`
`
`EXHIBIT 1007(A)
`EXHIBIT 1007(A)
`
`

`

`UNITED STA TES p A TENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria., Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/661,720
`
`03/18/2015
`
`AmarLULLA
`
`7590
`30652
`CONLEY ROSE, P.C.
`5601 GRANITE PARKWAY, SUITE500
`PLANO, TX 75024
`
`05/07/2015
`
`CRT/20632HUS
`(4137-04708)
`
`2856
`
`EXAMINER
`
`NIELSEN, THOR B
`
`ART UNIT
`
`PAPER NUMBER
`
`1616
`
`MAIL DATE
`
`DELIVERY MODE
`
`05/07/2015
`
`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)
`
`

`

`Application No.
`14/661,720
`
`Applicant(s)
`LULLA ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`Examiner
`THOR NIELSEN
`
`Art Unit
`1616
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`1 )~ Responsive to communication(s) filed on 03/25/2015.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)O This action is FINAL.
`2b)~ This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ; the restriction requirement and election have been incorporated into this action.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)~ Claim(s) 1-30 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 1-30 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:ilwww.usoto.gov/patents/init events/pph/index.isp or send an inquiry to PPHfeedback(wuspto.aov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)O All b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment{s)
`1) 0 Notice of References Cited (PTO-892)
`
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date __ .
`
`3) ~ Interview Summary (PTO-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20150504
`
`

`

`Application/Control Number: 14/661, 720
`Art Unit: 1616
`
`Page 2
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`Status of Claims and Examination
`
`The application was filed on March 18, 2015 with a Track One request. Claims
`
`1-14 are directed to a method for the treatment of seasonal allergic rhinitis were
`
`presented. Claims 1-15 are directed to a method for minimizing symptoms of seasonal
`
`allergic rhinitis.
`
`The Track One request was granted on April 8, 2015.
`
`The application was accompanied by eight Information Disclosure forms.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
`
`patenting rejection is appropriate where the claims at issue are not identical, but at least
`
`one examined application claim is not patentably distinct from the reference claim(s)
`
`because the examined application claim is either anticipated by, or would have been
`
`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
`
`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
`
`

`

`Application/Control Number: 14/661, 720
`Art Unit: 1616
`
`Page 3
`
`1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); and In re Thorington, 418 F.2d 528,163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the reference application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
`
`activities undertaken within the scope of a joint research agreement. A terminal
`
`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
`
`determine what form should be used. A web-based eTerminal Disclaimer may be filled
`
`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`requirements is auto-processed and approved immediately upon submission. For more
`
`information about eTerminal Disclaimers, refer to
`
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
`
`A.
`
`Claims 1-30 are rejected as the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-2, 4-18, 21-22, 24-26, 28-31, 33, and 35-48 of U.S. Patent
`
`No. 8,168,620. Although the claims at issue are not identical, they are not patentably
`
`distinct from each other because the conflicting claims are drawn to compositions
`
`

`

`Application/Control Number: 14/661, 720
`Art Unit: 1616
`
`Page 4
`
`having the instantly claimed ingredients and are indicated for use for nasal
`
`administration for treatment.
`
`B.
`
`Claims 1-30 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-2, 4-13, and 15-28 of U.S. Patent No. 8,163,723. Although
`
`the claims at issue are not identical, they are not patentably distinct from each other
`
`because the conflicting claims are drawn to a method for the prophylaxis or treatment in
`
`a mammal of a condition for which administration of one or more anti-histamines is
`
`indicated and recites the same active ingredients.
`
`Information Disclosure Statements
`
`Some references were cited without a year of public disclosure. These
`
`references are marked "no date" in the annotated Information Disclosure Statements. A
`
`date is required as part of the disclosure process.
`
`The Examiner notes that some references again submitted in Information
`
`Disclosure Statements were not legible in whole or in part. Among these, but not limited
`
`to these, are DeWester et al., Allergy and Asthma Proc 24: 331 (2003), Opponent's
`
`Submission Pursuant to Rule 116 (EPC) regarding European Patent 1 519 731, and
`
`Pettersson et al., Int J Systematic and Evolutionary Microbial 51: 633 (2001 ). Moreover,
`
`duplicate references were submitted in several instances including, but certainly not
`
`limited to a copy of a USPTO office action for application 12/374,523 mailed 07/06/2011
`
`and J Allergy Clin lmmunol Abstracts S440 Jan 1997.
`
`

`

`Application/Control Number: 14/661, 720
`Art Unit: 1616
`
`Page 5
`
`Conclusion
`
`Claims 1-30 are rejected.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to THOR NIELSEN whose telephone number is (571 )270-
`
`3476. The examiner can normally be reached on Monday through Friday from 9:00
`
`A.M. to 5:00 P.M.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Sue X. Liu can be reached on 571-272-5539. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Thor Nielsen/
`Patent Examiner
`Au 1616
`
`

`

`Application/Control Number: 14/661, 720
`Art Unit: 1616
`
`/SUE LIU/
`
`Supervisory Patent Examiner, Art Unit 1616
`
`Page 6
`
`

`

`
`
`
`EXHIBIT 1007(B)
`EXHIBIT 1007(B)
`
`

`

`Examiner-Initiated Interview Summary
`
`Application No.
`
`14/661,720
`
`Examiner
`
`THOR NIELSEN
`
`Applicant(s)
`
`LULLA ET AL.
`
`Art Unit
`
`1616
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) THOR NIELSEN.
`
`(2) Mr. Rodney Carroll. for the Applicant.
`
`(3) __ .
`
`(4) __ .
`
`Date of Interview: 21 April 2015.
`Type: ~ Telephonic D Video Conference
`D Personal [copy given to: D applicant
`Exhibit shown or demonstration conducted: D Yes
`If Yes, brief description: __ .
`
`D applicant's representative]
`
`□ No.
`
`Issues Discussed 0101 D112 0102 0103 □ Others
`(For each of the checked box( es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: __ .
`
`Identification of prior art discussed: __ .
`
`Substance of Interview
`(For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a
`reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc ... )
`
`The Examiner called to explain Obviousness-type Double Patenting reiections over US Patent Nos. 8. 168. 620 and
`8. 163. 723 and to request filing of Terminal Disclaimers over the cited patents. The Examiner was advised that the
`client would be contacted. The initial call was followed up on April 29. 2015 and May 1. 2015. Mr. Carroll
`subsequently said that he intended to file an additional Information Disclosure Statement. The presence of illegible
`references in previously-filed Information Disclosure Statements was discussed. It was agreed that no Terminal
`Disclaimers were immediately forthcoming and that an Action should be filed.
`
`Applicant recordation instructions: It is not necessary for applicant to provide a separate record of the substance of interview.
`
`Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of
`the substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the
`general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the
`general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.
`
`D Attachment
`
`/THOR NIELSEN/
`Examiner, Art Unit 1616
`
`U.S. Patent and Trademark Office
`PTOL-413B (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20150504
`
`

`

`
`
`
`EXHIBIT 1007(C)
`EXHIBIT 1007(C)
`
`

`

`A.tty Docket: CRT/20632HUS (4137-04708)
`
`Patent
`
`IN THE UNITED S"fATES PATENT AND TRADEMARK OFFICE
`
`Applicant:
`
`Cipla Limited
`
`Serial No.:
`
`14/661,720
`
`Filed:
`
`rvfarch 18, 2015
`
`For:
`COMBINATION OF AZELASTINE AND
`FLUTlCASONE FOR NASAL ADMINISTRATION
`
`Group Art Unit:
`
`1616
`
`Examiner:
`
`Thor B. Nielsen
`
`Confirmation No,: 2856
`
`Mail Stop: Amendment
`Commissioner for Patents
`PO Box 1450
`Alexandria, VA 22313-1450
`
`CER'IlFICATE OF EFS-WEB FILING
`
`Pursuant to 37 CFR § l .8, r hereby certify ,hat this
`correspondence is being electronically submitted lo the
`and
`Trademark Office website,
`U.S.
`Patent
`www.t1sp!o.gov, on
`
`Dear Sir:
`
`AMEND:MENTS AND RESPONSE TO
`01:TFICE ACTION DATED l.VlAY 7. 2015
`
`In response to the Office Action dated May 7, 2015 (hereinafter the "Office Action''),
`
`Applicant respectfully requests the followiug amendmeuts to the above-identified application as
`
`follows. The changes made are shown by underlining the added text and striking through the
`
`deleted text
`
`Amendments to the Claims are reflected in the listing of claims, ,vhich begins on page 2
`
`of this paper.
`
`Remarks/ Arguments begin on page 9 of this paper.
`
`329455-v2/4137-04708
`
`--1 ··
`
`

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`
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`
`

`

`21 ..
`
`(()rig;ir1al)
`
`]~he 1r1ethod. of clairn
`
`((Jrl gi .n al)
`
`··rhe rr1ethotl of clairn 15, \:vl1e.re.in the fo11111.1la.tior1 ct1.rnpr1ses edetate
`
`(().r.lginal)
`
`

`

`H1
`
`:29.
`
`si)ray forrr1l1iatior1 corn.:pr.is.in~1:
`
`7
`
`

`

`({)riginal)
`
`f()rrnulation 1s co11tained
`
`

`

`Stat.e1r1e.r1t t]led
`
`l.J.fJdttted
`
`refere11ces are subro1tte{1
`
`of the-
`
`f)isc~losu.re
`
`flrese11t flate11t arJl)lication:
`
`(:cn1r1tercla.in1s
`
`this case are
`
`

`

`rtjec.ted Oll
`
`'
`g)'(}tlflO of 11011stat11to.ry
`
`as
`
`

`

`Atty Docket: CRT/20632HUS (4137~04708)
`
`Patent
`
`CONCLUSION
`
`Consideration of the foregoing ame11dments and remarks, reconsideration of the
`
`application, and withdrawal of the rejections are respectfully requested by Applicant No new
`
`matter is introduced by way of the amendment It is believed that each ground of rejection raised
`
`in the Office Action dated May 7, 2015 has been fully addressed. If any fee is due as a result of the
`
`filing of this paper, please appropriately charge such foe to Deposit Account Number 50-1515 of
`
`Conley Rose, P.C., Texas. If a petition for extension of time is necessary in order for this paper to
`
`be deemed timely filed, please consider this a petition therefore.
`
`If a telephone conference would facilitate the resolution of any issue or expedite the
`
`prosecution of the applkatfo.n, the Examiner is invited to telephone the undersigned at the
`
`telephone number given below.
`
`Respectfully submitted,
`CONLEY ROSE, P,C.
`
`A TIORNEY FOR APPLICAN"T
`
`Date:
`
`5601 Granite Parkr;vay, Suite 500
`Plano, Texas 75024
`(972) 731-2288 (Telephone)
`(972) 731-2289 (Facsimile)
`
`329455-v2i4137--04708
`
`- 11 ..
`
`

`

`
`
`
`EXHIBIT 1007(D)
`EXHIBIT 1007(D)
`
`

`

`Atty Docket: CRT!20632HUS (4137-04708)
`
`Patent
`
`lN THE UNITED STATES PATE1¾7T AND TRADElvl..t-\.RK OFFICE
`
`Applicant:
`
`Cipla Limited
`
`Serial No,:
`
`l4i661,720
`
`Filed;
`
`March 18, 2015
`
`For:
`COMBINATION OF AZELASTINE AND
`FLUTICASOJ\i"'E FOR NASAL .ADMINISTRATION
`
`§
`§
`§
`§
`§
`§
`§
`§
`
`Group Art Unit:
`
`1616
`
`Examiner:
`
`Thor B. Nielsen
`
`Confirmation No,: 2856
`
`Mail Stop: Arnendrnent
`Commissioner for Patents
`PO Box 1450
`Alexandria, VA 22313-1450
`
`Pursuant to 37 CFR § 1.8, { hereby certify ,hat this
`ccme~pondencc is being electronically submitted lo I.he
`U.S.
`Patent
`and
`Trademark Office
`,vebsitc,
`www.uspto.gov, on
`
`! 1:::: l I{/-{! :5""
`~it.~tc ~~irV~i.1.i~k~'-ll
`------- <:;:::~l:tt::l_~---_ gl.E.k ________________ __
`
`-------------------------
`
`Ed.ith S. Shek
`
`-. . ......
`
`Dear Sir:
`
`SUPPLElvIENTAL RESPONSE TO
`OFFICE ACTlON DA,TED !>di\ Y 7, 2015
`
`Further to the response to Office A.ction filed August 7, 2015 and the Examiner's Interview
`
`of October 7, 2015, Applicant respectfully submits this Supplemental Response in the above(cid:173)
`
`identified application as proposed by the Examiner.
`
`A Listing of CJahns begins on page 2 of this paper.
`
`Remarks/Arguments begin on page 8 of this paper.
`
`352016-vl/4 ! 37-04708
`
`

`

`Atty Docket: CRT/20632HUS (4!37°04708)
`
`Patent
`
`LISTING OJ' CLAIMS
`
`L
`
`(Original)
`
`A method for the treatment of seasonal allergic rhinitis, comprising
`
`administration of a therapeutically effective amount of a nasal spray fonnulation compris111g:
`
`from CL001 % (weight/weight) to 1 % (weight/weight) of azelastine hydrochloride;
`
`frorn 0.0357% (weight/weight) to LYJ{; (weight/weight) of tluticasone propionate;
`
`one or more preservatives;
`
`011e or rnore thickening agents;
`
`one or more surfactants; and
`
`one or more isotonization agents.
`
`2,
`
`6.5,
`
`3,
`
`4.
`
`(Original)
`
`The method of claim l, wherein the fom1ulation has a pH of 4.5 to about
`
`(Original)
`
`The method of claim 1, Vv'herein the fommlation is an aqueous suspension.
`
`(Original)
`
`The method of claim 1, wherein the one or more preservatives comprise
`
`from 0,002% (vv'eight/weight) to 0.05 1~'6 (weight/weight) of edetate disodiurn and from 0,002%
`
`(weight/weight) to 0,05% (weight/weight) of benzalkonium chloride.
`
`5.
`
`(Original)
`
`The method of claim 1, wherein the one or more lhickening agents comprise
`
`microcrvstalline cellulose and carboxvmethyl cellulose sodium.
`
`•
`
`✓
`
`•
`
`6.
`
`(Original)
`
`The method of claim 1, wherein the one or more surfactants comprise
`
`polysorbate 80.
`
`(Original)
`
`The method of claim 1, wherein the one or more isotonization agents
`
`comprise from 2.3% (weight/vveight) to 2,6% (weight/weight) of glycerine.
`
`(Original)
`
`The method of claim 4, wherein the one or more preservatives further
`
`comprise 0.25% (weight/weight) of phenyl ethyl alcohot
`
`

`

`Any Docket: CRT/20632llUS (4137°04708)
`
`Patent
`
`9.
`
`(Original)
`
`The rnethod of claim 1, wherein the formulation comprises edetate
`
`disodium, benzalkonium chloride, microcrystalline cellulose, cmboxymethy1 cellulose sodium,
`
`polysorbate 80, glycerine, and phenyl ethyl a1cohoL
`
`(Original)
`
`The method of claim 9, wherein the formulation cornprises:
`
`from 0.002% (weight/weight) to 0.05% (vv'eight/weight) of edetate disodium;
`
`from 0,002% (weight/weight) to 0.05% (vveight/weight) ofbenzalkonium chloride;
`
`from 0065% (weight/weight) to 3% (weight/weight) of a combination of microcrystal1ine
`
`cellulose and carboxymethyl cellulose sodium; and
`
`from 2.JC;{J (weight/weight) to 2.6% (\veight/weight) of glycerine.
`
`11,
`
`(Original)
`
`The method of claim 1, wherein the formulation cornprises:
`
`0.1 % (weight/weight) azelastine hydrochloride;
`
`from 0.0357% (vv'eight/weight) to 15% (weight/weight) of fiuticasone propionate;
`
`from 0.002% (weight/\veight) to 0.05 1;..'f; (weight/weight) of edetate disodium;
`
`from 0.002% (weight/weight) to 0.021?.{; ('vveight/v,,reight) of benzalkonium chloride;
`
`from 0.65% (weight/weight) to 3% (weight/weight) of a combination of rnicrocrystaliine
`
`and carboxymethyl cellulose sodium;
`
`polysorbate 80;
`
`23% (weight/weight) of glycerine; and
`
`0.25% (weight/weight) of phenyl ethyl alcohol.
`
`12.
`
`(Original)
`
`The method of claim 1, wherein the one or more isotonization agents is
`
`present in an amount that a reduction in the freezing point of frnrn 0.50 °C to 0.56 °C is attained in
`
`comparison to pure water.
`
`.. 3 -
`
`

`

`Atty Docket: CR1'/20632HUS (4137~04708)
`
`Patent
`
`13.
`
`(Original)
`
`The roethod of dairn l, wherein the formulation is contained in a nasal
`
`spray product; and wherein from 0J)3 mg to 3 mg of azelastine hydrochloride and from 0.05 mg to
`
`0,15 mg of fluticasone propionate is released per individual actuation of the nasal spray product.
`
`14.
`
`(Previously Presented)The method of claim 29, wherein the thickening agent comprises
`
`microcrystalline cellulose and carboxymethyl cellulose sodium.
`
`15.
`
`(Original)
`
`A
`
`rnethod for minimizing symptoms of seasonal allergic rhinitis,
`
`comprising administration of a therapeutically effective amount of a nasal spray formulation
`
`comprising;
`
`from (LOOl % (weight/weight) to 1 % (weight/weight) of azelastine hydrochloride;
`
`from 0.03579-f (weight/weight) to L5% (weight/weight) of fluticasone propionate;
`
`one or more preservalives;
`
`one or more thickening agents;
`
`one or more surfactants; and
`
`one or more isotonization agents.
`
`16.
`
`(Original)
`
`The method of claim 15, wherein the fomrnlation has a pH of 4,5 to about
`
`6.5,
`
`17.
`
`(Original)
`
`The method of claim 15, wherein the fonnulation is an aqueous suspension.
`
`18,
`
`(Original)
`
`The method of claim 15, wherein the one or more preservatives comprise
`
`from 0,002% (weight/weight) to 0J15% (weight/weight) of edetate disodium and from 0,002%
`
`(weight/weight) to 0.05% (weight/weight) of benzalkonium chloride,
`
`19,
`
`(Original)
`
`The method of claim 15, wherein the one or more thickenfog ageuts
`
`comprise microcrystalline cellulose and carboxymethyl cellulose sodium.
`
`

`

`A.tty Docket: l"'RT/20632JIUS (4!37m04708)
`
`Patent
`
`(Original)
`
`The method of claim 15, wherein the one or rnore surfactants comprise
`
`polysorbate 80.
`
`21.
`
`(Original)
`
`The method of daim 15, wherein the one or more isotonization agents
`
`comprise from 23% (weight/weight) to 2.6% (weight/weight) of glycerine.
`
`(Original)
`
`The method of claim 18, wherein the one or more preservatives further
`
`comprise 0.25'1~) (weight/,,veight) of phenyl ethyl alcohol.
`
`23.
`
`(Original)
`
`The method of claim 15, wherein the formulation cornprises edetate
`
`disodium, benzalkonium chloride, microcrystalline ccHulose, carboxymethyl cellulose sodium,
`
`polysorbate 80, glycerine, and phenyl ethyl alcohol.
`
`24.
`
`(Original)
`
`The method of claim 23, wherein the formulation comprises:
`
`from 0.002% (weight/weight) to 0.05% (,veight/weight) of edetate disodium;
`
`from 0.002% (weight/weight) to (HIS% (weight/weight) of benzalkoniurn chloride;
`
`from 0.65% (,veight/weight) to 3% (weight/weight) of a combination of microcrystalline
`
`ce11u1ose and carboxymethyl cellulose sodium; and
`
`from 23% (weight/weight) to 2Jl}b (weight/weight) of glycerine.
`
`25,
`
`(Original)
`
`The method of claim 15, wherein the formulation comprises:
`
`O.F,{; (weight/weight) azelastine hydrochloride;
`
`from 0.03579{; (weight/weight) to LS% (weight/weight) of fluticasone propionate;
`from OJ)02~7c (vveight/weight) to (LOS% (weight/weight) of edetate disodium;
`
`from 0.002% (weight/weight) to 0.02% (weight/weight) of benzalkoniurn chloride;
`
`from 0.65% (weight/weight) to 3%, (weight/weight) of a cornbination of microcrystalline
`
`and carboxymethyl cellulose sodium;
`
`polysorbate 80;
`
`

`

`Atty Docket: CRT/20632HUS (4137-04708)
`
`Patent
`
`2.3% (weight/weight) of glycerine; and
`
`0,25% (weight/weight) of phenyl ethyl alcohol.
`
`26,
`
`(Original)
`
`The method of claim 15, wherein the one or n1ore isotonization agents is
`
`present in an amount that a reduction in the freezing point of from 050 °C to 0,56 °C is attained in
`
`comparison to pure vvateL
`
`(Original)
`
`The method of clairn 15, wherein the formulation is contained in a nasal
`
`spray product; and wheJein from 0.03 mg to 3 mg of azelastine hydrochloride and from (l.05 mg to
`
`0.15 mg of fiuticasone propionate is released per individual actuation of the nasal spray product
`
`28.
`
`(Previously Presented)The method of claim 19, wherein the formulation comprises from
`
`0.65% (weight/weight) to 3% (weight/weight) of microcrysta1line cellulose and carhoxymethyl
`
`celllllose sodium,
`
`29.
`
`(Original)
`
`A method for the treatment of seasonal allergic rhinitis, comprising
`
`administration of a therapeutically effective amount of a nasal spray fommlation comprising:
`
`frmn 0,001 % (weight/weight) to l ?+ (weight/weight) of azelastine hydrochloride;
`
`from about 50 ~tg/mL to about 5 mg/mL of Hutkasone propionate;
`
`from 0.002% (weight/weight) to 0,05% (weight/weight) of benzalkonium chloride;
`
`from 0.002Si; (weight/weight) to 0.05% (weight/weight) of edetate disodium;
`
`glycerine;
`
`polysorbate; and
`
`a thickening agent;
`
`wherein the formulation has a pH of 4.5 to about 6.5; and
`
`wherein the formulation is an aqueous suspension,
`
`

`

`Atty Docket: CRT/20632HUS (4137~04708)
`
`Patent
`
`30.
`
`(Original)
`
`The rnethod of claim 29, wherein the fonnulation is contained in a nasal
`
`spray product; and wherein from 0J}3 mg to 3 mg of azelastine hydrochloride and from 0,05 mg to
`
`0,15 rng of flutkasone propionate is released per individual actuation of the nasal spray product.
`
`

`

`A.tty Docket: CRT!20632HVS (4137-04708)
`
`Patent
`
`REMARKS/ARGUMENTS
`
`Status of Claims
`
`Claims 1-30 are currently pending in this application.
`
`Applicant hereby requests further examination and reconsideration of the preseutly clairned
`
`application.
`
`Examiner's Interview
`
`Applicant thanks the Examiner for the courtesy of a telephone interview on October 7,
`
`2015, wherein the participants discussed the issue of filing the declarations frorn the issued parent
`
`patent, US 8,168,620, in the instant application. While Applicant and the Examiner 'Were in
`
`general agreement that su