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 .
Claim Status
Claims 1-12 are rejected.
No claims are allowed.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 06-Feb-2025 and 22-Jul-2025 has been considered by the examiner.
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.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prieto et al. (Botrytis cinerea Pers. in postharvest apple fruit, control with Candida oleophila Montrocher strains and/or synthetic fungicides, 2019) (hereinafter Prieto).
With regards to claims 1-3, Prieto discloses "[t]he Candida oleophila L06, L07 smooth and L07 rugose strains (i.e. a bio-control agent) can grow and can be combined with Cyprodinil (i.e., anilino-pyrimidine) +Fludioxonil, Benomyl (i.e., benzimidazole), and Thiabendazole (i.e. at least one synthetic fungicide such as benzimidazole of claim 1)." Candida oleophila L06, L07 smooth and L07 rugose, when combined with Benomyl, Thiabendazole and Cyprodinil+Fludioxonil may have some degree of synergism between each one of them to control the damage due to Botrytis cinerea on postharvest Golden Delicious apple fruit (Page 80, Discussion and conclusion).
With regards to claim 4, Prieto discloses that “[w]ells were inoculated, before inoculation with Botrytis cinerea, with 20 μl of a 1.1x109 cfu/mL suspension of each one of the three Candida oleophila strains, depending on treatment, and then 20 μl of each fungicide doses were applied in the well, of those used, according with treatment" (Page 73, Method).
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
1. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prieto et al. (Botrytis cinerea Pers. in postharvest apple fruit, control with Candida oleophila Montrocher strains and/or synthetic fungicides, 2019) as applied to claim 1 above.
The teachings of Prieto are discussed above.
Prieto does not teach that the biologically effective amount of Candida oleophila is 0.1x101 cfu/g to 5 x1015 cfu/g of the combination.
However, Prieto further discloses that using Candida oleophila as an alternative method to control Botrytis cinerea damage on postharvest apple fruit means a reduction of synthetic fungicide use, plus avoiding fungicide residues on the treated apple fruit and on the environment, thus reducing the risk for human health damage (abstract).
Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of Candida oleophila through routine experimentation based on the level of synthetic fungicide reduction desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
2. Claim(s) 6-9, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prieto et al. (Botrytis cinerea Pers. in postharvest apple fruit, control with Candida oleophila Montrocher strains and/or synthetic fungicides, 2019) (hereinafter Prieto) in view of Pusey et al. (US 4,764,371, Patent: 16-Aug-1988, Filed: 13-Nov-1985) (hereinafter Pusey).
The teachings of Prieto are discussed above. Regarding claims 7 and 8, Prieto discloses both possible order of Candida oleophila and a fungicide application: “Wells were inoculated, before inoculation with Botrytis cinerea, with 20 μl of a 1.1x109 cfu/mL suspension of each one of the three Candida oleophila strains, depending on treatment, and then 20 μl of each fungicide doses were applied in the well, of those used, according with treatment” (Method, Page 73) and “Growing media used was PDA (potato, dextrose, agar, 39 g/lt) and the fungicides were mixed with the PDA. Once the Petri dishes with PDA plus the fungicide were inoculated, they were incubated at 22°C for one week” (Method, Page 73). Claim 12 is met since Prieto discloses “Cyprodinil+Fludioxonil (Switch ® 62.5 WG Syngenta), 0.75, 1.0, 1.5 g/l; Benomyl (Benlate ® 50 PM Du Pont), 0.25, 0.5, 0.75 g/l; Thiabendazole (Tecto ® 60 Syngenta) 0.25, 0.5, 0.75 g/l; and Captan (Captan ® 50 WP Adama Mexico), 1.5, 2,0, 2.5 g/l” (Method, Page 72).
Prieto does not teach a method comprising sanitizing the agricultural produce or applying a coating material to the agricultural produce.
However, Pusey discloses a method for treating postharvest stone fruit to prevent or inhibit brown rot of stone fruit with effective amounts of Bacillus subtilis (abstract). Since mycrobiocides are mixed in the hydrocooling water of commercial packing houses, one would not have expected B. subtilis to be compatible with such chemicals (col. 3, lines 13-17). It was totally unexpected for B. subtilis to (a) undergo normal respiration when covered with or incorporated into waxes which are used as carriers in coating of fruit in commercial fruit-packing operations and (b) adapt to the microenvironment on wax-coated fruit (col. 3, lines 7-12).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have applied the composition of Prieto to a sanitized fruit since biological control agents have been shown to be compatible with mycrobiocides present on fruits from hydrocooling water of commercial packing houses as taught by Pusey.
It would have been prima facie obvious to one of ordinary skill in the art to have applied the composition of Prieto with a coating material since this is a known and effective method to apply a biological control agent onto fruits as taught by Pusey.
3. Claim(s) 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prieto et al. (Botrytis cinerea Pers. in postharvest apple fruit, control with Candida oleophila Montrocher strains and/or synthetic fungicides, 2019) as applied to claim 1 above, and in view of Pusey et al. (US4764371, Patent: 16-Aug-1988, Filed: 13-Nov-1985) (hereinafter Pusey) and Hu et al. (Preparation of a multilayer antibacterial film and its application for controlling postharvest disease in temperate fruit (including apple, pear, and peach) under ambient storage, 11-Sep-2023) (hereinafter Hu).
Prieto teaches the biocontrol of post harvest produce using a combination of Candida oleophila and a synthetic fungicide as applied to claim 1 discussed supra. Prieto further teaches that applying the Candida oleophila and synthetic fungicide to post harvest apple fruit in a laboratory well assay, wherein the Candida oleophila suspension were applied to inoculated well accordingly with treatment (Page 73, Method).
However, Prieto does not teach a method comprising applying a coating material to the agricultural produce, and does not teach applying the biocontrol and fungicide combination after applying such a coating as recited in claim 10. For this reason, Pusey and Hu are added.
Pusey teaches a post harvest biological control method in which biocontrol treatment is incorporated into the standard commercial post harvest handling used in packing houses (Col 3, line 13-17). Hu teaches a post harvest antimicrobial/antibacterial multifilm coating applied to fruit to control post harvest disease during storage, teaching that such coatings are applied to the fruit surface as a finishing layer or protective layer to extend shelf life and control decay related pathogens (Page 5188, Abstract).
It would have been obvious to a person having ordinary skill in the art to modify Prieto’s Candida oleophila and synthetic fungicide combination such that it is applied to the agricultural produce after a coating material, as taught by Pusey and Hu, has been applied to that produce. One would be motivated to apply Prieto’s biocontrol and fungicide combination after the coating step because Pusey and Hu demonstrate that coating materials such as wax finishes and antimicrobial films are standard and known components of commercial post harvest fruit handling used to the protect the fruit surface and extend storage like. A skilled artisan would have recognized that deploying Prieto’s demonstrated disease control combination in a packing house setting would need to determine the order in which the biocontrol/fungicide treatment is applied relative to the standard coating step. Applying the Candida oleophila and fungicide combination after the coating step would produce a treated fruit product having both a protective and finished surface coating and a topically deposited biocontrol agent and fungicide, and could maximize direct contact with antagonistic organisms. Pusey and Hu both establish that applying a coating layer as a discrete step in post harvest fruit handling is conventional and separate from applying a biocontrol treatment. Because the relative order of applying a biocontrol and fungicide treatment before or after a coating step is a finite number of predictable sequencing options routinely selected based on packing house production workflow and desired efficiency, a skilled artisan would have found it obvious to apply Prieto’s combination after the coating step as one of a limited number of predictable alternatives.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Prieto with the coating steps of Pusey and Hu to arrive at the method of claim 10, and represents combining prior art elements according to known methods to yield predictable results.
4. Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prieto et al. (Botrytis cinerea Pers. in postharvest apple fruit, control with Candida oleophila Montrocher strains and/or synthetic fungicides, 2019) as applied to claim 1 above, and in view of Pusey et al. (US4764371, Patent: 16-Aug-1988, Filed: 13-Nov-1985) (hereinafter Pusey) and Ballet et al. (Efficacy of Candida oleophila, strain O, in preventing postharvest diseases of fruits, 2015) (hereinafter Ballet).
The teachings of Pusey are discussed above. Pusey does not teach a g/L application rate for the Candida oleophila biocontrol component.
This deficiency can be filled by Ballet which discloses that the commercial Candida oleophila product “NEXY® was applied at 233 g 100 L-1 corresponding to 33 g of NEXY® Biomass mixed to 200 g of NEXY additive” (Page 106, Biocontrol agent) (i.e. 2.33 g/L Candida oleophila) in fruits such as apples, citrus fruits, and bananas.
Ballet’s disclosed rate of 233 g/100L or 2.33 g/L falls within the claimed 0.1 to 10 g/L range, and routine scale up of a known and effective biocontrol treatment agent to the commercial line fruit packing context with a conversion of dosing units is well within ordinary skill.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for a person having ordinary skill in the art to convert the units and optimize Prieto’s concentration of Candida oleophila to the commercial concentration of Ballet to fall in the claimed range of 0.1 g/L to 10 g/L.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENHAN LI whose telephone number is (571)272-9143. The examiner can normally be reached Monday-Friday 7:30 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.L./Examiner, Art Unit 1614 /ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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