IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT
`Attorney Docket No. 01142.0368-00000
`
`)
`)
`) GroupArtUnit: 1617
`)
`) Examiner: Not Yet Assigned
`)
`)
`) Confirmation No.: 8444
`)
`)
`)
`
`In re Application of:
`
`Mahdi B. FAWZI et al.
`
`Application No.: 11/374,330
`
`Filed: March 13, 2006
`
`For: TIGECYCLINE COMPOSITIONS
`AND METHODS OF
`PREPARATION
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`INFORMATION DISCLOSURE STATEMENT UNDER 37 C.F.R. § 1.97(b)
`
`Pursuant to 37 C.F.R. §§ 1.56 and 1.97(b), Applicants bring to the attention of
`
`the Examiner the listed documents on the attached PTO SB/08 Form. This Information
`
`Disclosure Statement is being filed before the mailing date of a first Office Action on the
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`merits for the above-referenced application.
`
`Copies of the U.S. patent publications are not enclosed. Copies of the listed
`
`foreign and non-patent literature documents are attached with the exception of CN 139
`
`0 550. An English-language abstract is provided from the STN database HCAPLUS,
`
`Accession Number 2004:27 4666.
`
`Applicants respectfully request that the Examiner consider the listed documents
`
`and indicate that they were considered by making appropriate notations on the attached
`
`form.
`
`Apotex Exhibit 1034
`Page 1 of 6
`
`

`

`This submission does not represent that a search has been made or that no
`
`better art exists and does not constitute an admission that each or all of the listed
`
`documents are material or constitute "prior art." If the Examiner applies any of the
`
`documents as prior art against any claim in the application and Applicants determine
`
`that the cited documents do not constitute "prior art" under United States law,
`
`Applicants reserve the right to present to the U.S. Patent and Trademark Office the
`
`relevant facts and law regarding the appropriate status of such documents.
`
`Applicants further reserve the right to take appropriate action to establish the
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`patentability of the disclosed invention over the listed documents, should one or more of
`
`the documents be applied against the claims of the present application.
`
`If there is any fee due in connection with the filing of this Statement, please
`
`charge the fee to Deposit Account 06-0916.
`
`(~ { { I({'; ;c,.i
`Dated: __ ..._1-'-! -'-~;~__:.' '.....;~"'-/ _I ___ _
`
`Respectfully submitted,
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`
`Gretchen S. Peterson, Ph.D.
`Reg. No. 57,404
`
`-2-
`
`Apotex Exhibit 1034
`Page 2 of 6
`
`

`

`IDS Form PTO/SB/08: Substitute for form 1449A/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`I
`I
`1
`
`of
`
`I
`
`Sheet
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`Attorney Docket Number
`
`Complete if Known
`11/374,330
`March 13, 2006
`Mahdi B. Fawzi
`1617
`Not Yet Assigned
`01142.0368-00000
`
`4
`
`Examiner
`Initials
`
`Cite
`No.
`
`U.S. PATENTS AND PUBLISHED U.S. PATENT APPLICATIONS
`Document Number
`Issue or
`Name of Patentee or
`Pages, Columns, Lines, Where
`Publication Date
`Applicant of Cited Document
`Relevant Passages or Relevant
`MM-DD-YYYY
`Figures Appear
`9/11/2003
`
`Isbister
`
`Number-Kind Code (if known)
`
`US-2003/0171340
`
`US-3,026,248
`US-3, 145,228
`
`US-3,219,529
`
`US-4,038,315
`
`US-5,538,954
`
`US-5,908,838
`
`3/20/1962
`
`Noseworthy et aL
`
`8/18/1964
`
`Schach von Wittenau et aL
`
`11/23/1965
`
`Nash et aL
`
`7/26/1977
`7/23/1996
`
`6/1/1999
`
`Tobkes et al.
`
`Koch et aL
`Gans
`
`Examiner
`Initials
`
`Cite
`No.
`
`Foreign Patent Document
`
`FOREIGN PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MM-DD-YYYY
`Applicant of Cited Document
`
`Country Code Number Kind Code (if
`known)
`CN 1 390 550
`
`GB 2414668
`
`GB 901,107
`wo 02/055731
`WO 02/096354 A2
`wo 02/12170
`WO 03/005971 A2
`
`WO 03/066064 A2
`WO 04/038000 A2
`
`1/15/2003
`
`12/7/2005
`
`6/29/1959
`
`7/18/2002
`
`Peoples Republic of China
`Dexcel Ltd.
`
`Gordon et aL
`University of Texas et aL
`
`12/5/2002
`
`TAP Pharm Products Inc.
`
`2/14/2002
`
`1/23/2003
`
`8/14/2003
`
`5/6/2004
`
`Trustees of Tufts College
`Paratek Pharmaceuticals Inc.
`
`Advancis Pharm Corp
`Paratek Pharmaceuticals Inc.
`
`WO 04/078111 A2
`
`9/16/2004
`
`Ranbaxy Laboratories Ltd.
`
`Pages, Columns,
`Lines, Where
`Relevant Passages
`or Relevant Figures
`Appear
`
`Translation
`
`Abstr.
`
`Examiner
`Initials
`
`Cite
`No.
`
`I Exam1ner
`
`Signature
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`BABINCHAK, T. et aL "The efficacy and safety of tigecycline for the treatment of
`complicated intra-abdominal infections: analysis of pooled clinical trial data" Clin.
`Infect Dis A 1 (Suppl 5):8354-67 (Sep 1, 2005)
`BAIRD-BELLAIRE, S.J. et aL "Pharmacokinetics (PK) of tigecycline (TGC) in patients
`with hepatic impairment" Basic & Clinical Pharm. ToxicoL 97(SuppL 1 ):86, Abstr. 318
`(2005).
`
`I Date
`
`Considered
`
`Translation
`
`EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if
`not in conformance and not considered. Include copy of this form with next communication to applicant.
`
`Apotex Exhibit 1034
`Page 3 of 6
`
`

`

`IDS Form PTO/SB/08: Substitute for form 1449A!PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Sheet
`
`(Use as many sheets as necessary)
`2
`of
`
`I
`
`I
`
`J
`
`4
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`Attorney Docket Number
`
`Complete if Known
`11/374,330
`March 13, 2006
`Mahdi B. Fawzi
`1617
`Not Yet Assigned
`01142 0368-00000
`
`Examiner
`Initials
`
`Cite
`No.
`
`I Examiner
`
`Stgnature
`
`Translation
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`BElDEN BACH et. al. "In vitro antimicrobial activity of GAR-936 tested against
`antibiotic-resistant gram-positive blood stream infection isolates and strains producing
`extended-spectrum beta-lactamases" Diagn. Microbial. Infect. Dis. 40(4):173-7 (Aug
`2001)
`BETRIEU, C. et al. "In vitro activities of tigecycline against erythromycin-resistant
`Streptococcus pyogenes and Streptococcus agalactiae: mechanisms of macrolide and
`tetracycline resistance" Antimicrob. Agents Chemother. 48:323-5 (Jan 2004)
`BOUCHER, H.W. et al. "In vitro activities of the glycylcycline GAR-936 against gram-
`positive bacteria" Antimicrob. Agents & Chemother. 44:2225-29 (2000)
`BOUCHER, H.W. et al. "In vitro activity of GAR-936 against gram-positive bacteria"
`39th ICAAC Abstracts, American Society for Microbiology, Sept 26-29, 1999, San
`Francisco, CA; Abstr. 406, p. 300 (1999)
`BRADFORD, P.A. "Tigecycline: a first in class glycylcycline" Clin. Microbial. Newsletter
`26(21):163-8 (Nov 1, 2004)
`BRYANT, S.G. et al. "Increased frequency of doxycycline side effects"
`Pharmacotherapy 7(4): 125-9 (1987)
`CASWELL, A. H. et al. "Selectivity of cation chelation to tetracyclines: evidence for
`special conformation of calcium chelate" Biochem. Biophys. Res. Commun. 43(3):625-
`30 (May 7, 1971)
`CHIN, T-F. et al. "Drug diffusion and bioavailability: tetracycline metallic chelation" Am.
`J. Hosp. Pharm. 32(6):625-9 (Jun 1975)
`DARTOIS, R. "Results of a phase 3, double-blind, safety and efficacy study comparing
`tigecycline with vancomycin/aztreonam to treat complicated skin and skin structure
`infections" 44th ICAAC Abstracts, American Society for Microbiology, Oct 30- Nov
`2,1994, Washington, D.C.; Abstr L-986, p. 389 (1994)
`ELLIS-GROSSE, E.J. et al. "The efficacy and safety of tigecycline in the treatment of
`skin and skin-structure infections: results of 2 double-blind phase 3 comparison
`studies with vancomycin-aztreonam" Clin. Infect. Dis. 41 (Suppl 5):S341-53 (Sep 1,
`2005)
`FANNING, W.L. et al. "Distressing side-effects of minocycline hydrochloride" Arch.
`Intern. Med. 136:761-2 (Jul1976)
`FRAMPTON, J.E. et al. "Tigecycline" Drugs 65(18):2623-35 (2005)
`GARRISON, M.W. "Tigecycline: an investigational glycylcycline antimicrobial with
`activity against resistant gram-positive organisms" Clin. Ther. 27(1):12-22 (Jan. 2005)
`GUMP, D.W. et al. "Side effects of minocycline: different dosage regimens"
`Antimicrob. Agents Chemother. 12(5):642-6 (Nov 1977)
`HARRIS, R. et al. "Tigecycline (Tygacil): a novel first-in-class, broad-spectrum
`intravenous antibiotic for the treatment of serious bacterial infections" P& T 31 (1 ): 18-
`19,24-27,59 (2006)
`
`Date
`Considered
`
`EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if
`not in conformance and not considered. Include copy of this form with next communication to applicant.
`
`Apotex Exhibit 1034
`Page 4 of 6
`
`

`

`IDS Form PTO/SB/08: Substitute for form 1449A/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`I
`of
`3
`
`Sheet
`
`I
`
`I
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`Attorney Docket Number
`
`Complete if Known
`11/374,330
`March 13, 2006
`Mahdi B. Fawzi
`1617
`Not Yet Assigned
`01142.0368-00000
`
`4
`
`Examiner
`Initials
`
`Cite
`No.
`
`Translation
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`HIRATA, T. et al. "Effects of efflux transporter genes on susceptibility of Escherichia
`coli to tigecycline (GAR-936)" Antimicrob. Agents Chemother. 48(6):2179-84 (Jun
`2004)
`HU, M. et al. "Characterization and comparison of calcium chelation properties of
`minocycline and a new tetracycline analogue, glycylcycline" Pharm. Res. 11 (1 0
`Suppi.):S-272 (Oct 1994)
`HUNTER, P.A. et al. "GAR-936. Tetracycline Antibiotic. Tigecycline; TBG-MINO;
`WAY-GAR-936" Drugs of the Future 26(9):851-8 (2001)
`International Search Report for PCT/US2006/08827 dated August 14, 2006 (Atty.
`Docket No. 01142.0368-00304)
`KING, G.L. "Animal models in the study of vomiting" Can. J. Physiol. Pharmacal.
`68:260-8 (1990)
`Ll, C. et al. "Quantitation of tigecycline, a novel glycyclcycline, by liquid
`chromatography" J. Chromatog. B 811:225-9 (2004) Erratum included at the end.
`MILATOVIC, D. "Activities of the glycylcycline tigecycline (GAR-936) against 1,924
`recent European clinical bacterial isolates" Antimicrob. Agents Chemother. 47(1):400-
`4 (Jan 2003)
`MITSCHER, L.A. The Chemistry of the Tetracyline Antibiotics. Grunwald, Gary L. [ed.],
`Marcel Dekker, Inc., New York; Chapter 6.3, p. 172-173 and Chapter 2, p. 53-54
`(1978)
`MURALIDHARAN, G. et al. "Pharmacokinetics (PK), safety and tolerability of GAR-
`936, a novel glycylcycline antibiotic, in healthy subjects" 39th ICAAC Abstracts,
`American Society for Microbiology, Sept 26-29, 1999, San Francisco, CA; Abstr. 416,
`p. 303 (1999)
`NATHWANI, D. "Tigecycline: clinical evidence and formulary positioning" Int. J.
`Antimicrob. Agents 25(3): 185-92 (Mar 2005)
`PATEL, R. "In vitro activity of GAR-936 against vancomycin-resistant enterococci,
`methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus
`pneumoniae" Diagn. Microbial. Infect. Dis. 38(3): 177-9 (Nov 2000)
`PAWELCZYK, E. et al. "Kinetics of drug decomposition. Part 73. Kinetics and
`mechanism of vitamin K3 soluble form thermal decomposition in solid phase" Pol. J.
`Pharmacal. Pharm. 34(5-6):399-408 (Nov-Dec 1982)
`PAWELCZYK, E. et al. "Kinetics of drug decomposition. Part 73. Kinetics of
`degradation of minocycline in aqueous solution" Pol. J. Pharmacal. Pharm. 34:409-21
`(1982)
`
`I Examiner
`
`Signature
`
`I Date
`
`Considered
`
`EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if
`not in conformance and not considered. Include copy of this form with next communication to applicant.
`
`Apotex Exhibit 1034
`Page 5 of 6
`
`

`

`IDS Form PTO/SB/08: Substitute for form 1449AIPTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Sheet
`
`(Use as many sheets as necessary)
`I
`4
`of
`
`I
`
`I
`
`4
`
`Application Number
`Filing Date
`First Named Inventor
`Arl Unit
`Examiner Name
`Attorney Docket Number
`
`Complete if Known
`11/374,330
`March 13, 2006
`Mahdi B. Fawzi
`1617
`Not Yet Assigned
`01142.0368-00000
`
`Examiner
`Initials
`
`Cite
`No.
`
`Translation
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LEITERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`PETERSEN, P.J. et al. "In vitro and in vivo activities of tigecycline (GAR-936),
`daptomycin, and comparative antimicrobial agents against glycopeptide-intermediate
`Staphylococcus aureus and other resistant gram-positive pathogens" Antimicrob.
`Agents Chemother. 46(8):2595-601 (Aug 2002)
`PETERSEN, P.J. et al. "In vitro and in vivo antibacterial activities of a novel
`glycylcycline, the 9-t-butylglycylamido derivative of minocycline (GAR-936)"
`Antimicrob. Agents Chemother. 43( 4 ):738-44 (Apr 1999)
`RELLO, J. "Pharmacokinetics, pharmacodynamics, safety and tolerability of
`tigecycline" J. Chemother. 17(Supp. 1):12-22 (2005)
`REMMERS, E.G. "Some observations on the kinetics of the C.4 epimerization of
`tetracycline" J Pharm Sci. 52:752-6 (Aug 1963)
`SCHELL, S. et al. "Predictors of length of intravenous antibiotic treatment and
`hospitalization in patients with complicated intra-abdominal infections (ciAI): findings
`from pooled clinical studies comparing tigecycline and imipenem/cilastatin" 45th
`ICAAC Abstracts, American Society for Microbiology, Dec 16-19, 2005, Washington,
`D.C.; Abstr 503210 (2005)
`SMITH, K.L. et al. "Tigecycline" Formulary 40:245-254 (2005)
`YU, Hang "Freeze-Dried Powder Injection of Minocyline Hydrochloride and Its
`Preparation" [online] retrieved from STN Database, Chemical Abstracts Service,
`Accession No. 2004:274666 (2004)
`YUEN, P.H. et al. "Kinetics of concomitant degradation of tetracycline to
`epitetracycline, anhydrotetracycline, and epianhydrotetracycline in acid phosphate
`solution" J. Pharm. Sci. 66:1648-50 (1977)
`ZHANEL, G. G. et al. "The glycylcyclines: a comparative review with the tetracyclines"
`Drugs 64(1):63-88 (2004)
`
`I Examiner
`
`Signature
`
`I Date
`
`Considered
`
`EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if
`not in conformance and not considered. Include copy of this form with next communication to applicant.
`
`Apotex Exhibit 1034
`Page 6 of 6
`
`