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
Applicant’s election without traverse of Group 1 (a method of reducing corn rootworm (CRW) mediated damage to a corn plant comprising applying the bacteria to a corn plant, plant part, or seed, claims 1-2, 4-7, 24, 32, 46-47) in the reply filed on 20 Jan 2026 is acknowledged. Claims 11, 13, 16-17, 22-23, 31, 39, 41, 44-45, and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 20 Jan 2026.
Claim Status
The amended claim set filed 20 Dec 2023 is acknowledged. Claims 1-2, 4-7, 11, 13, 16-17, 22-24, 31-32, 39, 41, 44-47 and 49 are currently pending. Of those, claims 1-2, 4-7, 11, 13, 16-17, 22, 24, 31, 39, 41, 44, 46, and 49 are currently amended, and no claims are new. Claims 11, 13, 16-17, 22-23, 31, 39, 41, 44-45, and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 20 Jan 2026. Claims 3, 8-10, 12, 14-15, 18-21, 25-30, 33-38, 40, 42-43, 48, and 50 are cancelled. Claims 1-2, 4-7, 24, 32, 46-47 will be examined on the merits herein.
Priority
Applicant’s priority claim to provisional application 63/379,797 (filed 17 Oct 2022) is acknowledged. The effective filing date for the claims under examination is 17 Oct 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 Jan 2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. A signed copy of the statement is attached with this action.
Specification
The disclosure is objected to because of the following informalities: [0071] states that the Methylobacterium was applied at stage V1, but the remainder of Example 1 states that the Methylobacterium was applied at stage V3 instead. Appropriate correction is required.
Claim Objections
Claim 24 is objected to because of the following informalities: the claim is incomplete because it depends from a withdrawn claim that is not under examination. Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-7, and 46-47 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “reducing CRW mediated damage”, but there is no standard for comparison provided in the claim to determine what the damage is reduced in comparison to. The term “reducing” is a relative term which renders the claim indefinite. The term “reducing” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 4-7 and 46-47 are also rejected because they depend from claim 1 and do not obviate this grounds of rejection. Claim 2 is not rejected because it provides a standard for determining whether there is a reduction.
Claim Rejections - 35 USC § 112(a)
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 1-2, 4-7, 24, 32, 46-47 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. There is no scope within the current claims that is enabled because the claimed functional effect is not enabled for any of the claimed isolates.
The factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01. Although all factors were considered, the Wands factors that were most relevant for this decision are discussed in detail below.
The breadth of the claims: Claim 1 and its dependent claims are methods for reducing corn rootworm (CRW) mediated damage to a corn plant that comprises: (i) applying a composition comprising a CRW-active Methylobacterium sp. selected from the group consisting of ISO13 (NRRL B-50941), IS008 (NRRL B-50936), NLSO210 and NLS0617 to a corn plant, a part thereof, or a corn seed; and, (ii) growing the corn plant or a corn plant from the corn seed in the presence of CRW, thereby reducing CRW damage to the corn plant or to the corn plant grown from the corn seed.
Claim 24 is a method for treating a corn plant seed that can provide a corn rootworm (CRW) tolerant corn plant that comprises applying a composition comprising at least one CRW-active Methylobacterium sp. selected from NLSO210 and NLS0617, and an agriculturally acceptable adjuvant and/or and an agriculturally acceptable excipient to a corn seed, thereby obtaining a treated seed that can provide a CRW tolerant corn plant.
Claim 32 is a method for controlling corn rootworm (CRW) damage to a corn plant that comprises: (i) planting a corn seed that has been treated with a composition comprising a CRW- active Methylobacterium sp. selected from the group consisting of ISO13, ISO08, NLS0210 and NLS0617; and, (ii) growing a CRW-tolerant corn plant from the treated corn seed in the presence of CRW.
Importantly, all claims require that there be an effect on CRW (“reducing corn rootworm (CRW) mediated damage”, “provide a CRW tolerant corn plant”, “controlling corn rootworm (CRW) damage” and “growing a CRW-tolerant corn plant from the treated corn seed”), but this effect is not enabled. The claims require the effect occur when corn is treated with Methylobacterium strains that are NLSO210 and NLS0617 (in all claims) or additionally ISO13, ISO08 (all claims except claim 24). The claims are broader than what is enabled by the specification because the specification teaches this effect does not occur when the claimed bacteria are administered (see below).
The amount of direction provided by the inventor: The specification teaches Methylobacterium are known to be ubiquitous in nature [0003], but does not teach that there is an existing body of work using these bacteria for CRW. The specification states that ISO08 and ISO13 are “CRW-active Methylobacterium sp.” [0059] but does not provide evidence or a rationale to support that conclusion. The specification provides general information discussing how the method could be practiced, for example, stating the Methylobacterium could be combined with pesticide or sprayed [0060, 0063], but does not discuss specific isolates that should be used in this way.
The existence of working examples: The specification teaches the effect of ISO13 and ISO08 isolates when applied to corn in Example 1 [Tables 4-5 on pg. 38-40]. The specification teaches “Isolates ISO02, ISO03 and ISO04 exhibited a reduction in root lodging and also increased corn yields in comparison to the untreated checks, which are indicative of reductions in CRW damage to the plants treated with those isolates. Isolates ISO11,ISO09, ISO14, and ISO06 appear to be CRW inactive Methylobacterium sp. in so far as they did not provide for significant reductions in reductions in CRW damage when compared to a check.” [0082]. The specification does not teach that the claimed ISO13 and ISO08 isolates are have significant effects, so it teaches that these claimed isolates are “CRW inactive Methylobacterium sp.” like ISO11, ISO09, ISO14, and ISO06. Also, in Example 3, the specification teaches the strains “Methylobacterium sp. ISO010, ISO08, ISO05, ISO13, ISO11, ISO09, ISO14, and ISO06 that do not exhibit CRW activity” [0084, emphasis added].
The specification further teaches the effect of ISO13 and ISO08 isolates when applied to corn in Example 4 [0085]: “The fourteen PPFM strains ISO1-ISO14 were tested … There were no statistically significant differences between PPFM-treated plants and controls at p<0.05 in shoot and root dry weights. There were also no statistically significant differences in the number and size of recovered larvae from PPFM- treated plants and controls at p<0.05.”
The specification teaches the effect of applying the NLS0617 isolate in Example 5 [Table 6 at pg. 42-43]: “Methylobacterium treatments were not significantly different in this study” [0087].
The isolate NLS0210 is not tested in the working examples for an effect on CRW or CRW-mediated damage.
In summary, the specification specifically teaches that three of the four isolates are “CRW inactive Methylobacterium sp.” because they do not have a significant effect on CRW, and the specification is silent on the efficacy of the fourth isolate. The evidence in the specification shows that the majority of Methylobacterium isolates do not have an effect on CRW, although there are specific strains that are an exception.
The state of the prior art and the level of predictability in the art: The art at the time of filing had previously studied the ISO13 and ISO08 isolates, but not the NLS0617 or NLS0210 isolates. Jones et al. (US 20170238553 A1; PTO-892) “provides compositions comprising Corn Rootworm (CRW)-active Methylobacterium sp., methods for controlling CRW, and methods of making the compositions” [Abstract]. Example 1 of Jones et al. is a trial where Methylobacterium is applied to corn [0080]. The data is shown in Tables 4-5. Jones et al. teaches that some of the other isolates tested, but not ISO13 and ISO08, show significant data indicating a reduction in CRW damage [0088]. Example 2 of Jones et al. is a second trial where Methylobacterium is applied to corn, but none of the strains including ISO08 and ISO13 are able to reduce or resist CRW [0089].
The nature of the invention and the quantity of experimentation needed to make or use the invention: The nature of the invention requires in vivo reducing or controlling CRW damage and/or obtaining a CRW tolerant corn plant. There is specific evidence from both the specification and art that the ISO08, ISO13 and NLS0617 isolates do not have this effect, Also, the evidence of the specification and art shows that most Methylobacterium isolates do not have the required functions, so there is a high degree of predictability that the untested NLS0210 isolate also does not have the required functions.
There is no amount of experimentation that will change the properties of the bacterial strains. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully reducing or controlling CRW damage and/or obtaining a CRW tolerant corn plant.. Therefore, claims 1-2, 4-7, 24, 32, 46-47 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, for failing to meet the enablement requirement.
Claims 1-2, 4-7, 24, 32, 46-47 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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.
It is apparent that the Methylobacterium strains NLS0210 and NLS0617 are required to practice the claimed invention (see claims 1, 24, and 32). As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the biological isolates.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. Information about the source of these isolates is found in Table 1, pg. 14-15. Table 1 shows that isolating a bacterial strain from a biological source is not repeatable because multiple different strains were isolated from the same source of a corn plant. The specific NLS0210 and NLS0617 isolates required by the claims are not commonly available and cannot be reproducibly isolated from nature. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, 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.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) 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 enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Double Patenting
In the interest of compact prosecution, it is noted that the claims from the following applications and patents teach or render obvious all active steps currently claimed for one or more method claims. However, there is not a double patenting rejection because the claimed CRW-related outcomes do not occur when corn is treated with the claimed isolates, as discussed in the enablement rejection above, so the method claims are not anticipated.
US 10098353 B2: See claims 1, 9 for teachings related to Methylobacterium ISO13/ NLS0037 (NRRL B-50941) applied to corn.
US 10448645 B2: See claims 1, 10 for teachings related to Methylobacterium ISO08/ NLS0069 (NRRL B-50936) applied to corn.
US 10716307 B2: See claims 1, 12 for teachings related to Methylobacterium ISO13/ NLS0037 (NRRL B-50941) applied to corn.
US 12016338 B2: See claims 1, 10, 12 for teachings related to Methylobacterium ISO08/ NLS0069 (NRRL B-50936) and/or ISO13/ NLS0037 (NRRL B-50941) applied to corn.
US 12382961 B2: See claims 1, 8-9 for teachings related to Methylobacterium ISO08/ NLS0069 (NRRL B-50936) and/or ISO13/ NLS0037 (NRRL B-50941) applied to corn.
Application No. 18749915: See claims 41, 52, 54 for teachings related to Methylobacterium ISO08/ NLS0069 (NRRL B-50936) and/or ISO13/ NLS0037 (NRRL B-50941) applied to corn.
Application No. 18892863: See claims 1, 5, 47 for teachings related to Methylobacterium ISO08/ NLS0069 (NRRL B-50936) and/or ISO13/ NLS0037 (NRRL B-50941) applied to corn.
Application No. 19031502: See claims 41, 52, 54 for teachings related to Methylobacterium ISO08/ NLS0069 (NRRL B-50936) and/or ISO13/ NLS0037 (NRRL B-50941) applied to corn.
Application No. 19031518: See claims 1, 23 for teachings related to Methylobacterium ISO08/ NLS0069 (NRRL B-50936) and/or ISO13/ NLS0037 (NRRL B-50941) applied to corn.
Application No. 19269892: See claim 12 for teachings related to Methylobacterium ISO08/ NLS0069 (NRRL B-50936) and/or ISO13/ NLS0037 (NRRL B-50941) applied to corn.
Application No. 19299056: See claims 44, 47, 52 for teachings related to Methylobacterium ISO08/ NLS0069 (NRRL B-50936) applied to corn.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/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, Dan Kolker can be reached at (571) 272-3181. 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.
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
Prosecution Insights