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 6/16/26.
Claims 1-7 and 13-18 are under consideration in the instant application.
3. IN light of Applicant’s response filed on 6/16/26, the rejection under 35 U.S.C. 112(a)(see sections 6-7 of the office action mailed on 2/13/26) has been withdrawn.
4. The following rejections remain.
6. 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.
7. 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.
8. 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) for the reasons set forth in the office action mailed on 2/13/26.
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.
Applicant’s response filed on 6/16/26 has been fully considered but they were not persuasive.
Applicant has asserted that the teachings of the Polonelli are related to conjugated AFB that is structurally modified AnAFB1. The AnAFB1 is chemically modified non-toxic derivative of AFB. The reference fails to teach all the limitations of the claimed invention.
Unlike Applicant’s assertion, the instant specification in p.6 includes AFB1 and AFB2. In Pollonelli reference, p. 2, under ELISA titration of anti-AFB1 antibodies, the reference discloses administering cows with AFB1-BSA readable upon claimed method. As such, the reference remains anticipatory reference and the rejection is maintained.
9. 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.
10. 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, of record) in view of Meissonnier et al (Toxicology and Applied Pharmaceology, vol. 231, p. 142-149, 2008, of record) for the reasons set forth in the office action mailed on 2/16/26.
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.
Applicant’s response filed on 6/16/26 has been fully considered but they were not persuasive.
Applicant has asserted that Pollonelli reference teaches non-toxic chemically modified AnAFB1 and the combination of the references teaches away from using conjugated AFB. Further, Applicant has asserted that the claimed invention showed unexpected results including safely administered without prior detoxification, robust anti-AFB antibody response and neutralizing AFB toxicity.
As discussed above in section 8 of this office action, the teachings of the Pollonelli reference is not limited to AnAFB1 but teaches conjugated AFB1 as well. Further, the production of higher antibody titer and no prior detoxication of AFB1 was observed in Pollonelli. As such, the asserted unexpected results are deemed expected properties of conjugated AFB1. Applicant is advised to recite ascertaining properties of unexpected properties. The combination of the references remains obvious and the rejection is maintained.
11. No claims are allowable.
12. THIS ACTION IS MADE FINAL. 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.
13. 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
August 5, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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