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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Applicant’s response filed 10/02/2025 in reply to the office action of 06/02/2015 has been entered. Claims 1, 8 and 10 are amended. Claims 3 and 11 are cancelled.
Claims 1-2 and 4-10 are pending and examined.
Withdrawn Objections and Rejections
The objection to claim 10 has been withdrawn in view of Applicant’s amendment to the claim. The 112(a) rejection to claim 2, 6 and 8 regarding the deposit and the 102(a)(1) rejection to claims 1-2, 5, 7, and 9-11 have been withdrawn in view of Applicant’s amendment to the claims and/or upon further consideration. The written description rejection to regarding lack of breeding have been withdrawn upon further consideration because nowhere in the specification says the Brassica oleracea deposited under NCIMB 43452 has been produced by breeding.
Claim Rejections - 35 USC § 112
Claims 1-2 and 4-10 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. This rejection is repeated for the reasons of record as set forth in the last office action of 06/02/2025. Applicant’s arguments filed 10/02/2025 have been considered but are not deemed persuasive.
Applicant argues that the amendment to claim 1 and dependents claim thereof to recite specific genomic sequences linked to resistance to the plant pathogen Albugo candida, and the specific location of the genomic region that confers the resistance on chromosome 2 , provide adequate written description of the claimed invention. Applicant refers to pages 4, 5, 7, and 9-14, and Table 2 of the specification for the support. Applicant, therefore, concludes that one of ordinary skill in the art would understand that the inventors had possession of the claimed invention as claimed. Applicant requests withdrawal of the rejection.
These arguments are not found persuasive because of the following reasons: 1) the genomic region located between base pairs 5373001 and 6058829 on chromosome 2 (of the Brassica oleracea reference genome JZS v2) is 685,825 nucleotides in length and the specification does not provide evidence that an SNP with 101 nucleotides in length is sufficient to determine the identity of the encoded resistance. While the genomic region that confers the Albugo resistance is inherently present in the seed deposited under Accession number NCIMB 43452, the rejected claims do not recite the deposit seed information. 2) A substantial variation in phenotype and genotype is expected among Brassica oleracea plants comprising a genomic region located between base pairs 5373001 and 6058829 on chromosome 2 ( reference genome JZS v2 and and any one of SEQ ID NO: 1,3, 5, 7, 9, 11, 13, 15, 17, 19, 21,23, 25, 27, 29, 31, 33, 35, 37, 39, 41 and 43; or is obtainable from a Brassica oleracea seed/plant deposited under deposit number NCIMB 43452. 3) The specification fails to provide a representative species of the genus of Brassica oleraceae plants having resistance to the pathogen Albugo candida, said resistance encoded by a genomic region located between base pairs 5373001 and 6058829 on chromosome 2 of the Brassica oleracea reference genome JZS v2. The markers themselves do not describe the sequence structure required to confer the Albugo candida resistance. Therefore, none of the claims recite all the limitations required to describe a Brassica oleracea plant resistant to Albugo candida. 4) Neither the specification nor the prior art disclose a significant structural region/domain that is responsible for the Albugo candida resistance function. 5) The genomic region located between base pairs 5373001 and 6058829 on chromosome 2 of the Brassica oleracea reference genome JZS v2 that confers resistance to Albugo candida is only fully described when it is present in the genome Brassica oleracea line 947354, sample of seed deposited under accession number NCIMB 43452 in combination with at least one SNP marker from SEQ ID NO: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41 or 43 that segregates with the resistance to Albugo candida. 6) Claim 6 is included in the rejection because there is no that shows the Brassica oleraceae line 947354, sample of seed deposited under Accession number NCIMB 43452, was produced by breeding methods or by non-natural mutation. The seed or plant part of claim 9 reads further generation plants produced from the genus of Brassica oleraceae plant of claim 1 as stated in the last Office action.
Therefore, for all the reasons discussed above and in the last office action, one skilled in the art would not have been in possession of the genus claimed at the time this application was filed.
Claim Rejections - 35 USC § 101
Claim 8 remains rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature and natural phenomenon without significantly more. The claim(s) recite(s) a marker that comprises a nucleic acid sequence and a method of identifying/detecting resistance. This judicial exception is not integrated into a practical application because the method of identifying genomic resistance by detecting a genomic nucleic acid sequence that is naturally present in Albugo candid resistant Brassica oleracea plant genome because the method does not produce a new plant. No breeding or genetic transformation step is recited in the claims. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because SEQ ID NO: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41 or 43 are genomic sequences and any correlation between the Albugo candida resistance and SEQ ID NO: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41 or 43 is a natural phenomenon. Further, there is no evidence in the record that shows the Brassica oleraceae line 947354, sample of seed deposited under Accession number NCIMB 43452, was produced by breeding methods or by non-natural mutation.
Therefore, for all the reasons discussed above and in the last Office actions, the claimed method is not patent eligible.
Applicant may amend the claim to recite steps of crossing a plant of Brassica oleraceae line 947354, sample of seed deposited under Accession number NCIMB 43452, with a susceptible Brassica oleracea cultivar plant to produce progeny plants; and selecting Abugo candida resistant plants from the progeny plants by detecting one or more markers selected the group consisting of SEQ ID NO: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41 or 43.
Remarks
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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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.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662