I. ACKNOWLEDGEMENT
This Office Action addresses U.S. Application No. 18/689257 (“’257 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is March 5, 2024, 2024.
II. STATUS OF CLAIMS
Claims 1-22 were filed with the application. The preliminary amendment of 3/5/2024 cancelled claims 1-22 and added claims 23-48. Therefore, as of the date of this Office Action, the status of the claims is:
a. Claims 23-48 (“Pending Claims”).
b. Claims 23-48 are examined (“Examined Claims”)
III. PRIORITY AND CONTINUING DATA
The ‘257 application is a national stage entry of PCT/JP2022/046352, filed 12/16/022, which claims priority to Chinese application 202219149360.2, filed 2/18/2022. Because the earliest possible effective filing date is after March 16, 2013, the first to file provision of the AIA , apply to this proceeding.
IV. CLAIM INTERPRETATION
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
The obtainment unit, the classification unit, and the output unit in claims 35-46 and 48.
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.
V. REJECTIONS UNDER 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 23-48 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more (See MPEP 2106.04(a)).
Claim 23 recites the limitations:
Obtaining for a plurality of subjects with mild cognitive impairment, a score result of a clinical physiological test . . . and a hippocampus volume of the subject
Classifying the plurality of subjects into one of a plurality of groups based on the score and hippocampus volume . . .
Outputting a classification result of the classifying, wherein:
The hippocampus volume is a right hippocampus volume, …
the clinical psychological test is an Alzheimer’s disease assessment scale- cognitive subscale test,
in the classifying … the subject is classified into the first group if the score of the subject is greater than a first threshold and the right hippocampus volume of the subject is less than a second threshold, and classified into the second group if the score of the subject is less than the first threshold and the right hippocampus volume of the subject is greater than the second threshold, the first threshold is 20.0±1 SD, the second threshold is 3.651±1 SD [cm.sup.3], the 1 SD of the first threshold is 6.3, and the 1 SD of the second threshold is 0.653 [cm.sup.3].
The first step in the 101 analysis, step 1 in MPEP 2106, is whether the claimed invention is in one of the 4 statutory classes of invention. Here, the claim is drawn to a stratification method, which is one of the 4 statutory classes of invention. Hence, step 1 is satisfied.
The next step in the analysis, step 2A prong one, is whether the claim is directed to judicial exception, i.e. a law of nature, a natural phenomenon, or an abstract idea. Here, the classifying step is a mental process that can be performed using a pencil and paper. Furthermore, the classifying requires comparison to a threshold, which is a mathematical process. Both mental processes and mathematical processes are recognized as judicial exceptions that recite an abstract idea. See MPEP 2164
In Step 2A, prong two of the analysis, the claim is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application.
There are two additional elements in the claims. First, the obtaining step is merely a data-gathering step which is insignificant pre-solution activity. Second, the outputting step is insignificant post solution activity. Therefore, the additional elements and steps do not integrate the claim into a practical application. As such, the answer to step 2A, prong 2, is no.
The final step of the analysis, step 2B, where the claim is evaluated to determine whether the recited additional elements amount to significantly more than the judicial exception. Here, the additional steps and structure are simply well-understood, routine, and conventional processing steps and structure. Hence, the step does not recite an inventive concept.
As such, claim 23 is directed to an abstract idea and is not patent eligible.
Claims 24, 26-31, and 33 all recite different methods with essentially the same processing steps, with differing degree of detail. As such, those claims are also drawn to an abstract idea and are not patent eligible.
Dependent claims 25, 32, 43, and 47 do not add anything that changes the analysis and therefore the claims are also reject as being drawn to an abstract idea.
Claims 35-46 and 48 are drawn to devices that perform the same process as recited in the method. The structure recite is recited at a high level of generality and therefore does not integrate the abstract idea into a practical application. As such, the claims are also rejected.
V1. REJECTIONS UNDER 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.
Claims 24-26, 36-38, and 47-48 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.
Claims 24 and 36 are rejected as being indefinite in that the claims refer to a third and fourth threshold, but no first and second threshold has been recited. This causes confusion as to the number of thresholds in the claim.
Claims 26 and 38 are rejected as being indefinite in that the claims refer to a fifth, sixth, and seventh threshold, but no first, second, third, or fourth threshold has been recited. This causes confusion as to the number of thresholds in the claim.
Claims 25, 37, 47, and 48 are rejected as being dependent upon a rejected base claim.
VII. ALLOWABLE SUBJECT MATTER
Claims 23-48 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, 2nd paragraph, set forth in this Office action.
Claims 23 and 35 define over the art of record in that none of the art teaches the method where the subject is classified into a first group of relatively high risk of future progression of Alzheimer’s disease if the score from an Alzheimer’s disease assessment scale – cognitive subscale test of the subject is greater than a first threshold and the right hippocampus volume of the subject is less than a second threshold, and classified into a second group of relatively lower risk for future progression if the score of the subject is less than the first threshold and the right hippocampus volume of the subject is greater than the second threshold, the first threshold is 20.0±1 SD, the second threshold is 3.651±1 SD [cm.sup.3], the 1 SD of the first threshold is 6.3, and the 1 SD of the second threshold is 0.653 [cm.sup.3].
Claims 24, 25, 36, 37, 47, and 48 define over the art of record in that none of the art teaches the method where the subject is classified into a first group of relatively high risk of future progression of Alzheimer’s disease if the score from a preclinical Alzheimer’s cognitive composite test of the subject is less than a third threshold and the right hippocampus volume of the subject is greater than a fourth threshold and classified into a second group of relatively lower risk for future progression if the score of the subject is greater than the third threshold and the right hippocampus volume of the subject is greater than the fourth threshold, the third threshold is 0.111±1 SD, the fourth threshold is 3.651±1 SD [cm.sup.3], the 1 SD of the third threshold is 2.630, and the 1 SD of the fourth threshold is 0.653 [cm.sup.3].
Claims 26 and 38 define over the art of record in that none of the art teaches the method where the subject is classified into a first group of relatively high risk of future progression of Alzheimer’s disease in any of the following cases:
if a first score obtained as a result of the Alzheimer's disease assessment scale-cognitive subscale test performed on the subject is less than a fifth threshold, the right hippocampus volume of the subject is greater than a sixth threshold, the information indicates the subject is an apolipoprotein Eε4 gene carrier, and a second score obtained as a result of the preclinical Alzheimer's cognitive composite test performed on the subject is less than a seventh threshold, the first score being the score;
(2) if the first score of the subject is greater than the fifth threshold, the right hippocampus volume of the subject is greater than the sixth threshold, the information indicates the subject is an apolipoprotein Eε4 gene carrier, and the second score of the subject is less than the seventh threshold;
(3) if the first score of the subject is greater than the fifth threshold and the right hippocampus volume of the subject is less than the sixth threshold; or
(4) if the first score of the subject is less than the fifth threshold, the right hippocampus volume of the subject is less than the sixth threshold, the information indicates the subject is an apolipoprotein Eε4 gene carrier, and the second score of the subject is less than the seventh threshold
and classified into a second group of relatively lower risk for future progression in any of the following cases:
(5) if the first score of the subject is less than the fifth threshold, the right hippocampus volume of the subject is greater than the sixth threshold, the information indicates the subject is an apolipoprotein Eε4 gene carrier, and the second score of the subject is greater than the seventh threshold;
(6) if the first score of the subject is greater than the fifth threshold, the right hippocampus volume of the subject is greater than the sixth threshold, the information indicates the subject is an apolipoprotein Eε4 gene carrier, and the second score of the subject is greater than the seventh threshold; or
(7) if the first score of the subject is less than the fifth threshold, the right hippocampus volume of the subject is greater than the sixth threshold, and the information indicates the subject is not an apolipoprotein Eε4 gene carrier,
the fifth threshold is 20.0±1 SD, the sixth threshold is 3.651±1 SD [cm.sup.3], the seventh threshold is 0.111±1 SD, the 1 SD of the fifth threshold is 6.3, the 1 SD of the sixth threshold is 0.653 [cm.sup.3], and the 1 SD of the seventh threshold is 2.630.
Claims 27 and 39 define over the art of record in that none of the art teaches the method where the subject is classified into a first group of relatively high risk of future progression of Alzheimer’s disease if the score from an Alzheimer’s disease assessment scale – cognitive subscale test performed on the subject is greater than a first threshold and the left hippocampus volume of the subject is less than a second threshold and classified into a second group of relatively lower risk for future progression if the score of the subject is less than the first threshold and the left hippocampus volume of the subject is greater than the second threshold, the first threshold is 14.0±1 SD, the second threshold is 3.459±1 SD [cm.sup.3], the 1 SD of the first threshold is 6.9, and the 1 SD of the second threshold is 0.5435 [cm.sup.3].
Claims 28 and 40 define over the art of record in that none of the art teaches the method where the subject is classified into a first group of relatively high risk of future progression of Alzheimer’s disease if the score from an Alzheimer’s disease assessment scale – cognitive subscale test performed on the subject is greater than a first threshold and the left hippocampus volume of the subject is less than a second threshold and classified into a second group of relatively lower risk for future progression if the score of the subject is less than the first threshold and the left hippocampus volume of the subject is greater than the second threshold, the first threshold is 12.0, and the second threshold is 3.737 [cm.sup.3].
Claims 29 and 41 define over the art of record in that none of the art teaches the method where the subject is classified into a first group of relatively high risk of future progression of Alzheimer’s disease if the score from an Alzheimer’s disease assessment scale – cognitive subscale test performed on the subject is greater than a first threshold and the left hippocampus volume of the subject is less than a second threshold and classified into a second group of relatively lower risk for future progression if the score of the subject is less than the first threshold and the left hippocampus volume of the subject is greater than the second threshold, the first threshold is 21.0, and the second threshold is 3.080 [cm.sup.3].
Claims 30 and 42 define over the art of record in that none of the art teaches the method where the subject is classified into a first group of relatively high risk of future progression of Alzheimer’s disease if the score from an Alzheimer’s disease assessment scale – cognitive subscale test performed on the subject is greater than a first threshold and the left hippocampus volume of the subject is less than a second threshold and classified into a second group of relatively lower risk for future progression if the score of the subject is less than the first threshold and the left hippocampus volume of the subject is greater than the second threshold, the first threshold is 24.0, and the second threshold is 2.751 [cm.sup.3].
Claims 31-34 and 43-46 define over the art in that none of the art teaches where the subject is classified one of a first group of relatively high risk of future progression of Alzheimer’s disease and a second group of relatively lower risk for future progression based on a calculated volume score indicating a ratio between left hippocampus volume and a score from an Alzheimer’s disease assessment scale – cognitive subscale test.
VIII. CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
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/ROBERT L NASSER/ Primary Examiner, Art Unit 3992