DETALIED ACTION
Status of the Claims
Amendments submitted on 06/02/2026 have been entered.
Claims 1-18 are pending and claims 9-18 are withdrawn.
Claim 4 is canceled without prejudice and claims 1-3, and 9 are amended.
Claims 1-3 and 5-8 are examined herein.
Status of Objections and Rejections
All previous objections and rejections not set forth below have been withdrawn in view of Applicant’s amendments and/or upon consideration of Applicant’s arguments.
The text of those sections of Title 35 U.S. Code, not included in this action, can be found in a prior Office action.
Nonstatutory Double Patenting Rejection
The 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 Langi, 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 1-3, 5-6 and 7-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, 8, 11-12, 15-16, 20, and 26-27 of copending Application No. 18971656 (i.e., ‘656; Brown; See reference application publication US-20250197952-A1) and obvious over ‘656 and Bowen (U.S. Patent Application Publication No. 20170044568 A1, assigned to Monsanto Technology LLC, titled ' NOVEL INSECT INHIBITORY PROTEINS', published 2017-02-16). Although the claims at issue are not identical, they are not patentably distinct from each other. Details are listed below.
Claim 1 of ‘656 is drawn to a recombinant DNA molecule comprising a nucleotide sequence selected from the group consisting of SEQ ID NO:10; …; SEQ ID NO:9; a polynucleotide having a nucleotide sequence that is at least 90% identical to the full length of SEQ ID NO:10 or the full length of SEQ ID NO: 9; and a complete complement of any of the foregoing.
SEQ ID NO: 9-10 of ‘656 are 100% identical to the full length sequence of instant SEQ ID NO:1 (see snippet below) where they “comprise [SEQ ID NO: 1] in operable linkage” to a heterologous transcribable DNA polynucleotide wherein the SEQ ID NO: 1 region has transcriptional termination activity by virtue of being a 3’ UTR (c.f., instant claims 1-3)(‘656: Table 1, rows 5-7; para 0026). Also
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In ‘656’s SEQ ID NOs: 9-10, the heterologous transcribable DNA polynucleotide, comprised in operable linkage to identical to instant SEQ ID NO:1, is a codon-optimized coding sequence of a “protoporphyrinogen oxidase (PPO) from Enterobacter cloacae for conferring tolerance to PPO herbicides” (i.e., a gene of agronomic interest that confers herbicide resistance in plants)(c.f., claims 5-6)(see ‘656 Table 1 and para 0124).
Thus, ‘656’s claims 1-2 are not patentably distinct from instant claims 1-3 and 5-6.
‘656’s claim 6 and 8 are respectively drawn to “a DNA molecule comprising…a polynucleotide segment of sufficient length to function as a DNA probe specific for detecting in a sample…SEQ ID NO:9” and “DNA molecule of claim 6, wherein… the DNA molecule comprises a nucleotide sequence selected from the group consisting of…SEQ ID NO:9; SEQ ID NO:10” such that, depending on the length, the DNA molecule may comprise of:
a) a sequence with at least 85 percent sequence identity to instant SEQ ID NO:1;
b) a sequence comprising instant SEQ ID NO:1; and
c) a fragment comprising at least 50 contiguous nucleotides of instant SEQ ID NO:1, wherein the fragment comprises Transcription termination activity;
wherein instant SEQ ID NO: 1 or fragment thereof is operably linked to a heterologous transcribable DNA polynucleotide. Claim 20 inherits the limitations of claim 6. Claims 11-12 are similarly drawn to DNA molecules that comprise a fragment of SEQ ID NO: 10 and claims 15-16 inherit these limitations.
Claims 26 is drawn to “a DNA construct comprising… a polynucleotide having a sequence that is… 100% identical to the full length of SEQ ID NO: 9” and claim 26 inherits these limitations such that ‘656’s claimed inventions comprise instant SEQ ID NO:1.
Thus, ‘656’s claims 6, 8, 11-12, 15-16, 20, and 26-27, in addition to claims 1-2, are not patentably distinct from instant claims 1-3 and 5-6. Some of ‘656’s other claims recite plants comprising SEQ ID NOs: 9 and/or 10 (e.g., claims 3 and 41) while some recite methods with steps using SEQ ID NOs: 9 and/or 10 or fragments thereof (e.g., claims 15 and 19).
Regarding claims 7-8, ‘656 does not explicitly claim inventions that comprise the limitations of instant claims 7-8: wherein the gene of agronomic interest confers pest resistance in plants; or wherein the heterologous transcribable DNA polynucleotide encodes a dsRNA, a miRNA, or a siRNA. However, the specification of ‘656 teaches in para 0265 that “the DNA sequence of interest can comprise a gene expression cassette comprising a sequence selected from: an herbicide tolerance gene, an insecticidal resistance gene, a nitrogen use efficiency gene, a water use efficiency gene, a nutritional quality gene, a DNA binding gene, a selectable marker gene, a target site for a site-specific nuclease, and any combination thereof.” Nutritional quality genes include miRNAs like .
Also, Bowen teaches in para 0054 a “recombinant DNA construct comprising a TIC5290 protein encoding sequence can further comprise a region of DNA that encodes for one or more insect inhibitory agents which can be configured to concomitantly express … an insect inhibitory dsRNA molecule” (i.e., claim 7’s recitation of an agronomic gene of interest that confers pest resistance in plants, claim 8 where the heterologous DNA polynucleotide encodes a dsRNA).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine and modify ‘656 with insect inhibitory teachings of Bowen arriving at the instantly claimed inventions with a reasonable expectation of success and no surprising results. One would have been motivated to do this in order to take advantage of “pesticidal proteins with insect inhibitory activity… shown to exhibit inhibitory activity against one or more pests of crop plants” (Bowen, para 0012).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-3 and 5-8 are rejected.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YVETTE B TAMUKONG whose telephone number is (571)272-1040. The examiner can normally be reached M-Th 730-5 EST.
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/YVETTE B. TAMUKONG/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662
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