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 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 1-3, 8, 15, 16, 17, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fukuda et al (Fukuda, Satoshi, et al. "Preparation and characterization of anti-fumonisin monoclonal antibodies." Bioscience, biotechnology, and biochemistry 58.4 (1994): 765-767), hereinafter Fukuda, as evidenced by Jensen et al (Jensen, FC et al. “Adjuvant activity of incomplete Freund's adjuvant.” Advanced drug delivery reviews vol. 32,3 (1998): 173-186. doi:10.1016/s0169-409x(98)00009-x), hereinafter Jensen.
Fukuda teaches the generation of antibodies against fumonisin B1 (FB1) via the immunization of mice with conjugated-FUM. Here, FBI was conjugated, using glutaraldehyde, with ovalbumin (OVA) or keyhole limpet hemocyanin (KLH) for use as an immunogen (FBI-OVA and FBI-KLH). Eight-week-old BALB/c female mice were immunized by intraperitoneal injections. The first injection consisted of 100 uL of conjugate in PBS and the same volume of Freund's complete adjuvant – a water-in-oil emulsion. The second injection (day 15) consisted of 100 uL each of conjugate in PBS and Freund's incomplete adjuvant (Abstract and Page 765). Freund’s complete and incomplete adjuvants are water-in-oil emulsion adjuvants used for vaccine delivery as evidenced by Jensen (Jensen et al, see Abstract and 1st para. of Introduction). Per the instant claims, the minimal steps required for protecting an animal against fumonisin (FUM)-induced mycotoxicosis is administering conjugated FUM to the animal. As such, the methods disclosed by Fukuda would necessarily be capable of protecting an animal against fumonisin (FUM)-induced mycotoxicosis. It is noted that the primary “wherein” clause recited in claim 2—“wherein the method protects the animal against one or more clinical signs of FUM-induced mycotoxicosis”—merely states the intended result of the claimed method and thus does not provide patentable distinctiveness to the claimed methods. The only positive limitation in the claim is the administering step; and the courts have held that a “…whereby [or, in this case, wherein] clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”) (quoting Minton v. Nat’l Ass’n ofSecurities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) (see MPEP 2111.04). Further, the term “vaccine” in the preamble of claim 14 is the intended use of the composition, but does not result in any structural difference between the claimed invention and the prior art. As such, a composition comprising an adjuvant and a pharmaceutically acceptable carrier (in this case, Freund’s complete/incomplete adjuvant, PBS, and conjugated-FUM) is suitable as a vaccine. Lastly, per the instant claims, the KLH and OVA are proteins having a molecular mass above 10.000 Da.
Thus, Fukuda meets the limitations of instant claims 1-3, 8, 15, 16, 17, 18, and 19.
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fukuda, as applied to claims 1-3, 8, 15, 16, 17, 18, and 19 above, and further in view of Skountzou et al (US20170100477A1), hereinafter Skountzou.
The teachings of Fukuda have been discussed above and differ from the instantly claimed invention in that it is not specifically taught that the conjugated FUM vaccine is administered to an animal intradermally, orally, and/or intramuscularly.
However, Skountzou teaches that that immunogenic compositions comprising an antigen or vaccine and an adjuvant can be delivered to a subject by several routes of administration, including mucosal (e.g. oral) or parenteral (e.g. intradermal or intramuscular) (Abstract, Para. 0031, Para. 0077), wherein the subject is any animal (Para. 0037).
It would have been obvious to one of ordinary skill in the art to modify the method of immunizing animals with conjugated-FUM disclosed by Fukuda such that the conjugated-FUM is administered orally, intradermally, or intramuscularly. One of ordinary of skill in the art would have been motivated to do so since immunization of animals with an antigen/vaccine and adjuvant can occur by several routes of administration, including orally, intradermally, intramuscularly as taught by Skountzou. Therefore, one of ordinary skill in the art would reasonably expect that oral, intradermal, or intramuscular administration of conjugated-FUM to an animal can effectively protect the animal against FUM-induced mycotoxicosis.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda, as applied to claims 1-3, 8, 15, 16, 17, 18, and 19 above, and further in view of Emery et al (US5906826A), hereinafter Emery.
The teachings of Fukuda have been discussed above and differ from the instantly claimed invention in that it is not specifically taught that the conjugated FUM is administered to an animal at an age of 6 weeks or younger, 4 weeks or younger, or 1-3 weeks of age.
However, Emery teaches a method of priming an immune response in the presence of maternal antibodies in a young animal over an extended time so that the animal will produce a secondary active immune response substantially immediately upon contact with the immunogen when passive protection is no longer provided by circulating maternal antibodies, the method comprising administering to a 1–90-day old animal an immunogenic agent (see Abstract and Col. 2, Ln. 29-40), wherein the immunogenic agent can be derived from fungi and/or is a toxin (Col. 2, Ln. 58-67; and Col. 5, Ln. 46-48). A young animal that is 1-90 days old encompasses those that are 6 weeks or younger, 4 weeks or younger, and 1-3 weeks of age per the instant claims.
It would have been obvious to one of ordinary skill in the art to modify the method of immunizing an animal with conjugate-FUM disclosed by Fukuda such that the animal is a young animal that is 1-90 days old. One of ordinary skill in the art would have been motivated to do so in order to prime an immune response in the young animal such that the animal will produce a secondary active immune response upon contact with the immunogen when passive protection is no longer provided by circulating maternal antibodies as taught by Emery. Therefore, one of ordinary skill in the art would reasonably expect that administration of conjugated-FUM to a young animal 1-90-days old can effectively protect the animal against FUM-induced mycotoxicosis.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Fukuda, as applied to claims 1-3, 8, 15, 16, 17, 18, and 19 above, and further in view of Yang et al (Yang, Changwon, Gwonhwa Song, and Whasun Lim. "Effects of mycotoxin-contaminated feed on farm animals." Journal of Hazardous Materials 389 (2020): 122087), hereinafter Yang.
The teachings of Fukuda have been discussed above and differ from the instantly claimed invention in that it is not specifically taught that the animal administered conjugated FUM is swine or chicken.
However, Yang teaches that mycotoxins such as fumonisins are secondary products produced by fungi in cereals and are frequently found in the livestock industry as contaminants in farm animal feed. Exposure to mycotoxins can cause immunotoxicity and impair reproductive function in farm animals. In addition, exposure of tissues, such as the kidneys, liver, and intestines, to mycotoxins can exert histopathological changes that can interfere with animal growth and survival. Pigs and poultry are the most susceptible and sensitive farm animals to the effects of mycotoxins. For example, fumonisin B1 (FB1) is reported to cause porcine pulmonary edema. Moreover, when exposed to pigs, FB1 is associated with the development of disorders such as pulmonary edema and liver failure. FB1 causes pig intestinal disorders by increasing the level of free sphingolipid bases and reducing the number of glycolipids in the plasma membrane. Moreover, FB1 causes a reduction in feed intake, egg production, and body weight in poultry, while also causing disorders such as hepatic necrosis and thymic cortical atrophy (see Abstract and Section: 3.3. Effects of fumonisins on farm animals and Figure 1).
It would have been obvious to artisans to administer conjugated FUM to swine and chickens. One of ordinary skill in the art would have been motivated to do so since pigs and chickens are particularly susceptible to the detrimental health effects of mycotoxins such as fumonisin B1 as taught by Yang, and conjugated FUM can be used to immunize animals can against fumonisin as taught by Fukuda, and thus offer protection against FUM-induced mycotoxicosis. Therefore, one of ordinary skill in the art would reasonably expect that immunization of swine and chickens against fumonisin comprising administering conjugated FUM to said animals can protect these animals against FUM-induced mycotoxicosis.
Conclusion
No claims are allowable.
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/LIA E TAYLOR/ Examiner, Art Unit 1641
/MICHAEL SZPERKA/ Primary Examiner, Art Unit 1641