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 of Group I, claims 1-4,8-12 and 17 with the species of Locus CrB8 in the reply filed on 08/19/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-4 and 8-21 are pending.
Claims 13-16 and 18-21 are withdrawn from consideration as being directed to the non-elected invention.
claims 1-4,8-12 and 17 with the species of CrB8 locus 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).
Improper Markush Grouping Rejection
Claims 1-4, 8-12 and 17 are rejected under the judicially-created basis that it contains an improper Markush grouping of alternative. See In re Harnisch, 631 F.2d 716, 721-722 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. and Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or common use that flows from the substantial structural feature and/or common use that flows from the substantial structural feature for the following reasons:
Each of the locus of CrB8, CrG8, CrE8, and CrM8, is located on specific position on chromosome 8 and each is flanked by and included by SNP marker/alleles identified by specific SEQ ID NO: showing structural differences. However, no structural feature that is common between the loci of CrB8, CrG8, CrE8, and CrM8 that defines function has been disclosed. Each SNP has a different chemical structure in that it consists of a different sequence of nucleotides surrounding the SNP giving the context required to detect the particular variation. In addition, the search of the elected sequences of SEQ ID NO: 1, 5, 11, 16, 20, 23, 28, 30, 33 and 37 linked to the CrB8 locus do not reveal any of the other nucleotide sequences for the markers linked to the CrG8, CrE8, and CrM8 loci. Therefore, the nucleotide sequences do not share a substantial feature and/or common use that flows from the substantial structural feature and/or common use that flows from the substantial structural feature.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or groupings of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 USC 134 and 37 CFR 41.31 (a)(1).
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 1-4,8-12 and 17 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 method for introducing a clubroot resistance locus into a Brassica plant the method comprising: crossing a first parent Brassica plant comprising at least one clubroot resistance locus with a second Brassica plant of a different genotype to produce progeny plants; obtaining a nucleic acid-containing sample from one or more of the progeny plants; screening the samples for a sequence comprising a molecular marker allele or a haplotype of molecular marker alleles linked to clubroot resistance at CrB8 located on chromosome N8 interval flanked by and including 12.94 cM and 16.44 cM (as the elected species); and selecting one or more of the progeny plants comprising the screened for molecular marker allele or haplotype, thereby obtaining a Brassica plant comprising a clubroot resistance locus; wherein the one or more clubroot resistance loci physical positions on chromosome 8 (Chr 8) correspond to position 10,656,081 to position 13,303,318 of Chr 8; wherein the method further comprises screening the sample for the presence of the molecular marker or haplotype, wherein the molecular marker or haplotype comprises one or more CrB8 resistance marker alleles shown in SEQ ID NO: 1, 5, 11, 16, 20, 23, 28, 30, 33, or 37; wherein the molecular marker or haplotype comprises one or more of the allele N101BW0-001-Q001 (SEQ ID NO:23); said method further comprising further comprising: crossing the selected one or more backcross progeny plants with the second parent Brassica plant to produce additional backcross progeny plants: screening a nucleic acid-containing sample from one or more additional backcross progeny plants for a sequence comprising the screened for molecular marker allele or a haplotype; and selecting one or more additional backcross progeny plants comprising the screened for molecular marker allele or haplotype; said method further comprising repeating steps of screening and selecting additional backcross progeny plants two or more additional times to produce further backcross progeny plants that comprise the screened for molecular marker allele or haplotype-and the agronomic characteristics of the second parent plant when grown in the same environmental conditions; said method, wherein screening each sample comprises the use of a first probe comprising any probe for resistance allele SEQ ID NO: 1, 5, 11, 16, 20, 23, 28, 30, 33, 37, to detect the presence of a molecular marker allele linked to clubroot resistance, wherein the screening comprises nucleic acid sequencing, amplification or both comprising the nucleic acid.
The specification describes identification of SNP molecular markers of SEQ ID NO: 23,30, 33 and 37 linked to clubroot resistance locus CrB8 on chromosome 8 of brassica (as the elected species). These markers are specific to a proprietary resistance donor line that is not publicly available [0008]. Tables 1-8 show example of SNP markers for resistance and susceptible alleles for clubroot diseases, and probe sequences for detecting these markers. Tables 1 and 2 show CrB8 resistance marker alleles. The specification contemplates a method of introducing or introgressing at least one clubroot resistance locus into a brassica plant by crossing first brassica plant comprising one or more of CrB8, CrG8, CrE8, and CrM8 resistance locus with a second brassica plant to produce progeny plants which can be screened for the presence or absence of one or of said resistance locus using the markers on Tables 1-8, and identifying and selecting progeny plants having one or more of CrB8, CrG8, CrE8, and CrM8 resistance locus for further breeding.
The specification fails to describe a representative species of the genus of clubroot resistance loci and the genus molecular marker alleles linked thereto. The locus CrB8 is described by its location on chromosome 8 flanked by and including 13.94 cM and 16.44 cM or that corresponds physical position 10, 656, 081 to position 13,303318 which is 2, 647, 237 bp ( about 2.6Mbp) which encompass a large segment of Chr. 8. A substantial variation in structure and function are expected among the loci found on this segment and the specification fails to describe a representative number of markers located from physical position 10, 656, 081 to position 13,303318 on Chr. 8. The specification does not show that the chromosomal segment with 2, 647, 237 bp confer clubroot resistance.
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.
The claims require any number of markers of any type as long as it is located from physical position 10, 656, 081 to position 13,303318 on Chr. 8 in Brassica. Therefore, the claims are not limited to alleles with SNP marker indicative of clubroot resistance phenotype in Brassica . The specification does not describe 13.94 cM and 16.44 cM are polymorphic base or correspond to specific SNP allele. So it is unclear how “chromosomal location flanked by and including 13.94 cM and 16.44 cM would help the written description of the QTL located on chromosome N8 in Brassica.
Therefore, for all the reasons discussed above, 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.
Remarks
The claims are deemed free of the prior art of record.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Werner et al (Theor Appl Genet (2008)116:363-372) who teach genetic mapping of clubroot resistance genes in oilseed rape. The QTL associated to markers 84-258 and 79-168 are located at 57.8 cM and at 59.8 cM, respectively, on chromosome N08. The markers of instant claims are located on chromosome N8 interval from 12.94 cM and 16.44 cM.
Contac 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHUBO ZHOU can be reached at 5712720724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662