CTNF 18/751,420 CTNF 73962 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim s 7-11 and 13-14 are objected to because of the following informalities: the claims recite MR and/or MRS without their associated meaning, and should be preceded by their meaning . Appropriate correction is required. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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, 18, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. judicial exception without significantly more. Under the 35 U.S.C. 101 subject matter eligibility the 2019 guidance provides the following framework for analyzing the claims: Step 1: whether the claimed subject matter is directed to one of the four statutory categories of invention, i.e., process, machine, manufacture, or composition of matter. Step 2A (prong 1): If the claim does fall within one of the statutory categories, it must then be determined whether the claim is directed to a judicial exception (i.e., law of nature, natural phenomenon, and abstract idea). Step 2A (prong 2): If the claim is directed toward a judicial exception, it must then be determined whether the judicial exception is integrated into a practical application. Finally, if the judicial exception is not integrated into a practical application, it must additionally be determined in Step 2B whether the claim recites "significantly more" than the abstract idea. Step 1 : Independent claims 1, 18, and 19 are considered to be in a statutory category (machine, process, and manufacture respectively). Step 2A (Prong 1 ): Applying step 2A (prong 1) addresses whether the claim is directed to a judicial exception, i.e., law of nature, natural phenomenon, and abstract idea. Claims 1, 18, and 19 are directed toward the judicial exception of an abstract idea of: generate output data by using a composite function consisting of one or more functions on an acquired medical data, the one or more functions performing arithmetic processing of a fixed coefficient associated with information of interest in the medical data. The claims recite generating an output of an acquired image data using a mathematical operation of a fixed coefficient associated with information of interest in the data. The recited limitation identified above under its broadest reasonable interpretation, covers mathematical concepts (mathematical relationships, mathematical formulas or equations, mathematical calculations), but for the recitation of generic computer system/components That is, other than reciting the computer system/components, nothing in the claim elements preclude the step being performed via mathematical calculation. If a claim recites a numerical formula or equation will be considered as falling the "Mathematical Concepts" grouping. Accordingly, the claims recite an abstract idea. Step 2A (Prong (2) : Step 2A (prong 2) addresses whether the judicial exception is integrated into a practical application. As claimed, the judicial exception is not integrated into a practical application. The relevant question under Step 2A (prong 2) is not whether the claimed invention itself is a practical application, instead the question is whether the claimed invention includes additional elements beyond the judicial exception that integrate the judicial exception into a practical application by imposing a meaningful limit on the judicial exception. It is clear that applicant's claims do not comprise any additional elements that, individually or in combination, have integrated the judicial exception into a practical application. Since the claim is implemented on a computer system and there are no further limitations or structural elements that go beyond the computer/processor, it can clearly be seen that the abstract idea of generating output data by using a composite function consisting of one or more functions on an acquired medical data, the one or more functions performing arithmetic processing of a fixed coefficient associated with information of interest in the medical data. The claims recite generating an output of an acquired image data using a mathematical operation of a fixed coefficient associated with information of interest in the data, merely implemented in a computer system. Please note, according to the USPTO released new examination guidelines dated January 7, 2019, for determining whether a claim is directed to non-statutory subject matter, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application: an additional element reflects an improvement in the functioning of computer, or an improvement to other technology or technical field; additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim; an additional element effects a transformation or reduction of a particular article to a different state or thing; and an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize exception. It is clear that applicant's claims do not comprise any of the above additional elements that, individually or in combination, have integrated the judicial exception into a practical application. Step 2B : Step 2B addresses whether the claim has additional elements that amount to significantly more than a judicial exception. Applicant's claims do not recite additional elements that provide significantly more than the recited judicial exception. At least the claims require a processor/computer which is claimed to perform its basic functions of at least to generate output data by using a composite function consisting of one or more functions on an acquired medical data, the one or more functions performing arithmetic processing of a fixed coefficient associated with information of interest in the medical data. The claims recite generating an output of an acquired image data using a mathematical operation/calculation of a fixed coefficient associated with information of interest in the data. The recitation of the processor/computer limitation amount to a mere instruction to implement the abstract idea on the processor/computer. Accordingly, claims 1, 18, and 19 are not patent eligible. Dependent claims 2-12 and 15-17 are grouped under mathematical concepts (mathematical relationships, mathematical formulas or equations, mathematical calculations), and merely reiterate the same abstract idea as identified above, without imposing any meaningful limits, using the generic computer system components to perform the abstract idea, providing nothing more than generally linking the use of the abstract idea to a technological environment or field of use, without significantly more since there are no additional elements that impose any technical non-generic limits. Therefore, claims 2-12 and 15-17 are also rejected under 35 U.S.C. 101, and thus are not patent eligible. Notice re prior art available under both pre-AIA and AIA 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to ATA 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 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. Examiner's Note Examiner has cited particular columns and line numbers or figures in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, in preparing the responses, to fully consider the references in 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. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-3, 5-6, 12, 16, and 18-19 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Liu, et al. (Computer English Translation of WO 2021/169128 A1, hereinafter may be referred as the translated document) . With regard to claim 1, the translated document of Liu, et al. disclose an apparatus recognizing and quantifying fundus retina vessel, i.e., a medical data processing apparatus comprising processing circuitry (See for example, Figs. 1-3) configured to: acquire medical data, i.e., fundus image (See for example, Fig. 1; and Page 9, lines 31-34); and generate output data, i.e., target feature maps of multiple scales, by using a composite function consisting of one or more functions (that is, U-net model with multiple layers or the combined function of an encoder and decoder, and these feature/s meet the description made at paragraph 0025 of the instant application: “The composite function is, for example, a model used in machine learning, such as a neural network”), on the medical data, the one or more functions performing arithmetic processing (See the formula, i.e., “ CRAE= 0.88 ( A i 2 + A j 2 , a n d CRAE= 0.95 ( V i 2 + V j 2 , wherein A i and A j respectively represent the largest arterial vessel diameter and the smallest arterial vessel diameter of the region of interest obtained, and 0.88 is a fixed coefficient; and V i and V j respectively represent the maximum and minimum venous diameter of the region of interest obtained, 0.95 is a fixed coefficient” described in page 7 of the non-translated document ‘128) of a fixed coefficient associated with information of interest, i.e., region of interest, in the medical data (See for example, page 12, line 13 – page 13, line 16; 9, lines 43-44; and page 14, lines 14-23). Thus, each of the requirements of claim 1 is met. With regard to claim 2, the medical data processing apparatus according to claim 1, wherein the information of interest is information in the medical data that affects output from the composite function or information in the medical data that is identified to affect output from the composite function during training of the composite function (See for example, page 13, paragraphs 1-3). With regard to claim 3, the medical data processing apparatus according to claim 1, wherein in the composite function, the medical data is multiplied by the fixed coefficient as the arithmetic processing (See for example, the formula in page 7 of the non-translated document: CRAE= 0.88 ( A i 2 + A j 2 , wherein A i and A j respectively represent the largest arterial vessel diameter and the smallest arterial vessel diameter of the region of interest obtained, and 0.88 is a fixed coefficient (See for example, page 13, paragraphs 1-2 of the translated document). With regard to claim 5, the medical data processing apparatus according to claim 1, wherein the medical data, i.e., the fundus image data, is at least one of MR (magnetic resonance) data, CT (computed tomography) data, ultrasonic data, PET (positron emission tomography) data, SPECT (single photon emission computed tomography) data, vital data (emphasis added by the examiner), or biopsy data (See for example, the Abstract; page 6, paragraph 4; and page 9, paragraph 3). With regard to claim 6, the medical data processing apparatus according to claim 1, wherein the medical data is at least one of time-series data, image data, waveform data, examination data, or data having three or more dimensions (See for example, page 6, paragraph 7; and page 9 paragraph 3). With regard to claim 12, the medical data processing apparatus according to claim 1, wherein the composite function is a neural network, i.e., Unet (or U-shaped convolutional neural network model), and a function for performing the arithmetic processing of the fixed coefficient is a layer of the neural network that includes the fixed coefficient as a parameter (See for example, pages 11-13). With regard to claim 16, the medical data processing apparatus according to claim 1, wherein the output data is a result of any of medical classification processing, image reconstruction processing, denoising processing, segmentation processing, or super-resolution processing performed on the medical data (See for example, page 4, paragraph 4; and page 11, paragraph 1). Claim 18 is rejected the same as claim 1 except claim 18 is a method claim. Thus, argument similar to that presented above for claim 1 is applicable to claim 18. Claim 19 is rejected the same as claim 1. Thus, argument similar to that presented above for claim 1 is applicable to claim 19. Claim 19 distinguishes from claim only in that it recites 19. a non-transitory computer readable medium including computer executable instructions. Fortunately, Liu, et al. (See for example, page 13, paragraph 4 and/or page 15, paragraphs 7-8) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Liu, et al. 128’ in view of Iqbal, et al. (Super-Resolution 1 H Magnetic Resonance Spectroscopic Imaging Utilizing Deep Learning) . With regard to claim 10, Liu, et al. (hereinafter “Liu”) discloses all of the claimed subject matter as already addressed above in paragraph 10, and incorporated herein by reference. Liu does not expressly call for the medical data being and the composite function performs, on the MR image. However , Iqbal, et al.(See for example, page 2, Section I, last paragraph through page 5, Section 2.4.3) teach this feature. Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to incorporate the teaching as taught by Iqbal, et al. into the system of Liu, if for no other reason than to introduce an MR image instead of fundus image and make analysis of an output image generated by inputting the MR image into a model such as Unet/deep learning (See for example Fig. 2, and the associated text). Therefore, it would have been obvious to combine Liu with Iqbal, et al. to obtain the invention as specified in claim 10. With regard to claim 14, the medical data processing apparatus according to claim 12, wherein the medical data is an MR image, and if there are a plurality of image regions in which a user is interested in the MR image, the fixed coefficient relating to composite data of the plurality of image regions is set in the layer, or the fixed coefficient corresponding to each of the image regions is set in each channel in the layer (See for example, page 12, paragraph 3 - page 13, paragraph 2 of Liu; and page 2, Section I, last paragraph through page 5, Section 2.4.3 of Iqbal, et al.) . 07-21-aia AIA Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Liu, et al. 128’ in view of Guang, et al. (Computer English Translation of Chinese Patent Number CN 112926738 A) . With regard to claim 15, Liu discloses all of the claimed subject matter as already addressed above in paragraph 10, and incorporated herein by reference. Liu does not expressly call for a configuration of an output layer of the neural network is switched, whereby the output data is applied to multiple tasks. However, Guang, et al. (See for example, the Abstract; and page 3, paragraph 6) teach this feature. Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to incorporate the teaching as taught by Guang, et al. into the system of Liu, so that dynamic change of the dimension of the output layer of the neural network and migration and utilization of knowledge among different tasks are realized (See for example, page 3, paragraph 6). Therefore, it would have been obvious to combine Liu with Guang, et al. to obtain the invention as specified in claim 15 . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent Application Publication Numbers: 2021/0279863 (See entire document) and 2023/0412798 (See for example, paragraph 0128) . 17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL G MARIAM whose telephone number is (571)272-7394. The examiner can normally be reached M-F 7:30-5:00 EST. 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANDREW MOYER can be reached at (571)272-9523. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. 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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. /DANIEL G MARIAM/ Primary Examiner, Art Unit 2675 Application/Control Number: 18/751,420 Page 2 Art Unit: 2675 Application/Control Number: 18/751,420 Page 3 Art Unit: 2675 Application/Control Number: 18/751,420 Page 4 Art Unit: 2675 Application/Control Number: 18/751,420 Page 5 Art Unit: 2675 Application/Control Number: 18/751,420 Page 6 Art Unit: 2675 Application/Control Number: 18/751,420 Page 7 Art Unit: 2675 Application/Control Number: 18/751,420 Page 8 Art Unit: 2675 Application/Control Number: 18/751,420 Page 9 Art Unit: 2675 Application/Control Number: 18/751,420 Page 11 Art Unit: 2675 Application/Control Number: 18/751,420 Page 12 Art Unit: 2675
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