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
1. Claims 1-22 are pending and examined on the merits.
Claim Rejections - 35 USC § 112, 1st paragraph
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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Deposit
2. Claims 1-22 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.
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.
The deposit information in the specification indicates Applicant intends to comply with all requirements set forth in 37 CFR 1.801-1.80 (specification, page 28). However, Applicants fails to indicate that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent (emphasis added).
Written Description
3. Claim 11 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has clarified 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 Lilly 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 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.
Applicant claims a pea plant produced by the method of introducing a transgene conferring the trait into a pea plant of pea line SVQF0513.
Applicant describes pea plants of pea line SVQF0513 by the parental genetics and a list of physiological and morphological characteristics. (See Table 1).
Applicant does not describe pea plants as broadly claimed in Claim 11. The recited genus of pea plants encompassed by the claims includes pea plants produced by, for example, crossing a plant comprising the transgene into a plant of pea line SVQF0513.
It is well-known in the art that the introduction of a trait via backcrossing, for example, could result in numerous additional traits introduces as a results of linkage drag. For example, Fehr ((1997) Principles of Cultivar Development Vol. 1 Theory and Technique and Vol. 2 Crop Species, Soybean, pp. 360-376) teaches that a single backcross, on average, will yield a plant that has only 75% of the original genes (Fehr, Table 28-2). Fehr also teaches that genes conferring traits that are completely different from those of the target variety could be linked to a locus conversion being introduced by backcrossing (Fehr, pg. 371). As a result, the genus of plants derived from pea line SVQF0513 by introducing a locus conversion or transgene via backcrossing could have morphological and physiological characteristics that differ dramatically from those of pea line SVQF0513. Applicant has failed to describe a representative number of plants thus produced.
Applicant has described only pea line SVQF0513 with the characteristics listed in the specification. The claims, however, encompass plants that may differ from pea line SVQF0513 in any number of traits, and thus encompass a large, unspecified genus of soybean plants with varying genotypes and phenotypes, which have not been described and thus were not in Applicant's possession at the time of filing. See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification. In this case, there is no way that a practitioner would be able to determine if any particular soybean plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
This claim is a “reach through” claim in which the Applicant has described a starting material and at least one method step, however, they have not described the resulting product, and the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
Hence, Applicant has not, in fact, described the claimed invention within the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
The rejection could be overcome by noting that the pea plant produced in Claim 11 exhibits the traits and otherwise exhibits all of the physiological and morphological traits of pea line SVQF0513.
Conclusion
No claim is allowed.
However, the claims are free from the prior art for the failure of the prior art to teach or fairly suggest pea line SVQF0513.
The closest prior art is US Patent Application Publication Number 2020/0344970 which discloses the pea line “SV7441QC”. While Pendleton and the instant line share some characteristics they differ in at leaf wax, vine internodes and genetic background.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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/LI ZHENG/Primary Examiner, Art Unit 1662