DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 7, 2026 has been entered.
Claims 1-32, 34-59, 61-65, 69-165, 167-227, 229-237 and 239 are cancelled.
Claims 33, 60, 66, 67 and 68 are currently amended.
Claims 33, 60, 66-68, 166, 228, 238 and 240-243 are pending and are examined.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
All previous objections and rejections not set forth below have been withdrawn.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 33, 60, 66-68, 166, 228, 238 and 240-243 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims as currently amended are broadly drawn to a method for stimulating plant growth and/or promoting plant health, comprising applying a recombinant Bacillus bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein: the recombinant Bacillus bacterium expresses a phospholipase C or a β-1,4-Endoglucanase enzyme, wherein expression of the enzyme is increased as compared to the expression level of the enzyme in a wild-type Bacillus bacterium of the same kind under the same conditions; wherein the phospholipase C comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or the β-1,4-Endoglucanase comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42; and wherein the enzyme is not bound to the exosporium of the Bacillus bacterium, including methods that comprise applying the recombinant microorganism to the plant seed with an agriculturally acceptable carrier or an agrochemical.
In contrast the specification does not describe the application of any recombinant Bacillus bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein the recombinant Bacillus bacterium has increased expression of a phospholipase C that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or a β-1,4-Endoglucanase that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42, wherein the enzyme is not bound to the exosporium of the Bacillus bacterium, and wherein plant growth is stimulated and/or plant health is promoted.
With respect to techniques for expressing enzymes in microorganisms and for using microorganism to stimulate plant growth and/or promote plant health, it was known at the time of filing that such techniques are unpredictable, because multiple experimental variables must be optimized in order to express an enzyme in a microorganism and to use a microorganism to stimulate plant growth and/or promote plant health.
See, for example, Liu et al. (How to achieve high-level expression of microbial enzymes. Bioengineered, 2013 Apr 25;4(4):212–223), who teach that while bacterial hosts can be used to overexpress recombinant enzymes, bacterial systems cannot express very large proteins and proteins that require post-translational modifications (abstract). Liu et al. also teach that the main bacterial expression hosts, with the exception of lactic acid bacteria and filamentous fungi, can produce several toxins that are incompatible with the expression of recombinant enzymes in food and drugs (abstract). Liu et al. additionally teach that the choice of an expression system for the high-level production of recombinant enzymes depends on many factors, including cell growth characteristics, expression levels, intracellular and extracellular expression, post-translational modifications and biological activity of the protein of interest (page 212 column 2 first full paragraph). Liu et al. further teach that due to the multiplicity of the physiological impacts arising from the high-level expression of genes encoding enzymes, the goal of enzyme overproduction can hardly be achieved, with the yield of recombinant enzymes therefore being limited (paragraph spanning pages 212-213). Liu et al. also teach that in the microorganism E coli, the regulation of recombinant protein expression is a complex system consisting of interaction elements, and that the choice of expression plasmid and its configuration is crucial for the highest levels of the enzyme synthesis (page 213 column 1 first full paragraph). Liu et al. additionally teach that because E. coli secretes few proteins, the manipulation of the various transport pathways to facilitate secretion of foreign proteins is an important task, given that the secretion of foreign proteins facilitates many applications (page 214 column 2 first full paragraph). Liu et al. further teach that in the microorganism B. subtilis, an alternative system for heterologous gene expression due to its ability to secrete proteins directly, multiple regulators can affect the expression of secretion machineries as well as their post-transcriptional functions for protein secretion, and that the secretion of heterologous proteins can be enhanced by engineering components involved in the late stages of secretion (page 215 paragraph spanning columns 1 and 2). Liu et al. also teach that while different heterologous proteins (e.g., GFP, sugar-modifying enzymes and hydrolases) have been successfully produced in the microorganism B. megaterium, enzyme production processes in this microorganism use regulation-differentiation mechanisms for the degradation of enzymes, resulting in the production of exo-enzyme genes being repressed during the exponential growth by transition-state regulators (page215 column 2 first full paragraph).
See also, for example, Shaharoona et al. (Effect of plant growth promoting rhizobacteria containing ACC-deaminase on maize (Zea mays L.) growth under axenic conditions and on nodulation in mung bean (Vigna radiata L.). Lett. Appl. Microbiol. 2006 Feb;42(2):155-9), who teach that a significant positive correlation was observed between in vitro ACC-deaminase activity of rhizobacteria cells isolated from maize rhizosphere through enrichment on ACC as a sole N source, and root elongation in maize plants inoculated with the rhizobacteria cells under axenic conditions.
With respect to Bacillus bacteria, it was also known at the time of filing that the genus Bacillus is among the most prolific and diverse prokaryotic genera which includes a plethora of organisms of great medical, economic and historical importance, and which is a phylogenetically incoherent taxon whose members lack a common evolutionary history, comprise both aerobic and anaerobic spore-forming bacteria, and have no known characteristics that can distinguish species of this genus from other similar endospore-forming genera. See, e.g. Bhandari et al. Molecular signatures for Bacillus species: demarcation of the Bacillus subtilis and Bacillus cereus clades in molecular terms and proposal to limit the placement of new species into the genus Bacillus. Int. J. Syst. Evol. Microbiol. 2013 Jul;63(Pt 7):2712-2726. Epub 2013 Mar 8.
Given the breath of the claims which encompass methods for stimulating plant growth and/or promoting plant health, by applying any type of recombinant Bacillus bacterium to any type of plant growth medium, and any type of plant, plant seed, or area surrounding a\the plant or plant seed wherein the recombinant Bacillus bacterium has increased expression of a phospholipase C that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or a β-1,4-Endoglucanase that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42 and wherein the enzyme is not bound to the exosporium of the Bacillus thuringiensis, given that it was known at the time of filing that techniques for expressing enzymes in microorganisms and for using microorganism to stimulate plant growth and/or promote plant health are unpredictable, given that it was known at the time of filing that the genus Bacillus is a large genus comprising a diverse group of bacteria, and given the absence of any description of any method wherein plant growth is stimulated and/or plant health is promoted when a recombinant Bacillus bacterium having increased expression of a phospholipase C that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or a β-1,4-Endoglucanase that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42 not bound to its exosporium is applied to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, one skilled in the art would not recognize that the applicant was in possession of the claimed invention as a whole at the time of filing. Further, a representative number of species falling within the scope of the genus of recombinant Bacillus bacteria required to practice the claimed methods, and the structural features unique to the genus that are correlated with stimulating plant growth and/or promoting plant health, have not been described.
Response to Arguments
Applicants’ arguments filed January 7, 2026 have been fully considered but they are not persuasive.
Applicants respectfully traverse but note that the amended claims are directed to a method for stimulating plant growth encompassing applying a recombinant Bacillus bacterium having increased expression of a Bacillus-derived phospholipase C (90% identity to SEQ ID NOs: 14, 115, and 116) or Bacillus-derived ß-1,4-Endoglucanase (90% identity to SEQ ID NO: 42), and Applicants maintain that to the extent that the rejection relies on subject matter no longer encompassed by the claims, the rejection is moot in view of the amendments.
Applicants maintain that all claims comply with the written description requirement because the written description must be reviewed from the perspective of one of ordinary skill in the art at the time the application is filed and the Specification need not teach what is well known in the art, such that, Applicants need not describe features that are conventional. Applicants note that the Action asserts that the specification only includes general disclosure related to recombinant microorganisms and lacks guidance regarding how to carry out the claimed method using the same, and Applicants maintain in this regard that the Specification establishes the nexus between the over-expression of the recited enzymes by the recombinant Bacillus and the stimulation of plant growth when applied to plants, seeds, or their surrounding environments or plant growth media, in the Specification at [0017] and [00136].
Consistent with this description, Applicants point to the Declaration of Dr. Brian M. Thompson under 37 C.F.R. §1.132 submitted herewith which further explains that "it is the over expression of the recited enzymes by the recombinant Bacillus that leads to stimulating plant growth when applied to plants, seeds, or their surrounding environments or plant growth media. The Declaration explains that the claimed plant-growth stimulation is driven by the recombinant Bacillus bacterium's quantifiable overexpression of the recited phospholipase C and ß-1,4 Endoglucanase, respectively." Applicants also point out that the Specification recognizes this cause-and-effect relationship between the overexpression of the recited enzymes in Bacillus and the stimulation of plant growth when applied to plants and plant seeds. Applicants additionally maintain that the claimed recombinant Bacillus bacterium over-expressing the Bacillus-derived phospholipase C or ß-1,4-Endoglucanase may be prepared using molecular biology techniques known in the art. Dr. Thompson in the Declaration also explains that "skilled artisans have routinely applied beneficial or engineered plant-associated bacteria by seed coating, foliar spray, and rhizosphere/soil inoculation to promote growth or control disease, and these modes are repeatedly documented in field and controlled studies. Applicants maintain that As Bacillus recombinant expression, methods of assessing enzyme expression and activity levels, as well as techniques for applying Bacillus bacterium to plants were well known in the art as of the effective filing date, no additional description is required, as affirmed by Dr. Thompson in the Declaration at paragraph 9 and in Exhibits A and B, which provide objective, corroborating evidence demonstrating success of what the Specification teaches at a level commensurate with knowledge in the art. Applicants maintain that, when viewed from the perspective of one of ordinary skill in the art at the time the application is filed, the claims fully comply with the written description requirement.
Applicant's arguments are not persuasive.
With respect to Applicants’ assertion that Applicants the Specification establishes the nexus between the over-expression of the recited enzymes by the recombinant Bacillus and the stimulation of plant growth when applied to plants, seeds, or their surrounding environments or plant growth media, in the Specification at [0017] and [00136], this is not persuasive because paragraph [0017] only makes a general reference to phospholipases and glucanases, and only refers to a recombinant Bacillus cereus family member as the bacterium in which the enzyme is not bound to the exosporium, in the context of stimulating plant growth and/or promoting plant health upon application of the bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, whereas the claims as currently amended require a phospholipase C that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or a β-1,4-Endoglucanase that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42, and allow for the expression of the enzyme in any species of Bacillus bacterium, in the same context. This is also not persuasive because paragraph [000136] only makes a general reference to “enzymes” and only refers to a “recombinant bacteria” in the context of stimulating plant growth and/or promoting plant health upon application of the bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed.
With respect to Applicants’ reliance on the Declaration of Dr. Brian M. Thompson under 37 C.F.R. §1.132, Applicants’ arguments are not persuasive because the results submitted in support of the Declaration are not commensurate in scope with the claims as currently amended. The claims as currently amended are broadly drawn to a method for stimulating plant growth and/or promoting plant health comprising applying any recombinant Bacillus bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein: the recombinant Bacillus bacterium expresses a phospholipase C or a β-1,4-Endoglucanase enzyme, wherein expression of the enzyme is increased as compared to the expression level of the enzyme in a wild-type Bacillus bacterium of the same kind under the same conditions; wherein the phospholipase C comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or the β-1,4-Endoglucanase comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42; and wherein the enzyme is not bound to the exosporium of the Bacillus bacterium. In contrast, the results submitted in support of the Declaration were obtained by expressing the recited enzymes in a single species of Bacillus, Bacillus thuringiensis.
Accordingly the rejection is maintained.
Claims 33, 60, 66-68, 166, 228, 238 and 240-243 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims as currently amended are broadly drawn to a method for stimulating plant growth and/or promoting plant health, comprising applying a recombinant Bacillus bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein: the recombinant Bacillus bacterium expresses a phospholipase C or a β-1,4-Endoglucanase enzyme, wherein expression of the enzyme is increased as compared to the expression level of the enzyme in a wild-type Bacillus bacterium of the same kind under the same conditions; wherein the phospholipase C comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or the β-1,4-Endoglucanase comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42; and wherein the enzyme is not bound to the exosporium of the Bacillus bacterium, including methods that comprise applying the recombinant microorganism to the plant seed with an agriculturally acceptable carrier or an agrochemical.
In contrast the specification does not disclose how to make and use a recombinant Bacillus bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein the recombinant Bacillus bacterium has increased expression of a phospholipase C that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or a β-1,4-Endoglucanase that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42, wherein the enzyme is not bound to the exosporium of the Bacillus bacterium, and wherein plant growth is stimulated and/or plant health is promoted.
The claimed invention is not enabled because the specification does not provide sufficient guidance with respect to how to make a recombinant Bacillus bacterium wherein the expression of a phospholipase C that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or a β-1,4-Endoglucanase that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42 that is not bound to the exosporium is increased in such a manner that the application of the recombinant Bacillus bacterium to a particular type of plant stimulates plant growth and/or promotes plant health.
Such guidance is necessary because techniques for expressing enzymes in microorganisms and for using microorganisms to stimulate plant growth and/or promote plant health are unpredictable, because multiple experimental variables must be optimized in order to express an enzyme in a microorganism and to use a microorganism to stimulate plant growth and/or promote plant health.
See, for example, Liu et al. (How to achieve high-level expression of microbial enzymes. Bioengineered, 2013 Apr 25;4(4):212–223), who teach that while bacterial hosts can be used to overexpress recombinant enzymes, bacterial systems cannot express very large proteins and proteins that require post-translational modifications (abstract). Liu et al. also teach that the main bacterial expression hosts, with the exception of lactic acid bacteria and filamentous fungi, can produce several toxins that are incompatible with the expression of recombinant enzymes in food and drugs (abstract). Liu et al. additionally teach that the choice of an expression system for the high-level production of recombinant enzymes depends on many factors, including cell growth characteristics, expression levels, intracellular and extracellular expression, post-translational modifications and biological activity of the protein of interest (page 212 column 2 first full paragraph). Liu et al. further teach that due to the multiplicity of the physiological impacts arising from the high-level expression of genes encoding enzymes, the goal of enzyme overproduction can hardly be achieved, with the yield of recombinant enzymes therefore being limited (paragraph spanning pages 212-213). Liu et al. also teach that in the microorganism E coli, the regulation of recombinant protein expression is a complex system consisting of interaction elements, and that the choice of expression plasmid and its configuration is crucial for the highest levels of the enzyme synthesis (page 213 column 1 first full paragraph). Liu et al. additionally teach that because E. coli secretes few proteins, the manipulation of the various transport pathways to facilitate secretion of foreign proteins is an important task, given that the secretion of foreign proteins facilitates many applications (page 214 column 2 first full paragraph). Liu et al. further teach that in the microorganism B. subtilis, an alternative system for heterologous gene expression due to its ability to secrete proteins directly, multiple regulators can affect the expression of secretion machineries as well as their post-transcriptional functions for protein secretion, and that the secretion of heterologous proteins can be enhanced by engineering components involved in the late stages of secretion (page 215 paragraph spanning columns 1 and 2). Liu et al. also teach that while different heterologous proteins (e.g., GFP, sugar-modifying enzymes and hydrolases) have been successfully produced in the microorganism B. megaterium, enzyme production processes in this microorganism use regulation-differentiation mechanisms for the degradation of enzymes, resulting in the production of exo-enzyme genes being repressed during the exponential growth by transition-state regulators (page215 column 2 first full paragraph).
See also, for example, Shaharoona et al. (Effect of plant growth promoting rhizobacteria containing ACC-deaminase on maize (Zea mays L.) growth under axenic conditions and on nodulation in mung bean (Vigna radiata L.). Lett. Appl. Microbiol. 2006 Feb;42(2):155-9), who teach that a significant positive correlation was observed between in vitro ACC-deaminase activity of rhizobacteria cells isolated from maize rhizosphere through enrichment on ACC as a sole N source, and root elongation in maize plants inoculated with the rhizobacteria cells under axenic conditions.
Such guidance is also necessary because the genus Bacillus is a large genus that comprises a diverse group of bacteria.
See, for example, Bhandari et al. (Molecular signatures for Bacillus species: demarcation of the Bacillus subtilis and Bacillus cereus clades in molecular terms and proposal to limit the placement of new species into the genus Bacillus. Int. J. Syst. Evol. Microbiol. 2013 Jul;63(Pt 7):2712-2726. Epub 2013 Mar 8), who teach that the genus Bacillus is among the most prolific and diverse prokaryotic genera which includes a plethora of organisms of great medical, economic and historical importance, and which is a phylogenetically incoherent taxon whose members lack a common evolutionary history, comprise both aerobic and anaerobic spore-forming bacteria, and have no known characteristics that can distinguish species of this genus from other similar endospore-forming genera.
In the instant case the specification does not provide sufficient guidance with respect to how to make a recombinant Bacillus bacterium wherein the expression of a phospholipase C that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or a β-1,4-Endoglucanase that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42 that is not bound to the exosporium is increased in such a manner that the application of the recombinant Bacillus bacterium to a particular type of plant stimulates plant growth and/or promotes plant health. Absent such guidance one skilled in the art would have to express a variety of different phospholipase C and a beta-1,4-Endoglucanase enzymes in a variety of different recombinant Bacillus bacteria under a variety of different conditions, and then test each recombinant Bacillus bacterium on a variety of different plants under a variety of different conditions in order to determine which specific conditions, if any, would stimulate plant growth and/or promote plant health. Such a trial and error approach to practicing the claimed invention would constitute undue experimentation.
Response to Arguments
Applicant’s arguments filed January 7, 2026 have been fully considered but they are not persuasive.
Applicants respectfully traverse but note that the claims are amended herein to further limit the claimed method, as discussed supra. As far as the subject matter that is outside of the scope of the amended claims is the basis of any rejection, the rejection is believed to be moot, and withdrawal of the rejection is respectfully requested.
Applicants maintain that the claimed invention is fully enabled because only routine experimentation would be required for one of ordinary skill in the art to make and use the full scope of claimed subject matter, and Applicants note that some experimentation and routine screening does not preclude enablement, particularly when a reasonable amount of guidance with respect to the direction in which the experimentation should proceed is provided. Applicants maintain that a skilled artisan can make and use the claimed invention without undue experimentation because the Specification describes the recited enzymes and technical effects yielded by over-expressing such enzymes in recombinant Bacillus, including their ability to stimulate plant growth, in Sections IV ("Methods for stimulating plant growth and/or promoting plant health"), XV ("Effects on plants"), and XVI (Formulations, compositions, and co application of agrochemicals), and paragraphs [00480]-[00485], and [00497]).
Applicants maintain that the guidance provided in the Specification is consistent with the level of ordinary skill in the art, and that the (1) Bacillus-compatible constructs and autoinduction strategy, (2) standardized activity assays that operationalize 'increased expression,' and (3) seed/rhizosphere application provided in Exhibits A and B of Dr. Thompson's Declaration support this understanding in the art which are consistent with the Specification's guidance. Applicants maintain, therefore, that carrying out the claimed invention requires only routine experimentation within well-understood Bacillus expression and agronomic application paradigms.
With respect to Liu (2013) and Shaharoona (2006) cited in the Action as evidence of unpredictability in microbial enzyme expression and microorganism-mediated plant growth, Applicant points out that Dr. Thompson in the Declaration affirms that Liu appears to be largely about choosing hosts and handling secretion/PTMs and toxicity concerns for high-level recombinant enzyme production; and that Shaharoona appears to describe plant growth promotion of certain non- recombinant strains in corn and maize based on ACC-deaminase activity, such that neither of these references support the rejections raised in the Action, because the recited recombinant Bacillus bacterium over-express Bacillus-derived enzymes that may be over-expressed using methods known in the art, such as presented in Exhibit A. The Declaration assert that the claimed methods thus avoid the complexities raised in Liu (2013) Declaration;
paragraph 10.
Applicants maintain that The Specification describes how the over-expression of the recited enzymes by the recombinant Bacillus leads to plant growth stimulation, and that the record establishes Bacillus expression design, objective activity confirmation, and standard seed/rhizosphere application were well within the level of ordinary skill in the art, consistent with the application as-filed. See Declaration, paragraph 11 and Exhibits A and B, such that a person of ordinary skill in the art, viewing the Specification, is therefore readily able to make and use the claimed recombinant Bacillus for stimulating plant growth, with any additional optimization is routine, not undue.
Applicant's arguments are not persuasive.
With respect to Applicants’ assertion that the claimed invention is enabled in light of the disclosure in Sections IV ("Methods for stimulating plant growth and/or promoting plant health"), XV ("Effects on plants"), and XVI (Formulations, compositions, and co application of agrochemicals), and paragraphs [00480]-[00485], and [00497]), this is not persuasive, because this disclosure does not provide any specific guidance for practicing the claimed method. The claims as currently amended are broadly drawn to a method for stimulating plant growth and/or promoting plant health comprising applying any recombinant Bacillus bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein: the recombinant Bacillus bacterium expresses a phospholipase C or a β-1,4-Endoglucanase enzyme, wherein expression of the enzyme is increased as compared to the expression level of the enzyme in a wild-type Bacillus bacterium of the same kind under the same conditions; wherein the phospholipase C comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or the β-1,4-Endoglucanase comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42; and wherein the enzyme is not bound to the exosporium of the Bacillus bacterium. In contrast, the disclosure in Sections IV, XV and XVI only makes general reference the application of recombinant microorganisms that express recombinant enzymes to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed for the purpose of stimulating plant growth and/or promoting plant health. Further, while paragraphs [00480]-[00485] and [00497] make reference to a wide variety of bacterial genera, including the genus Bacillus, that could potentially be used to express recombinant enzymes, these paragraphs are silent with respect to the expression of any specific recombinant enzyme in any particular bacterial species, or the subsequence application of the bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed
With respect to Applicants’ reliance on the Declaration of Dr. Brian M. Thompson under 37 C.F.R. §1.132, Applicants’ arguments are not persuasive because the results submitted in support of the Declaration are not commensurate in scope with the claims as currently amended. The claims as currently amended are broadly drawn to a method for stimulating plant growth and/or promoting plant health comprising applying any recombinant Bacillus bacterium to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein: the recombinant Bacillus bacterium expresses a phospholipase C or a β-1,4-Endoglucanase enzyme, wherein expression of the enzyme is increased as compared to the expression level of the enzyme in a wild-type Bacillus bacterium of the same kind under the same conditions; wherein the phospholipase C comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116 or the β-1,4-Endoglucanase comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 42; and wherein the enzyme is not bound to the exosporium of the Bacillus bacterium. In contrast, the results submitted in support of the Declaration are narrow in that they were obtained by expressing the recited enzymes in only a single species of Bacillus bacteria, Bacillus thuringiensis.
With respect to Applicants’ assertion that the cited references of Liu (2013) and Shaharoona (2006) do not support the rejections raised in the Action because they are not specific to the expression of a phospholipase C or an β-1,4-Endoglucanase in a Bacillus bacterium, this is not persuasive, because Liu (2013) and Shaharoona (2006) were not cited for any specific teaching about the expression of any particular enzyme in any particular bacterial species. Liu (2013) and Shaharoona (2006) were cited to support the general assertion that techniques for expressing enzymes in microorganisms and for using microorganisms to stimulate plant growth and/or promote plant health are unpredictable, because multiple experimental variables must be optimized in order to express an enzyme in a microorganism and to use a microorganism to stimulate plant growth and/or promote plant health. The Examiner maintains that Liu (2013) and Shaharoona (2006) support this general assertion.
Accordingly the rejection is maintained.
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 33, 60, 66-68, 166, 228, 238 and 240-243 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 228 and 231 of copending Application No. 18/476256 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The composition claimed in the reference application comprises a recombinant Bacillus thuringiensis bacterium that expresses a phospholipase C enzyme that comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOS 14, 115 and 116, wherein the enzyme is not bound to the exosporium of the Bacillus thuringiensis bacterium, and wherein the composition also comprises a fertilizer, a polymer, a surfactant, an agrochemical, talc or a plant growth medium, which is a compositions are species within the genus of compositions used to practice the methods claimed in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Remarks
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662
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