DETAILED ACTION
Comments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-6 are pending and examined in the instant Office action.
Priority
The instant application is a continuation-in-part of PCT/CN2022/120423, filed 9/22/2022. Application ‘423 claims foreign priority to Chinese application CN202111182323.3, filed 10/11/2021. A certified copy of the Chinese patent application is in the image file wrapper.
This Office action includes a copy of WO2023061174A1, the published WIPO of PCT/CN2022/120423, and an English machine translation of WO2023061174A1.
Claim Interpretation - Means plus function
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: “data table establishment module,” “data sorting module,” “characteristic extraction module,” and “model construction module” in claims 5-6
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.
While paragraph 95 of the specification exemplifies the structure of each module as computer hardware components, paragraph 95 of the specification does not limit the modules to only consist of hardware components. Consequently, each module is interpreted to comprise hardware or software.
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 5-6 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. As discussed in the claim interpretation section above, since the modules can comprise software, the devices in each of claims 5 and 6 are interpreted to consist of software. Software, per se, is not a statutory category of invention.
Claims 1-4 are not rejected under this statute because claims 1-4 are drawn to methods.
While the algorithms of claims 1-6 recite judicial exceptions, the algorithms in each of claims 1-6 require use of the random forest algorithm as the core of the machine learning model in the ASD risk prediction model. Since this type of machine learning is too complex to be conducted in the human mind, the algorithms in claims 1-6 are considered subject matter eligible.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunkel et al. [WO 2011112961 A1].
Claims 1-6 are drawn to a method and device for constructing an ASD risk model.
The document of Kunkel et al. studies methods and compositions for characterizing ASD based on gene expression patterns [title]. The cover figure of Kunkel et al. illustrates a flow chart containing four tables of data: a training set containing blood data from 97 ASDs (first table) and 72 controls (second table) and a validation set containing blood data from 99 ASDs (third table) and 109 controls (fourth table). The cover figure of Kunkel et al. illustrates iteratively comparing and manipulating tables of training to tables of test data to develop a ASD risk prediction model. Lines 19-25 on page 4 of Kunkel et al. teaches use of random forest models as machine learning models. Table 1 on page 49 of Kunkel et al. lists relevant genes and their weights (i.e. p-values). While the machine learning in Kunkel et al. is binary (i.e. either autism is present or absent), Table 2 on page 50 of Kunkel et al. teaches stratification of autism into classes comprising autism, PDD-NOS, and Asperger’s disorder (i.e. a mild version of autism). Table 4 starting on page 51 of Kunkel et al. lists differentially expressed genes with their weightings (i.e. p-values), Welch’s t-test values, false discovery rates, and pAUCs. Page 48 of Kunkel et al. relates sensitivities to specificities. In addition to weightings, p-values give indication a probability is gene/marker is associated with autism.
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify the binary application of random forest models to identify the presence/absence pattern of autism by use of a more stratified spectrum predicting model, wherein the motivation would have been that stratifying the severity of autism in the machine learning model optimizes the autism prediction model to encompass more of the autism spectrum [Table 2 of Kunkel et al.].
Related Art
The document of Jing et al. [CN 113889274A] teaches a method and device for constructing risk prediction of autism spectrum disorder. Jing et al. is a Chinese publication with an overlapping inventive entity that discussed much of the same subject matter disclosed in the instant specification. A copy of Jing et al. and the English machine translation of Jing et al. are included with this Office action.
The document of Koeda et al. [WO 2021039883 A1] discusses a method and device for developing a model to predict autism using analysis of image data. A copy of Koeda and an English machine translation of Koeda et al. are included with this Office action.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/Primary Examiner, Art Unit 1686 4 August 2026
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