`
`CERTIFICATE OF CORRECTION
`
`PATENT NO.
`APPLICATION NO.
`
`: 8,168,620 B2
`: 10/518016
`
`DATED
`INVENTOR(S)
`
`: May 1, 2012
`: Amar Lulla et al.
`
`Page | of 1
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`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:
`
`In the claims:
`
`Column 12, Claim 7, Line 7; Replace: “a suspending agent a thickening agent” with --a suspending
`agent, a thickening agent--
`Column 12, Claim 10, Lines 20-21; Replace: “phenyl mercury borate, or benzoic acid” with --phenyl
`mercury borate, benzoic acid--
`Column 13, Claim 24, Lines 19-20; Replace: “dosage form of as a nasal spray” with --dosage form of
`a nasal spray--
`
`Signed and Sealed this
`Eighteenth Day of November, 2014
`
`Webthe Fo Lea
`
`Michelle K. Lee
`
`Deputy Director ofthe United States Patent and Trademark Office
`
`CIPLA LTD. EXHIBIT 2001 PAGE1
`
`CIPLA LTD. EXHIBIT 2001 PAGE 1
`
`
`
`Aftorney Docket No. CRT/Z0632 US (4137-04700)
`
`Patent
`
`iN PRE UNITED STATES PATENT AND TRADEMARE OFFICE
`
`Group Ari Unit:
`
`1616
`
`Hxeamimer: Thor B. Nielson
`
`Confirmation No. 4912
`
`§ §
`
`§ §
`
`§ 8
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`§
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`§T
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`T
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`CERTINICATEOFFILING
`
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`correspondence is being electronically submitted to the 1.5.
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`Patent and Trademark Office website, www_uspio.eoy, On
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`_SNANDICNAINNANANNENNNAANTEAR
`
`Patentees:
`
`Amar Lalla, et al.
`
`Patent No.
`
`=, 168,620 BZ
`
`issued:
`
`May 1, 2012
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`For
`
`COMBINATION OF AZELASTINE AND
`STEROIDS
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`Mail Stop: Certificate of Correction Branch
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`Patentees hereby request that a Certificate of Correction be issued pursuant to 37 CPLR.
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`$1,322 and 37 C.E.R. $1.323 to correct the mistakes as set out in the attached draft certificate,
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`The mistakes to be corrected are minor and editorial in nature. The Commissioner is
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`hereby authorized to charge payment of any fees associated with submission of the Certificate of
`Correction submited herewith to Deposit Account 50-1515, Conley Rose, PC.
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`Respectfully submitied,
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`CIPLA LTD. EXHIBIT 2001 PAGE2
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`CIPLA LTD. EXHIBIT 2001 PAGE 2
`
`
`
`ant
`
`$158620
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`
`ISSUE DATE
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`it is certified thal an error appears or errors appear in the above-tdentified patent and that eaid Letters Patent
`is hereby corrected as shawn below:
`in the claims:
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`AMAOEOLPEALALLOLPPPPOPPLAPLEEPEPELLEDPOEDDETTETEDEELESELLLLES
`
`CIPLA LTD. EXHIBIT 2001 PAGE3
`
`CIPLA LTD. EXHIBIT 2001 PAGE 3
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`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
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`
`APPLICATION NO.
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`10/518,016
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`ISSUE DATE
`
`05/01/2012
`
`30652
`
`7590
`
`04/11/2012
`
`CONLEYROSE,P.C.
`5601 GRANITE PARKWAY,SUITE 750
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`PATENTNO.
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`ATTORNEY DOCKET NO.
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`CRT/20632 US (4137-04700)
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`4912
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`ISSUE NOTIFICATION
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`Determination of Patent Term Adjustment under 35 U.S.C, 154 (b)
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`The Patent Term Adjustment is 987 day(s). Any patent to issue from the above-identified application will
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`APPLICANT(s) (Please see PAIR WEBsite http://pair.uspto.gov for additional applicants):
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`Amar T.ulla, Mumbai, INDIA:
`Geena Malhotra, Mumbai, INDIA;
`
`IR103 (Rev. 10/09)
`
`CIPLA LTD. EXHIBIT 2001 PAGE 4
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`CIPLA LTD. EXHIBIT 2001 PAGE 4
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`
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`
`
`
`3828080
`
`9081113
`
`d
`
`C t
`
`hange(s) pplie
`
`d documen
`4861765 JOOGes1989-08-29
`
`
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`Art Unit
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`ThorB. Nielsen Attorney Docket Number
`| 1616
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`INFORMATION DISCLOSURE
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`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`| CRT/20632 US{4137-04700)
`
`
`
`9
`
`4710495
`
`~53837699
`a3755302
`
`3557162
`
`5420120
`
`1987-12-01
`
`Bodor
`
`
`
`Voorschoten, et al.
`
`foMitsukuchietal.
`
`May,et al.
`
`Claussner, et al.
`
`Bodor, et al.
`
`1981-05-12
`
` 1980-09-09
`
`LBY
`p28/2012
`
`17
`
`18
`
`/ 9
`
`1997-03-04
`
`Stache, et al.
`
`EFS Web 2.1.17
`
`. ITN
`
`4
`ielsen/
`2
`01/13/2601
`Thor N
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH
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`2005-07-06
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`
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`STATEMENT BY APPLICANT
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`Ant Uninit | 1616
`( Not for submission under 37 CFR 1.99)
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`
`TheorB. Nielsen
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`Attorney Docket Number | CRT/20632 US(4137-04700)
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`Remove
`
`Nameof Patentee or Applicant Pages,Columns,Lines where
`Kind
`Examiner] Cite
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`of cited Document
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`Figures Appear
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`1
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`4198403
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`1980-04-15
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`Alvarez
`
`
`
`2
`
`6261539
`
`2001-07-17
`
`Adjei, et al.
`
`
`
`3
`
`4187301
`
`1980-02-05
`
`Edwards
`
`
`
`4
`
`5972920
`
`1999-10-26
`
`Seidel
`
`
`
`4377575
`
`1983-03-22
`
`.
`5
`C. hange(s) a plied
`
`
`
`Stache etal.
`Perippsetar
`
`
`3/28/2012|8 1974-12-24|Phillips,et al.3856828
`
`
`
`7
`
`8
`
`4113680
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`1978-09-12
`
`Kamano, etal.
`
`4093721
`
`1978-06-06
`
`Phillipps, et al.
`
`‘Thor Nieisen/
`
`01/43/2042
`
`EFS Web 2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/T.N./
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`CIPLA LTD. EXHIBIT 2001 PAGE 6
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`CIPLA LTD. EXHIBIT 2001 PAGE 6
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`
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`Attorney Docket Number
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`| CRT/20632 US(4137-04700)
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`
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`
`
`46|0154481 WO 2001-08-02 Rohm and Haas O
`
`
`
`Company
`
`
`
`
`
`1191965
`
`0048587
`
`1970-05-13
`
`Warmer-Lambert
`Pharmaceutical Company
`
`2000-08-24
`
`Novartis AG, etal.
`
`0104118
`
`Almirall Prodesfarma S.A.
`
`2001-08-09
`
`Pfizer Products Inc.
`
`Add
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`TS
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`Examiner] Cite
`tT
`*
`Initials
`No
`publisher, city and/or country where published.
`
`
`1
`
`"Azelastine," STN Registry No. 58581-89-8, STN Registry File, Retrieved 2010-11-23, page 1.
`
`|
`
`
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`"Fluticasone Furoate," STN Registry No. 397864-44-7, STN Registry File, Retrieved 2010-11-23, page 1.
`
`|
`
`2
`
`Astelin (azelastine hydrochloride) Nasal Spray, MedPointe Pharmaceuticals, 2006, U.S. Physicians Desk Reference,
`pp. 18/6-18/7.
`
`co
`
`‘Thor Nieisen/
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`C14 3/e012
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`EFS Web2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`CIPLA LTD. EXHIBIT 2001 PAGE 7
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`Application Number
`10518016
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`2005-07-06
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`INFORMATION DISCLOSURE
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`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`| 1616
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`Examiner Name
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`ThorB. Nielsen
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`APPLICATION NO.
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`10/518,016
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`
` FILING DATE
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`07/06/2005
`
`30652
`
`7590
`
`03/20/2012
`
`CONLEYROSE,P.C.
`5601 GRANITE PARKWAY,SUITE 750
`PLANO,TX 75024
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`Amar Lulla
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`CRT/20632 US
`(4137-04700)
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`CONFIRMATION NO.
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`4912
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`EXAMINER
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`NIELSEN, THOR B
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`ART UNIT
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`03/20/2012
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`PTOL-90A (Rev. 04/07)
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`UNITED STATES DEPARTMENT OF COMMERCE
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`FILING DATE
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`06 July, 2005
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`FIRST NAMED INVENTOR/
`PATENT IN REEXAMINATION
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`10518016
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`2005-07-06
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`First Named Inventor|Amar Lulla
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`STATEMENT BY APPLICANT
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`CIPLA LTD. EXHIBIT 2001 PAGE 10
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`2005-07-06
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`First Named Inventor|Amar Lulla
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`STATEMENT BY APPLICANT
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`1
`
`Office Action dated March 29, 2011 {3 pages) from counterpart application, AU2009243422.
`
`[|
`
`Astelin (azelastine hydrochloride) Nasal Spray, MedPointe Pharmaceuticals, 2006, U.S. Physicians Desk Reference,
`pp. 1876-1877.
`
`Veramyst(fluticasone furoate} Nasal Spray, GlaxoSmithKline, 2007, Summary Sheet, pp. 1-20.
`
`BARNES, PETER J., "Chronic obstructive pulmonary disease: new opportunities for drug development," Trends in
`Pharmacological Sciences, Vol. 19, No. 10, 1998, pp. 415-423.
`
`BARNES, PETER J., "Novel approaches and targets for treatment of chronic obstructive pulmonary disease,"
`American Journal of Respiratory and Critical Care Medicine, Vol. 160, 1999, pp. S$72-S79.
`
`BARNES, PETER J., "Efficacy of inhaled corticosteroids in asthma," The Journal of Allergy and Clinical Immunology,
`Vol. 102, No. 4, 1998, pp. 531-538, 1998.
`
`BOWLER, SIMON, "Long acting beta agonists," AUSTRALIAN FAMILY PHYSICIAN, Vol. 27, No. 12, 1998, pp. 1115,
`1117-1118, plus cover.
`
`KNOBIL, K., et al., "Adding salmeterol is more effective than increasing the dose offluticasone for patients with asthmal
`who are symptomatic on low dosefluticasone," European Respiratory Review, Copenhagen, DK,Vol. 12, Suppl. 29,
`December 1998 (1998-12), pages 195-208.
`
`LUMRY, WILLIAM R., "A review of the preclinical and clinical data of newerintranasal steroids in the treatment of
`allergic rhinitis," Allergy Clin. Immunol., October 1999, 104 (4 Pt 1), pp. $150-5158 plus one correction page.
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`MELTZER, et al., "Onset of therapeutic effect of fluticasone propionate aqueous nasal spray," Ann. Allergy Asthma
`Immunol., 7001, Vol. 86, No. 3, pp. 286-291.
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`MOLLMANN, H., et al., “Handbook of pharmacokinetic / pharmacodynamic correlation, Chapter 14, Pharmacokinetic-
`Pharmacodynamic Correlations of Corticosteroids, 323-336, CRC Press, 1995.
`/Tror Nielsen/
`
`20
`03/15/2012
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/T.N./
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`CIPLA LTD. EXHIBIT 2001 PAGE 11
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`Application Number 10518016
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`Art Unit | 1616
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` Malhotra Exhibit B, August 2011.
`Evolutio
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`INFORMATION DISCLOSURE
`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`ThorB. Nielsen
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`12
`
`NAEDELE-RISHA, R., et al., "Dual components of optimal asthma therapy: scientific and clinical rationale for the use
`of long acting beta-agonists with inhaled corticosteroids," THE JOURNAL OF THE AMERICAN OSTEOPATHIC
`ASSOCIATION, Vol. 101, No. 9, September 2001, pp. 526-533.
`
`O'CONNER, B. J., "Combination therapy," Pulmonary Pharmacology and Therapeutics, Vol. 11, No. 5/6, 1998, pp.
`397-399.
`
`HOLGATE, STEPHEN T., Difficult Asthma, 1999, cover page and publishing information.
`
`PCT/GB01/03495, International Preliminary Examination Report, date of mailing: August 30, 2002.
`
`POPPER, T. L., et al., "Structure-activity relationship of a series of novel topical corticosteroids," Journal of Steroid
`Biochemistry, 1987, Vol. 27, pp. 837-843.
`
`TANAKA,et al., "Synthesis of 4H-furo[3,2-b]indole derivatives. III (1). Preparation of 4H-furo[3,2-b]indole-2-carboxylic
`acid derivatives," Journal Heterocyclic Chemistry, Vol. 16, pp. 785-788, 1979.
`
`UENO,et al., "Synthesis and evaluation of antiinflammatory activities of a series of corticosteroid 17. Alpha - esters
`containing a functional group," JOURNAL OF MEDICINAL CHEMISTRY, AMERICAN CHEMICA SOCIETY, Vol. 34,
`No. 8, August 1991, pp. 2468-2473.
`
`VAN DER MOLEN, et al., "Effects of the long acting beta agonist formoterol on asthma control in asthmatic patients
`using inhaled corticosteroids," Thorax, Vol. 52, No. 6, 1997, pp. 535-539.
`
`Comparative data of azelastine with steroids, 2011.
`
`PETTERSSON, BERTIL, et al., "Re-evaluation of the classical mycoplasma lipophilum cluster (Weisburg, et al., 1989}
`and description of tvo new clusters in the hominis group based on 16S rDNA sequences,"Int'l Journal of Systematic &
`
`EFS Web2.1.17
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`CIPLA LTD. EXHIBIT 2001 PAGE 12
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`CIPLA LTD. EXHIBIT 2001 PAGE 12
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`ThorB. Nielsen
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`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT
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`Thor B. Nielsen
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`INFORMATION DISCLOSURE
`First Named Inventor|AmarLulla
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`STATEMENT BY APPLICANT
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`Thor B. Nielsen
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
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`[|
`Office Action dated March 29, 2011 (3 pages) from counterpart application, AU2009243422.
`1
`
`
`Astelin (azelastine hydrochloride) Nasal Spray, MedPointe Pharmaceuticals, 2006, U.S. Physicians Desk Reference,
`L|
`pp. 1876-1877.
`
`Veramyst(fluticasone furoate) Nasal Spray, GlaxoSmithKline, 2007, Summary Sheet, pp. 1-20.
`
`BARNES, PETER J., "Chronic obstructive pulmonary disease: new opportunities for drug development,” Trends in
`Pharmacological Sciences, Vol. 19, No. 10, 1998, pp. 415-423.
`
`BARNES,PETERJ.,"Novelapproachesandtargetsfortreatmentofchronicobstructivepulmonarydisease,"
`
`American Journal of Respiratory and Critical Care Medicine, Vol. 160, 1999, pp. $72-S79.
`
`je
`
`BARNES, PETER J., "Efficacy of inhaled corticosteroids in asthma," The Journal of Allergy and Clinical Immunology,
`Vol. 102, No. 4, 1998, pp. 531-538, 1998.
`
`BOWLER, SIMON, "Long acting beta agonists," AUSTRALIAN FAMILY PHYSICIAN, Vol. 27, No. 12, 1998, pp. 1115,
`1117-1118, plus cover.
`
`Pharmacodynamic Correlations of Corticosteroids, 323-336, CRC Press, 1995.
`
`KNOBIL, K., et al., "Adding salmeterol is more effective than increasing the doseoffluticasone for patients with asthmal
`who are symptomatic on low dosefluticasone," European Respiratory Review, Copenhagen, DK, Vol. 12, Suppl. 29,
`December 1998 (1998-12), pages 19S-20S.
`
`
`LUMRY, WILLIAM R., "A review of the preclinical and clinical data of newerintranasal steroids in the treatment of
`allergic rhinitis,” Allergy Clin. Immunol., October 1999, 104 (4 Pt 1), pp. $150-S158 plus one correction page.
`
`
`MELTZER, et al., "Onset of therapeutic effect of fluticasone propionate aqueous nasal spray," Ann. Allergy Asthma
`Immunol., 2001, Vol. 86, No. 3, pp. 286-291.
`
`
`MOLLMANN, H., et al., “Handbook of pharmacokinetic / pharmacodynamic correlation, Chapter 14, Pharmacokinetic-
`
`EFS Web2.1.17
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`CIPLA LTD. EXHIBIT 2001 PAGE 17
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`CIPLA LTD. EXHIBIT 2001 PAGE 17
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`INFORMATION DISCLOSURE
`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT (-
`( Not for submission under 37 CFR 1.99)
`
`
`
`Filing Date 2005-07-06
`
`Application Number
`
`10518016
`
`CRT/20632 US (4137-04700)
`
`Attorney Docket Number
`
`
`
`NAEDELE-RISHA, R., et al., "Dual components of optimal asthma therapy: scientific and clinical rationale for the use
`[|
`of long acting beta-agonists with inhaled corticosteroids," THE JOURNAL OF THE AMERICAN OSTEOPATHIC
`12
`ASSOCIATION, Vol. 101, No. 9, September 2001, pp. 526-533.
`
`
`13
`
`O'CONNER,B.J., "Combination therapy,” Pulmonary Pharmacology and Therapeutics, Vol. 11, No. 5/6, 1998, pp.
`397-399.
`
`L]
`
`HOLGATE, STEPHEN T., Difficult Asthma, 1999, cover page and publishing information.
`
`PCT/GB01/03495, International Preliminary Examination Report, date of mailing: August 30, 2002.
`
`POPPER,T.L.,etal.,"Structure-activityrelationshipofaseriesofnoveltopicalcorticosteroids,"JournalofSteroid
`
`Biochemistry, 1987, Vol. 27, pp. 837-843.
`
`je
`
`TANAKA,et al., "Synthesis of 4H-furo[3,2-b]indole derivatives. III (1). Preparation of 4H-furo[3,2-b]indole-2-carboxylic
`acid derivatives," Journal Heterocyclic Chemistry, Vol. 16, pp. 785-788, 1979.
`
`UENO, et al., "Synthesis and evaluation of antiinflammatory activities of a series of corticosteroid 17. Alpha - esters
`containing a functional group," JOURNAL OF MEDICINAL CHEMISTRY, AMERICAN CHEMICA SOCIETY,Vol. 34,
`No. 8, August 1991, pp. 2468-2473.
`
`Evolutionary Microbiology, 2001, Vol. 51, pp. 633-643.
`
`VAN DER MOLEN, etal., "Effects of the long acting beta agonist formotero! on asthma control in asthmatic patients
`using inhaled corticosteroids," Thorax, Vol. 52, No. 6, 1997, pp. 535-539.
`
`
`Comparative data of azelastine with steroids, 2011.
`
`
`
`Malhotra Exhibit B, August 2011.
`
`
`
`PETTERSSON, BERTIL, et al., "Re-evaluation of the classical mycoplasma lipophilum cluster (Weisburg, et al., 1989)
`and description of two new clusters in the hominis group based on 16S rDNA sequences,"Int'l Journal of Systematic & [|
`
`EFS Web2.1.17
`
`CIPLA LTD. EXHIBIT 2001 PAGE 18
`
`CIPLA LTD. EXHIBIT 2001 PAGE 18
`
`
`
`INFORMATION DISCLOSURE
`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`Filing Date 2005-07-06
`
`Application Number
`
`10518016
`
`Attorney Docket Number
`
`CRT/20632 US (4137-04700)
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