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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/3/2025 has been entered.
Applicants are informed that the rejections of the previous Office action not stated below have been withdrawn from consideration in view of the Applicant’s arguments and/or amendments.
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 7/8/24 is acknowledged.
Claim 45-49 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/8/24.
Claims 1-41, 43 and 44 are examined on the merits.
Response to Amendment
The declaration under 37 CFR 1.132 filed 12/3/25 is sufficient to overcome the rejection of claims 1-44 based upon Stoyanov et al., Dallmeier and Neyts, Cai et al and de los Rios et al.
Allowable Subject Matter
Claims 1-3, 6-10, 14, 16-20, 36 and 43 are allowable.
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.
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.
(New Rejection) Claims 37, 38, 40 and 41 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 a vaccine that induces an immune response against hepatitis B virus and a flavivirus, does not reasonably provide enablement for preventing infection by a hepatitis B virus and a flavivirus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Nature of the invention/Breadth of the claims. The claims are drawn to a vaccine that prevents an infection cause by hepatitis B virus or a simultaneous infection by hepatitis B virus and a flavivirus. The vaccine comprising a polynucleotide comprising a nucleotide sequence encoding a flavivirus wherein a nucleotide sequence encoding the sequence of the flavivirus is preceded by a sequence encoding:
- a part of a flavivirus Capsid protein comprising or consisting of an N terminal part of the flavivirus Capsid protein,
- an immunogenic core antigen of hepatitis B virus (HBC),
and
-a 2A cleaving peptide.
State of the prior art/Predictability of the art. Min et al. (Topics in Antiviral Medicine, 2025, Vol. 33, no. 6, pages 711-726) provide a summary of viruses that cause hepatitis. With regard to hepatitis B, while treatment options do exist, the ability to prevent infection by the virus does not appear to be possible based on the current treatments. [see pages 717-719]
Working examples. The working examples provided by applicants establish that immune responses can be elicited, but viral infection by hepatitis B and flavivirus were not prevented.
Amount of experimentation necessary. Additional research is required in order to determine how effective a vaccine as presently claimed would be able to prevent infection by hepatitis B virus or hepatitis B virus and a flavivirus.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed methods.
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.
(New Rejection) Claims 4, 5, 11-13, 15, 23-35, 39-41 and 44 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.
Claim 4 recites, “the flavivirus is Yellow Fever virus.”, however, claim 4 depends from claim 1 and claim 1 mentions flavivirus more than once and therefore it is unclear which recitation of flavivirus the claim is referring to.
Claim 5 recites the limitation "the N terminal part of the Yellow Fever virus capsid" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the immunogenic fragment thereof" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "fragment thereof" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "immunogenic fragment thereof" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the Yellow Fever virus" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the flavivirus" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 24-35, 39-41 and 44 are also rejected since they depend from calim 23 but do not remedy this deficiency.
Claim 25 recites, “the flavivirus is Yellow Fever virus.”, however, claim 25 depends from claim 23 and claim 23 mentions flavivirus more than once and therefore it is unclear which recitation of flavivirus the claim is referring to.
Claim 26 recites the limitation "the Yellow Fever virus capsid" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the immunogenic fragment thereof" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 34 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 34 recites, “…wherein the immunogenic protein is the core antigen of hepatitis B virus.”. However, claim 23 also recites, “an immunogenic protein of a core antigen of hepatitis B virus…” 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached on (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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/BENJAMIN P BLUMEL/ Primary Examiner, Art Unit 1671