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A Splodesheetablished Online in 2010 USOO8685381 B2 (12) United States Patent (10) Patent No.: US 8,685,381 B2 Schlessinger et al. (45) Date of Patent: Apr. 1, 2014 (54) TOPICAL BASE AND ACTIVE 4,346,086 A 8, 1982 Sattler et al. .................. 514f179 AGENTCONTAINING COMPOSITIONS, AND 25.6; A . 3. signe et al. :g - ww. Oil ......... E. RMPROVING AND 4,393,044 A 7/1983 Takada et all ... 424/64 4.478,853. A 10, 1984 Chaussee ... 514,772 4496,554 A 1/1985 Wong......... 514, 179 (76) Inventors: Joel Schlessinger, Omaha, NE (US); 4,504,465. A 3/1985 Sampson et al. ... 424/65 Daniel Isaac Schlessinger, Omaha, NE 4,610,978 A 9, 1986 Dikstein et al. 51446 (US) 263 A 38; unniSNi et A" 33 c 4,702,916 A 10, 1987 Geria ......... ... 424/400 (*) Notice: Subject to any disclaimer, the term of this 4,847,069 A 7, 1989 Bissett et al. ... 424/47 patent is extended or adjusted under 35 4,847,071 A 7, 1989 Bissett et al. 424,59 U.S.C. 154(b) by 0 days. 4,847,072 A 7, 1989 Bissett .......... ... 424,59 4,879,274 A 11, 1989 Kamiya et al. ... 424/780 (21) Appl. No.: 13/233,012 is: A 1982 alm 5:8: 4,902,682 A 2f1990 Sattler ........ 514, 179 (22) Filed: Sep. 14, 2011 4,996,044 A * 2/1991 Mercado et al. ... 424/64 5,061,700 A 10, 1991 Dow et al. ..... 514,169 (65) Prior Publication Data 5,185,150 A 2f1993 DeLuca et al. ... 424/401 5,254,109 A 10, 1993 Smith et al. ... ... 604,289 US 2012/O237.556A1 Sep. 20, 2012 5,290,561 A 3, 1994 Farhadieh ..... ... 424/449 5,292,512 A 3, 1994 Schaefer et al. ... 424/401 5,543,148 A 8/1996 Lapidus ........................ 424/401 Related U.S. Application Data (Continued) (63) Continuation-in-part of application No. 12/925,464, OTHER PUBLICATIONS filed on Oct. 23, 2010, now abandoned. Fancol VB search result in Google showing date that the web page (51) Int. Cl. was published. Available online Feb. 11, 2009; downloaded Feb. 9. A6 IK 8/49 (2006.01) 2012.* A63/74 (2006.01) Finsolv TN search result in Google showing date that the web page CO7I5/00 (2006.01) y published Available online Jun. 7, 2010; downloaded Feb. 9, C07J 7/00 (2006.01) Natunola Castor 1023 search result in Google showing date that the (52) U.S. Cl. web page was published. Available online as early as Jul. 19, 2007; USPC .............. 424/78.02; 424/59: 424/63; 424/64; downloaded Feb. 9, 2012.* 424/70.16; 424/70.9: 424/78.03; 424/78.05: Fancol VB data sheet, published online Feb. 11, 2009; downloaded *79:29:29:27:552/559:552/569,552.570; 552,577 ENYSE:A Splodesheetablished luct sheet, published online Jun.in 7, 2010.2010; down (58) Field of Classification Search oaded NOV. f. ZU12. None (Continued) See application file for complete search history. Primary Examiner — Robert A Wax (56) References Cited Assistant Examiner — Jeffrey T Palenik (74) Attorney, Agent, or Firm — Roberta L. Hastreiter; Keith U.S. PATENT DOCUMENTS D. Parr; Locke Lord LLP 3,644,613 A 2, 1972 Moeller et al. .................. 424/49 (57) ABSTRACT 3,914, 131 A 10, 1975 Hutchison ....... 106,268 3,947,571 A 3/1976 Murphy et al. ................. 424,64 The invention provides skin protecting and penetrating, easy 3,954,114. A 5/1976 Ostrowsky et al. ... 132,88.7 to-administer base and active agent-containing compositions, 3,957,969 A 5/1976 Fujiyama ........................ 424,64 Such as those including hydrocortisone, for treating the skin 3,960,757 A 6, 1976 Morishita et al. ... 427,213 3,976,789 A 8, 1976 Tomita et al. ... ... 424/365 of mammals for different dermatologic disorders. This is 3,981,996 A 9/1976 Leigh ........... ... 514,169 effected by topically administering effective amounts of the 4,048,309 A 9, 1977 Chen et al. ... 424,238 compositions thereto in forms that address the skin and 4,060,492 A 11, 1977 Yasui et al. .. 252/59 mucosa of the mouth and lips, and the rest of the body. 4,066,789 A 1/1978 Mores et al. ... 424,635 Additionally, an optional flavoring addition to these products 4,078,147 A 3, 1978 Ukai et al. ...... ... 560,180 affords significantly better tasting, and less bitter, composi 4,137,302 A 1/1979 Humbert et al. ... 424/47 tions, allowing a more pleasant experience and better com 4,151,272 A 4/1979 Geary et al. ... 424/68 4,177.267 A 12/1979 Herschler .... ... 424,238 pliance by patients. The compositions include a unique for 4,199,576 A 4, 1980 Reller et al. ... 424,230 mulation of FANCOL VB, Natunola Castor 1023, Finsolv 4,226,889 A 10, 1980 Yuhas ...... ... 424,59 TN, bees wax and, optionally, one or a plurality of plant or 4,229,432 A 10, 1980 Geria .... ... 424/68 plant seed oils, fatty alcohols, fats and flavorings, in desirable 4.252,796 A 2f1981 Yu et al. ... 514, 181 weight percents thereof, in various forms, and preferably in a 4,284,630 A 8, 1981 Yu et al. ........................ 514f179 4,291,018 A 9/1981 Oeda ............................... 424,64 form of a solid roll-on Stick in a variety of sizes and of ajar or 4,292,088 A 9/1981 Scheuffgen ... ... 106,268 pot. 4,299,828 A 11/1981 Wang et al. ... ... 424,238 4,305,961 A 12/1981 Tsutsumi . ... 424/361 52 Claims, 19 Drawing Sheets 4.322,400 A 3/1982 Yuhas ............................. 424,59 (19 of 19 Drawing Sheet(s) Filed in Color) US 8,685,381 B2 Page 2 (56) References Cited 2003.0099604 A1 5/2003 Light 2003. O199838 A1 10, 2003 Sheridan U.S. PATENT DOCUMENTS 2003/0232091 A1 12/2003 Shefer 2004/0091539 A1 5, 2004 Lindahl et al. 5,622,993 A 4/1997 McGinity .............. 514,626 2004/O151671 A1 8, 2004 Abram et al. 5,653,989 A 8, 1997 Sattler ...... 424/401 2004/0202725 A1 10, 2004 Dascalu 5,660,839 A 8, 1997 Alec et al. ............. 424/401 2004/0235803 A1 11, 2004 Britten 2005/0O25729 A1 2/2005 Groteluschen et al. 5,756,014 A 5/1998 Mathur .................. 264/4.1 5,785,976 A 7, 1998 Westensen 424/400 2005.0054991 A1 3/2005 Tobyn 5,804,572 A 9, 1998 Blank ...... 514f159 2005/0226903 A1 10/2005 Rogasch et al. 5,951,991 A 9/1999 Wagner ... 424/401 2005/0249774 A1 11/2005 Pauletti 5,961,997 A 10, 1999 Swinehart 424/401 2006, OO18933 A1 1/2006 Vaya 5,972.361 A 10, 1999 Fowler ..... 424/402 2006, OO18937 A1 1/2006 Friedman et al. 5,976,555 A 11/1999 Liu ................ 424/401 2006, OO52353 A1 3/2006 Johnson 5.990,100 A 1 1/1999 Rosenberg et al. 514,174 OTHER PUBLICATIONS 6,063,397 A 5/2000 Fowler ................... 424/443 6,096,326 A 8, 2000 Wikholm ............... 424/401 6,126,920 A 10/2000 Jones .......... ... 424/45 Natunola Castor 1023 Product Sheet; published Mar. 2010; down 6,132,746 A 10, 2000 Hasenoehrl. 424/403 loaded Feb. 9, 2012.* 6,228,351 B1 5, 2001 Viders ......... ... 424/64 Wayback showing of Dr. Dan's CortiBalm product description, dated 6,231,872 B1 5/2001 Mooney et al. 424/400 Dec. 31, 2009 and downloaded Sep. 2, 2013.* 6,251,425 B1 6/2001 Mathur .......... 424/450 Dr. Dan's CortiBalm product reviews dating May 2010 to present as 6,258,346 B1 7/2001 Scavone et al. .... ... 424/65 shown at MakeupAlley.com; downloaded Sep. 2, 2013.* 6,342,208 B1 1/2002 Hyldgaard et al. ... 424,59 PediaDerm package insert dated Nov. 2, 2009; downloaded Sep. 2, 6,375,942 B1 4/2002 Rico .............. 424/78.07 2013.* 6,403,123 B1 6, 2002 Van Scott et al. ... 424/489 “International Search Report” for International Patent Application B1 11/2002 McCadden .... 424/401 6.479,058 No. PCT/US 11/01742 of Joel Schlessinger, MD, filed internationally 6,503.944 B1 1/2003 Chanchani . 514,506 on Oct. 12, 2011 (3 pages). 6,528,071 B2 3/2003 Vatter et al. ............ 424/401 “Written Opinion of the International Searching Authority” for Inter 6,558,680 B1 5, 2003 Riedel et al. ........... 424/401 6,613,338 B1 9, 2003 Schreiber ....... 424/401 national Patent Application No. PCT/US 11/01742 of Joel 6,753,013 B1 6, 2004 Didrekson etal 424/484 Schlessinger, MD, filed internationally on Oct. 12, 2011 (29 pages). 6,765,001 B2 7/2004 Gans .............. 514f172 Fancol (R) VB, Elementis Specialty, PDS-FancolVB pdf Mar. 2011 6,780,439 B2 8, 2004 Wilk .... 424,642 http://www.elementis.com/esweb/webproducts.nsfallibydecid/ 6,787,529 B2 9/2004 Hoy ............ 514,167 18F 2112739A91D158525776F004DDACA/SFILE/PDS 6,790,460 B2 9, 2004 Shefer et al. 424/489 FANCOL%C2%AE%20VB.pdf (2 pages). 6,830,758 B2 12/2004 Nichols ....... 424/443 Natunola (R) Castor 1023, www.natunola.com, Mar. 2010 (Identified 6,881,756 B2 4/2005 Gendimenico 514,732 on the above International Search Report) (1 page). 6,926,886 B2 8, 2005 Lin et al. ..... ... 424,59 Finsolv-TN, Innospec, www.innospec.com, Apr. 2010 (Identified on 6,964,782 B1 11/2005 Smith et all 424,616 the above International Search Report) (3 pages). 6,967,023 B1 1 1/2005 Eini et al.
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