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 I, claims 82, 83, 88, 104, 106 and 121 in the reply filed on January 16, 2026 is acknowledged. The traversal is on the ground(s) that the nucleated cells comprising the mRNA encoding a protein are not a special technical feature over WO2019/178005). Applicant’s argument has been found persuasive in part. Due to the claim amendment, the restriction requirement between groups I and II is withdrawn.
Claims 82, 83, 88, 92, 96, 98, 99, 104, 106, 121, and 133 are under examination in this Office action. Claims 154, 156, 178, 180, 194, 197, 213, 289, and 290 are withdrawn as being drawn to non-elected invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 18, 2025 has been considered by the examiner.
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.
Claims 82, 92, 96, 98, 99, 104, 106, 121, and 133 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharei et al. (WO 2016/070136 A1).
Regarding present claims 82, 92, 96, 98, 104, 106, 121 and 133. Sharei et al. disclose compositions comprising nucleated cells, PBMCs, comprising a protein or an mRNA encoding the protein of HPV (see Table on page 37, wherein the immune response is generated in an HLA agnostic manner with mRNA encoding the full-length protein (see claims 1-20, page 3, page 20 and 23).
Regarding present claim 99. Sharein et al. disclose SLP, synthetic long peptide of the oncogenes E6 and E7 of the HPV16 (see pages 16-17 and 65).
Thus, by this disclosure Sharei et al. anticipate the present claims.
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 83, and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Sharei et al. (WO 2016/070136 A1), as applied to claim 82 and further in view of Liang et al. (bioRxiv, 2019, p. 1-47).
Sherai et al. teach the claimed invention as disused above. Sherai does not teach immunoproteasome targeting motif such as MITD domain.
Liang et al. teach that immunoproteasome targeting motif such as MITD domain linked to the C-terminal of the peptide of interest, has been shown to strongly improve the presentation of the MHC class I and class II epitopes (see page 15 and Figure 1).
It would have been prima facie obvious to provide the composition of Sharei et al. wherein the protein fragment further comprises Liang’s immunoproteasome targeting motif such as MITD domain linked to the C-terminal of the HPV peptide, because immunoproteasome targeting motif such as MITD domain linked to the C-terminal of the peptide of interest, has been shown to strongly improve the presentation of the MHC class I and class II epitopes (see Liang on page 15 and Figure 1).
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