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 .
Application Status
This action is written in response to applicant’s correspondence received 24 October 2025. Claims 1-19 and 21 are currently pending. For the purposes of examination, claims 17-18 have been rejoined into examination. Accordingly, claims 1-19 and 21 are examined herein. The restriction requirement mailed 8 November 2024 is still deemed proper. Applicant's elected Group I without traverse in the reply filed 15 April 2025.
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16, 19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,946,055 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim anticipate the currently pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1-7, patented claim 1 claims a P1 plasmid comprising
(a) a constitutively active P1 promoter having SEQ ID NO: 2 or SEQ ID NO: 7,
(b) a secretory leader sequence encoding SEQ ID NO: 6 or SEQ ID NO: 11,
(c) an attachment sequence encoding SEQ ID NO: 1, and
(d)(1) a polyA tail comprising at least 50 adenosine bases, 2) a self-cleaving ribozyme sequence encoding SEQ ID NO: 4, or both.
Regarding claims 8-9, patented claims 2-3 claim a Trp1 section marker and an HA tag.
Regarding claims 10-12, patented claims 4-6 recite identical limitations.
Regarding claim 13, patented claim 8 recites identical limitations.
Regarding claim 14, patented claim 9 recites identical limitations.
Regarding claims 15-16 and 19, patented claims 7 and 11-12 recite identical limitations.
Regarding claim 21, patented claim 10 recites identical limitations.
Claims 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,946,055 B2 above, and further in view of Zhong (ACS synthetic biology 7.12 (2018): 2930-2934).
Regarding claims 17-18, claims 1-12 of U.S. Patent No. 11,946,055 B2 anticipate claims 1-16, 19, and 21 as described above.
The patented claims do not claim a method of engineering a protein having a desired characteristic, which comprises subjecting the P1 expression plasmid of the yeast host cell of claim 16 to error prone orthogonal replication (epOrthoRep) and selecting yeast cells expressing, on their cell surface, the protein having the desired characteristic, wherein the P1 expression plasmid comprises a parental sequence of the protein (Claim 17). The patented claims do not claim a method of engineering a protein having a desired characteristic, which comprises identifying the one or more mutations in the protein of claim 17 that confer the desired characteristic and recombinantly or synthetically modifying the parental sequence to have one or more of the identified mutations (Claim 18).
However, one of ordinary skill in the art would have considered the teachings of Zhong as both references are common fields of endeavor pertaining to the use of P1 plasmids.
Zhong is drawn to a study concerned with tunable expression systems for orthogonal DNA replication by utilizing engineered plasmids (Abstract). Zhong teaches the use of a complete Pl and P2 orthogonal transcription/translation plasmid system for use in S. cerevisiae (pg. 2931; see Figure 1). Zhong teaches that the orthogonal translation system can be expressed on yeast surfaces in yeast surface display directed evolution experiments (pg. 2933). Zhong teaches the use of an error-prone DNA polymerase flanked by endogenous proteins on a plasmid parental sequence that replicates the P1 plasmid at an error rate above the average normal genomic error rate of the yeast host cell (pg. 2930-2931; see Figure 1). Zhong teaches that error-prone DNAPs can be supplied such that a large number of mutations can be induced in a gene of interest so that beneficial mutations present within a protein of interest can be selected for (pg. 2933). Zhong teaches that the disclosed P1/P2 orthogonal translation/transcription system is advantageous to utilize in the production of proteins because it is insulated from the less predictable behavior of synthetic genetic circuits (pg. 2933).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the claimed P1 plasmid in a method of protein engineering comprising subjecting the plasmid to orthogonal replication and selecting yeast cells expressing, on their surface, the protein having the desired characteristic and identifying one or more mutations present within the protein that confers the desired characteristic, as described by Zhong. A person of ordinary skill in the art would have been motivated to do so in order to utilize a method of protein production that is insulated from the less predictable behavior of synthetic genetic circuits. A person of ordinary skill in the art would have had a reasonable expectation of success because both the patented claims and Zhong teach the use of P1 expression plasmids.
Closest Prior Art
Regarding the claimed SEQ ID NOs: 6 and 11, the closest prior art is Nielsen (Pg Pub No. WO 2011/146902 A1). Nielsen is drawn to a study concerned with fusion proteins (Abstract). Nielsen teaches the use of an app8 leader polypeptide that has 98.8% sequence identity to the claimed SEQ ID NO: 6 ([0117]; see SEQ ID NO: 88 in previously attached sequence alignment). Nielson teaches the use of an app88 leader polypeptide that has 98.1% sequence identity with the claimed SEQ ID NO: 11 ([0118]; see SEQ ID NO: 88 in attached sequence alignment).
However, neither Nielsen nor the prior art teaches or suggests the use of the claimed SEQ ID NO: 6 nor the specific mutations required in order to arrive at the claimed SEQ ID NO: 6.
Regarding the claimed SEQ ID NO: 1, the closest prior art is Cao (PG Pub No. US 2003/0233675 A1). Cao is drawn towards an invention concerned with polypeptides functional in plant cells (Abstract). Cao teaches the use of a polypeptide that is useful for improving pathogen tolerance that has 68% sequence identity with the claimed SEQ ID NO: 1 (pg. 39; see SEQ ID NO: 21948 in attached sequence alignment).
However, neither Cao nor the prior art teaches or suggests the use of the claimed SEQ ID NO: 4 nor the specific mutations required in order to arrive at the claimed SEQ ID NO: 4.
Regarding the claimed SEQ ID NO: 4, the closest prior art is Wingler (Cell 176.3 (2019): 479-490). Wingler is drawn to an invention concerned with Angiotensin II Receptor Type 1 (AGTR1) binding proteins (Abstract). Wingler teaches the use of an AT110 protein, containing a VHH domain (pg. 480), having 96.83% sequence identity to the claimed SEQ ID NO: 4 (see Supplemental Figure S1 and previously attached sequence alignment).
However, neither Wingler nor the prior art teaches or suggests the use of the claimed SEQ ID NO: 4 nor the specific mutations required in order to arrive at the claimed SEQ ID NO: 4.
Response to Arguments
Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
Applicant alleges that a terminal disclaimer has been submitted over claims 1-12 of US 11,946,055; therefore, the currently pending double patenting rejection of record should be withdrawn.
This argument is not found persuasive because a terminal disclaimer has not been filed in the instant application. Thus, the double patenting rejection over US 11,946,055 is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KYLE T REGA whose telephone number is (571)272-2073. The examiner can normally be reached M-R 8:30-4:30, every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE T REGA/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636