DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
2. Claims 1-26 are pending and examined.
Information Disclosure Statement
3. The listing of references on page 33 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
4. Claims 3 and 4 should be amended to clearly indicate the relationship and antecedence between the terms “herbicide treatment composition” (in claim 3) and “Acetyl-CoA Carboxylase (ACCase)-inhibiting herbicide” (in claim 4). For example, the “wherein” clause in claim 4 could be amended to recite as follow: “wherein the herbicide treatment composition comprises an Acetyl-CoA Carboxylase (ACCase)-inhibiting herbicide.”
In claims 7 and 14, the conjunction “and” in the phrase “and quizalofop-ethyl” should be deleted to reflect proper Markush language which requires only one “and” between the last two terms of the grouping. Similarly, claim 13 is objected to for the use of the conjunction “or” in the Markush grouping.
In claim 15, the phrase “a plant part of claim 2” should be amended to recite “the plant part of claim 2” for proper antecedence with claim 2.
Claim 24 is objected for reciting the conjunction “or” between the last two member of the Markush grouping. The term “or” before “viral disease” should be replaced with an “and”.
In claim 26, part (a), the capitalized term “Crossing” should be made lower case. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
5. 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.
Deposit of Biological Material
6. Claims 1-26 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.
The invention appears to employ a novel rice plant. Since the plant is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the plant. A deposit of 625 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant and it is not apparent if the plant is readily available to the public.
It is noted that on page 34 of the specificaiton, Applicant provides a statement indicating that the deposit was made with NCMA but there is no evidence that the deposit was, in fact, accepted by the depository, and it is also unclear under what terms the deposit was made. Pursuant to MPEP 2409, where a statement is merely an indication that a deposit has been made (with no indication as to whether it has been accepted), there is no assurance that the requirements under 35 U.S.C. 112 have been satisfied. Given that in the instant case there is no indication that the deposit has been accepted, the deposit requirement is not met.
(a) If a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a 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 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) 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 effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
See MPEP 2404.01: The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
Written Description
7. Claims 11, 21, and 25 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.
Applicant claims a rice seed produced by the method of claim 10. Applicant claims rice plants produced by the methods of claims 18 and 24, which methods comprise crossing a plant of rice variety PVL04.
Applicant describes the morphological and physiological characteristics of rice cultivar PVL04 and identifies the proprietary parental varieties used to obtain the cultivar (Tables 1-11).
Applicant does not describe the genus of plants encompassed by the claims. Claims 11, 21 and 25 are drawn to a product-by-process and do not limit the resultant plants by a filial generation. As a result, the claims would encompass generations beyond F1. Neither do the active steps of the methods of claims 10, 18, or 24 require that the plants obtained in said methods be limited to F1. Therefore, the resultant plants may differ from cultivar PVL04 by any number of morphological and physiological characteristics. For example, while the specification describes the claimed cultivar as being resistant to ACCase inhibitor herbicides, claims 11, 21, or 25 do not require the plants to comprise any structures conferring that resistance. Nor has the specification described any structural features such as ACCase mutations that result in said characteristic. The sole described species, the plant of the cultivar PVL04, is thus not sufficiently representative of the claimed genus.
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).
See also 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. In this case, there is no way that a practitioner would be able to determine if any particular rice plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
Accordingly, the specification fails to provide adequate written description to support the genus of rice plants encompassed by the instant claims 11, 21, and 25.
Conclusion
8. No claims are allowed.
9. Claims are deemed free from the prior art. The prior art does not teach or reasonably suggest a rice plant having the genetic background and all of the morphological and physiological characteristics of the claimed cultivar PVL04. The closest prior art is Linscombe (US Patent Publication 2020/0196551, published January 25, 2020), which teaches a rice cultivar called PVL01 that shares a number of characteristics with the instantly claimed cultivar, including resistance to ACCase inhibitor herbicides, but differs with regard to parentage (see paragraphs 77-85; Table A of Linscombe).
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662