IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`First Named Inventor
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`Masayo HIGASHIYAMA
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`Serial No. 10/500,354
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`Filed June 30, 2004
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`AQUEOUS LIQUID PREPARATIONS AND
`LIGHT-STABILIZED AQUEOUS LIQUID
`PREPARATIONS
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`Attorney Docket No. 2004-1016A
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`Confirmation N0. 2612
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`Group Art Unit 1611
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`Examiner Barbara S. Frazier
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`Mail Stop: AF
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`AMENDMENT AFTER FINAL REJECTION
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`Commissioner for Patents
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`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`Sir/Madam:
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`In response to the Office Action of April 30, 2014, please amend the above-identified
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`application as follows:
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`The USPTO is hereby authorized to charge anyfees under 37 C.F.R. §§ 1.16, 1.17, and 1.492, which may be required by this
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`papertoDepositAccountNo. 23-0975.
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`MYLAN Ex. 1030, Page 1
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`Serial No. 10/500,354
`Attorney Docket No. 2004-l0l6A
`May 30, 2014
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`AMENDMENTS TO THE CLAIMS
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`1. (Currently Amended) An aqueous liquid preparation consisting f, in an
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`aqueous solution, an active ingredient consisting of (+)-(S)-4-[4-[(4-chlorophenyl)(2-
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`pyridyl)methoxy]piperidino] butyric acid or a pharrnacologically acceptable acid addition salt
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` a water-soluble metal chloride in a light-stabilizing effective ameuHt—,
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`amount; water; and optionally at least one material selected from the group consisting of a
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`buffer, a preservative, a chelating agent, and a flavor; wherein the metal chloride has a
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`concentration selected from the range of a lower limit concentration of 0.2 w/v% and an upper
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`limit concentration of 1.2 w/v%.
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`2. (Cancelled)
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`3. (Previously Presented) The aqueous liquid preparation of claim 1, wherein the metal
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`chloride is at least one kind selected from sodium chloride, potassium chloride and calcium
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`chloride.
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`4. (Cancelled)
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`5. (Previously Presented) The aqueous liquid preparation of claim 1, which is an acid addition
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`salt of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid.
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`6. (Original) The aqueous liquid preparation of claim 5, wherein the acid addition salt is
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`monobenzenesulfonate.
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`7. (Previously Presented) The aqueous liquid preparation of claim 1, wherein the aqueous
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`liquid preparation has a pH in the range of 4-8.5.
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`8. (Previously Presented) The aqueous liquid preparation of claim 1, which is an eye drop.
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`9. (Previously Presented) The aqueous liquid preparation of claim 1, which is a nasal drop.
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`2
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`MYLAN Ex. 1030, Page 2
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`Serial No. 10/500,354
`Attorney Docket No. 2004-1016A
`May 30, 2014
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`10-11. (Cancelled)
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`12. (Previously Presented) The aqueous liquid preparation of claim 1, wherein the metal
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`chloride is at least one kind selected from alkali metal chlorides and alkaline earth metal
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`chlorides.
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`13. (Currently Amended) An aqueous eye drop consisting QaLan active
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`ingredient consisting of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric
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`acid or a pharmacologically acceptable acid addition salt thereof ;
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`(pp water-soluble metal eh1er=id%,chloride; gc) sodium dihydrogen phosphate buffer; gdg a
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`preservative; ge) water; and optionally gig disodium edetate; wherein the metal chloride has a
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`concentration selected from the range of a lower limit concentration of 0.2 w/v% and an upper
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`limit concentration of 1.2 w/v%.
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`14. (Previously Presented) An aqueous liquid preparation consisting of, in an aqueous
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`solution, an active ingredient consisting of (+)-(S)-4-[4-[(4-chlorophenyl)(2-
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`pyridyl)methoxy]piperidino] butyric acid or a pharmacologically acceptable acid addition salt
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`thereof, a water-soluble metal chloride in a light-stabilizing effective amount, wherein the metal
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`chloride has a concentration selected from the range of a lower limit concentration of 0.2 w/v%
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`and an upper limit concentration of 1.2 w/v%, benzalkonium chloride, sodium
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`dihydrogenphosphate dihydrate, sodium hydroxide and water.
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`15. (Currently Amended) The aqueous eye drop of claim 13, wherein:
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`(a)-(i)_the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or
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`the pharmacologically acceptable acid addition salt thereof is (+)-(S)-4-[4-[(4-chlorophenyl)(2-
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`pyridyl)methoxy]piperidino]butyric acid monobenzenesufonate;
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`(b)—(fiLthe water-soluble metal chloride is sodium chloride; and
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`(Q-(fi)_the sodium chloride has a concentration selected from the range of a lower limit
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`concentration of 0.2 w/v% and an upper limit concentration of 0.8 w/v%.
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`3
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`MYLAN Ex. 1030, Page 3
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`Further and favorable reconsideration is respectfully requested in view of the foregoing
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`REMARKS
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`Serial No. 10/500,354
`Attorney Docket No. 2004-1016A
`May 30, 2014
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`amendments and the following remarks.
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`1.
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`Claim Amendments
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`Entry of the amendments is proper under 37 CFR §1.116, because the amendments place
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`the application in condition for allowance and do not raise any new issue requiring further search
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`and/or consideration. The amendments are necessary and were not earlier presented, because
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`they are made in response to arguments raised in the final rejection. In addition, the amendments
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`are submitted with a request under AFCP 2.0. Entry of the amendments is thus respectfully
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`requested.
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`Claims 1, 3, 5-9 and 12-15 are pending in this application.
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`Claim 14 has been allowed.
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`Claims 1 and 13 have been amended to replace “consisting essentially of’ with
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`“consisting of’.
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`Claim 1 has also been amended to include one or more “optional” materials selected from
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`the group consisting of “a buffer, a preservative, a chelating agent, and a flavor”. Support for
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`these optional materials can be found on page 6, lines 4-18 of the specification.
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`Claim 13 has also been amended to include “sodium dihydrogen phosphate buffer”, “a
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`CC
`preservative , water”, and, optionally, “disodium edetate”. Support for these amendments can
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`be found on page 6, lines 4-16, Tables 2 and 3, and Examples 1-3 and 8-12.
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`Claim 15 has been amended to make minor editorial changes in view of the amendments
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`to claim 13.
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`11.
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`Telephone Interviews
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`Applicant appreciates the courtesies extended to Applicant’s attorney by Examiner
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`Frazier during the telephone interviews held April 25, 2014, May 6, 2014 and May 22, 2014.
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`During the first interview, Applicant’s attorney pointed out that the Office Action issued
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`April 23, 2014 does not list claim 14 as allowed. The Examiner agreed to issue the new
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`outstanding Office Action to confirm that claim 14 has been allowed.
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`4
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`MYLAN Ex. 1030, Page 4
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`Serial No. 10/500,354
`Attorney Docket No. 2004-1016A
`May 30, 2014
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`During the second interview, Applicant’s attorney presented the amendments to claims 1,
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`13 and 15 mentioned above, and explained that changing “consisting essentially of” to
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`“consisting of’ should overcome the rejection under 35 U.S.C. § 103(a). Further, Applicant’s
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`attorney pointed out that claim 14, which recites “consisting of ’, has been allowed. Examiner
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`Frazier provisionally agreed that the amendments over the rejection, but stated that further
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`consideration and/or search are necessary before she could confirm allowance of the claims. The
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`Examiner also requested Applicant submit the amendments under AFCP 2.0.
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`During the third telephone interview, the Examiner confirmed that her Supervisor agrees
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`that the amendments appear to overcome the rejection.
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`Accordingly, Applicant has amended claims 1, 13 and 15 as discussed during the
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`interview, and submits the amendments under AFCP 2.0.
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`III.
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`Claim Re°ection Under 35 U.S.C.
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`103
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`The Examiner has rejected claims 1, 3, 5-9, 12, 13 and 15 under 35 U.S.C. § 103(a) as
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`being unpatentable over Lehmussaari et al. (US 5,795,913) in view of Kita et al. (US 6,307,052),
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`and optionally further in view of Araki et al. (W0 01/80858; US 2003/0139436). As applied to
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`the amended claims, Applicant respectfully traverses the rejection.
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`Claims 1 and 13 has been amended to recite the transitional phrase “consisting of”. The
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`transitional phrase “consisting of’ excludes any element, step, or ingredient not specified in the
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`claim (see MPEP 2111.03, citing In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931)).
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`The composition of Lehmussaari et al. requires the inclusion of an ion sensitive,
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`hydrophilic polymer having viscosity, such as Carbopol, to control the formation of the polymer
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`film on the cornea of the eye, and each of the reference’s examples contain Carbopol (please see
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`col. 2, line 57 to col. 3, line 6, and the Examples).
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`However, claims 1 and 13 do not recite “Carbopol”. As a result, this ingredient is
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`excluded from the aqueous liquid preparation of claim 1 and the eye drop of claim 13.
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`The references fail to disclose or suggest the aqueous liquid preparation of claim 1 or the
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`eye drop of claim 13, consisting of the ingredients recited therein.
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`Therefore, as agreed during the interview, claims 1 and 13 would not have been obvious
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`over the combination of references.
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`5
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`MYLAN Ex. 1030, Page 5
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`Serial No. 10/500,354
`Attorney Docket No. 2004-1016A
`May 30, 2014
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`Claims 3, 5-9, 12 and 15 depend from claim 1 or 13, and thus also would not have been
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`obvious over the references.
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`Accordingly, reconsideration and withdrawal of the rejection are respectfully requested.
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`IV.
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`Conclusion
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`For these reasons, Applicant takes the position that the presently claimed invention is
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`clearly patentable over the applied references.
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`Therefore, in View of the foregoing amendments and remarks, it is submitted that the
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`rejection set forth by the Examiner has been overcome, and that the application is in condition
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`for allowance. Such allowance is solicited.
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`If the Examiner finds that anything further is needed to place the application in better
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`condition for allowance, she is invited to contact the undersigned at the telephone number set
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`forth below.
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`Respectfully submitted,
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`[A n d
`o
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`F
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`o
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`B. |l=DriEiiSttae|:y1/signed by /Andrew B.
`DN: cn=/Andrew B. Freistein/, o, ou,
`emai|=afreistein@wenderoth.com,
`|| 2014.05.30 13:20:1 7 -04'00'
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`Andrew B. Freistein
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`Registration No. 52,917
`Attorney for Applicant
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`ABF/ats
`Washington, D.C. 20005-1503
`Telephone (202) 721-8200
`Facsimile (202) 721-825 0
`May 30, 2014
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`MYLAN Ex. 1030, Page 6