DETAILED ACTION
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2 December 2024 is being considered by the examiner.
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 1-15 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.
Independent claim 1 recites the variable N without defining it. Thus, the claims also allow for N to be zero, which would mean no image portions are selected, which would mean the risk is not even determined, thus calling into question whether the last limitation is even positively recited. Further, the specification merely recites, in paragraph [0024] for example, that N is a positive integer. Even if this definition is read into the claims, N could merely be the total number of the plurality of cell-image portions. In other words, all of the cell-image portions can be selected in the claims, and thus it is unclear how the selected N correspond to the greatest ones of the ratios could be selected if N allows all of them to be selected, which would also include the lowest one of the ratios. Therefore, the claim is indefinite.
Claims 2-15 are rejected due to their dependency from claim 1.
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 and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites a method of assessing a risk of a subject developing breast cancer, the method comprising: obtaining an original section image…for each of the cell-image portions, determining a number of specific protein signals shown in the cell-image portion as a specific protein number, the specific protein signals all indicating a specific protein, determining a number of specific chromosome signals shown in the cell-image portion as a specific chromosome number, the specific chromosome signals all indicating a specific chromosome, and calculating a ratio of the specific protein number to the specific chromosome number as an individual protein-to-chromosome ratio; selecting N number of critical cell-image portions from among the cell-image portions, the N number of critical cell-image portions respectively corresponding to greatest N ones of the individual protein-to-chromosome ratios that are calculated respectively for the cell-image portions; and determining the risk of the subject developing breast cancer based on the specific protein number and the specific chromosome number determined for each of the N number of critical cell-image portions.
The limitations of obtaining, determining, calculating, selecting and determining, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. Nothing in the claimed elements precludes the steps from practically being performed in the mind. For example, as admitted in paragraph [0004] of the applicant’s specification, the obtaining, determining, calculating, selecting and determining can be performed by hand by a user. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims don’t recite any additional elements to perform the recited steps. Accordingly, the claims do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim(s) does/do 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, there are no additional elements claimed. The claim is not patent eligible.
Claim 2 recites “wherein determining the risk of the subject developing breast cancer includes: calculating a sum of the specific protein numbers determined for all of the N number of critical cell-image portions as a total protein number; calculating a sum of the specific chromosome numbers determined for all of the N number of critical cell-image portions as a total chromosome number; calculating a ratio of the total protein number to the total chromosome number as a total protein-to-chromosome ratio; calculating a quotient of the total protein number divided by N as an average protein number; and determining the risk of the subject developing breast cancer based on the total protein-to-chromosome ratio and the average protein number.” Similar to the analysis of claim 1 above, the limitations cover performance of the limitations in the mind and fall within the “Mental Processes” grouping of abstract ideas. None of these limitations provide any additional elements that are sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 3 recites “making a first determination on whether the total protein-to-chromosome ratio is less than a first threshold; making a second determination on whether the average protein number is less than a second threshold; and determining the risk of the subject developing breast cancer based on a result of the first determination and a result of the second determination.” Similar to the analysis of claim 1 above, the limitations cover performance of the limitations in the mind and fall within the “Mental Processes” grouping of abstract ideas. None of these limitations provide any additional elements that are sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 4 recites “making a third determination on whether the average protein number is less than a third threshold that is greater than the second threshold; determining the risk of the subject developing breast cancer further based on a result of the third determination.” Similar to the analysis of claim 1 above, the limitations cover performance of the limitations in the mind and fall within the “Mental Processes” grouping of abstract ideas. None of these limitations provide any additional elements that are sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 5 recites “in response to determining that the total protein-to-chromosome ratio is not less than the first threshold and the average protein number is not less than the second threshold, determining that the risk of the subject developing breast cancer is relatively high; in response to determining that the total protein-to-chromosome ratio is not less than the first threshold and the average protein number is less than the second threshold, determining that the risk of the subject developing breast cancer is relatively low; in response to determining that the total protein-to-chromosome ratio is less than the first threshold and the average protein number is not less than the third threshold, determining that the risk of the subject developing breast cancer is relatively high; in response to determining that the total protein-to-chromosome ratio is less than the first threshold and the average protein number is less than the third threshold but is not less than the second threshold, determining that the risk of the subject developing breast cancer is relatively low; and in response to determining that the total protein-to-chromosome ratio is less than the first threshold and the average protein number is less than the second threshold, determining that the risk of the subject developing breast cancer is relatively low.” Similar to the analysis of claim 1 above, the limitations cover performance of the limitations in the mind and fall within the “Mental Processes” grouping of abstract ideas. None of these limitations provide any additional elements that are sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 13 recites “generating a critical-cell report that contains, for each of the N number of critical cell-image portions, the specific protein number, the specific chromosome number and the individual protein-to-chromosome ratio.” Similar to the analysis of claim 1 above, the limitations cover performance of the limitations in the mind and fall within the “Mental Processes” grouping of abstract ideas. None of these limitations provide any additional elements that are sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 14 recites “before selecting N number of critical cell-image portions, sorting the cell-image portions in order of the individual protein-to-chromosome ratios from greatest to smallest.” Similar to the analysis of claim 1 above, the limitations cover performance of the limitations in the mind and fall within the “Mental Processes” grouping of abstract ideas. None of these limitations provide any additional elements that are sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Allowable Subject Matter
Claims 6-12 and 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The primary reasons for indicating allowable subject matter in claim 6 is the inclusion of the limitations reciting “for each of the specific protein signals, determining a position of the specific protein signal in the original section image; for each of the specific chromosome signals, determining a position of the specific chromosome signal in the original section image; removing all of the specific protein signals and the specific chromosome signals from the original section image to obtain a signal-removed image; and for each of the cell-image portions in the signal-removed image, detecting a boundary of the cell-image portion to obtain a range of the cell-image portion, wherein determining the specific protein number for each of the cell-image portions is to count a number of the specific protein signals, each of which has the position within the range of the cell-image portion before being removed, as the specific protein number, and wherein determining the specific chromosome number for each of the cell-image portions is to count a number of the specific chromosome signals, each of which has the position within the range of the cell-image portion before being removed, as the specific chromosome number” which, in combination with the other recited features, is not taught and/or suggested either singularly or in combination within the prior art.
Claims 7-12 are objected to due to their dependency from claim 6.
The primary reasons for indicating allowable subject matter in claim 15 is the inclusion of the limitations reciting “subsequent to selecting N number of critical cell-image portions and prior to determining the risk of the subject developing breast cancer: calculating a sum of the specific protein numbers determined for all of the N number of critical cell-image portions as a total protein number; calculating a sum of the specific chromosome numbers determined for all of the N number of critical cell-image portions as a total chromosome number; calculating a ratio of the total protein number to the total chromosome number as a total protein-to-chromosome ratio; determining whether the total protein-to-chromosome ratio is between 1.8 and 2.2; and in response to determining that the total protein-to-chromosome ratio is between 1.8 and 2.2, selecting additional N number of critical cell-image portions from among the cell-image portions, and combining the additional N number of critical cell-image portions and the N number of critical cell-image portions previously selected into 2N number of critical cell-image portions, where the additional N number of critical cell-image portions respectively correspond to greatest N ones of the individual protein-to-chromosome ratios successive to the greatest N ones of the individual protein-to-chromosome ratios, to which the N number of critical cell-image portions respectively correspond, wherein determining the risk of the subject developing breast cancer includes calculating a sum of the specific protein numbers determined for all of the 2N number of critical cell-image portions as another total protein number, calculating a sum of the specific chromosome numbers determined for all of the 2N number of critical cell-image portions as another total chromosome number, calculating a ratio of the another total protein number to the another total chromosome number as another total protein-to-chromosome ratio, calculating a quotient of the another total protein number divided by 2N as an average protein number, and determining the risk of the subject developing breast cancer based on the another total protein-to-chromosome ratio and the average protein number” which, in combination with the other recited features, is not taught and/or suggested either singularly or in combination within the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Polyak et al. (US 11,644,466) discloses methods for treating, preventing and predicting risk of developing breast cancer.
Chukka et al. (US 2021/0285056) discloses image processing systems and methods for automatically analyzing digital images of biological samples stained for the presence of protein and/or nucleic acid biomarkers and automatically detecting and quantifying signals corresponding to one or more biomarkers.
Fu et al. (US 2021/0027890) discloses of detecting, evaluating and predicting system for cancer risk.
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/STEPHEN G SHERMAN/Primary Examiner, Art Unit 2621
24 August 2026
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