DETAILED ACTION
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 .
Election/Restrictions
Applicants’ election of Group II (claims 2, 9, 15-16, 19, 23-25, 27-29, 31, 33-34, 36, 39, 41, 87 and 90) drawn to a method of protecting a plant from a pest or pathogen by applying exogenously to the plant a composition comprising RNA (0.4-10%), a nonionic surfactant (4-7%), a cationic, zwitterionic or amphoteric second surfactant (0.5-3%) and a metal ion sequestrant (0.6-3%), is acknowledged. The election was made without traverse.
Applicants have indicated that new claims 2, 9, 15-16, 19, 23-25, 27-29, 31, 33-34, 36, 39, 87 and 90 read on the elected subject matter. The Examiner agrees.
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction requirement in the reply filed 9/2/25.
Accordingly, claims 2, 9, 15-16, 19, 23-25, 27-29, 31, 33-34, 36, 39, 41, 87 and 90 are under current examination.
Claim Objections
Claims 9 and 25 is objected to because of the following informalities:
Claim 9 recites a list of additional ingredients in the composition. The Examiner suggests adding a semicolon after the first in the list in order to be consistent with the language/punctuation throughout the claim.
Claim 25 recites “…beingpresent” in line 2. The Examiner suggests adding a space between the two words “being” and “present”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a), Written Description
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.
Claims 2, 9, 15-16, 19, 23-25, 27-29, 31, 33-34, 36, 39, 41, 87 and 90 are rejected under 35 U.S.C. §112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter that 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. Applicants are directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112 ¶1 "Written Description" Requirement, Rev. 1, 2008; at http://www.uspto.gov/web/menu/written.pdf.
The claims broadly embrace a method of protecting a plant from a pest or pathogen by applying exogenously to the plant a composition comprising RNA (0.4-10%), a nonionic surfactant (4-7%), a cationic, zwitterionic or amphoteric second surfactant (0.5-3%) and a metal ion sequestrant (0.6-3%), necessitating structure/function relationships.
The specification defines “exogenous application to a plant” as application of an RNAi biopesticide to the exterior of a plant. Furthermore, the specification states “RNAi technology has been shown to be a selective biological treatment for a wide variety of pests and ailments through internal biological process interference. But there is no description of what pests and pathogens are encompassed within this technology. There is no description of which pests or pathogens are encompassed in the claimed method of protecting plant from a pest or pathogen. Such terms are quite broad; for example, the USDA states the term “pest” can be simply defined as any organism detrimental to humans and from the agricultural viewpoint, pests “are organisms that diminish the value of resources in which man is interested” as they “interfere with the production and utilization of crops and livestock” used for food and fiber; the term “pest” applies to all noxious and damaging organisms, including insects, mites, nematodes, plant pathogens, weeds and vertebrates (p. 3, 1st paragraph). However, in the absence of the types of pests and/or pathogens being protected from, the artisan, would not have accepted that applicant was in possession of the claimed method of use. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984). (Holding that a claim was not adequately described because the specification did 'little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.') Mere indistinct terms (such as known classes of compounds which are now claimed based on a limited functional capability, such as “an ophthalmic agent” however, may not suffice to meet the written description requirement. A description of what a material does, rather than of what it is, usually does not suffice. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added). If the genus has substantial variance, as evidenced by the definitions provided by USDA, the disclosure must describe a sufficient number of species to reflect the variation within that genus. See MPEP §2163. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. MPEP §2163.
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.
Claims 9, 16, 25, 27-29, 31, 33-34 and 36 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 regards as the invention.
Claim 9 is unclear. Claim 9 recites: “…wherein the composition further comprises one or more of the following: a secondary surfactant…a UV protectant; at least buffer…”. Claim 9 depends from claim 41 and claim 41 already requires the presence of “a secondary surfactant”, wherein that secondary surfactant is narrowed to a cationic, zwitterionic or amphoteric surfactant. It is not clear if the scope of claim 9 requires an additional secondary surfactant to the surfactant required by claim 41 or if this is redundant and therefore, not in fact, an additional ingredient.
Claims 16 and 28 are unclear. Claims 16 and 28 contain the trademark/trade names: ATPLUS® PFA, REAX® 105M, KRAFTSPERSE® 8828, REAX® 910, REAX® 960, MORWET® D-425, MORWET® IP and MORWET® EFW. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe ingredients/products and, accordingly, the identification/description is indefinite.
Claims 25, 27, 29, 31, 33-34 and 36 depend from claim 9, and have thus been included in the rejection.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. recites: “…wherein the composition further comprises one or more of the following: a secondary surfactant…a UV protectant; at least buffer…”. Claim 9 depends from claim 41 and claim 41 already requires the presence of “a secondary surfactant”, wherein that secondary surfactant is narrowed to a cationic, zwitterionic or amphoteric surfactant. Claim 9 does not further limit claim 41, by further comprising a secondary surfactant as such is already required by the limitations of claim 41. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 2, 9, 15-16, 19, 23-25, 27-29, 31, 33-34, 36, 39, 41, 87 and 90 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 9-10, 12-15, 17-27 and 29-31 of copending Application No. 17/961,205 (note: this has been allowed but has not issued as a patent yet). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition (e.g., soluble liquid concentrate) comprising RNA (0.4-10%), a nonionic surfactant (4-7%; e.g., polysorbate 20), a cationic, zwitterionic or amphoteric second surfactant (0.5-3%; e.g., cetrimonium chloride) and a metal ion sequestrant (0.6-3%; e.g., EDTA), wherein the composition controls a plant pest or pathogen; wherein the composition is sufficient to provide shelf stability to RNA for one year at room temperature; wherein the pH of the composition remains within 2 units of the initial pH after the composition is stored for a time and at a temperature (e.g., 2 weeks at -20 °C); wherein the RNA present in the composition remains within 15% of the initial concentration of RNA present in the composition as measured by HPLC, after the composition is stored for a time and at a temperature (e.g., 2 weeks at -20 °C); and wherein the composition further comprises a UV protectant (1-15%; e.g., sodium lignosulfonate dispersant), at least one buffer (2-5%; e.g., monobasic potassium phosphate), at least one biological preservative (0.05-1%; e.g., CMIT); an antifoam agent (0.025-0.2%)and an antifreeze agent. The difference is that ‘205 claims are directed to the composition, whereas the instant claims are directed to the method of protecting a plant from pest or pathogen by exogenously applying the abovementioned composition. However, the specification of ‘205 teaches a method of using the composition to protect plants from a pest or pathogen. Attention is directed MPEP 804 (II)(B)(2)(a) which states: In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). Thus, the instant claims and the application claims are obvious variants.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617