DETAILED ACTION
Notices to Applicant
This communication is a Final Office Action on the merits. Claims 1-6, 8-14, 16-20, and 22-28 as filed 02/18/2026, are currently pending and have been considered below.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a U.S. National Stage Filing under 35 U.S.C. X371 from International Application No. PCT/IB2020/000923, filed on November 7, 2020, and published as W02021/090063 on May 14, 2021, which claims the benefit of priority of Chinese Application Serial No. 201911087723.9, filed November 8, 2019.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 8-14, 16-20, and 22-28 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “proximity” in claims 1, 14, and 20 is a relative term which renders the claim indefinite. The term “proximity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Independent claims 1, 14, and 20 each recite the limitation “another tumor located in proximity to at least one organ at risk,” wherein “proximity,” is a relative term of degree for the location of the tumor in relation to at least one organ at risk. Accordingly, claims 1-6, 8-14, 16-20, and 22-28 are indefinite in scope.
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, 8-14, 16-20, and 22-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claims 1-6, 8-13, and 26 are drawn to a system for providing a radiotherapy to a tumor in a subject, which is within the four statutory categories (i.e. machine).
Independent Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites:
1. A system for providing a radiotherapy to a tumor in a subject, the system comprising:
a radiation machine configured to generate a primary radiation dose profile using a primary dose algorithm;
a cloud-computing device or networked devices configured to provide cloud-based services accessible concurrently by multiple tenants, the cloud-based services including: a file service to receive image information of the subject produced by the radiation machine and information about the radiation machine;
a dose engine service to determine a secondary radiation dose profile independent of the primary radiation dose profile by applying a secondary dose algorithm, different from the primary dose algorithm, to the received image information and the radiation machine information and without using the primary radiation dose profile as an input to the secondary dose algorithm; and
a dose evaluation service to verify the primary radiation dose profile using the secondary radiation dose profile; and
a user interface configured to enable a client access to one or more of the cloud-based services via a communication network, and to output the verified primary radiation dose profile to a user or a process, wherein the radiation machine is configured to deliver the radiotherapy to the tumor in the subject in accordance with an individualized radiation treatment plan based at least in part on the verified primary radiation dose profile,
wherein the tumor comprises a prostate tumor or another tumor located in proximity to at least one organ at risk,
wherein the radiotherapy comprises at least one of an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy.
The above limitations, as drafted, is a machine that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, nothing in the claim precludes the steps from practically being performed in the mind. For example, but for the above bolded language, generate a primary radiation dose profile using a primary dose algorithm, determine a secondary radiation dose profile independent of the primary radiation dose profile by applying a secondary dose algorithm, different from the primary dose algorithm and without using the primary radiation dose profile as an input, to the received image information and the radiation machine information, and verify the primary radiation dose profile using the secondary radiation dose profile in the context of this claim encompasses the user manually analyzing imaging information through observation, evaluation, judgment, and/or opinion. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Further, the above limitations recite rules or instructions for managing personal behavior or interactions between people such that the claim also recites the abstract idea of “Certain Methods of Organizing Human Activity.” See MPEP § 2106.04(a)(2)(II)(C) (iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)). Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites using the above bolded additional elements (e.g. “a radiation machine”, “a cloud-computing device or networked devices configured to provide cloud-based services accessible concurrently by multiple tenants,” “a file service,” “a dose engine service,” “a dose evaluation service” “a user interface” and “a communication network,”) to perform the claim limitations. The additional elements in each of the steps are recited at a high-level of generality (i.e., a radiation therapy device that may include a radiation source (e.g. an x-ray source or a linac), a cloud computing device or networked devices performing services such as a cloud server with client devices such as computers, tablets, etc. and a user interface with a display device integrated into a device such as a tablet computer as they relate to a general purpose computers (Application Specification [0012], [0078], [0081], [0095], [0104])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). The additional elements of: a radiation machine is recited at a high-level such that it is a device for acquiring an image of a subject; a file service to receive image information of the subject produced by the radiation machine and information about the radiation machine; and to output the verified primary radiation dose profile to a user or a process are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g). Further, the additional element of “wherein the radiation machine is configured to deliver the radiotherapy to the tumor in a subject in accordance with an individualized radiation treatment plan based at least in part on the verified primary radiation dose profile, wherein the tumor comprises a prostate tumor or another tumor located in proximity to at least one organ at risk, wherein the radiotherapy comprises at least one an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy” amounts to adding insignificant extra-solution activity to the abstract idea. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements 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 of using the above bolded additional elements (e.g. “a radiation machine”, “a cloud-computing device or networked devices configured to provide cloud-based services accessible concurrently by multiple tenants,” “a file service,” “a dose engine service,” “a dose evaluation service” “a user interface” and “a communication network,”) to perform the claim limitations amounts to no more than mere instructions to apply the exception using generic computer components. (i.e., a radiation therapy device that may include a radiation source (e.g. an x-ray source or a linac), a cloud computing device or networked devices performing services such as a cloud server with client devices such as computers, tablets, etc. and a user interface with a display device integrated into a device such as a tablet computer as they relate to a general purpose computers (Application Specification [0012], [0078], [0081], [0095], [0104])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). The additional elements of: a radiation machine is recited at a high-level such that it is a device for acquiring an image of a subject; a file service to receive image information of the subject produced by the radiation machine and information about the radiation machine; and to output the verified primary radiation dose profile to a user or a process amount to receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II. Further, the additional element of “wherein the radiation machine is configured to deliver the radiotherapy to the subject in accordance with an individualized radiation treatment plan based at least in part on the verified primary radiation dose profile, wherein the tumor comprises a prostate tumor or another tumor located in proximity to at least one organ at risk, wherein the radiotherapy comprises at least one an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy” amounts to adding insignificant extra-solution activity to the abstract idea as post solution activity that is well-understood, routine and conventional in the art. See MPEP 2106.05(d)(g) (Application Specification, [0002] “Radiation therapy (or "radiotherapy") can be used to treat cancers or other ailments in mammalian (e.g., human and animal) tissue. One such radiotherapy technique is provided using a linear accelerator (also referred to as "linac"), whereby a tumor is irradiated by high-energy particles (e.g., electrons, protons, ions, high-energy photons, and the like)”). The claim is not patent eligible.
Dependent claims 2-6, 8-13, and 26 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the imaging data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the observation, evaluation, judgment, and/or opinion of data. Dependent claim 4 recites the additional elements of decompressing or decrypting a DICOM file, however, this additional element amounts to insignificant extra-solution activity to the judicial exception. See MPEP 2105.05(g). Dependent claim 5 recites the additional element of a cloud storage configured to store the DICOM file of the subject, however, this additional element is a high-level recitation of a generic computer component such that it amounts to using a computer as a tool to perform the abstract idea. See MPEP 2106.05(f), Application Specification at [0100] (i.e. a cloud server). Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 14, 16-19, and 27 are drawn to a method for providing a radiotherapy to a tumor in a subject, which is within the four statutory categories (i.e. method).
Independent Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 14 recites:
14. A method for providing a radiotherapy to a tumor in a subject using a radiation machine, the method comprising:
generating a primary radiation dose profile using a primary dose algorithm implemented in the radiation machine;
accessing a cloud-computing device or networked devices to use cloud-based services including:
receiving a DICOM file of the subject;
parsing the received DICOM file and extracting image information and information about the radiation machine from the received DICOM file;
determining a secondary radiation dose profile independent of the primary radiation dose profile, by applying a secondary dose algorithm, different from the primary dose algorithm, to the image information and the radiation machine information and without using the primary radiation dose profile as an input to the secondary dose algorithm;
verifying the primary radiation dose profile using the secondary radiation dose profile; and
delivering the radiotherapy to the tumor of the subject in accordance with an individualized radiation treatment plan based at least in part on the verified primary radiation dose profile,
wherein the tumor comprises a prostate tumor or another tumor located in proximity to at least one organ at risk,
wherein the radiotherapy comprises at least one an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy.
The above limitations, as drafted, is a method that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, nothing in the claim precludes the steps from practically being performed in the mind. For example, but for the above bolded language, generating a primary radiation dose profile using a primary dose algorithm, parsing the received DICOM file and extracting image information and information about the radiation machine from the received DICOM file, determining a secondary radiation dose profile independent of the primary radiation dose profile, by applying a secondary dose algorithm, different from the primary dose algorithm and without using the primary radiation dose profile as an input, to the image information and the radiation machine information, and verifying the primary radiation dose profile using the secondary radiation dose profile in the context of the claim encompasses the user manually analyzing imaging information through observation, evaluation, judgment, and/or opinion. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Further, the above limitations recite rules or instructions for managing personal behavior or interactions between people such that the claim also recites the abstract idea of “Certain Methods of Organizing Human Activity.” See MPEP § 2106.04(a)(2)(II)(C) (iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)). Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites using the above bolded additional elements (e.g. “the radiation machine”, “a cloud-computing device or networked devices to use cloud-based services including: receiving a DICOM file of the subject,”) to perform the claims limitations. The additional elements in each of these steps are recited at a high-level of generality (i.e., a radiation therapy device that may include a radiation source (e.g. an x-ray source or a linac), a cloud computing device or networked devices performing services such as a cloud server with client devices such as computers, tablets, etc. as they relate to a general purpose computers (Application Specification [0012], [0078], [0081], [0095], [0104])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). The additional elements of accessing a cloud-computing device or networked devices to use cloud-based services including: receiving a DICOM file of the subject are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g). Further, the additional element of “delivering the radiotherapy to the tumor of the subject in accordance with an individualized radiation treatment plan based at least in part on the verified primary radiation dose profile, wherein the tumor comprises a prostate tumor or another tumor located in proximity to at least one organ at risk, wherein the radiotherapy comprises at least one an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy” amounts to adding insignificant extra-solution activity to the abstract idea. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements 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 of using the above bolded additional elements (e.g. “the radiation machine”, “a cloud-computing device or networked devices to use cloud-based services including: receiving a DICOM file of the subject,”) to perform the claim limitations amounts to no more than mere instructions to apply the exception using generic computer components. (i.e., a radiation therapy device that may include a radiation source (e.g. an x-ray source or a linac), a cloud computing device or networked devices performing services such as a cloud server with client devices such as computers, tablets, etc. as they relate to a general purpose computers (Application Specification [0012], [0078], [0081], [0095], [0104])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). Further, the additional element of accessing a cloud-computing device or networked devices to use cloud-based services including: receiving a DICOM file of the subject amounts to receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II. and delivering the radiotherapy to the tumor of the subject in accordance with an individualized radiation treatment plan based at least in part on the verified primary radiation dose profile, wherein the tumor comprises a prostate tumor or another tumor located in proximity to at least one organ at risk, wherein the radiotherapy comprises at least one an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy” amounts to adding insignificant extra-solution activity to the abstract idea as post solution activity that is well-understood, routine and conventional in the art. See MPEP 2106.05(d)(g) (Application Specification, [0002] “Radiation therapy (or "radiotherapy") can be used to treat cancers or other ailments in mammalian (e.g., human and animal) tissue. One such radiotherapy technique is provided using a linear accelerator (also referred to as "linac"), whereby a tumor is irradiated by high-energy particles (e.g., electrons, protons, ions, high-energy photons, and the like)”). The claim is not patent eligible.
Dependent claims 16-19 and 27 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the imaging data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the observation, evaluation, judgment, and/or opinion of data. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 20-25 and 28 are drawn to a non-transitory machine-readable storage medium for verifying a primary radiation dose profile for providing a radiotherapy to a subject, which is within the four statutory categories (i.e. manufacture).
Independent Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 20 recites:
20. A non-transitory machine-readable storage medium that includes instructions that, when executed by one or more processors of a machine, cause the machine to perform operations comprising:
generating a primary radiation dose profile using a primary dose algorithm;
accessing a cloud-computing device or networked devices to use cloud-based services including:
receiving a DICOM file of a subject, the DICOM file generated by a radiation machine for providing a radiotherapy to a tumor in the subject;
parsing the received DICOM file and extracting image information and information about the radiation machine from the received DICOM file;
determining a secondary radiation dose profile independent of the primary radiation dose profile by applying a secondary dose algorithm, different from the primary dose algorithm, to the image information and the machine information and without using the primary radiation dose profile as an input to the secondary dose profile;
verifying the primary radiation dose profile using the secondary radiation dose profile;
generating a control signal to the radiation machine to deliver the radiotherapy to the tumor of the subject in accordance with an individualized radiation treatment plan based at least in part on the verified primary radiation dose profile,
wherein the tumor comprises a prostate tumor or another tumor located in proximity to at least one organ at risk,
wherein the radiotherapy comprises at least one an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy.
The above limitations, as drafted, is a manufacture that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, nothing in the claim precludes the steps from practically being performed in the mind. For example, but for the above bolded language, generating a primary radiation dose profile using a primary dose algorithm, parsing the received DICOM file and extracting image information and information about the radiation machine from the received DICOM file, determining a secondary radiation dose profile independent of the primary radiation dose profile by applying a secondary dose algorithm, different from the primary dose algorithm and without using the primary radiation dose profile as an input, to the image information and the machine information, and verifying the primary radiation dose profile using the secondary radiation dose profile in the context of the claim encompasses the user manually analyzing imaging information through observation, evaluation, judgment, and/or opinion. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Further, the above limitations recite rules or instructions for managing personal behavior or interactions between people such that the claim also recites the abstract idea of “Certain Methods of Organizing Human Activity.” See MPEP § 2106.04(a)(2)(II)(C) (iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)). Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites using the above bolded additional elements (e.g. “a non-transitory machine-readable storage medium that includes instructions that, when executed by one or more processors of a machine”, “accessing a cloud-computing device or networked devices to use cloud-based services including: receiving a DICOM file of a subject, the DICOM file generated by a radiation machine for providing a radiotherapy to a tumor in the subject,” and “generating a control signal to the radiation machine,”) to perform the claims limitations. The additional elements in each of these steps are recited at a high-level of generality (i.e., a radiation therapy device that may include a radiation source (e.g. an x-ray source or a linac), a memory device such as a read-only memory, a static memory, as well as other non-transitory medium that may be used to store information or computer-executable instructions capable of being access by the processor or any other type of computing device as they relate to a general purpose computers (Application Specification [0012], [0078], [0063], [0081], [0095], [0104])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). The additional elements of accessing a cloud-computing device or networked devices to use cloud-based services including: receiving a DICOM file of a subject, the DICOM file generated by a radiation machine for providing a radiotherapy to a tumor in the subject are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g). Further, the additional element of “generating a control signal to the radiation machine to deliver the radiotherapy to the subject in accordance with a radiation treatment plan based at least in part on the verified primary radiation dose profile, wherein the tumor comprises a prostate tumor or another tumor located in proximity to at least one organ at risk, wherein the radiotherapy comprises at least one an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy” amounts to adding insignificant extra-solution activity to the abstract idea. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements 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 of using the above bolded additional elements to perform the receiving and analyzing limitations amounts to no more than mere instructions to apply the exception using generic computer components. (i.e., a radiation therapy device that may include a radiation source (e.g. an x-ray source or a linac), a memory device such as a read-only memory, a static memory, as well as other non-transitory medium that may be used to store information or computer-executable instructions capable of being access by the processor or any other type of computing device as they relate to a general purpose computers (Application Specification [0012], [0078], [0063], [0081], [0095], [0104])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). The additional elements of: accessing a cloud-computing device or networked devices to use cloud-based services including: receiving a DICOM file of a subject, the DICOM file generated by a radiation machine for providing a radiotherapy to a tumor in the subject amount to receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II. Further, the additional element of “generating a control signal to the radiation machine to deliver the radiotherapy to the subject in accordance with a radiation treatment plan based at least in part on the verified primary radiation dose profile, wherein the tumor comprises a prostate tumor or another tumor located in proximity to at least one organ at risk, wherein the radiotherapy comprises at least one an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy” amounts to adding insignificant extra-solution activity to the abstract idea as post solution activity that is well-understood, routine and conventional in the art. See MPEP 2106.05(d)(g) (Application Specification, [0002] “Radiation therapy (or "radiotherapy") can be used to treat cancers or other ailments in mammalian (e.g., human and animal) tissue. One such radiotherapy technique is provided using a linear accelerator (also referred to as "linac"), whereby a tumor is irradiated by high-energy particles (e.g., electrons, protons, ions, high-energy photons, and the like)”). The claim is not patent eligible.
Dependent claims 21-25 and 28 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the imaging data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the observation, evaluation, judgment, and/or opinion of data. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Examiner Statement - 35 USC § 102/103
The closest prior art of record – U.S. Patent Application Pub. No. 2019/0046813 A1 (hereinafter “Zhou et al.”) in view of U.S. Patent Application Pub. No. 2012/0300912 A1 (hereinafter “Chung et al.”), U.S. Patent Application Pub. No. 2010/0082294 A1 (hereinafter “Adnani”) and U.S. Patent Application Pub. No. 2009/0154644 A1 (hereinafter “Nord et al.”), U.S. Patent Application Pub. No. 2019/0362836 A1 (hereinafter “Gruemer et al.”), and U.S. Patent Application Pub. No. 2010/0119032 A1 (hereinafter “Yan et al.”) – fail to anticipate or otherwise render obvious each limitation of the independent claims 1, 14, and 20 in the particular ordered combination as currently claimed. In particular, in view of the claim as a whole, the prior art fails to teach or suggest, “a dose engine service to determine a secondary radiation dose profile independent of the primary radiation dose profile by applying a secondary dose algorithm, different from the primary dose algorithm, to the received image information and the radiation machine information and without using the primary radiation dose profile as an input to the secondary dose algorithm; and a dose evaluation service to verify the primary radiation dose profile using the secondary radiation dose profile,” as primary reference Zhou et al. does not teach or suggest the independent primary and secondary radiation dose profile algorithms. See Zhou et al. at [0113, [0119]. Secondary references Chung et al., Adnani, Nord et al., Grumer et al., and Yan et al. fail to fill the gap. Accordingly, claims 1-6, 8-14, 16-20, and 22-28 are free of prior art as currently recited.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed on 02/18/2026.
In the remarks, Applicant argues in substance that:
Regarding the 101 rejection of claims 1-6, 8-14, 16-20, and 22-28, Applicant argues that the additional elements of the claims reflect particular treatment to a particular disease and also a technological improvement and integrate the claims into a practical application.
Regarding the 103 rejection of claims 1-6, 8-14, 16-20, and 22-28, Applicant argues that the prior cited references fail to teach the currently amended limitations of the independent claims.
In response to Applicant’s argument (a) regarding the 101 rejection of claims 1-6, 8-14, 16-20, and 22-28, Examiner respectfully disagrees.
Applicant argues that the claims recite additional elements that integrate the claims into a practical application through the additional element similar to Example 49 of the July 2024 PEG. Examiner respectfully disagrees. For distinguishment, Examiner points to Example 49 of the 2024 Guidance regarding Fibrosis Treatment, wherein it is concluded that the claims recite an integration into a practical application because a particular treatment (administer Compound X eye drops) is implemented for a particular disease (to glaucoma patients at high risk of PI after microstent implant surgery). In contrast to the particularity of the disease and corresponding treatment of Example 49, the instant claims do not recite a particular treatment for a particular disease, but under broadest reasonable interpretation, the claimed tumor “comprises a prostate tumor or another tumor located in proximity to at least one organ at risk” such that the tumor could be any tumor of any kind on any location on the body “proximate” to at least one organ at risk. Further, the claim under broadest reasonable interpretation of the treatment of the radiotherapy comprises at least one an intensity-modulated radiation therapy (IMRT), a volumetric-modulated arc therapy (VMAT), or another modulated external-beam radiotherapy such that the radiation therapy could belong to a whole class of external beam radiation therapies, which is not analogous to the particular treatment for a particular disease of Example 49.
Applicant further argues that the claims recite an improvement to the functioning of radiation machines themselves through the individualized radiation dose profiles. Examiner respectfully disagrees and submits that the individual radiation dose profile does not provide an improvement to the functioning of the radiation machine, but merely recites an improvement to the abstract idea itself i.e. individualized treatment for a particular patient using the radiation therapy machine in its ordinary capacity. See MPEP 2106.05(f)(2). Examiner respectfully submits that the radiation therapy machine, as currently claimed, is not improved, for example, the radiation machine itself isn’t operating more efficiently, but rather, its set to perform its ordinary functions as to its given dose profile. The present Application Specification is silent as to a particular problem in the functioning of the radiation therapy machine, but rather, sets for the problem directed to the abstract idea. See Application Specification at [0038] (“significantly reduce the workload of human dose verifiers, improve the accuracy and efficiency of dose verification, and increase data security and flexibility of data management.”).
Accordingly, Examiner respectfully maintains the 101 rejection of 1-6, 8-14, 16-20, and 22-28.
In response to Applicant’s argument (b) regarding the 103 rejection of claims 1-6, 8-14, 16-20, and 22-28, Examiner is persuaded and has withdrawn the prior 103 rejection as discussed in the above Office Action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Pub. No. 2020/0030632 A1 teaches calculated radiation dose distribution, dose calculation algorithms, details about the radiation beams and linear accelerator on which the patient will be treated, plan information in the electronic medical record system and the patient's documentation such as the prescribed radiation dose and fractionation, imaging instructions during treatment, independent verification of the calculated dose, measurement of the deliverability of the planned dose on the treatment machine ([0011]).
U.S. Patent No. 9,199,093 B2 teaches quickly identify possible sources of errors during QA and patient plan verification; perform a 3D dose verification in the patient's anatomy which is independent of original TPS, by using patient's anatomy data and a dose algorithm independent from the TP (Col. 8, Lines 62-67).
U.S. Patent Application Pub. No. 2015/0199478 A1 teaches systems and methods for identifying image acquisition parameters (Abstract); and
U.S. Patent Application Pub. No. 2020/0030632 A1 teaches automated methods and systems for evaluation and verification of treatment plans for radiation therapy ([0002]).
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/A.M.B./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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