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 .
Election / Restrictions
In response to previous restriction requirement, applicant has chosen to elect Group II for examination, consisting of claims 21-23, 25, 28-31 & 33-34, with traverse.
Claim Status
Claims 21, 23, 25, 28 & 33 are under examination on the merits.
Claims 2, 4, 6, 9-10, 12, 14-16, 18-20, 22, 24, 26-27, 29-32, 34-36 are cancelled.
Claims 1, 3, 5, 7-8, 11, 13, 17 & 37-46 are withdrawn from examination.
Priority
Claims 21, 23, 25, 28 & 33 receive the U.S. effective filing date of 08/04/2020
Previous rejection of claims 21-23, 25, 28-31 & 33-34 under 35 U.S.C. 112(a), for lacking enablement for ‘any and all plants’, is withdrawn due to Applicant’s amendment to the claims.
Previous rejection of claim 30 under 35 U.S.C. 112(b) as being indefinite, is withdrawn due to Applicant’s cancellation of the claim.
Previous rejection of claim 31 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement, is withdrawn due to Applicant’s cancellation of the claim. Previous rejection of claims 21-23, 25, 28-30 & 33-34 under 35 U.S.C. 101 is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 21-23, 25, 29-30 & 34 under 35 U.S.C. 102(a)(1) as being anticipated is withdrawn in view of Applicant’s amendment to the claims.
Claim Rejections – Nonstatutory 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 non-statutory 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 non-statutory 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 21, 23, 25, 28 & 33 are rejected on the ground of non-statutory double patenting as being unpatentable over Applicant’s previously issued U.S. Patent No.11565979 (‘979 patent).
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 23 Oct 2025, as previously applied to claims 21-23, 25, 28-31 & 33-34. Applicant's arguments filed 22 Jan 2026 have been fully considered but they are not persuasive.
Applicant’s previously issued ‘979 patent claims methods inherent to the claims of the instant application. Claim 1 of the ‘979 patent recites a method of reducing nitrogen fertilizer requirements for plants using “genetically engineered bacteria that fix atmospheric nitrogen”. The specification of the ‘979 patent discloses Klebsiella variicola ‘137-1036’ as a genetically engineered bacteria used in this manner [see col.11, ¶1; col.45, ¶1; col.49, Table A].
The instant application recites a method of reducing in-plant nitrogen variability using “remodeled Klebsiella” which are genetically engineered and fix atmospheric nitrogen (N). A plant associated with N-fixing microbes & having less variation in N level, would inherently require less N fertilizer to meet its nutrient needs. In the ‘979 patent, Applicant refers to genetically engineered Klebsiella variicola whereas in the instant application Applicant now calls these ‘remodeled’ Klebsiella variicola.
Regarding independent claim 21 of the instant application; this includes limitations of (i) a group of corn plants with reduced variation in whole plant nitrogen which are treated with genetically engineered Klebsiella variicola wherein (ii) the Klebsiella supplies nitrogen and plants (iii) are grown in a field with sandy soil (i.e. an ‘agricultural locus’ that is ‘agriculturally challenging’).
The ‘979 patent discloses increasing nitrogen fixation in plants by treating them with nitrogen-providing, genetically engineered bacteria [col.39, l.38-67] including Klebsiella variicola [col.45, l.1-8] and their application to corn [col.57, l.65-67—col.58, l.1-26]. The ‘979 patent describes application of their genetically engineered nitrogen-fixing microbes in diverse soil types representative of fields including nitrogen limiting environments [col.129, l.8-15] and application in ‘nitrogen stressed environments’ (i.e. ‘agriculturally challenging’ fields) [col.131, l.11-30].
Regarding dependent claims 23, 25 & 28 these are all drawn to phenotypes of the “plurality of corn plants” combined with associated N-fixing microbes. By necessity, this requires equivalent limitations as those claimed in Applicant’s previously issued patent.
Regarding dependent claim 33 of the instant application; it limits to N-fixing microbes that function in the presence of exogenous N. The ‘979 patent, under claim 1(c), limits to the use of the genetically engineered bacteria in the context of “applying a nitrogen-containing fertilizer” (i.e. exogenous N).
Thus, the issued patent and instant application have equivalent limitations. The only difference is in the instant application using slightly different terminology to claim an alternate, but inherent, outcome of the use of N-fixing microbes (i.e. ‘reduced variation in whole plant N’). The methods previously patented by Applicant, utilizing genetically engineered N-fixing Klebsiella variicola in crop production would inherently include characteristics recited as limitations in the instant application’s claim set.
It would be obvious to one skilled in the art that the methods outlined in the previously granted patent includes the limitations set forth in the instant application. It would also be obvious that the system of the previously issued patent could be restated using slightly different language to describe the same invention, albeit in terms of plant response rather than fertilizer application process.
One would be motivated to make such claims to the same invention from perspective of the plant response rather than aspects of fertilizer application per se, to replicate the system and benefits outlined the previously issued patent. Such an approach clearly would represent an obvious, non-inventive duplication of a previously issued patent and potentially, if granted, improperly extend patent rights of Applicant.
Because of this, claims 21, 23, 25, 28 & 33 are rejected as a non-statutory double patenting rejection.
Response to Arguments
Applicant urges that previous rejection under non-statutory double patenting is improper for the following reasons:
a. The office has not established all claim limitations of the instant application in the ‘979 patent [Remarks, p.15, ¶5], and,
b. presence of unexpected results [p.16, ¶1].
This is not found persuasive with respect to (a) because Applicant’s arguments are directed to the ‘979 patent as lacking (i) a ‘remodeled’ Klebsiella [Remarks, p.15, ¶5, l.2] in (ii) an ‘agriculturally challenging’ field [Remarks, p.15, ¶5, l.4] and (iii) having an effect on whole plant nitrogen [Remarks, p.15, ¶5, l.3].
The ‘979 patent clearly makes obvious the potential to use a genetically engineered Klebsiella for improved nitrogen fixation in claim 1. It also describes application of this genetically engineered (i.e. ‘remodeled’) microbe in nitrogen limiting or nitrogen stressed environments [col.129, l.8-15; col.131, l.11-30]. To one skilled in the art, this would obviously include fields that are not optimal due to high sand content or nitrogen leaching issues (i.e. nitrogen stressed environments). The primary inventive claims of the ‘979 patent are explicitly directed to effects that genetically engineered microbes, including K. variicola, can have on whole plant nitrogen. The effect on whole plant nitrogen (i.e. it is improved) is why use of the microbe would presumably lower the need for exogenous nitrogen application [see claim 1 of ‘979 patent].
Applicant’s arguments are not found persuasive with respect to (b) because Applicant points to data provided in their specification as evidence of ‘unexpected results’ including (iv) consistency in phenotypic effects despite environmental variability [Remarks, p.16, ¶2, l.1-2], (v) the microbes thrived in all evaluated locations [p.16, ¶2, l.3], and (vi) microbial treatment was effective at increasing corn yield [p.16, ¶2, l.5-6]. Such arguments rely on the objective results of the data presented.
However, Applicant has not responded to previous 112a rejection with respect to possession and inconsistencies in data provided by their written description [see p.17, ¶2 in Office action mailed 23 Oct 2025]. As such, the consistency or effects of microbial treatment using remodeled K. variicola and thus any claim to their representation of ‘unexpected results’ based on such data remain unsupported.
Claim Rejections - 35 USC § 112
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 21, 23, 25, 28 & 33 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.
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 23 Oct 2025, as previously applied to claims 30. Applicant's arguments filed 22 Jan 2026 have been fully considered but they are not persuasive.
Claim 21 is drawn to corn plants being grown at an “agricultural locus” (i.e. a field site) which has soil which is “agriculturally challenging”. Applicant has amended claim to recite that ‘challenging’ includes soils which are (a) more than 50% sand content, (b) less than 20% clay, (c) less than 30% silt, or (d) have pH in the range of 5-8 relative to ‘control soil’. Applicant does not specify what constitutes a ‘control soil’.
While one skilled in the art would generally recognize (a) as a challenging soil for nitrogen management due to leaching caused by higher sand content, it remains unclear how one would understand the scope of the claims provided situations (b), (c) or (d). Collectively, these appear to encompass soils within typical pH ranges and that would not be considered ‘challenging’ [see list of soil classifications, p.4—5 in ‘Guide to Describing Soil Profiles’, University of Michigan; Published 2003].
This is because definition (d) of soil pH range of 5-8 encompasses soils of neutral pH (i.e. pH 7, not overly basic or acidic). Again, Applicant’s recited definition includes a wide range of soils based on pH value, and includes those generally regarded as high productivity for corn growing. As an example, it is unclear if one growing corn in a heavy clay loam field (i.e. <30% silt) with a pH of 7.5 would be considered by Applicant to be growing in ‘an agriculturally challenging locus’ and potentially infringing based on Applicant’s definition.
Thus, the claim language which encompasses ‘normal’ pH values, does not provide any informative limitations as to how one would determine the metes and bounds of Applicant’s claim, or how to avoid infringing.
Because all claims under examination include the newly amended ‘agriculturally challenging’ soil limitation of claim 21 which is indefinite, all claims are rejected.
Response to Arguments
Applicant urges that 112b rejection of claims due to indefiniteness surrounding soil as ‘agriculturally challenging’ is overcome by amendments reciting optional soil texture profiles or pH values [Remarks, p.12, ¶4].
This is not found persuasive because the newly amended claim language potentially encompasses regular, agriculturally productive soils suitable for corn production based on pH range, as described in the modified rejection above. As such, Applicant’s response that their amended language clarifies the indefiniteness of scope introduced by ‘agriculturally challenging soils’ is unconvincing.
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 21, 23, 25, 28 & 33 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 written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 23 Oct 2025, as previously applied to claim 30. Applicant's arguments filed 22 Jan 2026 have been fully considered but they are not persuasive.
Independent claim 21 is drawn to an improvement (i.e. reduced variation) in whole plant nitrogen availability in corn via genetically engineered (i.e. ‘remodeled’) Klebsiella variicola. All other claims depend from 21.
Applicant’s specification describes two groups of plants, the first consisting of plants treated with N-fixing microbes and the second consisting of a control not treated with said microbes. The distinguishing limitation is that the first group displays “reduced variation in whole plant nitrogen” compared to the second control group, at a particular time point (i.e. ‘given growth stage’) in a particular field (i.e. ‘in an agricultural locus’).
Several examples of field data are provided, including descriptions of a ‘strip trial’ field experiment where aerial imaging and harvest yield were used to ascertain differences between microbe-treated and untreated control groups (Example 5). Klebsiella ‘137-1036’ was used for treatment in this experiment. No N sampling was performed on plants.
Yield data shows the untreated control had a higher yield than the ‘137-1036’ treated group. Yield data provides no indication of statistical significance with regards to the lower standard deviation reported [Table 7].
Figure 17 is provided to show the aerial imagery, which measured NDVI at a single time point 1.5 months after planting. No indication is given of the growth stage of the corn at the time of measurement, pest or weather conditions that season, or other variables that Applicant admits influence corn N/yield relationship [Specification, ¶99].
Referring to figure 17, two images are provided with the microbe-treated group outlined in rectangular strips. Two things are immediately noticeable, (1) the ‘Hybrid Map’ indicates differences in corn hybrid (i.e. cultivar or genotype) utilized for treatment vs control, and (2) the difference in relative area between the treatment and control groups (i.e. unequal sampling).
Notably, the ‘control’ areas appear to be significantly larger and would therefore reasonably encompass a greater range of variation in soil type, slope or other factors. The ‘control’ areas also appear to consist of multiple hybrids different from the treatment. There is no indication that Applicant’s example equally compared the same background genotype (hybrid/cultivar) utilizing equivalent sample sizes or plot formats, nor utilized any sort of blocking to account for naturally expected spatial variation in the field(s) examined. No soil maps or drainage/tile indicators are provided to clarify the extent of variation potentially introduced through the lack of experimental blocking when comparing these groups.
Use of multiple background genotypes in the control group, and lack of experimental blocking would suggest to one skilled in the art that any increased variance reported in the control is potentially due to those variables rather than the microbial treatment. Furthermore, data presented seems to indicate the untreated control potentially had higher yield than plants treated with the ‘137-1036’ strain.
Regarding Example 6; it describes a multi-location trial examining efficacy of the microbe treatment in 47 different environments. Applicant states treatment consisted of ‘remodeled microbes’ but does not indicate strains tested. Applicant does not indicate if these trials include the remodeled ‘137-1036’ strain from Example 5, or the wild type ‘KV137’ strain from field trials presented in Examples 9-11.
Once again, no nitrogen sampling was performed on plants, and only traditional harvest yield appears to have been recorded. No indication is given whether these environments were examined in a single season, or over the course of several years to account for year-to-year environmental variation in yield. While applicant focuses on discussing the impact of sandy soils and nitrate leaching/loss, they only provide data for 5 of the 47 locations assessed (approximately 89% omitted data). They do not provide description of the majority of their locations with individual site yield data. Applicant simply states that for the other 42 experimental sites “application of the microbes exhibited a ~7.7 bushel per acre advantage” [¶349].
Notably, increased yield is not recited in the claims. Claims include limitations of ‘reduced variation in whole plant nitrogen’, but this trait is not characterized in Example 6 or its associated yield trial data tables.
The data provided for ‘challenging locations’ in Table 8 would reasonably indicate information on other field sites was collected by Applicant. It is unclear why such data representing ‘non-challenging’ locations would have been omitted. It is unclear why the identity of strains used as treatments is also omitted.
Applicant states the increased yields seen in sandy soils is “surprising and unexpected” [¶349] despite the fact that it is well known, and admitted by Applicant, that sandy soils are more prone to leaching/loss of N fertilizers. This logically suggests non-chemical sources of N would display a larger impact on yield at such leaching-prone sites because non-chemical treatments would not leach compared to controls (i.e. leachable fertilizer). The default expectation would be that non-chemical, leaching resistant sources of N would have greater impact and consistency than chemical fertilizers in such leaching-prone, sandy soils. Further, given the omission of data on ‘non-challenging’ locations, it is not possible to draw conclusions on whether results would be considered surprising or unexpected.
Given the limited written description, no inferences can be made as to whether the treatment was causative of yield or N variation between the observed groups provided in Example 6.
Moving to Figure 24, we see several examples where the microbe-treated group had increased variation in yield. Only 64% of reported farms had less variability in yield, and there is no data regarding moisture availability, soil characteristics, and/or pests. Applicant acknowledges such variables impact yield, yet is silent as to these factors in their experiment. If yield is intended to act as a proxy for ‘reduced nitrogen variability’ then Applicant appears to be presenting examples where microbial treatment increased yield variation (i.e. presumably increased nitrogen variation).
One reading the written description provide would be uncertain as to whether the reported results are simply the random outcome of factors other than microbial treatement, choice of control comparisons presented, or, potentially, sampling methods.
Claims recite phenotypic outcomes of Klebsiella treated plants as limitations. Reasonably demonstrating that the recited phenotypic outcome (i.e. reduced variation in whole plant nitrogen) is predictably the result of using remodeled Klebsiella (i.e. treatment) and not merely an uncontrolled outcome attributed to other variables (i.e. experimental error) is necessary.
The written description provided does not adequately support such a claim, and it is not clear that Applicant is in possession of such an invention. Their specification only provides description of field observations that may be attributable to a number of factors plants encounter through a given growing season, or are the result wild-type strains of Klebsiella which are not genetically engineered. This ultimately weighs against their claim to be in possession of the invention.
Response to Arguments
Applicant urges previous rejection of claims under 35 U.S.C. 112(a) for lack of possession is improper because of data presented by Examples 5-7 & 9-10 which provide (a) evidence of nitrogen variance reduction via NDVI measures, (b) descriptions of reduced yield variability which can be reflective of nitrogen, (c) treatments with ‘ProveN’ which may also explain observed yields, (d) reduced standard deviation in yield from a large portion of field trials, and (e) examples of ‘several different strains’ of Klebsiella strain ‘137-1036’ as demonstrative of improved nitrogen fixation.
Applicant argues Examples 9 & 10 describe ‘corn plants treated with ProveN, which is Klebsiella variicola strain 137-1036’ [Remarks, p.14, ¶1, l.9-12].
Arguments not found persuasive because:
Regarding (a) & (b); Applicant has not addressed previously raised issues regarding experimental design in the NDVI/yield trial study, and restated above [see p.11, ¶6—p.12, ¶3] Applicant merely restates the previously described results from their specification.
Regarding (c); arguments are made that data represents treatment with strain ‘137-1036’. Applicant states in arguments that the commercial product ProveN is Klebsiella strain ‘137-1036’ [Remarks, p.14, ¶1, l.9-12].
This contradicts Applicant’s specification that indicates wild type Klebsiella strain ‘KV137’ is the commercial product ProveN [¶372; p.105, Table 6, Strain ID 137 = Wild type Klebsiella variicola strain].
Absent further clarification, the earlier disclosure that ProveN is wild type Klebsiella, ‘KV137’ is being used for examination purposes.
Examples 9-11 present data wherein treatment consists of strain ‘KV137’ [Example 9, ¶368; Example 10, ¶382, l.20-21; Example 11, ¶386, l.10-12]. The strain ‘KV137’ is wild-type Klebsiella, which is a product of nature and is not genetically engineered or modified. Thus, it appears wild type, non-genetically engineered Klebsiella is responsible for the field observations being presented and argued as improving nitrogen or yield in corn via the product ‘ProveN’.
Thus, Applicant’s examples do not actually test or provide written description of genetically engineered or ‘remodeled’ K. variicola – they provide information on the naturally occurring strain ‘KV137’ which is outside the scope of the amended claim limitations.
Further, Applicant has not addressed previously raised issues regarding Examples 9 & 11, specifically their own statements that observed results were not statistically significant [Specification, Example 9, p.123, ¶368; Example 11, p.129, ¶387]. They have not addressed the contradictory data presented in Table 15 which appears to indicate their seed treatment can potentially increase nitrogen variance depending on environment or growth stage. Applicant does not clarify under which specific conditions their claims are supported.
Regarding (d); Applicant argues that a ‘large portion of field trials’ have reduced standard deviation based on Example 6 but does not address the previously raised issue that only 5 out of 47 locations are presented, restated above [see p.13, ¶2].
Regarding (e); Applicant’s arguments refer to ‘Example 7’ which is a list of different Klebsiella strains having different engineered mutations. Presumably the argument is that engineering specific strain variants proves possession of the claimed invention.
However, Applicant’s claims do not recite a microbe; they are drawn to phenotypic response in corn plants, in corn fields.
It is unclear how production of ‘several different strains’, or potentially variants, of the specific Klebsiella strain ‘137-1036’ relate to prior possesion rejections. This is because Applicant’s field experiments utilize the specific genotype/strain of ‘KV137’ or ‘137-1036’ as the relevant microbial treatment. The existence of, or possession of, other Klebsiella strains is interesting but not relevant to field trial results which are strain-specific. While it is possible to generate many variants of a microbe in a laboratory setting, this alone does not support that any particular strain produced would have a functional effect in associated corn plants, in a non-laboratory setting. For reasons stated above, it is not clear from the written description provided that any remodeled Klebsiella strain, including ‘137-1036’, predictably results in ‘reduced variation in whole plant nitrogen’ in field settings.
Collectively, Applicant’s arguments are not persuasive in addressing the various technical issues and questions surrounding their data. They do not currently provide sufficient description of the claimed invention to support that the inventor is in possession of the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 21, 23, 25, 28 & 33 are rejected under 35 U.S.C. 103 as being unpatentable over Van Deynze [PLoS Biol 16(8):1-21; Published 17 Aug 2018] in view of Temme [U.S. Patent Application Publication US2019/0144352; Published 16 May 2019].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 23 Oct 2025, as previously applied to claim 31. Applicant's arguments filed 22 Jan 2026 have been fully considered but they are not persuasive.
Claims are drawn to a group of corn plants with reduced variation in whole plant nitrogen which are treated with genetically engineered Klebsiella variicola grown in a field prone to nitrogen stress (i.e. an ‘agricultural locus’ that is ‘agriculturally challenging’).
Van Deynze teaches populations of maize (i.e. ‘plurality of crop plants’) associated with N-fixing bacteria which obtain from 29-82% of their N from the atmosphere (i.e. >15% reduction in variable requirement). They teach that traditional ‘landraces’ of maize from Mexico, specifically forms from the Sirre Mixe region of Oaxaca, Mexico, produce various structures (aerial roots and root mucilage) that support communities of such microbes [p.1, ‘Abstract’].
An explicitly stated goal of their research was to determine if the association between Sirre Mixe maize and various N-fixing microbes could “fulfill, at least in part, the reduced [exogenous] nitrogen requirements of Sierra Mixe maize under field conditions” [p.8, ‘Nitrogen fixation contributes to maize N nutrition’]. Van Deynze teaches that Klebsiella are one such genus of microbes associated with nitrogen fixation in cereals [p.2, ¶2].
Van Deynze does not teach genetic engineering of such microbes for improved nitrogen fixation or fluctuation in corn.
Temme teaches increasing nitrogen fixation in plants by treating them with nitrogen-providing, genetically engineered bacteria [col.39, l.38-67] including Klebsiella variicola [col.45, l.1-8] and their application to corn [col.57, l.65-67—col.58, l.1-26]. The patent application filing describes use of their genetically engineered nitrogen-fixing microbes with corn in diverse soil types representative of fields including nitrogen limiting environments [col.129, l.8-15] and application in ‘nitrogen stressed environments’ (i.e. ‘agriculturally challenging’ fields) [col.131, l.11-30].
At the time of filing, it would have been obvious to one of skill in the art to combine the known N-fixing microbes associated with maize, including Klebsiella as taught by Van Deynze, with techniques of genetically engineering them to improve rates of N-fixation, as taught by Temme. Temme clearly outlines the use of genetic modification to target nitrogen fixation characteristics in K. variicola and teaches all relevant aspects of utilizing such microbes as seed treatment or inoculant.
One would be motivated to combine these disclosures in order to produce a corn production system with greater N production rate than that described in the naturally occurring systems reported in Mexico. One would do so with the genetically engineered (i.e. ‘remodeled’) Klebsiella disclosed by Temme.
Regarding claims 21, 28 & 33; the report of Van Deynze describes a comparison of N content of Sirre Mixe maize (i.e. ‘a plurality of crop plants…in association with a plurality of N fixing microbes’) grown alongside (i.e. ‘in an agricultural locus’) plant families with no known N-fixing members (i.e. ‘a control plurality of crop plants’). They describe a continuous uptake of N provided by the N-fixing microbes, in absence of addition of exogenous fertilizer [p.8, Table 1]. More continuous uptake of nitrogen would reasonably result in less fluctuation (i.e. variation) in N level. Temme describes genetically engineered K. variicola which are also used to improve nitrogen availability in corn plants [col.57, l.65-67—col.58, l.1-26].
Regarding claims 23 & 25 directed to developmental stages of maize; Van Deynze discloses maize populations (i.e. a cereal crop) grown in N-starved soils (i.e. ‘agriculturally challenging’) associated with naturally occurring (i.e. ‘wild type’) N-fixing microbes, across developmental stages from 2nd – 6th months of growth (i.e. between both V1-V9 stages and between R1-R6 stages).
At the time of filing, it would have been obvious that genetically engineered microbes including the Klebsiella taught by Temme could potentially provide higher rates of nitrogen fixation and consequently reduce the amount of exogenous N fertilizer required for maize production. If validated, such reductions would have clear economic and environmental benefits to a farmer.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 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, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
Request for Information under 37 CFR § 1.105
Applicant and the assignee of this application are required under 37 CFR § 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application.
This request is being made for the following reasons:
Applicant’s amended claims are now drawn to a remodeled Klebsiella variicola strain. Applicant’s remarks and specification indicate that the commercial product ‘ProveN’, which is a microbial product comprising nitrogen-fixing Klebsiella variicola, is critical to examination of the instant application. The requested information is required to make a meaningful and complete search of the prior art.
In response to this requirement, please provide answers to each of the following interrogatories eliciting factual information:
(i) What Klebsiella strain or strains comprise the product ‘ProveN’ presented as the microbial treatment in the examples provided?
(ii) At or before the time of filing of the instant application or any provisional application to which benefit is claimed, had said ‘ProveN’ microbial product been disclosed, made publicly available, or offered for commercial sale? If so, under what designation/denomination and under what conditions were the K. variicola strain(s) comprising ‘ProveN’ disclosed, made publicly available, or sold and from when to when? Provide any publications that reference ProveN or the strains that makeup ProveN.
If Applicant views any or all of the above requested information as a Trade Secret, then Applicant should follow the guidance of MPEP § 724.02 when submitting the requested information.
If any part of the response is marked DO NOT SCAN or TRADE SECRET, Applicant is reminded that a cover letter, not so marked, is to be included.
In responding to those requirements that require copies of documents, where the document is a bound text or a single article over 50 pages, the requirement may be met by providing copies of those pages that provide the particular subject matter indicated in the requirement, or where such subject matter is not indicated, the subject matter found in applicant' s disclosure. Please indicate where the relevant information can be found.
The fee and certification requirements of 37 CFR § 1.97 are waived for those documents submitted in reply to this requirement. This waiver extends only to those documents within the scope of this requirement under 37 CFR § 1.105 that are included in the applicant' s first complete communication responding to this requirement. Any supplemental replies subsequent to the first communication responding to this requirement and any information disclosures beyond the scope of this requirement under 37 CFR § 1.105 are subject to the fee and certification requirements of 37 CFR § 1.97.
The applicant is reminded that the reply to this requirement must be made with candor and good faith under 37 CFR § 1.56. Where the applicant does not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item.
This requirement is an attachment of the enclosed Office action. A complete reply to the enclosed Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the enclosed Office action.
/Amjad Abraham/ SPE, Art Unit 1663
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