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
Election/Restrictions
1. Applicant’s election without traverse of Group I (claims 1-3, 5-7, 9-11, 18 and 26-28) and SEQ ID NO: 2 in the reply filed on March 27, 2026 is acknowledged.
Claims 1-3, 5-7, 9-11, 13-15, 18-22, and 26-28 are pending. Claims 4, 8, 12, 16, 17, 23-25 and 29-38 are cancelled by the Applicant. Claims 13-15, 19-22, and SEQ ID NOs: 1, 3 and 4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, Claims 1-3, 5-7, 9-11, 18 and 26-28 in conjunction with SEQ ID NO: 2 are examined on merits in this Office action. This restriction is made FINAL.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the
inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Information Disclosure Statement
2. Initialed and dated copies of Applicant’s IDS form 1449 filed in the paper of 02/04/2025 & 11/07/2024 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
3. Claim 10, 18, 26, 27 and 28 are objected to because of the following informalities:
Claim 10 is objected for having non-elected subject matter. Non-elected subject matter is SEQ ID NOs: 1, 3 and 4.
Claims 18 and 26 are objected for dependent on non-elected claims 13 and 20, respectively.
In claim 27, it is suggested to insert --- broccoli plant--- before “according” for clarity of claimed subject matter.
In claim 28, it is suggested to insert --- broccoli plant--- before “tissue” for clarity of claimed subject matter.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a), deposit
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 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.
5. Claims 3 and 11 are rejected under 35 U.S.C. 112(a) 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.
It is also noted that Applicant has deposited seeds of the broccoli (Brassica oleracea) line BRM-8V21-4060SI. (see paragraph [0092] at page 24 of the specification). Applicant needs to perfect the requirements of the seed deposit.
Since the seed claimed 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 625 (25 packets of 25 seeds each) 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 NOT indicated that Applicant intends to deposit the seeds at the ATCC in accordance with 37 CFR 1.801-1.809. Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the NCMA Accession No. and evidence of deposit to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Applicant must clearly state items (a) through (e) above. For example, statements like “all restrictions upon availability to the public will be irrevocably removed upon granting of the patent” and “the viability of the biological material at the time of deposit will be tested” are missing in the deposit information provided at paragraph [0092] of the specification.
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.
6. Claims 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (BMC Plant Biology, 18:82(1), doi:10.1186/sl2870-018-1290-9, 2018; pages 1-56, including supplemental data).
Song et al. disclose anthocyanin biosynthetic pathway gene BoMYBL2-1 in Brassica oleracea var. capitata f. rubra (cabbage) which encodes a repressor protein, and whose expression was found to be inversely correlated to anthocyanin content and purple color in said cabbage. The reference further discloses that the purple color in cabbages was caused by either a promoter substitution or deletion of the gene which was located on chromosome 6 . The reference further discloses a number of marker primers used to distinguish between green and purple cabbages. Song et al. additionally disclose that BoMYBL2-1 is located in genomic regions of C6:35352718-35365579 of said of the BRAD Brassica oleracea genome and C06: 4483346-4514149 of the Ensemble plants Brassica oleracea (BOL), which includes instant sequences SEQ ID NOs: 1-4. It may be noted that the fine mapping of said genomic region comprising BoMYBL2-1 would also inherently comprise instant markers as set forth in SEQ ID NO: 2, unless Applicant provides evidence to the contrary.
See in particular, abstract; left column at page 12; Table 2 at page 5; Marker development and validation, left column at page 5; Figs. 2-3, 6, 8-9; Additional file 2: Figure S2.
Accordingly, Song et al. anticipated the claimed invention.
7. Claims 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yan et al. (TAG, 132(4):895-906, doi:10.1007/s00122-018-3245-9; 2019; pages 1-66, including supplemental data).
Yan et al. disclose BoMYB2 locus in in Brassica oleracea, cultivars kale, kohlrabi, and cabbage. The BoMYB2 locus comprised BoMYB2 gene encoding a negative regulator of anthocyanin biosynthesis pathway. The reference further discloses that expression of said BoMYB2 gene resulted in purple color in said three cultivars. The reference further discloses fine mapping of the gene controlling the purple trait in cabbage to the BoMYB2 locus on chromosome 6 (CO6) between markers AGH023 and AGH020 in an interval of 459kb region with 75 genes including the BoMYB2 gene, which was responsible for the purple trait in said Brassica oleracea, cultivars kale, kohlrabi and cabbage. Yan et al. further disclose a number of additional markers which may be used to detect the purple trait, such as AGH025 at 13.77M of Chromosome 6 (CO6), and AGH018 at 34.02M of Chromosome 6 (CO6) with the intervening region comprising sequence(s) listed in in instant Table 1 of the specification. It may be noted that the fine mapping of said BoMYB2 locus would also inherently comprise instant markers as set forth in SEQ ID NO: 2, unless Applicant provides evidence to the contrary. See in particular, abstract; left column, paragraphs 2-3 at page 900; Fig. 3; Fig. S6; right column, paragraph 2 at page 903; Fig. 6; Fig S6; Figs. 1, 4-6.
Accordingly, Yan et al. anticipated the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claim(s) 1-3, 5-7, 9-11, 18 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (BMC Plant Biology, 18:82(1), doi:10.1186/sl2870-018-1290-9, 2018; pages 1-56, including supplemental data) as applied to claims 9-11 above, and further in view of Quezada-Martinez et al. (TAG, 134:1711-1728, 2021).
Song et al. teach anthocyanin biosynthetic pathway gene BoMYBL2-1 in Brassica oleracea var. capitata f. rubra (cabbage) which encodes a repressor protein, and whose expression was found to be inversely correlated to anthocyanin content and purple color in said cabbage. The reference further teaches that the purple color in cabbages was caused by either a promoter substitution or deletion of the gene which was located on chromosome 6 . The reference further teaches a number of marker primers used to distinguish between green and purple cabbages. Song et al. additionally teach that BoMYBL2-1 is located in genomic regions of C6:35352718-35365579 of said of the BRAD Brassica oleracea genome and C06: 4483346-4514149 of the Ensemble plants Brassica oleracea (BOL), which includes instant sequences SEQ ID NO: 2. It may be noted that the fine mapping of said genomic region comprising BoMYBL2-1 would also naturally comprise instant marker as set forth in SEQ ID NO: 2. See in particular, abstract; left column at page 12; Table 2 at page 5; Marker development and validation, left column at page 5; Figs. 2-3, 6, 8-9; Additional file 2: Figure S2.
Applicant’s attention is also drawn to first paragraph at page 13 (under “conclusion”) which says:
“B. oleracea var. capitata plants possess two MYBL2 genes: BoMYBL2-l and BoMYBL2-2. Expression levels of BoMYBL2-l are inversely correlated to anthocyanin content, particularly in purple cabbage cultivars with defective expression of BoMYBL2- l. We found that most purple cabbages do not have an entire BoMYBL2-1 gene, due to deletion of the coding sequence and the substitution of the regulatory region with other DNA sequences, while others contain a version of the BoMYBL2-1 promoter that lacks transcription activity. We used sequence variations of BoMYBL2-1 to develop and validate molecular markers that distinguish purple cabbage cultivars with defective BoMYBL2-l. These markers will be useful in the production of intraspecific and interspecific hybrids that contain high anthocyanin levels useful for functional foods and industrial use.”
Song et al. do not teach broccoli plants with a recombinant chromosome 6 segment comprising an allele from red cabbage that confers the purple phenotype.
Quezada-Martinez et al. teach molecular breeding of Broccoli by transferring economically important traits through introgression of genes or chromosomal segments comprising useful genes into the genetic background of Broccoli using molecular breeding techniques. See in particular, abstract; introduction; Figs 1-2; pages 1711-1721.
Given that the genomic region responsible for the purple phenotype displayed by red cabbage and molecular markers associated with said genomic region were identified in Song et al. as discussed above, it would have been obvious and within the scope of an ordinary skill in the art prior to earliest filing date of the instantly claimed invention to use any molecular breeding based approach, including the one taught by Song et al. to arrive at the instantly claimed invention. Obviously one of ordinary skill in the art would have been motivated for the introgression of a known genomic segment from one Brassica plant to another Brassica plant to confer any desirable trait or phenotype, including increased anthocyanin content of Song et al. to obtain purple color Brassica plant with increased flavonoid content which protects plants against biotic and abiotic stress and acts as anti-inflammatory agent for human consumption of Brassica as asserted by Song et al. (see right column under “Background” on page 1, also see first paragraph at page 13 under “conclusion”.
Obviously obtaining a heterozygous and ultimately a homozygous plant with a desired trait is a part of any breeding program including the one taught by Quezada-Martinez et al. by using successive and controlled breeding cycles whereby perseverance and methodological rigor shall ultimately yield a homozygous plant line of stable and any reproducible traits including purple color trait to Broccoli to achieve genetic uniformity. Obviously seed would have been produced for the purpose of propagation, and cell culture or plant tissue culture of genetically modified Broccoli plant with purple color would have been desired for massive and rapid propagation of the generically improved Broccoli plant line, thus arrive at the Applicant’s invention with a reasonable expectation of success and without any surprising result, consistent with KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Therefore, the claimed invention as a whole is prima facie obvious over the combined teachings of the prior art.
9. Claim(s) 1-3, 5-7, 9-11, 18 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (TAG, 132(4):895-906, doi:10.1007/s00122-018-3245-9; 2019; pages 1-66, including supplemental data) as applied to claims 9-11 above, and further in view of Han et al. (Horticulturae, 7(9):280, doi:10.3390/horticulturae7090280; 2021, pages 1-21, including supplemental data).
Yan et al. teach BoMYB2 locus in in Brassica oleracea, cultivars kale, kohlrabi, and cabbage. The BoMYB2 locus comprised BoMYB2 gene encoding a negative regulator of anthocyanin biosynthesis pathway. The reference further teaches that expression of said BoMYB2 gene resulted in purple color in said three cultivars. The reference further teaches fine mapping of the gene controlling the purple trait in cabbage to the BoMYB2 locus on chromosome 6 (CO6) between markers AGH023 and AGH020 in an interval of 459kb region with 75 genes including the BoMYB2 gene, which was responsible for the purple trait in said Brassica oleracea, cultivars kale, kohlrabi and cabbage. Yan et al. further teach a number of additional markers which may be used to detect the purple trait, such as AGH025 at 13.77M of Chromosome 6 (CO6), and AGH018 at 34.02M of Chromosome 6 (CO6) with the intervening region comprising sequence(s) listed in in instant Table 1 of the specification. It may be noted that the fine mapping of said BoMYB2 locus would naturally comprise instant markers as set forth in SEQ ID NOs: 1-4. See in particular, abstract; left column, paragraphs 2-3 at page 900; Fig. 3; Fig. S6; right column, paragraph 2 at page 903; Fig. 6; Fig S6; Figs. 1, 4-6.
Yan et al. do not teach broccoli plants with a recombinant chromosome 6 segment comprising an allele from red cabbage that confers the purple phenotype.
Han et al. teach molecular breeding of Broccoli by transferring economically important traits through introgression of genes or chromosomal segments comprising useful genes into the genetic background of Broccoli using molecular breeding techniques. See in particular, abstract; pages 2-12; Table1; Supplementary materials in Table S1 using desired genes/QTLs at pages 13-18.
Given that the genomic region responsible for the purple phenotype displayed by red cabbage and molecular markers associated with said genomic region were identified in Yan et al. as discussed above, it would have been obvious and within the scope of an ordinary skill in the art prior to earliest filing date of the instantly claimed invention to use any molecular breeding based approach, including the one taught by Han et al. to arrive at the instantly claimed invention. Obviously one of ordinary skill in the art would have been motivated for the introgression of a known genomic segment from one Brassica plant to another Brassica plant to confer any desirable trait or phenotype, including increased anthocyanin content of Han et al. to obtain purple color Brassica plant with increased flavonoid content which protects plants against biotic and abiotic stress and acts as anti-inflammatory agent for human consumption of Brassica as asserted by Yan et al. (see introduction, right column of page 896).
Obviously obtaining a heterozygous and ultimately a homozygous plant with a desired trait is a part of any breeding program including the one taught by Han et al. by using successive and controlled breeding cycles whereby perseverance and methodological rigor shall ultimately yield a homozygous plant line of stable and any reproducible traits including purple color trait to Broccoli to achieve genetic uniformity. Obviously seed would have been produced for the purpose of propagation, and cell culture or plant tissue culture of genetically modified Broccoli plant with purple color would have been desired for massive and rapid propagation of the generically improved Broccoli plant line, thus arrive at the Applicant’s invention with a reasonable expectation of success and without any surprising result, consistent with KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Therefore, the claimed invention as a whole is prima facie obvious over the combined teachings of the prior art.
Conclusion
10. Claims 1-3, 5-7, 9-11, 18 and 26-28 are rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VINOD KUMAR whose telephone number is (571)272-4445. The examiner can normally be reached at (571)-272-44445.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. Abraham can be reached on (571) 270-7058 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VINOD KUMAR/Primary Examiner, Art Unit 1663
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