DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 June 2025 has been entered.
Claims 1 and 8 have been amended. Claim 27 has been cancelled. Claims 8-11, 13-17, and 19 remain withdrawn. Claims 1-3, 5-7, 24-26, 28, and 29 are currently pending and under examination.
This application is a U.S. National Stage under 35 USC § 371 of International Application No. PCT/US2020/025767, filed March 30, 2020, which claims priority to U.S. Provisional Application No. 62/828453, filed April 2, 2019.
Maintenance/Modification of Rejections:
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 1-3, 5-7, 24-26, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Johal (US 7,846,463; Published 2010 – Previously presented), and further in view of Lyn et al. (US 2009/0060965; Published 2009).
With regard to claims 1, 25, 28, and 29, Johal teaches a pest control composition, including for animal, insect, fungal, and bacterial pests, which are agricultural pests, that includes a pest control agent and a cellulosic fibrous sorbent carrier (Abs.; Col. 2, line 47-50; Col. 5, line 4-32). The carrier is a sorbent for the pest control agent, which includes adsorption and refers to adherence of the pest control agent onto the surface of the carrier (Col. 3, line 17-28), thus, the pest control agent is attached to the surface of the carrier. The sorbent carrier includes germ obtained from any suitable grain, including specifically corn germ (Col. 3, line 42-47), which is a nutrient carrier. The carrier, which includes corn germ, is present in the biocontrol composition in an amount including 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95% by weight (Col. 4, line 31-39).
While the pest control agent can be an agent to control fungal pests (Col. 5, line 4-32), it is not specifically taught that the pest control agent is a non-aflatoxigenic strain of Aspergillus.
Lyn et al. teach an agricultural biocontrol formulation that utilizes non-aflatoxigenic Aspergillus strain(s), including Aspergillus flavus, Aspergillus oryzae, Aspergillus sojae, or mixtures thereof, as the biocontrol agent to inhibit the growth of aflatoxin producing fungi (Abs.; claim 3), wherein an agriculturally acceptable carrier is utilized to deliver the non-aflatoxigenic Aspergillus strain(s) (Para. 18).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Johal and Lyn et al., because both teach an agricultural pest control composition that includes a pest control agent having fungicidal activity, and an agriculturally acceptable carrier to deliver the pest control agent. The use of non-aflatoxigenic Aspergillus strain(s), including Aspergillus flavus, Aspergillus oryzae, Aspergillus sojae, or mixtures thereof as the pest control agent in a fungicidal pest control composition, is known in the art as taught by Lyn et al. The use of non-aflatoxigenic Aspergillus strain(s), including Aspergillus flavus, Aspergillus oryzae, Aspergillus sojae, or mixtures thereof, as taught by Lyn et al., as the pest control agent in the pest control composition of Johal, amounts to the simple substitution of one known fungicidal pest control agent for another, and would have been expected to predictably and successfully provide a pest control composition having fungicidal activity as desired. Further, the inclusion of a non-aflatoxigenic Aspergillus strain as taught by Lyn et al., as the pest control agent in Johal, would also have been expected to predictably improve the pest control composition of Johal, by allowing for an additional use of inhibiting the growth of specifically aflatoxin producing fungi, thus also being usable for desirably preventing toxin contamination in agriculture commodities used for human an animal consumption (see Lyn et al., Abs.).
With regard to claim 2, Johal teaches that the pest control composition further comprises other carriers, spreading agents, stabilizers, binders, and preservatives (Col. 6, line 11-30; Col. 8, line 35-36).
With regard to claim 3, Johal teaches that the pest control composition further comprises a binder, where the binder can be a polysaccharide (Col. 6, line 11-30; Col. 7, line 36-62), which is a complex carbohydrate polymer. As the polysaccharide binder cannot be separated from its functions, this binder is usable as a seed binder.
Claims 5 and 6 are directed to corn germ which is produced by the claimed processes. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Here, the corn germ of Johal is likewise a carrier included in an agricultural biocontrol composition. Functionally, the corn germ of Johal is the same as the claimed corn germ. Therefore, the corn germ of Johal is the same as, or would have rendered obvious, the corn germ produced by the claimed process as a by-product of a corn wet-milling process; or by a process that does not comprise a step of devitalizing, pearling or rolling, sterilizing by roasting, and/or cooling the corn germ.
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"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
With regard to claim 7, Lyn et al. do not teach that the composition comprises fungi other than the Aspergillus species, or that it comprises disease-causing enterobacteria (see entire document). Thus, the composition of Johal and Lyn et al. is essentially free of fungi other than the non-aflatoxigenic strain of Aspergillus, and disease-causing enterobacteria.
With regard to claim 24, as the composition as rendered obvious by Johal and Lyn et al. comprises the components as claimed, and as these components cannot be separated from their properties, the composition of Johal and Lyn et al. would necessarily provide the result of supporting sporulation of the non-aflatoxigenic strain of Aspergillus 2 times more than sorghum within about 48 hours after the agricultural biocontrol composition is placed under conditions suitable for sporulation of the non-aflatoxigenic strain of Aspergillus.
With regard to claim 26, Johal teaches that the pest control composition comprises a pest control agent and a carrier that includes a cellulosic fibrous sorbent, including corn germ, and a mineral sorbent (Abs.; Col. 3, line 42-47). It is noted that the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). In finding the claims did not exclude the prior art dispersant, the court noted that appellants’ specification indicated the claimed composition can contain any well-known additive such as a dispersant, and there was no evidence that the presence of a dispersant would materially affect the basic and novel characteristic of the claimed invention (see MPEP 2111.03, III.). For the purposes of searching for and applying prior art under 35 U.S.C. §102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." (MPEP 2111.03, III.). If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of "consisting essentially of," applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of the claimed invention (MPEP 2111.03, III.).
Here, Applicant indicates that additional elements are included in the composition as claimed, including a carrier agent, a spreading agent, a binding agent, an osmoprotectant, an adhesive agent, a stabilizer, an agent the prevents fub-off, a colorant, and a preservative (see for example instant claims 2 and 3, and the specification at page 3, line 2-7). As an additional carrier agent is permitted and even required by Applicant, a mineral sorbent carrier component is permissibly present. Further, the mineral sorbent of Johal is preferably a bentonite clay (see Col. 2, line 61-64), wherein in addition to being a carrier, bentonite clay may also be considered to be a binding agent, an adhesive agent, a stabilizer, or an agent that prevents rub-off. Thus, this element is further permissibly present. There is no evidence in the specification that the presence of a mineral sorbent would materially affect the basic and novel characteristic of the claimed invention. As such, the carrier in the combined composition of Johal and Lyn et al. consists essentially of corn germ.
Response to Arguments
Applicant urges that there is no motivation to combine Johal and Lyn, as Lyn works differently from Johal, where Lyn describes that the non-aflatoxigenic strain of Aspergillus must crowd out the toxigenic strain. Johal’s method of action differs in that the carrier has sustained-release properties, and does not disclose or suggest that the carrier is intended to feed Aspergillus so that it generates spores. Additionally, there is no evidence that combining Johal and Lyn would produce predictable results. Lyn specifically requires a carrier containing nutrients to support non-aflatoxigenic Aspergillus sporulation and spore release, while Johal uses sorbents of questionable and undescribed nutritional value to Aspergillus that are intended to retain and slow release of a control agent. There is no evidence of record to suggest Johal’s carrier will adequately nourish Aspergillus so it sporulates in a way that out competes toxigenic strains. Further, Johan and Lyn do not disclose or suggest using at least 55% corn germ in a carrier. Johal’s reference to 55% etc. is referring to the amount of the “cellulosic fibrous component” present in the carrier system, and not to corn germ. Also, corn germ does not retain Aspergillus so that the spores have sustained release over an extended time, and extended release is contrary to the intended mechanism of action of the claims.
Applicant’s arguments have been fully considered, but have not been found persuasive.
With regard to Applicant’s arguments that Johan and Lyn do not disclose or suggest using at least 55% corn germ in a carrier, where Johal’s reference to 55% etc. is referring to the amount of the “cellulosic fibrous component” present in the carrier system, and not to corn germ; with regard to what the “cellulosic fibrous sorbent” can include, Johal expressly teaches:
In some embodiments, the cellulosic fibrous sorbent used in conjunction with the invention includes a grain germ, such as virgin grain germ or spent grain germ. As is known in the art, spent germ comprises a germ from which oil has been expelled, for instance, by pressing or extraction with an extracting liquid Such as hexane or water. Virgin germ (i.e., germ from which oil has not been extracted) also or alternatively may also be used. Germ obtained from any suitable grain may be employed in conjunction with the invention, Suitable grains including, for instance, corn, wheat, soy, sorghum, barley, and the like (emphasis added) (Col. 3, line 42-52).
Then with regard to the amount of the cellulosic fibrous sorbent, which can expressly be corn germ as recited above:
The cellulosic fibrous sorbent and mineral sorbent may be present in any suitable amount with respect to one another. For instance, with respect to the total weight of the mineral sorbent and cellulosic fibrous sorbent components present in the composition, the cellulosic fibrous sorbent may be present in an amount of 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% or 95% by weight (emphasis added) (Col. 4, line 31-39).
Given these express teachings, it is clear that the Johal et al. intends corn germ to be a cellulosic fibrous sorbent usable in the composition in the expressly taught amounts.
With regard to the argument that corn germ does not retain Aspergillus so that the spores have sustained release over an extended time, extended release is contrary to the intended mechanism of action of the claims, there is no evidence that the carrier of Johal will adequately nourish the Aspergillus, and Johal uses sorbents of questionable and undescribed nutritional value to Aspergillus that are intended to retain and slow release of a control agent; as shown above, Johal expressly teaches that amounts of corn germ up to 95% are intended to be used as a carrier in the taught composition. The corn germ carrier of Johal cannot be separated from its functional properties; thus, the corn germ has the inherent capability of nourishing the non-toxigenic Aspergillus. There is no evidence to suggest that corn germ is incapable of providing this function. Applicant’s own Specification provides evidence that corn germ is a nutrient carrier for non-aflatoxigenic Aspergillus (see for example p. 1, last para., p. 2, para. 4). If there were contrary evidence in the art that corn germ is incapable of being a nutrient carrier for non-toxigenic Aspergillus, it is likely Applicant’s claims would lack enablement.
With regard to Applicant’s arguments that there is no motivation to combine Johal and Lyn, as Lyn works differently from Johal, where Lyn describes that the non-aflatoxigenic strain of Aspergillus must crowd out the toxigenic strain, and there is no evidence that combining Johal and Lyn would produce predictable results; as discussed in the rejection, it would have been obvious to one of ordinary skill in the art to combine the teachings of Johal and Lyn et al., because both teach an agricultural pest control composition that includes a pest control agent having fungicidal activity, and an agriculturally acceptable carrier to deliver the pest control agent. The use of non-aflatoxigenic Aspergillus strains as the pest control agent in a fungicidal pest control composition, is known in the art as taught by Lyn et al. The use of non-aflatoxigenic Aspergillus strains as taught by Lyn et al. as the pest control agent in the pest control composition of Johal, amounts to the simple substitution of one known fungicidal pest control agent for another, and would have been expected to predictably and successfully provide a pest control composition having fungicidal activity as desired. Further, the inclusion of a non-aflatoxigenic Aspergillus strain as taught by Lyn et al., as the pest control agent in Johal, would also have been expected to predictably improve the pest control composition of Johal, by allowing for an additional use of inhibiting the growth of specifically aflatoxin producing fungi, thus also being usable for desirably preventing toxin contamination in agriculture commodities used for human an animal consumption (see Lyn et al., Abs.).
With regard to Applicant’s argument that Johal’s method of action differs in that the carrier has sustained-release properties, and does not disclose or suggest that the carrier is intended to feed Aspergillus so that it generates spores; as already discussed, Johal clearly teaches that the carrier can be corn germ, and the corn germ carrier of Johal cannot be separated from its functional properties. Further, in response to applicant's arguments that the corn germ carrier of Johal is not taught as a nutrient for the active biocontrol agent, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
For the forgoing reasons, the rejection is maintained.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653