DETAILED ACTION
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 without traverse of Group I (claims 2 and 16), and the species SEQ ID NO: 25, in the reply filed on June 30, 2026 is acknowledged. Claims 1 and 10 link inventions I-VII and X. Claims 3-5, 7-9, 11-12, 15 and 17-19 are withdrawn.
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, 10 and 16 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.
Claim 1 is drawn to any Brassica oleracea plant that is resistant to the diamondback moth Plutella xylostella, wherein said plant is further tolerant to the plant pathogen Xanthomonas campestris pv. campestris, and wherein said resistance to the diamondback moth Plutella xylostella and said tolerance to the plant pathogen Xanthomonas campestris pv. campestris are obtainable in an unspecified manner from a Brassica oleracea plant deposited under deposit number NCIMB 43822.
Claim 2 is drawn to the Brassica oleracea plant according to claim 1, wherein said plant further comprises in its genome: a first genomic region located on chromosome 6, said first genomic region is characterized by one or more sequences selected from the group consisting of SEQ ID Nos. 25, 27, 29 and 31.
Claim 10 is drawn to seeds, progeny, edible parts, egg cells, callus, suspension culture, somatic embryos, clones, embryos, or plant parts of a Brassica oleracea plant according to claim 1.
Claim 16 is drawn to the Brassica oleracea plant according to claim 2, wherein said first genomic region is between positions 21414859 and 23635544 of the Brassica oleracea HDEM assembly.
The specification describes the development of a single Brassica oleracea plant having resistance to the diamondback moth Plutella xylostella and tolerance to the plant pathogen Xanthomonas campestris pv. campestris, Brassica oleracea 200234, obtained from a first parental line Z344539 and a second parental line Z34409, said parental lines having tolerance to the plant pathogen Xanthomonas campestris pv. campestris, wherein Brassica oleracea 200234 was deposited under deposit number NCIMB 43822 and was coincidentally determined to have resistance to the diamondback moth Plutella xylostella in addition to tolerance to the plant pathogen Xanthomonas campestris pv. campestris (Examples 1-4). The specification also describes SNPs that were identified from Brassica oleracea 200234 for the detection of Plutella xylostella resistance QTLs (Table 4) and the sequences of the SNPs (SEQ ID NOS: 1-16, 33-34, and 17-32) that can be used to detect resistance to the diamondback moth Plutella xylostella, as well as their chromosomal locations and physical positions (bp) in HDEM (Table 5).
The specification does not describe Brassica oleracea plants that have obtained resistance to the diamondback moth Plutella xylostella and tolerance to the plant pathogen Xanthomonas campestris pv. campestris from the Brassica oleracea plant deposited under deposit number NCIMB 43822. The specification does not describe the genomic region(s) of the Brassica oleracea plant deposited under deposit number NCIMB 43822 that function to confer to a Brassica oleracea plant resistance to the diamondback moth Plutella xylostella and tolerance to the plant pathogen Xanthomonas campestris pv. campestris. The specification also does not describe other Brassica oleracea plants that have resistance to the diamondback moth Plutella xylostella and tolerance to the plant pathogen Xanthomonas campestris pv. campestris and that further comprise in their genome other combinations of SNP sequences.
The Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lily and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id.
See also MPEP 2163 IA which states that “The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. Consider the claim "A gene comprising SEQ ID NO:1." The claim may be construed to include specific structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient description of other structures embraced by the claim (e.g., promoters, enhancers, coding regions, and other regulatory elements).”
Here the essential or critical feature that confers to a Brassica oleracea plant resistance to the diamondback moth Plutella xylostella and tolerance to the plant pathogen Xanthomonas campestris pv. campestris is only fully described in form of the Brassica oleracea plant deposited under deposit number NCIMB 43822. The specific structures in the Brassica oleracea plant deposited under deposit number NCIMB 43822 that would function to confer to a Brassica oleracea plant resistance to the diamondback moth Plutella xylostella and tolerance to the plant pathogen Xanthomonas campestris pv. campestris are unknown and not described.
Given the breadth of the claims which encompass any Brassica oleracea plant that is resistant to the diamondback moth Plutella xylostella, wherein said plant is further tolerant to the plant pathogen Xanthomonas campestris pv. campestris, and wherein said resistance to the diamondback moth Plutella xylostella and said tolerance to the plant pathogen Xanthomonas campestris pv. campestris are obtainable in an unspecified manner from a Brassica oleracea plant deposited under deposit number NCIMB 43822, including a Brassica oleracea plant that further comprises in its genome a first genomic region located on chromosome 6 between positions 21414859 and 23635544 of the Brassica oleracea HDEM assembly and characterized by one or more sequences selected from the group consisting of SEQ ID Nos. 25, 27, 29 and 31, and given the extremely limited description of only a single plant within the broadly claimed genus, one skilled in the art would not recognize that the applicant was in possession of the claimed invention as a whole at the time of filing on the basis of the description in the specification. Further, Applicant has not described a representative number of species falling within the scope of the required genus of Brassica oleracea plants, or the structural features unique to the genus that are correlated with the function of conferring to a Brassica oleracea plant resistance to the diamondback moth Plutella xylostella and tolerance to the plant pathogen Xanthomonas campestris pv. campestris.
Claims 1, 2, 10 and 16 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.
The claims are drawn to a Brassica oleracea plant wherein said plant is resistant to the diamondback moth Plutella xylostella, wherein said plant is further tolerant to the plant pathogen Xanthomonas campestris pv. campestris, and wherein said resistance to the diamondback moth Plutella xylostella and said tolerance to the plant pathogen Xanthomonas campestris pv. campestris are obtainable from a Brassica oleracea plant deposited under deposit number NCIMB 43822.
Accordingly, seed of a Brassica oleracea plant from which resistance to the diamondback moth Plutella xylostella and tolerance to the plant pathogen Xanthomonas campestris pv. campestris are obtainable from a Brassica oleracea plant deposited under deposit number NCIMB 43822 is essential to the claimed invention. This seed must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the 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 seed is readily available to the public. Deposit of said seed with an acceptable depository is therefore required. While the specification at page 23 indicates that a Brassica oleracea plant 200234 was deposited at NCIMB with a deposit number of 43822, the specification is otherwise silent with respect to the terms of this deposit.
If a deposit has been made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention has been deposited and accepted, and will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If a 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 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, 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.
For each deposit made pursuant to these regulations, the specification shall be amended to contain (see 37 CFR 1.809):
(1) The accession number for the deposit;
(2) The date of the deposit;
(3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
(4) The name and address of the depository.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, and claims 2, 10 and 16 dependent thereon, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is indefinite in the recitation of “wherein said resistance to the diamondback moth Plutella xylostella and said tolerance to the plant pathogen Xanthomonas campestris pv. campestris are obtainable from a Brassica oleracea plant deposited under deposit number NCIMB 43822”. It is unclear whether the resistance to the diamondback moth Plutella xylostella and the tolerance to the plant pathogen Xanthomonas campestris pv. campestris comprised by the claimed Brassica oleracea plant are in fact obtained from the Brassica oleracea plant deposited under deposit number NCIMB 43822, or from some other source, since the claim does not explicitly require the Brassica oleracea plant deposited under deposit number NCIMB 43822 be the source of the resistance and the tolerance. Accordingly, the metes and bounds of the claimed in invention are unclear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2 and 16 fail to further limit the subject matter of claim 1 because the Brassica oleracea plant of claim 1 already comprises in its genome a first genomic region located on chromosome 6 between positions 21414859 and 23635544 of the Brassica oleracea HDEM assembly and characterized by one or more sequences selected from the group consisting of SEQ ID Nos. 25, 27, 29 and 31, because this genomic region is associated with resistance to the diamondback moth Plutella xylostella obtainable from a Brassica oleracea plant deposited under deposit number NCIMB 43822. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 10 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by van den Bosch et al. U.S. Patent No. 11,317,576, issued May 3, 2022.
Claim 10 is drawn to seeds, progeny, edible parts, egg cells, callus, suspension culture, somatic embryos, clones, embryos, or plant parts of a Brassica oleracea plant according to claim 1.
The offspring (seeds, progeny and embryos) of claim 10 are not required to retain any of the characteristics of the parental/ancestral plant of claim 1 and are not required to be produced by any particular breeding method. Accordingly claim 10 encompasses any Brassica oleracea plant.
van den Bosch et al. teach a Brassica oleracea plant. Accordingly, van den Bosch et al. anticipate claim 10.
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662
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