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 .
Claims 1-2, 4-5, 7, 14, 16, 18, 25-27, 29, 32, 34, 37, 39, 41, 47, and 51-52 are pending and examined herein on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 37, 47 and 52 are rejected for being drawn to a product of nature. The claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because they read upon products of nature.
The claims are drawn to plants or plant cells generated by a method wherein the RNA silencing target has been changed such that secondary silencing target is now silenced by the RNA silencing molecule, wherein the plant is non-genetically modified wherein the editing event is heterozygous or homozygous.
As a first matter, it is recognized that modifications to nucleic acids by genome editing such as CRISPR-Cas do not leave any indication as to the method by which the modification has occurred such that the product claims would read on products generated from other methods such as mutation, and secondly products that have natural mutations or even natural variation would read on a product of nature.
Chen et al (2016 New Phytologist 212:150-160) in a study on miRNAs show that numerous natural variation SNPs within miRNAs actually alter plant phenotype indicating a target site change (see Table 1 at least).
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 –
Claims 37, 47 and 52 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Chen et al (2016 New Phytologist 212:150-160).
The claims are drawn to plants or plant cells generated by a method wherein the RNA silencing target has been changed such that secondary silencing target is now silenced by the RNA silencing molecule, wherein the plant is non-genetically modified wherein the editing event is heterozygous or homozygous.
Chen et al (2016 New Phytologist 212:150-160) in a study on miRNAs show that numerous natural variation SNPs within miRNAs actually alter plant phenotype indicating a target site change (see Table 1 at least). This study in demonstrated natural variation with altered target sites inherently teaches the plants and/or plant cells of the instant claims as currently written. It is recognized that modifications to nucleic acids by genome editing such as CRISPR-Cas do not leave any indication as to the method by which the modification has occurred such that the product claims would read on products such as those disclosed by Chen et al and would be indistinguishable given that no structural specifics are required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 12331295. This is a statutory double patenting rejection.
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 2, 4-5, 14, 16, 26-27, 29 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 26, 29, 30 and 35 of U.S. Patent No. 11555199. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to overlapping scope of the similar methods wherein the wording is slightly different but the scopes are substantially the same. Both are drawn to methods of modifying RNA silencing molecules resulting in the molecule silencing a second target while abolishing the original target for silencing.
Claims 7, 18, 25, 32, 39, 41 and 51 are objected to for depending from rejected claims but would be allowable if rewritten in independent form.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 5712707058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663
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