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 1-2, 4, 6, 8-11, 17, 44-45, 49-50, 53-54 and 58, 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 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-2, 4, 6, 8-11, 17, 44-45, 49-50, 53-54 and 58 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. It is noted that Applicant deposited seed of alfalfa varieties C0416C4164 and H0415C4114. However, there is no indication that deposit was made under Budapest treat or comply with 37 CFR 1.801-1.809. Moreover, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 2500 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant has NOT indicated that Applicant intends to deposit the seeds atthe ATCC in accordance with 37 CFR 1.801-1.809. Accordingly, Applicant needs toprovide a signed statement indicating compliance with 37 CFR 1.801-1.809, theATCC Accession No. and evidence of deposit to overcome this rejection. Compliancewith this requirement may be held in abeyance until the application is otherwise incondition for an allowance.
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 1-2, 4, 6, 8-11, 17, 44-45, 49-50, 53-54 and 58 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-2, 4, 6, 8-9, 17, 44-45 and 58 are broadly drawn to a genus of Medicago sativa plants, progeny thereof and seed that produces said plants comprising an introgressed allele conferring increased broad spectrum resistance to Colletotrichum trifolii Race 5, wherein said introgressed allele comprises the resistance haplotype found in H0415C4112, H0415C4114, H0415C4115, H0415C4116; and a method of using said plant in breeding with itself with a plant of different genotype to produce progeny comprising said allele.
In contrast, the specification describes plants of Medicago sativa varieties C0416C4164 and H0415C4114 having resistance to Colletotrichum trifolii race 5, representative seed deposited under ATCC Accession Nos. PTA-124210 and PTA-125043, respectively; wherein the plant comprises Colletotrichum trifolii race 5 resistance allele is located within a chromosomal segment flanked and including by the markers SEQ ID NO: 1 and 7 in chromosome 4. These are genus claims.
The claimed alfalfa plant are described by a single phenotype, broad-spectrum resistance to Colletotrichum trifolii Race 5 conferred by unspecified allele. There is no known correlation between structure-function of alleles/genes that confer resistance to Colletotrichum trifolii Race 5. In addition, the specification fails to describe a sequence for the allele or locus that confers the broad resistance to Colletotrichum trifolii Race 5. The allele is found in the resistance haplotype found in H0415C4112, H0415C4114, H0415C4115, H0415C4116 is also unknown and not described in the specification. Therefore, the structure or the sequence of the introgressed allele is unknown. Also, the claimed method produces Medicago sativa plants and progeny of unknown genotype and phenotype. Furthermore, the state of the prior art as evidenced by Applicant’s own specification, is that no Medicago sativa variety with broad-spectrum resistance to Colletotrichum trifolii Race 5 is known.
The method of claims 10-11, 49-50 and 53-54 require a genus of Medicago sativa plants comprising a Colletotrichum trifolii Race 5 resistance allele, said allele is only described by its location within a genomic region by 16,945, 124 bp to19, 292, 176 bp on the Medicago truncatula Mt4.0 map as in claim 45 (c ) or flanked by marker locus of SEQ ID NO: 1 (FG2208) and marker locus SEQ ID NO:7 (FG27271) on chromosome 4 as in claim 45(b) . Claims 45, 50 and 53 , do not require that the genomic region comprises the marker loci SEQ ID NO: 1 and 7 and the deposit information . Therefore, the structure of the Colletotrichum trifolii Race 5 resistant allele is unknown and the claims are not limited to plants/seeds of the deposited line C0416C4164 or H0415C4114 .
In contrast, the specification describes a method of introgressing Colletotrichum trifolii Race 5 and Race 1 allele into a Medicago sativa plant by crossing the Medicago sativa plant varieties C0416C4164 and H0415C4114 comprising a marker allele on chromosome 4 and having increased resistance to Colletotrichum trifolii Race 5 and Race 1 as compared with a plant not comprising said allele, wherein a representative sample of seed comprising said allele has been deposited under ATCC Accession No. PTA-124210 or under ATCC Accession No. PTA-125043; wherein said marker allele comprises FG2208 (SEQ ID NO: 1), FG2218 (SEQ ID NO: 2), FG27062 (SEQ ID NO: 3), FG2226 (SEQ ID NO: 4), FG27232 (SEQ ID NO: 5), FG27251 (SEQ ID NO: 6), or FG27271 (SEQ ID NO: 7). The specification also describes a synthetic population of Medicago sativa plants comprising variety C0416C4164 or H0415C4114 (seed deposited under ATCC Accession NO. PTA-124210 or PTA-125043, respectively), wherein said population comprises an introgressed allele conferring to said plants an increased resistance to Colletotrichum trifolii Race 5.
The specification does not describe a representative species of Medicago sativa plant comprising a Colletotrichum trifolii Race 5 resistance allele which can be used in the claimed methods. Neither the identity/structure of Colletotrichum trifolii Race 5 resistance allele is disclosed in the specification or available in the prior art. In addition, The pathogen Colletotrichum trifolii Race 5 or alfalfa germplasm comprising Colletotrichum trifolii Race 5 resistance allele/genotype is neither described nor is known in the prior art. Therefore, the disclosed Medicago sativa plants of variety C0416C4164 or H0415C4114, representative sample of seed deposited under ATCC Accession NO. PTA-124210 or PTA-125043, respectively is insufficient to describe the genus of Medicago sativa plants comprising a Colletotrichum trifolii Race 5 resistance allele as required by the claimed method.
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 test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations. Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966”. While the written description requirement does not demand either examples or an actual reduction, actual “possession” or reduction to practice outside of the specification is not enough. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). Rather, it is the specification itself that must demonstrate possession. Id.
The Federal Circuit has recently clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398; 1406 (Fed. Cir. 1997). In summary, the court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures.
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.
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 9, 17 and 58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al (US 20080050821 A1).
Johnson et al teach alfalfa plants having resistance to Anthracnose Race 1, which reads on the plant produced by the specified method, since the claims recite no specific phenotype for the plant and the genotype is unknown (Tables 11a, 15a, 19a, 23a). Therefore, Johnson et al teach all claim limitations, absent evidence to the contrary.
at the time of filing.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4, 6, 8-11, 17, 44-45, 49-50, 53-54 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12, 356, 949 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the application and the issued patent are drawn to a method of introgressing Colletotrichum trifolii Race 5 resistance allele into a synthetic population of Medicago sativa plants by crossing a Medicago sativa plant comprising a Colletotrichum trifolii Race 5 resistance allele located within a genomic region flanked by marker loci of SEQ ID NO: 1 and 7 with a plant not comprising said allele; said introgressed allele conferring to said plants increased resistance to Colletotrichum trifolii Race 5 as compared with a plant not comprising said allele, wherein a representative sample of seed comprising said allele has been deposited under ATCC Accession No. PTA-124210 or under ATCC Accession No. PTA-125043.
The method claims 10-11 and 49-53 and the resultant plants of claims 17 and 58 of the instant application are broader in scope than the method claims 1-5 of the issued patent reciting the marker loci and the deposit information of the Colletotrichum trifolii Race 5 plant. Therefore, the claimed invention is obvious over the claims of the issued patent.
Claims 1-2, 4, 6, 8-11, 17, 44-45, 49-50, 53-54 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over each of claims 5 and 13-15 of U.S. Patent No. 11,051,482 B2, and claims 6-9 and 14-15 of US 11,800,848 B2) . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant application and the issued patent are drawn to a method of introgressing Colletotrichum trifolii Race 5 resistance allele into a Medicago sativa plants; said introgressed allele conferring to said plants increased resistance to Colletotrichum trifolii Race 5 as compared with a plant not comprising said allele, wherein a representative sample of seed comprising said allele has been deposited under ATCC Accession No. PTA-124210 or under ATCC Accession No. PTA-125043.
Instant claims are broader in scope because the instantly claimed method requires crossing any Medicago sativa plant comprising a Colletotrichum trifolii Race 5 resistance allele with at least one Medicago sativa of a synthetic population lacking said allele, wherein said allele is located with a genomic region flanked by marker loci SEQ ID NO: 1 and SEQ ID NO: 7, while the claims of each of the issued patent are limited to methods of using Medicago sativa plants of the deposited seed. Therefore, instant claims encompass the invention of the issued patent and are obvious over each.
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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