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 without traverse of Group I and species i) the gp41 fragment of claim 5 and ii) SARS-CoV as the source of the antigen in the reply filed on 6/16/2025 is acknowledged.
Status of the Claims
Claims 14-20 have been withdraw as being directed to a non-elected invention. Claims 6 and 10-13 have been withdrawn as being directed to a non-elected species. Claims 1-5 and 7-9 are under examination at this time.
Specification
The use of trademarks has been noted in this application. A trademark should be capitalized wherever it appears and be accompanied by the generic terminology.
Although the use of trademarks is 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 trademarks.
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 1-5 and 7-9 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.
The instant claims are directed to a human immunodeficiency virus (HIV) virus-like particle (VLP) comprising:
a Gag protein;
a fragment of gp41 protein comprising the C-terminal cytosolic domain of the gp41 protein; and
an antigen,
wherein the antigen is not a peptide or protein from HIV and is linked to the fragment of gp41 protein.
The specification and Figure 2 depict the claimed VLPs as having a membrane structure with the gp41 fragment inserted therein. However, claim 1 does not describe a membrane begin present in the VLPs. Claims 4, 5 and 7 recite that the gp41 fragment contains the “transmembrane domain”, but there is no membrane structure recited that the transmembrane domain traverses. Thus, it is not clear how the VLPs can contain a transmembrane domain of gp41 without a membrane structure being present in the VLPs. Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Claim 7 recites the limitation "the C-terminus ectodomain of the antigen" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the C-terminus of the transmembrane domain of the antigen" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672