United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2015-09-29 article Notices D09002ee1c7f713a2 D09002ee1c7f71408 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States National Institutes of Health originator org United States Government Agency or Subagency 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." 80 FR 58493 https://www.govinfo.gov/app/details/FR-2015-09-29/2015-24674 2015-24674 fr29se15-59 4140-01-P https://www.govinfo.gov/app/details/FR-2015-09-29/2015-24674 https://www.govinfo.gov/content/pkg/FR-2015-09-29/html/2015-24674.htm https://www.govinfo.gov/content/pkg/FR-2015-09-29/pdf/2015-24674.pdf 3 p. 58493 58495 80 FR 58493 Prospective Intent To Grant Start-Up Exclusive Patent License: Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs; Federal Register Vol. 80, Issue NOTICE 2015-24674 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 2015-10-14 4140-01-P 2015-24674 Notice.

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."

Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before October 14, 2015 will be considered. Start-Up Exclusive Patent License Approvals: Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs , karen.surabian@nih.gov Vol. 80, no. 188 Office of the Federal Register, National Archives and Records Administration 2015-09-29 continuing daily deposited born digital 246 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-09-29 P0b002ee18d9d9057 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr29se15 https://www.govinfo.gov/app/details/FR-2015-09-29 https://www.govinfo.gov/content/pkg/FR-2015-09-29/pdf/FR-2015-09-29.pdf https://www.govinfo.gov/content/pkg/FR-2015-09-29/xml/FR-2015-09-29.xml fdlp 58335 58572 DGPO 2015-09-29 2024-06-02 FR-2015-09-29 machine generated eng FR FR-2015-09-29 80 188