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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Acknowledgment is made of applicant's claim for foreign priority based on the
applications filed as CN 2020/115188288 on 12/21/2020.
It is noted, however, that applicant has not filed an English translation of the certified copies as required by 37 CFR 1.55.
All claims are given the filing date of 12/07/2021.
Application Status
Receipt is acknowledged of amendment, filed 07/06/2026. Claims 1-17 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group I, drawn to claims 1-11 and 13-15 in the reply filed on 07/06/2026 is acknowledged.
Claims 12, 16 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/06/2026.
Claims 1-11 and 13-15 are currently under examination.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statement filed on 06/19/2023 has been received and all references have been considered.
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 2, 4, 5, 11 and 15 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.
Claims 2 and 4 are vague and indefinite in that the metes and bounds of the phrase “preferably” is unclear. The phrase is unclear in that it is unknown whether the limitations that follow the phrase “preferably” are required limitations of the claims. It would be remedial to replace the phrase “preferably” with “optionally”.
Claim 5 is vague and indefinite in that the metes and bounds of the phrase “the nucleic acid construct is shown as” is unclear. The phrase is unclear in that it is unknown whether the claim limitations include the sequences in its entirety or not. It would be remedial to replace the phrase “the nucleic acid construct is shown as” with “the nucleic acid construct comprising”.
Claim 11 is vague and indefinite in that the metes and bounds of the phrase “the adeno-associated viral vector system further comprises a host cell” is unclear. The phrase is unclear if the host cell transformed with the vector or separately included in the system.
Claim 15 is vague and indefinite in that the metes and bounds of the phrase “Use of the nucleic acid construct according to claim 1” is unclear as the claim does not recite active steps for the product. A claim that merely recites the "use" of a product without active steps delimiting how the use is practiced leaves the metes and bounds of the process unclear.
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 1-4, 9-11 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al (J Clin Invest. 2018;128(6):2239-2251) as evidenced by Bruno et al (J Antimicrob Chemother 2010; 65: 1839–1841).
Regarding claims 1, 2, 4, Wu teaches a single gene-encoded (SG) BiIA (BiIA-SG) through fusion of the PGT128 VL/VH to the N-terminal of 1A-Hu5A8 VL/VH in tandem with a hIgG-Fc and as a result, BiIA-SG is structurally unique with 4 scFv binding domains (2 for HIV-1 gp120 and 2 for CD4) (Page 2240, Column 2 and Page 2241, Figure 2B). Wu teaches that AAV-vectored BiIA-SG eliminated HIV-infected splenocytes in humanized mice using a single injection (Page 2244, Column 1 and 2 and Page 2247, Column 1).
Regarding claim 3, Wu teaches the single gene-encoded (SG) BiIA (BiIA-SG) through fusion of the PGT128 VL/VH to the N-terminal of 1A-Hu5A8 VL/VH in tandem with a hIgG-Fc and as a result, BiIA-SG is structurally unique with 4 scFv binding domains (2 for HIV-1 gp120 and 2 for CD4) (Page 2240, Column 2 and Page 2241, Figure 2B) wherein Hu5A8 is an alternative name and clone designation for ibalizumab (Page 2247, Column 2). Bruno is only cited to show that Hu5A8 is the form named ibalizumab (Page 1839, Column 1).
Regarding claims 9-11, Wu teaches a single gene-encoded (SG) BiIA (BiIA-SG) through fusion of the PGT128 VL/VH to the N-terminal of1A-Hu5A8 VL/VH in tandem with a hIgG-Fc and as a result, BiIA-SG is structurally unique with 4 scFv binding domains (2 for HIV-1 gp120 and 2 for CD4) (Page 2240, Column 2 and Page 2241, Figure 2B). Wu teaches that AAV-vectored BiIA-SG eliminated HIV-infected splenocytes in humanized mice using a single injection (Page 2244, Column 1 and 2 and Page 2247, Column 1). Wu teaches the pAAV-MCS plasmid containing the BiIA-SG transgene or the pAAV-IRES-hrGFP control was cotransfected into AAV-293T cells together with the helper vector pHELP (catalog 240071, Agilent Technologies) and pAAV-DJ (Page 2249, Column 1).
Regarding claim 13-15, Wu teaches a single gene-encoded (SG) BiIA (BiIA-SG) through fusion of the PGT128 VL/VH to the N-terminal of1A-Hu5A8 VL/VH in tandem with a hIgG-Fc and as a result, BiIA-SG is structurally unique with 4 scFv binding domains (2 for HIV-1 gp120 and 2 for CD4) (Page 2240, Column 2 and Page 2241, Figure 2B). Wu teaches the pAAV-MCS plasmid containing the BiIA-SG transgene or the pAAV-IRES-hrGFP control was cotransfected into AAV-293T cells together with the helper vector pHELP (catalog 240071, Agilent Technologies) and pAAV-DJ (Page 2249, Column 1). Wu teaches that AAV-vectored BiIA-SG eliminated HIV-infected splenocytes in humanized mice using a single injection (Page 2244, Column 1 and 2 and Page 2247, Column 1).
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 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (J Clin Invest. 2018;128(6):2239-2251) in view of Anthony-Gonda et al (Sci. Transl. Med.11, eaav5685 (2019); Pgs. 1-17 and Supplemental Information Pgs 1-25).
The teachings of Wu are as described and applied above.
Regarding claims 6-8, Wu does not teach the viral vector is a lentiviral vector.
Anthony-Gonda teaches HIV-1-based lentiviral vectors encoding mono-, bi-, and trispecific anti-HIV CARs wherein these CARs target three putative sites on the Env trimer, which include the gpl20 CD4-binding site (mDl.22), gpl20 co-receptor-binding site (m36.4), and gp41 near the membrane-proximal external region (MPER) (C46 peptide) (Page 2, Column 2). Anthony-Gonda teaches a constructed lentiviral vector encoding bispecific duoCAR that contained the mDl.22-CAR and the m36.4-CAR (Dl3) single chain variable region fragments wherein the duoCAR can be engineered with two or more Env specificities via a bicistronic P2A comprising LV to allow for a simultaneous expression of both CARs in a single T cell (Page 2, Column 2 and Page 3, Figure 1). Anthony-Gonda teaches the lentiviral vectors expressing anti-HIV CAR transgenes were produced by transiently transfecting 293T suspension cells using a four-plasmid system comprising the CAR transfer plasmid, VSVg envelope, gag/pol, and rev plasmids (Page 4 of Supplementary Information, Last paragraph). Anthony-Gonda teaches duoCAR-T cells (D13) were intrasplenically co-injected into mice spleens with donor-matched PBMCs infected with C.Du422.lIMC-LucR (Page 9, Column 2). Anthony-Gonda teaches HIV infection in the hu-spl-PBMC-NSG mouse spleens were significantly more suppressed by the D13 duoCAR-T cells (97.S%, P = 0.004 for D13 versus MlCAR and P < 0.001 for D13 versus M13 CAR) (Page 9, Column 2 and Page 11, Figure 7B).
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 AAV vector of Wu for the Lentiviral vector as taught by Anthony-Gonda because Wu teaches it is within the ordinary skill in the art to use single gene-encoded (SG) BiIA (BiIA-SG) through fusion of the PGT128 VL/VH to the N-terminal of1A-Hu5A8 VL/VH in tandem with a hIgG-Fc within an adeno-associated viral vector and Anthony-Gonda teaches lentiviral vectors expressing anti-HIV CAR transgenes.
One would have been motivated to make such a modification in order to receive the expected benefit of the nucleic acid construct within a lentiviral vector as taught by Anthony-Gonda.
Conclusion
No claims are allowed.
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
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