Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim status
Claims 1-14 are examined.
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 1 and 4 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.
Claim 1 recites, “both of the 3’ ends of the first strand and/or second strand” referring to the nucleic acid construct; however, each sequence only has a single 3’ end. Therefore, the metes and bounds of the claim are indefinite.
Claim 4 depends from claim 1 and recites “the transcription regulatory region”; however, claim 1 not only does not recite “a” transcription regulatory region (lack of antecedent basis) but expressly states, “wherein the nucleic acid construct does not comprise a regulatory element.” Therefore, the metes and bounds of the claim are indefinite.
Closest Prior Art
The claimed invention requires a double-stranded DNA sequence which is 20-30 nucleotides long and is not operably linked to a promoter or otherwise part of a vector or construct.
The closest prior art is Chi (Chi et al. BMC Plant Biology. 14(62): 1-18. 2014). Chi does not apply as anticipatory art nor art which makes the instantly claimed invention obvious because Chi teaches a double stranded RNA (dsRNA) instead of a dsDNA.
Similar, but non-overlapping art includes the use of nanoparticles linked to DNA which are expressed in a host cell, such as claim 18 of Hauser (US 20190055555). This reference is not being applied as prior art because it does not teach or suggest a double stranded nucleic acid of the instant claims, including wherein a 3’ terminal overhang of said nucleic acid comprises a ribose unit.
Relevant prior art includes Allerson (US 20050026160), which discloses a double-stranded nucleic acid construct comprising RNA which is 21 nucleotides in length wherein both strands comprise a terminal overhang [0012]. Allerson discloses a methoxy group at the 3’ terminal end overhang [0158] at the 2’ position [0157]. This reference is not being applied as prior art because while the construct of Allerson is otherwise similar to the instant invention, it does not include a dsDNA between 20-30 nucleotides long.
After a complete search of the prior art there does not appear to be any anticipatory art nor art which makes obvious the instantly claimed invention of a 20-30 nucleotide-long, double stranded DNA molecule which rather than being expressed interacts directly with a DNA methyltransferase.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,591,608 (‘608). Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims of ‘608 and the instant application are drawn to a method of inducing an epigenetic modification in a plant by applying a formation comprising an excipient and a double-stranded nucleic acid construct comprising nearly identical requirements. Both with the reference claims and the instant claims specify that the method results in at least partial silencing of a gene. The claims differ in that the reference claims of ‘608 specify the “applying” results in a Markush group of modifications to the plant. The instant claims are generic regarding the modifications which can be made. The specific modification of the reference claims anticipates the unspecified genus of modifications which are encompassed by the instant claims.
Conclusion
Claims 1-14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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/DAVID R BYRNES/ Examiner, Art Unit 1662
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