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 1-5, 7, 13, 24 and 25) and the species of claim 2 in the reply filed on 2/10/2026 is acknowledged. The traversal is on the ground(s) that Groups I-IX and XII all share the special technical feature of the peptides of Group I that make a contribution over the prior art Qamar et al. This is not found persuasive.
Applicant amended claim 1 to delete reference to SEQ ID NO: 9, which was taught by Qamar et al. However, as outlined below, SEQ ID NO: 1 is taught by Rappuoli et al. (WO 2004/092360; published October 28, 2004). Accordingly, the technical feature shared by Groups I-IX and XII is not a special technical feature as it does not make a contribution over the prior art in view of Rappuoli et al.
The requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
Claims 6, 14-16, 18, 20-23, 26, and 28-32 have been withdraw as being directed to a non-elected invention. Claims 1, 5, 7, 13, 24 and 25 are under examination at this time.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see, for example, pages 79, 83, 84 and 87). 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 Objections
Claim 1 is objected to because of the following informalities: Claim 1 should recite “selected from the group consisting of” instead of “selected from the group below”. Appropriate correction is required.
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.
Claim(s) 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rappuoli et al. (WO 2004/092360; published October 28, 2004).
The instant claims are directed to a peptide of less than 15 amino acids having cytotoxic T cell (CTL)- inducing ability, which comprises the amino acid sequence selected from the group below:
(a) the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5,7, 10, 11, 12, 13, 14 and 15; and
(b) the amino acid sequence in which one or two amino acids are substituted in, deleted, inserted and/or added to the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5, 7, 10, 11, 12, 13, 14 and 15, wherein the substitution has any one of the following features (i) to (iii).
Rappuoli et al. discloses SEQ ID NO: 7943 which is identical to instant SEQ ID NO: 1 (see the alignment below) [claim 1(a) and claim 5].
CC PN WO2004092360-A2.
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CC PD 28-OCT-2004.
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CC PI Rappuoli R, Masignani V, Stadler K, Gregersen J, Chien D, Han J;
CC PI Polo J, Weiner A, Houghton M, Song HC, Seo MY, Donnelly JJ;
CC PI Klenk HD, Valiante N;
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CC PT Novel isolated polypeptide e.g. spike polypeptide, Env polypeptide, of
CC PT severe acute respiratory syndrome virus (SARS), useful as vaccine for
CC PT SARS.
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CC PS Disclosure; SEQ ID NO 7943; 839pp; English.
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Query Match 100.0%; Score 51; Length 10;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SLFDMSKFPL 10
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Db 1 SLFDMSKFPL 10
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7, 13 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Rappuoli et al. (WO 2004/092360; published October 28, 2004).
The instant claims are directed to a composition comprising a pharmaceutically acceptable carrier and at least one active ingredient selected from the group consisting of (a) to (e) below:
(a) one or more types of peptides of claim 1;
(b) one or more types of polynucleotides encoding the peptide(s) of claim 1 in an expressible form;
(c) an antigen-presenting cell (APC) that presents on its cell surface a complex of the peptide of claim 1 and an HLA antigen;
(d) an exosome that presents on its cell surface a complex of the peptide of claim 1 and an HLA antigen; and
(e) a CTL that targets the peptide of claim 1.
Regarding claim 7, Rappuoli et al. teaches that the invention relates to vaccine formulations comprising one or more SARS virus antigens and one or more other respiratory virus antigens (see page 3, lines 20-21). Rappuoli et al. further teaches that the T-epitopes identified in SEQ ID NOs: 7801-80401 are polypeptides for use as an antigen (see page 44, lines 29-32). Rappuoli et al. teaches that the composition administered to a subject is a pharmaceutical composition, which may also include a pharmaceutically acceptable carrier (see page 208, lines 1-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use any of the disclosed antigens from SEQ ID NOs: 7801-8040, e.g., SEQ ID NO: 7943, in a vaccine formulation. One would have been motivated to do so and there would have been a reasonable expectation of success given the suggestion by Rappuoli et al. that T-epitopes identified in SEQ ID NOs: 7801-8040 are polypeptides for use as an antigen.
Claim 13 merely states that the composition of claim 7 is formulated for administration to a subject. Accordingly, claim 13 is interpreted as having the same scope as claim 7.
Regarding claim 24, Rappuoli et al. teaches that the invention relates to vaccine formulations comprising one or more SARS virus antigens and one or more other respiratory virus antigens (see page 3, lines 20-21). Rappuoli et al. also teaches that the T-epitopes identified in SEQ ID NOs: 7801-8040 are polypeptides for use as an antigen (see page 44, lines 29-32). Rappuoli et al. further teaches that the compositions of the present invention can also contain adjuvants such as, but not limited to, preservatives, wetting agents, emulsifying agents, and dispersing agents (see page 208, lines 21-27). For emulsifying agents, Rappuoli et al. teaches that a particularly preferred adjuvant for use in the compositions is an oil-in-water emulsion (see page 163, lines 29-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine any of the disclosed antigens from SEQ ID NOs: 7801-8040 (e.g., SEQ ID NO: 7943) with an adjuvant such as an oil-in-water emulsion, which Rappuoli et al. teaches is a preferred adjuvant, for use as a vaccine. One would have been motivated to do so and there would have been a reasonable expectation of success given the suggestion by Rappuoli et al. that the T-epitopes identified in SEQ ID NOs: 7801-8040 are polypeptides for use as an antigen and that the invention relates to vaccine formulations comprising one or more SARS virus antigens.
Regarding claim 25, Rappuoli et al. teaches that the invention relates to vaccine formulations comprising one or more SARS virus antigens (see page 3, lines 20-21). Rappuoli et al. also teaches that the T-epitopes identified in SEQ ID NOs: 7801-8040 are polypeptides for use as an antigen (see page 44, lines 29-32). Rappuoli et al. further teaches that the compositions of the present invention can also contain adjuvants such as, but not limited to, preservatives, wetting agents, emulsifying agents, and dispersing agents (see page 208, lines 21-27). While Rappuoli et al. disclose many instances of kits, Rappuoli et al. does not disclose a kit comprising SEQ ID NO: 7943. However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to package any of the disclosed antigens (e.g., SEQ ID NO: 7943) and an adjuvant into a kit. One would be motivated to do this for commercial exploitation of the invention by providing convenience for the end user.
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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
1 SEQ ID NO: 7943 is identical to instant SEQ ID NO: 1.
Prosecution Insights