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 .
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 9 is objected to because of the following informalities: the full amino acid sequence is not required in the claims, claim 9 should read “The trimeric complex of claim 9, wherein the gp41 subunit comprises the amino acid sequence of SEQ ID NO: 7.” Appropriate correction is required.
Claim 36 is objected to because of the following informalities: “clam 12” in line 3 should read “claim 12”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 3 and 7 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 3 states that “each of the three monomeric polypeptides comprises [the] amino acid sequence of…” it is unclear is all monomeric peptides of the trimer must be the same sequence or if the trimer can contain three different monomeric polypeptides with three different amino acid sequences.
For the purposes of compact prosecution and applying prior art, the claim was interpreted as each monomeric polypeptide in the trimer comprises the same amino acid sequence.
The phrase “an amino acid sequence” in claims 3 (line 2) and 7 (lines 1-2) is indefinite because it is unclear if the claims encompass the entire amino acid sequences or just a portion of the sequences. For example, the first three amino acids of SEQ ID NO: 1 is “an amino acid sequence” of SEQ ID NO: 1. “[The] sequence” is the appropriate terminology, which would fix the indefiniteness of the claims.
For purposes of compact prosecution and applying prior art, the phrase “an amino acid sequence” was broadly interpreted herein to mean “the amino acid sequence.”
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 does not further limit the claim it depends on, claim 1, because the gp140 env trimer inherently comprises the gp120 and gp41 subunits (see Kong, et al. Nat Commun 7, 12040 (2016), NPL-IDS, filed, 12/30/2024, Introduction ¶1). Stating the inherent subunits of the gp140 protein does not further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2, 8, 10-12, 16, 19, 23, 27, 30, 36, 41, and 48 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Kong, et al. (US 20200165303 A1, hereinafter “Kong”).
Regarding claims 1 and 2, Kong discloses a trimeric complex comprising an uncleaved prefusion optimized gp140 env trimer (¶0006 and ¶0024-0025), which naturally comprises a monomeric polypeptide comprising a gp120 and gp41 subunit (¶0011).
Regarding claim 8, Kong discloses that the gp41 subunit is from the HIV-1 strain BG505 (¶0006).
Regarding claim 10, Kong discloses that the gp41 subunit is the ectodomain of gp41 (¶0006 and ¶0055).
Regarding claims 11-12 and 16, Kong discloses HIV-1 vaccine compositions comprising the trimeric complex (¶0014).
Regarding claims 19 23, and 27, Kong discloses a nucleic acid that encodes the monomeric polypeptide comprising gp120 and gp41 (claim 1 and).
Regarding claim 30, Kong discloses a method of inducing an immune response against HIV-1 by administering a composition comprising a trimeric complex of gp140 (¶0030).
Regarding claim 36, Kong discloses a method of generating neutralizing antibodies to HIV-1 by administering a composition comprising a trimeric complex of gp140 (¶0081).
Regarding claim 41, Kong discloses a method of treating a subject infected with HIV-1 by administering a composition comprising a trimeric complex of gp140 (¶0079).
Regarding claim 48, Kong discloses a method of generating antibodies that are cross-reactive against a broad array of HIV-1 isolates by administering a composition comprising a trimeric complex of gp140 (¶0068).
Accordingly, the claimed inventions are anticipated by Kong.
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 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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kong as applied to claims 1-2, 8, 10-12, 16, 19, 23, 27, 30, 36, 41, and 48 above, and further in view of Wen, et al. (PLoS One. 2018 Apr 26;13(4):e0194266., hereinafter “Wen”).
As discussed above, claims 1-2, 8, 10-12, 16, 19, 23, 27, 30, 36, 41, and 48 were anticipated by Kong.
Regarding claim 6, Kong teaches that the gp120 subunit can be derived from many HIV strains or subtypes (¶0006) but does not explicitly teach that the HIV strain is HIV-1 CRF01_AE A244. However, Wen teaches using HIV-1 strain CRF01_AE A244, specifically the gp120 protein of the strain in a HIV vaccine (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the HIV strain taught by Kong (¶0006) for the HIV-1 CRF01_AE A244 strain taught by Wen (Abstract). Wen teaches that the gp120 protein of CRF01_AE A244 is suitable for use in a vaccine and elicits distinct V2- specific Abs to the epitope shown to correlate with decreased risk of HIV-1 infection (Abstract). One of skill in the art would have substituted the HIV strain taught by Kong (¶0006) for the HIV-1 strain CRF01_AE A244 taught by Wen (Abstract) to create a trimeric complex comprising a gp120 subunit from CRF01_AE A244. One of skill in the art would have had a reasonable expectation of success of substituting the gp120 proteins of the different strains because they are both HIV-1 gp120 proteins.
Accordingly, the invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kong as applied to claims 1-2, 8, 10-12, 16, 19, 23, 27, 30, 36, 41, and 48 above, and further in view of He, et al. (US 11097002 B2, hereinafter “He”).
As discussed above, claims 1-2, 8, 10-12, 16, 19, 23, 27, 30, 36, 41, and 48 were anticipated by Kong.
Regarding claim 9, Kong teaches a modified gp41 sequence from BG505 (see SEQ ID NO: 7 residues 482-621) but Kong does not teach that the gp41 subunit comprises instant SEQ ID NO: 7 as Kong does not teach that the first amino acid residue of gp41 is Ser. However, He teaches SEQ ID NO: 23 which is a sequence for an HR1-modified gp140 trimer that comprises a gp41 subunit that has 100% sequence identity to instant SEQ ID NO: 7 (see alignment below).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the gp41 subunit from HIV-1 strain BG505 taught by Kong (¶0006) for the specific gp41 subunit from HIV-1 strain BG505 in SEQ ID NO: 23 taught by He. He teaches that the gp41 protein of BG505 is suitable for use in a vaccine (column 3 lines 66-67 and column 4 lines 1-2). One of skill in the art would have substituted the gp41 subunit from HIV-1 strain BG505 taught by Kong (¶0006) for the specific gp41 subunit from HIV-1 strain BG505 in SEQ ID NO: 23 to create a trimeric complex comprising the specific gp41 subunit from BG505. One of skill in the art would have had a reasonable expectation of success of substituting the gp41 proteins of the BG505 strain because they are both HIV-1 gp41 proteins.
Accordingly, the invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
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Allowable Subject Matter
Claims 4-5 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.
Claims 3 and 7 are also free of the art but are currently rejected under 112(b).
Conclusion
NO CLAIMS ARE ALLOWED
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
