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(12) United States Patent (10) Patent No.: US 6,569,468 B2 Xiao (45) Date of Patent: May 27, 2003

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(12) United States Patent (10) Patent No.: US 6,569,468 B2 Xiao (45) Date of Patent: May 27, 2003 USOO6569468B2 (12) United States Patent (10) Patent No.: US 6,569,468 B2 Xiao (45) Date of Patent: May 27, 2003 (54) CINNAMOMI AND PORIA COMPOSITION, Liao, Shizhong, et al. Guizhi Fuling Wan (GFW) (Pill of METHOD TO PREPARE SAME AND USES Ramulus Cinnamomi and Foria) in the treatment of 20 cases THEREOF of peripheral nervous lesion due to diabetes. Traditional Chinese Medicine in Inner Mongolia (Nei Meng Gu Zhong (75) Inventor: Wei Xiao, Jiangsu (CN) Yi) 1996(2), pp 8 (Exhibit 6). Hou, Lili, et al. Pharmacological experiment on Guizhi (73) Assignee: Jiangsu Kanion Pharmaceutical Co., Fuling Wan (GFW) (Pill of Ramulus Cinnamomi and Foria). Ltd., Jiangsu (CN) Traditional Chinese Medicine in Hebei (He Bei Zhong Yi). 1997(6), pp. 45–46 (Exhibit 7). (*) Notice: Subject to any disclaimer, the term of this Zhang, Bosheng. Theory of Guizhi Fuling Wan (GFW) (Pill patent is extended or adjusted under 35 of Ramulus Cinnamomi and Foria) in the prevention and U.S.C. 154(b) by 0 days. treatment of ischemic Stroke. Integrated Chinese and West ern Medicine for Practical First-aid in Clinic (Zhong Xi Jie (21) Appl. No.: 09/951,070 He Shi Yong Lin Chuang Ji Jiu). 1997(11) pp 527–528 (22) Filed: Sep. 13, 2001 (Exhibit 8). Yan, Xicai, et al. 39 cases of hyperlipemia treated by Guizhi (65) Prior Publication Data Fuling Wan (GFW) (Pill of Ramulus Cinnamomi and Foria). US 2002/0160059 A1 Oct. 31, 2002 Shan Dong Journal of Traditional Chinese Medicine (Shan Dong Zhong Yi Za Zhi). 1997(10) pp. 444-445 (Exhibit 9). Related U.S. Application Data Xu, Qingwei. Guizhi Fuling Wan (GFW) (Pill of Ramulus Cinnamomi and Foria) in treating 45 cases of hyperplasia of (63) Continuation-in-part of application No. PCT/CNOO/00273, prostate. Journal of Zhe Jiang College of Traditional Chi filed on Sep. 13, 2000. nese Medicine (Zhe Jiang Zhong Yi Xue Yuan Xue Bao). 2000 (2) pp. 40 (Exhibit 10). (51) Int. Cl." ......................... A65K 35/78; A65K 35/84 He, Jianguo, et al. Detecting techniques of Guizhi Fuling (52) U.S. Cl. .................. 424/739; 424/195.15; 424/725; Wan (GFW) (Pill of Ramulus Cinnamomi and Foria). Chi 424/735; 424/765; 424/773; 424/775; 424/776; nese Pharmacy (Zhong Guo Yao Shi). 2001(3). pp. 197-198 424/777; 424/779 (Exhibit 11). (58) Field of Search ............................ 424/195.15, 725, Feng, Yanqin, et al. Gas chromatography in content deter 424/735, 739, 765, 773,775, 776, 777, mination of paeonol in Guizhi Fuling Wan (GFW) (Pill of 779 Ramulus Cinnamomi and Foria). Journal of China Pharma cology University (Zhong Guo Yao Ke Da Xue Xue Bao). (56) References Cited 1994(1) pp 15–17 (Exhibit 12). U.S. PATENT DOCUMENTS Gu, Yanfang et al. Clinical application of Guizhi Fuling Wan (GFW) (Pill of Ramulus Cinnamomi and Foria). Journal of 5,411,733 A * 5/1995 Hozumi et al. Practical Chinese Internal Medicine (Shi Yong Zhong Yi Za 5,874,084 A * 2/1999 Yng-Wong Zhi) vol. 72.4–5 (1993). FOREIGN PATENT DOCUMENTS He, Huiqin et al. Clinical observation of Guizhi Fuling JP 62081322 : 4/1987 Jiaonang (GFJ) (Capsule of Ramulus Cinnamomi and Foria) JP O2255622 * 10/1990 in treating gynecological blood Stasis. Journal of Nanjing College of Traditional Chinese Medicine (Nan Jing Zhong OTHER PUBLICATIONS Yi Xue Yuan Xue Bao) vol. 10, 5.16–17 (1994). Xu, Zhaoshan Application of Guizhi Fuling Wan (GFW) Hou, Lidi Hysteromyoma and ovarian cyst treated mainly (Pill of Ramulus Cinnamomi and Flria) in external medi with Guizhi Fuling Wan (GFW) (Pill of Ramulus Cinna cine. Information of Traditional Chinese Medicine, 1996(6) momi and Foria). New Chinese Medicine (Xin Zhong Yi) pp 20 (Exhibit 1). 4.27–28 (1992). Peng, Qinghua. Clinical application of Guizhi Fuling Wan (GFW) (Pill of Ramulus Cinnamomi and Foria). Journal of (List continued on next page.) Hunan College of Traditional Chinese Medicine, 1984(2) pp 60–63. (Exhibit 2). Primary Examiner-Christopher R. Tate Li, Chenggong et al. 39 cases of Hyperlipemia treated with (74) Attorney, Agent, or Firm-Albert Wai-Kit Chan; Mark Guizhi Fuling Wan (GFW) (Pill of Ramulus Cinnamomi and Elkins Foria). Jiangxi Traditional Chinese Medicine, 1998(29) No. (57) ABSTRACT 1, pp 19. (Exhibit 3). Yan, Qi, et al. Examples of clinical application of Guizhi This invention provides a method for identifying a compo Fuling Wan (GFW) (Pill of Ramulus Cinnamomi and Foria) sition of Cinnamomi and Poria. This invention further in Gynecology. Jilin TCM Journal 1996 No. 5, pp 37 provides a composition comprising: Ramulus Cinnamomi, (Exhibit 4). Poria Cortex, Moutan Radicis, Radix Paeonize Alba, and Mu, Guili. Clinical observation of Guizhi Fuling Jiaonang Semen Persicae. This invention provides various uses of (GFJ) (Capsule of Ramulus Cinnamomi and Foria) in treat these compositions. ing hysteromyoma. Traditional Chinese Medicine in Gansu (Gan Su Zhong Yi) 2000(4), pp. 47–48 (Exhibit 5). 6 Claims, 4 Drawing Sheets US 6,569,468 B2 Page 2 OTHER PUBLICATIONS Jiajun et al. Effects of Guizhi Fuling Wan (GFW) (Pill of Jiang, Jiannan et al. Clinical observation of Guizhi Fuling Ramulus Cinnamomi and Foria) on blood rheology. Jiaonang (GFJ) (Capsule of Ramulus Cinnamomi and Foria) Research on Chinese Patent Medicine (Zhong Cheng Yao in treating 45 cases of cold accumulation pattern of gyne cological blood Stasis. Chinese Folk Therapy (Zhong Guo Yan Jiu) 5.24–26 (1986). Min Jian Liao Fa) 5.35–36 (1998). Xie, Jiajun et al. Pharmacological actions of Guizhi Fuling Li, Changcheng et al. Guizhi Fuling Wan (GFW) (Pill of Ramulus Cinnamomi and Foria) in treating hyster Wan (GFW) (Pill of Ramulus Cinnamomi and Foria) on the omyoma-analysis of the therapeutic effects in 13 cases. central nervous system. Research on Chinese Patent Medi Journal of Hubei Chinese Medicine (Hu Bei Zhong Yi Za cine (Zhong Cheng Yao Yan Jiu) 7.29–30 (1987). Zhi) vol. 1885.9 (1991). Liu, Guoxiang Examples of clinical application of Guizhi Zeng, Haiju Clinical observation of 45 cases of hyster Fuling Wan (GFW) (Pill of Ramulus Cinnamomi and Foria) omyoma treated mainly with Guizhi Fuling Wan (GFW) in gynecology. Journal of Anhui Clinical Chinese Medicine (An Hui Zhong Yi Lin Chuang Za Zhi) vol. 106.401-402 (Pill of Ramulus Cinnamomi and Foria). Journal of Gansu (1998). College of Traditional Chinese Medicine (Gan Su Zhong Yi Shi, Dangmin et al. Clinical observation of Guizhi Fuling Xue Yuan Xue Bao) vol. 12 2.20 (1995). Jiaonang (GFJ) (Capsule of Ramulus Cinnamomi and Foria) in treating 60 cases of hysteromyoma. Chinese Herbal Zhao, Weiguo Guizhi Fuling Wan (GFW) (Pill of Ramulus Medicine (Zhong Cao Yao) vol. 315.365 (2000). Cinnamomi and Foria) in treating benign tumors in gyne Tosa Kansu, et al. Effects of Guizhi Fuling Wan (GFW) (Pill cology. Traditional Chinese Medicine in Hebei (He Bei of Ramulus Cinnamomi and Foria) on blood viscosity, blood platelet function and blood coagulation in healthy people. Zhong Yi) vol. 20, 3.176–177 (1998). Chinese Medicine, medicine Abroad (Guo Wai Yi Xue, Zhong Yi Zhong Yao Fen Ce) vol. 106.12–15 (1988). * cited by examiner U.S. Patent May 27, 2003 Sheet 1 of 4 US 6,569,468 B2 Figure 1 U.S. Patent May 27, 2003 Sheet 2 of 4 US 6,569,468 B2 Figure 2 1: 3 12 ... .59 5 G U.S. Patent May 27, 2003 Sheet 3 of 4 US 6,569,468 B2 Figure 3 WWDA, wavelength=210 nm (CHENPCHENP180.D) Al " | 50 - U.S. Patent May 27, 2003 Sheet 4 of 4 US 6,569,468 B2 Figure 4 WoA, wavelength 242 nm (CHENPCHENP139.) mAU s 2 O 5 1 S i. 8 s 4. i 4 . kiš. ; : i : ...::... ---. ... ------ w -i. w... x8's. 8 ... ... arra- - - - “” W O s : : Yrriwww-r-Yr-rrre-or--r---------------- ... 10 20 3. 49. 50 SO 70 BO r US 6,569,468 B2 1 2 CINNAMOMI AND PORIA COMPOSITION, Like most TCM products, the Cinnamomi and Poria METHOD TO PREPARE SAME AND USES composition is prepared from multiple medicinal herbal THEREOF materials-five cultivated natural plants called Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Alba This application is a Continuation-In-Part application of and Semen Persicae. Different in weights and portions of the Patent Cooperation Treaty Application No. PCT/CNO0/ medicinal herbS for the Start-up materials and in the pro 00273, filed Sep. 13, 2000, the content of which is incor ducing courses, Cinnamomi and Poria composition shares porated herein to this application by reference. the same formula of five herbs with a previous medicinal Throughout this application, various publications are preparation-Bolus of Cinnamomi and Poria (BCP). referenced and full citations for these publications may be BCP, which has long been approved as an effective cure, found in the references at the end of the Specifications was a Sample of Success in medicinal practice in ancient preceding the claims. The disclosures of these publications China. The formula of five was sourced from Jinkui are hereby incorporated by reference into this application in Summary, a guide compiled by famous TCM practitioner order to more fully describe the state of the art as known to Zhongjing Zhang, Some 1,000 years ago. It was also col the skilled therein as of the date of the invention described 15 lected in many medicine directory resources, Such as the and claimed herein. “Traditional Chinese Medicine Dictionary.” With different courses of preparation, the five-plant for BACKGROUND OF THE INVENTION mula was always administered in combination with other Menstrual cramps and dysfunctional uterine bleeding are medicinal herbs. It claims to treat a variety of diseases and common disorders among women during their menstrual disorders, including many indications in the present inven period.
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