Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group II (an agricultural composition, claims 26, 37, 42-43 and 45-49) in the reply filed on 20 March 2026 is acknowledged.
Claim Status
The amended claim set filed 20 March 2026 is acknowledged. Claims 1-3, 8, 10, 12, 16, 22-23, 25-27, 37, 42-43, 45-49 are currently pending. Of those, claims 3 and 8 are currently amended, and claims 45-49 are new. Claims 1-3, 5, 7-12, 16-17, 22-23, and 25-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 20 March 2026. Claims 4-7, 9, 11, 13-15, 17-21, 24, 28-36, 38-41, and 44 are cancelled. Claims 26, 37, 42-43 and 45-49 will be examined on the merits herein.
Priority
The instant application claims priority to provisional application 63/242,846 (10 Sep 2021) and is a 371 of PCT/US2022/043043 (filed 9 Sep 2022). What follows is the examiner’s claim-by-claim analysis of effective filing date for the claims currently under examination. If the applicant disagrees with this examiner’s determination of effective filing date for any claim, the applicant may identify text within the prior applications that provides support the claimed language.
The examiner cannot identify support in the provisional application for an agricultural composition comprising the compound that the mutant is auxotrophic for as in claim 37, or specifically leucine and/or arginine as in claim 46 or specifically 1-100 mM of leucine and/or arginine as in claim 47. Therefore, there is also not support for the full scope of independent claim 27. The effective filing date used for searching claims 27, 37, and 46-47 was 9 Sep 2022.
However, dependent claims 42-43, 45, and 48-49 are supported in the provisional application. The effective filing date used for searching claims 42-43, 45, and 48-49 was 10 Sep 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8 March 2024 and 30 April 2024 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
Specification
The disclosure is objected to because of the following informalities: The use of the terms Firewall™, Fireline™, Blossom Protect™, Buffer Protect™, Previsto™ [100, Table 3]; Aliette™ [107, Table 2]; and Serenade™ Aso [Table 3], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Also, applicant is informed that the specification appears to have the following errors: This is not an objection and an amendment is not required. If making an amendment to the specification, applicant should be careful not to introduce new matter. An amendment to correct an obvious error does not constitute new matter where one skilled in the art would not only recognize the existence of error in the specification, but also the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971).
The specification states in Example 5 that “The PSU1 treatment contained the same rate of the Leucine-1 active ingredient that was effective in protecting apples from fire blight in Washington in the 2021 tests” [0121] and also states that “For the PSU1 treatment, Erwinia amylovora Leucine-1 strain was provided as a wet cell paste at 109 CFU/ml, which was gently resuspended at 2 g per gallon.” [0114] (i.e. the amount of E. amylovora applied is less than 109 CFU/ml because it has been diluted). However, Example 3 states that it was the experiment that occurred in Washington in 2021 [0102] and states that “The Leucine-1 auxotroph was applied at 109 cell/ml in water.” [0099].
The terms “Regulid”, “LI700” and “Aliette” [0107] are not defined in the specification.
Claim Interpretation
Regarding claim 47, the claim states “the compound is 1-100mM leucine and/or 1-100mM arginine.” The specification states “Unless otherwise clear from context, all numerical values provided herein are modified by the term about” [0030]. The claim is interpreted as claiming approximate numerical values.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 42 and 47 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.
Regarding claim 42, the term “an amount effective to reduce or prevent fire blight disease on pome fruit trees caused by Erwinia amylovora” is a relative term which renders the claim indefinite. The term “amount effective” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Instead, the specification specifically teaches that efficacy isn’t based on the ”amount” but on the application. “An effective amount means that quantity of Erwinia amylovora auxotrophic cells sufficient to inhibit the incidence or development of pathogenic Erwinia amylovora when applied to pome fruit blossoms. … The effective amount can be determined by environmental factors, which can affect the amount of auxotrophic strain to be used.” [0067]. See also [0109] in Example 4, where a repetition of a successful trial is “unsuccessful because the auxotroph was believed to be applied too early, when the weather was too cold for fire blight to develop”, or see [0121] in Example 5 where the same amount was successful in protecting apples but not protecting pears. Therefore, one of ordinary skill in the art would not be reasonably apprised of the “amounts” of bacteria that are included within the claim scope because the composition of Examples 4 and 5 simultaneously does and does not contain an effective amount, and one of ordinary skill in the art would not be able to clearly determine whether the composition falls within the claim scope. Also, the claim fails to put one of ordinary skill in the art on notice about potential infringement because they cannot determine whether or not their composition comprises an amount of Erwinia amylovora that infringes by being effective at reducing or preventing fire blight disease, even if they have performed experimentation to test for this effect. In the interest of compact prosecution, in this action the broadest reasonable interpretation used is that the “effective amount” is the effective range of CFUs disclosed in the specification, about 106-1010 CFU/mL [0067].
Regarding claim 47, the claim is indefinite because it depends from itself. In the interest of compact prosecution, in this action the claim is interpreted as depending from claim 46 instead.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 27, 37, 42-43, and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pugashetti and Starr (1975; hereafter Pugashetti; PTO-892) as evidenced by Chatterjee and Starr (1973; hereafter Chatterjee; PTO-892).
Regarding claim 27, Pugashetti teaches Erwinia amylovora strains that are serine or proline auxotrophs (EA178-M64S1 and EA178-M178S1, respectively) (Abstract, Table 1). Pugashetti teaches that the strains “were selected for prototrophy (to ser or pro) and for resistance to streptomycin” (pg. 487 col. 2 par. 1), and Table 1 teaches the source of the strains was ref. 4 (Chatterjee). Chatterjee provides evidence that these “auxotrophic mutants were induced by N-methyl-N'-nitro-N-nitrosoguanidine (NTG) treatment” (Chatterjee pg. 1100 col. 2 par. 3, Table 1). In this action, the evidentiary reference Chatterjee is cited to show that the E. amylovora strains of Pugashetti have the inherent characteristic of being non-transgenic (see MPEP 2131.01). Pugashetti teaches an agricultural composition comprising the bacteria suspended in phosphate buffer (0.01 M, pH 7.2) or water (i.e. agriculturally acceptable carriers) that is used for testing the virulence of the strains on pears (pg. 487 col. 1 par. 1).
Regarding claim 37, in some experimental conditions “To aid in determining whether the avirulence of the recipient strains might be due solely to their amino acid auxotrophy, as is the case in another system (5), the inoculum was supplemented with the needed amino acid (50 ug/ml) and the virulence was tested on pear fruits.” (pg. 487 col. 1 par. 4, Table 2).
Regarding claim 42-43, the compositions had cell concentrations of approximately 108 cells/ml (pg. 487 col. 1 par. 1).
Regarding claim 49, the strains were grown on agar (i.e. an alternate agriculturally acceptable carrier, pg. 486 col. 2 par. 2, pg. 487 col. 1 par. 1), resulting in a colony that is a wet paste, and also were preserved by lyophilization (pg. 486 col. 2 par. 2).
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 27, 37, 42-43, and 45-49 are rejected under 35 U.S.C. 103 as being unpatentable over Klee et al. (2019; hereafter Klee; PTO-892) as evidenced by Li et al. (2020; hereafter Li; PTO-892) in view of Klee et al. (2019; hereafter Klee2; PTO-892) and Pugashetti and Starr (1975; hereafter Pugashetti; PTO-892) as evidenced by Chatterjee and Starr (1973; hereafter Chatterjee; PTO-892).
Regarding claim 27, Klee teaches “A series of auxotrophic E. amylovora mutants, representing 21 metabolic pathways, were isolated” (Abstract). The Klee strains are not non-transgenic; the mutations were created by Tn5 transposon insertion and screening approximately 22,900 mutants for auxotrophs (pg. 3 par. 3). Li provides evidence that “Tn5 transposons were discovered in Escherichia cdi” (pg. 1 par. 1), and therefore that Tn5 is not a sequence that is native to E. amylovora (i.e. the strains are transgenic). Klee teaches compositions comprising these mutants that are used for infecting plants (i.e. an agricultural composition) comprising bacterial culture on an LB plate (i.e. an agriculturally acceptable carrier, pg. 16 par. 7), and also a second liquid composition comprising “inoculum” in an undisclosed liquid carrier (pg. 16 par. 9), and also a third liquid composition comprising cells and MgCl2 (pg. 17 par. 3). Klee teaches “mutants defective in arginine, guanine, hexosamine, isoleucine/valine, leucine, lysine, proline, purine, pyrimidine, sorbitol, threonine, tryptophan, and glucose metabolism had reduced virulence compared to the wild type” (Abstract). Klee points out arginine mutants as being particularly useful: “Pretreatment of apple flowers with an arginine auxotroph inhibited the growth of the wild-type E. amylovora, while heat-killed auxotroph cells did not exhibit this effect, suggesting nutritional competition with the virulent strain on flowers. The results of our study suggest that certain nonpathogenic E. amylovora auxotrophs could have utility as fire blight biocontrol agents.” (Abstract).
Regarding claims 37 and 46, the carrier of LB media comprises the amino acid for which the strains are auxotrophic, because the strains are able to grow on this media.
Regarding claims 42-43, Klee teaches “ scissors dipped in inoculum at 108 CFU ml−1” (pg. 16 par. 9) and “spray inoculum was prepared at cell densities of 109 or 1010 CFU ml−1"“ (pg. 17 par. 3).
Regarding claim 45, the mutants include leucine and arginine auxotrophic mutants (Abstract).
Regarding claim 48, “cells were suspended in sterile 10 mM MgCl2 supplemented with 0.015% nonionic detergent Tween 80 (T80)" (pg. 17 par. 3).
Regarding claim 49, the strains were grown on LB agar, resulting in a colony that is a wet paste.
Klee teaches transgenic auxotrophic mutants rather than non-transgenic mutants as in claim 27. Klee does not teach the composition further comprises 1-100mM leucine and/or 1-100mM arginine as in claim 47.
Regarding claim 27, Pugashetti teaches Erwinia amylovora strains that are serine or proline auxotrophs (EA178-M64S1 and EA178-M178S1, respectively) (Abstract, Table 1). Pugashetti teaches that the strains “were selected for prototrophy (to ser or pro) and for resistance to streptomycin” (pg. 487 col. 2 par. 1), and Table 1 teaches the source of the strains was ref. 4 (Chatterjee). Chatterjee provides evidence that these “auxotrophic mutants were induced by N-methyl-N'-nitro-N-nitrosoguanidine (NTG) treatment” (Chatterjee pg. 1100 col. 2 par. 3, Table 1). In this action, the evidentiary reference Chatterjee is cited to show that the E. amylovora strains of Pugashetti have the inherent characteristic of being non-transgenic (see MPEP 2131.01). Pugashetti teaches an agricultural composition comprising the bacteria suspended in phosphate buffer (0.01 M, pH 7.2) or water (i.e. agriculturally acceptable carriers) that is used for testing the virulence of the strains on pears (pg. 487 col. 1 par. 1).
Regarding claim 37, in some experimental conditions “To aid in determining whether the avirulence of the recipient strains might be due solely to their amino acid auxotrophy, as is the case in another system (5), the inoculum was supplemented with the needed amino acid (50 ug/ml) and the virulence was tested on pear fruits.” (pg. 487 col. 1 par. 4, Table 2). The concentration of 50 ug/ml is equivalent to 2.87 mM of arginine.
Regarding claim 42-43, the compositions had cell concentrations of approximately 108 cells/ml (pg. 487 col. 1 par. 1).
Regarding claim 49, the strains were grown on agar (i.e. an alternate agriculturally acceptable carrier, pg. 486 col. 2 par. 2, pg. 487 col. 1 par. 1), resulting in a colony that is a wet paste, and also were preserved by lyophilization (pg. 486 col. 2 par. 2).
Regarding claim 27, Klee2 teaches a method of generating targeted gene deletions in Erwinia amylovora (Abstract), using a method that inserts and then removes a plasmid (pg. 9 par. 6), resulting in a non-transgenic strain. Klee2 teaches creating targeted deletions to confirm the effect of the gene (in the reference, empB) after analysis of a Tn5 transposon mutant (pg. 2 par. 6 and pg. 3 par. 1).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the transposon insertion auxotrophic mutant of Klee by generating non-transgenic mutants as in Klee2 or Pugashetti, and testing whether the reduction in virulence for the arginine mutant is solely due to auxotrophy by supplementing arginine at the concentration disclosed in Pugashetti, thereby arriving at the claimed invention. Making non-transgenic mutants would be desirable because Klee2 teaches that this is an art-recognized experiment to confirm the effect of a gene after analysis of a Tn5 transposon mutant like the one in Klee. Also, as the Tn5 transposon mutants of Klee were not publicly available at the time of filing, using a targeted deletion method like in Klee2 or a targeted selection method like in Pugashetti would be desirable to directly obtain the mutant rather than spending the time and resources to screen 22,900 transposon mutants for the desired mutation as in Klee. Generating a agricultural composition supplemented with 50 ug/ml of arginine would be desirable because Pugashetti found that their auxotrophic strain had reduced virulence even in the presence of the necessary amino acid, but that this was not the case for all auxotrophic mutants; one of ordinary skill in the art would find it desirable to understand the safety of a “potential biocontrol agent”, as taught by Klee. The concentration of 50 ug/ml is equivalent to 2.87 mM of arginine. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” The modifications could be done with a reasonable expectation of success because the methods to make a non-transgenic mutant were well characterized in the art at the time of filing and because adding arginine to the composition requires only mixing ingredients together.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the use of known techniques to improve similar devices, methods or products in the same way is obvious because enhancing a particular class of devices, methods, or products has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. In the instant case, Klee teaches a “base” product comprising an auxotrophic Erwinia amylovora strain created using transposon mutagenesis, and Klee2 and Pugashetti each teaches a comparable method for generating Erwinia amylovora mutants wherein the use of targeted deletion or targeted selection is taught as advantageous for generating Erwinia amylovora mutants. Thus, one of ordinary skill in the art could have applied the known technique of either Klee2 or Pugashetti to the base method taught by Klee to yield predictable results (i.e. the same advantages).
Similarly, Klee teaches a “base” agricultural composition product comprising an auxotrophic Erwinia amylovora mutant, and Pugashetti teaches a comparable agricultural composition product comprising an auxotrophic Erwinia amylovora mutant that has been mixed with the necessary amino acid and teaches that the composition is useful for understanding whether the avirulence is solely due to the auxotrophy. Thus, one of ordinary skill in the art could have applied the known technique of Pugashetti (mixing) to the base product taught by Klee to yield predictable results (i.e. the same advantages). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
