UNITED STATES PATENT AND TRADEMARK OFFICE
`
`CERTIFICATE OF CORRECTION
`
`PATENT NO.
`APPLICATION NO.
`
`: 8,168,620 B2
`: 10/518016
`
`DATED
`INVENTOR(S)
`
`: May 1, 2012
`: Amar Lu11a et a1.
`
`Page 1 of1
`
`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 agen --
`
`Column 12, Claim 10, Lines 20-21; Replace: “phenyl mercury borate, or benzoic acid” With --pheny1
`
`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
`
`WMZKLL.
`
`Michelle K. Lee
`
`Deputy Director ofthe United States Patent and Trademark Ojfice
`
`CIPLA LTD. EXHIBIT 2001 PAGE 1
`
`CIPLA LTD. EXHIBIT 2001 PAGE 1
`
`

`

`Attamey flackm‘Na. CRT/22'3632 US (43374343703)
`
`Patent
`
`EN ’ETHE ’UNETED STATES PATENT ANS ’E‘RAEEEEMARK GE‘Ei’ECEE
`
`Group; Art Unit:
`
`16} 6
`
`Exaitiiner: Thor B. Niaismt
`
`Ceitfii‘matian N03 4912
`
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`
`Fat-3m Nil:
`
`8,168,626 E52
`
`issued:
`
`May 1, 2812
`
`Far;
`
`COMBINATION OFAZELASTENE AND
`
`STEROIDS
`
`Maii Stop: Certificate; Of Correction Branch
`Csmmissitmer for Fatems
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`
`Mexamdria, VA 223134450
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`
`Patmtaes hataby request that a Certificate, Of Cormatiou be issued pursuant t0 3‘? CFR.
`
`$.32? and 37 CPR, §L323 to wttect the mistaktas as sat. out in the attached draft cmtificate.
`
`The mistaksa to be: serrated are mimi and editorial in 113mm. The (Ifoinmissitmer is
`
`hereby autimrized t0 charge paymmt of any fees asgociated with submissien of this Certificatt: (if
`
`Comedian Submitttsti herewith to Depasit Acmunt SENSE, Caniey R9355, PC.
`
`Respectfuiiy submittad,
`
` CtiiNifiY RGSE, RC.
`
`‘
`ATTDRNEY FOR APPUCANI‘S
`
`5691 Granite Paikway, Suite 509
`Piane, Texas, ’75824
`(972:) ’73iu2288
`(9'72) 731422.39 (fax)
`
`298033-v1,’4! 37- 0-1730
`
`CIPLA LTD. EXHIBIT 2001 PAGE 2
`
`CIPLA LTD. EXHIBIT 2001 PAGE 2
`
`

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`
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`
`8168520
`
`10518615
`
`May 1, 2812
`
`V!aman
`
`it i5 eefiified that an error appears or errors; appear in the abovmdantified patent and that said Letters {Delight
`53 hereby corrected as Shawn beiow:
`
`
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`CIPLA LTD. EXHIBIT 2001 PAGE 3
`
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`
`CIPLA LTD. EXHIBIT 2001 PAGE 3
`
`
`
`
`
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COlVlMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.mspto.gov
`
`APPLICATION NO.
`
`10/518,016
`
`ISSUE DATE
`
`05/01/2012
`
`30652
`
`7590
`
`04/11/2012
`
`CONLEY ROSE, PC.
`5601 GRANITE PARKWAY, SUITE 750
`PLANO, TX 75024
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`8168620
`
`CRT/20632 US (4137—04700)
`
`4912
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 987 day(s). Any patent to issue from the above-identified application will
`include an indication of the adjustment on the front page.
`
`If a Continued Prosecution Application (CPA) was filed in the above—identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
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`Applicant will be able to obtain more detailed information by accessing the Patent Application Information
`Retrieval (PAIR) WEB site (http://pair.uspto. gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the
`Office of Patent Legal Administration at
`(571)—272—7702. Questions relating to issue and publication fee
`payments should be directed to the Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)—272—4200.
`
`APPLICANT(S) (Please see PAIR WEB site http://pairusptogov for additional applicants):
`
`Amar Ilulla, Mumbai, INDIA;
`Geena Malhotra, Mumbai, INDIA;
`
`1R103 (Rev. 10/09)
`
`CIPLA LTD. EXHIBIT 2001 PAGE 4
`
`CIPLA LTD. EXHIBIT 2001 PAGE 4
`
`

`

`
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`INFORMATION DISCLOSU RE
`
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR 1.99)
`
`
`First Named Inventor
`Amar Lulla
`Art Unit | 1616
`
`Examiner Name
`I CRT/20632 US(4137-04700)
`
` Thor B. Nielsen Attorney Docket Number
`
`
`
`9
`
`4710495
`
`1987-12-01
`
`Bodor
`
`
`
`
`
`
`
`
`
`1998-11-17
`
`Sequeira, et al.
`
`1973-08-28
`
`Ercoli, et al.
`
`1971-01-19
`
`Voorschoten, et al.
`
`1995-05-30
`
`Boltralik
`
`1974-08-06
`
`May, et al.
`
`1992-01-14
`
`1989-08-29
`
`1981 -05-1 2
`
`Claussner, et al.
`
`Mitsuiwcbi et ai.
`Jam-ai—
`
`Bodor, et al.
`
` 1980-09-09
`
`4267173
`
`
`
`17
`
`.Lb/
`28 2012,
`
`C
`
`/ 5
`
`18
`
`4221787
`
`5608093
`
`1997-03-04
`
`Stache, et al.
`
`EFS Web 2.1.17
`
`J'ThO!‘
`ALL
`
`01/13/20.12
`:elsen/
`.
`N'
`REFERENCES CONSiDERED EXCEPT WHERE LiNED THRQUGH.
`
`/Tni\E./
`
`CIPLA LTD. EXHIBIT 2001 PAGE 5
`
`CIPLA LTD. EXHIBIT 2001 PAGE 5
`
`

`

`PTO/saroaa (01-10)
`Doc code' IDS
`Approved for use through 0713112012. OMB 0651-0031
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`Doc description. Information Disclosure Statement (IDS) Filed
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`INFORMATION DISCLOSU RE
`
`
`First Named Inventor
`Amar Lulla
`
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR 1.99)
`
`
`Art Unit
`| 1616
`Examiner Name
`Thor B. Nielsen
`
`Attorney Docket Number
`
`I CRT/20632 US(4137-04700)
`
`
`
`
`
`
`
`
`
`
`U.S.PATENTS
`Remove
`
`Name of Patentee or Applicant Pages,Columns,Lines where
`Kind
`Examiner Cite
`.
`Relevant Passages or Relevant
`.
`.
`*
`Initial
`No
`Code1
`of Cited Document
`.
`Figures Appear
`
`
`Patent Number
`
`Issue Date
`
`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
`
`
`
`5
`,,
`L tange(s) a failed
`
`to
`
`4377575
`
`Staci-is et 33.
`1983-03-22 PHHW
`
`/c
`
`5/
`
`3856828
`1974-12-24
`Phillipps, et al.
`
`
`
`
`
`
`
`
`
`41 13680
`
`1978-09-12
`
`Kamano, et al.
`
`4093721
`
`1978-06-06
`
`Phillipps, et al.
`
`/Thor Nielsen"
`
`01/1 312012
`
`EFSWeb2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED TH RGUGH.
`
`/Tii\i./
`
`CIPLA LTD. EXHIBIT 2001 PAGE 6
`
`CIPLA LTD. EXHIBIT 2001 PAGE 6
`
`

`

`
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`INFORMATION DISCLOSU RE
`
`
`
`
`
`Amar LullaFirst Named Inventor
`
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR 1.99)
`
`
`Art Unit
`| 1616
`Examiner Name
`Thor B. Nielsen
`
`
`
`Attorney Docket Number
`
`I CRT/20632 US(4137-04700)
`
`
`
`46
`
`0154481
`
`WO
`
`2001-08-02
`
`Rohm and Haas
`Company
`
`
`
`
`
`
`
`1191955
`
`0048587
`
`0104118
`
`0157025
`
`19700543
`
`Warner-Lambert
`Pharmaceutical Company
`
`2000-08-24
`
`Novartis AG, et al.
`
`Almirall Prodesfarma S.A.
`
`2001-08-09
`
`Pfizer Products Inc.
`
`D
`
`
`
`
`
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`'
`'
`*
`T5
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s},
`Examlner Clte
`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.
`
`El
`
`
`
`2
`
`"Fluticasone Furoate," STN Registry No. 397864-44—7, STN Registry File, Retrieved 2010-11-23, page 1.
`
`El
`
`
`
`Astelin azelastine h drochloride Nasal Sara , MedPointe Pharmaceuticals, 2006, US. Ph sicians Desk Reference,
`
`.—
`
`
`
`fl‘hor Nielsen/
`
`(31/13/2012
`
`EFSWeb2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED TH RQUGH.
`
`/T,I\E./
`
`CIPLA LTD. EXHIBIT 2001 PAGE 7
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`CIPLA LTD. EXHIBIT 2001 PAGE 7
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`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313- 1450
`www.mspto.gov
`
`APPLICATION NO.
`
`10/518,016
`
`
`
`
`
` F ING DATE
`
`07/06/2005
`
`30652
`
`7590
`
`03/20/2012
`
`CONLEY ROSE, PC.
`5601 GRANITE PARKWAY, SUITE 750
`PLANO, TX 75024
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`Amar Lulla
`
`CRT/20632 US
`(4137—04700)
`
`
`
`CONF {MATION NO.
`
`4912
`
`EXAMINER
`
`
`
`N *LSEN, THOR B
`
`ART UNIT
`
`1616
`
`MAIL DATE
`
`03/20/2012
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this 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
`
`US. Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O.Box1450
`
`Alexandria, Virginia 22313-1450
`
`APPLICATION NO]
`CONTROL NO.
`
`FILING DATE
`
`FIRST NAMED INVENTORI
`PATENT IN REEXAMINATION
`
`ATTORNEY DOCKET NO.
`
`10/518,016
`04700)
`
`06 July, 2005
`
`LULLA ET AL.
`
`CRT/20632 US (4137-
`
`CONLEY ROSE, P.C.
`5601 GRANITE PARKWAY, SUITE 750
`PLANO, TX 75024
`
`EXAMINER
`
`_HORNIELSEN
`
`20120315
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`
`
`ART UNIT PAPER
`
`1616
`
`DATE MAILED:
`
`Please find below and/or attached an Office communication concerning this application or
`proceeding.
`
`Commissioner for Patents
`
`The references identified on the attached Information Disclosure Statement, filed on 02/23/2012, have been considered. TBN
`
`Examiner, Art Unit 1616
`
`/T. N./
`
`PTO-900 (ReV.O4-03)
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`CIPLA LTD. EXHIBIT 2001 PAGE 9
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`CIPLA LTD. EXHIBIT 2001 PAGE 9
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`

`PTOISBIOBa (01-10)
`DOC COde: IDS
`Approved for use through 071'3112012 OMB 0651 0031
`Doc description: Information Disclosure Statement (IDS) Filed
`us. Patent and Trademark Office; us. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`First Named Inventor
`Amar Lulla
`
`Art U .hit I 1616
`
`Examiner Name
`Thor B. Nielsen
`
`I CRT/20632 US (4137-04700)
`
`
`
` Attorney Docket Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Not for submission under 37 CFR 1.99)
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`Remove
`U.S.PATENTS
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`(book. magazme. Journal. serial. symp05ium. catalog, etc). date. pages(s), volume-issue number(s).
`Initials*
`No
`publisher, city and/or country where published.
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`
`,I’Thcr Nielsen/
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`03/15/2012
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`ALL REFERENCES CONSiDERED EXCEPT WHERE LiNED THRQUGH.
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`CIPLA LTD. EXHIBIT 2001 PAGE 10
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`D
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`

`

`
`
`INFORMATION DISCLOSU RE
`
`
`First Named Inventor
`Amar Lulla
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR 1.99)
`
`
`Art Unit
`| 1616
`Examiner Name
`Thor B. Nielsen
`
`
`
`
`
`
`
`Attorney Docket Number
`
`I 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, US. 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. 872-379.
`
`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 of fluticasone for patients with asthma
`who are symptomatic on low dose fluticasone," European Respiratory Review, Copenhagen, DK, Vol. 12, Suppl. 29,
`December 1998 (1998—12), pages 198-208.
`
`LUMRY, WILLIAM R., "A review of the preclinical and clinical data of newer intranasal steroids in the treatment of
`allergic rhinitis," Allergy Clin. Immunol., October 1999, 104 (4 Pt 1), pp. 8150—3158 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—
`Pharmacodynamic Correlations of Corticosteroids, 323—336, CRC Press, 1995.
`
`I’Thor Nietsen/
`
`EFSWeb2.1.17
`
`03/15" - 12
`(:23
`ALL REFERENCES CONStDERED EXCEPT WHERE LtNED TH RQ GH.
`
`/T.I\E./
`
`CIPLA LTD. EXHIBIT 2001 PAGE 11
`
`CIPLA LTD. EXHIBIT 2001 PAGE 11
`
`

`

`
`
`
`Application Number 10518016
`
`Filing Date 2005-07-06
`
`First Named Inventor Amar Lulla
`Art Unit | 1616
`
`Examiner Name
`Thor B. Nielsen
`
` Attorney Docket Number
`
`I CRT/20632 US (4137-04700)
`
`INFORMATION DISCLOSU RE
`
`STATEMENT BY APPLICANT
`
`(Not for submission under 37 CFR 1.99)
`
`
`
`
` Malhotra Exhibit B, August 2011.
`
`
`
`
`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. 516, 1998, pp.
`397-399.
`
`HOLGATE, STEPHEN T., Difficult Asthma, 1999, cover page and publishing information.
`
`PCT/GBO1/03495, 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-furc[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 cf the classical mycoplasma lipophilum cluster (Weisburg, et al., 1989)
`and description of two new clusters in the hominis group based on 168 rDNA sequences," Int'l Journal of Systematic &
`Evolutionary Microbiology, 2001, Vol. 51, pp. 633-643.
`rug-I.
`
`EFS Web 2.1.17
`
`CIPLA LTD. EXHIBIT 2001 PAGE 12
`
`CIPLA LTD. EXHIBIT 2001 PAGE 12
`
`

`

`2005-07-06
`Filing Date
`
`
`Amar Lulla
`First Named Inventor
`
`Art Unit
`| 1616
`
`Examiner Name
`Thor B. Nielsen
`
`Attorney Docket Number
`
`lCRT/20632 US (4137-04700)
`
`
`
` If you wish to add additional non-patent literature document citation information please click the Add button Add
`
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`
`10518016
`Application Number
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`
`INFORMATION DISCLOSU RE
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`STATEMENT BY APPLICANT
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`(Not for submission under 37 CFR 1.99)
`
`
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`EXAMINER SIGNATURE
` Examiner Signature
`[mgr Nielsen/
`Date Considered
`*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 wvwv.USPTO.GOV or MPEP 901.04. 2 Enter office that issued the document, by the two-letter code (WIPO
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`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible.
`5 Applicant is to place a check mark here if
`English language translation is attached.
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`EFSWeb2.1.17
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`ALI. REFERENCES CONSIDERED EXCEPT WHERE LINED TH RGUGH.
`
`/T.I\E./
`
`CIPLA LTD. EXHIBIT 2001 PAGE 13
`
`CIPLA LTD. EXHIBIT 2001 PAGE 13
`
`

`

`
`Art Unit
`| 1616
`Examiner Name
`Thor B. Nielsen
`
`Attorney Docket Number
`
`lCRT/20632 US (4137-04700)
`
`
`
`
`
`
`
`
`Application Number
`10518016
`
`
`Filing Date
`2005-07-06
`
`INFORMATION DISCLOSU RE
`
`
`
`
`
`Amar LullaFirst Named Inventor
`
`STATEMENT BY APPLICANT
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`(Not for submission under 37 CFR 1.99)
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`03/15/2012
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`EFSWeb2.1.17
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`ALL REFERENCES CONSiDERED EXCEPT WHERE LiNED TH ROUGH.
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`/T.l\i./
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`CIPLA LTD. EXHIBIT 2001 PAGE 14
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`CIPLA LTD. EXHIBIT 2001 PAGE 14
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`03/15/2012
`/Thor Nielsen/
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`EFS Web 2.1.17
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`ALI. REFERENCES CONSIDERED EXCEPT WHERE LINED THRQUGH.
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`/T.I\E./
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`CIPLA LTD. EXHIBIT 2001 PAGE 15
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`Application Number
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`10518016
`
`INFORMATION DISCLOSU RE
`
`
`
`
`
`Amar LullaFirst Named Inventor
`
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`Art Unit
`
`1616
`
`
`Attorney Docket Number
`CRT/20632 US (-413704700)
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`

`INFORMATION DISCLOSU RE
`
`STATEMENT BY APPLICANT
`( Not for submissmn under 37 CFR 1.99)
`
`
`
`Application Number
`10518016
`Filing Date 2005-07-06
`First Named Inventor
`Amar Lulla
`Art U .
`
`CRT/20632 US (-413704700)
`
`Attorney Docket Number
`
`
`
`Office Action dated March 29, 2011 (3 pages) from counterpart application, AU2009243422.
`
`|:|
`
`
`
`Astelin (azelastine hydrochloride) Nasal Spray, MedPointe Pharmaceuticals, 2006, US. Physicians Desk Reference,
`pp. 1876—1877.
`
`D
`
`Veramyst (fluticasone furoate) Nasal Spray, GlaxoSmithKline, 2007, Summary Sheet, pp. 1—20.
`
`Pharmacodynamic Correlations of Corticosteroids, 323-336, CRC Press, 1995.
`
`MOLLMANN, H., et al., “Handbook of pharmacokinetic / pharmacodynamic correlation, Chapter 14, Pharmacokinetic-
`
`EFS Web 2.1.17
`
`CIPLA LTD. EXHIBIT 2001 PAGE 17
`
`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," H
`
`American Journal of Respiratory and Critical Care Medicine, Vol. 160, 1999, pp. 872-879.
`
`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 of fluticasone for patients with asthma
`who are symptomatic on low dose fluticasone," European Respiratory Review, Copenhagen, DK, Vol. 12, Suppl. 29,
`December 1998 (1998—12), pages 198—208.
`
`D
`
`LUMRY, WILLIAM R., "A review of the preclinical and clinical data of newer intranasal steroids in the treatment of
`allergic rhinitis," Allergy Clin. Immunol., October 1999, 104 (4 Pt 1), pp. 8150—8158 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.
`
`
`CIPLA LTD. EXHIBIT 2001 PAGE 17
`
`

`

`INFORMATION DISCLOSU RE
`
`STATEMENT BY APPLICANT
`( Not for submissmn under 37 CFR 1.99)
`
`
`
`Application Number
`10518016
`Filing Date 2005-07-06
`First Named Inventor
`Amar Lulla
`Art U .
`
`CRT/20632 US (-413704700)
`
`Attorney Docket Number
`
`
`
`NAEDELE-RISHA, R., et al., "Dual components of optimal asthma therapy: scientific and clinical rationale for the use
`12
`of long acting beta-agonists with inhaled corticosteroids," THE JOURNAL OF THE AMERICAN OSTEOPATHIC
`|:|
`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.
`
`D
`
`HOLGATE, STEPHEN T., Difficult Asthma, 1999, cover page and publishing information.
`
`PCTIGBO1l03495, International Preliminary Examination Report, date of mailing: August 30, 2002.
`
`POPPER,T.L.,etal.,"Structure—activityrelationshipofaseriesofnoveltopicalcorticosteroids,"JournalofSteroid H
`
`Biochemistry, 1987, Vol. 27, pp. 837-843.
`
`TANAKA, et al., "Synthesis of 4H—furo[3,2—b]indole derivatives. Ill (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.
`
`D
`
`Comparative data of azelastine with steroids, 2011.
`
`
`
`Malhotra Exhibit B, August 2011.
`
`
`
`PETTERSSON, BERTIL, et al., "Re-evaluation of the classical mycoplasma Iipophilum cluster (Weisburg, et al., 1989)
`and description of two new clusters in the hominis group based on 168 rDNA sequences," Int'l Journal of Systematic &
`Evolutionary Microbiology, 2001, Vol. 51, pp. 633-643.
`
`EFS Web 2.1.17
`
`CIPLA LTD. EXHIBIT 2001 PAGE 18
`
`CIPLA LTD. EXHIBIT 2001 PAGE 18
`
`

`

`Application Number
`
`10518016
`
`
`
`Filing Date 2005-07-06
`
`INFORMATION DISCLOSU RE
`
`First Named Inventor
`
`Amar Lulla
`
`STATEMENT BYAPPL'CANT
`
`( Not for submission under 37 CFR 1.99)
`
`Attorney Docket Number
`
`CRT/20632 US (-413704700)
`English language translation is attached.
`
`
`
`If you wish to add additional non-patent literature document citation information please click the Add button Add
`EXAMINER SIGNATURE
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`Examiner Signature Date Considered
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`*EXAMINER: Initial if reference considered, wheth