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UNITED STATES PATENT AND TRADEMARKOFFICE
`
`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
`
`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
`

`
`§T
`
`T
`
`CERTINICATEOFFILING
`
`
`correspondence is being electronically submitted to the 1.5.
`
`
`Patent and Trademark Office website, www_uspio.eoy, On
`
`_SNANDICNAINNANANNENNNAANTEAR
`
`Patentees:
`
`Amar Lalla, et al.
`
`Patent No.
`
`=, 168,620 BZ
`
`issued:
`
`May 1, 2012
`
`For
`
`COMBINATION OF AZELASTINE AND
`STEROIDS
`
`Mail Stop: Certificate of Correction Branch
`Commussioner for Patents
`FPO Box 1456
`Alexandria, VA 97313-1450
`
`PETITIONFORCERTIBICATEOFCORRECTION
`
`COnmimissioner:
`
`Patentees hereby request that a Certificate of Correction be issued pursuant to 37 CPLR.
`
`$1,322 and 37 C.E.R. $1.323 to correct the mistakes as set out in the attached draft certificate,
`
`The mistakes to be corrected are minor and editorial in nature. The Commissioner is
`
`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.
`
`Respectfully submitied,
`
` CONLBY Ross, PC,
`
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`ATTORNEY FOR APPLICANTS
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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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`
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`
`ISSUE DATE
`
`
`
`POLEDDTPECTEDEECRAREOTERTMAEEESEEEEED
`POPPPLEDLPLEEPLOLPPLEEDPEEDPLELELEDEEDEDEES
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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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`
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`AMAOEOLPEALALLOLPPPPOPPLAPLEEPEPELLEDPOEDDETTETEDEELESELLLLES
`
`CIPLA LTD. EXHIBIT 2001 PAGE3
`
`CIPLA LTD. EXHIBIT 2001 PAGE 3
`
`
`
`
`
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 223 13-1450
`Www. uspto.gov
`
`APPLICATION NO.
`
`10/518,016
`
`ISSUE DATE
`
`05/01/2012
`
`30652
`
`7590
`
`04/11/2012
`
`CONLEYROSE,P.C.
`5601 GRANITE PARKWAY,SUITE 750
`PLANO,TX 75024
`
`PATENTNO.
`
`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
`
`8168620
`
`CRT/20632 US (4137-04700)
`
`4912
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`The projected patent numberand issue date are specified above.
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`ISSUE NOTIFICATION
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`Determination of Patent Term Adjustment under 35 U.S.C, 154 (b)
`(application filed on or after May 29, 2000)
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`The Patent Term Adjustment is 987 day(s). Any patent to issue from the above-identified application will
`include an indication of the adjustmenton the front page.
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`APPLICANT(s) (Please see PAIR WEBsite http://pair.uspto.gov for additional applicants):
`
`Amar T.ulla, Mumbai, INDIA:
`Geena Malhotra, Mumbai, INDIA;
`
`IR103 (Rev. 10/09)
`
`CIPLA LTD. EXHIBIT 2001 PAGE 4
`
`CIPLA LTD. EXHIBIT 2001 PAGE 4
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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
`
`ThorB. Nielsen Attorney Docket Number
`| 1616
`
`INFORMATION DISCLOSURE
`
`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
`
`CIPLA LTD. EXHIBIT 2001 PAGE 5
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`
`
`CIPLA LTD. EXHIBIT 2001 PAGE 5
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`PTO/SB/08a (01-10)
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`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`INFORMATION DISCLOSURE First Named Inventor|AmarLulla
`
`
`STATEMENT BY APPLICANT
`
`Ant Uninit | 1616
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`TheorB. Nielsen
`
`
`
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`
`
`
`
`
`Attorney Docket Number | CRT/20632 US(4137-04700)
`
`
`
`
`
`
`
`
`U.S.PATENTS
`Remove
`
`Nameof Patentee or Applicant Pages,Columns,Lines where
`Kind
`Examiner] Cite
`.
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`ae
`ie
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`Cade
`of cited Document
`.
`Figures Appear
`
`
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`
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`1
`
`4198403
`
`1980-04-15
`
`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
`
`1978-09-12
`
`Kamano, etal.
`
`4093721
`
`1978-06-06
`
`Phillipps, et al.
`
`‘Thor Nieisen/
`
`01/43/2042
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/T.N./
`
`CIPLA LTD. EXHIBIT 2001 PAGE 6
`
`CIPLA LTD. EXHIBIT 2001 PAGE 6
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`

`

`
`
`
`
`Attorney Docket Number
`
`| CRT/20632 US(4137-04700)
`
`
`
`
`
`
`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
`If you wish to add additional Foreign Patent Documentcitation information please click the Add button
`NON-PATENT LITERATURE DOCUMENTS Remove
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`Include name of the author (in CAPITAL LETTERS),title of the article (when appropriate},title of the item
`TS
`(book, magazine,journal, serial, symposium, catalog, etc}, date, pages(s), volume-issue number(s},
`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.
`
`|
`
`
`
`"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/
`
`C14 3/e012
`
`EFS Web2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/T.N./
`
`CIPLA LTD. EXHIBIT 2001 PAGE 7
`
`
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`INFORMATION DISCLOSURE
`
`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`Art Unit
`
`| 1616
`
`Examiner Name
`
`ThorB. Nielsen
`
`
`
`CIPLA LTD. EXHIBIT 2001 PAGE 7
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
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`www.uspto.gov
`
`APPLICATION NO.
`
`10/518,016
`
`
`
` FILING DATE
`
`07/06/2005
`
`30652
`
`7590
`
`03/20/2012
`
`CONLEYROSE,P.C.
`5601 GRANITE PARKWAY,SUITE 750
`PLANO,TX 75024
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`Amar Lulla
`
`CRT/20632 US
`(4137-04700)
`
`
`
`CONFIRMATION NO.
`
`4912
`
`EXAMINER
`
`
`
`NIELSEN, THOR B
`
`ART UNIT
`
`1616
`
`MAIL DATE
`
`03/20/2012
`
`PAPER NUMBER
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`DELIVERY MODE
`
`PAPER
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`Please find below and/or attached an Office communication concerningthis application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`CIPLA LTD. EXHIBIT 2001 PAGE 8
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`CIPLA LTD. EXHIBIT 2001 PAGE 8
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`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`U.S. Patent and Trademark Office
`Address : COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`APPLICATION NO./
`CONTROL NO.
`10/518,016
`04700)
`
`FILING DATE
`
`06 July, 2005
`
`FIRST NAMED INVENTOR/
`PATENT IN REEXAMINATION
`LULLAET AL.
`
`ATTORNEY DOCKETNO.
`
`CRT/20632 US (4137-
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`EXAMINER
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`20120315
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`CONLEY ROSE, P.C.
`5601 GRANITE PARKWAY,SUITE 750
`PLANO, TX 75024
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`The references identified on the attached Information Disclosure Statement, filed on 02/23/2012, have been considered. TBN
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`Commissionerfor Patents
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`Examiner, Art Unit 1616
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`/IT.NA/
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`PTO-90C (Rev.04-03)
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`PTO/SB/08a (01-10)
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`10518016
`Application Number
`
`
`2005-07-06
`Filing Date
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`
`First Named Inventor|Amar Lulla
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`Examiner Name
`ThorB. Nielsen
`
`Art Unit
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`| 1616
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`Attorney Docket Number | CRT/20632 US (4137-04700)
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`CIPLA LTD. EXHIBIT 2001 PAGE 10
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`CIPLA LTD. EXHIBIT 2001 PAGE 10
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`

`
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`First Named Inventor|Amar Lulla
`
`Art Unit
`
`| 1616
`
`
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`
`
`
`
`
`Examiner Name
`
`Thor B. Nielsen
`
`Attorney Docket Number
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`| CRT/20632 US (4137-04700)
`
`
`
`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.
`
`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.
`
`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.
`
`/T.N./
`
`EFS Web 2.1.17
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`CIPLA LTD. EXHIBIT 2001 PAGE 11
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`CIPLA LTD. EXHIBIT 2001 PAGE 11
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`
`
`
`
`Application Number 10518016
`
`
`
`Filing Date 2005-07-06
`
`
`
`Art Unit | 1616
`
`
` Malhotra Exhibit B, August 2011.
`Evolutio
`
`INFORMATION DISCLOSURE
`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`ThorB. Nielsen
`
` Attorney Docket Number
`
`| CRT/20632 US (4137-04700)
`
`
`
`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
`
`CIPLA LTD. EXHIBIT 2001 PAGE 12
`
`CIPLA LTD. EXHIBIT 2001 PAGE 12
`
`

`

`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`
`
`
`Art Unit
`
`| 1616
`
` If you wish to add additional non-patentliterature documentcitation information please click the Add button Add
`
`
`
`
`
`INFORMATION DISCLOSURE
`First Named Inventor|Amar Lulla
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`ThorB. Nielsen
`
`Attorney Docket Number
`
`| ert/20632 US (4137-04700)
`
`Examiner Signature
`
`
`
`Date Considered
`
`‘Thor Nielsen/
`
`EXAMINER SIGNATURE
`
`“EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
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`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP 901.04. 2 Enteroffice that issued the document, by the two-letter code (WIPO
`Standard ST.3). * For Japanese patent documents,the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible.
`5 Applicantis to place a check mark hereif|
`English language translation is attached.
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/T.N./
`
`CIPLA LTD. EXHIBIT 2001 PAGE 13
`
`CIPLA LTD. EXHIBIT 2001 PAGE 13
`
`

`

`
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`
`
`Art Unit
`
`| 1616
`
`
`
`
`
`
`
`INFORMATION DISCLOSURE
`
`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`Thor B. Nielsen
`
`Attorney Docket Number
`
`| ert/20632 US (4137-04700)
`
`Please see 37 CFR 1.97 and 1.98 to makethe appropriate selection(s}:
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`CERTIFICATION STATEMENT
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`That no item of information contained in the information disclosure statement was cited in a communication from a
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`anyindividual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
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`[_] See attached certification statement.
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`‘Thor Nieisen/
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`03/15/2012
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`EFS Web2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/T.N./
`
`CIPLA LTD. EXHIBIT 2001 PAGE 14
`
`CIPLA LTD. EXHIBIT 2001 PAGE 14
`
`

`

`Privacy Act Statement
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`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised
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`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
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`/Thor Nielsen/
`
`03/15/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/T.N./
`
`EFS Web 2.1.17
`
`CIPLA LTD. EXHIBIT 2001 PAGE 15
`
`CIPLA LTD. EXHIBIT 2001 PAGE 15
`
`

`

`PTO/SB/08a (01-10)
`Doc code: IDS
`Approved for use through 07/31/2012. OMB 0651-0031
`.
`:
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`age
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Doc description: Information Disclosure Statement (IDS) Filed
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OMB control number.
`
`Application Number
`
`10518016
`
`INFORMATION DISCLOSURE
`First Named Inventor|AmarLulla
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Art Unit
`
`1616
`
`Examiner Name
`
`Thor B. Nielsen
`
`CRT/20632 US (4137-04700)
`Attorney Docket Number
`
`
`Examiner] Cite
`ate
`Initial
`No
`
`Patent Number
`
`Kind
`Code"
`
`Issue Date
`
`Nameof Patentee or Applicant Pages,Columns,Lines where
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`Relevant Passages or Relevant
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`:
`Figures Appear
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`If you wish to add additional U.S. Patent citation information please click the Add button.
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`Remove
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`Initial”
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`Cite No Publication
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`If you wish to add additional U.S. Published Application citation information pleaseclick the Add button. Add
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`Examiner] Cite|Foreign Document Kind|Publication ameofPatentee Or|where RelevantCountry
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`Remove
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`Examiner) Cite
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`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, pages(s), volume-issue number(s),
`publisher, city and/or country where published.
`
`EFS Web2.1.17
`
`CIPLA LTD. EXHIBIT 2001 PAGE 16
`
`CIPLA LTD. EXHIBIT 2001 PAGE 16
`
`

`

`Application Number
`10518016
`Filing Date 2005-07-06
`INFORMATION DISCLOSURE
`First Named Inventor|Amar Lulla
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`CRT/20632 US (4137-04700)
`
`Attorney Docket Number
`
`
`
`[|
`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
`
`CIPLA LTD. EXHIBIT 2001 PAGE 17
`
`CIPLA LTD. EXHIBIT 2001 PAGE 17
`
`

`

`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)
`English languagetranslation is attached.
`
`
`If you wish to add additional non-patentliterature documentcitation information please click the Add button Add
`EXAMINER SIGNATURE
`
`
`
`Examiner Signature Date Considered
`
`*EXAMINER:Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line

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