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Prospective Intent To Grant Start-Up Exclusive Patent License: Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the Public Health Service, Department of Health and Human Services, is contemplating the grant of an e...

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the Public Health Service, Department of Health and Human Services, is contemplating the grant of an exclusive license to Research Think Tank Molecular Diagnostics, Inc. (RTTMDx) having a principal place of business in Georgia, U.S.A., to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 577,696, filed June 07, 2004, entitled ``Real-Time PCR Point Mutation Assays for Detecting the 103N and 184V Mutations in the Reverse Transcriptase of HIV-1'' (HHS Ref. No. E-198-2013/0-U.S.-01); PCT Application No. PCT/U.S.2005/019907, filed June 07, 2005, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-PCT-02); U.S. Patent Application No. 14/059,085, filed October 21, 2013, entitled ``Real- Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-11); U.S. Patent No. 8,043,809, filed December 07, 2006, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-07); U.S. Patent No. 8,318,428, filed January 24, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance for Antiviral Drugs'' (HHS Ref. No. E-198- 2013/0-U.S.-08); U.S. Patent No. 8,592,146, filed September 04, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-09); Australian Patent No. 20055252685, issued March 31, 2011, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs,'' (HHS Ref. No. E-198-2013/0-AU-03); Indian Patent No. 19/DELNP/2007, issued December 19, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-IN-06); Canadian Patent Application No. 2,891,079, filed May 19, 2015, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-CA-12); Canadian Patent Application No. 259747, filed December 07, 2006, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-CA-04); U.S. Provisional Patent Application No. 61/443,926, filed February 17, 2011, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-214-2013/0-U.S.-01); PCT Patent Application No. PCT/ U.S.2012/025638, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-PCT-02); U.S. Application No. 13/ 985,499, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-U.S.-06); Canadian Patent Application No. 2827324, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-CA-03); European Patent Application No. 12747199.3, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-EP-04); Indian Patent Application No. 7110/ DELNP/2013, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-IN-05); U.S. Provisional Patent Application No. 61/829,473, filed May 31, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs (HHS Ref. No. E-511-2013/0-U.S.-01); PCT Application No. PCT/U.S.2014/ 040514, filed June 02, 2014, entitled, ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-511-2013/0-PCT-02). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Patent License may be worldwide, and the field of use may be limited to ``Development, manufacture, and sale of an FDA-approved or foreign equivalent-approved Class III real-time PCR diagnostic assay for HIV-1 genotyping utilizing whole HIV-1 pol viral sequencing, limited to use in humans.''

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80 FR 58493

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“Prospective Intent To Grant Start-Up Exclusive Patent License: Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs,” thefederalregister.org (September 29, 2015), https://thefederalregister.org/documents/2015-24674/prospective-intent-to-grant-start-up-exclusive-patent-license-real-time-pcr-point-mutation-assays-for-detecting-hiv-1-re.