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 preliminary amendment filed on 3/28/2025 is acknowledged. Claims 1-14 are cancelled. New claims 15-25 are added. Claims 15-25 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 3/28/2025 has been considered. A signed copy is enclosed.
Claim Rejections - 35 USC § 102
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.
Claims 15 and 17-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maragos and McCormick (Food Agricultural Immunol., 12:3, 181-192, 2000; IDS filed 3/28/2025).
The instant claims are drawn to methods of protecting animals against DON induced mycotoxicosis comprising systemically administering conjugated DON to the animal.
Maragos et al disclose a method where mice were immunized with a DON-OVA conjugate (see page 184, paragraph 2). The mice were immunized 2-3 times and the DON-OVA was in an oil in water emulsion (Freund’s adjuvant) (see page 184, paragraph 2). The mice were immunized at an unknown age, then immunized again 8 weeks later. Therefore, conjugated DON was administered to the animal older than 6 weeks. If the method works as applicant claims, the animals would necessarily have been protected against the issues recited in claim 26.
Claims 15 and 18-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pichler et al (Mycotoxin Res. 2001 Jun:17 Suppl 2:202-5; IDS filed 3/28/2025).
The instant claims are drawn to methods of protecting animals against DON induced mycotoxicosis comprising systemically administering conjugated DON to the animal.
Pichler et al disclose a method where chickens where immunized with DON conjugated to KLH. The chickens were immunized multiple times and the DON-KLH was in an oil in water emulsion (Freund’s adjuvant) (see page 203, paragraph 2). If the method works as applicant claims, the animals would necessarily have been protected against the issues recited in claim 26.
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.
Claims 15-16 and 18-25 are rejected under 35 U.S.C. 103 as being unpatentable over Pichler et al (Mycotoxin Res. 2001 Jun:17 Suppl 2:202-5) in view of Eto et al (Brazilian J. Poultry Sci., 14:63-66, 2012).
The instant claims are drawn to methods of protecting animals against DON induced mycotoxicosis comprising systemically administering conjugated DON to the animal.
Pichler et al disclose a method where chickens where immunized with DON conjugated to KLH. The chickens were immunized multiple times and the DON-KLH was in an oil in water emulsion (Freund’s adjuvant) (see page 203, paragraph 2). If the method works as applicant claims, the animals would necessarily have been protected against the issues recited in claim 26.
Pichler et al differs from the instant invention in that they do not teach that the immunization was intramuscular, oral, or intradermal.
Eto et al state that, in chickens, intramuscular immunization is the most efficient route for total antibody production in the primary immune response (see abstract).
It would have been obvious to one of ordinary skill in the art, at the time of invention, to utilize intramuscular immunization in the immunization method of Pichler because intramuscular immunization is the most efficient route for total antibody production in the primary immune response. One would have had a reasonable expectation of success because intramuscular immunization is a commonly used route and because Eto showed that this route is the most efficient route for total antibody production in the primary immune response.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15-16 and 18-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12280035. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The patented claims clearly anticipate the instant invention. The only difference between the patented claims and the instant claims is that the patented claims require the animal to be aged 6 weeks or younger.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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