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 1-6, 8, 10-11, 13, 15, 19, 22 and 49 and the species of SEQ ID NO: 4 (genomic CGS, cystathionine gamma-synthase, sequence) and SEQ ID NO: 48 in the reply filed on 07/20/2026 is acknowledged. Applicant also elected SEQ ID NO: 7 (genomic 7S seed storage sequence) via telephonic election (see attached interview summary). According to Table 1 of the specification, SEQ ID NO: 4 and 7 encode SEQ ID NO: 6. and 9, respectively.
Claims 1-6, 8, 10-11, 13, 15, 17, 19, 22, 29-33 and 49 are pending .
Claims 29-33 are withdrawn from consideration as being directed to the non-elected invention.
Claims 1-6, 8, 10-11, 13, 15, 19, 22 and 49, and the species of SEQ ID NO: 4 (or 48) and 7 encoding SEQ IDNO: 6 and 9, respectively, are examined.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Improper Markush Grouping Rejections - 35 USC § 112
Claims 13, 19, 22 and 33 are rejected on the 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). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the CGS sequences of SEQ ID NO: 1 or 4, or the seed storage protein sequences of SEQ ID NO: 7, 10, 13, 16, 19, 22, 25, 28 and 62-108 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The sequences have different compositions that are structurally unrelated to each other. The species lack substantial structural feature as evidenced by the failure of the sequence search results of the elected sequences of SEQ ID NO: 4 and 7 to retrieve non-elected sequences. Each sequence is identified by specific sequence identifier showing structural differences. While each sequence encodes for a cystathionin gamma synthase or seed storage protein (7S), the claimed sequences lack a core common structure.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 102
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, 8, 10, and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by each of Ominato et al (The Journal of Biological Chemistry (2002), vol. 277 (39):36380-36386; Applicant’s IDS) and Song et al (Journal of Experimental Botany (2013) vol. 64:1917-1926; Applicant’s IDS); and Amir et al (US 7323338 B2).
The claims are drawn to a plant, plant cell, plant part, or seed comprising one or more modifications that increase seed protein or methionine content, the modification is a deletion, insertion, or substitution of a nucleotide or in-frame modification in a genomic sequence encoding a cystathionine gamma-synthase (CGS), the modification results suppression of the CGS while retaining enzymatic activity; the modification is at or near the MTO1 region of the genomic sequence encoding the CGS.
Ominato et al teach a plant or plant cell or plant part comprising a construct comprising a nucleotide sequence encoding a cystathionine gamma synthase (CGS) with one or more mutations; said mutations located within conserved region in close proximity to MTO1 region; said mutations provide soluble methionine accumulation and CGS accumulation. Ominata cites several prior art references that show expression of the CGS gene is feedback regulated at the mRNA stability and transgenic plants expressing mutated CGS, wherein the mutations results increased accumulation of methionine. See the whole document.
Song et al teach modification of a gene encoding CGS make it insensitive to methionine concentration in the cell, and overexpressing the Met-insensitive CGS gene in the transgenic soybean plants and show increased methionine amount in soybean seeds by 133% increase (page 1022, left column, last paragraph) and high levels of amino acids as compared to wild type seeds. Song et al show that that CGS plays a major role in methionine biosynthesis in soybean seeds (see the whole document).
Amir et al teach a method of increasing methionine and methionine containing metabolites in plants by expressing a cystathionine gamma synthase (CGS) encoded by a polynucleotide that is mutated or lacking a region encoding an N-terminal portion of the CGS (see the whole document).
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-6, 8, 10-11, 13, 15, 17, 19, 22, 29-33 and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to a plant, plant cell, plant part, or seed comprising one or more modifications that increase seed protein or methionine content, the modification is a deletion, insertion, or substitution of a nucleotide or in-frame modification in a genomic sequence encoding a cystathionine gamma-synthase (CGS) and/or a genome encoding a low methionine content seed storage protein including an alpha', alpha, and beta subunit of the 7S storage protein , the modification results suppression of the feedback regulation of the CGS while retaining enzymatic activity, and/or, the modification resulting in suppression of the activity of the low methionine content seed storage protein; the modification is at or near the MTO1 region of the genomic sequence encoding the CGS; the plant, plant cell, plant part, or seed of claim 1, wherein the deletion or insertion results in a frameshift mutation of the genomic sequence encoding the low methionine content seed storage protein, wherein 11S glycinin polypeptide content of the seed is increased relative to a control seed not, wherein the genomic sequence encoding the CGS comprises a nucleotide sequence having at least 80% sequence identity to SEQ ID NO: 4 (as the elected species), and/or wherein the genomic sequence encoding the low methionine content seed storage protein comprises a nucleotide sequence having at least 80% sequence identity to SEQ ID NO: 7 (as the elected species); wherein the modified CGS polynucleotide comprises the nucleotide sequence of SEQ ID NO: 48 or a sequence having at least 80% identity thereto (as the elected sequence). The claims are also drawn to a method of making a modified plant with high seed protein content compared to the seed protein content of a nonmodified plant by crossing the plant with a second plant; and selecting a progeny plant with high protein content for further breeding; a method of producing high protein seed meal comprising harvesting the seed of claim 1 from a plant comprising the modification and processing the seed to form meal; wherein the modified 7S polynucleotide comprises a sequence having at least 80%, at least 90%, at least to SEQ ID NO: 7. These are genus claims.
The specification fails to describe a representative species of the genus of CGS and seed storage protein sequences including modified CGS and modified seed storage protein sequences including 7S, 11S seed proteins. The specification describes modified CGS sequences of SEQ ID NO: 52 and the modified 7S sequences of SEQ ID NO: 62 (as the elected species). The specification, however, fails to described to further modified sequences having 80% or 90% sequence identity exemplified or non-exemplified sequences that retain the desired function.
The Federal Circuit 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 material". University of California v. Eli Lilly and Co., 43 USPQ2d 1398 (Fed. Cir. 1997). The court also stated "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 stated that to adequately describe a claimed genus, Applicant 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 members of the genus". Id.
Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
The specification has not described a representative number of species of the genus of modified and unmodified CGS and seed storage protein sequences. Neither the specification nor the prior art provides structure-function correlation of the CGS or seed storage protein sequences. It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (AbbVie, 759 F.3d at 1298, reiterating Enzo Biochem, Inc., 323 F.3d at 964)(emphasis added). However, in the instant application, there is insufficient evidence of such an established structure-function correlation.
The specification has not described a representative number of species of the genus of CGS and seed storge protein as recited in the claims. A substantial variation in structures and in function are expected among the claimed nucleic acid sequences that share 80% or 90% sequence identity to SEQ ID NO: 4 and 7 as well as their modified sequences. The specification fails to describe where and how to modify the exemplified sequences of SEQ ID NO: 4 or 7 to protein sequences that retain the desired structure (80% or 90% sequence identity) and functional activity. Furthermore, the specification fails to describe structural features common to members of the claimed genus of nucleic acid and protein sequences. Therefore, the specification has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly, and has not shown her/his possession of the claimed genus at the time of the application. Since the specification fails to describe the CGS and seed storage protein d sequences as broadly claimed, plant, plant parts, seed and composition comprising said sequences, and methods that employ with said nucleic acid sequences are similarly not described.
Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662
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