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 15-19 and 41-55, pending in this application, 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).
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 15-19 and 41-55 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 drawn to a recombinant DNA segment comprising a Sclerotinia sclerotiorum allele that confers to a plant increased resistance, wherein the allele lacks a deleterious allele genetically linked thereto that confers to a plant undesirable seed color; the recombinant DNA segment comprises at least one sequence of SEQ ID NO: 15, 20, 21 and 26; the recombinant DNA segment further defined as comprised within a plant, plant part, plant cell or within a seed. The claims are also drawn to a recombinant DNA segment comprising a Sclerotinia sclerotiorum allele that confers to a plant increased resistance, wherein said recombinant DNA segment comprises at least one of SEQ ID NO: 1, 2 and 7; said resistance allele is derived from plant bean line G122 or A195; the recombinant DNA segment further defined as comprised within a plant, plant part, plant cell or within a seed.
The specification describes a recombinant chromosomal segment on chromosome 2 and 7, wherein the recombinant chromosomal segment on chromosome 2 comprises marker loci of SEQ ID NO: 1 (M1), SEQ ID NO: 7 (M2), and SEQ ID NO: 2 (M3); and the recombinant chromosomal segment on chromosome 7 comprises marker loci of SEQ ID NO: 8 (M9), SEQ ID NO: 14 (M10), SEQ ID NO: 20 (M11), SEQ ID NO: 21 (M8) and SEQ ID NO: 26 (M12) associated with Sclerotinia sclerotiorum and lacks a genetically linked deleterious allele associated with undesirable seed color, wherein at marker locus of SEQ ID NO: 15 (M6) is shown to be associated with a desirable white seed color.
The specification does not describe a single Sclerotinia sclerotium resistance allele that confers Sclerotinia sclerotiorum resistance by structure, wherein the allele lacks a deleterious allele genetically linked thereto that confers to a plant undesirable seed color. The specification also does not describe DNA sequences other than marker loci M1 of SEQ ID NO: 1, M2 of SEQ ID NO: 7, and M3 of SEQ ID NO: 2 on chromosome 2 to track Sclerotinia sclerotiorum resistance ; and marker loci M9 of SEQ ID NO: 8, M10 of SEQ ID NO: 14, M11 of SEQ ID NO: 20, M8 of SEQ ID NO: 21 and M12 of SEQ ID NO: 26 on chromosome 7 to track Sclerotinia sclerotiorum resistance; and SEQ ID NO: 15 on chromosome 7 to track the allele for desired white seed color.
The purpose of the written description is to ensure that the inventor had possession at the time the invention was made, of the specific subject claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
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 fails to describe a representative number of DNA sequences or alleles that confers resistance to Sclerotinia sclerotiorum to a plant. The Sclerotinia sclerotiorum resistance allele is described by function and not by both structure and function. The specification does not describe a single Sclerotinia sclerotiorum resistance allele that is associated with the marker loci, or a single allele associated with a undesirable seed color. Further, there is no known structure-function correlation for alleles that confer Sclerotinia sclerotiorum resistance and lacking the undesirable color allele genetically linked thereto. The allele with desirable seed color is described by its location at marker locus M6 of SEQ ID NO: 15. Neither the prior art nor the instant specification disclose a correlation between the structure of DNA sequences that confer Sclerotinia sclerotiorum resistance or that confer desirable seed color. 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. None of the sequences of SEQ ID NO: 1-2, and 15, 20-21 and 26 is an allele or a part of an allele that confer Sclerotinia sclerotiorum resistance. The source of the allele being from A195 or G122 is also not sufficient to describe the identity or the structure of the allele. Therefore, the sequences recited in the claims are insufficient to describe the Sclerotinia sclerotiorum resistance allele.
Consequently , 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.
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 47-55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by each of Genchev et al (Bulgarian Journal of Agricultural Science (2002), 8:181-187; Applicant’s IDS); and Maxwell et al (Crop Science (2007), vol. 47:2285-2294; Applicant’s IDS).n
The claims are drawn to a recombinant DNA segment comprising a Sclerotinia sclerotiorum resistance allele that confers to a plant increased resistance to Sclerotinia sclerotiorum, wherein said recombinant DNA segment comprises at least one sequence selected from the group consisting of SEQ ID NOs: 1, 2, and 7, wherein said Sclerotinia sclerotiorum resistance allele is derived from a plant of bean line G122 or A195, wherein said recombinant DNA is defined as comprised within a plant, a plant part, a plant cell, and a seed. Claims 51-55 read on a plant, plant part or cell or seed comprising the recombinant DNA segment. Therefore, parent claims 47-50 are included in the rejection.
Genchev et al disclose a common bean plant exhibiting resistance to Sclerotinia sclerotiorum produced by breeding the resistant line A195 with susceptible line G2883. The plant comprises a recombinant DNA segment from A195 (see the whole document).
Maxwell et al teach a common bean plant exhibiting resistance to Sclerotinia sclerotiorum produced by breeding the resistant line G122 with susceptible line CO72548, and markers associated with the resistance. The plant comprises a recombinant DNA segment from G122 (see the whole document).
The bean plant disclosed by Genchev et al or Maxwell et al would inherently comprise the claimed recombinant DNA sequences of SEQ ID NO: 1, 2 and 7 introgressed from the resistant parent line A195 and G122 of the instant invention. The office contends the marker locus of SEQ ID NO: 1-2, and 7 would be inherent features of a bean plant exhibiting resistance to Sclerotinia sclerotiorum because the prior art and instant application both use parent resistant line A195 or G122 as the source of the resistance.
Pertinent prior art
Abawi et al (The Journal of Heredity (1978) 69:200-202) teach a white seeded bean that is highly resistant to white mold (Sclerotinia sclerotiorum).
Ender et al (Mol. Breeding (2008) 21:149-157; Applicant’s IDS) teach a method of marker-assisted breeding for Sclerotinia sclerotiorum resistance in common bean, markers on linkage groups B2 and B7 linked to said resistance that are linked to Sclerotinia sclerotiorum resistance, and direct and indirect selection for agronomic traits such as yield, seed or phenological traits associated with Sclerotinia sclerotiorum resistance. Ender et al teach a cross between Sclerotinia sclerotiorum resistance plants and susceptible plants and selection of resistant progenies using the markers (pages 150-154; Table 2).
Conclusion
No claim is allowed.
Contact Information
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662