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 species of Immunol stimulatory short oligonucleotide (ISS OND) that actives TLR-3 plus poly I:C plus , more specifically poly IC:U1212 in the reply filed on 12/04/2025 is acknowledged.
Claims 1-25 read on the elected species are considered.
Claim Objections
Claim 14 is objected to because of the following informalities: The claim is objected for reciting the expression vector encodes a separate peptide for each encoded neo-epitope. Because it is only nucleotide sequence encodes an amino acid sequence of a peptide but the peptide can comprises a neo-epitope, but it does not encode any other amino acid sequence of a neo-epitope.
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.
Claim 1 recites the limitation "The cells ". There is insufficient antecedent basis for this limitation in the claim. Please amend clam to overcome the rejection.
Claim 5 recites the limitation "The concentration ". There is insufficient antecedent basis for this limitation in the claim. Please amend clam to overcome the rejection.
Regarding claims 20-21, 23 and 25, the phrase of "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Please amend clam to overcome the rejection.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. In the instant case, the cited “optionally “ is considered indefinite because it fails to indicate what it is included or not included in the claim. This claim is an omnibus type of claim.
The term “about” in claims 12-13 and 23 is a relative term which renders the claim indefinite. The term “about” is not defined by the claims and the specification. Because the Application does not provide a standard for ascertaining the requisite degree, and one with an ordinary skill in the art would not be reasonably apprised of the scope of the invention. Please amend claims in order to overcome the rejection.
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 1-2, 6-8, 14-15, 18-19, 22-23 and 24-25 are rejected under 35 U.S.C. 102 a) (1) as being anticipated by WO 201732547A1 to Robert Petit et al.
Robert Petit et al. teach an immunotherapy delivery vector comprising a nucleic acid sequence that further comprises an open reading frame encoding a recombinant polypeptide comprising a PEST- containing peptide fused to one or more heterologous peptides, wherein the one or more heterologous peptides comprise one or more frameshift-mutation peptides comprising one or more or 1-20 immunogenic neo-epitopes of one or more tumors or cancers (Claims 1-9) or wherein the one or more heterologous peptides comprise multiple heterologous peptides operably linked in tandem, wherein the immunotherapy delivery vector the PEST-containing peptide is fused to one of the multiple heterologous peptides, wherein the multiple heterologous peptides are operably linked to each other via one or more peptide linkers or one or more 4x glycine linkers.
There are 50 neo-epitope peptides wherein each mutation is indicated by a Bolded amino acid letter and is flanked by 10 amino acids on each side providing a 21 amino acid peptide neo-epitope [paragraphs 00680-00881) and Table 5].
Moreover, The immunogenic composition also comprises an adjuvant (paragraph V) selected from a group consisting of a granulocyte/macrophage colony-stimulating factor (GM-CSF) protein, a nucleotide molecule encoding a GM-CSF protein, saponin QS21, monophosphoryl lipid A, an unmethylated CpG-containing oligonucleotide (Claim 4 and paragraphs 40 and paragraphs 00161, 0034, 00488] and pharmaceutical acceptable carrier [Paragraph 00463].
The cited reference further teaches a method of treating, suppressing, preventing, or inhibiting a disease or a condition in a subject, comprising administering to the subject the immunogenic composition (Claims 41-45).
Moreover, the cited reference also teaches at [00498] that in another embodiment, are administered to a subject by any method known to a person skilled in the art, such as parenterally, paracancerally, transmucosal, transdermally, intramuscularly, intravenously, intra-dermally, subcutaneously, intra-peritoneally, intra- ventricularly, intra-cranially, intra- vaginally or intra-tumorally.
Moreover, the cited reference at paragraph [00501-00503] also teaches that in one embodiment, a subject is administered a dose of the any of the compositions of the present disclosure every 1-2 weeks, every 2-3 weeks, every 3-4 weeks, every 4-5 weeks, every 6-7 weeks, every 7-8 weeks, or every 9-10 weeks in order to achieve the intended elicitation of an immune response targeted at the subject' s disease or condition. In one embodiment, a subject is administered a dose of the any of the compositions of the present disclosure every 1-2 months, every 2-3 months, every 3-4 months, every 4-5 months, every 6-7 months, every 7-8 months, or every 9-10 months in order to achieve the intended elicitation of an immune response targeted at the subject' s disease or condition.
Regarding the expression vector comprising plurality of peptides that are connected with peptide linkers, the cited reference teaches at [0024] that:” In a related aspect, the one or more recombinant polypeptide is operably linked to a tag at the C-terminal, optionally via a linker sequence. In another related aspect, the linker sequence encodes a 4X glycine linker. In another related aspect, the tag is selected from a group comprising a 6X Histidine tag, SIINFEKL peptide, 6X Histidine tag operably linked to 6X histidine, and any combination thereof. In another related aspect, the nucleic acid sequence encoding the recombinant polypeptide comprises 2 stop codons following the sequence encoding the tag.
Paragraph [00689] that “Each neo-epitope is connected with a linker sequence to the following neo- epitope encoded on the same vector. The final neo-epitope in an insert is fused to a TAG sequence followed by a stop codon. The TAG fused is set forth in SEQ ID NO: 57, a C- terminal SIINFEKL and 6xHis amino acid sequence. The TAG allows for easy detection of the tLLO-neo-epitope during for example secretion from the Lm vector or when testing construct for affinity to specific T-cells, or presentation by antigen presenting cells. The linker is 4Xglycine DNA sequence, selected from a group comprising Gl-Gl l (SEQ ID NOS: 46-56) accordingly, or any combination thereof.
Paragraph [00136] also teaches that Alternatively, the multiple heterologous peptides can be operably linked to each other via one or more linkers, such as one or more peptide linkers or one or more 4x glycine linkers. Such linkers are disclosed elsewhere herein.
Therefore, the cited reference anticipates claims 1-2, 6-8, 14-15, 18-19, 22-23 and 24-25.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAO Q LI whose telephone number is (571)272-0904. The examiner can normally be reached M-F 8 am to 8 pm EST.
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
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