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 .
Response to Election/Restriction
Applicant’s election without traverse of Group II, claims 37-38 and 40-48, and the species Azospirillum brasilense and Pseudomonas fluorescens in the reply filed on 17 February 2026, is acknowledged.
Status of Claims
The amendment filed on 17 February 2026, is acknowledged.
Claims 35-38 and 40-49 are amended.
Claim 39 has been cancelled.
Claims 35-38 and 40-49 are pending in the instant Office Action.
Claims 35-36 and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 17 February 2026.
Claims 37-38 and 40-48 are under consideration in the instant Office Action, to the extent of the elected species Azospirillum brasilense (A. brasilense) and Pseudomonas fluorescens (P. fluorescens).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1 August 2023, was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The IDS submitted on 17 February 2026, cites 4 documents, including 1 U.S. Patent, 2 foreign patent documents, and 1 non-patent literature document. The cited U.S. Patent and included non-patent literature document are considered, but a copy of the 2 foreign patent documents was not provided as required by 37 CFR 1.98(a)(2), and the 2 foreign patent documents (WO 1994/019924 A1 and WO 1999/009834 A2) are not considered.
Claim Objections
Claims 37, 40-41, and 44-46 are objected to because of the following informalities:
Claim 37 recites A. brasilense and P. fluorescens to be in a single product in step (a) and subsequent mixing in step (b) “to obtain a single product” in the final line of the claim. It is believed the duplicate recitations of “to obtain a single product” are an error and that one recitation should be removed. Claim 37 also recites the concentration of the microorganisms in units of “UFC/mL”. This is interpreted as a translation of the standard colony-forming units (CFU) per milliliter. In response to this Office Action, Applicant should confirm this interpretation is correct and amend the claims to define the abbreviated unit the first time it appears or change “UFC/mL” to “CFU/mL”, which is more commonly used in English language publications.
Claim 40 recites “the step of mixing…is carried out during about 1 to about 2 hours” in the final 3 lines of the claim (bold added for emphasis). The word “during” should be replaced with “for” so the resulting phrase reads “the step of mixing…is carried out for about 1 to about 2 hours” (bold added for emphasis).
Claims 41 and 44-46 recite the unit “Nm3/h” when reciting a limitation on air flow. The instant specification does not provide a definition of the unit and it is interpreted as “normal cubic meter per hour”. In response to this Office Action, Applicant should confirm this interpretation is correct and amend the claims to define the abbreviated unit the first time it appears.
Claims 44 and 45 recite “inox flasks”. The word “inox” is not defined in the instant specification and is interpreted as being an abbreviation of the French word “inoxydable”, which translates to stainless steel. Applicant should clarify in response to this Office Action if “inox” refers to the material from which the flasks are made and is stainless steel and, if so, Applicant should amend each instance of “inox flasks” to instead recite “stainless steel flasks”.
Claim 45 recites that the “microorganisms after the culture segregated” in line 5. The word “is” should be inserted so the phrase recites “microorganisms after the culture is segregated” (bold added for emphasis).
Claim 46 recites agitation of “about 40 hz to about 45 hz” in line 4. The recited unit “hz” is interpreted as hertz and the letter “h” should be capitalized so the unit is “Hz”. Claim 46 also recites a unit of pressure as “kgf/cm3”. Pressure is measured per surface area, rather than volume, and the superscript 3 should be a 2 (i.e., kgf/cm2) as in spec. para. [0036] and [0041].
Appropriate correction is required.
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 42-46 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.
Claim 42 recites in the final 2 lines that the sequential expansion of the bacterial culture “is made in volumes of about 100 mL, to about 10 L, about 180 L to about 2000 L.” It is unclear if all of the recited volumes must be followed in order or if “about 100 mL, to about 10 L” and “about 180 L to about 2000 L” are two different expansion limitation ranges and, if they are different, if both limitations are required or if they are in the alternative.
Claim 43 recites the two bacterial species to be inoculated separately in the final line. Claim 37, from which claim 43 depends, recites the two species to be fermented in a culture in a single product in step (a), and it is not clear if claim 43 is limiting claim 37 to place the two bacterial species into the same reactor at different times or if the two species are placed in separate bioreactors. Claim 44 depends from claim 43, does not resolve the indefiniteness of claim 43, and is therefore also rejected as being indefinite.
Claim 44 recites “expanded by incubation in an orbital agitator to about 80 rpm to about 200 rpm” in line 4. It is unclear what the units 80-200 rpm are limiting, rendering the claim indefinite. Claim 44 further recites 5 limitations separated by 4 semicolons. It is unclear if all 5 limitations are required or if one limitation from the 5 must be selected. If all 5 limitations are required, it is unclear if the 3 recitations of incubation for 18-96 hours must be summed (for a total of 54-288 hours of incubation) or if 18-96 hours is the total time of incubation.
Claim 45 recites the limitation that the “microorganisms after the culture segregated in two inox flasks of about 10 L” in line 5. There is insufficient antecedent basis for this limitation in the claim because neither claim 37 nor claim 44, from which claim 45 depend, recite segregation of the culture into two separate flasks.
Claim 46 recites the limitation “agitation of about 40 hz to about 45 hz” line 4. It is unclear if the unit Hz is related to the rotational agitation measured in units of rpm, such that 1 Hz is equal to 60 rpm, if 40-45 Hz relates to the motor driving the rotational agitation, or if a different method of agitation is being used. For the purpose of examination, the limitation is interpreted as describing the motor driving the rotational agitation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 43 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 43 recites the process of claim 37, wherein species A. brasilense and P. fluorescens are inoculated separately. Because claim 37 recites the species to be inoculated together, claim 43 therefore fails to further limit the subject matter of claim 37 as required by 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 37-38, 40, 43, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Ashby et al. (U.S. Patent Application Publication No. US 2017/0245503 A1, published on 31 August 2017, hereafter referred to as Ashby) in view of Prasad et al. (An. Acad. Bras. Cienc. 2017, 89 (2), 1027., provided by Applicant in the IDS filed on 1 August 2023, hereafter referred to as Prasad).
Ashby teaches plant growth promoting microbes (PGPMs), compositions containing PGPMs, and methods of their use (Abstract). The PGPM compositions taught by Ashby provide isolates, cultures, and methods “useful for enhancing the health, growth and/or yield of a plant” (para. [0006]). Genera of microbes that are taught to be in the PGPM compositions include Azospirillum and Pseudomonas (para. [0177], [0180], and [0235]). The PGPM compositions may comprise a “synthetic microbial consortium”, which is produced by combining a first set of microbes with a second set of microbes “into a single mixture”, which is considered equivalent to the recited “single product” in instant claim 37. The concentration of microbial strains in the PGPM compositions is taught to be, in some embodiments, 1x102 to 1x1010 CFU/mL, such as 1x105 to 1x109, and Ashby notes that the desired microbe concentration in a plant’s surrounding requires a minimum microbe concentration of 1x106 CFU/mL (para. [0026], [0028], [0191], and [0250]).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the concentration range of microbes in the composition taught by Ashby, which encompasses the range recited in instant claim 37.
A method for preparing the compositions is taught to use a bioreactor, in which liquid fermentation can be used to produce cultures of microorganisms (para. [0246]). The bioreactor is taught to range in size and scale, from 10 mL to liters to several cubic meters, which is equivalent to several thousand liters, and may be made from stainless steel (para. [0246]). The bioreactor is also taught to be capable of batch production or a continuous-type of production in which the bioreactor is equipped with a stirrer (para. [0246]). Ashby teaches that compositions with multiple microbes are mixed, in some embodiments in a bottle or flask, but does not teach the length of time for the mixing process (para. [0188], [0194], [0196], [0239], [0316], etc.). However, the length of time the microbes need to mix to produce a well dispersed, homogenous mixture would be a matter of routine optimization for one of ordinary skill in the art, and is therefore prima facie obvious. See MPEP § 2144.05.II. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Growth of microbes in the bioreactor is taught to typically occur under aerobic conditions at suitable temperatures and pH, though Ashby notes that optimal conditions may vary based upon the particular strains (para. [0247-248]). A range which is generally taught to be suitable is a temperature of 15-30 °C, a pH of 4-7, and incubation for 18-96 hours following inoculation (para. [0247]). Finally, Ashby teaches that their composition may be applied to a seed, a plant or plant part, which is considered to include leaves, and the plant surrounding or soil, which is considered equivalent to the plantation furrow recited in instant claim 48 (para. [0023-0026]).
Ashby does not teach the specific strains A. brasilense and P. fluorescens nor separate inoculation of A. brasilense and P. fluorescens. These deficiencies are offset by the teachings of Prasad.
Prasad teaches the synergistic effect of A. brasilense and P. fluorescens in promoting the growth of the groundnut crop via seed treatment, soil application, and foliar spray (Abstract). Mixed cultures are taught to benefit plants and soil because greater diversity leads to greater interactions and a more stable ecosystem (pg. 1028, left col., para. 2). After experimenting with various species of microbes, Prasad found that of A. brasilense and P. fluorescens were optimal in promoting growth based upon compatibility and synergy (pg. 1033, left col., para. 1-2 and pg. 1039, left col., para. 3). The cultures of A. brasilense and P. fluorescens are taught to be capable of being inoculated and cultured together or separately (pg. 1028, right col., Microbial Cultures to pg. 1029, left col., para. 1).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Ashby and Prasad to arrive at the invention of instant claims 37-38, 40, 43, and 47 because the use of a known technique to improve a similar technique in the same way yields predictable results. Ashby taught a method of producing a composition comprising plant growth promoting microbes using a bioreactor in which the microbes may be of the Azospirillum and Pseudomonas genera, in concentrations that encompass those recited in instant claim 37, which can be produced continuously or in a batch, with mixing to achieve a single product. In view of the teachings of Prasad, an ordinary artisan would be motivated to use the specific species A. brasilense and P. fluorescens because these species are taught by Prasad to have synergy and promoted plant growth, which the ordinary artisan would recognize as desirable. Ashby did not teach whether different microbial strains should be inoculated simultaneously or separately and Prasad further teaches that the A. brasilense and P. fluorescens strains can be inoculated via either method, which one of ordinary skill would be motivated to use to find an optimal method.
Ashby and Prasad are silent regarding exopolysaccharide and organic acid production. However, the production of these genera of molecules by A. brasilense and P. fluorescens is an inherent property of the two microbial species. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP § 2112.01. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Because the teachings of Ashby and Prasad have rendered obvious the process recited in instant claim 37, the production of exopolysaccharides and organic acids by the microbial species is necessarily present. As a result, there is a reasonable expectation of success in arriving at the method of instant claims 37-38, 40, 43, and 47 in view of the teachings of Ashby and Prasad.
Claims 42 and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Ashby (U.S. Patent Application Publication No. US 2017/0245503 A1, published on 31 August 2017) in view of Prasad (An. Acad. Bras. Cienc. 2017, 89 (2), 1027., provided by Applicant in the IDS filed on 1 August 2023) as applied to claims 37-38, 40, 43, and 47 above, and further in view of Trujillo-Roldan et al. (Appl. Microbiol. Biotechnol. 2013, 97, 9665., hereafter referred to as T-R) and Food Dive (Scale up production with the 10X rule, online article, published 7 August 2018, accessed on 9 April 2026).
Ashby and Prasad have been described above, and particularly relevant to claim 44 Prasad teaches initial incubation of A. brasilense and P. fluorescens cultures in flasks on a rotary shaker at 200 rpm for 96 hours (pg. 1028, right col., Preparation of Azospirillum and P. fluorescens Mixed Formulation).
Ashby and Prasad do not teach the sequential expansion of the culture, the volume of flasks for culturing, nor the air flow during incubation. These deficiencies are offset by the teachings of T-R and Food Dive.
T-R teaches a process for scaling up production of A. brasilense from shake flasks to pilot-scale production (Title and Abstract). A. brasilense is taught to be industrially significant, but due to the lack of literature support for scale up to meet commercial needs, T-R investigated methods to scale up from a shake flask to a 10 L lab-scale vessel to a 1,000 L pilot-scale bioreactor with A. brasilense concentrations of 3.5-7.5x108 CFU/mL (Abstract). T-R began with 100 mL of culture and sequentially increased to 10 L and finally 1,000 L while maintaining agitation speeds of 205 rpm and a total gas flow of 0.5 vvm (pg. 9667, Culture conditions, bioreactors, and control). T-R concluded their scale up was successful as the final product displayed a stable shelf life of 2 years and could “significantly increase the performance of aboveground biomass and corncobs in plants in greenhouse experiments” (pg. 9672, Discussion).
The limitation “about 100 mL, to about 10 L, about 180 L to about 2000 L” recited in the final line of claim 42 is indefinite (vide supra). For the purpose of examination, “about 180 L to about 2000 L” is interpreted as a range, so the sequence of expansion is ~100 mL to ~10 L to 180-2000 L.
Food Dive teaches the 10X rule as it pertains to scaling up production of food products in production scales (Title and pg. 1, Abstract). A general rule of thumb is taught that batch processes “can be expanded by approximately 10 times without adversely affecting your product” (pg. 2, para. 1). Food Dive provides examples, such as increasing from a 100 gallon vessel to a 1,000 gallon vessel possibly leading to head weight crushing lower components and mixing becoming more difficult (pg. 2, final para. to pg. 3, para. 4). Food Dive recommends incremental expansion, not surpassing 10X the original batch, and suggests smaller increments such as splitting into 2 separate 5X increases or even 4 separate 2.5X increases (pg. 3, para. 5-6).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, because applying a known technique to a known method ready for improvement yields predictable results. Ashby and Prasad rendered obvious a method of producing a composition comprising the plant growth promoting microbes A. brasilense and P. fluorescens using a bioreactor, in concentrations that encompass those recited in instant claim 37, which can be produced continuously or in a batch, with mixing to achieve a single product. In view of the teachings of T-R, one of ordinary skill in the art would be motivated to sequentially scale up their production of the A. brasilense and P. fluorescens composition because T-R teaches A. brasilense to be industrially significant, Prasad teaches the combination of A. brasilense and P. fluorescens to be effective at promoting plant growth, and the ordinary artisan would recognize scaled up production as desirable. The person of ordinary skill would be motivated to follow the sequence of 100 mL to 10 L to 1000 L utilizing agitation speeds of 205 rpm and a total gas flow of 0.5 vvm as taught by T-R because they teach the method to be suitable for A. brasilense cultures and neither Ashby nor Prasad teach the proper parameters for the bioreactor during sequential expansion.
In view of the teachings of Food Dive, one of ordinary skill would be motivated to split their sequential expansions to lower than 10X because Food Dive teaches larger expansions to introduce adverse effects, which the ordinary artisan would recognize as undesirable. Utilizing the teachings of Food Dive, a person of ordinary skill would be motivated to split the 10 L to 1000 L expansion taught by T-R into smaller sequential steps and progressing through multiple ~180 L batches would be a matter of routine optimization for the ordinary artisan and is therefore prima facie obvious. See MPEP § 2144.05.II. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As a result, there is a reasonable expectation of success in arriving at the method of claims 42 and 44-45 in view of the teachings of Ashby and Prasad and further in view of the teachings of T-R and Food Dive.
Claims 41 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Ashby (U.S. Patent Application Publication No. US 2017/0245503 A1, published on 31 August 2017) in view of Prasad (An. Acad. Bras. Cienc. 2017, 89 (2), 1027., provided by Applicant in the IDS filed on 1 August 2023) as applied to claims 37-38, 40, 43, and 47 above, and further in view of Bockrath (U.S. Patent Application Publication No. US 2015/0329877 A1, published on 19 November 2015).
Ashby and Prasad have been described above.
Ashby and Prasad do not teach the pressure, frequency of agitation, or air flow during fermentation. These deficiencies are offset by the teachings of Bockrath.
Bockrath teaches a fermentation method for microorganisms that produce hydrocarbons (Abstract). Fermentation is taught to be an important but potentially expensive process, presenting the need for cost efficient processes (para. [0002]). Bockrath teaches their fermentation method to be cost effective and suitable for microorganisms of various genera, including Pseudomonas (para. [0002-0005], [0034], and [0042]). The preferred fermentation conditions are a temperature of 30-37 °C and a pressure of 1-15 bar and in some embodiments elevated to 1.2-5 bar (para. [0018]). 1 bar is equivalent to 1.01972 kgf/cm2, so the teachings of Bockrath are equivalent to 1.02-15.3 kgf/cm2 and in some embodiments 1.22-5.10 kgf/cm2. Bockrath also teaches that the oxygen concentration during fermentation can be controlled by varying gas flow rates and that preferred rates are in the range of 0.05-0.5 vvm (para. [0046]). Finally, Bockrath teaches that agitation intensity can be modified to maintain a desired oxygen flow rate to the fermenting microorganisms (para. [0112]).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Bockrath with the method rendered obvious by Ashby and Prasad because utilizing a known method in a related field to improve another method in a known manner produces predictable results. Ashby and Prasad rendered obvious a method of producing a composition comprising the plant growth promoting microbes A. brasilense and P. fluorescens using a bioreactor, in concentrations that encompass those recited in instant claim 37, which can be produced continuously or in a batch, with mixing to achieve a single product. In view of the teachings of Bockrath, one of ordinary skill in the art would be motivated to use the fermentation parameters taught by Bockrath in the method rendered obvious by Ashby and Prasad because Bockrath teaches the pressure and air flow to be suitable for fermenting species of the Pseudomonas genus and neither Ashby nor Prasad teach specific parameters for the fermentation step of their methods, a missing piece of information that the ordinary artisan would desire to complete the method above.
The agitation limitation “about 40 hz to about 45 hz” recited in line 4 of claim 46 is unclear because elsewhere in the instant specification and claims the agitation is limited in units of “rpm” with rotational agitation. As stated above, for the purpose of examination the limitation is interpreted as describing the motor driving the rotational agitation. Ashby, Prasad, and Bockrath are silent on the parameters of the motor driving the rotational agitation, but do teach rotational agitation in units of rpm that render obvious the ranges recited in the instant method. The optimal motor parameters needed to achieve the taught rotational agitation would be a matter of routine optimization for one of ordinary skill in the art, and is therefore prima facie obvious. See MPEP § 2144.05.II. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As a result, there is a reasonable expectation of success in arriving at the method of instant claims 41 and 46 in view of the teachings of Ashby and Prasad and further in view of the teachings of Bockrath.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Ashby (U.S. Patent Application Publication No. US 2017/0245503 A1, published on 31 August 2017) in view of Prasad (An. Acad. Bras. Cienc. 2017, 89 (2), 1027., provided by Applicant in the IDS filed on 1 August 2023) as applied to claims 37-38, 40, 43, and 47 above, and further in view of Alvarez et al. (Rev. Bras. Eng. Agríc. Ambient. 2019, 23 (11), 840., hereafter referred to as Alvarez) and Garcia et al. (Rev. Bras. Eng. Agríc. Ambient 2016, 20 (11), 990., hereafter referred to as Garcia).
Ashby and Prasad have been described above, and particularly relevant to claim 48 Ashby teaches that their composition is applied to a plant, plant part, or plant’s surrounding in amounts to increase the concentration of the plant growth promoting microbe 2x, 5x, 10x, 100x, 500x, or 1000x the concentration of the same microbe in untreated control plants, plant parts, or plant surroundings (para. [0026], [0028], and [0250]).
Ashby and Prasad do not teach the volume per hectare (mL/ha) of the composition to be applied to seeds, soil, or leaves. These deficiencies are offset by the teachings of Alvarez and Garcia.
Alvarez teaches application methods of A. brasilense to seeds or in the sowing furrow of corn crops (Abstract). To assess the impact of treating seeds and soil with A. brasilense, Alvarez teaches an application of 500 mL/ha of a composition containing 2x108 CFU/mL to both seeds and soil, either alongside or in the absence of additional nitrogen-containing fertilizer (pg. 841, Material and Methods, Table 1). Utilizing an application of 500 mL/ha to the sowing furrow reduced the need for additionally applied nitrogen fertilizer while promoting greater plant growth and without causing loss of grain yield (pg. 845, Conclusions).
Garcia teaches application methods of A. brasilense to rice crops as a function of dosing and methods (Abstract). Due to the high nitrogen demand of rice crops, Garcia studied the impact of various concentrations of A. brasilense on the crop given the bacteria’s ability to promote nitrogen fixation (pg. 991, left col., para. 2-5). Garcia applied concentrations of 100, 200, and 300 mL/ha of a commercial product containing A. brasilense to the soil, seed, and leaves of plants and studied the impact on nitrogen content, plant growth, and crop yield (pg. 991-992, Material and Methods). Garcia found that the specific dose and location of A. brasilense application did not have a significant impact on the plant growth or crop yield, but in all cases was improved as compared to the control (Tables 2-4).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Alvarez and Garcia with the method rendered obvious by Ashby and Prasad because using prior art methods with a known method in the same manner yields predictable results. Ashby and Prasad rendered obvious a method of producing a composition comprising the plant growth promoting microbes A. brasilense and P. fluorescens using a bioreactor, in concentrations that encompass those recited in instant claim 37, which can be produced continuously or in a batch, with mixing to achieve a single product. In view of the teachings of Alvarez and Garcia, one of ordinary skill in the art would be motivated to apply the composition rendered obvious by Ashby and Prasad in amounts of 100-500 mL/ha to seeds, soil, and/or plant leaves because neither Ashby nor Prasad teach a volume per hectare to apply compositions containing A. brasilense and the teachings of Alvarez and Garcia provide missing information that one of ordinary skill would need to apply the method rendered obvious above. Alvarez taught application of 500 mL/ha to the seeds and soil and Garcia further taught that the specific dose applied does not have a significant impact, thus it would be obvious for an ordinary artisan to arrive at the specific value of 150 mL/ha via routine optimization by applying the composition within the range taught above. See MPEP § 2144.05.II. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As a result, there is a reasonable expectation of success in arriving at the method of instant claim 48 in view of the teachings of Ashby and Prasad and further in view of the teachings of Alvarez and Garcia.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 37-38 and 40-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-38 and 40-44 of copending Application No. 17/920,006 in view of Ashby (U.S. Patent Application Publication No. US 2017/0245503 A1, published on 31 August 2017), Prasad (An. Acad. Bras. Cienc. 2017, 89 (2), 1027., provided by Applicant in the IDS filed on 1 August 2023), Alvarez (Rev. Bras. Eng. Agríc. Ambient. 2019, 23 (11), 840.), and Garcia (Rev. Bras. Eng. Agríc. Ambient 2016, 20 (11), 990.).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 17/920,006 recites an industrial process for obtaining an agricultural composition containing microorganisms of the genera Bacillus, Lactobacillus, and Pseudomonas comprising the steps of a) culturing followed by fermentation, b) inducing biosynthesis of metabolites by selected fermentation parameters, c) sequentially expanding the culture, and d) mixing for 30-120 minutes (claim 43) and packaging the composition (claim 30). The fermenting conditions are recited as 22-38 °C with an air flow of 0.25-0.83 vvm (claim 31). The culturing of the microorganisms is taught to occur separately (claim 32), with sequential expansion from 100 mL to 1 L to 10 L to 180 L and then up to 2000 L (claim 33), and conditions of 0.16-0.25 vvm, 0.41-1.67 vvm, or 4.16-16.67 vvm (claims 35 and 38). Application ‘006 recites the 1 L and 10 L cultures to be agitated in an orbital shaker at 80-200 rpm for 8-48 hours (claim 34) and the 10 L cultures to be inoculated into a 180 L culture for 24-168 hours (claims 36-37). The fermentation step of the process is recited as being performed in batches (claim 40) at a pressure of 1.0-2.0 kgf/cm2, with agitation of 40-45 Hz, at a temperature of 22-30 °C, and with an airflow of 0.0085-0.021 vvm (claims 41-42). Finally, Application ‘006 recites the composition to be applied to seeds or a sowing furrow (claim 44).
Copending Application No. 17/920,006 does not recite the specific Pseudomonas species to be P. fluorescens, the composition to contain A. brasilense, the concentrations of the microbes, application of the composition to plant leaves, nor the quantity of the composition applied. These deficiencies are offset by the teachings of Ashby, Prasad, Alvarez, and Garcia.
Ashby, Prasad, Alvarez, and Garcia have been described above.
Instant claims 37-38 and 40-48 are obvious variations of copending Application No. 17/920,006 because it would have been prima facie obvious to a person of ordinary skill in the art at the time of filing to modify the method recited by Application ‘006 to produce P. fluorescens and A. brasilense, in the concentrations recited in the instant claims, to apply the composition to plant leaves, and to apply in the quantities in instant claim 48 in view of the teachings of Ashby, Prasad, Alvarez, and Garcia.
One of ordinary skill would be motivated to use the method recited by Application ‘006 to produce P. fluorescens and A. brasilense because Prasad teaches the two species to have synergy in promoting plant growth, which an ordinary artisan would recognize as desirable in an agricultural composition. The ordinary artisan would further be motivated to use the concentrations taught by Ashby and Alvarez because Ashby teaches their ranges to be suitable for species of the Azospirillum and Pseudomonas genera when producing the microbial compositions in a bioreactor and Alvarez specifically teaches the species A. brasilense to be suitable in their concentrations in agricultural compositions. Further, Application ‘006 does not recite a concentration and the teachings of Ashby and Alvarez provide missing information a person of ordinary skill in the art would need. Ashby additionally teaches that an agricultural composition comprising species of the Azospirillum and Pseudomonas genera can be beneficial when applied to plant leaves, which an ordinary artisan would recognize as a useful additional application of their product. Finally, in view of the teachings of Alvarez and Garcia, a person of ordinary skill in the art would be motivated to try applying the composition recited by 17/920,006 in a range of 100-500 mL/ha because ‘006 teaches application of their composition but not quantities and the teachings of Alvarez and Garcia provide missing information regarding the application of A. brasilense that an ordinary artisan would need to complete the method of Application ‘006.
Claims 37-38 and 40-48 are directed to an invention not patentably distinct from claims 30-38 and 40-44 of commonly assigned copending Application No. 17/920,006 in view of Ashby, Prasad, Alvarez, and Garcia. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned copending Application No. 17/920,006, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 37-38 and 40-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-11, 15-16, 22, 26, 31, and 35 of copending Application No. 18/843,110 in view of Ashby (U.S. Patent Application Publication No. US 2017/0245503 A1, published on 31 August 2017), Prasad (An. Acad. Bras. Cienc. 2017, 89 (2), 1027., provided by Applicant in the IDS filed on 1 August 2023), and Garcia (Rev. Bras. Eng. Agríc. Ambient 2016, 20 (11), 990.).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/843,110 recites a process for manufacturing an agricultural composition comprising the steps of a) fermenting one or more bacterial species of a genus which may be Pseudomonas, b) inducing metabolite production, and c) formulating a single product from the fermented culture (claim 9). The culture is recited as being sequentially expanded, from volumes of about 10 mL to 1 L to 10 L to 180 L to 2,000 L to 6,000 L, with incubation in an orbital shaker at 80-200 rpm and air flow of 0.41-1.67 vvm for 8-48 hours (claims 10-11). The fermentation step is recited by ‘110 to occur in batches, with different bacterial species cultivated separately and mixed for 60-120 minutes (claims 15 and 21-22). The fermentation conditions are recited as a pressure of 1.0-2.0 kgf/cm2, stirring at 40-45 hz, temperatures of 22-38 °C, and air flow of 0.0085-0.021 vvm for 24-168 hours (claim 16). Application ’110 recites step b) to occur at 22-38 °C with an air flow of 0.25-0.83 vvm (claim 26). Finally, ‘110 recites the use of the agricultural composition for treating plant disease or controlling pest resistance by applying to seeds, sowing furrow, or plant leaves in amounts from 0.5-1.5 L/ha (claims 31 and 35).
Copending Application No. 18/843,110 does not recite the specific Pseudomonas species to be P. fluorescens, the composition to contain A. brasilense, the concentrations of the microbes, nor the quantity of the composition applied to the seed to be 150 mL/ha. These deficiencies are offset by the teachings of Ashby, Prasad, and Garcia.
Ashby, Prasad, and Garcia have been described above.
Instant claims 37-38 and 40-48 are obvious variations of copending Application No. 18/843,110 because it would have been prima facie obvious to a person of ordinary skill in the art at the time of filing to modify the method recited by Application ‘110 to produce P. fluorescens and A. brasilense, in the concentrations recited in the instant claims, and to apply to seeds in the quantity in instant claim 48 in view of the teachings of Ashby, Prasad, and Garcia.
One of ordinary skill would be motivated to use the method recited by Application ‘110 to produce P. fluorescens and A. brasilense because Prasad teaches the two species to have synergy in promoting plant growth, which an ordinary artisan would recognize as desirable in an agricultural composition. The ordinary artisan would further be motivated to use the concentrations taught by Ashby and Alvarez because Ashby teaches their ranges to be suitable for species of the Azospirillum and Pseudomonas genera when producing the microbial compositions in a bioreactor and Alvarez specifically teaches the species A. brasilense to be suitable in their concentrations in agricultural compositions. Further, Application ‘110 does not recite a concentration and the teachings of Ashby and Alvarez provide missing information a person of ordinary skill in the art would need. Finally, in view of the teachings of Garcia, a person of ordinary skill in the art would be motivated to try applying the composition recited by 18/843,110 to seeds in a range of 100-500 mL/ha, less than the 0.5 L/ha recited by ‘110, because Garcia teaches the volume range to be appropriate for treating seeds with a composition containing a species of the Pseudomonas genus, the ordinary artisan would be motivated to use their composition more efficiently and not apply in excess, and could arrive at 150 mL/ha via routine optimization within the range. See MPEP § 2144.05.II.
Claims 37-38 and 40-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5-6, and 8-15 of copending Application No. 18/257,884 in view of Ashby (U.S. Patent Application Publication No. US 2017/0245503 A1, published on 31 August 2017), Prasad (An. Acad. Bras. Cienc. 2017, 89 (2), 1027., provided by Applicant in the IDS filed on 1 August 2023), Alvarez (Rev. Bras. Eng. Agríc. Ambient. 2019, 23 (11), 840.), and Garcia (Rev. Bras. Eng. Agríc. Ambient 2016, 20 (11), 990.).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/257,884 recites an industrial process for producing a composition comprising the steps of a) fermenting one or more species of the Rhodopseudomonas, Pseudomonas, Bacillus, and Saccharomyces genera at an air flow of 0.25-0.83 vvm to produce a fermentation culture, b) mixing the culture with chitosan for 60-180 minutes (claim 14), and c) packaging the composition (claim 2). The fermentation is recited as occurring in batches (claim 4) at a temperature of 22-38 °C (claims 5-6). The culture is further recited as being sequentially expanded, following separate inoculation, from volumes of 100 mL, 1 L, 10 L, 180 L, 2000 L, or up to 10,000 L (claims 8-10). The culture is recited to be expanded by incubation in an orbital agitator at 80-200 rpm for 8-48 hours, in glass or stainless steel flasks, with an air flow of 0.41-1.67 vvm (claim 11). Application ‘844 further recites the culture, when at 180 L volume, to be incubated for 24-168 hours at an air flow of 0.16-1.25 vvm (claim 12). When the culture has reached 2,000 L or 10,000 L, it is taught to be fermented at a pressure of 1.0-2.0 kgf/cm2, with agitation of 40-45 Hz, at a temperature of 22-38 °C, and with an air flow of 0.0085-0.021 vvm (claim 13). Finally, Application ‘844 recites the use of the composition in different dosages for promoting plant growth following application to seeds, furrow, or leaves (claim 15).
Copending Application No. 18/257,844 does not recite the specific Pseudomonas species to be P. fluorescens, the composition to contain A. brasilense, the concentrations of the microbes, nor the quantity of the composition applied. These deficiencies are offset by the teachings of Ashby, Prasad, Alvarez, and Garcia.
Ashby, Prasad, Alvarez, and Garcia have been described above.
Instant claims 37-38 and 40-48 are obvious variations of copending Application No. 18/257,844 because it would have been prima facie obvious to a person of ordinary skill in the art at the time of filing to modify the method recited by Application ‘844 to produce P. fluorescens and A. brasilense, in the concentrations recited in the instant claims, and to apply in the quantities in instant claim 48 in view of the teachings of Ashby, Prasad, Alvarez, and Garcia.
One of ordinary skill would be motivated to use the method recited by Application ‘844 to produce P. fluorescens and A. brasilense because Prasad teaches the two species to have synergy in promoting plant growth, which an ordinary artisan would recognize as desirable in an agricultural composition. The ordinary artisan would further be motivated to use the concentrations taught by Ashby and Alvarez because Ashby teaches their ranges to be suitable for species of the Azospirillum and Pseudomonas genera when producing the microbial compositions in a bioreactor and Alvarez specifically teaches the species A. brasilense to be suitable in their concentrations in agricultural compositions. Further, Application ‘844 does not recite a concentration and the teachings of Ashby and Alvarez provide missing information a person of ordinary skill in the art would need. Finally, in view of the teachings of Alvarez and Garcia, a person of ordinary skill in the art would be motivated to try applying the composition recited by 18/257,844 in a range of 100-500 mL/ha because ‘844 teaches application of their composition but not quantities and the teachings of Alvarez and Garcia provide missing information regarding the application of A. brasilense that an ordinary artisan would need to complete the method of Application ‘844.
Conclusion
No claims are allowed.
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/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
