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 20 May 2026 is acknowledged. Claims 1-8 and 20 are currently pending. Of those, claims 1-2 are amended. Claim 20 is new, and no claims are withdrawn. Claims 9-19 are cancelled. Claims 1-8 and 20 will be examined on the merits herein.
Response to Amendment
Applicant’s arguments filed 20 May 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 20 February 2026 will be referred to as “NFOA”.
Rejection(s) Withdrawn
The rejection of claims 1-4 and 8 under 35 U.S.C. 102 is withdrawn in view of the amendments to the claims.
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 § 103
Claim(s) 1-2 and 5-7 remain rejected and claim 20 is newly rejected under 35 U.S.C. 103 as being unpatentable over Manohar (1985, “Development of Vaccines to the Mycotoxin T-2”) in view of Yohannes et al. (2012, Vet. Immunol. Immunopathol.; herein “Yohannes”) as evidenced by Zegpi et al. (2019, Avian Dis.; herein “Zegpi”).
The previous rejection has been amended to reflect the claim amendments.
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) followed by oral challenge with unconjugated T-2 (pg. 7, para. 3). Manohar is silent on the age of the mice to which the T2 conjugate was administered.
Regarding the limitation, “wherein the method reduced at least one or more clinical signs of T2 mycotoxicosis selected from: decreased weight gain and intestinal damage” in claims 1-2, because Manohar’s conjugated T-2 is substantially identical to the claimed conjugated T-2, it must have the same properties of the claimed conjugated T-2. 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). ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, 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.”
Regarding claim 20, Manohar teaches that rats which were immunized with the conjugated T2 developed delayed and less intense reactions when challenged dermally, indicating the immunization was protective against skin and snout damage due to T2 exposure (Table 3 and para. bridging pg. 7-8).
However, Manohar does not teach a method in which the conjugated T2 is administered to a swine or chicken, as in claim 1, 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.
Regarding claims 1 and 5-7, 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, demonstrating that chicks as young as one day old are in need of protection from T-2 induced mycotoxicosis (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 day old), thereby arriving at the invention of claims 1-2, 5-7, and 20. 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 day 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.
Response to Arguments
Applicant argues (Remarks, pg. 6) that Yohannes does not disclose administering a conjugated T-2 toxin or achieving any reduction in clinical signs and that the combination of Manohar with Zegpi and/or Yohannes to achieve the claimed method can only be made through impermissible hindsight.
This argument has been fully considered but is not persuasive. It is noted that Zegpi is only used as an evidentiary reference to show that the IBV vaccine taught by Yohannes is given to 1 day old chicks and is not used to “cure the deficiency” of Manohar. Manohar is relied upon to teach administration of conjugated T-2 resulting in delayed and less intense reactions to exposure to unconjugated T-2 in model animals (see para. 8-10 above). Yohannes is relied upon to teach that T-2-induced mycotoxicosis is common and problematic for the poultry industry because T-2 has immunosuppressive properties that lead to vaccine failure (see para. 11 above). Therefore, one of ordinary skill in the art would have been motivated to use the beneficial method of administering the conjugated T-2 on poultry, based on the need for protection against mycotoxicosis described by Yohannes. One would expect that the method of Manohar would be successfully applied to poultry because of the successful administration of unconjugated T-2 to poultry by Yohannes. In response to applicant's arguments against the Yohannes reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The motivation to combine Manohar and Yohannes is set forth in the amended 103 rejection above and is based on teachings of the art before the effective filing date of the claimed invention.
Applicant argues (Remarks, pg. 6-7) that the NFOA does not establish inherency and that Manohar does not provide evidence that protection against skin effects in rodents would protect swine or chickens against intestinal effects of orally encountered mycotoxins.
This argument has been fully considered but is not persuasive. Regarding the argument that the NFOA does not establish inherency, it is reiterated that (emphasis added) “‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” (See MPEP 2112.01(I)) The product of the instant claims is “a conjugated T-2,” and the product of the prior art is T-2-HS coupled (i.e., conjugated) to KLH and monoclonal anti-IgD; therefore, the claimed product and the product of Manohar are the same and presumed to possess the same characteristics. “[T]he 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.” (See MPEP 2112.01(I)). Applicant has not provided evidence that the prior art product does not necessarily possess the claimed characteristics. Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
Regarding the argument that Manohar does not provide evidence that sine or chickens would be protected against orally encountered mycotoxins, the method of Manohar was performed on mice that were orally challenged with unconjugated T-2 (i.e., an orally encountered mycotoxin). Because protection against decreased weight gain and intestinal damage is presumed to be an inherent characteristic of the conjugated T2, one of ordinary skill in the art would predict that swine and chickens would be protected against decreased weight gain and intestinal damage based on the results found in rodents, which are a common model species in the art.
Applicant argues (Remarks, pg. 8) that the claimed reduction in decreased weight gain and/or intestinal damage in swine or chicken is an unexpected result.
This argument has been fully considered but is not persuasive. The instant specification does not assert that the reduction in decreased weight gain and/or intestinal damage is unexpected or surprising, and applicant has not pointed to any evidence of such unexpected results. MPEP 716.02(b)(I) states (emphasis added): “The evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.’ Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength ‘are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.’) It is reiterated that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
New Rejection(s)
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is newly rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2, which depends upon claim 1, recites, “wherein the method protects the animal against the clinical signs of the T2 induced mycotoxicosis of decreased weight gain and intestinal damage.” This limitation fails to further limit the subject matter of claim 1 because the scope of the limitation is the same as that of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
Claim(s) 1-8 and 20 are newly rejected under 35 U.S.C. 103 as being unpatentable over Manohar (1985, “Development of Vaccines to the Mycotoxin T-2”) in view of Yohannes (2012, Vet. Immunol. Immunopathol.) as evidenced by Zegpi (2019, Avian Dis.) as applied to claims 1-2, 5-7, and 20 above, and further in view of Wei and Chu (1987, Anal. Biochem.; cited in IDS; herein “Wei”).
The combination of Manohar and Yohannes is set forth in para. 8-14 above and teaches all limitations of claims 1-2, 5-7, and 20.
However, neither Manohar nor Yohannes teaches that the conjugated T2 systemically administered to the animal, as in claim 3, wherein the conjugated T2 is administered intramuscularly, orally, and/or intradermally, as in claim 4, or wherein the conjugated T2 is administered to the animal at least twice, as in claim 8.
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).
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 modify the method of Manohar and Yohannes by administering the conjugated T2 intradermally at least twice, as is taught by Wei, thereby arriving at the claimed invention. The person of ordinary skill in the art would have been motivated to make the modification because both Wei and Manohar teach that immunization with T2 conjugates confer protection against T-2-induced mycotoxicosis, and Yohannes teaches that chickens as young as one day 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 success because both Wei and Manohar teach the use of a conjugated T2, so one of ordinary skill in the art would predict that the administration method and schedule of one conjugated T2 could be successfully used for another conjugated T2 with at least similar results. 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., conjugated T2, administration to systemic administration, intramuscular, oral, or intradermal administration, multiple administrations, etc.) were known in the art. In addition, combining these elements yields a method 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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, SAMIRA JEAN-LOUIS can be reached at (571) 270-3503. 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
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
Prosecution Insights