DETAILED ACTION
The Amendment filed March 31, 2025 has been entered.
Claims 1-32, 34-59, 61-65, 69-165, 167-227, 229-237 and 239 are cancelled.
Claims 33, 60, 66-68, 228 and 238 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All previous objections and rejections not set forth below have been withdrawn.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 thuringiensis to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein: the recombinant Bacillus thuringiensis expresses an enzyme, wherein expression of the enzyme is increased as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions; wherein the enzyme is from any unspecified source and is selected from a phospholipase C and a beta-1,4-Endoglucanase, and wherein the enzyme is not bound to the exosporium of the Bacillus thuringiensis, 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 thuringiensis to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein the recombinant microorganism has increased expression, of an enzyme selected from a phospholipase C and a beta-1,4-endoglucanase, wherein the enzyme is not bound to the exosporium of the Bacillus thuringiensis, 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.
Given the breath of the claims which encompass methods for stimulating plant growth and/or promoting plant health, by applying a recombinant Bacillus thuringiensis 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 microorganism expresses an enzyme at a level that is increased as compared to the expression level of the enzyme in a wild-type microorganism of the same kind under the same conditions, wherein the enzyme is from any unspecified source and is selected from a phospholipase C and a beta-1,4-Endoglucanase, 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, 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 thuringiensis having increased expression of a phospholipase C or a beta-1,4-Endoglucanase enzyme 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 thuringiensis microorganisms 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
Applicant's arguments filed March 31, 2025 have been fully considered but they are not persuasive.
Applicants respectfully traverse the rejection, and note that the claims are amended to recite that the recombinant microorganism is limited to a recombinant Bacillus thuringiensis, and that the genera of enzymes having increased expression in the recombinant Bacillus thuringiensis is limited to a phospholipase C and a B-1,4- Endoglucanase.
Applicants maintain that the specification describes the structure and function of exemplary recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions, e.g., paragraphs [00497], [00328], [00213], SEQ ID NOs: 30, 36, and 42, SEQ ID NOs: 14-18, 115, and 116, and paragraphs [00498] — [00519].
Applicants also maintain that the adequacy of the description provided in the specification, in view of the knowledge in the art, is further demonstrated by the Declaration under 37 C.F.R. § 1.132 of Dr. Jorg Augustin. Applicant maintains that, consistent with Dr. Augustin’s comments, those skilled in the art would understand that recognition of the claimed genus can be further carried out through the optimal alignment of sequences with reference to sequences described in the Application as filed, as well as standardized biochemical assays for assessing enzymes that catalyze the degradation polysaccharides possessing B-1,4-glucan backbones (i.e. B-1,4-Endoglucanases activity) and the hydrolysis of the phosphodiester bond between the glycerol backbone and the head group phosphate of glycerophospholipid molecules (i.e. Phospholipase C activity). Applicant points out that Dr. Augustin specifically explains:
[for example, by using Sumner’s 3,5-dinitrosalicylic acid (DNSA)-based reducing sugar detection method to quantify B-1,4-endoglucanases activity or by following the release of the chromogenic p-nitrophenol resulting from the hydrolysis of the substrate p-Nitrophenylphosphorylcholine (NPPC) to assess Phospholipase C activity, respectively. That is, the structure and activity of many enzymes within the f-1,4-Endoglucanase (EC 3.2.1.4) and Phospholipase C (EC 3.1.4.3) enzyme classes were well-characterized as of the filing date. For example, many f-1,4-Endoglucanases comprise a glycosidic hydrolase 5 (GH5) catalytic domain as described in Santos et al., 2012 and Naas et al., 2015 (provided herein as Exhibit B and C), including SEQ ID NO:42. Such structural features, in addition to the ability to hydrolyze B-1,4-glucan backbones, may be used to identify species within the scope of the claims. Similarly, many phospholipase C enzymes are structurally related, including those of bacterial origin (e.g. SEQ ID NO:14), as described in Titball, 1993 (provided herein as Exhibit D). As such, those skilled in the art may readily recognize the claimed recombinant Bacillus thuringiensis expressing the same. Declaration; paragraph 6.
Applicants maintain that the description of the recited recombinant Bacillus thuringiensis combined with the defined genera of B-1,4-Endoglucanase and Phospholipase C enzymes would clearly convey to a person of skill in the art that Applicants were in possession of the claimed invention at the time of filing.
Applicant's arguments are not persuasive.
With respect to Applicants’ assertion that the claimed invention is adequately described because the specification describes the structure and function of exemplary recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions in paragraphs [00497], [00328], [00213], in SEQ ID NOs: 30, 36, and 42 and SEQ ID NOs: 14-18, 115, and 116, and in paragraphs [00498] — [00519], this is not persuasive because the citations do not, alone or in combination, describe the structure and function of a recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions, or the use of such a recombinant Bacillus thuringiensis to stimulate plant growth and/or promote plant health when applied to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed.
With respect to paragraph [00497], this disclosure is not sufficient to describe the claimed invention because this paragraph is silent with respect to a recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions, or the use of such a recombinant Bacillus thuringiensis to stimulate plant growth and/or promote plant health when applied to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed. Paragraph [00497] only makes general assertions about making unspecified recombinant microorganisms using standard molecular biology methods known in the art.
With respect to paragraph [00328], this disclosure is not sufficient to describe the claimed invention because this paragraph is silent with respect to a recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions, or the use of such a recombinant Bacillus thuringiensis to stimulate plant growth and/or promote plant health when applied to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed. Paragraph [00328] only makes general assertions that a glucanase is an enzyme that can be used for plant growth stimulating or plant health promoting purposes, and that the glucanase can be a beta-glucanase.
With respect to paragraph [00213], this disclosure is not sufficient to describe the claimed invention because this paragraph is silent with respect to a recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions, or the use of such a recombinant Bacillus thuringiensis to stimulate plant growth and/or promote plant health when applied to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed. Paragraph [00213] only makes general assertions that a phospholipase is an enzyme that can be used for plant growth stimulating or plant health promoting purposes, and that the phospholipase can be a phospholipase C.
With respect to SEQ ID NOs: 30, 36, and 42, and SEQ ID NOs: 14-18, 115, and 116, the disclosure of amino acid sequences of B-1,4-Endoglucanases and Phospholipase C enzymes is not sufficient to describe the claimed invention because the claims are not directed enzymes per se. The claims are directed to a method for stimulating plant growth and/or promoting plant health, comprising applying a recombinant Bacillus thuringiensis to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein: the recombinant Bacillus thuringiensis expresses an enzyme, wherein expression of the enzyme is increased as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions; wherein the enzyme is from any unspecified source and is selected from a phospholipase C and a beta-1,4-Endoglucanase, and wherein the enzyme is not bound to the exosporium of the Bacillus thuringiensis. The description of the amino acid sequences of enzymes used to practice the claimed invention is not sufficient to describe the claimed method given that it was known at the time of filing that techniques for expressing enzymes in microorganisms and for using microorganisms to stimulate plant growth and/or promote plant health are unpredictable.
With respect to paragraphs [00498] — [00519], this disclosure is not sufficient to describe the claimed invention because these paragraphs are silent with respect to a recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions, or the use of such a recombinant Bacillus thuringiensis to stimulate plant growth and/or promote plant health when applied to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed. Paragraphs [00498] — [00519] only make general assertions about making unspecified recombinant microorganisms, and applying these unspecified recombinant microorganisms to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed.
With respect to Applicant’s reliance on the Declaration which indicates that those skilled in the art would understand that recognition of the claimed genus can be further carried out through the optimal alignment of sequences with reference to sequences described in the Application as filed, as well as standardized biochemical assays for assessing enzymes that catalyze the degradation polysaccharides possessing B-1,4-glucan backbones (i.e. B-1,4-Endoglucanases activity) and the hydrolysis of the phosphodiester bond between the glycerol backbone and the head group phosphate of glycerophospholipid molecules (i.e. Phospholipase C activity), this is not persuasive, because the claims are not directed enzymes per se. The claims are directed to a method for stimulating plant growth and/or promoting plant health, comprising applying a recombinant Bacillus thuringiensis to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein: the recombinant Bacillus thuringiensis expresses an enzyme, wherein expression of the enzyme is increased as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions; wherein the enzyme is from any unspecified source and is selected from a phospholipase C and a beta-1,4-Endoglucanase, and wherein the enzyme is not bound to the exosporium of the Bacillus thuringiensis. That those skilled in the art would understand that recognition of the claimed genus can be further carried out through the optimal alignment of sequences with reference to sequences described in the Application as filed, as well as standardized biochemical assays for assessing enzymes that catalyze the degradation polysaccharides possessing B-1,4-glucan backbones (i.e. B-1,4-Endoglucanases activity) and the hydrolysis of the phosphodiester bond between the glycerol backbone and the head group phosphate of glycerophospholipid molecules (i.e. Phospholipase C activity) is not sufficient to describe the claimed method given that it was known at the time of filing that techniques for expressing enzymes in microorganisms and for using microorganisms to stimulate plant growth and/or promote plant health are unpredictable.
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 thuringiensis to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein: the recombinant Bacillus thuringiensis expresses an enzyme, wherein expression of the enzyme is increased as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions; wherein the enzyme is from any unspecified source and is selected from a phospholipase C and a beta-1,4-Endoglucanase, and wherein the enzyme is not bound to the exosporium of the Bacillus thuringiensis, 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 thuringiensis to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed, wherein the recombinant microorganism has increased expression, of an enzyme selected from a phospholipase C and a beta-1,4-endoglucanase, wherein the enzyme is not bound to the exosporium of the Bacillus thuringiensis, 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 thuringiensis wherein the expression of a phospholipase C or a beta-1,4-Endoglucanase that is not bound to the exosporium is increased in such a manner that the application of the recombinant Bacillus thuringiensis 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 microorganism 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.
In the instant case the specification does not provide sufficient guidance with respect to how to make a recombinant Bacillus thuringiensis wherein the expression of a phospholipase C or a beta-1,4-Endoglucanase that is not bound to the exosporium is increased in such a manner that the application of the recombinant Bacillus thuringiensis 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 recombinant Bacillus thuringiensis under a variety of different conditions, and then test each recombinant Bacillus thuringiensis 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 March 31, 2025 have been fully considered but they are not persuasive.
Applicants respectfully traverse the rejection, and note that the claims are amended to recite that the recombinant microorganism is limited to a recombinant Bacillus thuringiensis, and that the genera of enzymes having increased expression in the recombinant Bacillus thuringiensis is limited to a phospholipase C and a B-1,4- Endoglucanase.
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. 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 person of ordinary skill in the art, viewing the specification as-filed, is provided with ample guidance regarding how to make and use the claimed recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions, as recited in the claims. Applicants point in this regard to the Declaration under 37 C.F.R. § 1.132 of Dr. Jorg Augustin, which demonstrates that B-1,4-Endoglucanases and Phospholipase C enzymes, respectively, may be overexpressed in recombinant Bacillus thuringiensis strains, consistent with the description provided in the applications as-filed. Applicants point in particular to the explanation of Dr. Jérg Augustin that:
The inventors were not only in possession of the subject matter now claimed, but also fully understood the effects of such recombinant microorganisms when applied to plants. See, e.g. Section XV. Effects on Plants; paragraphs [00498] — [00519]. To objectively illustrate the sufficiency of this description in combination with knowledge in the art, Exhibit A is provided herein. Exhibit A provides exemplary data demonstrating that B-1,4- Endoglucanases and Phospholipase C enzymes, respectively, may be overexpressed in recombinant Bacillus thuringiensis strains, consistent with the description provided in the applications as-filed (as discussed supra). Moreover, applying such strains to plants yields increases in plant growth, including plant yield and plant height, as compared to the appropriate controls (further experimental details provided in Exhibit A). Declaration; paragraph 7.
Applicants maintain that a person of ordinary skill in the art, viewing the specification, is able to readily identify and obtain recombinant Bacillus thuringiensis strains overexpressing a B-1,4-Endoglucanase or a Phospholipase C enzyme, and that, similarly, those skilled in the art are able to make and use such recombinant strains based on the disclosure provided in the specification, further in view of knowledge in the art, as clearly evidence by the data provided in Exhibit A. Applicants maintain, therefore, that such a person could practice the claimed subject matter without undue experimentation.
Applicant's arguments are not persuasive.
With respect to Applicants’ assertion that the Declaration demonstrates that a person of ordinary skill in the art, viewing the specification as-filed, is provided with ample guidance regarding how to make and use the claimed recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions, since the Declaration demonstrates that B-1,4-Endoglucanases and Phospholipase C enzymes, respectively, may be overexpressed in recombinant Bacillus thuringiensis strains, this is not persuasive because the specification provides no specific guidance regarding to how to make a recombinant Bacillus thuringiensis wherein the expression of a phospholipase C or a beta-1,4-Endoglucanase that is not bound to the exosporium is increased in such a manner that the application of the recombinant Bacillus thuringiensis to a particular type of plant stimulates plant growth and/or promotes plant health.
With respect to Section XV. Effects on Plants, paragraphs [00498] — [00519] of the specification, this disclosure is not sufficient to enable the claimed invention because these paragraphs are silent with respect to hoe to make a recombinant Bacillus thuringiensis having increased expression of a B-1,4-Endoglucanases or a Phospholipase C enzyme as compared to the expression level of the enzyme in a wild-type Bacillus thuringiensis of the same kind under the same conditions, or how to use such a recombinant Bacillus thuringiensis to stimulate plant growth and/or promote plant health when applied to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed. Paragraphs [00498] — [00519] only make general assertions about making unspecified recombinant microorganisms, and applying these unspecified recombinant microorganisms to a plant growth medium, a plant, a plant seed, or an area surrounding a plant or a plant seed.
With respect to the exemplary data provided in Exhibit A demonstrating that B-1,4- Endoglucanases and Phospholipase C enzymes, respectively, may be overexpressed in recombinant Bacillus thuringiensis strains, and that applying such strains to plants yields increases in plant growth, including plant yield and plant height, as compared to the appropriate controls, this is not persuasive because the data provided in Exhibit A were not obtained using any specific teaching disclosed in the specification directed to making a recombinant Bacillus thuringiensis having expression of a phospholipase C or a beta-1,4-Endoglucanase that is not bound to the exosporium wherein the expression of the enzyme is sufficiently increased to stimulate plant growth and/or promote plant health upon the application of the recombinant Bacillus thuringiensis to a plant, and then using such a recombinant Bacillus thuringiensis to stimulate the growth and/or promote the health of a plant. Additionally, Exhibit A is silent with respect to how to make the recombinant Bacillus thuringiensis having expression of a phospholipase C or a beta-1,4-Endoglucanase that is not bound to the exosporium wherein the expression of the enzyme is sufficiently increased to stimulate plant growth and/or promote plant health upon the application of the recombinant Bacillus thuringiensis to the plant. Further, the manner of Application of the recombinant Bacillus thuringiensis to the corn seed described in Exhibit A is nowhere set forth in the specification.
Accordingly, the rejection is maintained
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Remarks
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662
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