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
In response to the previous Office action, a non-Final rejection (mailed on 12/29/2025), Applicants filed a response and amendment received on 04/09/2026. Said amendment canceled Claims 4, 6-12, 14, 16-17, 22-34, 37-40, 47-52, 55-58 and 61-75, and amended Claims 1-2. Thus, Claims 1, 3, 5, 18-20, 35, 41-42 and 80-81 are at issue and present for examination.
It is noted by the Examiner that Claims 2, 13, 15, 21, 36, 43-46, 53-54, 59-60, 76-79 and 82-85 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a non-elected invention in the previous Office actions, a non-Final rejection (mailed on 12/29/2025).
Claim Rejections - 35 USC § 112 - WITHDRAWN
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.
The previous rejection of Claim 1 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn by virtue of Applicants’ amendment.
Claim Rejections - 35 U.S.C. § 102 - MAINTAINED
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 para [0044]; Figures 1-4) comprising a cloning site for insertion of a nucleotide sequence encoding a polypeptide or interest (see para [0020]; [0035]-[0037]; [0106]), optionally wherein said mRNA is provided in a vector (see para [0171]-[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” 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 claim 1, and
[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.
Applicants’ Arguments:
As noted by the Office, the instant claims address the following:
1. A nucleic acid, comprising
a. A mRNA display cassette, comprising
b. A cloning site for insertion of
c. a nucleotide sequence,
i. the sequence encoding a protein of interest operably linked to
ii. a nucleotide sequence encoding a RNA binding protein, so that the sequence encodes a fusion protein of the protein of interest and the RNA binding protein,
and to
iii. a nucleotide sequence encoding a cognate RNA sequence wherein the RNA binding protein binds to the cognate RNA sequence.
Thus, the present claims require 7 distinct elements, including two specific nucleic acid sequences.
In stark contrast, even as expressly cited by the Office, the Wagner reference does not expressly include each of these 7 distinct elements, much less "in as complete detail as contained in the claim."
For example, the Office cites Wagner at [0020], [0035] to [0037], [0106], as well as Figures 1-4. At [0020] and [0035] to [0037], Wagner describes the "X-display complex" as comprising a nucleic acid molecule comprising a polypeptide-encoding sequence, covalently bound to a first high infinity ligand; a polypeptide encoded by the nucleic acid molecule; and a ligand acceptor bound to a peptide acceptor. The ligand is bound to the ligand acceptor and the peptide acceptor is covalently bound to the polypeptide. See [0020]. See also [0035] to [0037]; [0106]; Figures 1- 4; and Figures 16A to 16B (cited by [0106]).
Wagner's structure as cited does not encompass the mRNA display cassette as specified in the claims. Functionally, the X-display complex is not a nucleic acid structure. It clearly is missing at least the following claimed elements:
- the cloning site for insertion of a nucleotide sequence;
- the nucleotide sequence encoding a fusion protein of the protein of interest and the RNA binding protein; and
- the nucleotide sequence encoding a cognate RNA sequence wherein the RNA binding protein binds to the cognate RNA sequence.
Accordingly, Wagner does not set forth each and every element as set forth in the claim, and cannot reasonably be deemed to anticipate the pending claims. Applicant respectfully requests reconsideration and withdrawal of these rejections, for at least these reasons.
Examiner’s Explanation:
Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons.
First, as mentioned above, the following limitations recited in claims 1, 5 and 80-81”
[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 claim 1, and
[b] descriptions of what/where the RNA binding protein or the cognate RNA sequence is as recited in claims 5 and 80-81
are interpreted as “intended use” limitations 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. In other words, the only structural feature claimed in claim 1 is a nucleic acid comprising a mRNA display cassette, the mRNA display cassette comprising a cloning site.
Therefore, contrary to Applicants’ assertion, the X-display complex taught by Wagner et al. is made up of mRNA display cassette (see para [0044]; Figures 1-4). Further evidences from Wagner et al. teach that X-display complex is indeed a nucleic acid structure, i.e. ssDNA as shown in Figure 16A, dsDNA as shown in Figure 16B, and Figures 27-28 and additional support para [0008]-[0012] teach that the X-display complex comprises (a) a first nucleic acid molecule comprising a polypeptide-encoding sequence, i.e., protein of interest (POI); (b) a polypeptide encoded by the first nucleic acid molecule; and (c) a second nucleic acid molecule comprising a nucleic sequence complementary to a portion of the first nucleic acid molecule, wherein the first nucleic acid molecule is bound to the second nucleic molecule through complementary nucleic acid base pairing, and wherein the second nucleic acid molecule is non-covalently bound to the polypeptide.
Furthermore, contrary to Applicants’ assertion, Wagner et al. directly teach library construction via designed primer-defined sites for cloning/insertion (see Table 2) which are used to directly insert POI into a suitable display construct, i.e. “suitable vectors can be chosen or constructed, containing appropriate regulatory sequences, including promoter sequences, terminator sequences, polyadenylation sequences, enhancer sequences, marker genes and other sequences as appropriate. Vectors may be plasmids, viral e.g. ‘phage, or phagemid, as appropriate for a particular expression or in vitro translation system…” (see para [0171]-[0172]) which have cloning/insertion sites (italicized for added emphasis).
Therefore, due to the “intended use” recited in claims as discussed above, the claimed composition is not required to comprise the nucleotide sequence encoding a fusion protein of the protein of interest and the RNA binding protein; and the nucleotide sequence encoding a cognate RNA sequence wherein the RNA binding protein binds to the cognate RNA sequence as argued by Applicants.
For the reasons provided herein and in the previous office action, teachings of Wagner et al. anticipate claims 1, 3, 5, 18-20, 35, 41-42 and 80-81.
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.
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 extension fee 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 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Prosecution Insights