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 .
Election/Restrictions
Applicant's election with traverse of Group IV in the reply filed on 7/30/2026 is acknowledged. The traversal is on the ground(s) that the teachings of Rath et al. are drawn to identifying amino acid sequences of ASFV p30 or p54 highly hydrophilic regions. Applicant asserts that the instantly claimed subject matter constitutes a technical contribution over Rath et al.
This is not found persuasive because the special technical feature defining previously pending claims, i.e., at least one ASFV amino acid sequence of p30, p54, etc., is taught by Rath et al. However, applicant’s amendments to elected Group IV does not recite the special technical feature previously claimed.
Applicant elects SEQ ID NOs: 11-20 without traverse. However, all sequences recited were searched.
Claims 19-31 are pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 14, 2022 has been considered by the examiner.
Specification
The use of the term, ‘GenBank’ which is a trade name or a mark used in commerce, has been noted in this application in paragraphs [0075-0084] of the instant published disclosure, USPgPub 2025/0152695. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 19 and 20 are objected to because of the following informalities: “the vaccine” recited in line two of each claim, lacks antecedent basis. Replacing “the” with “a” prior to “vaccine” in each claim would ameliorate this objection.
Line 3 of claim 19 recites, “ a polynucleotide of comprising”, which is ungrammatical.
Line 3 of claim 20 recites, “ a plasmid of comprising”, which is ungrammatical.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19-23, 26, 27, and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Line 3 of claim 19 and lines 3-4 of claim 20 recite:
“a nucleotide sequence of
SEQ ID NOs: 11 to 14,
SEQ ID NOs: 15 to 20, or
SEQ ID NOs: 11 to 20; or
a nucleotide sequence encoding an amino acid sequence of
SEQ ID NOs: 1 to 4,
(ii) SEQ ID NOs: 5 to 10, or
(iii) SEQ ID NOs: 1 to 10.”
There is a missing transitional phrase clarifying if a nucleotide sequence is selected from SEQ ID NOs: 11 to 20, each in the alternative, or a nucleotide sequence encoding an amino acid sequence of SEQ ID NOs: 1 to 10, each in the alternative, as described in paragraphs [0024, 0025, 0030, and 0031] of the instant published disclosure, USPgPub 2025/0152695. According to MPEP 2173.05(h), the pending claims recite improper Markush language and are indefinite. It cannot be determined if claims 19 and 20 are intending to recite single polynucleotide sequences selected in the alternative or combinations or mixtures of the alternatives set forth in the Markush grouping, as described in paragraphs [0040-0047]. This rejection could be cured if the claims include qualifying language preceding the recited alternatives (such as "at least one member” selected from the group), or within the list of alternatives. See also MPEP § 2111.03. In the interest of compact prosecution, claims 19 and 20 are interpreted as intending to recite single polynucleotide sequences selected from SEQ ID NOs: 11-20 or a single nucleotide sequence encoding SEQ ID NOs: 1-10 in the alternative, gleaned from paragraphs [0024, 0025, 0030, and 0031]. The interpretation gleaned from the instant disclosure does not preempt the requirement for a clarifying amendment. This rejection affects all dependent claims
Line 3 and lines 3-4 of claims 19 and 20 are drawn to, “a polynucleotide”…”comprising a nucleotide sequence of SEQ ID NOs” or “a nucleotide sequence encoding an amino acid sequence of SEQ ID NOs. It is unclear whether the nucleotide sequence is intended to encompass the entire length of any SEQ ID NO recited or any sequence fragment of indeterminable length within the recited SEQ ID NOs. In the interest of compact prosecution and broadest reasonable interpretation, claims 19 and 20 are interpreted as encompassing any sequence fragment of the recited SEQ ID NOs. This rejection could be ameliorated if the claim is amended to language such as, "a nucleotide sequence comprising the sequence of SEQ ID NO: ". This rejection affects all dependent claims.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 19-23, 26, 27, and 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for preventing African Swine Fever Virus infection in porcine with a DNA vaccine comprising ASF virus genes p30, p54, C-type lectin, CD2v, p49, pp62, EP364R, F317L, A104R and K205R and ubiquitin, “ASF_Ubi_10G DNA vaccine; ubiquitin”, does not reasonably provide enablement for treating ASFV with a nucleotide sequence selected from SEQ ID NOs: 11 to 20, each in the alternative, or a nucleotide sequence encoding an amino acid sequence of SEQ ID NOs: 1 to 10, each in the alternative, or any combination or fragment thereof or preventing ASFV in any non-human animal besides porcine.
Due to the missing transition phrase of claims 19 and 20, it is unclear whether the claims intend to be drawn to a nucleotide sequence selected from SEQ ID NOs: 11 to 20, each in the alternative, or a nucleotide sequence encoding an amino acid sequence of SEQ ID NOs: 1 to 10, each in the alternative. Paragraphs [0024, 0025, 0030, and 0031] of the instant published disclosure, USPgPub 2025/0152695 describe polynucleotide sequences selected from SEQ ID NOs: 11-20 or a single nucleotide sequence encoding SEQ ID NOs: 1-10, each in the alternative. However, there is no data provided indicating that any polynucleotide sequence encoding one or any combination of nucleic acids encoding SEQ ID NOs: 1-4 and/or nucleic acids of SEQ ID NOs: 11-20, or fragments thereof, induces a therapeutic and/or prophylactic immune response, as asserted in claims 19 and 20, for the “vaccine” administered, as asserted in claims 21-23, 26, 27, and 31. The only protective efficacy presented in the instant disclosure, depicted in Figure 7, is a DNA comprising ASF virus genes p30, p54, C-type lectin, CD2v, p49, pp62, EP364R, F317L, A104R and K205R and ubiquitin, “ASF_Ubi_10G DNA vaccine; ubiquitin”, presented in Example 4.
There is no demonstrated protective efficacy in any other mammal and there is no appreciation in the art that other non-human animals, except Suidae (and ticks), are susceptible to ASFV infection. See the paragraph bridging pages 1-2 of Souto et al. ("Vaccine Potential of Two Previously Uncharacterized African Swine Fever Virus Isolates from Southern Africa and Heterologous Cross Protection of an Avirulent European Isolate." Transboundary and emerging diseases (2014).
While there is a clear showing of protective efficacy upon administration of “ASF_Ubi_10G DNA vaccine; ubiquitin” to piglets in Example 4 and Figure 7 resulting in a 66% survival rate, there is no teaching in the instant disclosure that demonstrates "treatment", as defined in the instant disclosure described in paragraph [0064]:
“the term “treatment” or “treating” refers to any action that improves, cures, improves, or partially treats symptoms of ASF by administration of the composition according to the present invention.
The skilled artisan would not expect success for treating a porcine with an ASFV infection or inducing protective efficacy with any single or combination nucleic acids expressing one or more ASFV proteins. In section 3.2, Zhang et al. (Microbial Pathogens. 2024; 197: 107063) review the progress of ASFV DNA vaccine development. Administration of nucleic acids encoding p30 and p54 induced specific antibody responses and SLA-II restricted T cells, but failed to protect porcine against lethal challenge. In another study, specific cytotoxic T cell responses were induced after administration of plasmids expressing ubiquitin fused to ASFV p30, p54, and CD2v, but failed to induce virus-specific antibodies. Zhang et al. conclude that DNA vaccination against ASFV is perplexing due to the unknown mechanisms sufficiently activating cytotoxic T cells and neutralizing antibodies.
Without additional data and guidance provided by the inventor to bridge the gaps in knowledge in the ASFV vaccine art, the instant invention would require an undue quantity of experimentation to use the invention in its full scope.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 19-23, 26, 27, and 31 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Willemsen et al. (WO 2020/060406).
Willemsen et al. anticipate a method for preventing or ameliorating infection of African Swine Fever Virus in pigs, comprising administering a DNA molecule encoding antigens of p30 and BG02L; p72 and A104R; and/or p54 and EP402R, see page 13, lines 21-28; page 23, lines 11-18, and claims 8 and 12, as required by instant claims 21 and 22. SEQ ID NOs: 36 and 37 of Willemsen et al. share 95.6% (rounds to 96%) and 92.8% (rounds to 93%) identity with instant SEQ ID NOs: 11 and 12, respectively, see the alignments provided, anticipating “a nucleotide sequence of” SEQ ID NOs: 11 and/or 12 fragments, encompassed by the broadest reasonable interpretation of instant claims 19 and 20, discussed above. Page 17, lines 9-22 of Willemsen et al. anticipate administration of the vaccine by electroporation of a plasmid, anticipating instant claims 26 and 31. Claim 5 of Willemsen et al. anticipates the nucleic acids further encoding ubiquitin, anticipating instant claims 23 and 27.
Allowable Subject Matter
Claims 24, 25, and 28-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art does not teach or suggest SEQ ID NOs: 30-40, 42, 44, or 50-54.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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