DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Amendments to the Claims and Arguments/Remarks filed 27 July 2026, in response to the Office Correspondence dated 25 March 2026, are acknowledged.
The listing of Claims filed 27 July 2026, have been examined. Claims 1-6, 8, 11-20, 22, and 24-31 are pending. Claims 1, 8, 15, 16, 18, 22, 24, and 27 have been amended, claims 7, 9, 10, 21, and 23 have been canceled, and no new claims have been added.
Response to Amendment
The applicant states that the amended storage limitations are supported by the originally-filed disclosure. That position is accepted for purposes of the present amendment. The application originally recited the relevant high initial viable-cell concentration and 26-week post-storage viable-cell concentration in its claim set, and the specification further describes nonaqueous Methylobacterium formulations stored at room temperature and reports formulations stable for up to one year with titer loss of one log or less.
As amended, independent claims 1 and 18 now expressly require a Methylobacterium concentration of at least about 1×10^8 CFU/g of composition and retention of at least about 1×10^7 CFU/g after storage for 26 weeks at room temperature.
The applicant argues principally that Mbarga’s storage data concern fungal Trichoderma asperellum conidia rather than vegetative Methylobacterium cells; that Clary does not provide a working example demonstrating 26-week storage of Methylobacterium, and that Clary itself recognizes microbial viability as dependent upon the identity and inherent stability of the microorganism and the storage conditions. The applicant therefore contends that the prior rejection improperly assumes that substitution of Methylobacterium into Mbarga’s oil dispersion necessarily produces the presently claimed long-term viable-cell concentration.
The applicant’s arguments are persuasive to the limited extent that the prior rejection should not rely upon inherency or upon the storage behavior of Mbarga’s fungal conidia, standing alone, to establish that a Methylobacterium formulation necessarily retains at least 1×10^7 CFU/g after 26 weeks at room temperature. The record does not establish such inevitability.
The applicant’s arguments do not, however, establish patentability because the relevant inquiry under 35 U.S.C. §103 is not whether Mbarga alone proves the claimed result or whether success was certain. The proper inquiry is whether the combined teachings would have provided a person of ordinary skill with a reason to make the claimed composition and a reasonable expectation of obtaining the claimed result (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417–18 (2007); MPEP §§2141, 2143 and 2143.02). Reasonable expectation of success does not require absolute predictability or a guarantee of success, but it does require an evidentiary basis for expecting the proposed modification to work for its intended purpose.
For the reasons below, the rejection is reformulated to rely not merely upon Mbarga’s fungal viability results, but upon the combined teachings of Mbarga, Clary, and Allen and Bogosian (US20160073641A1; published 17 March 2016), which together provide the formulation architecture, an express teaching to formulate vegetative bacteria including Methylobacterium in nonaqueous/oil carriers with extended viable-count targets, and Methylobacterium-specific evidence of prolonged room-temperature survival. To the extent necessary to establish the established character of Tensiofix 869, Harris et al. (AU2015101156A4; published 24 August 2015), is cited as corroborating evidence that Tensiofix 869 was known as an oleophilic clay used in oil-dispersion formulations.
In addition, the amendments to the claims introduce new issues necessitating a new 35 USC § 112(b) rejection, detailed below. The examiner makes note that claim 1 redundantly employ both the percent symbol and the word “percent”, wherein each should use either “%” or “percent,” but not both, and in claim 15 “homogenously dispersed” should be “homogeneously dispersed”.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 25 March 2026, as the applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
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 Applicant regards as his invention.
Claims 18-20, 22, and 24-26 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, regards as the invention.
In claim 18, step ii introduces “a dried Methylobacterium inoculant composition,” whereas step iii subsequently refers to “said dried Methylobacterium inoculant.” Although the intended referent appears reasonably understandable, the terminology should be made consistent, preferably by reciting “said dried Methylobacterium inoculant composition” in step iii. However, more importantly, a claim is indefinite where “said” or “the” refers to more than one previously recited element such that it is uncertain which element is intended (MPEP §2173.05(e)). Thus, in claim 18, the identity of “said Methylobacterium inoculant composition” and “said composition” is ambigious.
Claim 18 recites in its preamble a stable liquid Methylobacterium inoculant composition and subsequently introduces, as a distinct material in step ii: a dried Methylobacterium inoculant composition. Thus, the claim therefore expressly establishes at least two separate Methylobacterium inoculant compositions, the stable liquid product that the claimed method is directed to making, and the dried inoculant composition that is incorporated into the liquid formulation.
The last limitation then recites, in substance, that “said Methylobacterium inoculant composition” has an initial concentration of at least about 1×10^8 CFU/g and a concentration of at least about 1×10^7 CFU/g following storage for 26 weeks at room temperature. Because two different Methylobacterium inoculant compositions have already been positively recited, it is unclear whether the required viable-cell concentrations apply to the dried inoculant composition before incorporation, the resulting stable liquid inoculant composition, or potentially both compositions.
The ambiguity is compounded by the subsequent phrase “per gm of said composition.” Claim 18 has previously recited at least a “liquid composition,” a “dried Methylobacterium inoculant composition,” and the resulting “stable liquid Methylobacterium inoculant composition.” The generic expression “said composition” therefore does not uniquely identify which composition supplies the denominator for the claimed CFU/g values.
The alternative constructions impose materially different limitations. A dried inoculant powder could possess a substantially different CFU/g value from the final liquid product after dilution into solvent, rheology modifier, and emulsifier. Likewise, the 26-week storage requirement has a materially different scope depending upon whether the dried starting material or the final liquid product must retain the recited viable-cell titer. Accordingly, one of ordinary skill cannot determine with reasonable certainty which claimed composition is required to possess the initial and 26-week viable-cell concentrations. Thus, claim 18 fails to particularly point out and distinctly claim the subject matter regarded as the invention. Claims 19, 20, 22, 24, 25, and 26 depend directly or indirectly from claim 18 and do not cure the ambiguity and thus are included in the rejection for the same reason.
The defect may be corrected, for example, by consistently identifying the final product as the “stable liquid Methylobacterium inoculant composition” and reciting, for example, “wherein said stable liquid Methylobacterium inoculant composition comprises Methylobacterium at a concentration of at least about 1×10^8 CFU per gram of said stable liquid Methylobacterium inoculant composition, and retains Methylobacterium at a concentration of at least about 1×10^7 CFU per gram of said stable liquid Methylobacterium inoculant composition following storage for 26 weeks at room temperature.”
In addition, claim 18 also repeatedly characterizes the resulting product as a “stable liquid Methylobacterium inoculant composition.” The specification uses stability in more than one sense. It separately discusses physical stability, such as settling or suspension behavior, and biological stability measured by retained viable-cell titer. For example, the disclosed compositions are evaluated for settling and separately for CFU retention during accelerated storage.
Accordingly, if the term “stable” is intended to impose a limitation in addition to the expressly recited ≥1×10^7 CFU/g after 26 weeks, the claim does not identify whether “stable” means physical suspension stability, emulsion stability, biological/titer stability, or some combination thereof, nor does it provide an objective claim boundary for the additional characteristic.
To the extent “stable” is intended to require a property separate from and additional to the expressly recited viable-cell retention requirement, claim 18 is additionally indefinite because the claim does not provide an objective standard for determining when a composition is “stable.” If the applicant confirms by amendment, for example, that “stable” merely characterizes the expressly recited 26-week viable-cell-retention endpoint and does not impose a separate physical-stability limitation, the §112(b) rejection of the word “stable” would no longer apply.
Here, claim 16 reasonably identifies the nonaqueous composition of claim 1 as one component of a larger emulsion containing an aqueous phase. The specification likewise expressly describes emulsions formed from the nonaqueous Methylobacterium liquid dispersion and an aqueous continuous phase containing agricultural chemicals. Accordingly, no rejection of claim 16 is made stemming from its reference to “the composition of claim 1.”
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-AlA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1-6, 8, 11-15, 18-20, 22, and 25-31 are rejected under 35 U.S.C. § 103 as being unpatentable over Mbarga et al. (A new oil-based formulation of Trichoderma asperellum for the biological control of cacao black pod disease caused by Phytophthora megakarya. Biological Control, Volume 77, 2014, Pages 15-22; 13 June 2014 publication date, hereinafter “Mbarga”), in view of Clary et al. (US20200138041A1; 07 May 2020 publication date, hereinafter “Clary”), and in further view of Allen and Bogosian (US20160073641A1; published 17 March 2016, hereinafter “Allen”).
Mbarga teaches the basic claimed nonaqueous microbial-inoculant formulation architecture. Mbarga teaches an oil-dispersion microbial formulation prepared by mixing oil with an emulsifying-dispersing agent, adding the structural agent, progressively incorporating T. asperellum conidia, and homogenizing the mixture for 10 minutes at 5000 rpm (§ 2.2.2). Mbarga's Formulation 1 comprises 74 wt.% soybean oil, 15 wt.% Tensiofix NTM emulsifying/dispersing agent, 5 wt.% Tensiofix 869 structural agent (bentonite clay, a hydrophobic organoclay drawn from its being an oleophilic bentonite structural agent in an oil phase; see §2.2.1 and Discussion; see also Harris, cited below, Example 6, characterizing Tensiofix 869 as an “oleophilic clay” dispersed into the organic solvent phase of an oil dispersion), 4 wt.% glucose, no added water, and 2 wt.% T. asperellum conidia dispersed in the oil phase (Table 1). This formulation is directed as a water-free oil dispersion (nonaqueous formulation), wherein the “continuous phase” is not expressly stated, however the characterization is inferred from the oil-dispersion architecture.
Each of those numerical amounts falls within the corresponding ranges of instant claim 1 of 15-98.8 wt.% solvent, 0.1-5 wt.% hydrophobic rheology modifier, 0.1-20 wt.% emulsifier, and 1-60 wt.% microbial isolate. A prior-art disclosure encompassing or overlapping a claimed numerical range ordinarily establishes a prima facie case of obviousness (see In re Peterson, 315 F.3d 1325, 1329–30 (Fed. Cir. 2003) and where the general conditions are known, discovering workable or optimum ranges by routine experimentation ordinarily is not inventive (see In re Aller, 220 F.2d 454, 456 (CCPA 1955), as such for optimizing amounts of solvent, emulsifier, rheology modifier, microbial loading, and similar known formulation parameters. Mbarga further teaches progressively incorporating the microbial material into the oil formulation and homogenizing the resulting dispersion (§ 2.2.2; conidia progressively incorporated and homogenized 10 min at 5000 rpm).
Mbarga does not teach that its microorganism is Methylobacterium and does not establish the presently claimed Methylobacterium-specific viable count after 26 weeks. Those teachings are supplied by Clary and Allen, as detailed below.
Clary teaches nonaqueous inoculant compositions comprising methylated plant oils (¶[0075], and ¶[0008]-[0009]) and broadly teaches use of agriculturally beneficial microorganisms (¶[0076]) , expressly including bacteria (¶[0077]) and Methylobacterium specifically (¶[0076]; Appendix A ¶[0511]). Clary is not limited to fungal spores, wherein it explicitly contemplates compositions comprising vegetative microbial cells and separately provides working examples in which dried bacterial inoculants are dispersed in soy oil or methyl soyate and subjected to viability testing (¶[0008], ¶[0326]-[0329]).
More importantly for the newly added limitation, Clary expressly describes embodiments in which at least 1×10^7, 1×10^8, 1×10^9 or greater CFU/g or CFU/mL of microbial cells/spores (¶[0088] and ¶[0261]) survive storage at temperatures encompassing room temperature, and identifies extended storage periods including 24 weeks and 28 weeks, as well as still longer periods (¶[0261], ¶[0272]). A prior-art disclosure encompassing or overlapping a claimed numerical range ordinarily establishes a prima facie case of obviousness (see In re Peterson, 315 F.3d 1325, 1329–30 (Fed. Cir. 2003)). Here, although Clary does not report a working Methylobacterium experiment at exactly 26 weeks. Clary explicitly lists 24 and 28 weeks, bracketing the 26-week instant claim limitation, directing one of ordinary skill in the art toward viable-count targets and storage conditions that bracket and encompass the presently claimed practical objective. Unexpected results or criticality must be shown relative to the prior art to establish nonobviousness of exactly 26 weeks (see In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990)).
In addition, Clary expressly connects methylated plant oil and formulation/storage variables to survival, so those variables have an evidentiary nexus as a result-effective-variable, wherein variation of the parameter affects the relevant property or result and thus, optimization carries the usual obviousness inference (see In re Applied Materials, Inc., 692 F.3d 1289, 1295-98 (Fed. Cir. 2012), and E.I. du Pont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018)).
Allen materially reinforces the reasonable expectation of success for Methylobacterium itself. Allen identifies numerous Methylobacterium isolates, including NLS0042 (NRRL B-50932) and NLS0064 (NRRL B-50938) (¶[0024]), the same deposited strains recited in instant claims 8 and 22 as ISO04 and ISO10, respectively.
Allen additionally reports a room-temperature shelf-life experiment using a dried Methylobacterium preparation (¶[0024], Example 16, ¶[0212]). In that experiment, isolate NLS0020/NRRL B-50930 had an initial viable concentration of approximately 5.4×10^9 CFU/g and retained approximately 5.1×10^9 CFU/g after 311 days at room temperature, with no detectable decline of practical significance over the reported interval (¶[0212]-¶[0223]; ¶[0088]-[0090]). This experiment concerns NLS0020/B-50930 rather than the specifically claimed B-50932 or B-50938 strains, which does not anticipate of the claimed strain/storage combination, rather it is direct evidence that dried agricultural Methylobacterium preparations were known to tolerate prolonged room-temperature storage at viable concentrations substantially exceeding the thresholds presently claimed.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, seeking to formulate a shelf-stable agricultural Methylobacterium product to combine Mbarga’s demonstrated oil-dispersion architecture and its quantitative solvent/structural-agent/emulsifier/microbial loading; Clary’s express teaching that nonaqueous plant-oil carriers are useful for maintaining viable bacterial inoculants, expressly including Methylobacterium, together with Clary’s ≥107/≥108 CFU viable-count targets at room-temperature-range conditions through at least 28 weeks; and Allen’s direct teaching that dried agricultural Methylobacterium preparations can retain very high viable counts for substantially longer than 26 weeks at room temperature.
The proposed modification represents the application of known microbial-inoculant formulation techniques to a microorganism expressly identified by the prior art as suitable for such agricultural inoculant systems, with the expectation of prolonged viability independently supported by Allen (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417021 (2007)).
The motivation is supplied by the references themselves, to obtain a concentrated agricultural microbial inoculant having improved storage stability while remaining dispersible for agricultural application. The combination is not premised on a conclusion that fungal conidia and vegetative bacteria possess identical storage physiology. Rather, the reasonable expectation is supplied independently by Clary’s bacterial oil-formulation teachings and Allen’s Methylobacterium-specific shelf-life teaching.
Thus, one of ordinary skill in the art would have had a reasonable expectation that a high-titer dried Methylobacterium preparation, when incorporated into the known nonaqueous microbial dispersion systems taught by Mbarga and Clary, could be formulated to retain at least 1×10^7 CFU/g after 26 weeks at room temperature. Absolute assurance that every Methylobacterium strain would meet the endpoint is not required (see In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988); Almirall, LLC v. Amneal Pharmaceuticals LLC, 28 F.4th 265, 275-76 (Fed. Cir. 2022); MPEP § 2143.02).
Mbarga’s soybean-oil continuous phase satisfies instant claim 2’s water-immiscible-solvent requirement (Table 1, inferred from the soybean oil-dispersion architecture containing no added water that upon mixing with water it forms a good emulsion). As to instant claims 3-6, Clary expressly teaches methylated plant oils (¶[0052]), including methylated soybean oil/methyl soyate as carriers for microbial inoculants (¶[0097]). Methyl soyate is the methyl-ester form of soybean-oil fatty acids and therefore supplies the claimed esterified plant oil, methyl plant oil, soybean-oil-derived material, and methyl soybean oil limitations. Clary further teaches such methylated plant oils in the context of enhancing microbial-inoculant stability (¶[0008]-[0009], ¶[0100]-[0101], ¶[0326]-[0329]).
Thus, it would have been obvious to substitute Clary’s methylated soybean-oil carrier for the soybean-oil carrier of Mbarga because Clary expressly recommends that carrier for the same microbial-inoculant storage function. The substitution represents use of a known alternative carrier for its known purpose, with no identified technical incompatibility.
Regarding instant claim 8, which requires that the Methylobacterium be selected from ISO04/NRRL B-50932, ISO10/NRRL B-50938, and ISO20/NRRL B-67743. Because the claim is written in the alternative, disclosure of any one recited alternative is sufficient for purposes of the claimed selection. Allen expressly identifies NLS0042 (NRRL B-50932) and NLS0064 (NRRL B-50938) among its agricultural Methylobacterium isolates (¶[0024]). The identity is established by the deposit numbers themselves, irrespective of differences in internal isolate nomenclature.
Regarding instant claims 11 and 25, Mbarga employs Tensiofix 869 as the structural agent in the oil dispersion (bentonite clay; § 2.2.1, Table 1, and Discussion, wherein characterization as a hydrophobic/organophilic organoclay is drawn from it being an oleophilic bentonite structural agent in an oil phase). This renders obvious the claimed hydrophobic organoclay rheology modifier. Clary additionally describes hydrophobic or hydrophobically coated fumed silica materials in microbial inoculant compositions (¶[0198], AEROSIL hydrophobic fumed silica powders and hydrophobically coated silica in inoculant compositions), providing an independently known hydrophobic particulate alternative.
Regarding instant claims 12 and 13, Clary expressly teaches addition of stabilizing compounds to microbial inoculant compositions (¶[0126]) and specifically discloses xanthan gum in such formulations (¶[0137]). Thus, it would have been obvious to include such a conventional stabilizer in the combined nonaqueous microbial composition for its disclosed stabilization/functionality purpose.
Regarding instant claims 14 and 26, Clary expressly identifies sorbitan fatty-acid ester ethoxylates among suitable surfactant/emulsifying materials for inoculant formulations (¶[0193]). Accordingly, selection of an ethoxylated sorbitan fatty ester as the emulsifier in the Mbarga-type dispersion would have represented selection of a known emulsifier for its established function.
Regarding instant claim 15, Mbarga teaches progressively incorporating the microbial material and then homogenizing the formulation for approximately ten minutes at about 5,000 rpm (§ 2.2.2), and demonstrates that Formulation 1 produces a homogeneous dispersion with only trace conidial sedimentation upon dilution (§ 3.1). These teachings would have provided reason to homogenously distribute the substituted Methylobacterium throughout the oil dispersion, by employing Mbarga’s deliberate high-shear homogenization and suspension-stabilizing structural agent, to distribute the microbial material substantially uniformly through the continuous phase. A homogeneous dispersion is the expected objective of Mbarga’s express homogenization step.
Regarding independent claim 18, Mbarga expressly teaches preparing its oil dispersion by mixing the oil with the emulsifying/dispersing agent, adding the structural agent and other components, progressively incorporating the harvested microbial material, and homogenizing the resulting composition (§2.2.2). Clary goes further with respect to the amended requirement for a dried bacterial inoculant (dried microbial cells ¶[0095]), with bacterial examples placing spray-dried Bradyrhizobium material into soy-oil or methyl-soyate formulations and subject the mixture to vigorous/high-shear mixing before storage and viable-count determination (¶[0506]-[0507]). Allen teaches dried Methylobacterium preparations (¶[0024], ¶[0088]) and demonstrates maintenance of high viable counts during prolonged room-temperature storage (¶[0219]-[0223]), as discussed above.
Accordingly, the combination teaches or suggests each operative step of instant claim 18, as preparing a nonaqueous formulation containing the required formulation aids, incorporating a dried microbial inoculant, dispersing that inoculant, selecting Methylobacterium as the microbial material, and selecting formulation/loading conditions directed to the claimed initial and post-storage viable-count endpoints.
Regarding instant claims 19 and 20, the water-immiscible and esterified-plant-oil limitations follow from Mbarga’s soybean-oil carrier and Clary’s express methylated plant-oil/methyl-soyate teachings for bacterial inoculants, for the reasons stated above with respect to instant claims 2-6. Regarding instant claim 22, Allen expressly discloses Methylobacterium isolates that correspond to two of the alternatives expressly recited by instant claim 22, as cited above.
Regarding instant claims 27, 28, 30, and 31, Clary teaches application of its microbial inoculant compositions to plant propagation material, including seed (¶[0010]), and to plants (¶[0029] coating to outer surface of plant or plant part, ¶[0322] plant or plant part), and plant-growth media/soil (¶[0323] plant growth medium, ¶[0324] soil, and ¶[0324] growth medium). Application of the combined Methylobacterium-containing formulation to a plant, seed, or soil therefore constitutes use of the prior-art agricultural inoculant for its expressly taught agricultural purpose. Allen additionally gives direct Methylobacterium-specific coating support by teaching application of dried viable Methylobacterium to a plant or plant part, partially or completely coating a seed, stem, root, flower, cotyledon, coleoptile, fruit, or leaf (¶[0091]).
Instant claim 29 requires at least about 10^3 CFU per seed after six months of room-temperature storage. Clary teaches nonaqueous inoculant-coated seeds retaining viable microbial populations including at least 10^3 and 10^4 CFU/seed and higher, stored at 20-30°C (encompassing room temperature) for extended time periods including 24 weeks and 28 weeks (¶[0263]). Thus, the prior-art storage periods bracket the approximately 26-week/six-month period of instant claim 29, wherein the 28-week timepoint is more stringent with respect to viable count and extends through a period encompassing approximately six months. The claimed ≥10^3 CFU/seed endpoint consequently does not distinguish the instant claimed seed from the storage-performance ranges taught by Clary.
Claims 1, 16-18, and 24 are rejected under 35 U.S.C. § 103 as being unpatentable over Mbarga et al. (A new oil-based formulation of Trichoderma asperellum for the biological control of cacao black pod disease caused by Phytophthora megakarya. Biological Control, Volume 77, 2014, Pages 15-22; 13 June 2014 publication date, hereinafter “Mbarga”), in view of Clary et al. (US20200138041A1; 07 May 2020 publication date, hereinafter “Clary”), and in further view of Allen and Bogosian (US20160073641A1; published 17 March 2016, hereinafter “Allen”), and Harris et al. (AU2015101156A4; published 24 August 2015), hereinafter “Harris”).
Mbarga, in view of Clary, in further view of Allen, teach the limitations of instant claims 1 and 18, as described above, from which instant claims 16, 17, and 24 depend, however do not explicitly teach the specific aqueous agrochemical emulsion of instant claims 16, 17, and 24.
Mbarga establishes that its oil dispersion is designed to be diluted/mixed with water and form a usable aqueous emulsion for agricultural application (§ 2.2.3, formulation added to 95 mL water and homogenized, with resulting homogeneity/sedimentation assessed; § 3.1, Formulation 1 remained homogeneous when mixed with water and was considered a “good emulsion”; and Discussion, soybean-oil dispersion “mixes readily with water,” with conidia remaining in stable suspension, intended to facilitate uniform distribution in a sprayer tank). Thus, Mbarga directly support dilution/emulsification. Clary teaches microbial inoculant compositions in conjunction with agricultural pesticides, including herbicides (¶[0143]), and teaches agricultural application of those inoculants (¶[0324]).
Harris provides additional evidence that, well before the effective filing date, viable bacterial inoculants mixtures comprising water were conventionally tank-mixed with agricultural pesticide products, including commercial fungicide/insecticide seed-treatment products (¶[0050]-[0053], Example 6, and ¶[0099]).
Accordingly, after preparing the oil-based Methylobacterium concentrate rendered obvious for instant claims 1 and 18, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine that concentrate with an aqueous agricultural-chemical mixture for application (as conventional bacterial inoculant with water and pesticide mixing/tank mixing is taught by Harris), thereby producing the claimed multiphase emulsion. The motivation is the conventional agricultural practice expressly taught in the references, delivering a viable microbial inoculant together with an agricultural treatment composition while taking advantage of an oil-dispersion concentrate that is expressly designed to emulsify upon dilution with water. Mbarga’s oil dispersion supplies the water-immiscible dispersed phase when diluted, while the added aqueous agricultural-chemical solution supplies the continuous aqueous phase. The use of emulsifier already present in the concentrate provides the conventional mechanism for forming the emulsion.
One of skill in the art would have a reasonable expectation of success that Methylobacterium would retain the claimed concentration after 26 weeks because Mbarga supplies the quantitative nonaqueous microbial-dispersion architecture and demonstrates prolonged storage of a concentrated biological inoculant in that architecture; Clary teaches bacterial and Methylobacterium inoculants in nonaqueous/methylated-oil systems, provides actual oil-formulation experiments using dried vegetative bacteria, and expressly identifies viable-count targets of ≥10^7 and ≥10^8 CFU/g at room-temperature-range conditions through 28 weeks and longer; and Allen supplies organism-specific evidence that dried agricultural Methylobacterium preparations can begin at multi-billion-CFU/g titers and remain at approximately that level after 311 days at room temperature, and expressly discloses B-50932 and B-50938 among its agricultural Methylobacterium isolates.
Thus, the references collectively supplied one of ordinary skill in the art with both a reason to make the proposed formulation and concrete evidence that the relevant class of bacterial inoculants, and Methylobacterium itself, possessed sufficient room-temperature stability to render the claimed 26-week viable-count target reasonably predictable.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 27 July 2026, have been fully considered.
The applicant argues that Mbarga concerns fungal conidia, not Methylobacterium. This argument is acknowledged however, the prior rejection did not rely on Mbarga alone. Mbarga supplies the non-aqueous oil-dispersion formulation architecture. Clary supplies the express teaching that Methylobacterium is a suitable agriculturally beneficial microorganism and that oil-based carriers can stabilize microbial cells.
The references cannot be evaluated in isolation (e.g., what Mbarga or Clary fails individually to disclose) where the rejection rests on their combined teachings (see In re Keller, 642 F.2d 413, 425 (CCPA 1981)) and doing so does not address the rejection as stated. The fact that Mbarga alone concerns fungal conidia does not negate Clary’s express bacterial/Methylobacterium teachings or Allen’s direct Methylobacterium shelf-life evidence. The claims are directed to a composition and method defined by their components and process steps, not to a specific biological interaction unique to fungal conidia. No evidence has been presented that Methylobacterium would be incompatible with Mbarga’s oil-based formulation.
The applicant’s observation that Clary does not contain a working example of the exact claimed Methylobacterium/oil/rheology-modifier/emulsifier combination is acknowledged but is not dispositive. The prior art is not required to contain an actual reduction to practice of the claimed combination. What is required is an articulated reason to combine with a reasonable expectation of success (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-421 (2007); MPEP §2143.02).
A prior art reference is not limited to its working examples. Clary’s entire disclosure is available as prior art. Clary expressly identifies Methylobacterium as a suitable organism and discloses survival of microbial cells at concentrations of 1 x 10^7 and 1 x 10^8 CFU/gm for storage periods of 24 and 28 weeks at 20-30°C. The claimed 26-week room-temperature storage period falls within or directly adjacent to Clary’s disclosed ranges. The absence of a specific Methylobacterium viability experiment in Clary does not negate a reasonable expectation of success. The test for obviousness does not require actual prior success with the identical organism, it requires that a person of ordinary skill would have had a reasonable expectation that the combination would work for its intended purpose (see In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988).
Clary’s statement at ¶[0086] that viability may be affected by organism type, storage conditions, and other factors does not teach away from using Methylobacterium. Clary’s disclosure does not negate the rejection, as presently formulated, it merely identifies routine factors that a formulator would consider. It explains why a skilled artisan would select the organism, carrier, starting titer, and storage formulation with those variables in mind. The present rejection does not infer Methylobacterium stability merely from Penicillium, Trichoderma, Bradyrhizobium, or Pseudomonas. Allen supplies direct evidence that Methylobacterium itself is capable of prolonged high-titer room-temperature survival, while Clary expressly identifies Methylobacterium as an organism suitable for its inoculant technology and teaches storage endpoints extending through 28 weeks. Here, the evidence goes materially beyond a generalized invitation to experiment. The claimed invention does not require an unexpectedly high stability outside the ranges disclosed by Clary. Variability in biological stability is a routine optimization problem, not a barrier to obviousness.
Regarding the claimed CFU concentrations and storage period, Clary expressly discloses concentrations of at least 1 x 10^7 and 1 x 10^8 CFU/gm and storage periods of 24 and 28-104 weeks. The claimed initial concentration of at least about 1 x 10^8 CFU/gm and post-storage concentration of at least about 1 x 10^7 CFU/gm after 26 weeks are therefore within or substantially overlapping with Clary’s teachings. The specific 26-week endpoint is a routine selection within the disclosed range.
For clarity, the present rejection does not maintain that the ≥1×10^7 CFU/g after 26 weeks limitation is inherent merely because Methylobacterium is placed into an oil formulation. The rejection instead rests on obviousness. Clary expressly identifies substantially the claimed storage target for microbial inoculants, and Allen demonstrates prolonged room-temperature survival of Methylobacterium at titers far above the claimed minimum. Those teachings provide the factual basis for the reasonable expectation of success.
The selection of specific Methylobacterium strains ISO04, ISO10, and ISO20 from a genus expressly disclosed by Clary is not patentable absent a showing of unexpected results. The applicant has not provided any comparative data showing that these strains possess unexpectedly superior stability or performance relative to other known Methylobacterium strains.
The applicant argues that organism-dependent variability prevents a guarantee that Methylobacterium will retain ≥10^7 CFU/g. The law does not require absolute predictability of success, rather, the relevant inquiry is whether the prior art supplied a reasonable expectation of success (see In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988). Here, Mbarga supplies the quantitative nonaqueous microbial-dispersion architecture and demonstrates prolonged storage of a concentrated biological inoculant in that architecture. Clary teaches bacterial and Methylobacterium inoculants in nonaqueous/methylated-oil systems, provides actual oil-formulation experiments using dried vegetative bacteria, and expressly identifies viable-count targets of ≥10^7 and ≥10^8 CFU/g at room-temperature-range conditions through 28 weeks and longer. Allen supplies organism-specific evidence that dried agricultural Methylobacterium preparations can begin at multi-billion-CFU/g titers and remain at approximately that level after 311 days at room temperature, and expressly discloses B-50932 and B-50938 among its agricultural Methylobacterium isolates. Thus, the rejection does not rely upon an assumption that “all microorganisms behave alike.” The references collectively supplied the skilled artisan with both a reason to make the proposed formulation and concrete evidence that the relevant class of bacterial inoculants, and Methylobacterium itself, possessed sufficient room-temperature stability to render the claimed 26-week viable-count target reasonably predictable.
The claimed solvent, rheology-modifier, emulsifier, and microorganism-loading ranges do not independently confer patentability where Mbarga’s exemplified formulation falls within or at the boundary of the recited ranges and Clary supplies overlapping microbial-loading teachings. The applicant has not identified evidence demonstrating that the particular claimed numerical boundaries, apart from the newly emphasized storage endpoint, produce an unexpected formulation property relative to the prior-art compositions.
In conclusion, the applicant’s arguments are persuasive insofar as they demonstrate that Mbarga’s fungal-conidia data alone do not establish, inherently or otherwise, the newly recited 26-week Methylobacterium viability limitation. The amendments nevertheless do not place the application in condition for allowance. When Mbarga is considered together with Clary and Allen, the prior art supplies the claimed nonaqueous oil-dispersion architecture and component concentrations; express teachings of bacterial and Methylobacterium inoculants in nonaqueous plant-oil carriers; actual formulation of dried vegetative bacteria in oil carriers; expressly contemplated ≥107/≥108 CFU viable-count targets extending through 28 weeks at room-temperature-range conditions; direct evidence of high-titer Methylobacterium survival for 311 days at room temperature; express disclosure of NRRL B-50932 and NRRL B-50938; and the claimed seed, plant, soil, emulsion, and agricultural-treatment applications. The combined evidence therefore supplies both an articulated reason to make the claimed formulations and a reasonable expectation of achieving the amended storage endpoint, and does not depend upon an unsupported assumption of fungal/bacterial equivalence.
Conclusion
No claims are allowed.
The 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 (87 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.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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