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 .
DETAILED ACTION
1. Claims, 1-29 are pending, are examined.
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.
2. Claims 1-29 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.
The claims are broadly drawn to a pepper plant of any cultivated pepper variety comprising a recombinant introgression on chromosome 5 that comprises a first allele conferring improved resistance to Phytophthora capsici and wherein said first allele lacks a second allele genetically linked to said first allele, wherein the second allele would confer light immature fruit color phenotype if present; or wherein said recombinant introgression is flanked in the genome of said plant by marker locusSNPmarker_7 (SEQ ID NO:1) and marker locus SNPmarker_12(SEQ ID NO:6); or wherein the introgression is located between about 39.4 cM and 41.8cM on chromosome 5; or wherein said recombinant introgression comprises the geme AIG1 on chromosome 5 of said plant; or wherein the pepper plant further comprises an introgressed chromosomal segment from chromosome 6 conferring improved Phytophthora capsici resistance under all disease pressure; or wherein the chromosomal segment is associated with marker locus SNPmarker_1 or SNPmarker_2; or wherein the chromosomal segment is located between about 26.4 cM and 28.7 cM on chromosome 6 . The claims are also drawn to a method for producing a pepper plant having improved resistance to Phytophthora capsici comprising: a) crossing the pepper plant of claim 1 with itself or with a second pepper plant of a different genotype to produce one or more progeny plants; and b) selecting a progeny plant comprising said recombinant introgression; said method, wherein selecting said progeny plant comprises detecting at least one polymorphism at a locus SNPmarker_8 and SNPmarker_21; said method, wherein the progeny plant is an F2-F6 progeny plant or comprises from 2-7 generations of backcrossing. The claims are also drawn to a method for producing a pepper plant having improved resistance to Phytophthora capsici comprising: a) crossing the pepper plant of claim 8 with itself or with a second pepper plant of a different genotype to produce one or more progeny plants; and b) selecting a progeny plant comprising said recombinant chromosomal segment; or wherein said method, wherein selecting said progeny plant comprises detecting at least one polymorphism at a locus SNPmarker_8, SNPmarker_21 and SNPmarker_1, SNPmarker_2; said method, wherein the progeny plant is an F2-F6 progeny plant or comprises from 2-7 generations of backcrossing.
The specification describes crossing between P. capsici resistance donor (CM334) and P. capsici susceptible parent (SBR-99-1274),and F1 progeny from said cross, SBRHJ12-G011, that exhibited P. capsici resistance and does not produce light green fruit at the immature stage.
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. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. The court goes on to say, "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 of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus." See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
First, the claims are broadly drawn to a genus of cultivated pepper plants comprising unspecified first allele that confers resistance to Phytophthora capsici, and wherein the plant lacks unspecified second allele that would confer light immature fruit color phenotype if present. The specification has disclosed the breeding history of a pepper plant using genetic markers. The first and second allele are described by function only and not by both structure and function. There is no known correlation between the structure and function of an allele from chromosome 5 that confers resistance to Phytophthora capsici and not linked to an allele that confers undesirable light immature fruit color phenotype. In addition, the specification fails to describe a sequence for the allele or locus that confers resistance to Phytophthora capsici. The specification also fails to describe a sequence of the second allele that confers undesirable light immature fruit color phenotype. The identity of an allele is located in the genomic region encoding AIG1 is also unknown.
Second, the claims are also broadly drawn to a genus of cultivated pepper plants further comprising unspecified introgressed chromosomal segment from chromosome 6 conferring improved Phytophthora capsici resistance under all disease pressure; or wherein the chromosomal segment is associated with marker locus SNPmarker_1 or SNPmarker_2; or wherein the chromosomal segment is located between about 26.4 cM and 28.7 cM on chromosome 6 .The specification has disclosed DH lines developed from F1 progeny generated from a cross between HAS-144-6103 and HAS-144-1357 . The chromosomal segment is described by function only and not by both structure and function. There is no known correlation between the structure and function of an allele from chromosome 6 that confers additional resistance to Phytophthora capsici under all disease pressure.
Furthermore, the specification fails to sufficiently describe a representative number of DNA sequences that corresponds to Phytophthora capsici resistance alleles or describe structural features common to the genus of Phytophthora capsici resistance alleles recited in the claims or representative number of pepper plants comprising recombinant introgression conferring Phytophthora capsici resistance without light immature fruit color phenotype or genotype. The only structure described is a region of between about 39.4 cM and 41.8 cM and flanked by marker locus SEQ ID NO:1 and 6 as well as encoding AIG1 gene on chromosome 5 of PTA-123693 line. The only structure described for chromosomal segment for additional resistance to Phytophthora capsici under all disease pressure is the chromosomal segment located between about 26.4 cM and 28.7 cM on chromosome 6 and associated with marker locus SNPmarker_1 or SNPmarker_2 from DH lines developed from F1 progeny generated from a cross between HAS-144-6103 and HAS-144-1357 .
Therefore, given this lack of adequate written description of the allele that confers resistance Phytophthora capsici and lack of a second allele that confers light immature fruit color phenotype and the lack of written description of a representative number of cultivated pepper plant comprising said allele, one of skill in the art would not have recognized Applicants in possession of the claimed invention at the time the application was filed. Therefore, the claimed invention is not adequately described.
Deposit
4. Claim 5 is rejected under 35 U.S.C. 112, first paragraph, as containing 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 deposited as PTA-123693 as claimed in claim5 is essential to the claimed invention, it must be obtainable by a reproducible 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 reproducible 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. If the deposit of the seed 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 the seed have been deposited under the Budapest Treaty and that the seed 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 criteria 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 unviable.
Applicant has made the deposit the seeds at the ATCC but the deposit information on page 20 fails to in state that such deposit was made accordance with 37 CFR 1.801-1.809 as discussed above. Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809 to overcome this rejection.
Claim Rejections - 35 USC § 103
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.
5. Claims 1-10, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Brian Just (US Patent Application Publication No. 2013/0205419).
The claims are broadly drawn to a pepper plant of any cultivated pepper variety comprising a recombinant introgression on chromosome 5 that comprises a first allele conferring improved resistance to Phytophthora capsici and wherein said first allele lacks a second allele genetically linked to said first allele, wherein the second allele would confer light immature fruit color phenotype if present; or wherein said recombinant introgression is flanked in the genome of said plant by marker locusSNPmarker_7 (SEQ ID NO:1) and marker locus SNPmarker_12(SEQ ID NO:6); or wherein the introgression is located between about 39.4 cM and 41.8cM on chromosome 5; or wherein said recombinant introgression comprises the geme AIG1 on chromosome 5 of said plant; or wherein the pepper plant further comprises an introgressed chromosomal segment from chromosome 6 conferring improved Phytophthora capsici resistance under all disease pressure; or wherein the chromosomal segment is associated with marker locus SNPmarker_1 or SNPmarker_2; or wherein the chromosomal segment is located between about 26.4 cM and 28.7 cM on chromosome 6.
Brian Just teach a hybrid pepper SBR 163-5031 with dark green immature fruit color and intermediate resistance to Phytophthora capsici (Table 2, paragraph [0030]).
Although the reference did not teach the recombinant introgression on chromosome 5 or chromosomal segment on chromosome 6, it exhibits same phenotype of the claimed plant which includes Phytophthora capsici resistance. Although the reference does not teach the lack of light green immature fruit color, it would have been obvious exhibited by SBR 163-5031 which show dark green immature fruit color. Although the Office is not in position to determine the genetic structure associated with these phenotypes are the same in SBR 163-5031 and instant claimed pepper plant, they are obviously possessed by the SBR 163-5031 line given the same phenotype as those described in the claimed plant.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
6. Claims 1-10, 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No.8,962,944. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims are broadly drawn to a pepper plant of any cultivated pepper variety comprising a recombinant introgression on chromosome 5 that comprises a first allele conferring improved resistance to Phytophthora capsici and wherein said first allele lacks a second allele genetically linked to said first allele, wherein the second allele would confer light immature fruit color phenotype if present; or wherein said recombinant introgression is flanked in the genome of said plant by marker locusSNPmarker_7 (SEQ ID NO:1) and marker locus SNPmarker_12(SEQ ID NO:6); or wherein the introgression is located between about 39.4 cM and 41.8cM on chromosome 5; or wherein said recombinant introgression comprises the geme AIG1 on chromosome 5 of said plant; or wherein the pepper plant further comprises an introgressed chromosomal segment from chromosome 6 conferring improved Phytophthora capsici resistance under all disease pressure; or wherein the chromosomal segment is associated with marker locus SNPmarker_1 or SNPmarker_2; or wherein the chromosomal segment is located between about 26.4 cM and 28.7 cM on chromosome 6.
US Patent NO. 8,962,944 teaches a hybrid pepper SBR 163-5031 with dark green immature fruit color and intermediate resistance to Phytophthora capsici (Table 2, paragraph bridging columns 5-6, claim 1-28).
Although the reference did not teach the recombinant introgression on chromosome 5 or chromosomal segment on chromosome 6, it exhibits same phenotype of the claimed plant which includes Phytophthora capsici resistance. Although the reference does not teach the lack of light green immature fruit color, it would have been obvious exhibited by SBR 163-5031 which show dark green immature fruit color. Although the Office is not in position to determine the genetic structure associated with these phenotypes are the same in SBR 163-5031 and instant claimed pepper plant, they are obviously possessed by the SBR 163-5031 line given the same phenotype as those described in the claimed plant.
7. Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No.10,858,667. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims are broadly drawn to a pepper plant of any cultivated pepper variety comprising a recombinant introgression on chromosome 5 that comprises a first allele conferring improved resistance to Phytophthora capsici and wherein said first allele lacks a second allele genetically linked to said first allele, wherein the second allele would confer light immature fruit color phenotype if present; or wherein said recombinant introgression is flanked in the genome of said plant by marker locusSNPmarker_7 (SEQ ID NO:1) and marker locus SNPmarker_12(SEQ ID NO:6); or wherein the introgression is located between about 39.4 cM and 41.8cM on chromosome 5; or wherein said recombinant introgression comprises the geme AIG1 on chromosome 5 of said plant; or wherein the pepper plant further comprises an introgressed chromosomal segment from chromosome 6 conferring improved Phytophthora capsici resistance under all disease pressure; or wherein the chromosomal segment is associated with marker locus SNPmarker_1 or SNPmarker_2; or wherein the chromosomal segment is located between about 26.4 cM and 28.7 cM on chromosome 6 . The claims are also drawn to a method for producing a pepper plant having improved resistance to Phytophthora capsici comprising: a) crossing the pepper plant of claim 1 with itself or with a second pepper plant of a different genotype to produce one or more progeny plants; and b) selecting a progeny plant comprising said recombinant introgression; said method, wherein selecting said progeny plant comprises detecting at least one polymorphism at a locus SNPmarker_8 and SNPmarker_21; said method, wherein the progeny plant is an F2-F6 progeny plant or comprises from 2-7 generations of backcrossing. The claims are also drawn to a method for producing a pepper plant having improved resistance to Phytophthora capsici comprising: a) crossing the pepper plant of claim 8 with itself or with a second pepper plant of a different genotype to produce one or more progeny plants; and b) selecting a progeny plant comprising said recombinant chromosomal segment; or wherein said method, wherein selecting said progeny plant comprises detecting at least one polymorphism at a locus SNPmarker_8, SNPmarker_21 and SNPmarker_1, SNPmarker_2; said method, wherein the progeny plant is an F2-F6 progeny plant or comprises from 2-7 generations of backcrossing.
US Patent NO. 10,858,667 teaches a pepper plant of a cultivated pepper variety comprising a recombinant introgression on chromosome 5 that comprises a first allele conferring resistance to Phytophthora capsici, wherein said recombinant introgression is flanked in the genome of said plant by marker locus SNPmarker_7 (SEQ ID NO: 1) and marker locus SNPmarker_12 (SEQ ID NO: 6), wherein said first allele lacks a second allele genetically linked thereto that confers a light green immature fruit color phenotype when present, and wherein a representative sample of seed comprising said allele conferring resistance to Phytophthora capsici has been deposited under ATCC Accession No. PTA-123693; or wherein the introgression is located between about 39.4 cM and 41.8cM on chromosome 5; or wherein said recombinant introgression comprises the geme AIG1 on chromosome 5 of said plant; or wherein the pepper plant further comprises an introgressed chromosomal segment from chromosome 6 conferring improved Phytophthora capsici resistance under all disease pressure; or wherein the chromosomal segment is associated with marker locus SNPmarker_1 or SNPmarker_2; or wherein the chromosomal segment is located between about 26.4 cM and 28.7 cM on chromosome 6 . The claims are also drawn to a method for producing a pepper plant having improved resistance to Phytophthora capsici comprising: a) crossing the pepper plant of claim 1 with itself or with a second pepper plant of a different genotype to produce one or more progeny plants; and b) selecting a progeny plant comprising said recombinant introgression; said method, wherein selecting said progeny plant comprises detecting at least one polymorphism at a locus SNPmarker_8 and SNPmarker_21; said method, wherein the progeny plant is an F2-F6 progeny plant or comprises from 2-7 generations of backcrossing. The claims are also drawn to a method for producing a pepper plant having improved resistance to Phytophthora capsici comprising: a) crossing the pepper plant of claim 8 with itself or with a second pepper plant of a different genotype to produce one or more progeny plants; and b) selecting a progeny plant comprising said recombinant chromosomal segment; or wherein said method, wherein selecting said progeny plant comprises detecting at least one polymorphism at a locus SNPmarker_8, SNPmarker_21 and SNPmarker_1, SNPmarker_2; said method, wherein the progeny plant is an F2-F6 progeny plant or comprises from 2-7 generations of backcrossing.
Therefore, the reference anticipated instant claims.
8. Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No.12,116,587. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims are discussed above.
US Patent NO. 12,116,587 teaches a method for selecting a pepper plant of a cultivated variety exhibiting resistance to Phytophthora capsici comprising: a) detecting in said plant a Phytophthora capsici resistance enhancing allele on chromosome 6, wherein said allele is flanked in the genome of said plant by marker locus SNPmarker_1 (SEQ ID NO: 8) and marker locus SNPmarker_2 (SEQ ID NO: 9), and wherein said Phytophthora capsici resistance enhancing allele confers to said plant improved resistance to Phytophthora capsici relative to a plant lacking said allele; and b) selecting a pepper plant comprising said Phytophthora capsici resistance enhancing allele (claim 1); or wherein the method further comprises introgressing said Phytophthora capsici resistance enhancing allele into a further pepper plant; or wherein said introgressing comprises: a) crossing the plant comprising said Phytophthora capsici resistance enhancing allele with itself or with a second pepper plant of a different genotype to produce one or more progeny plants; and b) selecting a progeny plant comprising said Phytophthora capsici resistance enhancing allele; or wherein said second pepper plant comprises an introgressed Phytophthora capsici resistance allele within a second recombinant chromosomal segment flanked in the genome of said plant by marker locus SNPmarker_7 (SEQ ID NO: 1) and marker locus SNPmarker_12 (SEQ ID NO: 6) on chromosome 5; or wherein selecting said progeny plant comprises detecting a first marker locus within or genetically linked to a chromosomal segment flanked in the genome of said plant by marker locus SNPmarker_1 (SEQ ID NO: 8) and marker locus SNPmarker_2 (SEQ ID NO: 9) on chromosome 6 and a second marker locus within or genetically linked to a chromosomal segment flanked in the genome of said plant by marker locus SNPmarker_7 (SEQ ID NO: 1) and marker locus SNPmarker_12 (SEQ ID NO: 6) on chromosome 5.
Although the reference did not teach the pepper plant per se, such plant would have been obviously generated by the method of claims 1-10 of U.S. Patent No.12,116,587.
Conclusion
No claim is allowed.
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/LI ZHENG/Primary Examiner, Art Unit 1662