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(12) United States Patent (10) Patent No.: US 8,765,685 B2 B00kbinder Et Al

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(12) United States Patent (10) Patent No.: US 8,765,685 B2 B00kbinder Et Al US008765685B2 (12) United States Patent (10) Patent No.: US 8,765,685 B2 B00kbinder et al. (45) Date of Patent: *Jul. 1, 2014 (54) METHODS FORTREATING EDEMABY (52) U.S. Cl. ADMINISTERING ASOLUBLE USPC .......................... 514/20.9; 514/21.2:435/201 HYALURONIDASE GLYCOPROTEIN (58) Field of Classification Search (SHASEGP) USPC ................................. 514/20.9, 21.2:435/201 See application file for complete search history. (75) Inventors: Louis Bookbinder, San Diego, CA (US); Anirban Kundu, San Diego, CA (56) References Cited (US); Gregory I. Frost, Del Mar, CA (US) U.S. PATENT DOCUMENTS 3,536,809 A 10/1970 AppleZweig .................... 424/28 (73) Assignee: Halozyme, Inc., San Diego, CA (US) 3,598,123 A 8, 1971 Zaffaroni ...................... 424/435 (*) Notice: Subject to any disclaimer, the term of this (Continued) patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days. FOREIGN PATENT DOCUMENTS This patent is Subject to a terminal dis CA 1243,948 11, 1988 claimer. CA 23.18356 T 2000 (Continued) (21) Appl. No.: 13/506.783 OTHER PUBLICATIONS (22) Filed: May 16, 2012 Letter/Written Disclosure of the Information Disclosure Statement for the above-referenced application, mailed on Jul. 12, 2012, 3 (65) Prior Publication Data pageS. US 2012/O251620 A1 Oct. 4, 2012 (Continued) Primary Examiner — Rosanne Kosson Related U.S. Application Data (74) Attorney, Agent, or Firm — McKenna Long & Aldridge (60) Continuation of application No. 12/378.969, filed on LLP, Stephanie Seidman Feb. 20, 2009, now Pat. No. 8,202,517, which is a division of application No. 10/795,095, filed on Mar. 5, (57) ABSTRACT 2004, now Pat. No. 7,767,429, application No. Provided are soluble neutral active Hyaluronidase Glycopro 13/506.783, which is a continuation of application No. teins (shASEGPs), methods of manufacture, and their use to 12/378.984, filed on Feb. 20, 2009, now Pat. No. facilitate administration of other molecules or to alleviate 8,431,380, application No. 13/506,783, which is a glycosaminoglycan associated pathologies. Minimally active continuation of application No. 12/386,473, filed on polypeptide domains of the soluble, neutral active shASEGP Apr. 16, 2009, now Pat. No. 8,431,124. domains are described that include asparagine-linked Sugar moieties required for a functional neutral active hyalu (60) Provisional application No. 60/452,360, filed on Mar. ronidase domain. Included are modified amino-terminal 5, 2003. leader peptides that enhance secretion of shASEGP. Sialated and pegylated forms of the shASEGPs also are provided. (51) Int. C. Methods of treatment by administering shASEGPs and A6 IK38/4 (2006.01) A6 IK38/17 (2006.01) modified forms thereof also are provided. CI2N 9/26 (2006.01) 23 Claims, 1 Drawing Sheet SacI-72l-GAGCTC Pst - 830 - CTGCA'G Sca-13-AGTACT Nie-l.052- GCTAG C Sca-5244-AGTACT Band I-3967 - GGATCC Cia-3960-ATCG AT Not-3722- GCGGCC GC \ Mia-3693 - A'CGCGT Nor-3115-GC'GGCC GC Sac - 3389 - GAGCTC Sca-3228-AGTACT US 8,765,685 B2 Page 2 (56) References Cited 2002fOO52430 A1 5/2002 Harris et al. .................. 523,406 2002fOO72573 A1 6/2002 Bentley et al. .. 525/409 U.S. PATENT DOCUMENTS 2003/0143596 A1 7/2003 Bentley et al. .................... 435/6 2004/O151714 A1 8/2004 Soll et al. ................... 424/94.61 3,630,200 A 12, 1971 Higuchi . 424/427 2005/0287.134 A1 12/2005 Klein ......................... 424/94.61 3,710.795 A 1, 1973 Higuchi et al. 424/424 2006, O104968 A1 5, 2006 Bookbinder et al. ...... 424/94.61 3,845,770 A 11, 1974 Theeuwes et al. ............ 424/427 2009/O123367 A1 5/2009 Bookbinder et al. ........ 424,149 3,916,899 A 11/1975 Theeuwes et al. ............ 424/424 2009, O181013 A1 7/2009 Bookbinder et al. 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