Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2006-09-25
2010-02-16
Chang, Celia (Department: 1625)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
07662835
ABSTRACT:
The present invention is related to novel processes for preparing anhydrous and hydrated forms of piperidine derivatives, polymorphs and pseudomorphs thereof of the formulaswhich are useful as antihistamines, antiallergic agents and bronchodilators.
REFERENCES:
patent: 3448152 (1969-06-01), Milligan
patent: 3862173 (1975-01-01), Carr
patent: 3878217 (1975-04-01), Carr
patent: 3965257 (1976-06-01), Carr
patent: 4254129 (1981-03-01), Carr et al.
patent: 4254130 (1981-03-01), Carr
patent: 4285957 (1981-08-01), Carr
patent: 4285958 (1981-08-01), Carr
patent: 4672133 (1987-06-01), Crookes
patent: 4742175 (1988-05-01), Fawcett
patent: 5204249 (1993-04-01), Schwartz
patent: 5308840 (1994-05-01), Sugiyama
patent: 5375693 (1994-12-01), Woosley
patent: 5574045 (1996-11-01), Ortyl et al.
patent: 5576610 (1996-11-01), D'Ambra
patent: 5581011 (1996-12-01), D'Ambra
patent: 5631375 (1997-05-01), King
patent: 5738872 (1998-04-01), Ortyl et al.
patent: 5750703 (1998-05-01), D'Ambra
patent: 5855912 (1999-01-01), Ortyl
patent: 5932247 (1999-08-01), Ortyl
patent: 6037353 (2000-03-01), Woodward
patent: 6039974 (2000-03-01), MacLaren
patent: 6113942 (2000-09-01), Ortyl
patent: 6147216 (2000-11-01), Krauss
patent: 6187791 (2001-02-01), Woodward
patent: 6242606 (2001-06-01), Krauss
patent: 6399632 (2002-06-01), Woodward et al.
patent: 6613906 (2003-09-01), Davies
patent: 2002/0177608 (2002-11-01), Dolitzky et al.
patent: 2004/0077683 (2004-04-01), Reddy et al.
patent: 1123438 (1982-05-01), None
patent: 1123439 (1982-05-01), None
patent: 2117892 (1993-10-01), None
patent: 2181089 (1994-12-01), None
patent: WO 93/21156 (1993-10-01), None
patent: WO 94/03170 (1994-02-01), None
patent: WO 94/09008 (1994-04-01), None
patent: WO 95/00480 (1995-01-01), None
patent: WO 96/26726 (1996-09-01), None
Rowland and Tozer “Clinical pharmacokinetics concepts and application” p. 123 (1995).
Gibson et al. “Modulation of antagonisti binding . . . ” Br. J. Pharmcol. v. 111 (Apr.) p. 1262-1268 (1994).
Muzaffar et al. “Polymorphism and drug availability” J. Phar. 1(1) 59-66 (1979).
Jain et al. “Polymorphisom in pharmacey” Indian Drugs 23(g)315-329 (1986).
Doelker et al. “Crystalline modification . . . ” CA 138:209993 (2002).
Doelker et al. “Physicochemical behavior or active . . . ”CA 132:325872 (2000).
Otsuka et al. “Effect of polymorphic . . . ” Chem. Pharm. bull 47(6)852-856 (1999).
copies in parent case.
Glusker et al. “Crystal structure analysis a primer” p. 12 (1985).
Copending claims as of Oct. 30, 2007, for related U.S. Appl. No. 11/534,828.
Copending claims as of Oct. 26, 2006, for related U.S. Appl. No. 11/553,751.
Copending claims as of Oct. 30, 2007, for related U.S. Appl. No. 11/978,669.
Copending claims as of Oct. 30, 2007, for related U.S. Appl. No. 11/978,670.
Advisory Action dated Sep. 24, 2003, in U.S. Appl. No. 10/160,883.
Affidavit of Lilach Goldman, dated Jul. 10, 2006.
Akaishi et al. “Synthesis of diamond using nonmetallic catalysts.” Chemical Abstracts 116:73144 (1992).
Amon, U. et al.; Anti-allergic effects of H1-receptor antagonists on histamin-containing cells; 178(8) Dematologische Monatsschrift 327-33 (1992).
Bailey, D.G. et al.; Effect of Grapefruit Juice and Naringin on Nisoldipine Pharmacokinetics; 54 Clinical Pharmacology & Therapeutics 589-94 (1993).
Bailey, D.G. et al.; Grapefruit Juice—Felodipine Interaction: Mechanism, Predictability, and Effect of Naringin; 53 Clinical Pharmacology & Therapeutics 637-42 (1993).
Bailey, D.G. et al.; Grapefruit Juice and Drugs: How Significant is the Interaction; 26(2) Clinical Pharmacokinetics 91-98 (1994).
Bailey, D.G. et al.; Grapefruit Juice—Felodipine Interaction: Reproducibility and Characterization with the Extended Release Drug Formulation; 40 Br. J. Clinical Pharmacology 135-40 (1995).
Baroody, F. et al.: The Effects of H1 antihistamines on the Early Allergic Response; 63 Annals of Allergy 551-55 (1989).
Bennett et al.; Concise Chemical and Technical Dictionary 553 (Chemical Publishing Co. 1974).
Brittain, Polymorphism in Pharmaceutical Solids, p. 2, 185 (Marcel Dekker Inc. 1999).
Burlage, H.M. et al.; Fundamental Principles and Processes of Pharmacy 464-67 (McGraw-Hill 2nd ed. 1949).
Cantilena, L. et al.; Effect of Cimetidine and Ranitidine on the Pharmacokinetics and ECG Pharmacodynamics of Terfenadine; 53(2) Clinical Pharmacology & Therapeutics 161 (1993).
Chan, K.Y. et at.; Direct Enantiomeric Separation of Terfenadine and Its Major Acid Metabolite by High-Performance Liquid Chromatography, and the Lack of Stereoselective Terfenadine Enantiomer Biotransformation in Man; CA 116:50726(1992).
Chan, K.Y. et al.; Direct Enantiomeric Separation of Terfenadine and its Major Acid Metabolite by High-Performance Liquid Chromatography, and the Lack of Stereoselective Terfenadine Enantiomer Biotransformation in Man; 571 J. Chromatography 291-97 (1991).
Charlesworth, E.N. et al.; Cutaneous Late-Phase Response in Food-Allergic Children and Adolescents with Atopic Dermatitis; 23 Clinical and Experimental Allergy 391-98 (1993).
Chen, T.-M. et al.; Determination of the Metabolites of Terfenadine in Human Urine by Thermospray Liquid Chromatography—Mass Spectrometry; 9(10-12) J. Pharmaceutical and Biomedical Analysis 929-33(1991).
Cheronis, N. D. Semimicro Experimental Organic Chemistry, A Laboratory Manual 4, 8 (J de Graft 1958).
Cheronis, ND.; Semimicro Experimental Organic Chemistry. A Laboratory Manual 16-17 (J de Graff 1958).
Cheronis, N.D.; Semimicro Experimental Organic Chemistry, A Laboratory Manual 31-42 (J de Graft 1958).
Argentine Search Report, dated Sep. 9, 1999.
Canadian Office Action, with references cited therein, dated Nov. 6, 1998.
European Search Report, dated Dec. 20, 2001.
Norwegian Search Report, dated Nov. 21, 2001.
PCT International Search Report, dated Aug. 10, 1995.
Coutant, J.E. et al.; Determination of Terfenadine and Terfenadine Acid Metabolite in Plasma Using Solid-Phase Extraction and High-Performance Liquid Chromatography with Flourescence Detection; 570 J. Chromatography 136-48 (1991).
Crumb, W.J. et al.; Blockade of Multiple Human Cardiac Potassium Currents by the Antihistamine Terfenadine: Possible Mechanism for Terfenadine-Associated Cardiotoxicity; 47 Molecular Pharmacology 181-90(1995).
Dean, J.A., Analytical Chemistry Handbook, 10.2-10.26 (McGraw-hill inc. 1955).
Declaration of Dr. Marcus F. Brackeen, signed Jul. 7, 2006, and submitted in Israeli litigation docket No. C.F. 1088/0, with exhibits A-F.
Declaration of Prof. Anthony Michael Glazer, signed Jul. 7, 2006, and submitted in Israeli litigation docket No. C.F. 1088/0, with exhibits A-F.
Declaration of Prof. Clare Grey, signed Jul. 7, 2006, and submitted in Israeli litigation docket No. C.F. 1088/06, with exhibits A-F.
Declaration of Dr. Mark D. Hollingsworth, signed Jul. 6, 2006, and submitted in Israeli litigation docket No. C.F. 1088/06, with exhibits A-E.
Declaration of Dr. Alan P. Kozikowsky, signed Jul. 7, 2006, and submitted in Israel litigation docket No. C.F. 1088/06, with exhibits A-M.
Declaration of Dr. William E. Mayo, signed Jul. 7, 2006, and submitted in Israel litigation docket No. C.F. 1088/0, with exhibits A-M.
Declaration of Prof. Abraham Rubinstein, signed Jul. 7, 2006, and submitted in Israel litigation docket No. c.F. 1088/06, with exhibits A-C, including English-language Translation of Appendix B.
Declaration of Prof. Peter W. Stephens, signed Jul. 7, 2006, and submitted in Israel litigation docket No. C.F. 1088/06.
Distinction between Crystalline and Amorphous Solids, Encyclopedia Britannica Online (2004).
Doelker et al. “Crystalline modification and polymorphism changes during drug manufacturing.” 63-Pharmaceuticals. Chemical Abstracts 138:209993 (2003).
Doelker et al. “Physicochemical behavior of active substances, Consequences for the feasibility and stability of pharmaceutical forms.” 63-Pharmaceuticals. Chemical Abstracts 132:325872 (2000).
Eagleson
Carr Albert A.
McCarty Frederick J.
Aventis Holdings, Inc.
Chang Celia
O'Brien Jones PLLC
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