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 1, 2 and 18-22 in the reply filed on 14 May 2026 is acknowledged. The grounds of the traversal were not disclosed.
The restriction requirement is maintained with the understanding that should any claim be found allowable, then all claims that require all limitation of the allowable claim will be rejoined.
The requirement is deemed proper and is therefore made FINAL.
Status of the Claims
The status of the claims filed 31 January 2025 is as follows:
Claims 1-2, 4-5, 7-8, 10-15, 17-22 and 24-25 are pending.
Claims 2, 5, 7, 10-15, 18-19 and 21-22 have been amended.
Claims 4-5, 7-8, 10-15, 17 and 24-25 have been withdrawn.
Claims 1, 2 and 18-22 have been hereby examined.
Information Disclosure Statement
References listed on the IDS, filed 9 April 2025, have been considered.
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 –
(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.
Claims 1, 2 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Satoh et al (2008. Mutation of the plastidial α-glucan phosphorylase gene in rice affects the synthesis and structure of starch in the endosperm. The Plant Cell 20:1833-1849.).
The claims are broadly drawn to a genetically altered plant, part thereof or plant cell comprising reduced or abolished expression or activity of at least on PHS1 (plastidial α-glucan phosphorylase) gene wherein the plant comprises a mutation in at least one gene encoding PHS1 and/or the PSH1 promoter, wherein the mutation in at least one gene is a loss of function or partial loss of function mutation. The claims are further drawn to a plant, plant part, plant cell or grain or starch obtained from the grain with reduced expression or activity of at least one PHS1 gene which alters the starch granule characteristics of a plant.
Satoh et al teach generating a numerous rice mutants altered in endosperm starch by N-methyl-N-nitrosourea (MNU) treatment of fertilized egg cells [page 1834, para. Bridging left and rt. columns.]. Many of the mature seed mutant lines generated by MNU treatments were screened for Pho1 (PHS1) mutant were found to lack the 106-kD polypeptide completely and native-PAGE/activity staining analysis showed the absence of the Pho1 activity band in the mutant lines [page 1836, lf. col., para. 1] (which reads on a genetically altered plant, part thereof or plant cell comprising reduced or abolished expression or activity of at least on PHS1 gene). More than 15 plastidial Pho1 mutants were isolated by independent mutation treatments of rice [page 1836, rt. col., para. 1; Fig. 3] and determined that Pho1 to be essential for normal starch biosynthesis [page 1836, rt. col., para. 2; Figure 3] (which reads on a plant, plant part or plant cell obtained or obtainable from a reducing the expression or activity of at least one PHS1 gene, which reads on grain derived from the genetically altered plant comprising reduced or abolished expression or activity of at least one PHS1 gene, wherein the grain is characterized by reduced or abolished expression of a PHS1 gene and/or reduced or abolished activity of a PHS1 polypeptide and which reads on wherein the grain comprises at least one mutation in a PHS1 gene and/or promoter). Mutagenesis by MNU was found in the treatment of the fertilized egg cell in rice, in which most of the mutations were observed to be nucleotide transitions of G:C to A:T resulting in retention of the intron which in turn resulted in a frame shift and the insertion of a premature stop codon 66 nucleotides downstream of the mutation site resulting in a truncated polypeptide [page 1837, lf. col., para. 2] (which reads on wherein the plant comprises a mutation in at least one gene encoding PHS1 and/or the PHS1 promoter wherein the mutation in at least one gene encoding PHS1 is a loss of function or partial loss of function mutation). Satoh et al teach that scanning electron microscopy revealed that the pho1 mutation resulted in modification in starch granule morphology [page 1838, rt. col., para. 2; Fig. 7] (which reads on starch obtained or obtainable from at least one plant cell of the genetically altered plant containing reduced or abolished expression or activity of at least one PHS1 gene).
Therefore, Satoh et al clear anticipates the inventions encompassed by claims 1, 2 and 18-21.
Claim Rejections - 35 USC § 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Satoh et al (2008. Mutation of the plastidial α-glucan phosphorylase gene in rice affects the synthesis and structure of starch in the endosperm. The Plant Cell 20:1833-1849.) as applied to claims 1, 2 and 18-21 above, and further in view of Diaz, F. (2020. Starch content in calf starter feed, what is the optimum concentration. Dellait knowledge center. Optimum concentration level of starch in calf starter feed.)
The claim is drawn to food or feed composition prepared from the grain derived from the genetically altered plant wherein the grain is characterized by reduced or abolished expression of a PHS1 gene and/or reduced or abolished activity of PHS1 polypeptide, wherein the grain comprises at least one mutation in a PHS1 gene and/or promoter.
The teachings of Satoh et al are supra.
Satoh et al does not teach a food or feed composition prepared from the grain characterized by reduced or abolished expression of a PHS1 gene and/or reduced or abolished activity of PHS1 polypeptide wherein the grain comprises a mutation in the PSH1 gene and/or promoter.
Diaz teaches that starch is one of the most abundant nutrients in calf stater feed and that high starch intakes can reduce ruminal pH [pages 1 and 2]. Diaz teaches that high starch intakes however can reduce ruminal pH and increase the risk of sub-clinical acidosis causing rumen and ruminal papillae characterized by ruminal pH drops below 5.6 [page 2, para. 2]. Diaz found that calves that received the feed with the highest starch content showed lower ruminal pH which causes a drop in ruminal pH causing in increase potential of metabolic problems [page 2, para. 4].
It would have been obvious to one of ordinary skill in the art before the effective filing date to include grains with reduced starch content, including grains derived from genetically altered plants that have a reduced or abolished expression of a PHS1 gene and/or reduced or abolished activity of a PHS1 polypeptide. One would have been motivated to include such grains with reduced starch content to decrease the potential of metabolic problems caused by feed composition containing high starch content. One would have had a reasonable expectation of success given that components of feed compositions are modified, substituted and excluded depending on the intent of the composition.
Conclusion
No claim is allowable.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN M REDDEN whose telephone number is (571)270-0298. The examiner can normally be reached 730-6 Monday-Thursday.
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/KAREN M REDDEN/Primary Examiner, Art Unit 1661
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