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
Status of claims
1. Claims 1-22 are pending. Claims 1-22 are examined on merits in the present Office action.
Information Disclosure Statement
2. Initialed and dated copies of Applicant’s IDS form 1449 filed in the paper of 07/19/2024 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
3. The disclosure is objected to because of the following informalities:
Accession number is missing throughout the specification.
Page 13 of the specification: The deposit statement lacks NCMA Accession No. and the date deposit was made.
Appropriate corrections are required.
Claim Objections
4. Claims 7-11 and 20 are objected to because of the following informalities:
In claim 7, it is suggested to insert the recitation ---regenerated peanut--- before “plant has” in line 1 for clarity of the claimed subject matter.
In claim 7, it is suggested to insert the recitation ---, wherein a representative sample of seed of the variety ‘Arnie’ having been deposited under NCMA Accession No. ____________---- at the end of the claim for clarity of the claimed subject matter.
In claim 8, it is suggested to insert the article ---a--- before “tissue capable” in part (a) of the claim for clarity of the claimed subject matter.
In claim 9, it is suggested to insert the recitation ---all of--- before “the morphological” in line 1 of part (d) of the claim for clarity of the claimed subject matter.
In claim 10, it is suggested to insert the recitation ---, wherein the peanut plant produced by said method has all of the physiological and morphological characteristics of peanut variety ‘Arnie’, and wherein a representative sample of seed of the peanut variety ‘Arnie’ having been deposited under NCMA Accession No. ____________---- at the end of the claim for clarity of the claimed subject matter.
In claim 11, it is suggested to insert the recitation ---added--- before “trait” in line 2 of the claim for clarity of the claimed subject matter.
In claim 11, it is suggested to insert the recitation ---, wherein the peanut plant produced by said method has the added trait and all of the physiological and morphological characteristics of peanut variety ‘Arnie’, and wherein a representative sample of seed of the peanut variety ‘Arnie’ having been deposited under NCMA Accession No. ____________---- at the end of the claim for clarity of the claimed subject matter.
In claim 20, it is suggested to insert the recitation ---, wherein a representative sample of seed of the variety ‘Arnie’ having been deposited under NCMA Accession No. ____________---- at the end of the claim for clarity of the claimed subject matter.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-23 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 and 2 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, 2, 7, 18, 20, 21 and 22 are rejected under 35 U.S.C. 112(b) as being indefinite in their recitation peanut variety “Arnie” because the recitation does not clearly identify the claimed peanut variety and seed. Furthermore, the recitation does not set forth the metes and bounds of the peanut invention. Since the name “Arnie” 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 peanut plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the NCMA Accession number.
Dependent claims are also rejected because they fail to overcome the deficiencies of parent claims.
Claim Rejections - 35 USC § 112(a), deposit
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 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 1-23 are rejected under 35 U.S.C. 112(a) 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.
It is noted that at paragraph [0062], a deposit of representative sample of seed of peanut variety ‘Arnie’ was made, however deposit accession number and date of deposit is missing.
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.
Claim Rejections - 35 USC § 112(a), (Written Description)
7. Claims 10 and 17-20 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).
Claim 10 is broadly drawn to a peanut plant produced by the method of claim 9.
Claim 17 is broadly drawn to a method of plant breeding comprising applying plant breeding techniques to a plant according to claim 1., and claim 18 is broadly drawn to a method of claim 17 comprising producing a peanut variety ‘Arnie’-derived peanut plant.
Applicant’s broadly claimed genus encompasses a genus with unknown species whose structure and function relationship is unknown and not described.
The specification describes some morphological and physiological characteristics of the peanut plant of variety ‘Arnie’, and comparison with a control variety. See in particular, pages 10-12, Tables 1-3.
The specification does not describe progeny of peanut plant of variety ‘Arnie’ beyond the
F1 hybrid, said F1 hybrid should comprise a complete set identifiable genetic elements
from peanut plant of variety ‘Arnie’. This implies that it is unclear whether the Applicant was in possession of the invention as encompassed by the breadth and scope as claimed.
The specification does not describe which specific plant breeding technique steps were applied to produce unknown peanut plant of variety ‘Arnie’ -derived peanut plant(s).
See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424, 1433 (DC WNY 2003) which teaches knowing the "starting point” is not enough; that is little more than a research plan. The court held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. It light of this, it is unclear that Applicant was in possession of the invention as broadly claimed.
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 peanut plant of variety ‘Arnie’, representative seeds of which are to be deposited under NCMA Accession Number 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. The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
Conclusion
8. Claims 1-22 are rejected. The closest prior art Branch (U.S. Patent No. US 11,197,449 B2, Issued April 15, 2021) teach a peanut variety “GEORGIA-18RU” which share some characteristics (e.g. resistance to TSWV) of instant peanut plant of variety ‘Arnie’. However many other characteristics (e.g. resistance to white mold etc.) 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
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