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
Election Restrictions
1. Applicant’s election of Group II and species ((i), Gag; SEQ ID NO: 10) in the reply filed on 9/30/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-11, 19, 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 9/30/2025.
Claims 12-18, 21 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 4/1/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
3. Applicant is advised that should claim 12 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
4. Claim 14 is 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.
See claim 14 as submitted 3/26/2026.
As to claim 14, the claim recites the limitation "the HIV-specific peptide”. There is insufficient antecedent basis for this limitation in the claim.
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.
5. Claims 12, 16, 17, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (WO2016061232)(cited in applicant's IDS submitted 8/18/2023) in view of Sahaf et al. (“Culturing of human peripheral blood cells reveals unsuspected lymphocyte responses relevant to HIV disease,” PNAS, Vol. 105, No. 13: 5111-5116 (2008))(See PTO-892: Notice of References Cited).
See claims 12, 16, 17, 21 as submitted 3/26/2026.
Wu et al. teaches: (it is noted the following teachings are supported and cited in provisional application 62/063583): treating HIV infection [0033](as recited in claims 12, 21); PBMC obtained from HIV infected individuals [0033]; transduced with HIV-1 env pseudotyped 7 shRNA-miR encoding lentivirus [0033](interpreted as ex vivo contacting PBMC isolated from a subject as recited in claims 12, 21; transducing the PBMC ex vivo with a viral delivery system encoding at least one genetic element); culturing [0025](as recited in claims 12, 17, 21); shRNA-miRs targeting CCR5 and multiple HIV-1 genes [0026, 0046](as recited in claims 12, 21); expressing individual shRNA- miRs in the multiplex, wherein siRNAs included CCR5, tat and vif [0022](as recited in claims 12, 21); gag [42](as recited in claim 16); multiple shRNA-miR constructs [0023]; wherein the level of each appears to be adequate to suppress all targeted genes [0022]; expression of 1, 2, 5, 7 shRNAs [0024]; reinfusion of cells [0033] (as recited in claims 12, 21).
Wu et al. does not teach: contacting PBMC obtained from a subject with a stimulatory agent, wherein the contacting is ex vivo.
Sahaf et al. teaches: PHA/IL-2 stimulation is typically used to prime for and support HIV infection in PBMCs (p. 5111).
One of ordinary skill in the art would have been motivated to ex vivo contact PBMC with stimulatory agent as taught by Sahaf et al. in the method of Wu et al. Wu et al. teaches transduction of PBMCs with lentivirus, and Sahaf et al. teaches the advantage known and used in the art of priming PBMC cells for HIV infection using PHA/IL-2 stimulation.
As to time frames as recited in claims 1, 12, 17, such recitations are considered to be those determined by routine optimization to one of ordinary skill in the art in view of Wu et al. in view of Sahaf et al. absent unexpected results (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955))
One of ordinary skill in the art would have had a reasonable expectation of success for contact PBMC with stimulatory agent as taught by Sahaf et al. in the method of Wu et al. There would have been a reasonable expectation of success given the underlying materials and methods (infecting and transducing PBMC cells as taught by Wu et al. and Sahaf et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
6. Claims 12-14, 16, 17, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (WO2016061232)(cited in applicant's IDS submitted 8/18/2023) in view of De Rose et al. (“Safety, immunogenicity and efficacy of peptide-pulsed cellular immunotherapy in macaques,” J Med Primatol (Suppl 2) 69-78 (2008))(See PTO-892: Notice of References Cited).
See claims 12-14, 16, 17, 21 as submitted 3/26/2026.
See the teachings of Wu et al. above.
Wu et al. does not teach: contacting PBMC obtained from a subject with a stimulatory agent, wherein the contacting is ex vivo; HIV vaccine; Gag peptide.
De Rose et al. teaches: immune control of HIV in humans and SIV in macaques (p. 69); intravenous re-infusion of PBMC pulsed with overlapping 15mer SIV peptides (p. 69); use of Gag (p. 70); peptide pulsed PBMC as a safe, immunogenic and effective immunotherapy.
One of ordinary skill in the art would have been motivated to ex vivo contact PBMC with Gag peptide (or HIV gag, correlate for humans to SIV) as taught by De Rose et al. in the method of Wu et al. Wu et al. teaches HIV treatment including reinfusion of PBMC cells, and De Rose et al., which also teaches HIV treatment including reinfusion of PBMC cells, teaches the advantage wherein using peptide pulsed PBMC is a safe, immunogenic and effective immunotherapy.
As to time frames as recited in claims 1, 12, 17, such recitations are considered to be those determined by routine optimization to one of ordinary skill in the art in view of Wu et al. in view of De Rose et al. absent unexpected results (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955))
One of ordinary skill in the art would have had a reasonable expectation of success for contact PBMC with stimulatory agent as taught by De Rose et al. in the method of Wu et al. There would have been a reasonable expectation of success given the underlying materials and methods (reinfusing PBMC cells as taught by Wu et al. and De Rose et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
7. Claims 12-14, 16, 17, 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 9 of copending Application No. 18/227768 in view of De Rose et al. (cited above).
See claims 12-14, 16, 17, 21 as submitted 3/26/2026.
Claims 1-4, 8, 9 of copending Application No. 18/227768 recite a method of treating HIV comprising: (a) ex vivo contacting peripheral blood mononuclear cells (PBMC) isolated from a
subject; (b) transducing the PBMC ex vivo with a viral delivery system encoding at least one
genetic element; and (c) culturing the transduced PBMC for at least 1 day, wherein the viral delivery system encoding at least one genetic element comprises: (i) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5 and at least one microRNA capable of inhibiting the production of HIV tat gene. (ii) at least one microRNA capable of inhibiting the production of HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene or (iii) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5, at least one microRNA capable of inhibiting the production of
HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene; RNA inhibiting gag; infusing transduced PBMC.
Claims 1-4, 8, 9 of copending Application No. 18/227768 do not recite contacting PBMC obtained from a subject with a stimulatory agent, wherein the contacting is ex vivo; HIV vaccine; Gag peptide.
See the teachings of De Rose et al. above.
One of ordinary skill in the art would have been motivated to ex vivo contact PBMC with Gag peptide (or HIV gag, correlate for humans to SIV) as taught by De Rose et al. in the method as recited in claims 1-4, 8, 9 of copending Application No. 18/227768. Claims 1-4, 8, 9 of copending Application No. 18/227768 recite HIV treatment including infusion of PBMC cells, and De Rose et al., which also teaches HIV treatment including infusion of PBMC cells, teaches the advantage wherein using peptide pulsed PBMC is a safe, immunogenic and effective immunotherapy.
As to time frames as recited in claims 1, 12, 17, such recitations are considered to be those determined by routine optimization to one of ordinary skill in the art in view of Wu et al. in view of claims 1-4, 8, 9 of copending Application No. 18/227768 absent unexpected results (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955))
One of ordinary skill in the art would have had a reasonable expectation of success for ex vivo contacting PBMC with Gag peptide as taught by De Rose et al. in the method as recited in claims 1-4, 8, 9 of copending Application No. 18/227768. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. Claims 12, 13, 15-17, 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11980663.
See claims 12, 13, 15-17, 21 as submitted 3/26/2026.
Claims 1-18 of U.S. Patent No. 11980663 recite a method of treating HIV infection, comprising: (a) immunizing a subject with a therapeutically effective amount of an HIV vaccine; (b) purifying peripheral blood mononuclear cells (PBMC) obtained from the subject; (c) contacting the PBMC ex vivo with a therapeutically effective amount of an HIV vaccine; (d) transducing the PBMC ex vivo with a viral delivery system that comprises a microRNA cluster encoding: (i) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5 and at least one microRNA capable of inhibiting the production of HIV tat gene, (ii) at least one microRNA capable of inhibiting the production of HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene or (iii) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5, at least one microRNA capable of inhibiting the production of HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene; (e) culturing the transduced PBMC for about 1 to about 35 days; and (f) infusing the transduced PBMC into the subject, wherein the subject receives a cyclophosphamide pre-treatment prior to infusing the transduced PBMC; a method of treating HIV in a HIV+subject, comprising: (a) immunizing a subject with a therapeutically effective amount of an HIV vaccine; (b) purifying peripheral blood mononuclear cells (PBMC) obtained from the subject; (c) contacting the PBMC ex vivo with a therapeutically effective amount of an HIV vaccine; (d)transducing the PBMC ex vivo with a viral delivery system that comprises a microRNA cluster encoding: (i) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5 and at least one microRNA capable of inhibiting the production of HIV tat gene, (ii) at least one microRNA capable of inhibiting the production of HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene or (iii) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5, at least one microRNA capable of inhibiting the production of HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene; (e) culturing the transduced PBMC for about 1 to about 35 days; and (f) infusing the transduced PBMC into the subject, wherein the subject receives a cyclophosphamide pre-treatment prior to infusing the transduced PBMC; CXCR4.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 12, 13, 15-17, 21 and claims 1-18 of U.S. Patent No. 11980663 recite a method of treating HIV in a HIV+ subject, comprising: (a) contacting PBMC obtained from a subject with a stimulatory agent, wherein the contacting is ex vivo; (b) transducing the PBMC ex vivo with a viral delivery system that comprises a genetic element encoding: (i) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5 and at least one small RNA capable of inhibiting the production of HIV Tat gene; (ii) at least one small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; or, (iii) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5, at least small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; (c) culturing the transduced PBMC for at least 1 day; and (d) infusing the transduced PBMC into the subject; CXCR4.
9. Claim 12, 17, 18, 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17, 19-22 of copending Application No. 16218010.
See claims 12, 17, 18, 21 as submitted 3/26/2026.
Claims 15-17, 19-22 of copending Application No. 16218010 recite a method of treating cells infected with HIV, the method comprising: a. contacting or having contacted peripheral blood mononuclear cells (PBMC) isolated from a subject infected with HIV with a therapeutically effective amount of an ex vivo stimulatory agent, wherein the contacting is conducted ex vivo; b. transducing or having transduced the PBMC ex vivo with a lentiviral particle, wherein the lentiviral particle comprises: i. an envelope protein capable of infecting the PBMC; and ii. an encoded microRNA cluster, wherein the encoded microRNA cluster comprises a sequence comprising (i) at least 90% sequence identity with SEQ ID NO: 1, (ii) at least 90% sequence identity with SEQ ID NO: 2, and (iii) at least 90% sequence identity with SEQ ID NO: 3; further comprising infusing or having infused the transduced PBMC into a subject. It is noted that SEQ ID NO: 1 has 100% identity with instant SEQ ID NO: 10 (See Result 1 of STIC Sequence Search Result 20260603_141444_us-18-615-749-10.rnpbm in Supplemental Content Tab).
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 12, 17, 18, 21 and claims 15-17, 19-22 of copending Application No. 16218010 recite a method of treating HIV in a HIV+ subject, comprising: (a) contacting PBMC obtained from a subject with a stimulatory agent, wherein the contacting is ex vivo; (b) transducing the PBMC ex vivo with a viral delivery system that comprises a genetic element encoding: (i) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5 and at least one small RNA capable of inhibiting the production of HIV Tat gene; (ii) at least one small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; or, (iii) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5, at least small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; (c) culturing the transduced PBMC for at least 1 day; and (d) infusing the transduced PBMC into the subject; SEQ ID NO: 10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Claims 12-14, 17, 18, 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 74-86 of copending Application No. 16476529.
See claims 12-14, 17, 18, 21 as submitted 3/26/2026.
Claims 74-86 of copending Application No. 16476529 recite a method of treating cells, wherein the cells were isolated from a subject not previously immunized with an HIV-1 vaccine, the method comprising: (a) contacting peripheral blood mononuclear cells (PBMC) isolated from a subject infected with HIV-1 and not previously immunized with an HIV vaccine, with a
therapeutically effective amount of a stimulatory agent, wherein the contacting is carried
out ex vivo; (b) transducing, the PBMC ex vivo with a viral delivery system encoding at least one genetic element, wherein at least one genetic element comprises: a sequence having at least 95% 80% sequence identity with SEQ ID NO: 31; or at least two of: (i) a sequence comprising at least 95% 80% sequence identity with SEQ ID NO: 1, (ii) a sequence comprising at least 95% 80% sequence identity with SEQ ID NO: 2, and (iii) a sequence comprising at least 95% 90% sequence identity with SEQ ID NO: 3; or each of: (iv) a sequence comprising at least 95% 80% sequence identity with SEQ ID NO: 97, (v) a sequence comprising at least 95% 80% sequence identity with SEQ ID NO: 6, and (vi) a sequence comprising at least 95% 80% sequence identity with SEQ ID NO: 7 and (c) culturing, or having cultured, the transduced PBMC for at least 1 day; further comprising infusing, or having infused, the transduced PBMC into a subject; wherein the stimulatory agent comprises a peptide; wherein the peptide comprises a GAG
peptide; it is noted that SEQ ID NO: 1 has 100% identity with instant SEQ ID NO: 10 (See Result 1 of STIC Sequence Search Result 20260603_141444_us-18-615-749-10.rnpbm in Supplemental Content Tab).
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 12-14, 17, 18, 21 and claims 74-86 of copending Application No. 16476529 recite a method of treating HIV in a HIV+ subject, comprising: (a) contacting PBMC obtained from a subject with a stimulatory agent, wherein the contacting is ex vivo; (b) transducing the PBMC ex vivo with a viral delivery system that comprises a genetic element encoding: (i) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5 and at least one small RNA capable of inhibiting the production of HIV Tat gene; (ii) at least one small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; or, (iii) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5, at least small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; (c) culturing the transduced PBMC for at least 1 day; and (d) infusing the transduced PBMC into the subject; SEQ ID NO: 10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. Claims 12-14, 17, 18, 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-39 of U.S. Patent No. 11090379.
See claims 12-14, 17, 18, 21 as submitted 3/26/2026.
Claims 12-39 of U.S. Patent No. 11090379 recite a method of treating cells infected with HIV, the method comprising: (a) obtaining, or having obtained, peripheral blood mononuclear cells (PBMC) from a subject infected with HIV, wherein the subject has been previously immunized with a therapeutically effective amount of a first stimulatory agent; (b) contacting, or having contacted, the PBMC with a therapeutically effective amount of a second stimulatory agent, wherein the contacting is carried out ex vivo; (c) transducing, or having transduced, the PBMC ex vivo with a viral delivery system encoding at least one genetic element, wherein at least one encoded genetic element comprises: at least two of: (i) a sequence comprising at least 80% sequence identity with SEQ ID NO: 1, (ii) a sequence comprising at least 80% sequence identity with SEQ ID NO: 2, and (iii) a sequence comprising at least 80% sequence identity with SEQ ID NO: 3; or each of: (iv) a sequence comprising at least 80% sequence identity with SEQ ID NO: 97, (v) a sequence comprising at least 80% sequence identity with SEQ ID NO: 6, and (vi) a sequence comprising at least 80% sequence identity with SEQ ID NO: 7; and (d) culturing, or having cultured, the transduced PBMC for at least 1 day; further comprising infusing, or having infused, the transduced PBMC into a subject; wherein at least one of the first stimulatory agent and the second stimulatory agent comprises a peptide; wherein the peptide comprises a gag peptide. It is noted that SEQ ID NO: 1 has 100% identity with instant SEQ ID NO: 10 (See Result 1 of STIC Sequence Search Result 20260603_141444_us-18-615-749-10.rnpbm in Supplemental Content Tab).
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 12-14, 17, 18, 21 and claims 12-39 of U.S. Patent No. 11090379 recite a method of treating HIV in a HIV+ subject, comprising: (a) contacting PBMC obtained from a subject with a stimulatory agent, wherein the contacting is ex vivo; (b) transducing the PBMC ex vivo with a viral delivery system that comprises a genetic element encoding: (i) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5 and at least one small RNA capable of inhibiting the production of HIV Tat gene; (ii) at least one small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; or, (iii) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5, at least small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; (c) culturing the transduced PBMC for at least 1 day; and (d) infusing the transduced PBMC into the subject; SEQ ID NO: 10.
12. Claims 12-14, 17, 18, 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49-55, 67-94 of U.S. Patent No. 11612649.
See claims 12-14, 17, 18, 21 as submitted 3/26/2026.
Claims 49-55, 67-94 of U.S. Patent No. 11612649 recite a method of treating cells infected with HIV, the method comprising: (a) contacting or having contacted peripheral blood mononuclear cells (PBMC) isolated from a subject infected with HIV with a therapeutically effective amount of an ex vivo stimulatory agent, wherein the contacting is conducted ex vivo; (b) transducing or having transduced the PBMC ex vivo with a lentiviral particle, wherein the lentiviral particle comprises: (i) an envelope protein capable of infecting the PBMC; and (ii) an encoded microRNA cluster, wherein the encoded microRNA cluster comprises a sequence comprising (a) at least 90% sequence identity with SEQ ID NO: 1, (b) at least 90% sequence identity with SEQ ID NO: 2, and (c) at least 90% sequence identity with SEQ ID NO: 108; further comprising infusing or having infused the transduced PBMC into a subject; a method of treating cells infected with HIV, the method comprising: (a) obtaining, or having obtained, peripheral blood mononuclear cells (PBMC) from a subject infected with HIV, wherein the subject has been previously immunized with a therapeutically effective amount of a first stimulatory agent; (b) contacting, or having contacted, the PBMC with a therapeutically effective amount of a second stimulatory agent, wherein the contacting is carried out ex vivo; (c) transducing, or having transduced, the PBMC ex vivo with a viral delivery system encoding at least one genetic element, wherein at least one encoded genetic element comprises: at least two of: (i) a sequence comprising at least 80% sequence identity with SEQ ID NO: 1, (ii) a sequence comprising at least 80% sequence identity with SEQ ID NO: 2, and (iii) a sequence comprising at least 80% sequence identity with SEQ ID NO: 108; or each of: (iv) a sequence comprising at least 80% sequence identity with SEQ ID NO: 97, (v) a sequence comprising at least 80% sequence identity with SEQ ID NO: 6, and (vi) a sequence comprising at least 80% sequence identity with SEQ ID NO: 7; and (d) culturing, or having cultured, the transduced PBMC for at least 1 day; further comprising infusing, or having infused, the transduced PBMC into a subject; wherein at least one of the first stimulatory agent and the second stimulatory agent comprises a peptide; wherein the peptide comprises a gag peptide. It is noted that SEQ ID NO: 1 has 100% identity with instant SEQ ID NO: 10 (See Result 1 of STIC Sequence Search Result 20260603_141444_us-18-615-749-10.rnpbm in Supplemental Content Tab).
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 12-14, 17, 18, 21 and claims 49-55, 67-94 of U.S. Patent No. 11612649 recite a method of treating HIV in a HIV+ subject, comprising: (a) contacting PBMC obtained from a subject with a stimulatory agent, wherein the contacting is ex vivo; (b) transducing the PBMC ex vivo with a viral delivery system that comprises a genetic element encoding: (i) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5 and at least one small RNA capable of inhibiting the production of HIV Tat gene; (ii) at least one small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; or, (iii) at least one small RNA capable of inhibiting the production of chemokine receptor CCR5, at least small RNA capable of inhibiting the production of HIV Tat gene and at least one small RNA capable of inhibiting the production of HIV Vif gene; (c) culturing the transduced PBMC for at least 1 day; and (d) infusing the transduced PBMC into the subject; SEQ ID NO: 10.
Conclusion
13. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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