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 .
Status of the Claims
Claims 1-20 are pending in the present application.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, in the reply filed on April 29, 2026 is acknowledged.
Applicant’s election of Phytophthora infestans as the species in the reply filed on April 29, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The election of species requirement for Group I has been reconsidered and is hereby withdrawn. Examination has been expanded to encompass the controlling of all pests of the phylum Oomycota.
Claims 5-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 29, 2026.
Claims 1-4 are currently under examination as they relate to the elected invention of controlling pests of the phylum Oomycota comprising applying one or more cervinomycins.
Priority
This application claims priority to U.S. Provisional Application No. 63/434,585, filed December 22, 2022.
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 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of controlling a pest comprising applying an effective amount of one or more cervinomycins to the pest or an area in need of pest control, wherein the one or more cervinomycins is selected from cervinomycin A1 and cervinomycin A2 and the pest is selected from the group consisting of Pseudoperonospora cubensis, Bremia lactucae, Plasmopara viticola, Phytophthora infestans, Phytophthora capsici and Pythium ultimum, does not reasonably provide enablement for the use of the use of any cervinomycin or a method of controlling any pest from the phylum Oomycota or orders Peronosporales or Pythiales. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
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 of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill of those in the art
The invention is drawn to the use of one or more cervinomycins to control pests of the phylum Oomycota.
The relative skill of those in the art is high, generally that of a Ph.D. The artisan using Applicant’s invention would generally have experience using and selecting different pesticides to control different pests.
The factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant’s invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain).
At the time the instant application was filed, the state of the art of controlling a fungus of phylum Oomycota as recited in claims 1-4 embraces treatment of numerous classes, orders, families, genera, and species. According to Thines (Current Biology 28, R803–R825, August 6, 2018), the oomycetes (members of Oomycota) comprise over 1,200 named species and likely 10,000 or more plant-pathogenic species in total (p. R813, section “How many species of oomycetes are there?”). These species infect a diverse array of hosts, including plants such as potatoes, grape, spinach and maize (p. 813, section “Are crops and ornamentals impacted by omycetes?”) as well as a few species capable of colonizing mammals (p. R813, section “Are there oomycetes that are able to parasitise humans or other mammals?”). Furthermore, the species capable of infecting mammals are often resistant to treatment with classical fungicides.
In addition, an order within Oomycota such as Peronosporales can contain dozens if not hundreds of genera, and each genus may contain hundreds of distinct species with different pathologies and mechanisms of infection. For example, Buechel (Common Pythium Species in Greenhouse Crops) notes that the genus Pythium contains over 120 species that have infected plants (p. 1, para. 2), including P. aphanidermatum, P. ultimum, and P. irregulare. These species may infect different plants (p. 2, sections “Host preferences of each Pythium species”), and fungicides used to control one of these species may not work to control the other two species (p. 3, para. 4).
Thus, the art of developing and testing pesticides, particularly for use in controlling any species of the phylum Oomycota and even for orders or genera within Oomycota, is extremely unpredictable.
The breadth of the claims
Claim 1 is very broad in that all species of phylum Oomycota are claimed to be treated with any cervinomycin. Although claim 2 narrows the scope to orders within Oomycota, these orders still contain thousands of species each. Although claim 3 narrows the scope of species to be controlled, it still recites the use of any cervinomycin. Although claim 4 narrows the scope of cervinomycins, it does not narrow the scope of species to be treated.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides in vitro data for the application of cervinomycins A1-2- to control Plasmopara viticola (Table 1, p. 13) as well as in vivo data for the application of cervinomycins A1-2 to control Phytophthora infestans, Pseudoperonospora cubensis, Bremia lactucae, Phytophthora capsici and Pythium ultimum (all Table 5).
The cervinomycins as defined by the specification include 11 compounds: cervinomycins A1-A3, B1-B4, and C1-C4- (p. 6, para. [021]). The structures are depicted and compared below. The structures of cervinomycins A1-2 are rotated 180° compared to the structures in paras. [022]-[023] of the specification. The structures of cervinomycins C1-4 are taken from Hu et al. (The Journal of Antibiotics (2020) 73:812–817).
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The core structure of cervinomycins A1-2 and cervinomycins C1-4 differ in a few ways. First, the ring labeled D in the structures of C1 and C3 is not aromatic or planar, whereas the corresponding ring in A1-2 is aromatic. Second, the ring B differs: in C1-4 this is the last ring in the ring system, whereas in A1-2 this ring is further fused to a five-membered ring. These differences in structure and 3D geometry would mean cervinomycins A1-2 and cervinomycins C1-4 may have different biological activities and efficacies depending on the mechanisms these different cervinomycins target.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that cervinomycins other than A1 and A2 could be predictably used as prevention or treatment for all species of Oomycota other than those expressly tested in the specification.
Determining if a particular cervinomycin or combination of compounds will treat any particular disease in any particular plant would require formulation into a suitable composition and testing that specific composition on that specific plant. This is undue experimentation given the limited guidance and direction provided by Applicant. As noted supra, even species within the same genus may not be treatable with the same compounds, let alone species in the dozens if not hundreds of other genera within the same order.
Accordingly, the inventions of claims 1-4 do not comply with the scope of enablement requirement of 35 U.S.C 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of copending Application No. 19/460,585 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1 and 4 are anticipated by reference claims 2-3.
Reference claim 2 teaches a method of controlling a pest comprising applying an effective amount of a pesticidal mixture comprising one or more cervinomycins and at least one additional compound to the pest or an area in need of pest control, wherein the pest is a species of the Phylum Oomycota. Reference claim 3 teaches wherein the one or more cervinomycins is selected from cervinomycin A1 and cervinomycin A2.
Therefore, reference claim 2 is in essence a “species” of the generic invention of instant claim 1: where instant claim 1 requires a composition comprising one or more cervinomycins, reference claim 2 requires one or more cervinomycins and an additional compound. Similarly, reference claim 3 is a “species” of the generic invention of instant claim 4. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-4 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVER D. HEES whose telephone number is (571)272-9840. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/O.D.H./Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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