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 .
Response to Amendment
The amendment filed 28 May 2026 in which claims 40-48, 52, 56, 68, and 74 were amended and claims 49-51 and 55 were cancelled has been entered.
Claims 40-48, 52, and 56-81 are under examination on the merits.
Specification
(Previous objection, withdrawn). Applicant’s amendments to the Specification submitted 28 May 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 05 March 2026.
Drawings
(Previous objection, withdrawn). Applicant’s amendments to the Drawings submitted 28 May 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 05 March 2026.
Claim Objections
(Previous objection, withdrawn). Applicant’s amendments to claim 40 submitted 28 May 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 05 March 2026.
Claim Rejections - 35 USC § 112(b)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn). Claim 40 was 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. Applicant’s amendments to claim 40 submitted 28 May 2026 have overcome the rejection previously set forth in the Non-Final Office Action mailed 05 March 2026.
(Previous rejection, withdrawn). Claim 51 was 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. Applicant’s cancellation of claim 51 submitted 28 May 2026 has rendered the rejection previously set forth in the Non-Final Office Action mailed 05 March 2026 moot.
(Previous rejection, withdrawn). Claims 41-48 were 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.
(Previous rejection, withdrawn). Claims 49-52 and 55 were 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. Applicant’s cancellation of claim 49-51 and 55 submitted 28 May 2026 has rendered the rejection previously set forth in the Non-Final Office Action mailed 05 March 2026 moot. Applicant’s amendments to claim 52 submitted 28 May 2026 have overcome the rejection previously set forth in the Non-Final Office Action mailed 05 March 2026.
(Previous rejection, maintained). Claims 58-67 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 Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, maintained and modified as to claim 40-48, 52, 56-57, 71, and 74 and withdrawn as to claims 49, 51, and 55 due to cancellation of the claims). Claims 40-48, 52, 56-57, 71, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey and further in view of Gautam as evidenced by Mendoza. Applicant’s cancellation of claims 49, 51, and 55 submitted 28 May 2026 has rendered the rejection previously set forth in the Non-Final Office Action mailed 05 March 2026 moot.
Regarding claims 40-48 and 52, Caskey teaches a method for treating or preventing HIV in a human by co-administering an effective amount of 10-1074-LS (zinlirvimab) and 3BNC117-LS (teropavimab) (LS Variants: Study Design and Endpoints). Caskey further teaches intravenously administering 30 mg/kg of both 10-1074-LS (zinlirvimab) and 3BNC117-LS (teropavimab) (LS Variants: Study Design and Endpoints). Caskey does not teach the total dose of antibodies administered. However, routine optimization of Caskey’s dosage (mg/kg) of antibodies would have led to the claimed dose of 2550mg because the total amount of antibody administered is based on the subject’s weight, the dosage of 30 mg/kg taught by Caskey (LS Variants: Study Design and Endpoints) would translate to 2550mg for subjects 85kg in weight. The person of ordinary skill in the art would have found it obvious to optimize the dose of antibodies given by starting optimization from the dosage taught by Caskey and determining the final dose by using the subjects weight to order to calculate the appropriate final dose of antibodies.
Caskey does not teach administering a 10-1074-LS (zinlirvimab) and 3BNC117-LS (teropavimab) at a second time point. However, Gautam teaches that the two antibodies in combination give a subject an extended period of protection and that the combination of 10-1074-LS (zinlirvimab) and 3BNC117-LS (teropavimab) can be used for an effective semiannual or annual immunoprophylactic for preventing HIV-1 in humans (Abstract). The semiannual time point reasonably encompasses 6 months, 24-26 weeks, and twice a year for multiple years. Indeed, Gautam teaches that “[t]he extended period of protection observed in macaques for the 3BNC117-LS (teropavimab) plus 10-1074-LS (zinlirvimab) combination could translate into an effective semiannual or annual immunoprophylaxis regimen for preventing HIV-1 infections in humans.”
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Caskey for a combination treatment of 10-1074-LS (zinlirvimab) and 3BNC117-LS (teropavimab) for treating and preventing HIV in humans with the teachings of Gautam for using the combination of 10-1074-LS (zinlirvimab) and 3BNC117-LS (teropavimab) as a semiannual prophylaxis regimen. Gautam provides motivation by teaching that the combination of the two antibodies protects subjects for an extended period of time, for 6 months, and repeat treatments would further extend protection (Abstract). One of skill in the art would have had a reasonable expectation of success at combining Caskey and Gautam because they both teach combination 10-1074-LS (zinlirvimab) and 3BNC117-LS (teropavimab) therapy to treat and prevent HIV.
Regarding claim 56, Caskey teaches that serum levels of the antibodies remain above 10µg/ml for up to 24 weeks (Serum Antibody Levels). Caskey did not monitor subjects past 24 weeks. However, as evidenced by Mendoza, serum levels remain above 10µg/ml up to 30 weeks after intravenous administration of 30 mg/kg of 10-1074-LS (zinlirvimab) and 3BNC117-LS (teropavimab) (pg. 481 column 2). Therefore, absent evidence to the contrary, the method taught by Caskey and Gautam would maintain the recited serum levels 26 weeks after the first time point. The serum levels are not an additional step to be performed, but, rather, the inherent result of practicing the method taught by Caskey and Gautam. See MPEP § 2112.
Regarding claim 57, Caskey teaches that HIV RNA is less than 50 copies/ml for up to 24 weeks (Effects on Plasma Viremia). Caskey did not monitor subjects past 24 weeks. However, as evidenced by Mendoza, HIV RNA copies remain below 20 copies/ml for up to 30 weeks after IV administration with both antibodies (pg. 480 column 2 and 481 column 1). Therefore, absent evidence to the contrary, the method taught by Caskey and Gautam would maintain the recited HIV RNA levels 26 weeks after the first time point. The HIV RNA levels are not an additional step to be performed, but, rather, the inherent result of practicing the method taught by Caskey and Gautam. See MPEP § 2112.
Regarding claim 71, Caskey teaches that the subject is viremic with an HIV-1 RNA count of 500-125,000 cp/ml (LS Variants: Study Design and Endpoints).
Regarding claim 74, Caskey teaches that the subject discontinued ART for 4 weeks before antibody administration (LS Variants: Study Design and Endpoints).
Accordingly, the claimed method was prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention, especially in the absence of evidence to the contrary.
(Previous rejection, withdrawn as to claim 50 due to cancellation of the claim). Claims 50 was rejected under 35 U.S.C. 103 as being unpatentable over Caskey and Gautam and further in view of Rockefeller. Applicant’s cancellation of claim 50 submitted 28 May 2026 has rendered the rejection previously set forth in the Non-Final Office Action mailed 05 March 2026 moot.
(Previous rejection, maintained as to claims 58-59, 64-68, and 75-81). Claims 58-59, 64-68, and 75-81 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey and Gautam and further in view of Moldt as evidenced by Lorenzi.
(Previous rejection, maintained as to claims 58-61 and 63). Claims 58-61 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey and Gautam and further in view of Gilead and Gilead2.
(Previous rejection, maintained as to claim 62). Claims 62 is rejected under 35 U.S.C. 103 as being unpatentable over Caskey, Guatam, Gilead, and Gilead2 and further in view of Daar.
(Previous rejection, maintained as to claims 69-70). Claims 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey and Gautam and further in view of Kufel.
(Previous rejection, maintained as to claims 72-73). Claims 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey and Gautam and further in view of Rockefeller and Moldt.
Response to Arguments
Applicant contends on page 11 of the Remarks submitted 05 May 2026 that as claim 40 “comprises” the first and second timepoints, multiple administrations past the first two are included and do not render the claims indefinite.
In response: Applicant’s arguments have been fully considered and have been fully persuasive. The term “comprising” does allow for additional steps in a method claim.
Applicant contends on page 11 of the Remarks submitted 05 May 2026 that co-administration is defined within the Specification and does not require the long-acting HIV drugs to be administered at the first or second time point.
In response: While co-administration is defined as within 72 hours of administration of the antibodies, it is still unclear when the long-acting HIV drugs are administered, with 72 hours of first time point, second time point, or both. The claims, therefore, are still indefinite.
Applicant contends on pages 12-14 of the Remarks submitted 05 May 2026 that the newly amended claims require flat dosing of the antibodies rather than weight-based dosing as required by the prior art and that one of skill in the art would not be motivated to exploit flat dosing, or more specifically, flat dosing regimens of the antibodies of 2550mg.
In response: The flat dose required in the claims would be administered to any subject weighing 85kg with weigh-based dosing. The flat dose of 2550 mg is therefore obvious to administer to subjects with this weight. The prior art may not explicitly teach this dose but optimization of the prior art weight-based dosing would lead to the claimed dose of 2550mg. The instant claims are intended as a flat dosing regimen of 2550mg of each of the antibodies, which is not explicitly taught by the prior art. However, the weight-based dosing of the prior encompasses this claimed method as the flat dose of 2550mg is attainable to a subject weighing 80kg with weight-based dosing of both antibodies.
Conclusion
NO CLAIMS ARE ALLOWED
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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