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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged. Therefore Claims 1-17 and 20-28 have an effective filing date of 10/14/2019.
Status of the Claims
Amendments dated 01/15/2026 have been entered.
Claims 1-17 and 20-28 are pending.
Claims 8-13, 16-17, and 20-28 are withdrawn as being directed to a non-elected invention.
Claims 1-7 and 14-15 are examined herein.
The objections to Claims 2-3 and 15 have been withdrawn in view of Applicant’s amendments to the claims.
The rejections of Claims 1 and 4-7 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are withdrawn in view of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claims 14-15 remain 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 14 recites the term “and” between Claim 14 part (a) and part (b) which renders the claim indefinite. With the deletion of the previously recited Markush group and the recitation of “and” between Claim 14 part (a) and (b), it is unclear if both a polypeptide comprising the amino acid sequence of SEQ ID NO: 29 and a polypeptide comprising an amino acid sequence having at least 99% sequence identity to the amino acid sequence of SEQ ID NO: 29 are required components of the recombinant nucleic acid molecule recited in the preamble of Claim 14, or if a recombinant nucleic acid molecule comprising only one of (a) or (b) satisfies the claim limitation. Essentially, it is unclear if the claimed invention is intended to have two separately expressed polypeptides that comprise the amino acid sequence of SEQ ID NO: 29 (and variants thereof) or just one polypeptide that comprises the amino acid sequence of SEQ ID NO: 29 (or variants thereof). If the recombinant nucleic acid molecule of Claim 14 is meant to merely encompass one of the two polypeptides (a or b), Applicant should amend Claim 14 to recite “or” between parts (a) and (b).
Claim 15 depends from Claim 14 and is therefore rejected for the same reasons as given above.
Response to Arguments
Regarding Claim 14, Applicant’s Remarks on pgs. 6-7 in the reply filed on 01/15/2026 are acknowledged but do not overcome this rejection. In particular, Applicant’s Remarks rely on the premise that Applicant has amended claim 14 to indicate the proper wording and has reinserted the phrase “is selected from the group consisting of” to clarify the claim language (Remarks, paragraph bridging pgs. 6-7).
Examiner disagrees, as the claim language in the amendments to the claims dated 01/15/2026 does not reflect the amendments that Applicant discusses in the Remarks.
Nonstatutory 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.
Nonstatutory Double Patenting over US Patent No. 12,241,075
Claims 1, 4-7, and 14-15 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, and 14-15 of U.S. Patent No. 12,241,075 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to the same subject matter and recite the same limitations of the instant application in parallel, except that the independent claims of ‘075 (Claims 1 and 14) are directed to a recombinant nucleic acid molecule (relevant to instant Claim 1) comprising a nucleotide sequence encoding an amino acid sequence having pesticidal activity, wherein said nucleotide sequence is selected from the group consisting of: a) the nucleotide sequence set forth in SEQ ID NO: 10; and b) a nucleotide sequence that encodes a polypeptide comprising the amino acid sequence of SEQ ID NO: 25, a recombinant polypeptide with pesticidal activity (relevant to instant Claim 14) comprising the amino acid sequence of SEQ ID NO: 25, further comprising heterologous amino acid sequences (relevant to Claim 15), wherein said recombinant nucleic acid molecule is a synthetic sequence that has been designed for expression in a plant (relevant to instant Claim 4), wherein said nucleotide sequence is operably linked to a promoter capable of directing expression of said nucleotide sequence in a plant cell (relevant to instant Claim 5), a vector comprising the recombinant nucleic acid molecule of claim 1 (relevant to instant Claim 6), the vector further comprising a nucleic acid molecule encoding a heterologous polypeptide (relevant to instant Claim 7).
However, both the claimed SEQ ID NOs in the instant application and ‘075 encompass the same genus of Axmi486 polypeptides. For example, instant SEQ ID NO: 11 and SEQ ID NO: 10 of ‘075 share 99.5% sequence identity to each other. Additionally, instant SEQ ID NO: 29 and SEQ ID NO: 25 of ‘075 share 99.5% sequence identity to each other.
As such, the claims of ‘075 are prima facie obvious over the claims of the instant invention.
Response to Arguments
Applicant’s Remarks on pg. 7 in the reply filed on 01/15/2026 are acknowledged but do not overcome this rejection. In particular, Applicant’s Remarks rely on the premise that SEQ ID NO: 25 from the '075 patent has two other additional variations, and therefore, the claims of the '075 patent cannot be prima facie obvious over the claims of the instant invention (Remarks, pg. 7).
Examiner disagrees. The instant claims encompass an amino acid sequence having at least 99% sequence identity relative to the amino acid sequence of SEQ ID NO: 29. Sequence variants with 99% sequence identity relative to the 315 amino acids long SEQ ID NO: 29 encompass sequences with any three amino acid changes (additions, substitutions, deletions, etc.) known in the art relative to SEQ ID NO: 29. SEQ ID NO: 29 already comprises the variations, H97L, T100N, and D96P, and the scope of the instant claims allows for up to three more variations within SEQ ID NO: 29 (X1, X2, and X3) for a sequence to be a sequence variant of SEQ ID NO: 29 at 99% sequence identity. SEQ ID NO: 25 of the reference application comprises the variations H97L, T100N, and D96P, as well as two other variations denoted as R60T (X1) and E275D (X2), and therefore has only two amino acid changes relative to instant SEQ ID NO: 29. As such, SEQ ID NO: 25 in the reference application is a species of the genus of sequence variants with 99% sequence identity relative to the 315 amino acids long SEQ ID NO: 29; therefore, SEQ ID NO: 25 of ‘075 is prima facie obvious over the genus of claimed sequence variants of instant SEQ ID NO: 29.
Provisional Nonstatutory Double Patenting over US Application 19/041,718
Claims 1, 4-7, and 14-15 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, and 14-15 of copending Application No. 19/041,718 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to the same subject matter and recite the same limitations of the instant application in parallel, except that the independent claims of ‘718 (Claims 1 and 14) are directed to a recombinant nucleic acid molecule (relevant to instant Claim 1) comprising a nucleotide sequence encoding an amino acid sequence having pesticidal activity, wherein said nucleotide sequence is selected from the group consisting of: a) the nucleotide sequence set forth in SEQ ID NO: 11; and b) a nucleotide sequence that encodes a polypeptide comprising the amino acid sequence of SEQ ID NO: 26, a recombinant polypeptide with pesticidal activity (relevant to instant Claim 14) comprising the amino acid sequence of SEQ ID NO: 26, further comprising heterologous amino acid sequences (relevant to Claim 15), wherein said recombinant nucleic acid molecule is a synthetic sequence that has been designed for expression in a plant (relevant to instant Claim 4), wherein said nucleotide sequence is operably linked to a promoter capable of directing expression of said nucleotide sequence in a plant cell (relevant to instant Claim 5), a vector comprising the recombinant nucleic acid molecule of claim 1 (relevant to instant Claim 6), the vector further comprising a nucleic acid molecule encoding a heterologous polypeptide (relevant to instant Claim 7).
However, both the claimed SEQ ID NOs in the instant application and ‘718 encompass the same genus of Axmi486 polypeptides. For example, instant SEQ ID NO: 11 and SEQ ID NO: 11 of ‘718 share 99.5% sequence identity to each other. Additionally, instant SEQ ID NO: 29 and SEQ ID NO: 26 of ‘718 share 99.0% sequence identity to each other.
As such, the claims of ‘718 are prima facie obvious over the claims of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s Remarks on pg. 7 in the reply filed on 01/15/2026 are acknowledged but do not overcome this rejection. In particular, Applicant’s Remarks rely on the premise that SEQ ID NO: 26 from the '718 patent differs from SEQ ID NO: 29 by at least one amino acid, and therefore, the claims of the '718 patent cannot be prima facie obvious over the claims of the instant invention (Remarks, pg. 7).
Examiner disagrees. The instant claims encompass an amino acid sequence having at least 99% sequence identity relative to the amino acid sequence of SEQ ID NO: 29. Sequence variants with 99% sequence identity relative to the 315 amino acids long SEQ ID NO: 29 encompass sequences with any three amino acid changes (additions, substitutions, deletions, etc.) known in the art relative to SEQ ID NO: 29. SEQ ID NO: 29 already comprises the variations, H97L, T100N, and D96P, and the scope of the instant claims allows for up to three more variations within SEQ ID NO: 29 (X1, X2, and X3) for a sequence to be a sequence variant of SEQ ID NO: 29 at 99% sequence identity. SEQ ID NO: 26 of the reference application comprises the variations T100N, and D96P, as well as two other variations denoted as R60S (X1) and the absence of H97L, and therefore has only two amino acid changes relative to instant SEQ ID NO: 29. As such, SEQ ID NO: 26 in the reference application is a species of the genus of sequence variants with 99% sequence identity relative to the 315 amino acids long SEQ ID NO: 29; therefore, SEQ ID NO: 26 of ‘718 is prima facie obvious over the genus of claimed sequence variants of instant SEQ ID NO: 29.
Closest Prior Art
Claims 1-7 and 14-15 appear to be free of the prior art. The closest prior art in regard to Claims 1-7 and 14-15 can be found in Lehtinen et al. (United States Patent Application Publication No. 2016/0311865 A1; published 0/27/2016; IDS document) which discloses the amino acid sequence denoted as SEQ ID NO: 17, encoding a protein that has pesticidal activity (pg. 6, paragraph 0043) that shares 98.7% sequence identity with instant SEQ ID NO: 29. Additionally, Lehtinen discloses SEQ ID NOs: 11, 12, 26, 20, 21, 22, 23, 15, and 16 that all share at least 95% sequence identity with instant SEQ ID NO: 29 (See 20231213_135118_us-17-768-984-29.rapbm in file wrapper). Lehtinen also discloses a recombinant nucleic acid molecule comprising a nucleotide sequence encoding an amino acid sequence having pesticidal activity, wherein said nucleotide sequence is selected from the group consisting of: b) a nucleotide sequence that encodes a polypeptide comprising the amino acid sequence of any of SEQ ID NO: 5-26; c) a nucleotide sequence that encodes a polypeptide comprising an amino acid sequence having at least 95% sequence identity to the amino acid sequence of any of SEQ ID NO: 5-26 (pg. 49, Claim 1), wherein said nucleotide sequence is a synthetic sequence that has been designed for expression in a plant (pg. 49, Claim 2), and wherein said nucleotide sequence is operably linked to a promoter capable of directing expression of said nucleotide sequence in a plant cell (pg. 49, Claim 3). Lehtinen also discloses a vector comprising the recombinant nucleic acid molecule of claim 1 (pg. 49, Claim 4), further comprising a nucleic acid molecule encoding a heterologous polypeptide (pg. 49, Claim 5). Additionally, Lehtinen discloses a recombinant polypeptide with pesticidal activity, selected from the group consisting of: a) a polypeptide comprising the amino acid sequence of any of SEQ ID NOs: 5-26; and b) a polypeptide comprising an amino acid sequence having at least 95% sequence identity to the amino acid sequence of any of SEQ ID NOs: 5-26 (pg. 50, Claim 12), wherein the polypeptide further comprises heterologous amino acid sequences (pg. 50, Claim 13). However, Lehtinen does not disclose any amino acid sequences with 99% sequence identity to instant SEQ ID NO: 29, nucleotide sequences with 100% sequence identity to instant SEQ ID NO: 11, or any Axmi486 polypeptides with specific mutations at positions 60, 96, 97, 100, and 162 relative to instant SEQ ID NO: 38, or any motivations or teachings to modify SEQ ID NO: 29 at those specific positions, much less wherein the polypeptide shows resistance against Helicoverpa zea.
Conclusion
Claims 2 and 3 are allowed.
Claims 1, 4-7, and 14-15 remain rejected.
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 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 KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMJAD ABRAHAM can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663