UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO.
`APPLICATION NO.
`DATED
`INVENTOR(S)
`
`: 8,168,620 B2
`: 10/518016
`: May 1, 2012
`: Amar Lulla et al.
`
`Page 1of1
`
`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 ofNovember, 2014
`
`Michelle K. Lee
`Deputy Director of the United States Patent and Trademark Office
`
`Exhibit 1002 (Part 1 of 2)
`IPR2017-00807
`ARGENTUM
`
`000001
`
`

`

`Attorney Docket No. CRT/20632 US (4137~04700)
`
`Patent
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFHCE
`
`Patentees:
`
`Amar Lulla, et al.
`
`Patent No.:
`
`8, 168,620 B2
`
`Issued:
`
`May 1, 2012
`
`Foe COMBINATION OF AZELASTINE AND
`STEROIDS
`
`Mail Stop: Certificate of Correction Branch
`Commissioner for Patems
`PO Box 1450
`Alexandria, VA 22313~1450
`
`§
`§
`§
`R s
`§
`§
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`Group Art Unit:
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`Exarnlner: Thor R Nielson
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`Confirmation No.: 4912
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`Pummnt to 37 C. P.R. § J.8, l her~by certify that
`this
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`Patent and Trndemark Office w~!faite, w_w_w_,\!~f'_tQ,gQ\', on
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`=~~~k····························
`
`PETITION FOR CERTIFICATE OF CORRECTION
`.. .............................................. ,..,..,.. .................................... ...
`...................................................................................................................................................................... ,,..
`
`Comm1ssioner:
`
`Patentees hereby request that a Certificate of Correction be issued pursuant to 37 C.F.R.
`
`§L322 and 37 CF.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 Coinmissioncr is
`
`hereby authorized to charge payment of any fees associated with submission of the Certificate of
`
`Correction submitted here'vvlth to Deposit Account 50-1515, Conley Rose, P.C
`
`Respectfully submitted,
`
`ATTORNEY FOR APPLICANTS
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`CONLEY ROSE, P .C.
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`000002
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`

`

`F;1"0/SB/4.4 W9·G?}
`/·\Pf:'f"-NtXi h.x u~":{:~ t.h:tx:~)h 08/3·;/20'13. GMB :)::;5·1.QG3:3
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`
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`
`PATENT NO.
`
`8168620
`
`APPLICAT:ON NO.: 10518016
`
`ISSUE DATE
`
`May i, 2012
`
`IWENTOR(S)
`
`Amar Lulla, Geena Malhotra
`
`It is certified that an error appears or errors appear in the above-identified patent and that said Letters Patent
`
`! is hereby corrected as shown below:
`~
`! ! Column 12, Claim 7, Line 7; Replace: "a suspending agent a thickening agent" with --a suspending agent, a
`
`In the clairns:
`
`thickening agent--
`Column i 2, Claim 10, Lines 20-21: Replace: ''phenyl mercury borate, or benzojc acid" with --phenyl mercury
`borate, benzolc acid--
`Column 13, Claim 24, Lines 19-20; Replace: "dosage form of as a nasal spray" with --dosage form of a nasal
`spray--
`
`(~on!ey f~G8H1 F~.(: .. ; RodnH~:i 8, c:ar:-o!!
`5t)0·1 C3n::nit~:~ ~"}ark~vay. Suite SOO
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`
`000003
`
`

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`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`10518016
`
`06-Jul-2005
`
`Title of Invention:
`
`COMBINATION OF AZELASTINE AND STEROIDS
`
`First Named Inventor/Applicant Name:
`
`Amar Lui la
`
`Filer:
`
`Rodney B. Carroll/Adrianna Krenzer
`
`Attorney Docket Number:
`
`CRT/20632 US (4137-04700)
`
`Filed as Large Entity
`
`U.S. National Stage under 35 USC 371 Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
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`Sub-Total in
`USO($)
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`Basic Filing:
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`Claims:
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`Miscellaneous-Filing:
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`Post-Allowance-and-Post-Issuance:
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`Certificate of Correction
`
`1811
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`1
`
`100
`
`100
`
`Extension-of-Time:
`
`000004
`
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`

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`
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`Total in USO($)
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`100
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`000005
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`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`20178591
`
`10518016
`
`International Application Number:
`
`Confirmation Number:
`
`4912
`
`Title of Invention:
`
`COMBINATION OF AZELASTINE AND STEROIDS
`
`First Named Inventor/Applicant Name:
`
`Amar Lulla
`
`Customer Number:
`
`30652
`
`Filer:
`
`Rodney B. Carroll/Adrianna Krenzer
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`Filer Authorized By:
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`Attorney Docket Number:
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`CRT/20632 US (4137-04700)
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
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`New A~~lications Under 35 U.S.C. 111
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`UNITED STA TES p A TENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
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`www .uspto.gov
`
`APPLICATION NO.
`
`10/518,016
`
`ISSUE DATE
`
`05/01/2012
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`8168620
`
`CRT/20632 US (4137-04700)
`
`4912
`
`7590
`30652
`CONLEY ROSE, P.C.
`5601 GRANITE PARKWAY, SUITE 750
`PLANO, TX 75024
`
`04/11/2012
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`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.
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`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
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`APPLICANT(s) (Please see PAIR WEB site http://pair.uspto.gov for additional applicants):
`
`Amar Lulla, Mumbai, INDIA;
`Geena Malhotra, Mumbai, INDIA;
`
`IR103 (Rev. 10/09)
`
`000008
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`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`10518016
`
`2005-07-06
`
`First Named Inventor
`
`I Amar Lui la
`
`Art Unit
`
`1616
`
`Examiner Name
`
`I Thor B. Nielsen
`
`Attorney Docket Number
`
`CRT/20632 US{4137-04700)
`
`9
`
`4710495
`
`1987-12-01
`
`Bodor
`
`10
`
`5837699
`
`1998-11-17
`
`Sequeira, et al.
`
`11
`
`3755302
`
`1973-08-28
`
`Ercoli, et al.
`
`12
`
`3557162
`
`1971-01-19
`
`Voorschoten, et al.
`
`13
`
`5420120
`
`1995-05-30
`
`Boltralik
`
`14
`
`3828080
`
`1974-08-06
`
`May, et al.
`
`15
`
`5081113
`
`1992-01-14
`
`Claussner, et al.
`
`c h nge(s) <.
`lied
`n ,16
`
`tc
`
`~
`
`J/ 28/2012
`
`4861765
`
`1989-08-29
`
`1 .......... ,,...:---.1
`
`17
`
`4267173
`
`1981-05-12
`
`Draper
`
`18
`
`4221787
`
`1980-09-09
`
`Bodor, et al.
`
`19
`
`5608093
`
`1997-03-04
`
`Stache, et al.
`
`EFS Web 2.1.17
`
`01 /13/2012
`/Thor Nielsen/
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /T.N./
`
`000009
`
`

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`PTO/SB/08a (01-10)
`Doc code: IDS
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`U.S. Patent and Trademark Office; U.S. 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.
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`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`10518016
`
`2005-07-06
`
`First Named Inventor
`
`I Amar Lu Ila
`
`Art Unit
`
`1616
`
`Examiner Name
`
`I Thor B. Nielsen
`
`Attorney Docket Number
`
`CRT/20632 US{4137-04700)
`
`Examiner Cite
`Initial*
`No
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`Patent Number
`
`Kind
`Code1
`
`Issue Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`U.S.PATENTS
`
`Remove
`
`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
`
`c
`
`range
`
`5
`ap
`
`tn
`rlnr11mPn1
`
`4377575
`
`1983-03-22
`
`P"1illi1515s, et al.
`
`~
`
`v
`128/2
`
`6
`
`3856828
`
`1974-12-24
`
`Phillipps, et al.
`
`7
`
`4113680
`
`1978-09-12
`
`Kamano, et al.
`
`8
`
`4093721
`
`1978-06-06
`
`Phillipps, et al.
`
`/Thor Nielseni
`
`Oiii 3/2012
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /T.N./
`
`000010
`
`

`

`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`10518016
`
`2005-07-06
`
`First Named Inventor
`
`I Amar Lui la
`
`Art Unit
`
`1616
`
`Examiner Name
`
`I Thor B. Nielsen
`
`Attorney Docket Number
`
`CRT/20632 US{4137-04700)
`
`46
`
`0154481
`
`WO
`
`2001-08-02
`
`Rohm and Haas
`Company
`
`47
`
`1191965
`
`GB
`
`1970-05-13 Warner-Lambert
`Pharmaceutical Company
`
`48
`
`0048587
`
`WO
`
`2000-08-24
`
`Novartis AG, et al.
`
`c ti ngels) ~ ~~1 ~
`I
`n1 '49
`
`to
`
`~
`
`-
`·-
`,_
`r/ IJ/ LV' L
`
`0104118
`
`WO
`
`2811 81 18
`
`Almirall Prodesfarma S.A.
`
`50
`
`0157025
`
`WO
`
`2001-08-09
`
`Pfizer Products Inc.
`
`D
`
`D
`
`D
`
`D
`
`D
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
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`NON-PATENT LITERATURE DOCUMENTS
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`Examiner Cite
`Initials* No
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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.
`
`T5
`
`1
`
`"Azelastine," STN Registry No. 58581-89-8, STN Registry File, Retrieved 2010-11-23, page 1.
`
`2
`
`"Fluticasone Furoate," STN Registry No. 397864-44-7, STN Registry File, Retrieved 2010-11-23, page 1.
`
`~
`
`-
`
`Astelin (azelastine hydrochloride) Nasal Spray, MedPointe Pharmaceuticals, 2006, U.S. Physicians Desk Reference,
`pp. 1876-1877.
`
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`
`01 /13/2012
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`EFS Web 2.1.17
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`

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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10/518,016
`
`07/06/2005
`
`Amar Lulla
`
`TITLE OF INVENTION: COMBINATION OF AZELASTINE AND STEROIDS
`
`CRT/20632 US
`(4!37-04700)
`
`4912
`
`. APPLN. TYPE
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`COMBINATION OF AZELASTINE AND STEROIDS
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`I Amar Lui la
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`1616
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`I Thor B. Nielsen
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`Examiner Name
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`I Thor B. Nielsen
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`1
`
`Office Action dated March 29, 2011 {3 pages) from counterpart application, AU2009243422.
`
`D
`
`2
`
`Astelin (azelastine hydrochloride) Nasal Spray, MedPointe Pharmaceuticals, 2006, U.S. Physicians Desk Reference, D
`pp. 1876-1877.
`
`3
`
`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. S72-S79.
`
`D
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`D
`
`D
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`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`BARNES, PETER J., "Efficacy of inhaled corticosteroids in asthma," The Journal of Allergy and Clinical Immunology, D
`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, D
`1117-1118, plus cover.
`
`KNOB IL, 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, D
`December 1998 ( 1998-12), pages 19S-20S.
`
`LUMRY, WILLIAM R., "A review of the preclinical and clinical data of newer intranasal steroids in the treatment of
`allergic rhinitis," Allergy Clin. lmmunol., October 1999, 104 (4 Pt 1 ), pp. S150-S158 plus one correction page.
`
`D
`
`D
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`10
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`MELTZER, et al., "Onset of therapeutic effect of fluticasone propionate aqueous nasal spray," Ann. Allergy Asthma
`lmmunol., 2001, Vol. 86, No. 3, pp. 286-291.
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`11
`
`MOLLMANN, H., et al., "Handbook of pharmacokinetic I pharmacodynamic correlation, Chapter 14, Pharmacokinetic- D
`Pharmacodynamic Correlations of Corticosteroids, 323-336, CRC Press, 1995.
`/Thor Nielseni
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`I Amar Lui la
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`1616
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`Examiner Name
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`I Thor B. Nielsen
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`Attorney Docket Number
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`CRT/20632 US (4137-04700)
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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.
`
`13
`
`O'CONNER, B. J., "Combination therapy," Pulmonary Pharmacology and Therapeutics, Vol. 11, No. 5/6, 1998, pp.
`397-399.
`
`14
`
`HOLGATE, STEPHEN T., Difficult Asthma, 1999, cover page and publishing information.
`
`15
`
`PCT/GB01/03495, International Preliminary Examination Report, date of mailing: August 30, 2002.
`
`16
`
`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.
`
`D
`
`D
`
`D
`
`D
`
`D
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`17
`
`TANAKA, et al., "Synthesis of 4H-furo[3,2-b]indole derivatives. Ill {1 ). Preparation of 4H-furo[3,2-b]indole-2-carboxylic D
`acid derivatives," Journal Heterocyclic Chemistry, Vol. 16, pp. 785-788, 1979.
`
`18
`
`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, D
`No. 8, August 1991, pp. 2468-2473.
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`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.
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`D
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`Comparative data of azelastine with steroids, 2011.
`
`21
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`Malhotra Exhibit B, August 2011.
`
`D
`
`D
`
`22
`
`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," lnt'I Journal of Systematic & D
`Evolutionary Microbiology, 2001, Vol. 51, pp. 633-643.
`/Th"'" f\I ;"1~"";
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