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, 2, 7-10 and 13-22 are pending and are examined in the instant application.
Specification
2. The disclosure is objected to because of the following:
The status of parent Application No. 18/128566 should be updated in paragraph [0001] of the specification.
In paragraph [0086], the Deposit Information does not indicate that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent..
Appropriate correction is required.
Claim Objections
3. Claims 1, 2, 7-10 and 13-22 are objected to because of the following:
In claims 1, 15 and 17, “a sample of seed” should be amended to “a sample of seeds”, because more than one seed is deposited.
Dependent claims are included.
Correction is required.
Claim Rejections – 35 USC § 112(a)
4. 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.
5. Claims 1, 2, 7-10 and 13-22 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 claims contain 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 of line SVPS0897 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 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 specification does not indicate that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent. Evidence of an accepted deposit is requested.
6. Claim 14 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 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.
Enablement factors to consider include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Pepper variety SVPS0897 is a hybrid (claim 1), whereby its genome is heterologous at every locus. Outcrossing of hybrid variety SVPS0897 with an undisclosed parent, then backcrossing to hybrid variety SVPS0897, would not regain all or most the morphological and physiological characteristics of hybrid variety SVPS0897 due to the presence of heterologous dominant and recessive alleles at every locus of the genome of hybrid variety SVPS0897. Applicant has no working example of a plant produced by the claimed method. The state of the prior art does not teach the introduction of a transgene to a hybrid plant by outcrossing and backcrossing to said hybrid plant to produce a converted plant having otherwise all the morphological and physiological characteristics of said hybrid plant. The art teaches that the first absolute requirement for a successful backcross program is that the recurrent parent is an inbred line (Plant & Soil Sciences eLibrary 2023, downloaded Aug. 26, 2023 (U), first page, last paragraph). Otherwise, the recurrent parent goes through meiosis to produce pollen or an ovule, and the genome is not the same as the genome of variety SVPS0897. While one skilled in the art can backcross a hybrid progeny to its hybrid parent, there is no guidance as to how many backcrossings to the hybrid parent are required to regain all of its morphological and physiological characteristics in addition to the transgene. It is highly unpredictable what combinations of dominant and recessive alleles at every locus would be present in each backcrossed progeny. Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue. Weighing all the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
7. Claims 7 and 9 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.
Claims 7 and 9 lack adequate written description because the plant part comprising a cell of the hybrid plant of claim 1 encompasses a progeny seed or embryo cell . A hybrid of variety SVPS0897 has a genome that is heterologous at every locus. When said hybrid is crossed with an unknown parent, it is unpredictable what genetic material its progenies would inherit. The specification does not disclose a representative number of progenies of hybrid variety SVPS0897 to allow one skilled in the art to predict the genetic makeup or physiological and morphological characteristics of the claimed progeny cells. No identifying characteristics are set forth for the progenies. There are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine the genomic structure or morphological and physiological characteristics of the claimed progeny cells, absent further guidance. Accordingly, the claimed plant part and cells lack adequate written description.
Conclusion
8. No claim is allowed. The “cell” is understood by the Office to be a regenerable cell. The claims are free of the prior art. The closest prior art teaches pepper line HJA114-1077 which shares at least 42 morphological and physiological characteristics (+/- 10% std. dev.) with line SVPS0897, including days from direct seeding until mature green stage, mature leaf shape, flowers per leaf axil, calyx lobes, corolla color, anther color, fruit group, calyx diameter, fruit diameter at mid-point, average fruit weight, texture of fruit surface, fruit color at maturity, absence of stalk cavity, pedicel length, pedicel thickness, pedicel shape, fruit base shape, fruit shape, calyx: aspect, fruit flavor, fruit glossiness, seed cavity diameter, seed color and anthocyanin coloration in anther (Berke, T., US Pub. No. 20130024963 (Applicant’s IDS), Table 2). However, at least their days from transplanting until mature green stage, plant habit, plant height, plant width, basal branches, branch flexibility, leaf width, leaf length, petiole length, flower diameter, corolla throat markings, style length, fruit length, flesh thickness at mid-point, average number of fruits per plant, fruit shape in longitudinal section, fruit shape in cross section, fruit set, number of locules, pungency, capsaicin in placenta, seed cavity length, placenta length, grams per 10000 seeds and seed color differ.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663