Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 23-25 and 35-44 are pending and under examination on their merits. Claims 26-34 are cancelled.
The nonstatutory double patenting rejections over claims of U.S. Patent No. 12,024,703, 11,788,052, and 10,499,651 are withdrawn in view of the disclaimer terminal filed on 12/12/2026.
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
Applicant argues that the claims are eligible under 35 U.S.C. 101 because the composition comprising a non-naturally occurring carrier increases the virulence of the bacteriophage relative to the same bacteriophage in the absence of said composition or maintains the virulence of said bacteriophage for a longer period of time relative to the same bacteriophage in the absence of said composition, thus the bacteriophage in combination with the non-naturally occurring carrier in the composition has markedly different characteristics than a product of nature (Arguments, paragraph 2 on page 6).
These arguments are unpersuasive. First, the specification lacks written description support for the genus of compositions that increase bacteriophage virulence or maintain bacteriophage virulence for a longer period of time, so the claims are now rejected under 35 U.S.C. 112(a). Second, both the period of time and the increase in virulence are not limited to any specific amounts and thus the broadest reasonable interpretation of either limitation includes a trivial increase in virulence or a trivial increase in the period of time the bacteriophage maintains virulence. The only other component recited in the composition besides the bacteriophage itself is the non-naturally occurring carrier, which is recited at a very high level and the functional limitations do not rectify this because there is an absence of structure provided within the specification. Therefore, the limitations are merely equivalent to adding the words “apply it” to the bacteriophage. In summary, the claims are neither eligible under 35 U.S.C. 101 or 35 U.S.C. 112(a) (written description).
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.
(New Rejection Necessitated by Amendment) Claim 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 a plant disease biocontrol composition formulated for delivery to a plant, the composition comprising at least one non-naturally occurring carrier and at least one bacteriophage isolate of Xfas500 phage type…wherein the plant disease biocontrol composition increases the virulence of said bacteriophage relative to the same bacteriophage in the absence of said composition, or maintains the virulence of said bacteriophage for a longer period of time relative to the same bacteriophage in the absence of said composition. Claim 23 is indefinite because the composition comprises at least one non-naturally occurring carrier and at least one bacteriophage isolate of Xfas500 phage type. Since the wherein clause refers to “the composition” (which includes the bacteriophage) rather than the carrier, it is unclear whether the wherein clause is limiting the at least one non-naturally occurring carrier to only carriers that are capable of increasing or maintaining the virulence of the bacteriophage or whether the wherein clause is limiting some other (unspecified) component of the composition.
Claims 24-25 and 35-44 are rejected for depending from 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.
(New Rejection Necessitated by Amendment) 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 plant disease biocontrol composition increases the virulence of said bacteriophage relative to the same bacteriophage in the absence of said composition, or maintains the virulence of said bacteriophage for a longer period of time relative to the same bacteriophage in the absence of said composition.
The wherein clause is interpreted as limiting the at least one non-naturally occurring carrier.
The person of ordinary skill in the art would not have recognized that the inventors were in possession of the claimed genus of plant disease biocontrol compositions comprising at least one non-naturally occurring carrier that increases the virulence of the Xfas 500 phage type bacteriophage or maintains the virulence of the bacteriophage for a longer period of time 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 increase the virulence of said bacteriophage relative to the same bacteriophage in the absence of said composition, and 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, nor does not the specification exemplify any carriers that increase the virulence of the bacteriophage.
Frampton (International journal of microbiology 2012.1 (2012): 326452) 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). However, Frampton does not teach non-pathogenic mutants of Xylella fastidiosa or Xanthomonas that increase the virulence of bacteriophages.
Balogh et al. (Current pharmaceutical biotechnology 11.1 (2010): 48-57) 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). However, Balogh also teaches that these materials improve bacteriophage longevity (Table 2 caption), so “better control” likely results from the longevity of the bacteriophage and does not necessarily imply increased virulence. 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 UV A 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) 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. The prior art does not teach any species of non-naturally occurring carriers that increase bacteriophage virulence (i.e. increases the phage’s ability to harm or kill its bacterial host).
Based on the above analysis, the person of ordinary skill in the art would not have recognized that the inventors were in possession of the claimed genus of plant disease biocontrol carriers that increase bacteriophage virulence or maintain virulence for a longer period of time. 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.
(New Rejection Necessitated by Amendment) 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 plant disease biocontrol composition increases the virulence of said bacteriophage relative to the same bacteriophage in the absence of said composition, or maintains the virulence of said bacteriophage for a longer period of time 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, increases the virulence of the bacteriophage relative to the same bacteriophage in the absence of the composition or maintains the virulence of the bacteriophage for a longer period of time 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 the virulence increases or for how much longer the bacteriophage maintains virulence in the presence of the composition. Thus, even a trivial increase in virulence or 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. Furthermore, synthetic carriers for bacteriophage in plant disease biocontrol compositions are well-understood, routine, and conventional. See, for example, Balogh et al. (Current pharmaceutical biotechnology 11.1 (2010): 48-57; page 51, right column, Protective formulations, paragraph 1), which discusses the chemically processed polymer Casecrete NH-400. 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657