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 without traverse of Group I, claims 72-73, 78 and 81-86 in the reply filed on 01/28/2026 is acknowledged.
Claims 74-77 and 79-80 are hereby withdrawn by the Examiner as being drawn to nonelected subject matter.
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 73 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 73 is drawn to an engineered plant wherein the at least four genes encode OsSOS1, OSNHX1, OsHKT1 and one selected from OsSODA, OsAHA3, OsVHA-A. In order for the gene names to have meaning, it must be understood that there are specific DNA sequences encoding specific amino acid sequences. However, the claim indicates that comprising the sequences that are disclosed as those gene names is “optional”. In the cases wherein more than one allelic variation is disclosed, this optional language would be definite, however, in those cases both allelic variations are listed in the claim as optional. This implies that other sequences alternative to these may exist, however, the specification does not disclose this, nor does the specification indicate this specifically, and accordingly the gene names as currently claimed are indefinite in their meaning. Does the gene name refer to the listed SEQ ID Nos, or is the gene name more generic to a certain number of allelic variants, and if so, are such allelic variants known in the art since they are not otherwise disclosed in the specification?
Accordingly, the claim as currently written is indefinite.
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 72-73, 78 and 81-86 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 in the case of 72, 78 and 81-86 are drawn broadly to plants, plant parts, feed or food comprising said plants and methods of making said plant wherein the plant comprises at least any 4 genes of interest wherein the genes are from categories encompassing hundreds if not thousands of genes wherein the genes are plasma membrane ion transporter genes from any species, vacuolar ion transporters from any species and then 2 selected from the groups potassium transporters, hydrogen exporting ATPases, protein kinases (there are hundreds of genes from this category alone per species) and antioxidants wherein the genes are operatively linked to enhancers wherein the expression level is changed compared to the expression level of the genes in a wild-type plant.
In contrast, the specification teaches specific 4 gene combinations, specifically from rice for use with their invention. The specification does not teach any other genes for use with salt tolerance separately or in combination with any of the other genes listed in the specification.
The Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention “requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.” Id.
Finally, the court held:
A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP section 2163, page 174 of chapter 2100 of the August 2005 version, column 1, bottom paragraph, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene (which includes a promoter) is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Given the claim breadth and lack of description as discussed above, the specification fails to provide an adequate written description of the genus of sequences as broadly claimed. Given the lack of written description of the claimed genus of sequences, any method of using them, such as transforming plant cells and plants therewith, and the resultant products including the claimed transformed plant cells and plants containing the genus of sequences, would also be inadequately described. Accordingly, one skilled in the art would not have recognized Applicant to have been in possession of the claimed invention at the time of filing. See the Written Description Requirement guidelines published in Federal Register/ Vol. 66, No. 4/ Friday January 5, 2001/ Notices: pp. 1099-1111.
Claim 73 is drawn to an engineered plant wherein the at least four genes encode OsSOS1, OSNHX1, OsHKT1 and one selected from OsSODA, OsAHA3, OsVHA-A. In order for the gene names to have meaning, it must be understood that there are specific DNA sequences encoding specific amino acid sequences. However, the claim indicates that comprising the sequences that are disclosed as those gene names is “optional”. In the cases wherein more than one allelic variation is disclosed, this optional language would be described, however, in those cases both allelic variations are listed in the claim as optional. This implies that other sequences alternative to these may exist, however, the specification does not disclose this, nor does the specification indicate this specifically, and accordingly the gene names as currently claimed are indefinite in their meaning. Does the gene name refer to the listed SEQ ID Nos, or is the gene name more generic to a certain number of allelic variants, and if so, are such allelic variants known in the art since they are not otherwise disclosed in the specification? Accordingly, the gene names are not adequately described such that one of skill in the art would be able to determine whether a given sequence would fall within the scope of the claims as currently written.
No claims are allowed.
The claims appear to be free of the prior art given the failure of the prior art to teach or reasonably suggest the specified gene combinations expressed simultaneously in a plant with enhancers to change the expression of the genes relative to wild type expression. The closest prior art, Zhang et al (2017 Frontiers in Plant Science 8:1-8) teach that SOS1, HKT1 and NHX1 work synergistically to modulate sodium. However the prior art does not teach the 4th gene relative to this combination, nor does the prior art teach using enhancers to modulate expression of these gene combinations in plants.
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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