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 .
DETAILED ACTION
Responsive to claim set of 8/23/2024
Claims pending 1-20
Claims currently under consideration 1-20
Priority
This application has a filing date of 01/12/2024 and is a 371 of
PCT/EP2022/069899 filed 07/15/2022.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Europe on 07/16/2021. It is noted, however, that applicant has not filed a certified copy of the EP 21186218.0 application as required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
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 –
(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.
Claims 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyer et al (2021 Aging Cell 20(3):e13320 17 pages – as entered in IDS)
Meyer et al teach throughout the document and especially the abstract and the materials and methods section (5), inherently unsupervised (without knowledge of gene pathway) machine learning to create a (binarized and unbinarized linear model) predictors of C. elegans and diseased human age based on transcriptome(s) thereof. Whereas on pp 2-3 including figure 1; figure 2; and section 2.4 including figure 6 - all as detailed in section 5 again, Meyer et al:
receives and transforms (e.g. rescales linearly) transcription data sets obtained from samples comprising single cells having relative (respective) values over time, such that each transcription level is a transcription level of individual gene transcripts or else pooled transcriptions level of individual gene transcripts; then
(i) generates an inner loop (embedded data) set comprising for each data sample an embedded sample, wherein a number of dimensions of the embedded samples is less than the number of transcription levels;
(ii) applies the embedded data set as an input to the predictor to produce a predicted value of the time-varying property for each embedded sample;
(iii) adjusts prediction coefficients of the predictor to reduce an error measure of prediction error between respective predicted and actual values of the time-varying property;
and repeats (i) to (iii) in an effort to select an optimal (subset) gene set for predicting organism age; then finally
measures covariance with Meyer et al reporting the binarized model performing better.
The foregoing reads on claims 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is drawn to an abstract idea without significantly more. Sole independent claim 1 lines 1-3,8-13 is directed to applying machine learning to gene transcription data to generate a predictor model (algorithm) of a property that varies over time by typical steps including:
receiving a data set comprising data;
generating an embedded data set comprising for each data sample an embedded sample, wherein a number of dimensions of the embedded samples is less than the number of transcription levels;
applying the embedded data set as an input to the predictor to produce a predicted value of the time-varying property for each embedded sample; and
adjusting prediction coefficients of the predictor to reduce an error measure of prediction error between respective predicted and actual values of the time-varying property. Said step(s) is(are) further delineated in terms of transformations, statistics and/or different thinking (without knowledge of gene pathway) steps or else the model further transformed in dependent claims 2-12; 15 particularly when drawn to simply chronological age; 16,17; and 18 particularly when drawn to simply a condition.
Such receiving, generating, applying and adjusting constitute(s) mental process(es) or else mathematical concepts.
MPEP 2106 eligibility step 1 & 2A prong 1: statutory but a judicial exception ?
While the presently claimed subject matter is a process that falls under the four categories of statutory subject matter, as interpreted in MPEP 2106.04(a) particularly at pp 2100-37 or 2100-32, the courts have held methods that can be performed mentally (without knowledge), using pen and paper or even aided by a computer; and mathematical concepts including calculations with equations (e.g. matrix transformations, scaling, mapping), algorithms or performing a resampled statistical analysis as in claims 2-9;10 lines 1-2, 4-12; 11 lines 1-2,4-12;12 are judicial exceptions to patent eligible subject matter.
MPEP 2106 eligibility step 2A prong 2: is the judicial exception integrated ?
In accordance with MPEP 2106.05(g,f, & h), such judicial exceptions are not integrated into a practical application as follows.
Samples being obtained from respective cell samples having different values of the time-varying property, each data sample comprising a number of transcription levels, and a respective actual value of the time-varying property of the cell sample for each data sample, wherein each transcription level is a transcription level of an individual gene transcript or a pooled transcription level of gene transcripts of an individual gene per claim 1 lines 3-7; 10 & 11 each in line 2; and outputting (generating) a report of claim 13 represent extra-solution activity in being mere data gathering.
Claim 11 lines 12-18 represent instructions to apply the model (predictor).
Claims 19-20 being drawn to the recited condition being Alzheimer's disease or Parkinson's disease represent a token or incidental field of use or technological environment limitation.
MPEP 2106 eligibility step 2B: do any other additional elements provide an inventive concept with significantly more ?
A single cell from an organism or subject per claims 13 lines 1-2; and 14 are insufficient to amount to significantly more than the judicial exception(s), since measuring properties of one cell constitutes well-understood, routine, conventional activity in molecular biology, as evidenced by Stuart et al (2019 Nature Reviews Genetics 20:257-72 – as entered in IDS; cf title, first paragraph of text). And moreover, single cell transcriptome analysis applied toward cancer biology as now similarly being well-understood, routine, conventional like claims 18-19 is further shown by the Stuart review in the first full paragraph of p 263.
As such considered separately and in combination, the additional elements do not furnish an inventive concept, and as such claims 1-20 represent patent ineligible subject matter.
In the event the determination of the status of the application as subject to AIA 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684
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