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 1-20 are pending and are examined on merits in the present Office action.
Drawings
2. No drawings have been submitted in the instant application.
Information Disclosure Statement
3. Initialed and dated copies of Applicant’s IDS form 1449 filed in the paper of 04/10/2025 is 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.
Specification
4. The disclosure is objected to because of the following informalities:
Page 59 of the specification: The deposit statement lacks ATCC Accession No. and the date deposit was made.
Appropriate corrections are required.
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.
5. Claims 1-20 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1, 4, 18 and 19 are rejected under 35 U.S.C. 112(b), as being indefinite in their recitation “Accession No.-____” because the “Accession No” is missing.
Claims 1, 4, 7, 13, 16, 17 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite in their recitation soybean variety “5PRBQ80” because the recitation does not clearly identify the claimed soybean variety and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “5PRBQ80” is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of the soybean plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the NCMA deposit number.
Claims 1, 4, 7, 13, 16, 17 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite in their recitation “soybean variety” or “variety” because the recitation “variety“ does not clearly identify the claimed soybean plant and seed line 5PRBQ80. Applicant’s attention is drawn to the specification at page 19, paragraph [0114] which defines variety as:
“[0114] VARIETY. A substantially homozygous soybean line and minor modifications thereof that retains the overall genetics of the soybean line including but not limited to a subline, a locus conversion, a mutation, a transgenic, or a somaclonal variant. Variety includes seeds, plants, plant parts, and/or seed parts of the instant soybean line.”
In light of the definition provided in the specification, the breadth and scope of the term “variety” is unclear as it appears to encompass plants and seeds which also fall outside the scope of soybean plant and seed line 5PRBQ80. Additionally, the representative seed of the variety will include seeds having genetic composition that also falls outside the scope of soybean plant and seed line 5PRBQ80. The metes and bound of the recitation “variety” is unclear. It is unclear what is encompassed by the recitation and what is not? It is unclear what is intended? Appropriate claim amends and clarifications are requested. It is suggested to replace the recitation “variety” with ---line--- everywhere in the claims that may overcome this rejection.
Dependent claims are also rejected for failing to overcome deficiencies of parent claims.
Claim Rejections - 35 USC § 112, deposit
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.
6. Claims 1-20 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 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 ATCC 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.
7. Claims 1-20 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(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has recently 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 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 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.
Finally, the court held:
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 a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP Section 2163, page 174 of Chapter 2100 of the August 2005 version, column 1, bottom paragraph, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Claims are broadly drawn to plant or plant parts thereof and seeds of “soybean variety 5PRBQ80”.
Applicant’s attention is drawn to the specification at page 19, paragraph [0114] which defines variety as:
“[0114] VARIETY. A substantially homozygous soybean line and minor modifications thereof that retains the overall genetics of the soybean line including but not limited to a subline, a locus conversion, a mutation, a transgenic, or a somaclonal variant. Variety includes seeds, plants, plant parts, and/or seed parts of the instant soybean line.”
In light of the definition provided in the specification, the breadth and scope of the term “variety” encompass plants and seeds which also fall outside the scope of soybean plant and seed line 5PRBQ80. Additionally, the representative seed of the variety will also include seeds having genetic composition that falls outside the scope of soybean plant and seed line 5PRBQ80.
The breadth of claim encompasses a very large genus comprising unknown mutations, unknown soybean plant or parts thereof and seed (structures) with unknown genetic composition and having unknown or undescribed function.
Applicant’s broadly claimed genus encompasses a genus with unknown species whose structure and function relationship is unknown and not described.
The instant specification, however, only describes soybean line “5PRBQ80” having physiological and morphological characteristics as described in Table 1.
Applicant fails to describe structure of representative species of Applicant’s broadly claimed genus and thus their function is either unknown or unpredictable.
There is no description of the structure required for the recited function, and no description of the necessary and sufficient elements of functional activity of diverse species involved in obtaining the desired functional phenotype. Applicant’s broadly claimed genus encompasses structures whose function is unknown.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, species soybean line “5PRBQ80” is insufficient to describe the claimed genus.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing.
Conclusion
8. Claims 1-20 are rejected. The closest prior art Hoffman et al. (U.S. Patent Publication No. US 20110003055 A1, Published January 6, 2011) teach a soybean variety A1015993 which share some characteristics (e.g. purple flower color) of instant soybean variety 5PRBQ80. However many other characteristics, including breeding history of the two soybean varieties are different.
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 on 8.30 a.m. to 5.00 p.m.
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