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. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Claim Objections Claim 2 is objected to because of the following informalities: Regarding claim 2, line 4, “which is one of components of the Tomotherapy ” is unclear and perhaps should be “ … which is a component of the Tomotherapy ... ” . Appropriate correction is required. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a data analysis unit, a parameter selection unit, a calculation unit and a determination unit in claim 5. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not set forth sufficient structure with respect to the data analysis unit, parameter selection unit, calculation unit and determination unit . It is unclear if these “ units ” refer to a computer, a processor or software per se. 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 appl icant regards as his invention. Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 1, line 6, “the pass rate of dose DQA” appears to lack antecedent basis. In lines 3-4 , the claim sets forth “a pass rate and a prediction model” but it is not clear that this pass rate is specifically the “pass rate of dose DQA”. Regarding claim 1, last two lines, “the first and second determination results” appears to lack antecedent basis . Regarding claim 5, line 6, “the pass rate of dose DQA” appears to lack antecedent basis. In lines 3-4 , the claim sets forth “a pass rate and a prediction model” but it is not clear that this pass rate is specifically the “pass rate of dose DQA”. Regarding claim 5, last two lines, “the first and second determination results” appears to lack antecedent basis. 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 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to an abstract idea without significantly more. With Respect to claims 1 and 5 the claims recite the following limitation(s): Claim 1: A method for carrying out dose delivery quality assurance (DQA) for high- precision radiation treatment, the method comprising: a correlation deriving step of establishing, by a data analysis unit, a parameter affecting a pass rate and a prediction model for the pass rate by deriving a correlation between parameter data of a subject to be treated who has completed high-precision radiation treatment comprising Tomotherapy and the pass rate of dose DQA based on regression analysis; a parameter selection step of extracting, by a parameter selection unit, parameters affecting the pass rate of dose DQA derived from the correlation deriving step from among parameters for establishing a treatment plan of a subject to be radiation treated; a pass rate calculation step of receiving, by a control unit, a variable value of the subject to be treated corresponding to the parameters extracted in the parameter selection step, and calculating, by a calculation unit, a predicted value of the pass rate of dose DQA by substituting 5 the variable value into an equation related to the pass rate prediction model based on a control command of the control unit; and a pass rate determination step of determining, by a determination unit, firstly determining whether the predicted value of the pass rate calculated in the pass rate calculation step meets a preset prediction threshold, when the predicted value of the pass rate meets the prediction threshold as a result of determination, carrying out dose DQA according to the treatment plan, and secondly determining whether the predicted value of the pass rate meets a preset execution threshold as a result of carrying out dose DQA, wherein actual treatment is performed only when both of the first and second determination results meet the threshold. Claim 5 : An apparatus for carrying out dose delivery quality assurance (DQA) for high- precision radiation treatment, the apparatus comprising: a data analysis unit configured to establish a parameter affecting a pass rate and a prediction model for the pass rate by deriving a correlation between parameter data of a subject to be treated who has completed high-precision radiation treatment including Tomotherapy and the pass rate of dose DQA based on regression analysis; a parameter selection unit configured to extract parameters affecting the pass rate of dose DQA derived by the data analysis unit from among parameters for establishing a treatment plan of the subject to be radiation treated; a calculation unit configured to calculate a predicted value of the pass rate of dose DQA by substituting a variable value (a variable value of the subject to be treated corresponding to the parameters extracted in the parameter selection step) received from a data input unit into an equation related to the pass rate prediction model based on a control command of the control unit; and a determination unit configured to firstly determine whether the predicted value of the pass rate calculated by the calculation unit meets a preset prediction threshold, when the predicted value of the pass rate meets the prediction threshold as a result of determination, carry out dose DQA according to the treatment plan, and secondly determine whether the predicted value of the pass rate meets a preset execution threshold as a result of carrying out the dose DQA, wherein actual treatment is performed only when both of the first and second determination results meet the threshold. Step 1 - Claims 1 and 5 are directed to a method and a n apparatus for carrying out dose delivery quality assurance (DQA) for high- precision radiation treatment . Step 2a Prong 1 – The claimed invention is directed to non-statutory subject matter. The above limitations, under their broadest reasonable interpretation, fall within the “Certain Mathematical concepts and mental processes grouping of abstract ideas, enumerated in MPEP 2106.04(a)(2)(II), in that they recite a series of mathematical calculations and mental steps which produce an optimized dose delivery quality assurance for a radiation treatment plan. When given their BRI, the limitations are considered an abstract idea of being certain mathematical concepts and mental processes. With respect to claim 1 , The method sets forth correlating subject specific parameter data that affects pass rate and a prediction model for the pass rate based on regression analysis, extracting parameters for establishing a treatment plan, calculating a predicted value of the pass rate of dose delivery quality assurance, and determining whether the predicted pass rate meets a preset threshold and determining whether the pass rate meets a preset execution threshold. With respect to claim 5 , The system claim merely sets forth a data analysis unit, a parameter selection unit, a calculation unit and a determination unit which appear to be merely control and processing for which the Mathematical concepts and mental processes of claim 1 are implemented. Step 2a Prong 2 - The recitation of the additional elements of data analysis unit, a parameter selection unit, a calculation unit and a determination unit merely invokes such additional element(s) as a tool to perform the abstract idea. MPEP 2106.05(f). Further, the recitation of these additional element(s) in the claim generally links the use of the abstract idea to a particular technological environment or field of use, i.e., a computerized environment. MPEP 2106.05(h). As such, under Prong 2 of Step 2A, when considered both individually and as a whole, the limitations of claims 1, 9 , and 17 are not indicative of integration into a practical application (Prong 2, Step 2A: NO). MPEP 2106.04(d) With respect to claim s 1 , There do not appear to be any additional elements provided and the abstract idea is not integrated into a practical application of utilizing any system components and actually performing radiation treatment . With respect to claim 5 , the apparatus merely sets forth additional elements including data analysis unit, a parameter selection unit, a calculation unit and a determination unit . These additional elements are all recited at an extremely high level of generality and may be interpreted as generic computing devices used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not integrate the abstract idea into a practical application. As such, these additional elements do not integrate the abstract idea into a practical application and therefore the claim is directed to the judicial exception . Step 2B - The recitation of the additional elements is acknowledged, as identified above with respect to Prong 2 of Step 2A. These additional elements do not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A. Even when considered as an ordered combination, the additional elements of claims 1 and 5 do not add anything that is not already present when they are considered individually. Therefore, under Step 2B, there are no meaningful limitations in claim s 1 and 5 that transform the judicial exception into a patent eligible application such that the claim amounts to significantly more than the judicial exception itself (Step 2B: NO). MPEP 2106.05. Accordingly, under the Subject Matter Eligibility test, claim s 1 and 5 are ineligible. Furthermore, the dependent claims, 2-4 do not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A. Claim 5 is rejected under 35 U.S.C. 101 because : T he claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because as claimed and disclosed in the specification the data analysis unit, parameter selection unit, calculation unit and determination unit are set forth without any further structure and appear to represent software per se. Conclusion Allowable Subject Matter Claims 1-5 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action. The following is an examiner’s statement of reasons for allowance: Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” The prior art of record such as VALDES et al.(US 20180085168) teaches receiving one or more plan parameters of a first radiation treatment plan for a first patient and one or more passing rate data for the first treatment plan; generating a predictive model for passing rate data from the plan parameters of the first radiation treatment plan and the passing rate data for the first treatment plan; receiving one or more plan parameters of a second radiation treatment plan for a second patient; and applying the predictive model to the plan parameters of the second radiation treatment to generate one or more predicted passing rate data for the plan parameters for the second patient. However the prior art of record does not teach the subject matter of claims 1 and 5 as set forth: A method for carrying out dose delivery quality assurance (DQA) for high- precision radiation treatment, the method comprising: a correlation deriving step of establishing, by a data analysis unit, a parameter affecting a pass rate and a prediction model for the pass rate by deriving a correlation between parameter data of a subject to be treated who has completed high-precision radiation treatment comprising Tomotherapy and the pass rate of dose DQA based on regression analysis; a parameter selection step of extracting, by a parameter selection unit, parameters affecting the pass rate of dose DQA derived from the correlation deriving step from among parameters for establishing a treatment plan of a subject to be radiation treated; a pass rate calculation step of receiving, by a control unit, a variable value of the subject to be treated corresponding to the parameters extracted in the parameter selection step, and calculating, by a calculation unit, a predicted value of the pass rate of dose DQA by substituting the variable value into an equation related to the pass rate prediction model based on a control command of the control unit; and a pass rate determination step of determining, by a determination unit, firstly determining whether the predicted value of the pass rate calculated in the pass rate calculation step meets a preset prediction threshold, when the predicted value of the pass rate meets the prediction threshold as a result of determination, carrying out dose DQA according to the treatment plan, and secondly determining whether the predicted value of the pass rate meets a preset execution threshold as a result of carrying out dose DQA, wherein actual treatment is performed only when both of the first and second determination results meet the threshold. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. VALDES et al.( US 20180085168 ) teaches a method comprises receiving one or more plan parameters of a first radiation treatment plan for a first patient and one or more passing rate data for the first treatment plan; generating a predictive model for passing rate data from the plan parameters of the first radiation treatment plan and the passing rate data for the first treatment plan; receiving one or more plan parameters of a second radiation treatment plan for a second patient; and applying the predictive model to the plan parameters of the second radiation treatment to generate one or more predicted passing rate data for the plan parameters for the second patient. CHEN et al.( WO 2007014108 ) teaches a method involves acquiring an image data of a patient, and generating a treatment plan for a patient based on the image data, where the treatment plan includes a calculated radiation dose to be delivered to the patient. An on-line image of the patient is acquired in a treatment position, and a portion of the calculated radiation dose is delivered to the patient. A quality assurance criteria related to the delivery of the treatment plan is monitored, and the radiation dose received by the patient is calculated. CORDERO et al.( US 20200197726 ) teaches m ethods and systems for generating dose estimation models for radiotherapy treatment planning are provided. One example method may comprise obtaining model configuration data that specifies multiple anatomical structures based on which dose estimation is performed by a dose estimation model. Lu et al.( US 20070041499 ) teaches a s ystem and method of evaluating quality assurance criteria related to the delivery of a radiation therapy treatment plan. Dessy ( US 20170203129 ) teaches a method for determining an interest in applying a Quality Assessment (QA) procedure to a proposed treatment plan in radiation therapy. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT BRIAN L CASLER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-4956 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-Th 6:30 to 4:30 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BRIAN L CASLER/ Primary Examiner, Art Unit 3791