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
In reply to a restriction requirement, Applicant elected Group I directed towards claims 1, 4-6 and 9. As to the requirement for election of species, Applicant elects species (A-1) a PPR motif consisting of the sequence of SEQ ID NO: 9 from claim 1; and species (1st A-1) a PPR motif consisting of the sequence of SEQ ID NO: 402 having the defined substitutions from claim 6. Claims 1, 4-6 and 9 read on the elected species. Claims 1, 4-6 and 9 are hereby examined on the merits. Claims 2, 3, 7, 8, 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 11/04/2025.
Priority
The instant application filed 11/24/2021 is a National Stage entry of PCT/JP2020/021472, international filing date, 05/29/2020 and claims foreign priority to 2019-100551, filed 05/29/2019 but no certified copy has been provided.
Information Disclosure Statement
The information disclosure statements (IDS) submitted 02/23/2022, 10/18/2022, 08/28/2023, 10/20/2023, 12/14/2023, 05/13/2024, 08/15/2024, 03/10/2025, 09/24/2025 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Objections/Rejections Withdrawn
Objections and/or rejections not reiterated from previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Interpretation
Claim 1 is directed to a PPR motif consisting of the sequence of SEQ ID NO: 9. Applicant elected species (A-1), a PPR motif consisting of the sequence of SEQ ID NO: 9 from claim 1. The Examiner interprets the transitional phrase “consisting of” as excluding any element, step, or ingredient not specified in the claim (see MPEP § 2111.03). Accordingly, SEQ ID NO: 9 requires the full-length sequence with 100% identity to SEQ ID NO: 9 without any N/C terminal additions.
Claim 6 is directed to PPR motif consisting of the sequence of SEQ ID NO: 402. Applicant elected species (1st A-1), a PPR motif consisting of the sequence of SEQ ID NO: 402 having the defined substitutions from claim 6. Examiner interprets the transitional phrase “consisting of” as excluding any element, step, or ingredient not specified in the claim (see MPEP § 2111.03). Accordingly, SEQ ID NO: 402 requires the full-length sequence with 100% identity to SEQ ID NO: 402 without any N/C terminal additions.
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.
Claims 1, 4-6 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to PPR motifs and PPR motifs consisting of specific substitutions within the motif.
Regarding claim 1, (A-2), (C-2), (G-2) and (U-2) recite having a ‘substitution, deletion or addition’. Applicant reduced to practice, sequences of PPR motifs, and PPR motifs representing substitutions. For the sequence of A-2, an addition or deletion of 1-20 amino acids, as recited in the claim would significantly increase or decrease the total length and composition of the PPR motif. For the sequence of C-2, deletion or addition of 1-25 amino acids can generate an array of sequences that vary in composition and length. This is also true for G-2 (1 to 21 amino acid deletion/addition) and U-2 (1 to 22 amino acid deletion/addition).
Consequently, one of ordinary skill in the art would not conclude Applicant was in possession of the claimed genus of PPR motifs of varying lengths and composition. Claim 1 lacks written description because the instant application does not provide sufficient guidance to one of ordinary skill in the art to determine the sequences falling within the scope of the genus of PPR motifs, comprising additions/deletions or of a recitation of structural features common to the members of the genus. In the case of A-2, C-2, G-2, U-2, the claim limitation ‘addition or deletion’ is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. A “representative number of species” means that the species are adequately described are representative of the entire genus. See MPEP §2163.
Regarding claim 6, (A-2), (C-2), (G-2) and (U-2) recite having a ‘substitution, deletion or addition’. For the reasons set forth above, the ‘deletion or addition’ of sequences do not meet the written description requirement.
Claims 4, 5, 9, which depend from claims 1 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112(pre-AIA ), first paragraph, as these claims incorporate by dependency the lack of adequate written description of claims 1 and 6.
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.
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.
Claim 1 is 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.
Claim 1 recites the limitation, ‘wherein the amino acid…adenine-binding property’ (lines 17-18). Here, it is not clear if the claim conveys that, positions 1, 2, etc ‘are identical’ to the positions in SEQ ID NO: 9 or if the claim term ‘are identical’ is referring to repetitive residues at the positions recited. As a result, the scope of the claim is ambiguous.
The indefiniteness reasoning stated above is also applicable to lines 32-33; 44-45; 60-61.
For prior art purpose, Examiner interprets the phrase ‘are identical’ as being identical to the sequence not containing a substitution.
Regarding claim 1, for A-2, C-2, G-2 and U-2, the claim recites ‘deletion or addition’ and ‘other than at amino acid positions….property’. Here, it is unclear how deletion or addition can retain the amino acid positions in the sequence as recited.
Claim 4 is 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.
Claim 4 recites the limitation “comprising n PPR motifs” and ‘consisting of n bases’ referring to the same variable ‘n’. As a result, the meaning of ‘n’ remains ambiguous, in referring to the number of PPR motifs and at the same time also referring to the number of bases. Appropriate correction is required so that the variable is assigned to a single specific term.
Claim 5 is 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.
Claim 5 is dependent on claim 4 and recites the limitation "n". It is unclear which ‘n’ the Applicant is making reference to. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 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.
Claim 6 recites the limitation, ‘wherein the… property’ (lines 10, 17, 26 and 35). Here, it is not clear if the claim intends that, the amino acid positions ‘are identical’ to the positions in SEQ ID NO: 402, SEQ ID NO: 403, SEQ ID NO: 404, SEQ ID NO: 405 respectively, or if the claim term ‘are identical’ is referring to repetitive residues at the positions recited. As a result, the scope of the claim is ambiguous.
For prior art purpose, Examiner interprets the phrase ‘are identical’ as being identical to the sequence not containing a substitution.
Regarding claim 6, for A-2, C-2, G-2 and U-2, the claim recites ‘deletion or addition’ and ‘other than at amino acid positions….property’. Here, it is unclear how deletion or addition can retain the amino acid positions in the sequence as recited.
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.
(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.
Claim(s) 1, 4-6 and 9 are rejected under 35 U.S.C. 102 (a)(1) and 35 U.S.C. 102 (a)(2) as being anticipated by Shen, C., et al., hereinafter Shen (Shen, C., et al. Nat Commun 7, 11285 (2016)).
Regarding claim 1, Shen teaches repeat U (Fig 1a), which meets the limitation of (U-2). The instant sequence differs from the sequence in Shen (compare repeat U and SEQ ID NO: 12) at residues 15, 20, 21, 23 and 26 which is other than the amino acid positions recited in the claim (i.e., 1, 2, 3, 4, 6, 11, 12, 14, 19, 26, 30, 33, and 34).
Shen teaches repeat U (Fig 1a), which meets the limitation of (U-3). The instant sequence differs from the sequence in Shen (compare repeat U and SEQ ID NO: 12) at residues 15, 20, 21, 23 and 26 which is other than the amino acid positions recited in the claim (i.e., 1, 2, 3, 4, 6, 11, 12, 14, 19, 26, 30, 33, and 34).
Examiner notes that A-1, A-2, A-3, C-1, C-2, C-3, G-1, G-2, G-3, and U-1 are not anticipated by Shen.
Regarding claim 4, Examiner interprets ‘comprising’ as open ended and includes any choice of PPR motifs listed in the instant claim. Accordingly, Shen teaches (U-2) and (U-3) as noted above in the rejection for claim 1.
Regarding claim 5, Shen teaches 6-15 PPR repeats (see Results-‘Structural explanation of conformational plasticity of dPPR’, page 4, line 14).
Regarding claim 6, 1st U-1, 1st U-2, 1st U-3, Shen does not anticipate the sequence as recited by the claim limitations in the instant claim.
Regarding 1st G-1, 1st G-2, 1st G-3, Shen does not anticipate the sequence as recited by the claim limitations in the instant claim.
Regarding 1st C-1, 1st C-2, 1st C-3, Shen does not anticipate the sequence as recited by the claim limitations in the instant claim.
Regarding 1st A-1, 1st A-2, 1st A-3, Shen does not anticipate the sequence as recited by the claim limitations in the instant claim.
Regarding claim 9, Shen teaches (U-2) and (U-3) as noted above in the rejection for claim 1. In the Methods section (see page 6, Protein preparation), Shen teaches dPPR proteins fused with 6xHis tag at the C-termini.
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, 4-6 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5 of U.S. Patent No.12559528. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, reference patent ‘528 teaches a PPR motif which is any one of the following PPR motifs. In the instant claim, A-1, A-2 and A-3 consisting of SEQ ID NO: 9 and substitutions disclosed therein, is met by SEQ ID NO: 8 in the reference patent ‘528 (see claim 1).
A-1, A-2 and A-3 consisting of SEQ ID NO: 401, is not met by SEQ ID NO: 8 in the reference patent ‘528 (see claim 1). Therefore, in claim 1, SEQ ID NO: 401 is free of the prior art.
In the instant claim, C-1, C-2 and C-3 consisting of SEQ ID NO: 10 and substitutions disclosed therein, is met by SEQ ID NO: 4-7 in the reference patent ‘528 for C-2 and C3. The limitations for C-1 in the instant claim is not met by SEQ ID NO:4-7 by the reference patent ‘528.
Therefore, in claim 1, C-1 is free of the prior art.
In the instant claim, G-1, G-2 and G-3 consisting of SEQ ID NO: 11 and substitutions disclosed therein, is met by SEQ ID NO: 9 in the reference patent ‘528.
In the instant claim, U-1, U-2 and U-3 consisting of SEQ ID NO: 12 and substitutions disclosed therein, is met by SEQ ID NO: 10 in the reference patent ‘528.
Regarding claim 4, reference patent ‘528 teaches A-1, A-2 or A-3; C-1, C-2 or C-3; G-1, G-2 or G-3; U-1, U-2 or U-3. See claims 1-3.
Regarding claim 5, reference patent ‘528 teaches PPR motifs. Embodiments in the specification of the reference patent ‘528 teach PPR motif as comprising 1-30 PPR motifs (see [0018] [6], line 3) (i.e. 15 or greater). See claims 1-3.
Regarding claim 6, reference patent ‘528 teaches 1st_C1, 1st_C2 and 1st_C3, consisting of SEQ ID NO: 403 and mutations encompassed in the claim which is identical to SEQ ID NO: 4 in the reference patent ‘528. The claim limitation ‘is any one of the following motifs’ meets the limitation of the claim.
Reference patent ‘528 does not teach 1st_A1, 1st_A2 and 1st_A3 consisting of SEQ ID NO: 402 and the recited substitutions; 1st_G1, 1st_G2 and 1st_G3 consisting of SEQ ID NO: 404 and the recited substitutions; 1st_U1, 1st_U2 and 1st_U3 consisting of SEQ ID NO: 405 and the recited substitutions. Therefore, SEQ ID NO: 402, SEQ ID NO: 404 and SEQ ID NO: 405 are free of the prior art.
Regarding claim 9, reference patent ‘528 teaches fluorescent protein, nuclear localization signal peptide, tag protein (see claim 5).
Claims 1, 4-6 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19,455,190 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, reference application ‘190 teaches a PPR motif which is any one of the following PPR motifs. In the instant claim, A-1, A-2 and A-3, consisting of SEQ ID NO: 9 and substitutions disclosed therein, is met by SEQ ID NO: 8 in the reference application ‘190 (see claim 1).
A-1, A-2 and A-3 consisting of SEQ ID NO: 401, is met by SEQ ID NO: 8 in the reference application ‘190 (see claim 1).
In the instant claim, C-1, C-2 and C-3 consisting of SEQ ID NO: 10 and substitutions disclosed therein, is met by SEQ ID NO: 7 in the reference application ‘190 for C-3. The limitations for C-1 in the instant claim is not met by SEQ ID NO:4-7 by the reference application ‘190.
Therefore, in claim 1, C-1 is free of the prior art.
In the instant claim, G-1, G-2 and G-3 consisting of SEQ ID NO: 11 and substitutions disclosed therein, is met by SEQ ID NO: 9 in the reference application ‘190.
In the instant claim, U-1, U-2 and U-3 consisting of SEQ ID NO: 12 and substitutions disclosed therein, is met by SEQ ID NO: 10 in the reference application ‘190.
Regarding claim 4, reference application ‘190 teaches A-1, A-2 or A-3; C-1, C-2 or C-3; G-1, G-2 or G-3; U-1, U-2 or U-3. See claim 1.
Regarding claim 5, reference application ‘190 teaches PPR motifs. Embodiments in the specification of the reference application ‘190 8 teach PPR motif as comprising 15 or more PPR motifs (see [0006], line 2) (i.e. 15 or greater). See claim 1.
Regarding claim 6, reference application ‘190 teaches 1st_C1, 1st_C2 and 1st_C3, consisting of SEQ ID NO: 403 and mutations encompassed in the claim which is identical to SEQ ID NO: 4 in the reference application ‘190. The claim limitation ‘is any one of the following motifs’ meets the limitation of the claim.
Reference application ‘190 does not teach 1st_A1, 1st_A2 and 1st_A3 consisting of SEQ ID NO: 402 and the recited substitutions; 1st_G1, 1st_G2 and 1st_G3 consisting of SEQ ID NO: 404 and the recited substitutions; 1st_U1, 1st_U2 and 1st_U3 consisting of SEQ ID NO: 405 and the recited substitutions. Therefore, SEQ ID NO: 402, SEQ ID NO: 404 and SEQ ID NO: 405 are free of the prior art.
Regarding claim 9, reference application ‘190 teaches PPR motif (see claim 1). Embodiments of the specification disclose PPR motif as comprising fluorescent protein, nuclear localization signal peptide, tag protein (see page 6, [11]).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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