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 1-10 are pending and examined in the instant Office action.
Withdrawn Rejections
The 35 U.S.C. 112(b), written description, and first enablement rejections of the previous Office action are withdrawn in view of amendments filed to the instant set of claims on 23 December 2025.
Claim Rejections - 35 USC § 112(a) - Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following rejection is reiterated:
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
1. The claims recite a gene circuit (or method of construction a gene circuit) that performs the functions of an artificial neural network. It is not understood as to how a series of gene activations by promoters imitates an artificial neural network.
2. The specification does not disclose how to make a neural network. Figure 1 of the drawings illustrates a conceptualized neural network with sets of chain reactions of cascading promoters activating gene expressions of other promoters. However, the specification does not explain how this is a neural network. Figures 2 and 4 also illustrate that a plurality of input nodes interact with a plurality of hidden nodes, and a plurality of hidden nodes interact with a plurality of output nodes in artificial neural networks. The configuration illustrated in Figure 1 does not possess this property of an artificial neural network. In other words, in Figure 1, the gene expression acts in single downstream sets of reactions.
3. The prior art of Kalogirou et al. [Encyclopedia of Energy, 1st edition, 2004] illustrates in Figure 3 artificial neural networks, it is normal for hidden layers to interact with both preceding and following layers.
4. The claims do not teach how to use generate a gene circuit that imitates a neural network. While the specification and prior art explain how artificial neural networks work, the alleged imitated neural network of Figure 1 of the specification does not teach a plurality of input nodes interacting with a plurality of hidden nodes, and a plurality of hidden nodes interacting with a plurality of output nodes (i.e. that is typical of a neural network). In the absence of guidance from the application, it is unpredictable as to how to use of cascading networks of gene expression in Figure 1 to imitate an artificial neural network Such unpredictability yields UNDUE EXPERIMENTATION.
In view of the above, it is the Examiner’s position that with the insufficient guidance and working examples and in view of unpredictability and the state of art, one of skill in the art could not make and/or use the invention with the claimed breadth without an undue amount of experimentation.
Response to Arguments
Applicant's arguments filed 23 December 2025 have been fully considered but they are not persuasive.
Applicant argues that paragraph 30 of the specification describes how the gene circuit functions as a neural network. This argument is not persuasive because paragraph 30 of the specification describes cascading gene expression and promoter generation, which is not equivalent to an artificial neural network.
Applicant argues that paragraph 6 of the specification describes the gene circuit imitates the function of an artificial neural network. This argument is not persuasive because paragraph 6 of the specification describes gene expression.
Applicant argues that since paragraph 43 of the specification describes a correlation of 0.496 when predicting toxicity, the gene circuit is a successful artificial neural network. This argument is not persuasive because successful property prediction do not necessarily result from usage of an artificial neural network.
Applicant argues that neural networks to not require bidirectional calculations. Bidirectional calculations are not cited in the aforementioned rejection statement.
Applicant provides the general assertion that paragraph 32 of the specification discloses that the gene circuit imitating an artificial neural network can be modified to mimic other artificial neural network gene circuits, such as a recurrent neural network. However, applicant does not provide evidence or a description of how this is accomplished.
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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 28 February 2026