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 .
Receipt and entry of the response dated 4/21/2026 is acknowledged.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 11, 12, 17, 19, 25-29, 31, 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Green et al (Cell, 2014, of record). This rejection is maintained for reasons made of record in the Office Action dated 1/22/2026 and for reasons set forth below.
Claim 1 has been amended to recite that the initiator protein comprises an enzyme.
Response to Arguments
Applicant's arguments filed 4/21/2026 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) Green et al do not teach a “second stage” signal activation component that is responsive to the initiator protein; 2) GFP is not an enzyme; 3) Green et al do not teach a “two-stage cascade architecture” or “pre-formed signal amplification system already present in…the composition.”; 4) Green et al do not teach claims 11 or 12; 5) Green et al do not teach claims 17, 19, 25-29, 31 or 32.
Regarding 1), The claims do not recite a “second stage” signal activation component. All that is required is that the signal amplification component be responsive to the expression of the initiator protein. In this case, the signal amplification component is the visible light emitted by GFP, which is responsive to expression of the GFP.
Regarding 2), this is correct. However, Green et al go on to teach the use of toehold switches in the same manner to control expression of the enzymes Beta-glucoronidase and Beta-galactosidase, which are then detected with “signal activation components” (i.e. substrates) X-Gluc and X-Gal. See page 931, second column, last ¶ and Fig. 5.
Regarding 3), In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “second stage” signal activation component, “two-stage cascade architecture”, “pre-formed signal amplification system already present in…the composition.”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding 4), claim 11 recites “…(iii) a fluorescent protein…”, considered to be taught by GFP; and “(v)… one or more components of a beta-galactosidase complex…”, also taught by Green et al. Regarding claim 12, it only modifies the “…(i) a peptide comprising a protease cleavage site…” limitation of the parent claim. A fair reading of the claim does not remove the other alternatives recited in claim 11, e.g., “… a beta galactosidase complex…”.
Regarding 5), proteins, nucleic acids lipids, water are all components of “a cell free expression system”. All are found in the teachings of Green et al. Claim 19 recites “..an RNA molecule..”, as previously stated and conveniently ignored by applicants. Applicants present no specific arguments directed to claims 25-29, 31 or 32.
Claim Rejections - 35 USC § 112
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.
Claims 1-2, 7-12, 17, 19, 23, 25-29, 31 and 32 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is maintained for reasons made of record in the Office Action dated 1/22/2026 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 4/21/2026 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) the claims have been amended to recite an enzyme as the initiator protein; 2) the instant analyte recognition domain binds via nucleic acid hybridization to other nucleic acids; 3) the specification describes how the instant invention can be developed to detect other analytes; 4) the specification describes other potential substrates for the enzyme-based system; 5) the reliance on U. Rochester is inappropriate.
Regarding 1) and 4), such is not convincing. The broad claims are not limited to any particular enzyme, and the specification has not demonstrated a functional composition or method as claimed with any initiator protein other than GFP. The claims are not directed to enzymes themselves, or their characterized substrates, but rather to a complex system that requires biomolecules to interact with each other in a functional way.
Regarding 2), such is stipulated. The claims are not limited to any particular analyte, as previously set forth.
Regarding 3), such is not convincing. Applicants are requiring the skilled artisan to innovate what they have not invented or described.
Regarding 5), such is not convincing. The genus-species comparison still applies for reasons set forth above. The only species described within the claimed genus remains a system that detects nucleic acids with an RNA-based component and a GFP component.
Conclusion
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 Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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