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
Claims 1-28 are pending and examined on the merit.
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.
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.
2. Claims 1-28 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.
In claims 1 and 11, the recitation “seed capable of growing into a broccoli plant” renders the claim indefinite. The recitation does not clearly what condition or process enables the seed to grow into the broccoli plant. The metes and bounds are not clear.
In claim 12, the recitation “tissue capable of being propagated from the broccoli plant” renders the claims indefinite. The recitation does not clearly what condition or process enables the seed to grow into the broccoli plant. The metes and bounds are not clear.
In claim 22, the recitation “F1 broccoli seed” render the claim indefinite. It is unclear what the reference plant (F0) refers to. The metes and bounds are not clear.
In claim 26, the recitation “variety 25-BO239 RZ” renders claim indefinite. The term “25-BO239 RZ“ is an arbitrary name with no meaning in the art. It is unclear what the plant refers to. It is suggested to specify that a sample of seed of variety 25-BO239 RZ having been deposited under UCIMB Accession NO. 44350.
Written Description
3. Claims 1-2, 4-5, 8-10, 12-13, 15-23 and 28 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 drawn to a broccoli seed capable of growing into a broccoli plant have a set of characteristics including a short to very short plant height, and a head size of about 2 to about 10 cm when directly sown in high density ranging from 20 to 100 plants per m2, representative seed comprising genetic information that confers said characteristics having been deposited under NCIMB Accession No. 44350; or wherein the plant further exhibits extra short leaves.
Since those characteristics are only some of the phenotypic characteristics not ALL of the phenotypic characteristics of broccoli variety 25-BO239 RZ. Neither the specification nor the prior art teaches the correlation between genome structure and those phenotypes of broccoli variety 25-BO239 RZ, except for broccoli variety 25-BO239 RZ itself. The specification fails to describe conserved structure for the genus as claimed. The only correlation is the whole genome of broccoli variety 25-BO239 RZ responsible for all the the phenotypic characteristics of broccoli variety 25-BO239 RZ.
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).
Applicants fail to describe a representative number of broccoli lines falling within the scope of the claimed genus. Applicants only describe a single species which is broccoli variety 25-BO239 RZ. Hence, Applicants fail to meet either prong of the two-prong test set forth by Eli Lilly. Furthermore, given the lack of description of the necessary elements essential for genus of broccoli lines, it remains unclear what features identify a genus of claimed broccoli seed, plant part, plant or plant cell with only subset of the phenotypic characteristics of broccoli variety 25-BO239 RZ. Since said genus has not been described by specific structural features, the specification fails to provide an adequate written description to support the breath of the claims.
Deposit
4. Claims 1-20 are 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 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 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.
Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, including indicating that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent to overcome this rejection (emphasis added).
Conclusion
No claims are allowed.
The closest prior art is US Patent Application Publication NO.2022/0408676, which teaches a broccoli variety B1199, which shares some of the same traits (e.g. leaves blade color, head color) as the instantly claimed watermelon variety, however, it differs at least in plant height as well as genetical background.
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/LI ZHENG/Primary Examiner, Art Unit 1662
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