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
1. Claims 1-32 are pending and are examined on merits in the present Office action.
Applicant’s amendments to claims 10-11, 16, 22, 24, 25, 29-30 and 32 in the reply filed 12/15/2025 are acknowledged.
2. The rejection and objections not recited in this action are withdrawn.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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 following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
3. Claims 3, 6, 16 and 24-32 are rejected are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
The term “substantially” in claim 6 is a relative term which renders the claim indefinite. The term “substantially” 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. The metes and bounds are not clear.
In claims 3, 16, 24 and 26, the recitation “capable of” renders the claims indefinite. It is unclear what the recitation encompasses. The metes and bounds are not clear.
Claim 17 recites the limitation "the plasmid" in line 1. It is unclear what the limitation is intended to modify given vector and plasmid are independent with each other. The metes and bounds are not clear. It is suggested to replace the recitation with –the vector--.
Applicants traverse in the paper filed 12/15/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants argue that complement substantially all of the first nucleotide sequence means that a sequence is not completely complementary to a sequence but that sufficient bonding occurs to form a stable hybrid complex in set of hybridization condition.
The Office contends that without knowing the hybridization condition and location of mismatches, it is still unclear what the claimed genus encompasses.
Applicants further argue that “Capable of” in the context of the claims proposes an ability to perform a function (responses, page 9).
The Office contends that it is unknown under what condition such ability was rendered. The metes and bounds are not clear.
Scope of Enablement
4. Claims 1-32 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for IRES from CrPV with insertion site as exemplified in the specificition, does not reasonably provide enablement for any Group I Dicistroviridae IRES for any combination of insertions sites. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Instant claims are drawn to an inducible expression system using a modified Group I Dicistroviridae IRES.
The specification teaches an IRES-based system based on the CrPV IRES was used for the development of a eukaryotic toehold (eToehold). Here, eight specific sites (fig. 14D of the application) known in the art were elected where insertions, absent modifications to the overall secondary structure, would not erase CrPV IRES activity. Different CrPV IRES sequences with complementary sequences inserted at the eight possible sites were screened. A number of site combinations (1-2, 1-8, 2-7, 6-7 and 8-6) behaved as expected and site combinations 6-7 and 8-6 were focused on for further experiments for reasons of reproducibility. No other IRES was used in the examples and the selected eight putative integration sites were chosen according to the overall secondary structure of the chosen IRES. Of these, only 5 site combinations were found to retain significant translational ability despite the newly introduced insertions with increase in signal production in the presence of trigger RNA and only two site combinations led to reproducible folds increase in signal production in the presence of trigger RNA.
Given the unpredictability demonstrated by Applicants’ own data, undue experimentation would have been required for skilled in the art to test all IRES encompassed by the present set of claims with all possible sites for insertion of exogenous nucleotide sequences to find out, which specific systems are suitable for instant invention.
Applicants traverse in the paper filed 12/15/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicants argue that a sufficient representative number of Group I Dicistroviridae IRES to enable the claims (response, page 9).
Applicants are reminded that instant rejection is due to lack of enablement not written description. As discussed above, the specification only are enabling for IRES from CrPV with insertion site as exemplified in the specification given the unpredictability of the art.
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.
5. Claims 1-32 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11, 20, 22, 26, 28, 32 and 37 of copending Application No. 18/009,534 (US Patent Application Publication No. 20230212592). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims are drawn to a recombinant plant, comprising: a) DNA encoding an mRNA which comprises a recombinant nucleic acid molecule, wherein the recombinant nucleic acid molecule comprises: i) a first segment encoding a recombinant Group 1 Dicistroviridae internal ribosome entry site (IRES) that has been modified to incorporate exogenous nucleotide sequences at a first site and a second site, and it) a second segment encoding a protein, downstream from and operably linked to the first segment such that translation of the protein is repressed when the IRES is in an inactivated state; wherein the first site comprises a first nucleotide sequence, and the second site comprises a second nucleotide sequence which 1s the reverse complement of at least a portion of the first nucleotide sequence; and wherein the Group 1 Dicistroviridae IRES is configured to activate expression of the protein in response to the presence of an mRNA which comprises a segment that is the reverse complement of the first nucleotide sequence; or wherein mRNA was generated by a pathogen; or wherein the protein is capable of a metabolic pathway response to the environmental stress; or the plant is a corn; or wherein the DNA is integrated into the genomic DNA of the plant; or wherein the second nucleotide sequence is the reverse complement of substantially all of the first nucleotide sequence; or wherein the first and second sites are independently selected from Site 1-8; or wherein the first nucleotide sequence is 25-80/8-25 nt in length; or the protein is a heat shock protein/pesticide; or wherein the expression level is at least 1.5 fold higher. Instant claims are also drawn to a vector/recombinant nucleic acid molecule/plasmid comprising the nucleotide wherein the protein is capable modulating the plant response to pathogen; such as shock protein/pesticide; or a method for modulating protein expression in plant or controlling cell differentiation by expression a toxin;
claims 1-9, 11, 20, 22, 26, 28, 32 and 37 of copending Application No. 18/009,534 teach ecombinant nucleic acid molecule, comprising: a) a first segment encoding a recombinant Group | Dicistroviridae internal ribosome entry site (IRES) that has been modified to incorporate exogenous nucleotide sequences at a first site and a second site, and b) a second segment encoding a protein, downstream from and operably linked to the first segment such that translation of the protein is repressed when the IRES is in an inactivated state; wherein the first site comprises a first nucleotide sequence, and the second site comprises a second nucleotide sequence which is the reverse complement of at least a portion of the first nucleotide equence; or wherein the IRES that is modified is a Group 1 Discistroviridae IRES such as CrPV; or wherein the first and second sites are each independently selected from any of Site 1-8; wherein the first nucleotide sequence is the reverse complement of a sequence found in a target eukaryotic organism or target virus; or a system for the control of gene expression, comprising: a) the recombinant nucleic acid molecule of claim 1 any of the preceding claims; and b) a trigger RNA molecule comprising a third nucleotide sequence, wherein the third nucleotide sequence is the reverse compliment of the first nucleotide sequence of the recombinant nucleic acid molecule.
Although the reference does not teach using the expression system in plant, it would have been obvious for skilled in the art to use it to control the expression of the gene of interest in the plant given that plant is an obvious design choice for a eukaryotic organism. Although the reference does not teach gene of interest is heat shock protein or pesticide or particular plant species such as maize, such gene of interest or plant species are both well known in the art and are merely considered as a design choice.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants traverse in the paper filed 12/15/2025. Applicants’ arguments have been fully considered but were not found persuasive.
Applicant’s intention to hold this rejection in abeyance, however, is acknowledged.
Summary
All claims are rejected.
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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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/LI ZHENG/Primary Examiner, Art Unit 1662
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