relied on for the proper interpretation and also to verify and ascertain the metes and bound of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Simeon P Drapeau whose telephone number is (571)-272-1173. The examiner can normally be reached Monday - Friday, 8 a.m. - 5 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ryan Pitaro can be reached on (571) 272-4071. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIMEON P DRAPEAU/ Examiner, Art Unit 2188
/RYAN F PITARO/ Supervisory Patent Examiner, Art Unit 2188