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
Applicant's election with traverse of Group I, claims 1-3 and 6-9, and species SEQ ID NO: 8 in the reply filed on 7 April 2026 is acknowledged. The traversal is on the ground(s) that the Examiner has improperly separated the claims into two different groups because the claims of Group III depend from claim 1 of Group I. This is not found persuasive because search of the prior art would not be coextensive and thus would constitute a search and examination burden. Because Applicant has elected Group I and Group III is directed to a method of using the product of Group I, if the non-elected claims during examination are amended according to the elected invention and the elected invention is found allowable the Examiner will consider rejoinder.
Claims 10-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7 April 2026.
The requirement is still deemed proper and is therefore made FINAL.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
Claims 1-4 and 6-9 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.
Claims 1 and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the mts-siRNA encoding element need to be operably linked 3’ of the transcribable polynucleotide molecule. Yang et al (2018 PLOS | one, 13(8) e0202921 August 23, 2018) who teach that the mts-siRNA encoding element must be operably linked 3’ of the CP4 EPSPS transgene in order for expression of the CPS EPSPS protein to confer glyphosate tolerance to all maize tissues except tassels (page 3/17, 2nd paragraph). Hence, the claims omit a critical feature for the asserted use of the claimed recombinant DNA molecule and transgenic plant.
Claims 2, 3 and 6-8 are also indefinite because they depend from claim 1 and do not obviate the incompleteness of the claim(s) upon which they depend.
Claims 1 and 4 are indefinite because it is unclear what order the elements recited are operably linked, in particular the mts-siRNA target element and the full-length complements thereof and the heterologous transcribable polynucleotide molecule. Hence, the metes and bounds of the claims are unclear.
Improper Markush Grouping
Claim 1 and 4 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: in the instant case the listed SEQ ID Nos do not appear to recite a group of species that share a substantial structural feature and a common specific functional feature. In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4 and 6-9 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al (WO 2013/006472 A1).
Huang et al disclose a recombinant DNA molecule comprising a mts-siRNA target element comprising both instant SEQ ID NO: 5 and 6 at SEQ ID NO: 67 (see Figure 14, claim 4) operably linked to a heterologous transcribable polynucleotide molecule encoding a glyphosate tolerant EPSPS (see claim 6). For example, instant SEQ ID NO: 5 is disclosed at nucleotides 64-177 of SEQ ID NO: 67. Huang et al disclose that the mts-siRNA can comprise an exact DNA complement at paragraph [0028]. Huang et al disclose that an mts-siRNA element can be about 500 nucleotides, SEQ ID NO: 67 being 511 nucleotides in length (paragraph [0029]. Huang et al disclose producing said recombinant DNA molecule (Figure 14). Huang et al disclose a maize plant comprising said recombinant DNA molecule at claim 13 and a seed of the transgenic plant at claim 11.
Hence, Huang et al had previously disclosed the claimed invention.
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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 6-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4 and 7-9 of U.S. Patent No. 11,560,574. Although the claims at issue are not identical, they are not patentably distinct from each other because instant SEQ ID NOs: 5 and 6 are comprised in SEQ ID NO: 67 of the’574 Patent and thus the instant claims overlap in scope with the claims of the ‘574 Patent.
Conclusion
No claims are allowed.
Elected species SEQ ID NO: 8 appears to be free of the prior art. Under the practice of election of species, additional species, SEQ ID NO: 5 and 6, were searched.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (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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/David H Kruse/
Primary Examiner, Art Unit 1663
Prosecution Insights