UNITED STATES PATENT 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.
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`F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF {MATION NO.
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`10/500,354
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`06/30/2004
`
`Masayo Higashiyama
`
`2004_1016A
`
`2612
`
`WENDEROTH,LIND&PONACK,L.L.P.
`1030 15th Street, N.W.,
`Suite
`East
`
`FRAZIER, BARBARA s
`ART UNIT
`PAPER \1Ul\/IBER
`1611
`
`12/20/2010
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on aboVe—indicated "Notification Date" to the
`following e—mail address(es):
`ddalecki @Wender0th.c0m
`e0a@ Wender0th.c0m
`
`PTOMOA (ReV_04,07)
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`MYLAN Ex. 1026, Page1
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`MYLAN Ex. 1026, Page1
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`

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`Office Action Summary
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`Application No.
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`App|icant(s)
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`10/500,354
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`HIGASHIYAMA, MASAYO
`
`Examiner
`BARBARA FRAZIER
`
`Art Unit
`1611
`
`-- 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 CFR1.136(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
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`1)lXl Responsive to communication(s) filed on 12 October 2010.
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`2a)IXI This action is FINAL.
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`2b)I:I This action is non—final.
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`3)|:l Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Ouayle, 1935 C.D. 11 , 453 O.G. 213.
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`Disposition of Claims
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`4)lZ Claim(s) 1-10 12 and 13 is/are pending in the application.
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`4a) Of the above claim(s) _ is/are withdrawn from consideration.
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`5)I:I Cla1m(s) j is/are allowed.
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`6)lXl Claim(s) 1-10 12 and 13is/are rejected.
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`7)I:I Claim(s) _ is/are objected to.
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`8)|:l Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:l The specification is objected to by the Examiner.
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`10)|:l The drawing(s) filed on j is/are: a)|:| accepted or b)|:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)|:l All
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`b)I:I Some * c)I:l None of:
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`1.I:l Certified copies of the priority documents have been received.
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`2.I:I Certified copies of the priority documents have been received in Application No. j
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`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) Q Notice of References Cited (PTO-892)
`2) El Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) El Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date
`.
`U.S. Patent and Trademark Office
`
`4) El Interview Summary (PTO-413)
`Paper N°(3)/IVI-3“ DaT9- L
`5) I:I NOTICQ Of Inform-3' Patent APPIICaTI0“
`6) D Other:
`.
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mail Date 20101213
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`Application/Control Number: 10/500,354
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`Page 2
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`Art Unit: 1611
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`DETAILED ACTION
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`Status of Claims
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`1.
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`Claims 1-10, 12, and 13 are pending in this application. Claim 11 stands
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`canceled.
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`2.
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`Claims 1-10, 12, and 13 are examined.
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`Claim Rejections - 35 USC § 103
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`3.
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`4.
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`The rejection of claims 1-10, 12, and 13 under 35 U.S.C. 103(a) as being
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`unpatentable over Stevenson (US Patent 4,053,628) in view of Kita et al (US Patent
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`6,307,052) is withdrawn in view of Applicant's amendments to claims 1, 10, and 13
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`limiting the active ingredient to that consisting of (+)-(S)-4-[4-[(4-chlorophenyl)(2-
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`pyridyl)methoxy]piperidino]butyric acid (i.e., bepotastine) or a pharmaceutically
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`acceptable acid addition salt thereof. However, in light of and as necessitated by
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`Applicant’s amendment, a new ground of rejection is made in view of Kita et al and
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`Lehmussaari et al (see paragraph 5, below).
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`Application/Control Number: 10/500,354
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`Page 3
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`Art Unit: 1611
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`5.
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`Claims 1-10, 12, and 13 are rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Kita et al (US Patent 6,307,052, previously cited) in view of
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`Lehmussaari et al (US Patent 5,795,913).
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`The claimed invention, as amended, is drawn to an aqueous liquid preparation
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`comprising, in an aqueous solution, an active ingredient consisting of (+)-(S)-4-[4-[(4-
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`chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid (i.e., bepotastine) or a
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`pharmaceutically acceptable acid addition salt thereof, and a water-soluble metal
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`chloride in a light stabilizing effective amount of 0.2 W/V°/o or more (see claim 1).
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`Kita et al teach that the benzenesulfonic acid salt or benzoic acid salt of (S)-4-[4-
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`[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butanoic acid (i.e., bepotastine) is
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`excellent in antihistaminic activity and antiallergic activity, has little hygroscopicity and
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`excellent in physicochemical stability, so that it is particularly suitable compound as a
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`medicine. Kita et al also teach that its present invention relates to a medical
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`composition containing the compound as an effective ingredient (see col. 1, lines 10-
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`22).
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`While Kita et al teach a medical composition comprising bepotastine, Kita et al do
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`not specifically teach how the composition is formulated, and do not specifically teach a
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`water-soluble metal chloride in a light stabilizing effective amount of 0.2 w/v°/-.. or more.
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`Lehmussaari et al teach an ophthalmic composition in the form of a topical
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`aqueous solution consisting essentially of an ophthalmologically active agent containing
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`basic groups, an ion sensitive hydrophilic polymer containing acidic groups, and at least
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`one salt selected from the group of inorganic salts and buffers in a total amount of from
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`Application/Control Number: 10/500,354
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`Page 4
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`0.01 to 2.0% by weight (abstract). The ophthalmologically active agent may be an
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`antiallergic agent containing basic groups, including basic heterocycles, such as
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`pyridine and piperidine (col. 4, lines 2-9). Choices of salts include sodium chloride and
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`potassium chloride (claim 5); sodium chloride in an amount of 0.9% w/v is exemplified
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`(col. 5, Example 2). The composition is administered as a liquid and obtains a desired
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`beneficial effect of the active agent in the eye, while simultaneously reducing any
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`discomfort in the patient’s eye, as compared to the administration of a composition in
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`gel form. The composition also provides for an additional wetting effect while providing
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`for a better contact and thus a controlled absorption of active agent into the eye (col. 2,
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`lines 10-18).
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`It would have been obvious to a person having ordinary skill in the art at the time
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`the invention was made to formulate the medical composition of Kita et al with the
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`aqueous solution of Lehmussaari et al; thus arriving at the claimed invention. One
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`skilled in the art would be motivated to do so because the aqueous solution of
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`Lehmussaari et al provides the benefits of better contact and controlled absorption of
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`active agent into the eye, as well as additional wetting effect, as taught by Lehmussaari
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`et al (col. 2, lines 10-18). One would reasonably expect success from the use of the
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`formulation of Lehmussaari et al to formulate the medical composition of Kita et al
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`because Lehmussaari et al teaches that the opthalmalogically active agent may be an
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`antiallergic agent containing basic groups such as pyridine and piperidine, and Kita et al
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`teach that it compounds have excellent antiallergic activity, and contain both pyridine
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`and a piperidine groups.
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`Application/Control Number: 10/500,354
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`Page 5
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`Art Unit: 1611
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`Regarding the limitations, “a water-soluble metal chloride in a light—stabilizing
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`effective amount of 0.2 w/v% or more” (claim 1), “sodium chloride at not less than 0.2
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`w/v% and not more than 0.8 w/v% in a light—stabilizing effective amount” (claim 10), and
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`“light-stabilized with a water-soluble metal chloride at not less than 0.2 w/v% (claim 13),
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`Lehmussaari et al exemplify an amount of sodium chloride of 0.9% (col. 5, Example 2).
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`This amount would necessarily be a light—stabilizing effective amount, as evidenced by
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`Applicant’s specification (e.g., see page 2, line 27 — page 3, line 10).
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`Regarding claims 2, 3, and 12, Lehmussaari et al exemplify sodium chloride as
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`the salt present in the composition, in an amount of 0.9% w/v (col. 5, Example 2), which
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`is within Applicant’s range.
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`Regarding claim 4, Lehmussaari et al teach that the amount of active agent in the
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`final composition is usually between 0.01 and 0.5% by weight (col. 4, lines 32- 34). This
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`range overlaps that of the claimed invention; one skilled in the art would be motivated to
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`manipulate the amount of active agent from within said ranges by routine
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`experimentation, in order to optimize the efficacy of the resultant composition.
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`Regarding claims 5 and 6, Kita et al teach the benzenesulfonic acid salt of
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`bepotastine (col. 1, lines 11-13).
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`Regarding claim 7, Lehmussaari et al teach that the pH of the composition is
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`suitably from 5 to 8 (col. 3, lines 59-60), which is within Applicant's range.
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`Regarding the limitation that the composition is an eye drop (claims 8, 10 and
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`13), Lehmussaari et al teach that its invention is an easy-to-use eye drop formulation
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`with improved patient compliance (col. 2, lines 3-5).
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`Page 6
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`Regarding the limitation that the composition is a nasal drop (claim 9), said
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`limitation recites an intended use of the composition. Since the components of the
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`composition of the combined references are suitable for use in the nose, said
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`composition would be capable of use as a nasal drop.
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`Response to Arguments
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`6.
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`Applicant's arguments with respect to claims 1-10, 12, and 13 have been
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`considered but are moot in view of the new ground(s) of rejection.
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`Applicant’s arguments are directed to the teachings of Stevenson et al; however,
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`this reference is no longer a part of the rejection applied, in light of Applicant’s
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`amendment (see paragraph 4, above).
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`No claims are allowed at this time.
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`Conclusion
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`7.
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
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`CFR1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`Application/Control Number: 10/500,354
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to BARBARA FRAZIER whose telephone number is
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`(571)270-3496. The examiner can normally be reached on Monday-Thursday 9am-4pm
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`EST.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Sharmila Landau can be reached on (571)272-0614. The fax phone
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`number for the organization where this application or proceeding is assigned is 571 -
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`273-8300.
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`Application/Control Number: 10/500,354
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toII—free).
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`If you would like assistance from a
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`BSF
`
`/Ashwin Mehta/
`
`Primary Examiner, Technology Center 1600
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