Source: https://www.federalregister.gov/documents/2005/08/03/05-15347/government-owned-inventions-availability-for-licensing
Timestamp: 2017-08-19 19:45:35
Document Index: 303913487

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 10', 'Application No. 60', 'Application No. 10', 'Application No. 60', 'Application No. 10', 'Application No. 60', 'Application No. 10', 'Application No. 60', 'Application No. 08', 'Application No. 10', 'Application No. 10', 'Application No. 10', 'Application No. 97929777']

70 FR 44665
44665-44667 (3 pages)
05-15347
https://www.federalregister.gov/d/05-15347 https://www.federalregister.gov/d/05-15347
Che-Hung Robert Lee and Carl Frasch (FDA).
U.S. Provisional Application No. 60/493,389 filed 06 Aug 2003 (HHS Reference No. E-301-2003/0-US-01);
PCT Application No. PCT/US04/25477 filed 06 Aug 2004 (HHS Reference No. E-301-2003/0-PCT-02);
PCT Application No. PCT/US04/26431 filed 06 Aug 2004 (HHS Reference No. E-301-2003/1-PCT-01).
Current methods for synthesis and manufacturing of polysaccharide-protein conjugate vaccines employ conjugation reactions with low efficiency (about twenty percent). This means that up to eighty percent of the added activated polysaccharide (PS) is lost. In addition, inclusion of a chromatographic process for purification of the conjugates from unconjugated PS is required.
The present invention utilizes the characteristic chemical property of hydrazide groups on one reactant to react with aldehyde groups or cyanate esters on the other reactant with an improved conjugate yield of at least sixty percent. With this conjugation efficiency the leftover unconjugated protein and polysaccharide would not need to be removed and thus the purification process of the conjugate product can be limited to diafiltration to Start Printed Page 44666remove the by-products of small molecules. The new conjugation reaction can be carried out within one or two days with reactant concentrations between 1 and 25 mg/mL at PS/protein ratios from 1:2 to 3:1, at temperatures between 4 and 40 degrees Centigrade, and in a pH range of 5.5 to 7.4, optimal conditions varying from PS to PS.
Therefore, this invention can reduce the cost of conjugate vaccine manufacture.
E.M. Sternberg (NIMH), J.I. Webster (NIMH), L. H. Tonelli (NIMH), S. H. Leppla (NIAID), and M. Maoyeri (NIAID).
U.S. Provisional Application No. 60/416,222 filed 04 Oct 2002 (HHS Reference No. E-247-2002/0-US-01);
U.S. Provisional Application No. 60/419,454 filed 18 Oct 2002 (HHS Reference No. E-348-2003/0-US-01);
PCT Application No. PCT/US03/31406 filed 03 Oct 2003 (HHS Reference No. E-247-2002/1-PCT-01);
U.S. Patent Application No. 10/530,254 filed 04 Apr 2005 (HHS Reference No. E-247-2002/1-US-02).
Daniel Coffman, Steven Giardina, Jianwei Zhu (NCI).
U.S. Provisional Application No. 60/328,017 filed 09 Oct 2001 (HHS Reference No. E-075-2001/0-US-01);
PCT Application No. PCT/US02/31114 filed 27 Sep 2002 (HHS Reference No. E-075-2001/0-PCT-01);
U.S. Patent Application No. 10/492,105 filed 08 Apr 2004 (HHS Reference No. E-075-2001/0-US-02).
This invention claims processes and compositions for fermentation, recovery, and purification of recombinant bacterial superantigens (rSAgs), exemplified by a recombinant staphylococcal enterotoxin B SEB (rSEB) protein mutated for use in administration to a mammalian recipient. This process generates an economically viable quantity of rSEB vaccine protein meeting FDA parenteral drug specifications. The purification methods generally involve multiple steps including hydrophobic interaction chromatography (HIC), buffer exchange (desalting), and cation exchange. The final product of the purification is a highly purified rSAg composition satisfying clinical safety criteria and is immunogenic and protective against lethal aerosol challenge in a murine model. The methods and compositions claimed in the patent application provide possible therapeutics and prophylactics for diseases caused by bacterial SAgs, such as food poisoning, bacterial arthritis and other autoimmune disorders, toxic shock syndrome, and the potential use of SAg biowarfare agents.
Carl R. Merril (NIMH), Sankar Adhya (NCI), Dean M. Scholl (NIMH).
U.S. Provisional Application No. 60/351,458 filed 23 Jan 2002 (HHS Reference No. E-318-2000/0-US-01);
PCT Application No. PCT/US03/02179 filed 23 Jan 2003 (HHS Reference No. E-318-2000/0-PCT-02);
U.S. Patent Application No. 10/498,428 filed 10 Jun 2004 (HHS Reference No. E-318-2000/0-US-03).
The current invention claims a method for selecting a therapeutic bacteriophage that would be effective against a particular disease-causing bacteria, comprising a number of bacteriophages containing reporter nucleic acids capable of being expressed Start Printed Page 44667when the bacteriophage infects a bacterial cell. These bacteriophages are separately contacted with a sample contaminated by a bacterium. Expression of the reporter is then detected, indicating which bacteriophage has infected a bacterial cell and is thus a potential therapeutic phage against the particular bacteria. Also claimed in the application are kits allowing for the rapid identification of potentially therapeutic bacteriophages.
Carl Merril (NIMH), Sankar Adhya (NCI), Dean Scholl (NIMH).
U.S. Provisional Application No. 60/220,987 filed 25 Jul 2000 (HHS Reference No. E-257-2000/0-US-01);
PCT Application No. PCT/US01/22390 filed 25 Jul 2001 (HHS Reference No. E-257-2000/0-PCT-02);
U.S. Patent Application No. 10/350,256 filed 21 Jan 2003 (HHS Reference No. E-257-2000/0-US-03).
U.S. Provisional Application No. 60/018,508 filed 28 May 1996 (HHS Reference No. E-090-1996/0-US-01);
U.S. Patent Application No. 08/864,458 filed 28 May 1997 (HHS Reference No. E-090-1996/0-US-04);
U.S. Patent Application No. 10/439,845 filed 15 May 2003 (HHS Reference No. E-090-1996/0-US-05);
U.S. Patent Application No. 10/700,313 filed 31 Oct 2003 (HHS Reference No. E-090-1996/0-US-06);
U.S. Patent Application No. 10/846,185 filed 14 May 2004 (HHS Reference No. E-090-1996/0-US-07);
PCT Application No. PCT/US97/09586 filed 28 May 1997 (HHS Reference No. E-090-1996/0-PCT-02);
European Patent Application No. 97929777.7 filed 28 May 1997 (HHS Reference No. E-090-1996/0-EP-03).
[FR Doc. 05-15347 Filed 8-2-05; 8:45 am]