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
The amended claim set filed on 12 November 2025 is acknowledged. Claims 1-8 and 14 are currently pending. Of those, claims 3 and 8 are amended. There are no new claims and no claims are withdrawn. Claims 9-13 and 15-19 are cancelled. Claims 1-8 and 14 will be examined on the merits herein.
Response to Amendment
The Applicants’ arguments filed 12 November 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 13 August 2024 will be referred to “NFOA”.
Objection(s) and Rejection(s) Withdrawn
The objections to claims 3 and 8 are withdrawn in view of the claim amendments.
The rejection of claims 1-8 and 14 under 35 U.S.C. 103 is withdrawn in view of the statement of Common Ownership under 35 U.S.C. 102(b)(2)(C), stating that the instant application and PCT/EP2020/068599 (published as WO2021/001462) were owned by the same owner no later than the effective filing date of the instant invention.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 102
Claims 1-4 and 8 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei and Chu (1987, Anal. Biochem.; cited in IDS; herein “Wei”) for the reasons of record and the reasons herein.
Regarding claims 1-2, Wei teaches a method comprising administering to rabbits a T-2 toxin conjugated to bovine serum albumin (Abstract and pg. 403, paragraph bridging columns). Wei reports that the immunized rabbits had a quick immune response and high antibody titers after immunization.
Regarding claims 3-4, Wei teaches that the conjugated T2 was administered intradermally (pg. 403, paragraph bridging columns).
Regarding claim 8, Wei teaches that the rabbits received booster injections, i.e., the conjugated T2 was administered at least twice (pg. 403, paragraph bridging columns).
Response to Arguments
Applicant argues (Remarks, pg. 4-5) that Wei does not teach or suggest the method of protecting an animal against T-2 toxin (T2) induced mycotoxicosis, as in claim 1, and is silent on a method to protect against a symptom of T-2 mycotoxicosis, as in claim 2.
This argument has been fully considered but is not persuasive. Applicant’s arguments rely on language solely recited in preamble recitations in claim 1. When reading the preamble in the context of the entire claim, the recitation "A method of protecting an animal against T-2 toxin (T2) induced mycot is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. In this case, the preamble of claim 1 recites an intended use of the claimed invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding the intended use of “protecting an animal against T-2 toxin (T2) induced mycotoxicosis” and the argument that Wei is silent on a method to protect against a symptom of T-2 mycotoxicosis, MPEP 2112.01(I) states: “Where the claimed and prior art products are identical or substantially identical in structure or composition,… a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)…. the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.” In this case, the conjugated T-2 taught by Wei is substantially identical to the product recited in the instant claims (i.e., a conjugated T2) and is administered to the same subject recited in the instant claims (i.e. an animal); therefore, the properties of protecting against T2 induced mycotoxicosis and protecting against one or more of the clinical signs of mycotoxicosis when administered to an animal are presumed to be inherent. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See also MPEP 2112.02(II), which states: “when the claim recites using an old composition or structure and the ‘use’ is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).”
New Rejection(s)
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 1-2, 5-7, and 14 are newly rejected under 35 U.S.C. 103 as being unpatentable over Manohar (1985, “Development of Vaccines to the Mycotoxin T-2”; herein “Manohar”) as evidenced by Zegpi et al. (2019, Avian Dis.; herein “Zegpi”) in view of Yohannes et al. (2012, Vet. Immunol. Immunopathol.; herein “Yohannes”).
Regarding claims 1-2, Manohar teaches a method comprising administering to mice T-2-HS coupled to KLH and monoclonal anti-IgD (i.e., a conjugated T2) (pg. 7, para. 3). Rats which were immunized with the conjugated T2 developed delayed and less intense reactions when challenged dermally, indicating the immunization was protective against skin damage due to T2 exposure (Table 3 and para. bridging pg. 7-8). Manohar is silent on the age of the mice to which the T2 conjugate was administered.
However, Manohar does not teach a method in which the conjugated T2 is administered to an animal less than 6 weeks or 4 weeks old, as in claims 5 and 6, or to an animal 1-3 weeks old as in claim 7, or an animal that is a swine or chicken, as in claim 14.
Regarding claims 5-7 and 14, Yohannes teaches that T-2 induced mycotoxicosis is a common and important disease that hampers the poultry industry and that the T-2 mycotoxin, which is a common contaminant in poultry feed, has immunosuppressive properties that lead to increased susceptibility to infection and failure of the infectious bronchitis virus (IBV) vaccine (pg. 246, left col., para. 1 and 3-4 and pg. 252, left col., para. 2), which is typically given to 1 day old chicks (as is evidenced by Zegpi, pg. 303, left col., para. 1). Yohannes teaches that four week old broiler chickens exposed to T-2 toxin in their feed and co-infected with IBV had significantly lower IBV titers measured by ELISA than IBV-infected broiler chickens that did not have toxin in their feed (Abstract and Table 3). Yohannes also teaches that haemagglutination inhibition (HI) testing was used to measure the humoral immune response of broiler chickens using Newcastle disease F strain virus (NDF or ND) as an indicator (section 2.5.2, para. 1). The HI test showed that broiler chickens as young as four weeks old had decreased ND titers when exposed to T-2 toxin in their feed (Abstract and Table 2). Yohannes is silent on IBV or ND titers in chickens less than four weeks old.
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to administer the T2 conjugate of Manohar to the population of broiler chickens taught by Yohannes (i.e., broiler chickens as young as one week old), thereby arriving at the invention of claims 1-2, 5-7, and 14. The person of ordinary skill in the art would have been motivated to make the modification because Manohar teaches that immunization with T2 conjugate confers protection against T-2-induced mycotoxicosis, and Yohannes teaches that chickens as young as one week old can be exposed to T-2 toxin in their feed and that exposure to the mycotoxin leads to immunosuppression which causes vaccine failure. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of successfully administering the T-2 conjugate to one- to six-week-old mice because Yohannes teaches that unconjugated T-2 toxin may be administered to chickens as young as one week old, and one of ordinary skill in the art would expect that conjugated T-2 toxin may be administered to the same population of broiler chickens. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., administration of conjugated T-2 toxin and administration to 1- to 6-week-old chickens) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DANIEL KOLKER can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BAILEY M MORGAN/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645