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 .
Status of Claims
Claims 47-52, 54-65 and 67-69 are pending. Claims 1-46, 53 and 66 have been cancelled.
The objections to the claims are withdrawn in light of the amendments.
The rejection of claims 47-65 and 67 under 35 U.S.C. 112(a), first paragraph, for failing to comply with the scope of enablement requirement is withdrawn because of the amendments to the claims.
The rejection of claims 47-65 and 67 under 35 U.S.C. 112(a), first paragraph, for failing to comply with the written description requirement is withdrawn because of the amendments to the claims.
The rejection of claims 47, 50-59, 62-65 and 67 under 35 U.S.C. 103 as being unpatentable over Liljegren et al (2000, Nature, 404:766-770) in view of Raman et al (2014, PLOS ONE, 9:1-13) and Kord et al (2015, 3 Biotech, 5:271-277) and in further view of Sauer et al (2016, Plant Physiology, 170:1917-1928) is withdrawn because none of the cited reference reasonably teaches, suggests or arriving at the particularly claimed nucleotide sequences.
Drawings
The objection to the drawings are withdrawn in light of the amendments.
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.
Claim 67 is 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 67 is drawn to a plant produced by growing seed of a cross between a plant comprising at least three loss of function mutations in SHP genes wherein the plant has “all the physiological and morphological characteristics” of the plant comprising said mutations.
The metes and bounds of the claim are indefinite because it is not clear (1) if this plant comprises the mutated SHP genes; (2) if this plant comprises the same mutations at the plant of claim 47 as the method of claim 65 encompasses crossing the plant of claim 47 with a different plant; and (3) it is not clear what all of the morphological and physiological characteristics are as the specification fails to describe what characteristics are associated with a plant comprising three mutations as opposed to four mutations as opposed to five mutations.
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 67 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claim 67 is drawn to a plant produced by growing seed from a cross between a plant comprising loss of function mutations in at least three SHP genes and another plant and wherein said produced plant comprises all of the morphological and physiological characteristics of the plant comprising loss of function mutations in at least three SHP genes.
Thus, the claims encompass plants produced that need not even comprise the mutations of the plant of claim 47. All that is required of the plant of claim 67 is that is comprise all of the morphological and physiological characteristics of the plant comprising loss of function mutations in at least three SHP genes.
Moreover, 67 encompasses plants that extend beyond the F1 filial generation. This means the resulting progeny will differ genetically from the original cross due to recombination and crossover events.
Here, the specification fails to describe, in fact, the morphological and physiological characteristics of each species of plant comprising different combinations of loss of function mutations in the SHP genes. Furthermore, the specification fails to describe a representative number of species from the genus of plants that further removed from the F1 generation.
Given the lack of written description in the specification with regard to these plants as broadly claimed, it is not clear that Applicant was in possession of the invention at the time this application was filed.
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 47-52 and 54-65 and 67 REMAIN rejected, and claims 68 and 69 are NOW rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,359,208 B2 (referred to herein as ‘208). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 47-65 and 67 are broadly drawn to a plant or part thereof comprising at least one mutation in at least three nucleic acid sequences encoding SHP genes, wherein the nucleic acid sequences have as little as 90% sequence identity to SEQ ID NO: 1-8, wherein the mutation reduces the expression or activity of the gene SHP gene or polypeptide and wherein the plant or part thereof exhibits reduced susceptibility to preharvest dehiscence, methods for producing said plant by introducing mutations into said genes, and a method of making seeds.
Meanwhile, ‘208 claims a Brassica napus plant comprising homozygous loss of function mutations in a least three SHP polypeptide wherein the gene encoding said polypeptide has a nucleotide sequence with at least 90% identity to SEQ ID NO: 1-8, wherein the mutation is frameshift mutation that results in a premature stop codon and exhibits reduced susceptibility to preharvest shattering, a method for producing said plant, wherein the mutations are introduced CRISPR or a GRON system, F1 plants produced therefrom, a method of making seeds therefrom comprising crossing said plant with another plant, plants grown from said seed, and wherein the plant has mutations in at least five to eight of the genes.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the instant invention because ‘208 claims a specific plant species comprising at least one mutation in at least three SHP genes as encompassed by the claims.
Conclusion
No claim is allowed.
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 JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
