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 .
Claim Status
The amended claim set filed 27 July 2026 is acknowledged. Claims 1, 4, 7, 11, 13, 16-17, 22-24, 31-32, 39, 41, 44, 46-47, 49, and 51-52 are currently pending. Of those, claims 1, 32, 39, 41, 44 are currently amended, and claims 51-52 are new. Claims 11, 13, 16-17, 22-23, 31, 39, 41, 44, and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2-3, 5-6, 8-10, 12, 14-15, 18-21, 25-30, 33-38, 40, 42-43, 45, 48, and 50 are cancelled. Claims 1, 4, 7, 24, 32, 46-47, and 51-52 will be examined on the merits herein.
Claim 24 is listed as “withdrawn” but is part of the elected invention & will be examined in this action. The Office has not required restriction of the subject matter of claim 24. Applicant is reminded that MPEP 804.01 states “The 35 U.S.C. 121 prohibition applies only where the Office has made a requirement for restriction. The prohibition does not apply where the divisional application was voluntarily filed by the applicant and not in response to an Office requirement for restriction.”
Response to Arguments
The Applicants’ arguments filed 27 July 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 29 April 2026 will be referred to as “NFOA.”
Objection(s) and Rejection(s) Withdrawn
The objection to the specification (NFOA par. 6) is withdrawn in view of the amended specification.
The rejection of claims 1, 4-7 and 46-47 under 35 U.S.C. 112(b) related to the term “reducing” (NFOA par. 8-9) is withdrawn in view of the claim amendments and arguments.
The rejection of claims 1-2, 4-7, 32, and 46-47 under 112(a) relating to the deposit of the strains NLS0210 and NLS0617 (NFOA par. 25-29) is withdrawn in view of the claim amendments, but see the maintained rejection below for claim 24.
Objection(s) and Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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Claim 24 is objected to because of the following informalities: the claim is incomplete because it depends from a withdrawn claim that is not under examination.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.
Response to Arguments
Applicant requests (Remarks pg. 7) that claim 24 be withdrawn.
This argument has been carefully considered but is not found persuasive. As discussed above (par. 3), claim 24 is part of the invention under examination. It is suggested that applicant either copy the text from claim 39 into claim 24 so that the claim can be interpreted on its own, or that applicant cancel claim 24 if they would prefer that the subject matter not be examined.
Claim Rejections - 35 USC § 112(a)
Claims 1, 4, 7, 24, 32, 46-47 remain rejected and claims 51-52 are newly 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) and IS008 (NRRL B-50936) 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 NLS0210 and NLS0617, and an agriculturally acceptable adjuvant and/or 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, and ISO08; 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 or NLS0617 (claim 24) or ISO13 or 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, 4, 7, 24, 32, 46-47 and 51-52 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, for failing to meet the enablement requirement.
Response to Arguments
Applicant argues (Remarks pg. 8) that “Example 1 demonstrates lower lodging following application at the R1 stage for both IS008 and ISO 13 relative to the untreated check. The specification therefore supports the claimed reduction for each claimed strain.”
This argument has been carefully considered but is not found persuasive. It is unclear where in Example 1 applicant is referring to. The specification at [0079] states “There were no isolates that showed a reduction in lodging vs the check at the R1 application stage” in relation to the data in Table 4, which include both ISO08 and ISO13. Specifically, Table 4 shows that the effect size observed cannot be differentiated from chance variation that would be expected if the treatment has no effect at all (note the high P values in the final column).
Applicant further argues (Remarks pg. 8) that “The specification identifies ISO 13 and ISO8, provides their NRRL accession numbers, and describes suitable compositions, titers, application methods, growth conditions, and objective measures of reduced CRW damage. The claims are limited to these identified strains and do not require further screening to identify an operative strain. A skilled artisan can therefore practice the claimed methods without undue experimentation. Paragraphs [0065]-[0067] also describe treatment of corn seed before planting; a separate example for each disclosed application method is not required.”
This argument has been carefully considered but is not found persuasive. The examiner agrees that the claims are limited to the identified strains, but disagrees that they are “an operative strain” for the reasons addressed above. The examiner agrees that treatment of seeds/plants can be performed without undue experimentation in view of the teachings of the specification (assuming the strains themselves can be obtained, see the deposit rejection for two of the claimed strains below); however, this rejection relates to whether the claimed method has the claimed effects.
Claim 24 remains 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 24 and 39). 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).
Response to Arguments
Applicant requests (Remarks pg. 8) that claim 24 be withdrawn, so the issue is moot.
This argument has been carefully considered but is not found persuasive. As discussed above (par. 3), claim 24 is part of the invention under examination. It is suggested that applicant cancel claim 24 if they would prefer that the subject matter not be examined.
New Rejection(s)
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 51-52 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “imbibing” in claim 51, from which claim 52 depends, is used by the claim to mean applying a treatment to a plant in some undisclosed manner, while the accepted meaning is “to drink.” (see Cambridge Dictionary screenshot saved by Wayback Machine 3 May 2022; PTO-892). It is self-evident that a corn plant part or corn seed cannot be drunk because they are not liquids. The term is indefinite because the specification does not clearly redefine the term.
Conclusion
No claims are allowed.
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 AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-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, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMELIA N DICKENS
Examiner
Art Unit 1645
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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