Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/27/2026 has been entered.
DETAILED ACTION
Claims 1-22 and 26-34 are cancelled. Claims 23-25 and 35-44 are pending and under examination.
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive.
Applicant argues against the written description rejection of claims 23-25 and 35-44 under 35 U.S.C. 112(a) on the grounds that the structure of non-naturally occurring carriers that maintain the virulence of a bacteriophage in a plant disease biocontrol composition relative to the same bacteriophage in the absence of the carrier were well-known in the art, Applicant presents Exhibits A-D (Arguments, bottom paragraph on page 6). Balogh et al. (2003) (Exhibit A) teaches the carriers flour/corn flour, sucrose, Casecrete (casein polymer), and skim milk. Balogh et al. (2010) (Exhibit B) teaches milk, sugar, flour, and Casecrete NH-400. See Arguments, paragraphs 1-2 on page 7. Similarly, Iriarte et al. (Exhibit C) teaches Casecrete/casein, flour-based formulations (corn flour), sucrose, and dried/powdered skim milk (Arguments, paragraph bridging pages 7-8). Frampton et al. (Exhibit D) teaches Casecrete NH-400/casein polymer, corn flour, and skim milk/dried skim milk (Arguments, first full paragraph on page 8). Applicant argues that the functional principle common to these species is that they are known to protect phage from environmental inactivation, especially UV and wash-off, thereby maintaining higher viable phage levels for longer on plants (Arguments, bottom paragraph on page 8). Applicant argues that skim milk, casein, and flour are processed materials that are not naturally occurring (Arguments, paragraph 1 on page 9).
In response, these arguments are unpersuasive. Out of all of Exhibits A-D, the only species of non-naturally occurring carrier is Casecrete. Each of the other carriers (e.g. corn flour, skim milk, and sucrose) taught by the prior art of Exhibits A-D is naturally occurring. Therefore, there is an insufficient number of representative species of the claimed genus taught by the prior art and disclosed within the specification. The property that the few known species of non-naturally occurring carriers that maintain bacteriophage virulence generally protect the phage from environmental inactivation by UV and wash-off is not a sufficient structure-function correlation. Applicant has not presented any objective evidence of markedly different characteristics of skim milk, casein, and flour compared to their natural counterparts, not are the claims limited to these carriers.
Applicant argues against the rejection of claims 23-25 and 35-44 under 35 U.S.C. 101 on the grounds that the non-naturally occurring carrier is not merely equivalent to adding the words “apply it” to the natural product (Arguments, first full paragraph on page 10). Applicant argues that the difference recited in claim 23 is practically meaningful because Balogh et al. (2003) explains that protective formulations such as pregelatinized corn flour (PCF) + sucrose, Casecrete + sucrose + PCF, and skim milk + sucrose were used because bacteriophages are rapidly degraded on foliage, and reports that these formulations increased phage populations 4,700-, 38,500-, and 100,000-fold, respectively, two days after application (Arguments, paragraph 2 on page 10). Applicant makes similar arguments regarding Exhibits B-C (Arguments, paragraph 2 on page 10).
In response, these arguments are unpersuasive because the claims are not limited to any of the carriers in Exhibits A-D. Thus, the claimed composition does not have markedly different characteristics than a product of nature. The presence of the functional limitation that the carrier maintains the virulence of the bacteriophage in the composition for a longer period of time relative to the bacteriophage in the absence of the carrier does not require any specific and non-trivial period of time. Both the non-naturally occurring carrier and the functional limitation itself are recited at a high level of generality. Thus, none of the claims are eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23-25 and 35-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites the limitation "said non-naturally occurring carrier" in lines 15-16. There is insufficient antecedent basis for this limitation in the claim. The claim recites the composition comprises at least one non-naturally occurring carrier. Thus, the indefiniteness arises when there is more than one carrier because it is unclear whether the bacteriophage is required to maintain virulence in the composition relative to the bacteriophage in the absence of a specific non-naturally occurring carrier (“said non-naturally occurring carrier”) or in the absence of said at least one non-naturally occurring carrier (i.e. all carriers in the composition).
Claims 24-25 and 35-44 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
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 23-25 and 35-44 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.
Claims 23-25 and 35-44 are drawn to a plant disease biocontrol composition comprising at least one non-naturally occurring carrier and at least one bacteriophage isolate of the Xfas500 phage type, wherein the at least one non-naturally occurring carrier maintains the virulence of said bacteriophage for a longer period of time in the plant disease biocontrol composition relative to the same bacteriophage in the absence of said non-naturally occurring carrier.
Virulence is interpreted as the phage’s ability to harm or kill its bacterial host.
The person of ordinary skill in the art would not have recognized that the inventors had possession of the claimed genus of plant disease biocontrol compositions comprising at least one non-naturally occurring carrier that maintains the virulence of the bacteriophage for a longer period of time in the plant disease biocontrol composition relative to the same bacteriophage in the absence of the carrier.
The specification defines carrier as a diluent, adjuvant, surfactant, excipient, or vehicle with which the phage is administered ([0092]). The specification exemplifies such carriers as sterile liquids, including those of synthetic origin ([0092]).
The specification also discloses that, in some embodiments, the carrier is a non-naturally occurring carrier ([0022]). Plant disease biocontrol compositions of the present invention may maintain the virulence of said bacteriophage for a longer period of time relative to the same bacteriophage in the absence of said composition ([0022]).
The specification does not exemplify any non-naturally occurring carriers that maintain the virulence of a bacteriophage for a longer period of time relative to the same bacteriophage in the absence of the carrier.
Frampton (International journal of microbiology 2012.1 (2012): 326452; cited in the Final Action mailed on 1/28/2026) teaches the use of carrier bacteria in order to improve phage persistence and efficacy (page 5, left column, 3.3 Use of carrier bacteria, paragraph 1). Frampton also teaches a non-pathogenic mutant derivative of the phytopathogen can be used as hosts for phage replication in the environment (page 5, right column, paragraph 2).
Balogh et al. (Current pharmaceutical biotechnology 11.1 (2010): 48-57; cited in the Final Action mailed on 1/28/2026) teaches protective carriers for phages (Table 2), which include Casecrete NH-400, a relatively water-soluble casein polymer (page 51, right column, Protective Formulations). Balogh teaches the use of these formulations results in better control of tomato bacterial spot under both greenhouse and field conditions (page 51, right column, Protective Formulations). Balogh also teaches that these materials improve bacteriophage longevity (Table 2 caption). Balogh suggests proposed mechanisms of action for protection for the protective agents. For example, Congo Red is proposed to absorb in the spectrum of sunlight UVA or B and N-propyl-gallate is proposed to counteract the damaging action of oxidation done by reactive radicals generated by sunlight due to its antioxidant properties (Table 2).
Jones et al. ("Considerations for using bacteriophages for plant disease control." Bacteriophage 2.4 (2012): e23857; cited in the Final Action mailed on 1/28/2026) teaches that inactivation by UV light is the biggest factor reducing bacteriophage persistence on plant surfaces (Abstract). Jones teaches that protective formulations have been identified which prolong phage viability on the leaf surface; however, UV inactivation continues to be the major limiting factor in developing more effective bacteriophage treatments (Abstract). Jones also teaches that establishing non-pathogenic or attenuated bacterial strains that are sensitive to the phages specific to the target bacterium also potentially increases persistence (Abstract). Jones teaches that skim milk is a protective formulation that increases persistence of bacteriophages on leaf surfaces (page 210, right column, Persistence of phages on leaf surfaces). However, milk is not a non-naturally occurring carrier since cows naturally produce milk.
In summary, the prior art teaches a small number of species of non-naturally occurring carriers that maintain virulence of bacteriophages and proposes some mechanisms of action. However, these are proposed mechanisms and not an art-recognized structure-function relationship. The majority of the species of carriers that maintain virulence of bacteriophages are naturally occurring rather than non-naturally occurring.
Based on the above analysis, the person of ordinary skill in the art would not have recognized that the inventors had possession of the claimed genus of non-naturally occurring carriers that maintain virulence of the Xfas500 bacteriophage in the plant disease biocontrol composition for a longer period of time relative to the Xfas500 bacteriophage in the absence of the carrier. The specification does not disclose any species of the claimed genus and there is an insufficient number of species taught by the prior art. Furthermore, there is no structure-function correlation for the claimed genus disclosed within the specification or taught by the prior art.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 23-25 and 35-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more.
The rationale for this determination is explained below.
A flowchart has been established to determine subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 part (III) and 2106.04 part (II)(A). The flowchart comprises answering: Step 1) Is the claim to a process, machine, manufacture or composition of matter? Step 2A Prong One) Does the claim recite an abstract idea, law of nature or natural phenomenon? Step 2A Prong Two) Does the claim recite additional elements that integrate the judicial exception into a practical application? Step 2B) Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Claims 23-25 and 35-44 are drawn to a plant disease biocontrol composition comprising at least one non-naturally occurring carrier and at least one bacteriophage isolate of the Xfas500 phage type, wherein the at least one non-naturally occurring carrier maintains the virulence of said bacteriophage for a longer period of time in the plant disease biocontrol composition relative to the same bacteriophage in the absence of said composition.
The Xfas500 phage type, comprising Mijo and Mija, is a naturally occurring bacteriophage: phage Mija was isolated from Duck salad weed collected from rice fields and phage Mijo was isolated from a water sample collected from a ditch (specification [0181]). Although Applicant discloses sequencing the genomes of Mijo and Mija (see specification [0184] and dependent claim 25), no genetic modifications of Mijo and Mija are described within the specification.
Claim 23 recites the additional element of a non-naturally occurring carrier. However, the carrier is recited with a high level of generality and is not limited in structure. There is no evidence of record of markedly different characteristics of the bacteriophage in the presence of the carrier. The claim recites in the wherein clause that the composition, which includes at least one non-naturally occurring carrier, maintains the virulence of the bacteriophage for a longer period of time in the plant disease biocontrol composition relative to the same bacteriophage in the absence of the composition. However, this limitation is insufficient to ensure that the composition has markedly different characteristics than a product of nature. The claim does not recite how much longer the bacteriophage maintains virulence in the composition relative to the bacteriophage in the absence of the carrier. Thus, even a trivial duration of maintaining virulence would fall within the claim scope.
In summary, claims 23-25 and 35-44 are drawn to a composition of matter (Step 1: Yes) that is also the judicial exception of a product of nature (Step 2A Prong One: Yes).
Although claims 23-25 and 35-44 recite the preamble “plant disease biocontrol composition,” this is an intended use of the composition and does not further limit the structure of the composition. Claims 23 and 39 recite that the bacteriophage are capable of lysing Xylella fastidiosa or Xanthomonas bacteria, but these are inherent characteristics of the bacteriophage rather than integration into a practical application.
Therefore, claims 23-25 and 35-44 are not integrated into a practical application (Step 2A Prong Two: No).
Regarding Step 2B of the analysis, claim 23 recites the additional element of a non-naturally occurring carrier but as discussed above, this limitation is recited at a high level of generality and is merely a drafting effort designed to monopolize the judicial exception rather thana meaningful limitation of the judicial exception. Therefore, the additional element of the carrier does not amount to significantly more than the judicial exception of a product of nature (Step 2B: No).
Claims 24-25 further limit the judicial exception by reciting accession numbers or DNA sequences of the bacteriophages. However, sequencing a genome and depositing a strain do not result in a markedly different characteristic in the claimed nature-based product (Step 2B: No).
Claim 35 recites that the composition is formulated for introduction to a plant via injection, spraying, misting, or dusting. The bacteriophage in the presence of any liquid carrier is inherently capable of performing the intended use of the composition. Therefore, the additional elements present in claim 35 do not amount to significantly more than the judicial exception of a product of nature (Step 2B: No).
Likewise, claim 36, which further limits the formulation to an injectable formulation, does not amount to significantly more than the judicial exception of a product of nature (Step 2B: No).
Claim 37 limits the concentration of the bacteriophage in the composition. However, there are no additional elements recited in the claim besides the amount of the naturally occurring bacteriophage (Step 2B: No).
Claim 38 further limits the intended use of the composition, but the additional limitations are insufficient to integrate the judicial exception into a practical application (Step 2A Prong Two: No and Step 2B: No).
Claims 39-44 further limit the composition by introducing additional phages. However, each of these phages are also naturally occurring (Step 2A Prong One: Yes). The specification discloses that the bacteriophages are isolated from the environment, a sewage treatment plant, or effluent, a plant, or a surface thereof or from the surrounding soil ([0006]). Xfas106-109 and Xfas306 were isolated from wastewater treatment plants (Specification [0112]). Xfas304 is isolated from environmental samples (Specification [0126]). Therefore, claims 39-44 are drawn to mixtures of naturally occurring phages. There is no evidence of record to support that the phages have markedly different characteristics when combined. Claims 39-44 do not recite additional elements besides the natural products themselves and their inherent characteristics, such as their genome sequences and the genes within their genomes, or strain deposit numbers (Step 2B: No).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
