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 .
Election/Restrictions
Applicant's election with traverse of Group III in the reply filed on 7/6/2026 is acknowledged. The traversal is on the ground(s) that the office has not shown that a serious burden would be required to examine all of the claim. This is not found persuasive because the restriction requirement mailed on has shown that invention I, II and IV do not share a technical feature with Group III that make a contribution over prior art, Yao. When there is no shared technical feature that make a contribution over prior art under PCT Rule 13.2, there would have been a search burden.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 1, 24, 37, 50 are withdrawn from consideration for being directed to non-elected subject matter. Claims 25, 51-61 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/1/2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 61 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 61 recites the cell is either a prokaryotic cell or eukaryotic cell. There are only two categories of cell in nature: eukaryotic cell and prokaryotic cell. The cell claimed in claim 25 can only be one of the two. As such, claim 61 does not further limit claim 25. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 25, 51-61 is/are rejected under 35 U.S.C. 102(a1)as being anticipated by Kasey (ACS Synth. Biol. 2018-1-19, Vol.7, no.1, pages 227-239).
Claim 25 comprises the following steps: a) identifying a naturally occurring substrate promiscuous regulator; b) engineering the naturally occurring substrate promiscuous regulator for increased sensitivity to an input signal when compared to the naturally occurring substrate promiscuous regulator; c) introducing into a cell a nucleic acid encoding the engineered regulator; and a transduction system for providing an output signal, wherein said output signal is generated in response to interaction with the input signal; d) exposing the cell of step c) to the input signal; and e) detecting an output signal.
Kasey teaches development of transcription factor based designer macrolide biosensors for metabolic engineering and synthetic biology (title). Kasey teaches identification of variants of MphR, a macrolide sensing transcription factor, that display improved sensitivity to macrolides that were very poor inducers of the wild type MphR biosensor (abstract) which meets the limitation of step a). Kasey teaches MphR was engineered by multisite saturation mutagenesis and error prone PCR, and screening to improve sensitivity to ErA (page 4, 2nd paragraph). Kasey teaches a two plasmid macrolide detection system in E. coli, which comprises a nucleic acid encoding the MphR, a transduction system that provides an output signal, PmphR promoter operably linked to gfp, when ErA is the macrolide activator (the input signal), the output is the gfp fluorescence, the output is generated when ErA is present (Figure 1B and legend). Therefore, Kasey teaches all claimed method step of claim 25.
Regarding claim 51, MphR wild type is a prokaryotic gene that encodes a substrate promiscuous regulator (page 3, 2nd paragraph).
Regarding claim 52 and 53, Kasey teaches random mutagenesis of the RBS of MphR (page 5, 3rd paragraph).
Regarding claim 54, Kasey teaches random mutagenesis throughout entire MphR coding and non-coding region provided hits with improved ErA sensitivity due to RBS mutations, and then focusing random mutation to RBS (page 5, 3rd paragraph).
Regarding claim 55-58, Kasey teaches the input signal, ErA is converted to the output signal, fluorescence, by the transduction system that comprises a transcriptional repressor, MphR and a promoter (Figure 1B and legend).
Regarding claim 59, Kasey teaches the input signal is ErA (erythromycin), which is a natural product.
Regarding claim 60, Kasey teaches MphR has broad macrolide inducer specificity including three natural occurring macrolides and three synthetic derivatives (page 9, last paragraph).
Regarding claim 61, Kasey teaches the macrolide detection system is in E. coli, which is a prokaryotic cell (page 3, last paragraph).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/Primary Examiner, Art Unit 1637
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