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 .
DETAILED ACTION
Priority
his Application is a national phase application filed under 35 U.S.C. § 371 claiming priority to International Application No. PCT/US2022/074946, filed on August 13, 2022, which claims priority to U.S. Provisional Patent Application No. 63/232,722 filed August 13, 2021, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 09/16/2024 is acknowledged. Claims 1, 3, 5-8, 12-17, 20-22, 24-27 and 32 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application
specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and
(b)), and MPEP § 609.04(a), subsection I. states, "the list must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawing filed on 02/12/2024 are acknowledged and accepted by the Examiner.
Claim Objections
Claims 6,12 and 14-17 are objected to for the following informalities:
Claims 6, 12 and 14-17 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.
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.
Claims 22 and 25 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Regarding claim 22, the claim recites the vector of claim 19, claim 19 has been cancelled. There is insufficient antecedent basis for this limitation in the claim. Accordingly, one of ordinary skill in the art would not know the metes and bounds of the claims.
Regarding claim 25, the claim recites the phrase "a polynucleotide sequence comprising SEQ ID NO: 5, 7, 9, 11, 13, or 15, or a functional fragment thereof," but SEQ ID NO: 5 comprises an amino acid sequence. For purposes of this Office action, claim 25 is interpreted as "a polynucleotide sequence comprising SEQ ID NO: 7, 9, 11, 13, or 15, or a functional fragment thereof." (Para. [0076] of the instant application, Ad contains polynucleotide sequences that encode a plurality of influenza antigens, including without limitation SEQ ID NO: 7, SEQ ID NO: 9, SEQ ID NO: 11, SEQ ID NO: 13, or SEQ ID NO: 15).
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.
(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, 3, 5, 7-8 and 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qianhong et al. “Qianhong” (CN109609538, IDS of record dated 02/12/2024).
The claims are directed to an immunogenic composition comprising: a full-length nucleoprotein (NP) of a H7N9 influenza virus with or without expressing 22 amino acid residues of Autophagy-Inducing Peptide C5 (AIP-C5) from a CFP10 protein of Mycobacterium tuberculosis, or a functional fragment thereof; and a pharmaceutically acceptable carrier; wherein the immunogenic composition is cross-protective against two or more subtypes of influenza viruses when administered to a subject.
Regarding claims 1, 7-8 and 26-27, Qianhong discloses oral vaccines and preparation methods thereof for preventing H7N9 virus infection (Abstract). Qianhong discloses an immunogenic composition (Claim 7- A vaccine for the prevention of H7N9 virus infection) comprising: a full-length nucleoprotein (NP) of a H7N9 influenza virus (Claim 7- comprising: the preparation is prepared by taking the recombinant yeast as an active ingredient according to claim 3; Claim 3- A recombinant yeast, which is characterized in that: it is a yeast containing the recombinant plasmid of claim 1; Claim 1- A recombinant plasmid, characterized in that: it is a polypeptide comprising SEQ ID NO: 2; Para. [0018] the nucleotide sequence of the gene segment of the H7N9 influenza virus is NP, shown in... SEQ ID NO: 2) with or without expressing 22 amino acid residues of Autophagy-lnducing Peptide C5 (AIP-C5) from a CFP10 protein of Mycobacterium tuberculosis, or a functional fragment thereof; and a pharmaceutically acceptable carrier (Claim 7 comprising pharmaceutically acceptable adjuvant or auxiliary ingredients). Further, in regards to "wherein the immunogenic composition is cross-protective against two or more subtypes of influenza viruses when administered to a subject," the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not necessarily make the limitation(s) novel, since the previously unknown property is inherently present in the prior art composition, a vaccine of Qianhong.
Regarding claim 3, Qianhong discloses the immunogenic composition of claim 1. In regards to "wherein, when administered to a subject, the composition confers general immunogenicity protection against the subtypes of viruses selected from the group consisting of H1, H3, H5, H7, H9 and influenza B viruses," the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not necessarily make the limitation(s) novel, since the previously unknown property is inherently present in the prior art composition, a vaccine of Qianhong.
Regarding claim 5, Qianhong discloses the immunogenic composition of claim 1, wherein the full-length NP or functional fragment thereof comprises SEQ ID NO: ,1 (Paras. [0654]-[0721] SEQ ID NO: 8 ... amino acid sequence encoded by NP Gene (H7N9 avian influenza); wherein SEQ ID NO: 8 of Qianhong comprises an amino acid sequence with 100% identity to SEQ ID NO: 1 of the instant application, see below).
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Therefore, the cited prior art anticipates the claimed invention.
Claims 13, 20, 21 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sambhara et al. “Sambhara” (US2010/0358939), IDS of record dated 02/12/2024).
The claims are directed to an immunogenic composition comprising: a full-length nucleoprotein (NP) of a H7N9 influenza virus with or without expressing 22 amino acid residues of Autophagy-Inducing Peptide C5 (AIP-C5) from a CFP10 protein of Mycobacterium tuberculosis, or a functional fragment thereof; and a pharmaceutically acceptable carrier; wherein the immunogenic composition is cross-protective against two or more subtypes of influenza viruses when administered to a subject.
Regarding claim 13, Sambhara discloses a human or bovine adenoviral (Ad) vector (Para. [0039] recombinant adenovirus vectors; Para. [0042] bovine adenovirus vectors (for example, BAd3 ... vectors)) comprising a polynucleotide sequence that encodes a full-length nucleoprotein (NP) from H7N9 influenza virus, a functional fragment thereof and/or one or more other immunogenic domains of an influenza virus (Para. [0039] recombinant adenovirus vectors that include polynucleotide sequences that encode one or more influenza antigens; Para. [0039] recombinant adenovirus vectors that include polynucleotide sequences that encode one or more influenza antigens ... The vector can include a sequence that encodes a single HA of an avian influenza strain).
Regarding claim 20, Sambhara discloses the Ad vector of claim 13, wherein at least E1 and E3 regions are deleted (Para. [0166] bovine adenovirus type 3, BAd3 with deletions in E1 and E3 regions; Para. [0022] (C) Diagrammatic representation of structures of BAd vectors: BAd-ΔE1 E3 (BAd with E1 and E3 deletions)).
Regarding claim 21, Sambhara discloses the Ad vector of claim 20, wherein the polynucleotide sequence of the full-length NP, functional fragment thereof and/or one or more other immunogenic domains of an influenza virus is inserted in the deleted E1 region (Para. [0022] BAd vector (BAd-H5HA) carrying the hemagglutinin subtype 5 (H5HA) gene of avian H5N1 influenza virus (A/HK/156/97) under the control of the cytomegalovirus (CMV) immediate early promoter inserted in the early region 1 (E1) of the BAd genome was generated. (C) Diagrammatic representation of structures of ... BAd-H5HA (BAd-ΔE1 E3 with the H5HA gene cassette): wherein FIG. 7C shows CMV-H5-pA cassette inserted into ΔE1 of BAd-ΔE1 E3).
Regarding claim 24, Sambhara discloses the Ad vector of claim 13, wherein the Ad is bovine Ad type 3 (BAd3) (Para. [0042] bovine adenovirus vectors (for example, BAd3 ... vectors)).
Therefore, the cited prior art anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 32 is rejected under 35 U.S.C. 103(a) as being unpatentable over Qianhong et al. “Qianhong” (CN109609538, IDS of record dated 02/12/2024) as applied to claim 26 above.
The teachings of Qianhong et al. are outlined above and incorporated herein.
Regarding claim 32, Qianhong does not explicitly teach the administration of the composition or the Ad vector induces a dose-dependent increase in cell-mediated immunity in the subject.
However, the composition disclosed by Qianhong is the same as the present invention, thus, would have the same functional limitations. Moreover, Applicant is claiming a feature that is only determined after the method is performed and the assay results are analyzed. The “wherein” clauses are functional limitations that do not modify what is being claimed (e.g. an Ad vector comprising said sequences) but merely a result of what is done by the claimed method. According to MPEP 2111.04, a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.' " Id. (quoting Minton v. Nat' l Ass' n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the AAV vector is already produced with said SEQ ID NOs. and Applicant is claiming a feature that is only determined after the product is utilized and after the composition’s results are analyzed. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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