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`Case 1:14—cv—O1453—LPS Document 43-7 Filed 10/22/15 Page 1 of 79 Page|D #: 460
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`EXHIBIT 14
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`EXHIBIT 14
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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 2 of 79 PageID #: 461
`Page 2 of 79 Page|D #: 461
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Vi
`'nia 22313-1450
`www.uspto.go
`
`APPLICATION NO.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`10/518,016
`
`07/06/2005
`
`Amar Lulla
`
`30652
`7590
`calm ROSE, pp.
`5601 GRANITE PARKWAY, SUITE 750
`PLANO, TX 75024
`
`02/16/2011
`
`PAC/20632 US
`(413704700)
`
`4912
`
`N *LSEN, THORB
`PAPER NUMBER
`
`ART UNIT
`
`1616
`
`MAIL DATE
`
`02/ 16/201 1
`
`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)
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`MED_DYM_00000765
`
`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 3 of 79 PageID #: 462
`Case 1:14—cv—01453—LPS Document 43-7 Filed 10/22/15 Page 3 of 79 PagelD #: 462
`Application No.
`App|icant(s)
`
`Office Action Summary
`
`10/518,016
`
`Examine,
`THOR B. NIELSEN
`
`LULLA ET AL.
`
`A“ Unit
`1616
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, 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)IXl Responsive to communication(s) filed on 24 September 2010.
`
`2a)I:I This action is FINAL.
`
`2b)IXl This action is non—final.
`
`3)I:l 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)IZl Claim(s) 1 2 4 6-22 26 27 30 35-38 44 45 and 53-56 is/are pending in the application.
`
`4a) Of the above claim(s) j is/are withdrawn from consideration.
`
`5)I:l Claim(s) j is/are allowed.
`
`6)IX| Claim(s) 1 2 4 6-22 26 27 30 35-38 44 45 and 53-56 is/are rejected.
`
`7)I:l Claim(s) j is/are objected to.
`
`8)I:l Claim(s) j are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)I:l The specification is objected to by the Examiner.
`
`10)|:| The drawing(s) filed on j is/are: a)I:I accepted or b)I:l 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).
`
`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`a)|:| All
`
`b)I:l Some * c)|:| None of:
`
`1.|:I Certified copies of the priority documents have been received.
`
`2.|:| Certified copies of the priority documents have been received in Application No. _.
`
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
`
`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) El Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) El Information Disclosure Statement(s) (PTO/SB/08)
`
`Paper No(s)/Mail Date 9/24/2010' 10/19/2010.
`U.S. Patent and Trademark Office
`
`4) El Interview Summary (PTO-413)
`Paper N°(5)/Ma" DaIe- E -
`5) I:I Notice of informal Patent Application
`6) D Other:
`.
`
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20110131
`
`MED_DYM_00000766
`
`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 4 of 79 PageID #: 463
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 4 of 79 PagelD #: 463
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`Application/Control Number: 10/518,016
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`Page 2
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`Art Unit: 1616
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`DETAILED ACTION
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`Status of Examination
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`in brief, the claims were initially reviewed and a non—Final rejection mailed on
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`January 23, 2009.
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`In that action, the claim set was restricted and claims 23, 24, and 46-
`
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`52 were withdrawn from consideration. Then—pending claims 1-4 7 9-10 12-21 30-32
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`and 44-45 were rejected as anticipated by EP 0780127 (Cramer).
`
`In that same action,
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`then-pending claims 5 and 35-38 were rejected as obvious over Cramer; claims 22 and
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`26-27 were rejected as obvious over Cramer in view of US 6,294,153 (Modi); claims 1-3
`
`and 6 were rejected as obvious over US 6,391,340 (Malmqvist-Granlund); and claims
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`E were rejected as obvious over Cramer in view of US 6,017,963 (Alfonso). No
`
`claims were allowed.
`
`In response, Applicant amended the claims, submitted a Declaration under 37
`
`CFR 1.132, and argued for patentability. Of note, the Applicant incorporated the
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`limitations of claim 5, which had not been rejected as anticipated, into claim 1.
`
`A Final Office Action was mailed on April 28, 2010, rejecting then-pending claims
`
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`1-2 4 7-21 30 35-38 44-45 and 53-56 as obvious over Cramer.
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`In addition, claims
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`22 and 26-27 were rejected as obvious over Cramer in view of Modi; claims 1-2 and 6
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`were rejected as obvious over Cramer in view of US 6416743 (Fassberg); and claims
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`1 25 28-29 were rejected as obvious over Cramer in view of Alfonso. No claims were
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`allowed.
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`MED_DYM_00000767
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 5 of 79 PageID #: 464
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 5 of 79 PagelD #: 464
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`Application/Control Number: 10/518,016
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`Page 3
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`Art Unit: 1616
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`The current Action is responsive to the Amendment and Response to Final
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`Rejection filed on September 24, 2010, and the revised Declaration under 37 CFR
`
`1.132 by Geena Malhotra, with Exhibits A-D, dated September 23, 2010.
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`A Request for Continuing Examination was filed on September 27, 2010.
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`The examiner in this application has changed. Please address future
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`correspondence accordingly.
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`Status of Claims
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`Claims 1-2, 4, 6-22, 26-27, 30, 35-38, 44-45, and 53-56 are pending. Of these
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`claims, claims 26, 27, and 30 were amended in the most recent response. The
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`Amendments are entered of right.
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`Anticipation rejection, reinstated in part and new in part
`
`In the Office Action that was mailed on January 23, 2009, claim 5, directed to a
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`steroid range, was not rejected as anticipated by Cramer. That was an error, because,
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`as discussed further below, Cramer discloses the claimed amounts of steroid. This
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`examiner recognizes that the correction of the error places an additional burden on the
`
`Applicant.
`
`
`The rejection of claims 1-2 9-10 12-21 30 45 and 55-56 as obvious over
`
`Cramer is withdrawn in favor of the following anticipation rejection.
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`Claim Rejections - 35 USC § 102
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`MED_DYM_00000768
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 6 of 79 PageID #: 465
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 6 of 79 PagelD #: 465
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`Application/Control Number: 10/518,016
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`Page 4
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`Art Unit: 1616
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in
`the United States.
`
`
`Claims 1-2 9-10 12-21 30 45 and 55-56 are rejected as anticipated by
`
`Cramer.
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`Cramer is directed generally to a nasal spray containing a steroid and an
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`antihistamine. Abstract. The compositions are suitable for treatment of symptoms
`
`associated with seasonal or perennial allergic rhinoconiunctivitits. At page 2,
`
`lines 28-30. Cramer discloses a pharmaceutical composition that can have a safe and
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`effective amount of Azelastine. At page 2, lines 36-44, esp. line 42. The composition
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`can also have a safe and effective amount of Fluticasone.
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`ld., esp. line 39. The
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`Fluticasone can be present in an amount from about 0.001 to about 0.2 wt. % or
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`from about 0.01 to about 0.1 wt. %. Atpage 3, lines 19-20 and page 2, line 58. The
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`disclosed compositions are prepared in saline or isotonic glucose (see Examples).
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`Such dilute solutions are essentially the same in weight/volume units, because the
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`density of the solution differs little from the density of water. Also, the disclosure uses
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`the broadening term “about.” Cramer discloses Azelastine hydrochloride. Atpage 6,
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`Example ll, esp. line 33. The amount of Azelastine can be from about 0.01 to about 4
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`wt. %, preferably from about 0.01 % to about 1 wt. %. At page 3, lines 28-30.
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`Cramer discloses that the composition can have a surfactant, e.g. a polysorbate, in a
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`usual amount from 0.5 to 10 wt. °/-... At page 5, lines 11-15. The compositions can have
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`MED_DYM_00000769
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 7 of 79 PageID #: 466
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 7 of 79 PagelD #: 466
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`Application/Control Number: 10/518,016
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`Page 5
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`Art Unit: 1616
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`sodium chloride, dextrose/glucose, polypropylene glycol, among other named
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`agents, for controlling isotonicity. At page 4, lines 50-55. Cramer discloses
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`compositions with a thickener which can be a cellulose derivative (page 4, line 56 to
`
`page 5, line 2), a buffer (page 3, lines 47-49), and a preservative (Id.). The buffer can
`
`have citric acid, and hence citrate. At page 4, lines 50-53. The pH can be from about
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`4.5 to about 9, preferably from about 6 to about 7. Atpage 2, line 57. Cramer
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`envisions solutions (e.g. page 5, line 57) and suspensions (e.g. page 5, lines 27-30).
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`Cramer discloses the preparation of nasal sprays. See Examples.
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`This rejection is proper under In re Petering, 133 USPQ 275, 280 (CCPA 1962),
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`in which disclosure of a genus of 20 related compounds rendered obvious a claim to
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`one of those compounds. See also In re Schaumann, 197 USPQ 5, 7 (CCPA 1978),
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`which found a claim to one compound obvious over the disclosure of a genus having
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`105 compounds that encompassed the claim.
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`In the instant application, Cramer discloses a genus consisting of the
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`combinations of six steroids and three antihistamines, thus corresponding to eighteen
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`combinations. That the antihistamines are available in various salt forms and that the
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`steroids are available in various esters does not negate the validity of the rejection,
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`because the salts and esters are well-known variants. Moreover, Cramer specifically
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`discloses the chloride salt of Azelastine.
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`In re Ruschig, 145 USPQ 274 (1965) is not in
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`point because Cramer defines a small recognizable class with common properties,
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`unlike the fact situation in Ruschig.
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`MED_DYM_00000770
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 8 of 79 PageID #: 467
`Case 1:14—cv—01453—LPS Document 43-7 Filed 10/22/15 Page 8 of 79 PagelD #: 467
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`Application/Control Number: 10/518,016
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`Page 6
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`Art Unit: 1616
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`Claim Rejections - 35 USC § 103
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`The text of those sections of Title 35, U.S. Code not included in this action can
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`be found in a prior Office action.
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`The rejection of claim 44 over Cramer, as stated in the Office Action of April 28,
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`2010, is withdrawn because the claim depends from a claim not rejected over Cramer.
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`The rejection of claims 1 25 and 28-29 as obvious over Cramer in view of US
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`6,017,963 (Alfonso) (of record) is withdrawn because of the cancellation of claims 25,
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`and 28-29.
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`The rejection of claims4 7 8 11 35 36 37 38 53 and 54 as obvious over
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`Cramer, as stated in the Office Action of April 28, 2010, is maintained for reasons of
`
`record.
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`The rejection of claims 22 and 26-27 as obvious over Cramer in view of
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`US6294153 (Modi) (of record) is maintained for reasons of record.
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`The rejection of claims 1 2 and 6 as obvious over Cramer in view of US
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`6,416,743 (Fassberg) (of record) is maintained for reasons of record.
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`Claim 44 is newly rejected over Cramer in view of US6294153 (Modi) (of record).
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`Determination of the scope and content of the prior art (MPEP 2141.01)
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`The disclosure of Cramer is discussed above. Modi teaches aerosol
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`formulations for nasal delivery comprising pharmaceutical agents (i.e. anti-
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`inflammatories, steroids, etc.), water, excipients and a propellant. Abstract and column
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`3, lines 30-40.
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`Improved penetration into the nasal cavity and absorption of the
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`MED_DYM_00000771
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 9 of 79 PageID #: 468
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 9 of 79 PagelD #: 468
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`Application/Control Number: 10/518,016
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`Page 7
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`Art Unit: 1616
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`formulations can be achieved by mixing the formulation with propellants such as
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`tetrafluroethane, etc., especially when delivered through aerosol devices (i.e. MDI).
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`Column 2, lines 5-24.
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`Ascertainment of the difference between the prior art and the claims
`(MPEP 2141.02)
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`Cramer does not teach aerosol sprays or metered dose inhalers (MDI). As
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`discussed above, Modi teaches aerosols and MDI and thus, Modi cures the deficiency
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`in Cramer.
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`Finding of prima facie Obviousness Rationale and Motivation
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`(MPEP 2142-2143)
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`One of ordinary skill in the art, familiar with the disclosure of Cramer, would have
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`been motivated to make a composition further comprising a propellant because Modi
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`suggests that adding propellants to nasal formulations can increase penetration and
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`absorption in the nasal cavity. Thus, it would have been obvious to one of ordinary skill
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`in the art at the time the claimed invention was made to make a composition further
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`comprising a propellant for the purpose of increasing penetration of active formulations
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`into the nasal cavity. Therefore, the invention as claimed in claim 44 would have been
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`prima facie obvious to one of ordinary skill in the art at the time the invention was made
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`because the prior art is fairly suggestive of the claimed invention.
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`Response to Remarks and Arguments
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`Applicant’s arguments with regard to obviousness of claims 1-2, 9-10, 12-21, 30,
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`45, and 55-56 is mooted by the new or reinstated anticipation rejection. Thus,
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`MED_DYM_00000772
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 10 of 79 PageID #: 469
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 10 of 79 PagelD #: 469
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`Application/Control Number: 10/518,016
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`Page 8
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`Art Unit: 1616
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`Applicant’s arguments will be considered in view of the remaining claims: 4, 6-8, 11, 22,
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`26-27, 35-38, 44, 53, and 54.
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`A. Argument for lack of establishment of a prima facie case of obviousness
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`Applicant argues that the instant claims as amended are A. patentable over the
`
`art of record and B. patentable in view of objective evidence of nonobviousness.
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`In
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`particular, Applicant asserts that the examiner has not established a prima facie case of
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`obviousness and that objective evidence shows that a pharmaceutical formulation
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`comprising Azelastine (an antihistamine) and Fluticasone (a corticosteroid) displays
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`unexpectedly beneficial properties, is commercially successful, and fills a long felt but
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`unsolved need. At page 10. Each of these assertions is discussed in detail below.
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`In the Office Action dated January 23, 2009, the Examiner observed that the prior
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`art reference (Cramer) disclosed a nasal spray comprising the combination of a
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`glucocorticoid and an antihistamine. Moreover, Cramer disclosed six corticosteroids
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`and three antihistamines, but did not exemplify the combination of Azelastine and
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`Fluticasone. The examiner then stated that it was well within the means for one of
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`ordinary skill in the art to try the instant combination as there are a small number of
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`actives to choose from. At pages 14-15.
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`Applicant characterizes the rejection as an obvious-to-try rejection. Amendment
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`of September 24, 2010, atpage 11. Applicant, quoting In re Kubin, further asserts that
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`an obvious-to-try rejection requires an indication of which parameters were critical or
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`which of many possible choices is likely to be successful. 90 USPQ2d 1417, 1423
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`(Fed. Cir. 2009) ('[W]here a defendant merely throws metaphorical darts at a board filled
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`MED_DYM_00000773
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 11 of 79 PageID #: 470
`Case 1:14—cv—01453—LPS Document 43-7 Filed 10/22/15 Page 11 of 79 PagelD #: 470
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`Application/Control Number: 10/518,016
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`Page 9
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`Art Unit: 1616
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`with combinatorial prior art possibilities, court should not succumb to hindsight claims of
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`obviousness.”)
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`The Applicant’s arguments are mooted by the reinstatement of a rejection for
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`anticipation, above.
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`B. Argument for secondary considerations
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`Applicant argues in the alternative that secondary considerations render the
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`instant claims, as amended, nonobvious over the art of record, and has provided a
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`second Declaration (dated September 23, 2010) under 37 CFR 1.132, which has
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`“amended values [that] represent clarifications and the remedying of typographical
`
`errors in the previously submitted data.” Atpage 13.
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`Both the current and previous Declarations had the statement in which the
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`Declarant “declare[d] that all statements made herein of my own knowledge are true
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`and that all statements made on information and belief are believed to be true; and
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`further that these statements are made with the knowledge that willful false statements
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`and the like so made are punishable by fine, imprisonment, or both .
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`.
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`. and that such
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`willful false statements may jeopardize the validity of this application or any patent
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`issuing thereon.” E.g., Declaration dated September 23, 2010, page 3.
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`Second Declaration under 37 CFR 1.132
`
`In brief, the examiner observes the following items in the second Declaration:
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`1. Table I (of Exhibit A) shows the compositions of the Azelastine, Budesonide,
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`the combination of Azelastine and Budesonide, Fluticasone, and the combination of
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`MED_DYM_00000774
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 12 of 79 PageID #: 471
`Case 1:14—cv—01453—LPS Document 43-7 Filed 10/22/15 Page 12 of 79 PagelD #: 471
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`Application/Control Number: 10/518,016
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`Page 10
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`Art Unit: 1616
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`Azelastine and Fluticasone formulations. The values of some of the units and of the
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`actual constituents have been changed from the Exhibit of the previous Declaration.
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`2. Table II (of Exhibit A) shows the initial assay of the five formulations described
`
`in Table I. Table II also shows the level of impurities in the initial formulations and after
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`storage for either 1 month or 3 months under either of two conditions: 25 °C at 60 °/o
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`relative humidity or 40 °C at 75 °/o relative humidity.
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`(Note that Budesonide was stored
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`for 2 months, rather than three months, and that no data was presented for Fluticasone
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`or the combination of Azelastine and Fluticasone at one month at 25 °C.) All the
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`formulations, except for the combination of Azelastine and Budesonide were
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`substantially stable. The Declaration states that the stability of the combination of
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`Azelastine and Fluticasone was surprising. At page 2.
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`3. Six medical practitioners provided statements supporting and extolling the
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`advantages and superior results associated with use of the combination formulation.
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`In
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`addition, some statements stated that the combination formulation provided a benefit
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`that was not realized by previously existing products.
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`4.
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`Information from a commercially available product (Duonase Nasal Spray
`
`from Cipla) was provided as Exhibit C, which reported the availability of a formulation
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`comprising Fluticasone, Azelastine, benzalkonium chloride, and phenyl ethanol.
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`5. The Declaration provided a description of the testing method and the nature of
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`the impurities detected.
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`MED_DYM_00000775
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 13 of 79 PageID #: 472
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`Application/Control Number: 10/518,016
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`Page 11
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`Art Unit: 1616
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`6. The Declaration further provided a statement that, based on the data
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`provided, the Declarant observed a beneficial stability when compared to the Azelastine
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`and Budesonide compositions.
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`7. The Declaration also stated that the Declarant was not aware of another
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`commercially available pharmaceutical formulation comprising an antihistamine and a
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`steroid.
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`8. According to the Declaration, the instant application is licensed to Meda
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`Pharmaceuticals.
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`Applicant argues that the [second] Declaration demonstrates that the claimed
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`pharmaceutical formulation comprising Azelastine and Fluticasone has unexpected and
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`beneficial stability. Applicant also argues that one of skill in the art would understand
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`that improved product stability is extremely important in pharmaceutical compositions.
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`Amendment, at page 14.
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`None of the above arguments are directed to the elements in the claims currently
`
`rejected for obviousness. Thus the examiner finds that all of the Applicant’s arguments
`
`are addressed to the rejection as obvious over Cramer and are mooted by the rejection
`
`as anticipated over Cramer.
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`1. Argument that the combination of Azelastine and Fluticasone displays
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`unexpected, beneficial results
`
`Applicant further asserts that the Declaration’s Exhibits B1 and B3 demonstrate
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`that a formulation of Azelastine and Fluticasone has unexpected efficacy when
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`MED_DYM_00000776
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`

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`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 14 of 79 PageID #: 473
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`Application/Control Number: 10/518,016
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`Page 12
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`Art Unit: 1616
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`administered to patients, specifically that the product is very effective when compared
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`[to] available other nasal sprays. At page 14, quoting an Exhibit. Applicant also notes
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`that another physician wrote that the combination formulation “is v_ery, v_ery effective in
`
`all types of allergic rhinitis” and a “single drug was not effective as compared with the
`
`combination of both.”
`
`Again, the argument is mooted by the rejection of the claims as anticipated by
`
`Cramer.
`
`Applicant also argues that the doctor’s statements demonstrate a synergistic
`
`benefit in efficacy over Azelastine alone or Fluticasone alone.
`
`The applicant is arguing a feature not claimed.
`
`Response to alleged deficiencies of 1.132 Declaration
`
`The Applicant recounts four deficiencies that were noted in the previous Office
`
`Action regarding the first Declaration under Rule 132.
`
`Applicant states that the Office Action noted that there was no description of the
`
`testing method, assay utilized, or calculation of the impurity level.
`
`In response
`
`Applicant provided Exhibit D of the instant Declaration, which describes the method of
`
`identifying the impurities.
`
`Two, Applicant provided, also in Exhibit D, the reference substances used for
`
`comparison with the impurities found in each composition. In particular, one Azelastine
`
`HCI impurity was monitored and nine Fluticasone propionate impurities were monitored.
`
`Third, in response to the examiner’s comment that the Applicant did not test
`
`against the closest prior art examples disclosed in Cramer, Applicant noted that Cramer
`
`MED_DYM_00000777
`
`

`
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 15 of 79 PageID #: 474
`Case 1:14—cv—O1453—LPS Document 43-7 Filed 10/22/15 Page 15 of 79 PagelD #: 474
`
`Application/Control Number: 10/518,016
`
`Page 13
`
`Art Unit: 1616
`
`treated Fluticasone and Budesonide as alternatives. Thus, one of skill in the art would
`
`consider the appropriate comparative to be the one tested.
`
`Fourth, Applicant addresses the examiner’s comment that the compositions that
`
`contained Fluticasone also had the preservative phenyl ethanol, whereas the
`
`Budesonide compositions did not. The Applicant observes first that the impurity levels
`
`of the Azelastine, Budesonide, and Fluticasone solo formulations are similar, although
`
`the preservative is present in Fluticasone. Thus, Applicant asserts, the presence of
`
`phenyl ethyl alcohol did not serve to distinguish the stability of the Fluticasone sample
`
`from that of the Azelastine or Budesonide samples.
`
`The arguments are not addressed to the limitations found in the claims that are
`
`currently rejected as obvious and are thus mooted by the anticipation rejection.
`
`The Applicant further argues that the presence of phenyl ethyl alcohol in the
`
`Azelastine and Fluticasone composition cannot account for the observed dramatic
`
`increase in stability of this composition when compared to the Azelastine and
`
`Budesonide composition.
`
`This argument is mooted by the current rejection.
`
`The Applicant next provides excerpts from the Handbook of Microbiological
`
`Quality Contro/and an article entitled “Preservatives in Ophthalmic Formulations.” The
`
`references do not mention the effect of preservatives on the chemical stability of the
`
`drug actives.
`
`This argument is also mooted by the current rejection.
`
`MED_DYM_00000778
`
`

`
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 16 of 79 PageID #: 475
`Case 1:14—cv—01453—LPS Document 43-7 Filed 10/22/15 Page 16 of 79 PagelD #: 475
`
`Application/Control Number: 10/518,016
`
`Page 14
`
`Art Unit: 1616
`
`Applicant asserts that the Examiner’s assertion that the preservative may have
`
`an effect on the chemical stability of the actives is a mere assumption, because the
`
`standard is whether the result or characteristic is necessarily present.
`
`The argument is moot.
`
`2. The combination of Azelastine and Fluticasone is commercially successful
`
`Applicant asserts that a combination formulation of Azelastine and Fluticasone is
`
`commercially available. At page 19. Applicant also asserts that the doctor’s statements
`
`and successful licensing support commercial success.
`
`Id.
`
`Not unexpectedly, Applicant has not addressed how the elements found in the
`
`claims currently rejected as obvious are factors in the commercial success of the
`
`product. Rather, the argument appears directed to the elements of claim 1, and thus is
`
`moot.
`
`3. The combination of Azelastine and Fluticasone fills a long-felt need
`
`The Applicant asserts that despite Cramer’s patent, no commercial formulation of
`
`an antihistamine and a steroid is available, even ten years later. At page 19.
`
`The argument is not directed to the limitations found in claims currently rejected
`
`as obvious. Thus, the argument is moot.
`
`All pending claims are rejected.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to THOR B. NIELSEN whose telephone number is
`
`MED_DYM_00000779
`
`

`
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 17 of 79 PageID #: 476
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 17 of 79 PageID #: 476
`
`Application/Control Number: 10/518,016
`
`Page 15
`
`Art Unit: 1616
`
`(571)270-3476. The examiner can normally be reached on Monday through Friday from
`
`9:00 A.M. to 4:00 P.M.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Johann Richter can be reached on 571-272-0646. 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
`
`/Johann R. Richter/
`
`Supervisory Patent Examiner, Art Unit 1616
`
`MED_DYM_00000780
`
`

`
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 18 of 79 PageID #: 477
`Case 1:14—cv—O1453—LPS Document 43-7 Filed 10/22/15 Page 18 of 79 Page|D #: 477
`
`
`
`EXHIBIT 15
`
`EXHIBIT 15
`
`
`
`

`
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 19 of 79 PageID #: 478
`Case 1:14—cv—01453—LPS Document 43-7 Filed 10/22/15 Page 19 of 79 Page|D #: 478
`Atty. Docket: PAC/20632 US (4137-04700)
`Patent
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Group Art Unit:
`
`1616
`
`Examiner: Thor B. Nielsen
`
`Confirmation No.: 4912
`
`CERTIFECATE OF EFS-WEB FILING
`
`§ §
`
`§ §
`
`§ §
`
`§
`
`§ §
`
`this correspondence is being
`I hereby certify that
`zlectroinicallygled at the USPTQ website 8): 11%/Iail1ASé<:)p
`men ment,
`ommissloner
`01'
`ate I,
`.
`.
`OX
`,
`
`A‘?Za“z“§‘EVA 223g‘
`
`E with Shek
`A
`
`
`Applicants:
`
`Amar Lulla, et al.
`
`Serial No.:
`
`10/518,016
`
`Filed:
`
`July 6, 2005
`
`For:
`
`COMBINATION or AZELASTINE AND
`STEROIDS
`
`Mail Stop: Amendment
`Commissioner for Patents
`PO BOX
`
`Alexandria, VA 22313-1450
`
`AMENDMENTS AND RESPONSE TO
`
`OFFICE ACTION DATED FEBRUARY 16 2011
`
`Dear Sir:
`
`In response to the Office Action dated February 16, 2011, Applicants respectfully request
`
`reconsideration of the above—identified application as follows.
`
`Amendment to the Specification begins on page 2 of this paper
`
`Amendments to the Claims are reflected in the listing of claims, which begins on page 4
`
`of this paper.
`
`Remarks/Arguments begin on page 15 of this paper.
`
`Supplemental IDS is submitted herewith.
`
`113683 v3/4137.o47oo
`
`— 1 -
`
`M ED_DYM_0O000793
`
`

`
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 20 of 79 PageID #: 479
`Case 1:14—cv—01453—LPS Document 43-7 Filed 10/22/15 Page 20 of 79 Page|D #: 479
`Atty. Docket: PAC/20632 US (4137-04700)
`Patent
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Group Art Unit:
`
`1616
`
`Examiner: Thor B. Nielsen
`
`Confirmation No.: 4912
`
`CERTIFECATE OF EFS-WEB FILING
`
`§ §
`
`§ §
`
`§ §
`
`§
`
`§ §
`
`this correspondence is being
`I hereby certify that
`zlectroinicallygled at the USPTQ website 8): 11%/Iail1ASé<:)p
`men ment,
`ommissloner
`01'
`ate I,
`.
`.
`OX
`,
`
`A‘?Za“z“§‘EVA 223g‘
`
`E with Shek
`A
`
`
`Applicants:
`
`Amar Lulla, et al.
`
`Serial No.:
`
`10/518,016
`
`Filed:
`
`July 6, 2005
`
`For:
`
`COMBINATION or AZELASTINE AND
`STEROIDS
`
`Mail Stop: Amendment
`Commissioner for Patents
`PO BOX
`
`Alexandria, VA 22313-1450
`
`AMENDMENTS AND RESPONSE TO
`
`OFFICE ACTION DATED FEBRUARY 16 2011
`
`Dear Sir:
`
`In response to the Office Action dated February 16, 2011, Applicants respectfully request
`
`reconsideration of the above—identified application as follows.
`
`Amendment to the Specification begins on page 2 of this paper
`
`Amendments to the Claims are reflected in the listing of claims, which begins on page 4
`
`of this paper.
`
`Remarks/Arguments begin on page 15 of this paper.
`
`Supplemental IDS is submitted herewith.
`
`113683 v3/4137.o47oo
`
`— 1 -
`
`M ED_DYM_0O000794
`
`

`
`Case 1:14-cv-01453-LPS Document 43-7 Filed 10/22/15 Page 21 of 79 PageID #: 480
`Case 1:14—cv—01453—LPS Document 43-7 Filed 10/22/15 Page 21 of 79 Page|D #: 480
`
`Atty. Docket: PAC/20632 US (413 7-04700)
`
`Patent
`
`AMENDMENTS TO THE CLAIMS
`
`Listing of claims:
`
`1.
`
`(Currently Amended) A pharmaceutical formulation comprising:
`
`azelastine, or a pharmaceutically acceptable salt, solvate or physiologically functional
`
`derivative thereof, and
`
` a pharmaceutically acceptable ester thereefof fluticasone,
`
`wherein said pharmaceutical
`
`formulation is
`
`in a dosage form suitable for nasal
`
`
`
`2.
`
`(Currently Amended) [[A]]Lm pharmaceutical
`
`formulation iclaim 1,
`
`wherein said pharmaceutically acceptable salt of azelastine is preseneasazelastine hydrochloride.
`
`3.
`
`(Canceled)
`
`4.
`
`(Currently Amended) [[A]]The pharmaceutical
`
`f