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
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional applications 63/373,597 (filed on 08/26/2022) and 63/514,711 (filed on 07/20/2023).
Claim Status
An amendment was received on 01/28/2026. Claims 40-52 and 55-81 are pending, all of which have been considered on the merits.
Election/Restriction
Applicant’s election without traverse of Group I, corresponding to claims 40-52 and 55-81, in the reply filed on 28 January, 2026 is acknowledged. It is noted that claim 82 was canceled by Applicant in the reply filed 28 January, 2026.
Specification
The Specification is objected to because the drawings are indicated by “Fig” or “Figure” rather than “FIG.” as required by 37 C.F.R. § 1.84 (u)(1) (see also MPEP §608.02 (V)).
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).
The drawings are objected to because the drawings are indicated by “Fig.” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 40 is objected to because of the following informalities: (teropavimab; (GS-5423)) should read (teropavimab; GS-5423). Appropriate correction is required.
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 40-52 and 55-81 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.
Regarding claim 40, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The phrase “at least about” in claim 40 is a relative term which renders the claim indefinite. The phrase “at least about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The amount of time between the first and second time point required is rendered indefinite by use of the phrase “at least about”. The dependent claims do not add additional clarity and, therefore, are also indefinite.
The term “about” in claim 51 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The amount of antibody required to be administered is rendered indefinite by use of the term “about”. The dependent claims do not add additional clarity and, therefore, are also indefinite.
Claims 41-48 are further indefinite because they recite co-administering the claimed antibodies over multiple time points. The independent claim 40, which these claims are dependent, only recites a first and second time point. Claims 41-44 suggest multiple administrations past just the two time points claimed, reciting every 6 months, every 24 weeks, etc., while claims 45-48 do not clarify the time period between administrations and claims 46-48 require multiple administrations above the two claimed in claim 40.
Claims 49-52 and 55 are indefinite as they recite the doses of antibodies being administered. The claims do not specify if these dosages for the first time point, the second time point, or both time points. The dependent claims do not add additional clarity and, therefore, are also indefinite.
Claims 58-67 recite co-administering long-acting HIV drugs along with the claimed antibodies. The claims do not specify if these drugs should be administered at the first time point, the second time point, or both. The dependent claims do not add additional clarity and, therefore, are also indefinite.
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.
Claims 40-49, 51-52, 55-57, 71, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey, et al. (Conference on Retrovirusesand Opportunistic Infections, Virtual, February 12-16, 2022, available at https://www.natap.org/2022/CROI/croi_70.htm, NPL-IDS, filed, 03/19/2024, hereinafter “Caskey”) and further in view of Gautam, et al (Nat Med 24, 610–616 (2018), NPL-IDS, filed, 03/19/2024, hereinafter “Gautam”) and evidenced by Mendoza, et al. (Nature 561, 479–484 (2018), NPL-IDS, filed, 03/19/2024, hereinafter “Mendoza”).
Regarding claims 40-48, Caskey teaches a method for treating or preventing HIV in a human by co-administering an effective amount of 10-1074-LS and 3BNC117-LS (LS Variants: Study Design and Endpoints). Caskey does not teach administering a 10-1074-LS and 3BNC117-LS 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 and 3BNC117-LS 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 plus 10-1074-LS 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 and 3BNC117-LS for treating and preventing HIV in humans with the teachings of Gautam for using the combination of 10-1074-LS and 3BNC117-LS 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 and 3BNC117-LS therapy to treat and prevent HIV.
Regarding claim 49, Caskey teaches intravenously administering 30 mg/kg of both 10-1074-LS and 3BNC117-LS (LS Variants: Study Design and Endpoints).
Regarding claims 51-52 and 55 Caskey teaches intravenously administering 30 mg/kg of both 10-1074-LS and 3BNC117-LS (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 range 500 to 3000 mg 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 500 to 3000 mg for subjects 60 to 100 kg 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.
It would further be obvious that final dose of the antibody combination administered to a subject is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); 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 re Aller, 220 F.2d 454, 456, 105 USPQ 2.
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 and 3BNC117-LS (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.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Caskey and Gautam as applied to claims 40-49, 51-52, 55-57, 71, and 74 above, and further in view of NCT03554408 (ClinicalTrials.gov ID NCT03554408, published 05/31/2018, available at https://clinicaltrials.gov/study/NCT03554408?tab=history&a=1#version-content-panel., hereinafter “Rockefeller”)
As discussed above, claims 40-49, 51-52, 55-57, 71, and 74 were rendered prima facie obvious over Caskey and Gautam.
Regarding claim 50, Caskey and Gautam teach administering 3BNC117-LS at 30 mg/kg (see claim 49 above). Caskey and Gautam do not teach administering 10-1074-LS at 10mg/kg. However, Rockefeller teaches administering 10-1074-LS at 10 mg/kg (Detailed study description).
Routine optimization of Rockefeller’s dosage of antibodies both 10-1074-LS and 3BNC117-LS would have led to the claimed combination of 10 mg/kg 10-1074-LS and 30 mg/kg 3BNC117-LS because the total amount of antibody is based on safety, tolerability and effectiveness and Caskey teaches that up to30 mg/kg of 10-1074-LS is safe and tolerated. 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 Rockefeller and determining the final dose through testing.
It would further be obvious that final dose of the antibody combination administered to a subject is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); 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 re Aller, 220 F.2d 454, 456, 105 USPQ 2.
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.
Claims 58-59, 64-68, and 75-81 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey and Gautam as applied to claims 40-49, 51-52, 55-57, 71, and 74 above, and further in view of Moldt, et al. (US 2020/0368347 A1, hereinafter “Moldt”) and evidenced by Lorenzi, et al. (J Virol 95:10.1128/jvi.01909-20., hereinafter “Lorenzi”).
As discussed above, claims 40-49, 51-52, 55-57, 71, and 74 were rendered prima facie obvious over Caskey and Gautam.
Regarding claims 58-59 and 64-67, Caskey and Gautam teach administering 10-1074-LS and 3BNC117-LS (see claim 40). The references do not teach as administering a long-acting HIV drug that is a long-acting capsid inhibitor, an INSTI, and NNRTI, and NRTI, or a protease inhibitor. However, Moldt teaches that anti-HIV antibodies that bind to HIV gp120 V3 glycan (10-1074-LS binds to HIV gp120 V3 glycan as evidenced by Lorenzi (pg. 2 ¶6)) can also be administered with other long-acting HIV drugs including bictegravir (INSTI), rilpivirine (NNRTI), renofovir alafenamide (NRTI), and atazanavir (protease inhibitor) (¶0160).
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 and Gautam for administering 10-1074-LS and 3BNC117-LS with the teachings of Moldt for administering antibodies and either INSTIs, NNRTIs, NRTIs, and protease inhibitors. Moldt provides motivation by teaching that new and long-acting treatments are needed due to current multi-drug-resistant HIV and lack of patient adherence to daily dosing regimens (¶0003). One of skill in the art would have had a reasonable expectation of success at combining Caskey, Gautam, and Moldt because they all teach treating HIV with anti-HIV antibodies.
Regarding claim 68, Caskey and Gautam do not teach determining a subject’s sensitivity to the antibodies administered before treatment. However, Moldt teaches methods of identifying a human subject infected with an HIV or population of HIV sensitive to an antibody that binds to gp120 V3 (10-1074-LS binds to HIV gp120 V3 glycan as evidenced by Lorenzi (pg. 2 ¶6)) (¶0007).
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 and Gautam for treating HIV with 10-1074-LS and 3BNC117-LS with the teachings of Moldt for treating a HIV in a human subject that is infected with an HIV population that is sensitive to an anti-HIV antibody with said anti-HIV antibody. Moldt provides motivation by teaching that a subject needs to be infected with a population of HIV that is sensitive to the antibody treatment being used for the antibody treatment to work and for these patients to benefit from the treatment (¶0005). One of skill in the art would have had a reasonable expectation of success at combining Caskey, Gautam, and Moldt because they all teach treating HIV with anti-HIV antibodies.
Regarding claim 75, Moldt teaches that the subject is acutely infected with HIV (Claim 16).
Regarding claim 76, Moldt teaches that the subject has an HIV infection of Fiebig stage IV or earlier (Claim 17).
Regarding claim 77, Moldt teaches teach that the subject has not seroconverted (Claim 18).
Regarding claim 78, Moldt teaches that the subject is recently infected with HIV (Claim 19).
Regarding claim 79, Moldt teaches teach that the antibody is administered to a subject having an HIV infection of Fiebig stage V or Fiebig stage VI (Claim 20).
Regarding claim 80, Moldt teaches that the subject is chronically infected with HIV (Claim 21).
Regarding claim 81, Moldt teaches that the subject is infected with HIV clade B viruses (Claim 22).
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.
Claims 58-61 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey Gautam as applied to claims 40-49, 51-52, 55-57, 71, and 74 above, and further in view of NCT04811040 (ClinicalTrials.gov ID NCT04811040, published 03/19/2021, available at https://clinicaltrials.gov/study/NCT04811040?tab=history&a=1#version-content-panel, hereinafter “Gilead”) and Gilead Press Release from June 28, 2021 (Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options, Published June 28, 2021, available at https://www.gilead.com/news/news-details/2021/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-lenacapavir-an-investigational-long-acting-capsid-inhibitor-for-the-treatment-of-hiv-1-in-people-with-limited-thera, hereinafter “Gilead2”).
As discussed above, claims 40-49, 51-52, 55-57, 71, and 74 were rendered prima facie obvious over Caskey and Gautam. Regarding claims 58-61 and 63, Caskey and Gautam teach administering 10-1074-LS and 3BNC117-LS (see claim 40). Caskey and Gautam do not teach also administering a long-acting HIV drug that is a long-acting capsid inhibitor. However, Gilead teaches co-administering Lenacapavir (GS-6207; a long-acting capsid inhibitor) orally or subcutaneously to treat subjects with HIV who are currently on ART and virologically suppressed (Arms and Interventions).
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 and Gautam for treating HIV with 10-1074-LS and 3BNC117-LS with the teachings of Gilead for treating HIV with 10-1074-LS, 3BNC117-LS, and Lenacapavir. Gilead2 provides motivation by teaching that Lenacapavir is used for HIV treatment in heavily-treatment experienced people with multi-drug-resistant HIV infection (¶1). One of skill in the art would have had a reasonable expectation of success at combining Caskey, Gautam, Gilead, and Gilead2 because they all teach treating HIV.
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.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Caskey, Gautam, Gilead, and Gilead2 as applied to claims 58-61 and 63 above, and further in view of Daar, et al. (CROI 2020 conference Abstract, available at https://www.croiconference.org/abstract/dose-response-relationship-of-subcutaneous-long-acting-hiv-capsid-inhibitor-gs-6207/, hereinafter “Daar”).
As discussed above, claims 58-61 and 63 were rendered prima facie obvious over Caskey, Gautam, Gilead, Gilead2.
Regarding claim 62, Caskey, Gautam, Gilead, and Gilead2 teach administering 10-1074-LS, 3BNC117-LS and Lenacapavir to treat HIV (see claim 61 above). The references do not teach the dose of Lenacapavir administered. However, Daar teaches administering up to 750 mg of GS-6207 (Lenacapavir) to treat capsid-inhibitor naïve subjects not on ART for HIV (¶2).
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, Gautam, Gilead, and Gilead2 for treating HIV with 10-1074-LS, 3BNC117-LS, and Lenacapavir with the teachings of Daar for the dose of Lenacapavir. Daar provides motivation by teaching that up to 750mg demonstrates potent antiviral activity and is generally safe and well tolerated (¶4). One of skill in the art would have had a reasonable expectation of success at combining Caskey, Gautam, Gilead, Gilead2, and Daar because they all teach treating HIV.
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.
Claims 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey and Gautam as applied to claims 40-49, 51-52, 55-57, 71, and 74 above, and further in view of Kufel (Int J Antimicrob Agents. 2020 Dec;56(6):106186.).
As discussed above, claims 40-49, 51-52, 55-57, 71, and 74 were rendered prima facie obvious over Caskey and Gautam.
Regarding claims 69-70, Caskey and Gautam do not teach that the subject is heavily treatment experienced or resistant to one or more other long-acting HIV drugs. However, Kufel teaches that antibody-based therapies for treating HIV are used for management of multi-drug-resistant HIV infection in patients who are failing their current regimens (Abstract).
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 and Gautam for treating HIV with anti-HIV antibodies with the teachings of Kufel for treating subjects that are infected with multi-drug-resistant HIV. Kufel provides motivation by teaching that antibodies are useful for treatment when limited therapeutic options exist due to MDR (Abstract). One of skill in the art would have had a reasonable expectation of success at combining Caskey, Gautam, and Kufel because they all teach treating HIV with anti-HIV antibodies.
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.
Claims 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Caskey and Gautam as applied to claims 40-49, 51-52, 55-57, 71, and 74 above, and further in view of Rockefeller and Moldt.
As discussed above, claims 40-49, 51-52, 55-57, 71, and 74 were rendered prima facie obvious over Caskey and Gautam.
Regarding claims 72-73, Caskey and Gautam do not teach that the subjects are virologically suppressed and receiving ART. However, Rockefeller teaches that the subjects are on ART and virologically suppressed (Arms and Interventions, Group 6A).
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 and Gautam for treating HIV with 10-1074-LS and 3BNC117-LS with the teachings of Rockefeller for treating HIV with 10-1074-LS and 3BNC117-LS in subjects virologically suppressed on ART. Moldt provides motivation by teaching that combining antibody HIV treatments with other therapies (ART) helps treat MDR HIV (¶0003). One of skill in the art would have had a reasonable expectation of success at combining Caskey, Gautam, Rockefeller, and Moldt because they all teach treating HIV with anti-HIV antibodies.
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.
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