DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-7 and 13-18 are pending upon entry of amendment filed on 6/15/23.
The instant application has 2 independent claims and relates method of protecting an animal against aflatoxin B (AFB) comprising administering a conjugated AFB and a vaccine comprising the conjugated AFB.
3. Applicant’s IDS filed on 12/20/24 and 1/27/26 have been acknowledged.
4. The oath filed on 6/15/23 has been acknowledged.
5. Applicant’s claim for foreign priority under 35 U.S.C. (a)-(d) is acknowledged.
6. 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.
7. Claims 1-7 and 13-18 rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of increasing serological response in exhibiting higher titer of anti-Aflatoxin antibody upon administering a conjugated AFB or a vaccine comprising a conjugated AFB thereof, does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would use a conjugated aflatoxin in actively protecting against aflatoxin induced mycotoxicosis other than exhibiting IgG titer increase against AFB1. In specification p. 9, the protection for mycotoxicosis includes protection against a decrease in average daily weight gain, immune suppression, icterus, or hemorrhagic enteritis and these are considered as a sign of mycotoxicosis induced by AFB.
Examples 5-9 showed anti-AFB antibody titer increase upon administration of a conjugated AFB in various animals including swine, fish and chicken. Further, the instant application uses Examples 7 and 9 in in vitro assays in neutralizing AFB effect in C6 cells but no studies in showing protection as seen in decrease in average daily weight gain, immune suppression, icterus, or hemorrhagic enteritis that are considered symptoms of mycotoxicosis induced by AFB. At most, the higher antibody titer may be indication of reduction of AFB in milk transfer in cows (Giovati et al, Annals of Vaccines and Immunization, vol. 2(1):1010, p. 1-7, 2015, IDS reference). In page 2, the table 1 indicates Aflatoxin has biological effect of carcinogenic, mutagenic, immunotoxic, immunosuppressive, hepatotoxic or teratogenic and p.5 discloses that the AFB-KLH conjugates with Freund adjuvant improves reduction of toxic AFB transfer in milk of cows.
As such, reduction of toxin transfer in milk may be a species of “active protection” of AFB induced mycotoxicosis cannot be extrapolated any active protection defined by the instant specification in p.9. The dose of the conjugated AFB is 12.5ug per 20g of fish or 80ug/ml of toxin in cell assays used. It is unpredictable to develop method of preparing vaccine composition in eliciting actively protection of AFB induced mycotoxicosis encompassed by the claimed method. One exemplary dose in 20g of fish disclosed in the example 9 cannot be extrapolated to various protection method encompassed by the claimed invention.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
8. 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 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.
9. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claim(s) 1-3, 7, 14-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Polonelli et al ( PLoS one, vol. 6, issue 10, p. 1-9, e26777, 2011).
Polonelli et al. teach vaccination of conjugated AFB-KLH in cows intramuscularly (p. 6-7) to control AFB effect in cows and milk production (abstract, p. 6-7). The administration of the composition comprising AFB-KLH is in Freund’s adjuvant (readable upon emulsion of oil and water and oil-in water emulsion) results in reduction of transfer of toxin in milk and increases antibody titer (p. 2-4). Further, the composition comprising AFB-KLH in Freund’s adjuvant is considered as vaccine and claims 14-16 are included in this rejection.
Fig 2 indicates multiple immunization of cows and claim 7 is included in this rejection. Given that the AFB conjugation is achieved with KLH, protein mass having above 10,000Da is achieved and claims 17-18 are included in this rejection. Therefore, the reference teachings anticipate the claimed invention.
11. 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 of this title, 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.
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.
12. Claims 1-7 and 13-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Polonelli et al (PLoS one, vol. 6, issue 10, p. 1-9, e26777, 2011) in view of Meissonnier et al (Toxicology and Applied Pharmaceology, vol. 231, p. 142-149, 2008).
The teachings of the Polonelli reference have been discussed, supra.
The disclosure of the Pollonelli reference differs from the instant claimed invention in that it does not teach the administration of conjugated AFB-KLH to swine of younger than 3 weeks as in claims 4-6 and 14 of the instant application.
Meissonnier et al. teach immunotoxicity of aflatoxin B in 3 week old weaned pigs and the pigs are very sensitive to the toxin and contamination to the toxin decrease lymphocyte proliferation and antigen specific stimulation (p. 143-148).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to include 3 week old pigs as taught by the Meissonier reference into the method and vaccine composition taught by Polonelli reference.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the 3 week old pigs are very prone to AFB toxin and the toxin reduces immunity of the animal and administration of AFB-KLH prevents or reduces toxin effect in animals.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
13. No claims are allowable.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
February 5, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641