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 2, 4, 5, and the species the promoter of the SLB1 gene, in the reply filed on April 30, 2026 is acknowledged. Claim 1 links inventions I-II.
The traversal is on the ground(s) that the shared technical feature as merely "DNA methylation as a form of environmental stress memory" is overly broad and does not accurately reflect the actual claim limitations.
This is not found persuasive because independent claim 1 requires “a promoter with an effectively controlled methylation level”. This is also not found persuasive because Applicant proposes no alternative shared technical feature for consideration.
The traversal is also on the ground(s) that no undue burden is placed on the Examiner to search and consider the claims in their entirety.
This is not found persuasive because lack of unity is not predicated on search burden. This is also not found persuasive because while the different groups of invention may overlap with respect to the shared technical feature, their searches are not coextensive, since each group of invention requires additional searches directed to different, unshared technical features.
The traversal is additionally on the ground(s) that all claims were searched and considered for the International Search Report and Written Opinion issued in PCT/JP2023/013510, of which the present application is the U.S. National Phase entry.
This is not found persuasive because the International Search Report and Written Opinion does not preclude the imposition of lack of unity in the U.S. National Phase where the technical feature shared by the groups of invention is not a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3 and 6-12 are withdrawn.
Improper Markush Grouping
Claims 1-2 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: Claim 1 is drawn to a seed of a plant or a product thereof, or a harvested product obtained therefrom or a processed product thereof, the seed having a promoter with an effectively controlled methylation level, the promoter being for any gene selected from the group consisting of the SLB1 gene, Hd1 gene, AGPS2b gene, GBSSI gene, SuSy2 gene, AMy1A gene, and Amy3D gene. The genes recited in claim 1 are structurally and functionally distinct genes that comprise structurally and functionally distinct promoters. Claim 2 is drawn to the seed or a product thereof, or a harvested product obtained therefrom or a processed product thereof according to claim 1, wherein the promoter is a hypermethylated promoter for any gene selected from the group consisting of the SLB1 gene, AGPS2b gene, GBSSI gene, and SuSy2 gene. The genes recited in claim 2 are structurally and functionally distinct genes that comprise structurally and functionally distinct promoters. 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 § 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 1-2 and 4-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claim(s) recite(s) a seed of a plant or a product thereof, or a harvested product obtained therefrom or a processed product thereof, the seed having a promoter with an effectively controlled methylation level, the promoter being for any gene selected from the group consisting of the SLB1 gene, Hd1 gene, AGPS2b gene, GBSSI gene, SuSy2 gene, AMy1A gene, and Amy3D gene. The recited genes are understood to be naturally occurring endogenous genes. The specification at page 18 indicates that “an effectively controlled methylation level” means that the promoter is methylated to such an extent that it can control expression of a downstream gene. Methylation of a promoter to such an extent that it can control expression of a downstream gene is also under stood to be a naturally occurring phenomenon.
This judicial exception is not integrated into a practical application because the claims are directed to a product of nature (a seed of a plant or a product thereof, or a harvested product) comprising naturally occurring endogenous genes (the SLB1 gene, Hd1 gene, AGPS2b gene, GBSSI gene, SuSy2 gene, AMy1A gene, and Amy3D gene) having a promoter that is effectively controlled by a naturally occurring process (methylation level)
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements that are not naturally occurring.
Accordingly, the claimed invention is directed to a product of nature without significantly more.
Claim Rejections - 35 USC § 102 or § 103
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 –
(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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2 and 4-5 are is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over, Suriyasak et al. Mechanism of delayed seed germination caused by high temperature during grain filling in rice (Oryza sativa L.). Sci. Rep. 2020 Oct 15;10(1):17378.
Claim 1 is drawn to a seed of a plant or a product thereof, or a harvested product obtained therefrom or a processed product thereof, the seed having a promoter with an effectively controlled methylation level, the promoter being for any gene selected from the group consisting of the SLB1 gene, Hd1 gene, AGPS2b gene, GBSSI gene, SuSy2 gene, AMy1A gene, and Amy3D gene.
Claim 2 is drawn to the seed or a product thereof, or a harvested product obtained therefrom or a processed product thereof according to claim 1, wherein the promoter is a hypermethylated promoter for any gene selected from the group consisting of the SLB1 gene, AGPS2b gene, GBSSI gene, and SuSy2 gene.
Claim 4 is drawn to the seed or a product thereof, or a harvested product obtained therefrom or a processed product thereof according to claim 2, wherein the promoter is the SLB1 gene P2 promoter.
Claim 5 is drawn to the seed or a product thereof, or a harvested product obtained therefrom or a processed product thereof according to claim 4, wherein the plant is a Poaceae plant, and the promoter has a relative methylation level of 1.6% input or higher.
Suriyasak et al. teach seeds from rice plants (a Poaceae plant) exposed to high temperature during the grain filling stage. Suriyasak et al. teach that expression of abscisic acid (ABA) biosynthesis genes (OsNCEDs) was higher than in those of control seeds, whereas that of ABA catabolism genes (OsABA8′OHs) was lower, and that the transcripts of α-amylase genes OsAmy1C, OsAmy3B, and OsAmy3E were significantly down-regulated in heat-stressed seeds in comparison with controls. Suriyasak et al. teach that changes in promoter methylation levels were consistent with transcriptional changes of ABA catabolism-related and α-amylase genes.
Suriyasak et al. are silent with respect to the specific type and level of the promoter methylation of the promoter from the SLB1 gene, the Hd1 gene, the AGPS2b gene, the GBSSI gene, the SuSy2 gene, the AMy1A gene, and the Amy3D gene.
In support of the claimed subject matter, the specification at page 26 discloses that rice plants were grown under control conditions and subjected to a heat stress treatment during the grain filling stage as previously reported by the cited art of Suriyasak et al., and that rice was collected after threshing, with grain moisture content being calculated from the dry weight of the grains dried at 80° C. for 24 hours. The specification at page 27 also discloses that comprehensive DNA methylation analysis was perform using the WGBS method using genomic DNA extracted from dried seed.
Accordingly, it appears that the claimed plant seed is anticipated by or, in the alternative, is obvious over, the plant seed of Suriyasak et al., because the plant seed exemplified as having the characteristics of the claimed plant seed, and the plant seed of the prior art, were made by the same, or nearly the same, processes.
See In re Best, 562, F.2d 1252, 195 USPQ 430 (CCPA 1977).See MPEP 2112 III: “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA1977).”
See also MPEP 2112.01 I: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Since the Patent Office does not have the facilities to examine and compare the plant seed of Applicant with the plant seed of Suriyasak et al., the burden of proof is upon the Applicant to show an unobvious distinction between the claimed plant seed and the plant seed of the prior art.
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662
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