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 1-6, 8-18 and 21-23 are pending and examined herein on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
Claims 1-2, 5-6, 8-9 and 21-23 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a multitude of seeds, plants and tissue cultures wherein the products comprise a reduced RNA OR protein expression of vacuolar proton pyrophosphatase 5 wherein the reduction is at least 50% and the seed, plant or tissue is a genetically engineered Oryza sativa subsp japonica wherein the modification can be any modification as in claim 1, any mutation in the promoter as in claim 2, wherein the chalkiness is reduced by at least 50%. The claims are additionally drawn to methods of downregulating VPP5 by at least 50% relative to a non-engineered plant and wherein the chalkiness is reduced by at least 50%. The claims require a function but do not specify a structure required for this function that is commensurate in scope with the claims as currently written.
In contrast, the specification describes specified mutations in the GATA element wherein the expression or activity is reduced by at least 50% of the Vpp5 gene or protein and wherein the chalkiness was reduced by at least 50%. The specification does not describe any other mutations, mutations at any other locations, or mutations of other types (large deletions etc) that result in the claimed phenotypes as broadly claimed.
In a study of the correlation between Chalk5 and the expression levels of the gene that is now known as vpp5, Li et al (2014 Nature Genetics 46:398-404) Used transgenic lines to modify Oryza japonica subspecies to study chalkiness and demonstrated that different alleles (different sequences) including in the promoter region of vpp5 lead to different expression levels of the gene (see Figure 4 in particular) wherein although 50% less expression is recorded, several lines with other sequences differed much less, indicating that any mutation in the gene or even any mutation in the promoter region is insufficient for determining the function of 50% less expression and or activity for vpp5. It is noted as well that the differences also varied by location. For example, Li et al state “Compared to NIL(H94) with lower grain chalkiness, NIL(ZS97) with higher grain chalkiness had 19.0% higher PPi hydrolysis activity in crude membrane vesicles and 44.3% higher PPi hydrolysis activity in vacuolar membrane vesicles” (see paragraph following Figure 4).
Given the claim breadth and the lack of representative working examples, and the disclosure by Li et al, one of skill in the art would not be able to determine whether or not they were in possession of the claimed invention or not simply by looking at whether or not vpp5 is mutated or modified. Accordingly the claims as currently written lack adequate written description.
Claim Rejections - 35 USC § 103
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.
Claims 1-6, 8-18 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (2014 Nature Genetics 46:398-404).
The claims are drawn to a multitude of seeds, plants and tissue cultures wherein the products comprise a reduced RNA OR protein expression of vacuolar proton pyrophosphatase 5 wherein the reduction is at least 50% and the seed, plant or tissue is a genetically engineered Oryza sativa subsp japonica wherein the modification can be any modification as in claim 1, any mutation in the promoter as in claim 2, wherein the chalkiness is reduced by at least 50%. The claims are additionally drawn to methods of downregulating VPP5 by at least 50% relative to a non-engineered plant and wherein the chalkiness is reduced by at least 50%. The claims are also drawn to the above wherein the modification is made in the promoter region, and wherein the modification is made in the DATA element.
Li et al (2014 Nature Genetics 46:398-404) Used transgenic lines to modify Oryza japonica subspecies to study chalkiness and demonstrated that different alleles (different sequences) including in the promoter region of vpp5 lead to different expression levels of the gene (see Figure 4 in particular) wherein 50% less expression is recorded. Li et al disclosed that the promoter region of the gene was highly correlated with the phenotypic differences and stated “Comparison of the promoter sequences identified ten polymorphisms in one group relative to the other in the 1.8-kb region upstream of the translation start site. Using PLACE (plant cis-acting regulatory DNA elements) analysis, we identified two cis elements in the Chalk5 promoter of Zhenshan 97 that were absent in the promoter of H94 (Fig. 3c). One was a RY/G-box (CATGCA) at −721 required for seed-specific expression and ABA (abscisic acid) response20,21, and the other was a CACT tetranucleotide at −485 required for the phosphoenolpyruvate carboxylase activation involved in the transport and metabolism of photosynthetic carbon dioxide assimilation in developing seed” (see paragraph following Figure 3). In short, Li et al transformed Oryza sativa subsp japonica with constructs that contained sequences complementary to vpp5 wherein vpp5 was downregulated compared to vpp5 in lines with another allele, and wherein the modification was in the promoter region identified by Li et al.
Li et al do not teach modifying the GATA element, however, one of skill in the art would have been pointed to the promoter region based on Li et al and would have bene motivated to look for modifications to reduce chalkiness as taught by Li et al in rice of the japonica sub species.
Given the state of the art, the breadth of the claims and the teaching by Li et al it would have been obvious for one of ordinary skill in the art to practice the invention of the instant claims simply by following the approach and experiments of Li et al in other rice cultivars for the purpose of reducing chalkiness in rice grains as instantly claimed.
No claims are allowed.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663
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