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 .
Applicant’s preliminary amendment filed on June 16, 2023 is acknowledged. Claims 23-34 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 2, 2025, July 28, 2025 and November 23, 2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 23-29 and 31-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims are drawn to a method for determining whether a swine is infected with a wild-type ASFV or vaccinated with an accompanying ASFV live attenuated virus CD2v-marker vaccine (LAV CD2v-marker vaccine) wherein the method is an immunoassay, characterized in that an isolated antigenic fragment of a ASFV CD2v protein that is bound to a solid support is used as an antigen in the immunoassay and the method comprises a step of examining a test sample obtained from the swine for the presence of ASF V CD2v antibodies that bind to the antigen, and in that the antigen is a polypeptide comprising an antigenic fragment of the extracellular domain of the CD2v protein, wherein the antigenic fragment of the extracellular domain is a polypeptide comprising an amino acid sequence with at least 95 % amino acid sequence identity to SEQ ID NO: 25.
The present claims are rejected because they fail to recite active method steps required to practice the claimed method. The only active method step recited in the present claim 23 is the step of “examining”. This step is not sufficient to carry out the claimed invention. Claim 30 recites active method steps and is not rejected.
The recitation of “characterized in that” does not adequately describe method steps required to carry out the present invention.
Applicant is required to recite active method steps required to carry out the preamble of “determining whether a swine is infected with a wild-type ASFV or vaccinated with an accompanying ASFV live attenuated virus CD2v-marker vaccine”.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 23-34 are rejected under 35 U.S.C. 103 as being unpatentable over Arias et al. (Vaccines, 2017, p. 1-20 in IDS on December 23, 2024) in view of Song et al. (August 11, 2020, CN111518174A in IDS on December 23, 2024).
Arias et al. teach a method for determining whether a swine is infected with a wild-type ASFV or vaccinated with an accompanying ASFV live attenuated virus CD2v-marker vaccine (LAV CD2v-marker vaccine) wherein the method is an immunoassay. Arias et al. method comprises using an immunoassay comprising an isolated antigenic fragment of a ASFV CD2v protein bound to a solid support is used as an antigen in the immunoassay and the method comprises a step of examining a test sample obtained from the swine for the presence of ASF V CD2v antibodies that bind to the antigen (see Subunit vaccine approaches on page 6 and Development of DIVA test on page 9).
Song et al. teach a polypeptide identical with present SEQ ID NO: 25 derived from African swine fever CD2v protein that binds to porcine CD2 used for diagnosing African swine fever virus (ASF) and for preparing an African swine fever subunit vaccine. (see SEQ ID NO: 71 and a sequence alignment below, Claim 4, paragraphs [0001-0157] of the English translation in IDS on 12/23/2024).
Present SEQ ID NO: 25 and SEQ ID NO: 71 in Song.
Query Match 100.0%; Score 284; Length 71;
Best Local Similarity 100.0%;
Matches 53; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 NINDTFVKYTNESILEYNWNNSNINNFTATCIINNTISTSNETTLINCTYLTL 53
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 14 NINDTFVKYTNESILEYNWNNSNINNFTATCIINNTISTSNETTLINCTYLTL 66
Regarding present claim 23. It would have been prima facie obvious to provide the method of Arias comprising determining whether a swine is infected with a wild-type ASFV or vaccinated with an accompanying ASFV live attenuated virus CD2v-marker vaccine, wherein the method uses Song’s ASFV polypeptide identical with present SEQ ID NO: 25 because Song teaches detecting ASFV virus infection in an animal comprising using a polypeptide sequence identical with present SEQ ID NO: 25.
Regarding present claim 24. The claim recites a consisting language with regard to the polypeptide of SEQ ID NO: 25. It is noted that present SEQ ID NO: 25 is 53 amino acids in length while the polypeptide in Song is 71 amino acids in length. It is the position of the Examiner that the 71 amino acids polypeptide contains the entire present SEQ ID NO: 25 and thus it contains the epitope responsible for binding and detection of the African Swine Fever Virus. Absent unexpected results obtained with using a 53 amino acids long peptide versus the 71 amino acids peptide, the epitope of present SEQ ID NO: 25 would have been prima facie obvious at the time of the present invention and in view of the teachings of Song.
Regarding present claims 25-27. Arias teaches a vaccine wherein expressing altered CD2v/EP402R comprising deleted extracellular domain (see page 8). It would have been prima facie obvious to provide the method of Arias wherein the vaccine comprises CD2v/EP402R comprising deleted extracellular domain, lacking present SEQ ID NO: 25, in order to distinguish between vaccinated and infected animals.
Regarding present claims 28-31. Song et al. teach he method according to claim 23, characterized in that the method comprises the steps of incubating the test sample with the antigen in an assay mixture, allowing the formation of an ASFV CD2v antibody-antigen complex in the assay mixture, and detecting the presence of the antibody-antigen complex in the assay mixture (see
Regarding present claim 32. Song et al. teach an ELISA immunoassay (see paragraph [0038] and Figures 3 and 4).
Regarding present claims 33-34. Song et al. teach diluting the sample. However, he does not mention the stringency.
It would have been within the skill of the ordinary artisan to optimize the dilution factor to arrive at the desired stringency for optimal antigen detection.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648