DETAILED ACTION
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 .
The amendment filed February 20, 2026 is acknowledged. Claims 1, 3-10, 12, 14-16, and 19-20 are pending in the application. Claims 2, 11, 13, 17-18, and 21 have been cancelled. Claims 1, 9, 12, and 14-16 are withdrawn from consideration.
Deposit of Biological Material
The present application employs specific phages. A deposit was made in this application as filed as indicated on P17-P18 and Tables 3a and 3b of the specification which also includes the deposit (accession) number, date of deposit, and name and address of the depository. Applicant’s representative provided a statement in the reply filed August 23, 2024 indicating that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent. Thus, the deposit meets all of the criteria set forth in 37 CRF 1.801 – 1.809.
Claim Objections
Claims 3 and 10 are objected to because of the following informalities:
In claim 3 at line 2, it is suggested to remove “and” after “in” and before “an”.
In claim 10 at lines 3-15, it is suggested to amend (i), (ii), (iii), (iv), (v), (vi), (vii), (viii), and (ix) to (ix), (x), (xi), (xii), (xiii), (xiv), (xv), (xvi), and (xvii), respectively.
Appropriate correction is required.
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 3-8, 10, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Czajkowski, “Bacteriophages of Soft Rot Enterobacteriaceae-a minireview” (hereinafter “Czajkowski”) in view of Burnett et al. US 20090246336 (hereinafter “Burnett”) and Sullivan, “Page Buffer” (hereinafter “Sullivan”).
With respect to claim 3, Czajkowski teaches a product (P5, Current Applications of SRE Bacteriophages).
It is noted that the recitation of “for the decontamination of food of one or more microorganisms” in the preamble of claim 3 is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the recitation of a liquid formulation comprising phages suspended in an added buffer, wherein the buffer comprises tris(hydroxymethyl)aminomethane, and wherein said phages comprise the listed group of phages in claim 3, Czajkowski teaches the product comprises bacteriophages (P5, Current Applications of SRE Bacteriophages). It is noted that the instant specification indicates (i) Phage deposited as NCIMB 42294 targets Pectobacterium atrosepticum and was isolated from water, (ii) Phage deposited as NCIMB 42296 targets Pectobacterium atrosepticum and was isolated from water, (iii) Phage deposited as NCIMB 42302 targets Pectobacterium sp. and was isolated from water, (iv) Phage deposited as NCIMB 42304 targets Dickeya solani and was isolated from potato stem (see P17-P18, Table 3a of the specification), (v) Phage deposited as NCIMB 43321 targets Pectobacterium sp., (vi) Phage deposited as NCIMB 43323 targets Pectobacterium brasiliense, (vii) Phage deposited as NCIMB 43325 targets Pectobacterium parmentieri, and (viii) Phage deposited as NCIMB 43327 targets Pectobacterium carotovorum (see P18, Table 3b of the specification 1). Additionally, the phages of Czajkowski target Pectobacterium spp., Pectobacterium brasiliense (Pectobacterium carotovorum subsp. brasiliense), Pectobacterium parmentieri (Pectobacterium wasabiae), Pectobacterium carotovorum, Pectobacterium atrosepticum, and Dickeya solani and may be isolated from potato stem, water, and potato tuber (P1, Introduction; P3, Table 1). Further, it is well understood in the art as described in Burnett that bacteriophages may be selected using information about the types of bacteria to be controlled, the reaction of potential bacteriophages with the bacteria, the activity of the bacteriophages against the target bacterial pathogens in the host, and the stability of the various bacteriophages in the host (paragraph [0033]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Czajkowski and Burnett, to select the presently claimed phages with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Czajkowski teaches Pectobacterium spp. and Dickeya spp. are necrotrophic bacterial pathogens, using phage applications for controlling bacterial infections in animals and plants, such as phage applications for prevention of potato tuber decay caused by P. atrosepticum and D. solani, bacteriophages are known to be extremely abundant in the biosphere, and bacteriophages are present everywhere where host bacteria persist (Abstract; P1, Introduction; P2, Initial SRE Bacteriophage Isolations 1st and 3rd paragraphs; and P4, Bacteriophages ᶲD3 and ᶲD3), Burnett teaches one skilled in the art can readily determine the appropriate bacteriophages to be included in the composition through routine experimentation (paragraph [0033]), and it would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success.
However, Czajkowski does not expressly disclose the product is a liquid formulation and the phages are suspended in an added buffer, wherein the buffer comprises tris(hydroxymethyl)aminomethane.
Burnett teaches a composition comprising at least one bacteriophage. The composition may be in the form of a liquid, and the phages are suspended in a buffer (paragraphs [0001], [0009], [0033], [0036], [0043], [0064], [0066], and [0095]).
Sullivan relates to a phage buffer. The buffer comprises Tris (tris(hydroxymethyl)aminomethane) and can be used for phage preparations (P1, Abstract and #6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Burnett and Sullivan, to select a liquid formulation and a buffer comprising tris(hydroxymethyl)aminomethane based in their suitability for their intended purpose in the product of Czajkowski with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Czajkowski, Burnett, and Sullivan similarly teach phages, Czajkowski and Burnett similarly teach products comprising phages as well as using the products in food against bacteria (Burnett: paragraphs [0001], [0027]-[0031], and [0064]; and Czajkowski:P5, Current Applications of SRE Bacteriophages), Burnett teaches the buffering agent stabilizes the bacteriophage and maintains the bacteriophage at a pH level that sustains the bacteriophage so that the bacteriophage remains viable to attack and eliminate target bacterial strains and the form of the composition depends on the manner of application (paragraphs [0009], [0043], and [0036]), and said combination would amount to the use of known elements for its intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
With respect to claims 4-8, modified Czajkowski is relied upon for the teaching of the formulation of claim 3 as addressed above.
Regarding the recitation of wherein the food is selected from the group listed in claim 4, wherein the one or more microorganisms are part of the microbial flora of the food as in claim 5, wherein the one or more microorganisms are a microbial contaminant or pathogens of the food in claim 6, wherein the one or more microorganisms are associated with spoilage, premature ripening and/or rotting of the food in claim 7, and wherein the formulation comprises one or more phage types specific for one or more microorganisms in claim 8, it is noted that these recitations relate to the intended use of the claimed formulation as discussed above in claim 3 and do not limit the structure of the claimed formulation. Additionally, the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art since modified Czajkowski teaches a formulation that is substantially similar to the presently claimed formulation as addressed above in claim 3. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Further, the prior art structure is capable of performing the intended use since Czajkowski teaches the product may be used as a biological control product against pathogenic bacteria in food production (P5, Current Applications of SRE Bacteriophages), and Burnett teaches the composition reduces or eliminates bacterial contamination in food (paragraphs [0001], [0027]-[0031], and [0064]). See MPEP 2111.02.
With respect to claim 10, modified Czajkowski is relied upon for the teaching of the formulation of claim 3 as addressed above.
Regarding wherein the formulation further comprises at least one of the phages listed in claim 10, Czajkowski teaches the product comprises bacteriophages (P5, Current Applications of SRE Bacteriophages). It is noted that the instant specification indicates (ix) Phage deposited as NCIMB 42290 targets Pectobacterium atrosepticum and was isolated from potato stem, (x) Phage deposited as NCIMB 42292 targets Pectobacterium atrosepticum and was isolated from soil, (xi) Phage deposited as NCIMB 42298 targets Pectobacterium atrosepticum and was isolated from potato tuber, and (xii) Phage deposited as NCIMB 42300 targets Pectobacterium atrosepticum and was isolated from water. Additionally, the phages of Czajkowski target Pectobacterium spp. and Pectobacterium atrosepticum and may be isolated from potato stem, soil, water, and potato tuber (P1, Introduction; P3, Table 1). Further, it is well understood in the art as described in Burnett that bacteriophages may be selected using information about the types of bacteria to be controlled, the reaction of potential bacteriophages with the bacteria, the activity of the bacteriophages against the target bacterial pathogens in the host, and the stability of the various bacteriophages in the host (paragraph [0033]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Czajkowski and Burnett, to select any of the presently claimed phages with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Czajkowski teaches Pectobacterium spp. are necrotrophic bacterial pathogens, using phage applications for controlling bacterial infections in animals and plants, such as phage applications for prevention of potato tuber decay caused by P. atrosepticum, bacteriophages are known to be extremely abundant in the biosphere, and bacteriophages are present everywhere where host bacteria persist (Abstract; P1, Introduction; P2, Initial SRE Bacteriophage Isolations 1st and 3rd paragraphs; and P4, Bacteriophages ᶲD3 and ᶲD3), Burnett teaches one skilled in the art can readily determine the appropriate bacteriophages to be included in the composition through routine experimentation (paragraph [0033]), and it would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success.
With respect to claim 19, modified Czajkowski is relied upon for the teaching of the formulation of claim 3 as addressed above.
Regarding the recitation of wherein the formulation is suitable for pouring, spraying or whipping onto a food, plant, or seed for decontamination in claim 19, it is noted that this recitation refers to an intended use of the claimed composition and does not limit the structure of the claimed composition. Additionally, the intended use recited in the present claim does not result in a structural difference between the presently claimed invention and the prior art since modified Czajkowski teaches a formulation that is substantially similar to the claimed formulation as addressed above in claim 3. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Further, the prior art structure is capable of performing the intended use since Czajkowski teaches the product may be used as a biological control product against pathogenic bacteria in food production (P5, Current Applications of SRE Bacteriophages), and Burnett teaches the composition reduces or eliminates bacterial contamination in food and can be applied by submersing, rising, coating, or spraying onto the food product (paragraphs [0001], [0027]-[0031], [0050], and [0064]). See MPEP 2111.02.
With respect to claim 20, modified Czajkowski is relied upon for the teaching of the formulation of claim 19 as addressed above.
Regarding the recitation of wherein the total phage content has a concentration of 102 pfu/ml, 103 pfu/ml, 104 pfu/ml, 105 pfu/ml, 106 pfu/ml, 107 pfu/ml, 108 pfu/ml, 109 pfu/ml, 1010 pfu/ml, or between 104 pfu/ml and 108 pfu/ml in claim 20, Czajkowski teaches the phage population may be as high as 108-109 phage particles per mL (P1, Introduction, 1st paragraph), and Burnett teaches the bacteriophage concentration may range from about 105 to about 1011 pfu/mL (paragraph [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed ranges, including the instantly claimed ranges of phage concentration, from the ranges disclosed in the prior art references. One of ordinary skill in the art would have been motivated to do so because Czajkowski and Burnett similarly teach products comprising phages, Czajkowski teaches the product may be used as a biological control product against pathogenic bacteria in food production (P5, Current Applications of SRE Bacteriophages), and Burnett teaches the composition reduces or eliminates bacterial contamination in food (paragraphs [0001], [0027]-[0031], and [0064]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Response to Arguments
Applicant’s reply filed February 20, 2026 is acknowledged.
Due to the amendments to the claims, the claim objections, the 35 USC 112 rejection, and the 35 USC 101 rejection in the previous Office Action have been withdrawn (P7-P9). However, the claim objections above are necessitated by the amendments made to the claims.
Applicant’s arguments have been fully considered, but they are unpersuasive.
Applicant argues the phages detailed in Czajkowksi are not the same as the phages in the instant claims. The phages recited in instant claim 3 are clearly from a different source and location and the person of ordinary skill in the art simply could not have arrived at the specific combination of phages recited in instant claim 3. The phages described in the present application were identified by the present inventors as being particularly useful as they provide an unexpectedly broad host range. Thus, they can be used in various combinations to provide highly effective formulations for decontaminating food. Different combination of phage give rise to different results. Accordingly, the claimed phage combination is not an arbitrary selection and is associated with an unexpected technical effect. The present inventors have demonstrated that the specific combination of phages of instant claim 3 are associated with a surprising technical effect which could not have been anticipated from the teachings of the prior art. There simply is no teaching or suggestion in Czajkowski which would have led the skilled person specifically to identify the specific combination of phages of claim 3, nor combine the specific phages as a liquid formulation as recited in instant claim 3 in the expectation of a favorable decontaminating effect against certain selection of bacterial species. The improved activity against a selected host range associated with the combination of the specific phages defined in claim 3 simply could not have been predicted from Czajkowski. The deficiencies of Czajkowski cannot be remedied by the teachings of Burnett as Burnett relates to bacteriophages which target Listeria and does not suggest the specific combination of phages recited in instant claim 3. The skilled person in the art simply could not have arrived at the specific combination phages recited in instant claim 3 in the expectation of achieving the technical effect identified by the instant inventors from the teachings of Czajkowski taken alone, or in combination with Burnett (P9-P15).
Examiner disagrees. The claimed combination of phages is obvious in view of the prior art. Applicant is reminded that obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006)
It is noted that the figures in the Supporting Documents as well as within the remarks are illegible. Nonetheless, Czajkowski is not limited to phages PP1 and Peat 1 since the reference teaches bacteriophages are present everywhere where host bacteria persist and may be isolated from various sources (P1, Introduction). Also, the instant specification indicates (i) Phage deposited as NCIMB 42294 targets Pectobacterium atrosepticum and was isolated from water, (ii) Phage deposited as NCIMB 42296 targets Pectobacterium atrosepticum and was isolated from water, (iii) Phage deposited as NCIMB 42302 targets Pectobacterium sp. and was isolated from water, (iv) Phage deposited as NCIMB 42304 targets Dickeya solani and was isolated from potato stem (see P17-P18, Table 3a of the specification), (v) Phage deposited as NCIMB 43321 targets Pectobacterium sp., (vi) Phage deposited as NCIMB 43323 targets Pectobacterium brasiliense, (vii) Phage deposited as NCIMB 43325 targets Pectobacterium parmentieri, and (viii) Phage deposited as NCIMB 43327 targets Pectobacterium carotovorum (see P18, Table 3b of the specification 1). Additionally, the phages of Czajkowski target Pectobacterium spp., Pectobacterium brasiliense (Pectobacterium carotovorum subsp. brasiliense), Pectobacterium parmentieri (Pectobacterium wasabiae), Pectobacterium carotovorum, Pectobacterium atrosepticum, and Dickeya solani and may be isolated from potato stem, water, and potato tuber (P1, Introduction; P3, Table 1). Further, it is well understood in the art as described in Burnett that bacteriophages may be selected using information about the types of bacteria to be controlled, the reaction of potential bacteriophages with the bacteria, the activity of the bacteriophages against the target bacterial pathogens in the host, and the stability of the various bacteriophages in the host (paragraph [0033]).
Thus, one of ordinary skill in the art would have been motivated to select the presently claimed phages with the expectation of successfully preparing a functional product because Czajkowski teaches Pectobacterium spp. and Dickeya spp. are necrotrophic bacterial pathogens, using phage applications for controlling bacterial infections in animals and plants, such as phage applications for prevention of potato tuber decay caused by P. atrosepticum and D. solani, bacteriophages are known to be extremely abundant in the biosphere, and bacteriophages are present everywhere where host bacteria persist (Abstract; P1, Introduction; P2, Initial SRE Bacteriophage Isolations 1st and 3rd paragraphs; and P4, Bacteriophages ᶲD3 and ᶲD3), Burnett teaches one skilled in the art can readily determine the appropriate bacteriophages to be included in the composition through routine experimentation (paragraph [0033]), and it would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success.
Further, the features as described by Applicant are indeed expected in view of the prior art since Czajkowski teaches the product may be used as a biological control product against pathogenic bacteria in food production (P5, Current Applications of SRE Bacteriophages), and Burnett teaches the composition reduces or eliminates bacterial contamination in food (paragraphs [0001], [0027]-[0031], [0050], and [0064]). Burnett also teaches one skilled in the art can readily determine the appropriate bacteriophages to be included in the composition through routine experimentation (paragraph [0033]). Thus, Applicant has failed to show new and unexpected features of the claimed invention. Applicant is remined that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In other words, the unexpectedness must be sufficient “to secure the validity of the claims in suit.” Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1381 (Fed. Cir. 2005) and MPEP 716.02.
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.
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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