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
Application status
Claims 1-3, 5, 13, 15, 18-21, 35-36, 41-46, 53-54, 59-60 and 76-85 are pending in this application.
Priority
The instant application is the 371 national stage entry of PCT/US2021/021249, filed on 03/05/2021, which claims benefit of 62985538 filed on 03/05/2020.
Election
Applicant's election with traverse of Group I, Claims 1, 3, 5, 18-20, 35, 41-42 and 80-81 in the response filed on 04/23/07, is acknowledged.
Applicant argues that examining both the product claims and the process claims would require minimal additional searching compared to either set of claims alone. Second, even as between the claims of Groups I and II, the different structures required include substantially the same components. Accordingly, Applicant respectfully asserts that the incremental searching required for both Groups of claims would be minimal, compared to the searching for either set of claims alone. A similar relationship exists between the claims in Groups III and IV, and between the claims in Groups V and VI. For at least these reasons, Applicant submits that the extent of the required restrictions between the groups of claims is excessive. On this basis, Applicant reserves the right to petition under 37 CFR 1.144 for reconsideration of the restriction requirement.
Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons. The restriction for examination purposes as indicated previously is proper because there would be a serious search and examination burden if restriction were not required because (i) the prior art applicable to one invention would not likely be applicable to another invention; and (ii) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph (italicized for added emphasis).
Claims 2, 13, 15, 21, 36, 43-46, 53-54, 59-60, 76-79 and 82-85 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a non-elected invention.
For the reasons provided above, this restriction requirement is deemed proper, and therefore, it is made final.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/31/2023 and 06/28/2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the phrase “high affinity” which is a relative term which renders the claim indefinite. The phrase “high affinity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the interest of advancing prosecution, claim 1 is interpreted as “a nucleic acid comprising a mRNA display cassette, the mRNA display cassette comprising a cloning site for insertion of a nucleotide sequence encoding a protein of interest operably linked to (i) a nucleotide sequence encoding a RNA binding protein so that it encodes a fusion protein of the protein of interest and the RNA binding protein and (ii) to a nucleotide sequence encoding a cognate RNA sequence wherein the RNA binding protein binds to the cognate RNA sequence.”
Claim Rejections - 35 U.S.C. § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5, 18-20, 35, 41-42 and 80-81 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Wagner et al. (US Patent Application No. 2018/0094256 A1, see IDS).
The instant claims are drawn to a nucleic acid comprising a mRNA display cassette, the mRNA display cassette comprising a cloning site for insertion of a nucleotide sequence encoding a protein of interest operably linked to (i) a nucleotide sequence encoding a RNA binding protein so that it encodes a fusion protein of the protein of interest and the RNA binding protein and (ii) to a nucleotide sequence encoding a cognate RNA sequence wherein the RNA binding protein binds to the cognate RNA sequence.
Wagner et al. teach a nucleic acid or a population of nucleic acids (see para [0160]) comprising a mRNA display cassette (an X-display complex comprising a nucleic acid molecule, i.e., an mRNA molecule, (see Figures 1-4) comprising a cloning site for insertion of a nucleotide sequence encoding a polypeptide or interest (see para [0020]; [0035]-[0037], [0106]) [0035]-[0037]), optionally wherein said mRNA is provided in a vector (see para [0172]), which can be comprised in a host cell (see para [0176] and [0344]), and further wherein said mRNA display cassette comprises a second nucleotide sequence encoding a different protein of interest (see para [0043]), which anticipates Applicants’ claims 1, 3, 5, 18-20, 35, 41-42 and 80-81.
It is noted by the Examiner the “intended use” limitations recited in claims 1, 5 and 80-81 are included in this rejection, i.e.,
[a] “for insertion of a nucleotide sequence encoding a protein of interest operably linked to (i) a nucleotide sequence encoding a RNA binding protein so that it encodes a fusion protein of the protein of interest and the RNA binding protein and (ii) to a nucleotide sequence encoding a cognate RNA sequence wherein the RNA binding protein binds to the cognate RNA sequence with high-affinity” as recited in the preamble of claim 1, or
[b] descriptions of what/where the RNA binding protein or the cognate RNA sequence is as recited in claims 5 and 80-81,
because they do not result in a structural difference between the claimed composition and the prior art in order to distinguish the claimed composition from that of the prior art. Therefore, because Applicants’ claimed composition is identical in structure to the nucleic acid comprising a mRNA display cassette as taught by Wagner et al., it anticipates claimed invention regardless of the “intended use” limitations. For the reasons provided herein, the invention as claimed is anticipated by teachings of Wagner et al.
Conclusion
Claims 1, 3, 5, 18-20, 35, 41-42 and 80-81 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
The instant Office action is non-final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656