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 1-20 are pending and examined.
Claim Objections
Claim 5 is objected to because of the following informality: claim 5 recites the limitation “the plant of claim 1”. It is suggested the limitation “the plant of claim 1” be replaced with the limitation --said plant--.
Appropriate correction is required.
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.
Claims 1-20 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 specification teaches that cotton variety 20R741B3XF was developed from an initial cross of 21R041*5/10T251B2R2-DGT-B3R2-T1D2 and then with recurrent parent 16Y0598, and that it has been judged to be uniform for breeding purposes and testing (¶ 0016 and 0017).
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 has NOT deposited the seeds at the NCMA in accordance with 37 CFR 1.801-1.809 by indicating all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
Applicant has also not indicated an intention to deposit the seeds in accordance with the Budapest Treaty, and 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 NCMA 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.
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.
Claims 12-17 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.
Instant claims 12-17 are drawn to seeds and plants of cotton variety 20R741B3XF further comprising a single locus conversion or a transgene.
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Here, claims 12-17 encompass vast genus of cotton plants comprising locus conversions or transgenes because said plants are not required to retain any of the genetic and/or morphological and physiological characteristic of cotton variety 20R741B3XF. This interpretation is supported by the fact that the specification discloses that plants comprising loci conversions retain “essentially all” of the characteristics of a variety (¶ 0142).
The Federal Circuit has 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. See MPEP 2163.
Applicant should note that the written description requirement serves to warn an innocent purchaser of the infringement of a patent, and conversely requires the patentee to distinguish the invention in the disclosure, and thus prevents the inventor from practicing upon the credulity or fears of other persons or from pretending that the invention is more than what it is. see Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115.
Here, the instant specification has merely described cotton variety 20R741B3XF with specific traits, and has failed to describe any other characteristic or trait that would be imparted on said variety through locus conversions or transgenes that would persuade a skilled artisan that Applicant was in possession of the broad genus of plants as encompassed by the claims.
As such, these claims are “reach through” claims in which Applicant has only described a starting material and at least one method step, but has not described the resulting product such that 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 would not readily envision the members of the claimed genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as cited in “Deltapine” (“Deltapine adds 2 cotton varieties to Class of ’22, published 11, December 2021, https://www.cottonfarming.com/breakingnews/deltapine-adds-2-cotton-varieties-to-class-of-22).
Instant claims 1-3, 19 and 20 are drawn to cotton variety 20R741B3XF, seeds therefrom, parts thereof, and commodity products produced therefrom.
Deltapine discloses cotton variety 20R741B3XF which was grown in 2021 and has a distinct germplasm that allows for a broad fit consistent with performance across varying conditions and is very responsive to plant growth regulators with potential for improved micronaire (p. 1, ¶ 3-5). Cotton variety 20R741B3XF is also referred to as “DP 2239 B3XF”. Performance testing necessarily means that Deltapine discloses methods for collecting commodity plant products and products produced therefrom as encompassed by claims 19 and 20.
This disclosure was not made by the inventor or joint inventor or by another who obtained the claimed plant directly or indirectly from the inventor or joint inventor. Therefore, Deltapine demonstrates the instantly claimed cotton variety was in the public domain prior to the effective filing date in the U.S.
Claims 1-3, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as cited by “Statewide Variety Testing” (Preliminary Results Cotton and Peanuts January 14, 2021, https://swvt.uga.edu/content/dam/caes-subsite/statewide-variety-testing/docs/performance-trials/2021/2021-peanut-cotton-prelim.pdf).
Instant claims 1-3, 19 and 20 are drawn to cotton variety 20R741B3XF, seeds therefrom, parts thereof, and commodity products produced therefrom.
Statewide Variety Testing discloses instantly claimed cotton variety 20R741B3XF and that it was grown in performance trials at different localities during 2021 (p. 3, line 9 under the “Strains” subheading). Performance trials necessarily means that Statewide Variety Testing discloses methods for collecting commodity plant products and products produced therefrom as encompassed by claims 19 and 20.
This disclosure was not made by the inventor or joint inventor or by another who obtained the claimed plant directly or indirectly from the inventor or joint inventor. Therefore, Statewide Variety Testing demonstrates the instantly claimed cotton variety was in the public domain prior to the effective filing date in the U.S.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 3-18 are rejected under 35 U.S.C. 103 as being unpatentable over “Deltapine” (“Deltapine adds 2 cotton varieties to Class of ’22, published 11, December 2021, https://www.cottonfarming.com/breakingnews/deltapine-adds-2-cotton-varieties-to-class-of-22) and “Statewide Variety Testing” (Preliminary Results Cotton and Peanuts January 14, 2021, https://swvt.uga.edu/content/dam/caes-subsite/statewide-variety-testing/docs/performance-trials/2021/2021-peanut-cotton-prelim.pdf) and in view of Sharma et al (Patent No. US 10,856,513 B2).
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary.
Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Instant claims 1 and 3-18 are drawn to cotton variety 20R741B3XF, seeds therefrom, parts thereof, commodity products produced therefrom, methods of crossing said variety with itself or other varieties, F1 plants and seeds produced therefrom, compositions comprising the deposited variety, and the deposited variety comprising a locus conversion or transgene.
Deltapine teaches cotton variety 20R741B3XF which was grown in 2021 and has a distinct germplasm that allows for a broad fit consistent with performance across varying conditions and is very responsive to plant growth regulators with potential for improved micronaire (p. 1, ¶ 3-5). Cotton variety 20R741B3XF is also referred to as “DP 2239 B3XF”.
Similarly, Statewide Variety Testing teaches instantly claimed cotton variety 20R741B3XF was available in the art and that it was grown in performance trials at different localities during 2021 (p. 3, line 9 under the “Strains” subheading).
Thus while Deltapine and Statewide Variety Testing reasonably teach, suggest and provide motivation for making and using the instantly claimed variety, the issue is whether one would have used this variety to produced hybrids or in methods of crossing or for introducing locus conversions or transgenes into said variety.
To this point, Sharma et al teach a cotton variety 16R338B3XF (Claim 1), a plant part of the plant of claim 1 wherein the part comprises at least one cell of the plant (Claim 2), a seed that produces the plant of claim 1 (Claim 3), a method of producing cotton seed, wherein the method comprises crossing the plant of claim 1 with itself or a second, distinct cotton plant to produce the cotton seed (Claim 4), the method of claim 4 wherein the method comprises crossing said plant with the second, distinct cotton plant to produce F1 hybrid cotton seed (Claim 5), An F1 hybrid cotton seed produced by the method of claim 5 (Claim 6), A cotton plant produced by growing the F1 hybrid cotton seed of claim 6 (Claim 7), The method of claim 5 wherein the method further comprises (a) crossing a plant grown from the F1 hybrid cotton seed with itself or a different cotton plant to produce seed of a subsequent generation; (b) growing a progeny plant of the subsequent generation from said seed and crossing the progeny plant with itself or a second plant to produce seed of a further subsequent generation; and (c) repeating step (b) with sufficient inbreeding to produce seed of an inbred cotton plant derived from cotton variety 16R338B3XF (Claim 8), the method of claim 8 further comprising crossing a plant grown from said seed of an inbred cotton plant derived from cotton variety 16R338B3XF with a plant of a different genotype to produce seed of a hybrid cotton plant derived from cotton variety 16R338B3XF (Claim 9), a composition comprising the seed of claim 3, wherein the seed is comprised in plant seed growth media (Claim 10), the composition of claim 10 wherein the plant seed growth media is soil or a synthetic cultivation media (Claim 11), a seed of cotton variety 16R338B3XF further comprising a single locus conversion, wherein representative seed of cotton variety 16R338B3XF have been deposited under ATCC Accession No. PTA-125974 (Claim 12), the seed of claim 12 wherein the single locus comprises a nucleic acid sequence that enables site-specific genetic recombination or confers a trait selected from the group consisting of male sterility, herbicide tolerance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress resistance, modified carbohydrate metabolism, and modified cotton fiber characteristics (Claim 13), a plant grown from the seed of claim 12 (Claim 14), a seed of cotton variety 16R338B3XF further comprising a transgene, wherein representative seed of cotton variety 16R338B3XF have been deposited under ATCC Accession No. PTA-125974 (Claim 15), the seed of claim 15 wherein the transgene comprises a nucleic acid sequence that enables site-specific genetic recombination or confers a trait selected from the group consisting of male sterility, herbicide tolerance, insect of pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress resistance, modified carbohydrate metabolism, and modified cotton fiber characteristics (Claim 16), a plant grown from the seed of claim 15 (Claim 17), a method of modifying a cotton plant, wherein the method comprises introducing a transgene or a single locus conversion into the plant of claim 1 (Claim 8), a method of producing a commodity plant product, wherein the method comprises collecting the commodity plant product from the plant of claim 1 (Claim 19), and a commodity plant product that is produced by the method of claim 19 wherein the commodity plant product comprises at least one cell of cotton variety 16R338B3XF (Claim 20).
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to modify cotton variety 20R741B3XF in breeding methods to produce hybrids or compositions or by introducing locus conversions or transgenes because to do so is a widely accepted practice, for example, as taught and evidenced by Sharma et al.
One would have a reasonable expectation of success in doing so because Sharma et al provide explicit teachings on how to do so and would result in cotton variety 20R741B3XF having additional traits such as disease resistance in addition to having a distinct germplasm that allows for a broad fit consistent with performance across varying conditions and is very responsive to plant growth regulators with potential for improved micronaire.
Conclusion
No claim is allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joe Zhou can be reached at (571)272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662