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 .
This action is in response to the amendment filed 05/26/2026, in which claims 1, 2, 8-10, 12, 13 and 37 were amended and claims 67-74 were newly added. Claims 1-2, 8-10, 12, 13, 21-24, 28-31, 37 and 67-74 are currently pending and under examination.
Applicant’s arguments have been thoroughly reviewed, but are not persuasive for the
reasons that follow. Any rejection and objections not reiterated in this action have been
withdrawn. This action is FINAL.
Priority
Acknowledgment is made of applicant’s claim for priority based on a foreign application filed as PCT/EP 2020/087469 on 12/21/2020.
All claims are given the priority date of 12/21/2020.
Drawings
The previous objection to the drawings has been withdrawn in view of Applicant’s corrected drawings filed on 05/26/226.
Specification
The substitute specification filed 06/02/2026 has not been entered because it does not
conform to 37 CFR 1.125(b) and (c) because: it is not accompanied by a statement of no new matter.
Therefore, the previous objection to the specification is maintained in view of the
substitute specification not being entered. The previous objection is as follows:
The disclosure is objected to because it contains an embedded hyperlink and/or other
form of browser-executable code (Page 2, Paragraphs 1 and 3 and Page 170, Paragraph 1). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 21 and 22 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 21 is dependent upon a canceled claim (i.e., claim 6) and is therefore “incomplete.” See MPEP § 608.01(n)(V).
Claim 22 recites the limitation "the poly-A sequence comprises or consists of the nucleotide sequence of SEQ ID NO: 15" in line 2. Claim 22 relies on claim 8 which does not recite a poly-A sequence. There is insufficient antecedent basis for this limitation in the claim.
Response to Amendments - Claim Rejections - 35 USC § 112
The previous rejection of claim 12 under 35 U.S.C. 112(b) has been withdrawn in view of Applicant’s amendment to the claim filed on 05/26/2026.
The previous rejection of claims 1-6, 8-10, 12, 13, 21-24, 28-31 and 37 under 35 U.S.C. 112(a) has been withdrawn in view of Applicant’s amendment to the claims filed on 05/26/2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 2, 8, 13, 21, 23, 24, 28, 29 and 30 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Huang et al (WO 2021/076805 A1; Published 10/15/2020). This is a NEW Rejection necessitated by the amendment filed on 05/26/2026.
Regarding claims 1 and 2, Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 98.8% identical to instant SEQ ID NO: 6 and 100% identical to instant SEQ ID NO: 3, respectively (See NEW Appendix I and II; Page 6, Lines 31-35, Page 49, Lines 20-24 and Page 130, Table 1A).
Regarding claim 8, Huang teaches the lipid nanoparticle composition comprising the RNA sequence encoding only the hIL-2 and human albumin sequence within the RNA sequence without comprising an additional human albumin sequence and interleukin protein (Page 6, Lines 31-35, Page 49, Lines 20-24 and Page 130, Table 1A).
Regarding claim 13, Huang teaches the mRNA encoding an IL-2 polypeptide
comprises a poly A tail, e.g., a poly A tail is 100 nucleotides in length (SEQ ID NO: 29) (Page 407, lines 15-25).
Regarding claim 21, for the purpose of this rejection, claim 21 is interpreted as relying on claim 13.
Huang teaches the mRNA encoding an IL-2 polypeptide comprises a poly A tail, e.g., a poly A tail is 100 nucleotides in length (SEQ ID NO: 29) (Page 407, lines 15-25).
Regarding claims 23 and 24, Huang teaches the lipid nanoparticle (LNP) composition comprising the RNA sequence encoding the hIL-2 and human albumin sequence for administration to a subject (Page 6, Lines 31-35; Page 15, Lines 25-35; Page 49, Lines 20-24 and Page 130, Table 1A).
Regarding claims 28 and 29, Huang teaches a pharmaceutical composition comprising
an LNP disclosed above wherein the pharmaceutical composition is formulated for subcutaneous administration and comprises a pharmaceutically acceptable carrier or excipient (Page 13, Lines 12-16).
Regarding claim 30, Huang teaches a kit comprising a container comprising the lipid nanoparticle (LNP) composition disclosed above as a pharmaceutical composition (Page 28, Lines 9-16).
Claims 1-2, 8, 23, 24, 28-31 and 37 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang et al (WO 2022/115396 Al; with priority to Provisional Application 63/118,285 filed 11/25/2020). This is a NEW Rejection necessitated by the amendment filed on 05/26/2026.
Regarding claims 1 and 2, Wang teaches composition comprising a fusion protein comprises an IL-7 protein, an albumin protein and a hinge region that joins the IL-7 protein and the albumin protein [0007]. Wang teaches the human IL-7 fusion protein comprises human IL-7 (hIL-7) as SEQ ID NO:15 (which is 100% identical to a portion instant SEQ ID NO: 4; See NEW Appendix III), the HSA as SEQ ID NO: 16 (which is 100% identical to the entire sequence of instant SEQ ID NO: 3; See NEW Appendix IV), and the hinge peptide as SEQ ID NO: 18 ([0034] ; Page 27, Table 3 and Page 28, Table 4). Wang teaches the fusion protein comprising the human IL-7 protein, the albumin protein and the hinge region that joins the IL-7 protein and the albumin protein as SEQ ID NO: 19 which is 94.4% identical to the entire sequence of instant SEQ ID NO: 4 (See NEW Appendix V; [0035]; Page 27, Table 3 and Page 28, Table 4).
Regarding claim 8, Wang teaches the fusion protein comprising the signal peptide, HSA, IgD hinge and hIL-7 without another human interleukin protein (Page 36, Figs. 1A and 1B).
Regarding claims 23 and 24, Wang teaches the composition is formulated as a sterile liquid and administered via injection [0081; 0105 and 0114].
Regarding claims 28 and 29, Wang teaches the JL18008-1 composition is diluted in saline and administered intravenously to C57BL6/N mice [0114].
Regarding claims 30 and 31, Wang teaches a kit for therapeutic administration of the fusion protein of the disclosure [0103]. Wang teaches the formulation comprised within the vial is the fusion protein and saline to be administered intravenously [0104-0105 and 0114].
Regarding claim 37, Wang teaches treating cancer by the administration of the fusion protein composition to a subject wherein the composition comprises the human IL-7 protein, the albumin protein and the hinge region that joins the IL-7 protein and the albumin protein as SEQ ID NO: 19 which is 94.4% identical to the entire sequence of instant SEQ ID NO: 4 (See NEW Appendix V; [0035, 0086 and 0090]; Page 27, Table 3 and Page 28, Table 4).
Response to Arguments - Claim Rejections - 35 USC § 102
The previous rejection of claims 1-6, 8-10, 13, 21, 23, 24, 28-31 and 37 under 35 U.S.C. 102(a)(1)/(a)(2) under Sahin et al (WO 2019/154985 A1) has been withdrawn in view of the amendments filed by Applicant on 05/26/2026.
The previous rejection of claims 1, 10, 12, 13, 21, 22, 30, 31 and 37 under 35 U.S.C. 102(a)(1)/(a)(2) under Gieseke et al (WO 2018/160540 A1) has been withdrawn in view of the amendments filed by Applicant on 05/26/2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 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 1, 2, 8, 10, 21, 23, 24, 28-31, 37, 67 and 70 are rejected under 35 U.S.C. 103 as being unpatentable by Sahin et al (WO 2019/154985 A1) in view of Huang et al (WO 2021/076805 A1; Published 10/15/2020) and Wang et al (WO 2022/115396 Al; with priority to Provisional Application 63/118,285 filed 11/25/2020).
Regarding claims 1 and 70, Sahin teaches an RNA encoding peptides or proteins used for vaccination and RNA encoding hIL-2 attached to a pharmacokinetic modifying group and RNA encoding hIL-7 attached to a pharmacokinetic modifying group (Page 1, Abstract). Sahin teaches the human IL2 (hlL2) was fused to the N- (hlL2-hAlb) or C-terminus (hAlb-hlL2) of human Albumin (hAlb) (Page 82, Line 33 bridging Page 83, Line 4). Sahin teaches the hAlb sequence of SEQ ID NO: 5 which is 100% identical to the entire sequence of instant SEQ ID NO: 3 (See NEW Appendix VI; Page 35, lines 20-26).
Sahin does not teach the specific IL-2 or IL-7 sequences with at least 80% identity over the entirety of the sequence.
Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 100% identical to instant SEQ ID NOs: 6 and 3, respectively (See NEW Appendix I and II; Page 6, Lines 31-35, Page 49, Lines 20-24 and Page 130, Table 1A).
Haung does not teach the specific IL-7 sequences with at least 80% identity over the entirety of the sequence.
Wang teaches composition comprising a fusion protein comprises an IL-7 protein, an albumin protein and a hinge region that joins the IL-7 protein and the albumin protein [0007]. Wang teaches the human IL-7 fusion protein comprises human IL-7 (hIL-7) as SEQ ID NO:15 (which is 100% identical to a portion instant SEQ ID NO: 4; See NEW Appendix III), the HSA as SEQ ID NO: 16 (which is 100% identical to the entire sequence of instant SEQ ID NO: 3; See NEW Appendix IV), and the hinge peptide as SEQ ID NO: 18 ([0034] ; Page 27, Table 3 and Page 28, Table 4). Wang teaches the fusion protein comprising the human IL-7 protein, the albumin protein and the hinge region that joins the IL-7 protein and the albumin protein as SEQ ID NO: 19 which is 94.4% identical to the entire sequence of instant SEQ ID NO: 4 (See NEW Appendix V; [0035]; Page 27, Table 3 and Page 28, Table 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the IL-2 and IL-7 protein sequences of Sahin for the hIL-2 protein sequence of Huang and the hIL-7 protein sequence of Wang because Sahin teaches it is within the ordinary skill in the art to use a first RNA encoding peptides or proteins used for vaccination and RNA encoding hIL-2 attached to a human albumin protein and a second RNA encoding hIL-7 attached to a human albumin protein, Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding a fusion protein comprising the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 100% identical to instant SEQ ID NOs: 6 and 3, respectively and Wang teaches the fusion protein comprising the human IL-7 protein, the albumin protein and the hinge region that joins the IL-7 protein and the albumin protein as SEQ ID NO: 19 which is 94.4% identical to the entire sequence of instant SEQ ID NO: 4 and the human albumin protein as SEQ ID NO: 16 which is 100% identical to the entire sequence of instant SEQ ID NO: 3.
One would have been motivated to make such a modification in order to receive the expected benefit of two fusion proteins wherein the first fusion protein comprises the human IL-2 fused to the human albumin protein and the second fusion protein comprises the human IL-7 fused to the human albumin protein as taught by Sahin, Huang and Wang, respectively.
Regarding claim 8, Sahin teaches RNA encoding peptides or proteins used for vaccination and RNA encoding IL-2 attached to a pharmacokinetic modifying group and RNA encoding IL-7 attached to a pharmacokinetic modifying group (Page 1, Abstract).
Regarding clam 10, Sahin teaches RNA encoding peptides or proteins used for vaccination and RNA encoding IL-2 attached to a pharmacokinetic modifying group and RNA encoding IL-7 attached to a pharmacokinetic modifying group (Page 1, Abstract). Sahin teaches the human IL2 (hlL2) was fused to the N- (hlL2-hAlb) or C-terminus (hAlb-hlL2) of human Albumin (hAlb) (Page 82, Line 33 bridging Page 83, Line 4). Sahin teaches the hAlb sequence of SEQ ID NO: 5 which is 100% identical to the entire sequence of instant SEQ ID NO: 3 (See NEW Appendix VI; Page 35, lines 20-26).
Sahin does not teach the specific IL-2 sequence with at least 80% identity over the entirety of the sequence.
Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 100% identical to instant SEQ ID NOs: 6 and 3, respectively (See NEW Appendix I and II; Page 6, Lines 31-35, Page 49, Lines 20-24 and Page 130, Table 1A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the IL-2 and IL-7 protein sequences of Sahin for the hIL-2 protein sequence of Huang and the hIL-7 protein sequence of Wang because Sahin teaches it is within the ordinary skill in the art to use a first RNA encoding peptides or proteins used for vaccination and RNA encoding hIL-2 attached to a human albumin protein and a second RNA encoding hIL-7 attached to a human albumin protein and Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding a fusion protein comprising the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 100% identical to instant SEQ ID NOs: 6 and 3, respectively.
One would have been motivated to make such a modification in order to receive the expected benefit of a fusion protein wherein the fusion protein comprises the human IL-2 fused to the human albumin protein as taught by Sahin and Huang, respectively.
Regarding claim 21, Sahin teaches a 3’ poly(A) tail wherein the poly(A) tail comprises at least about 20, at least about 40, at least about 80, or at least about 100, and up to about 500 nucleotides in length (Page 28, Lines 1-5).
Regarding claims 23 and 24, Sahin teaches 20 μg gp70 RNA-LPX intravenously, and either 3 μg hAlb-hlL2, hlL7-hAlb, or the combination of the two, formulated as lipid nanoparticles (LNP) and injected intravenously (Page 83, Lines 24-25).
Regarding claims 28 and 29, Sahin teaches 20 μg gp70 RNA-LPX intravenously, and either 3 μg hAlb-hlL2, hlL7-hAlb, or the combination of the two, formulated as lipid nanoparticles (LNP) and injected intravenously (Page 83, Lines 24-25).
Regarding claims 30 and 31, Sahin teaches the medical preparation comprises: the RNA encoding extended-PK IL2; the RNA encoding extended-PK IL7; the RNA encoding a peptide or protein comprising an epitope for inducing an immune response against an antigen in a subject; and the immune checkpoint inhibitor as a kit wherein the medical preparation
comprises each RNA in a separate container (Page 6, Lines 18-30).
Regarding claims 37 and 67, Sahin teaches co-administering to the subject RNA encoding peptides or proteins used for vaccination and RNA encoding IL-2 attached to a pharmacokinetic modifying group and/or RNA encoding IL-7 attached to a pharmacokinetic modifying group (Page 1, Abstract).
Sahin does not teach the specific IL-2 or IL-7 sequences with at least 80% identity over the entirety of the sequence.
Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 100% identical to instant SEQ ID NOs: 6 and 3, respectively (See NEW Appendix I and II; Page 6, Lines 31-35, Page 49, Lines 20-24 and Page 130, Table 1A).
Haung does not teach the specific IL-7 sequences with at least 80% identity over the entirety of the sequence.
Wang teaches composition comprising a fusion protein comprises an IL-7 protein, an albumin protein and a hinge region that joins the IL-7 protein and the albumin protein [0007]. Wang teaches the human IL-7 fusion protein comprises human IL-7 (hIL-7) as SEQ ID NO:15 (which is 100% identical to a portion instant SEQ ID NO: 4; See NEW Appendix III), the HSA as SEQ ID NO: 16 (which is 100% identical to the entire sequence of instant SEQ ID NO: 3; See NEW Appendix IV), and the hinge peptide as SEQ ID NO: 18 ([0034] ; Page 27, Table 3 and Page 28, Table 4). Wang teaches the fusion protein comprising the human IL-7 protein, the albumin protein and the hinge region that joins the IL-7 protein and the albumin protein as SEQ ID NO: 19 which is 94.4% identical to the entire sequence of instant SEQ ID NO: 4 (See NEW Appendix V; [0035]; Page 27, Table 3 and Page 28, Table 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the IL-2 and IL-7 protein sequences of Sahin for the hIL-2 protein sequence of Huang and the hIL-7 protein sequence of Wang because Sahin teaches it is within the ordinary skill in the art to use a first RNA encoding peptides or proteins used for vaccination and RNA encoding hIL-2 attached to a human albumin protein and a second RNA encoding hIL-7 attached to a human albumin protein, Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding a fusion protein comprising the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 100% identical to instant SEQ ID NOs: 6 and 3, respectively and Wang teaches the fusion protein comprising the human IL-7 protein, the albumin protein and the hinge region that joins the IL-7 protein and the albumin protein as SEQ ID NO: 19 which is 94.4% identical to the entire sequence of instant SEQ ID NO: 4 and the human albumin protein as SEQ ID NO: 16 which is 100% identical to the entire sequence of instant SEQ ID NO: 3.
One would have been motivated to make such a modification in order to receive the expected benefit of two fusion proteins wherein the first fusion protein comprises the human IL-2 fused to the human albumin protein and the second fusion protein comprises the human IL-7 fused to the human albumin protein as taught by Sahin, Huang and Wang, respectively.
Claims 12, 13, 22, 73 and 74 are rejected under 35 U.S.C. 103 as being unpatentable by Sahin et al (WO 2019/154985 A1) in view of Huang et al (WO 2021/076805 A1; Published 10/15/2020) and Wang et al (WO 2022/115396 Al; with priority to Provisional Application 63/118,285 filed 11/25/2020), as applied to claims 1, 2, 8, 10, 21, 23, 24, 28-31, 37, 67 and 70, and further in view of Gieseke et al (WO 2018/160540 A1).
The teachings of Sahin, Huang and Wang are described above and applied as before.
Regarding claims 12 and 73, Sahin, Huang and Wang do not specifically teach codon-optimization of the sequences.
Gieseke teaches an IL-2 RNA composition comprising or consisting of the nucleotides of SEQ ID NO: 13 (amino acid sequence of SEQ ID NO: 9), wherein the RNA comprises a 5' cap, a 5' UTR, a nucleic acid encoding IL-2, a 3' UTR, and a poly-A tail, in that order and the sequence of SEQ ID NO: 13 is a codon-optimized sequence of the IL-2 sequence (Page 55, Table 1; Page 91 and [Paragraphs 0088 and 0090-0097]). Gieseke teaches codon optimization was performed manually editing each codon separately and a GC content comparable to the wild type sequence was maintained during the optimization process to achieve increased protein expression compared to the wild-type sequence [00261 and 00266].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the non-codon-optimized sequences of Sahin, Huang and Wang for the codon-optimization of hIL-2 and hIL-7 sequences of Gieseke because Sahin teaches it is within the ordinary skill in the art to use a first RNA encoding peptides or proteins used for vaccination and RNA encoding hIL-2 attached to a human albumin protein and a second RNA encoding hIL-7 attached to a human albumin protein, Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding a fusion protein comprising the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 100% identical to instant SEQ ID NOs: 6 and 3, respectively, Wang teaches the fusion protein comprising the human IL-7 protein, the albumin protein and the hinge region that joins the IL-7 protein and the albumin protein as SEQ ID NO: 19 which is 94.4% identical to the entire sequence of instant SEQ ID NO: 4 and the human albumin protein as SEQ ID NO: 16 which is 100% identical to the entire sequence of instant SEQ ID NO: 3 and Gieseke teaches the sequence of SEQ ID NO: 13 is a codon-optimized sequence of the IL-2 sequence and the codon optimization was performed manually editing each codon separately and a GC content comparable to the wild type sequence was maintained during the optimization process.
One would have been motivated to make such a modification in order to receive the expected benefit of increased protein expression by using codon-optimized sequences as taught by Gieseke.
Regarding claims 13 and 74, Sahin teaches the RNA composition comprises a 5’ and 3’ UTR flanking the protein sequence comprising the human albumin protein that is fused to either an IL-2 or human IL-7 (Page 27, Lines 23-32).
Sahin, Huang and Wang do not teach the specific sequences of the 5’ and 3’ UTR sequences.
Gieseke teaches an IL-2 RNA composition comprising or consisting of the nucleotides of SEQ ID NO: 13 (amino acid sequence of SEQ ID NO: 9), wherein the RNA comprises a 5' cap, a 5' UTR, a nucleic acid encoding IL-2, a 3' UTR, and a poly-A tail, in that order and the sequence of SEQ ID NO: 13 is a codon-optimized sequence of the IL-2 sequence (Page 55, Table 1; Page 91 and [Paragraphs 0088 and 0090-0097]). Gieseke teaches the 5’ UTR is SEQ ID NO: 2 which is 100% identical to instant SEQ ID NO: 13 (See NEW Appendix VII; Page 55, Table 1). Gieseke teaches the 3’ UTR sequence is SEQ ID NO: 8 which is 100% identical to instant SEQ ID NO: 14 (See NEW Appendix VIII; Page 55, Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the 5’ and 3’ UTR sequences of Sahin for the specific 5’UTR sequence identified as SEQ ID NO: 2 and the specific 3’ UTR sequence identified as SEQ ID NO: 8 as taught by Gieseke because Sahin teaches it is within the ordinary skill in the art to use a first RNA encoding peptides or proteins used for vaccination and RNA encoding hIL-2 attached to a human albumin protein and a second RNA encoding hIL-7 attached to a human albumin protein further comprising the 5’ and 3’ UTR sequences flanking the protein sequences on both fusion proteins, Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding a fusion protein comprising the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 100% identical to instant SEQ ID NOs: 6 and 3, respectively, Wang teaches the fusion protein comprising the human IL-7 protein, the albumin protein and the hinge region that joins the IL-7 protein and the albumin protein as SEQ ID NO: 19 which is 94.4% identical to the entire sequence of instant SEQ ID NO: 4 and the human albumin protein as SEQ ID NO: 16 which is 100% identical to the entire sequence of instant SEQ ID NO: 3 and Gieseke teaches the 5’ UTR is SEQ ID NO: 2 which is 100% identical to instant SEQ ID NO: 13 and the 3’ UTR sequence is SEQ ID NO: 8 which is 100% identical to instant SEQ ID NO: 14.
One would have been motivated to make such a modification in order to receive the expected benefit of fusion protein comprising the specific sequences for the 5’ and 3’ UTR as taught by Gieseke.
Regarding claim 22, Sahin teaches a 3’ poly(A) tail wherein the poly(A) tail comprises at least about 20, at least about 40, at least about 80, or at least about 100, and up to about 500 nucleotides in length (Page 28, Lines 1-5).
Sahin, Huang and Wang do not teach the specific sequence of SEQ ID NO: 15.
Gieseke teaches the poly(A) tail is at least 100 nucleotides in length wherein Gieseke teaches the poly(A) tail sequence as SEQ ID NO: 78 which is 100% identical to instant SEQ ID NO: 15 (Page 82, Table 1; See PREVIOUS Appendix IV from Office Action mailed on 02/24/2026 and Page 91, [0096]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the poly-A tail sequence of Sahin for the specific poly-A tail sequence as taught by Gieseke because Sahin teaches it is within the ordinary skill in the art to use a first RNA encoding peptides or proteins used for vaccination and RNA encoding hIL-2 attached to a human albumin protein and a second RNA encoding hIL-7 attached to a human albumin protein further comprising a poly-A tail sequence on the 3’ end, Huang teaches a lipid nanoparticle (LNP) composition comprising RNA encoding a fusion protein comprising the amino acid sequence of hIL-2 and the amino acid human albumin sequence as SEQ ID NO: 10 which is 100% identical to instant SEQ ID NOs: 6 and 3, respectively, Wang teaches the fusion protein comprising the human IL-7 protein, the albumin protein and the hinge region that joins the IL-7 protein and the albumin protein as SEQ ID NO: 19 which is 94.4% identical to the entire sequence of instant SEQ ID NO: 4 and the human albumin protein as SEQ ID NO: 16 which is 100% identical to the entire sequence of instant SEQ ID NO: 3 and Gieseke teaches the poly(A) tail is at least 100 nucleotides in length and wherein the poly(A) tail sequence as SEQ ID NO: 78 which is 100% identical to instant SEQ ID NO: 15.
One would have been motivated to make such a modification in order to receive the expected benefit of fusion protein comprising the specific sequences for the poly-A tail sequence as taught by Gieseke.
Allowable Subject Matter
Claims 9, 68, 69, 71 and 72 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/CELINE X QIAN/Primary Examiner, Art Unit 1637
Prosecution Insights