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
Applicant’s amendment filed July 24, 2026 is acknowledged. This application is a continuation of PCT/CN2022/131943, filed November 15, 2022, with a foreign priority application CN202111344662.7, filed November 15, 2021.
Claim 8 is canceled, and claims 1, 5-7, and 9-10 are amended. Currently claims 1-7 and 9-10 are pending and under examination.
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 7 and 9-10 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 applying onto soil to a peanut field at least 2 kg/mu spread of the microbial agent comprising at least 2x109 cfu/g Bacillus amyloliquefaciens, at least 2x109 cfu/g Brevibacillus laterosporu, at least 1 x 1010cfu/g Bacillus mucilaginosus Krassilnikov, at least 1x 1010cfu/g Enterobacter ludwigii, and at least 2 x109cfu/g Myroides odoratimimus is, at a mass ratio of 1:10 mixed bacterial suspension to the carrier, wherein the carrier consists of humic acid, tapioca flour, and bentonite binder at a ratios of 8.5:10:0.5, to reduce the abundance of aflatoxigenic strains and promote an increase in root nodules, does not reasonably provide enablement for application of the microbial agent without limitation as to the relative amounts and/or viable concentrations of the 5 strains, formulation of the agent, amount applied, or type of crop, while requiring the results of preventing and controlling aflatoxin and aflatoxigenic strains in the field and promoting an increase in number of root nodules. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The breadth of the claims:
Claims 7 and 9-10 are drawn to a method for using the microbial agent in any concentration, formulated in any way, comprising the recited 5 strains, and applying it at any concentration at any time to prevent and control aflatoxin and aflatoxigenic strains, and promote increase of number root nodules in any type of crops.
The nature of the invention:
The nature of the invention relies upon using the recited microbial agent to prevent and control aflatoxin and aflatoxigenic strains, and promote number of root nodules of any type of crop.
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
The state of the prior art:
A review of the patent and non-patent literature indicates that the state of the art demonstrating that applying a microbial agent used for preventing and controlling aflatoxin and aflatoxigenic strains does not inherently corelate with an increased root nodulation or crop yield across different crops. As disclosed by Bonkoungou et al. (CABI Agriculture and Bioscience, 2024, 5:106, pgs. 1-21, cited in PTO-892 mailed 4/24/2026), application of an aflatoxin biocontrol agent Aflasafe which effectively reduced aflatoxin levels in maize, groundnut, and sorghum crops, but was silent on promoting yield increase (abstract). Similarly, a study on the effects of Aflasafe TZ01 by Fundikira et al. (Toxins 2025, 17, 419, pgs. 1-15, cited in PTO-892 mailed 4/24/2026), demonstrated that controlling aflatoxin in maize crops resulted in higher concentrations of Fusarium mycotoxins, which highlights that even successful aflatoxin control can lead to compensatory or adverse effects, undermining the assumption of universal improvement or increase in root nodules (abstract).
Alori et al. (The Open Agriculture Journal, 2019, Volume 13, pgs. 1-8, cited in PTO-892 mailed 4/24/2026) discloses impacts of microbial inoculants on growth and yield of maize plants, and demonstrates even applying beneficial microbes (i.e. Pseudomonas species) do not produce consistent yield increase across all crops due to the effect of a particular microbe on crop genotypes as seen in Table 5 (title, abstract, pg. 7).
Thus, a review of the prior art does not find a correlation between applying a microbial agent that prevents and controls aflatoxin as inherently resulting in promoting an increase of root nodules in any type of crop as claimed.
The level of one of ordinary skill:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention. Because the state of the prior art does not provide evidence of the degree of predictability that methods for promoting an increase in the number of root nodules or aflatoxin control by applying a microbial agent comprising any amount of concentrations of bacteria at any application amount to any type of crop would yield results as claimed, one of ordinary skill in the art would look for guidance or direction in the instant specification.
The level of predictability in the art:
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03).
The amount of direction provided by the inventor:
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004).
The existence of working examples:
The working embodiment in the instant application describes preparing the microbial agent in Examples 2 and 3, and applying the recited microbial agent on peanut crops and its effect on controlling aflatoxigenic strains and increasing root nodules in Examples 3 and 4. The microbial agent was prepared by separate fermentation of the 5 strains, concentrated at the specific cfu/g in [0037] for each strain, dissolved in appropriate amount of water to prepare a mixed bacterial suspension, wherein the carrier formulated in [0036] was mixed with the bacterial suspension at a mass ratio of bacterial suspension to carrier at 1:10, then applied to the soil at a usage amount of 2 kg/mu. The working embodiments do not describe any other concentrations of bacteria ratios or amount applied or to any type of crop the microbial agent is applied. While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the role that the microbial agent at any concentration and formulation, and amount to applied is useful in preventing and controlling aflatoxin and aflatoxigenic strains plays in increasing number of root nodules to any type of crop, and it is unpredictable if using the claimed microbial agent on any other concentrations, formulations, or amount applied to any type of crop would behave the same as broadly claimed. The specification does not provide sufficient guidance on using the microbial agent at any concentration, formulation, or any amount applied on any type of crop, except for the described examples using the specific microbial agent composition and applying at least 2kg/mu on peanut crops.
Without further guidance, one of skill in the art would have to practice a substantial amount of trial-and-error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring organisms without significantly more.
The Supreme Court has required analysis based on a 3-part test for subject
matter eligibility.
- Step 1: Is the claim to a process, machine, manufacture, or composition of
matter?
- Step 2A (The Judicial Exceptions): Prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
-Step 2A (The Judicial Exceptions): Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
- Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
Claims 1-6 recite a microbial agent compounded from 5 microbes comprising Bacillus amyloliquefaciens, Brevibacillus laterosporu, Bacillus mucilaginosus Krassilnikov, Enterobacter ludwigii and Myroides odoratimimus by separate fermentative cultivation, concentration and mixing, which is a statutory category of invention (Step 1: Yes).
Claims 1-6 recite naturally occurring microbes isolated from nature according to the Specification [0014], thus recites a judicial exception in the form of being a product of nature (Step 2A, Prong 1: Yes).
Claims 1-6 are drawn to the microbial agent comprising the 5 microbes as being capable of preventing and controlling aflatoxin and aflatoxigenic strain thereof and promoting yield increase of crops. As evidenced by the Specification, the strains were isolated from peanut pods and rhizospheres and can effectively antagonize the growth of Aspergillus flavus and inhibit aflatoxin production [0014]. As seen in the prior art (US 20190159463 A1, cited in PTO-892 mailed 4/24/2026), bacteria isolated from peanut crops (including Enterobacter strains) are commonly characterized as having aflatoxin inhibiting ability. There is no evidence that these particular claimed microbial strains have been genetically modified or altered that would enhance functionality of the aflatoxin inhibition ability, nor that mixing said strains would alter their functionality that differs from their natural ability. Therefore, the microbial agent comprising the recited strains are naturally occurring organisms and do not recite additional elements that integrate it into a practical application (Step 2A, Prong 2: No).
Claims 1-6 recite the microbial agent is compounded from the 5 microbes by separate fermentative cultivation, concentration, and mixing. Claim 5 recites the microbial agent is in the form of a granule, a powder, or a solution, which does not transform the microorganisms into a different physiological state (structure, function, or other properties) than the organisms that naturally exist in nature. Similarly, claim 6 recites the microbial agent is compounded with a particle carrier comprising humic acid, tapioca flour, and a bentonite binder, which are naturally occurring and do not affect the physiological state (structure, function, or other properties) of, or add a markedly different characteristic to the microbial strains as they exist in nature. Thus the claims do not recite additional elements that amount to significantly more than the judicial exception (Step 2B: No).
Therefore, claims 1-6 are not patent eligible subject matter.
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 1-7 and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/664304 in view of Zhang et al. (US 11622560 B2, cited in PTO-892 mailed 4/24/2026, hereinafter “Zhang”).
Claims 1-10 of ‘304 recite a microbial agent and method for promoting nodule number increase and root nodule nitrogenase activity increase in leguminous crops, compounded from 4 microbes comprising Bacillus amyloliquefaciens, Brevibacillus laterosporu, Bacillus mucilaginosus Krassilnikov, and Enterobacter ludwigii by separate fermentative cultivation, concentration and mixing, which are the same deposited strains recited in the instant claims.
‘304 claims do not recite that the microbial agent also comprises Myroides odoratimimus 3J2MO strain with accession number CCTCC NO: M2017329, with functions of preventing or controlling aflatoxin or aflatoxigenic strains thereof.
However, Zhang teaches the 3J2MO strain as a biocontrol strain for efficiently degrading aflatoxin, and teaches a method of applying the strain to prevent and control aflatoxin (abstract, claim 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate a microbial agent comprising the 4 strains as recited in ‘304, adding the 3J2MO strain that is effective at controlling and preventing aflatoxin and aflatoxigenic strains as taught by Zhang, in order to use the microbial agent in a method for preventing and controlling aflatoxin and aflatoxigenic strains and promote an increase in crop yield as taught by Zhang with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed July 24, 2026 have been fully considered but they are not persuasive.
Regarding Remarks directed to the 35 USC § 112(a) rejection, Applicant argues the amended method claims now overcome the previous 112(a) scope of enablement rejection. However, as explained in the modified rejection above, the currently claimed method is not enabled through the full scope of the claims.
Regarding Remarks directed to the 35 USC § 101 rejection, Applicant argues the bacteria in the microbial agent are all non-rhizobium bacteria, and are not the conventional rhizobia that can form root nodules in symbiosis with leguminous plants. Applicant argues the compounded form significantly increased number of root nodules, inducing supernodulation. Applicant also argues none of the bacteria reported in the prior art, individually, has the effect of significantly increasing the number of root nodules.
As described above in the maintained 101 rejection, the composition is evaluated as comprising naturally occurring microorganisms that maintain the same physiological state as they occur in nature under the markedly different characteristics analysis. Furthermore, all the bacteria were isolated from peanut pods and rhizospheres, which would naturally coexist in nature, thus their existence in the currently claimed composition would not result in different functionality of the strains. Thus the claimed compositions are not patent eligible material.
Regarding Remarks directed to the provisional nonstatutory double patenting rejection, Applicant argues the copending application 18/664304 is not approved and the PCT application of the copending application is not earlier than the PCT application of the instant, thus should be withdrawn.
However, the Examiner will follow the MPEP § 1490(VI)(D)(2)(a) guidelines, thus the provisional non-statutory double patenting rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
Prosecution Insights