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 .
Claim Status
Claims 1-25 are pending and examined.
Claim Rejections - 35 USC § 112(a)
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.
Claim 21 is rejected under 35 U.S.C. 112(b), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 21 is drawn to a method of producing a seed of corn line SHY-6S20-3107LN by repeating producing and crossing steps. The metes and bounds of the claim are indefinite because the steps of the method do not clearly produce the corn line SHY-6S20-3107LN.
To overcome the rejection the following amendment is suggested:
21. (Currently amended) The method of claim 20, the method further comprising producing a corn plant grown from [repeating said producing and crossing steps of (a) and (b) using] the seed [from] of said step (b) and crossing said corn plant with itself or a different corn plant [for producing a plant according to step (a) for at least one generation] to produce a seed of a[n additional] corn line SHY-6S20-3107LN-derived corn plant.
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 1-25 are rejected under 35 U.S.C. 112(a) 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 transmittal letter dated 24 April 2025 indicates that the instantly claimed variety was made by crossing proprietary lines SHY-6RLAL201 and SHY-6S15-4568LN followed by pedigree selection until the fifth generation.
However, 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 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 by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stated that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the ATCC Accession No. and evidence of deposit to overcome this rejection. Alternatively, Applicant may by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, state that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Claims 8, 12 and 14 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 8, 12 and 14 are drawn to a corn plant having all of the physiological and morphological characteristics of a corn plant comprising at least a first set of chromosomes of corn line SHY-6S20-3107LN, and a corn plant comprising the morphological and physiological characteristics of said line in addition to a trait or a transgene conferring a trait.
Meanwhile, the specification describes variety SHY-6S20-3107LN by various morphological and physiological characteristics and traits (e.g., see Table 1).
However, it is well-known in the art that the introduction of a trait via backcrossing could result in numerous additional traits introduces as a results of linkage drag. For example, Fehr describes that a single backcross, on average, will yield a plant that has only 75% of the original genes (1987, Principles of Cultivar Development Vol. 1 Theory and Technique and Vol. 2 Crop Species, Soybean, pp. 360-376; see Table 28-2).
Moreover, Fehr describes 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 (p. 371).
As a result, the genus of plants derived from sweet corn variety SHY-6S20-3107LN by introducing a trait or transgene via backcrossing could have morphological and physiological characteristics that differ from those corn variety SHY-6S20-3107LN.
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.
Here, Applicant has failed to describe a representative number of plants as encompassed by the claims and had only described corn variety SHY-6S20-3107LN with the characteristics disclosed in the specification while the encompass plants that may differ from sweet corn variety SHY-6S20-3107LN in any number of traits, and thus encompass a large, unspecified genus of sweet corn plants with varying genotypes and phenotypes, which have not been.
These claims are “reach through” claims 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)).
Given the breadth of the genus of plants encompassed by the claims, and the fact that the only plant that Applicant has described is that of corn variety SHY-6S20-3107LN, the instant claims are not adequately described and it is unclear whether at the time of filing Applicant was in possession of the invention as broadly claimed.
Regarding the breeding history of the instantly claimed variety, MPEP 2402 provides that every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112 [emphasis added].
However, as with other biological material deposited for purposes of patents for inventions under 35 U.S.C. 101, the deposit of plant material together with the written specification must enable those skilled in the art to make and use the claimed invention, in accordance with the requirements of 35 U.S.C. 112. See MPEP 2403.02.
MPEP 2163(I) also provides that "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1613. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 ( "reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material" ); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 FR 34,864 (August 22, 1989) ("The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.).
Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985).
In the instant matter, the specification only provides a description of the traits of the variety but is silent and/or incomplete with respect to the breeding history of said variety. This breeding history is critical because it provides the genetics of the variety and, in turn, its corresponding traits. Thus, in the absence of a breeding history, the specification has failed to provide an adequate written description of the claimed variety.
To overcome this rejection, Applicant must amend the specification/drawing(s) to provide the breeding history used to develop the instant corn line. When identifying the breeding history, applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety.
For example, if Applicant’s breeding history uses proprietary line names, applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information.
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant variety). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
Conclusion
The closest prior art is Hellewell (Patent No. US 11,191,235 B2) which teaches corn line SHY-6S17-3035LL having many of the same characteristics of the instantly claimed variety (e.g., see Table 1). However, corn line SHY-6S17-3035LL does not have all of the traits of the instantly claimed variety and was developed using a different breeding history.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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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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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662