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.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`10/500,354
`
`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
`
`08/3 0/201 3
`
`ELECTRONIC
`
`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.
`
`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 (KW 04,07)
`
`MYLAN Ex. 1029, Page 1
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`MYLAN Ex. 1029, Page 1
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`

`
`Application No.
`1o/500,354
`
`App|icant(s)
`HIGASHIYAMA, MASAYO
`
`Office Action Summary
`
`AIA (First lnventorto File)
`Art unit
`Examiner
`,3\,*:‘)‘”S
`1611
`BARBARA FRAZIER
`-- 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)IXI Responsive to communication(s) filed on See Continuation Sheet.
`I:I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)lXl This action is non—final.
`2a)I:l This action is FINAL.
`3)I:I 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)I:I 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)IZI Claim(s) 13 5-9 and 12-15 is/are pending in the application.
`5a) Of the above Claim(s) j is/are withdrawn from consideration.
`6)I:I Claim(s) j is/are allowed.
`
`7)IZI Claim(s) 1 3 5-9 and 12-15 is/are rejected.
`8)I:I Claim(s) _ is/are objected to.
`9)I:I 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
`
`
`
`://www.us:>to. ow atents/init events/' , .h/index.’s or send an inquiry to PPI--lfeedbackf,<%usj;)togov.
`
`htt
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I 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)I:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
`
`b)I:l Some * c)I:l None of the:
`a)|:l All
`1.|:l Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No. j.
`3.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.
`
`Attach ment(s)
`
`1) E Notice of References Cited (PTO-892)
`3) D jntervjew summary (pTo-413)
`_
`_
`Paper No(s)/Mail Date. j
`2) E Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 9/14/12. 4) I:I Other‘ :-
`
`U.S. Patent and Trademark Office
`
`PTOL—326 (Rev. 08-13)
`
`Office Action Summary
`
`MYLF;qrp\p1E§9_er1@2lga,il 1 Q0822
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`MYLAN Ex. 1029, Page 2
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`

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`Continuation Sheet (PTOL-326)
`
`Application No. 10/500,354
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`Continuation of Status 1).Responsive to communication(s) filed on: 30 May 2012, 14 September 2012 and 15 February 2013.
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`MYLAN EX. 1029, Page 3
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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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`1.
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`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`Continued Examination Under 37 CFR 1. 114
`
`2.
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
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`application is eligible for continued examination under 37 CFR 1.114, and the fee set
`
`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 May
`
`2012 has been entered.
`
`Status of Claims
`
`3.
`
`4.
`
`Claims 1, 3, 5-9, and 12-15 are pending in this application.
`
`Cancellation of claims 2, 4, and 10 is acknowledged; claim 11 already stands
`
`canceled.
`
`5.
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`6.
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`Addition of new claims 14 and 15 is acknowledged.
`
`Claims 1, 3, 5-9, and 12-15 are examined.
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`MYLAN EX. 1029, Page 4
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`Page 3
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`Claim Rejections - 35 USC § 103
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`7.
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousness rejections set forth in this Office action:
`
`(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.
`
`8.
`
`The rejection of claims 1-10, 12, and 13 under 35 U.S.C. 103(a) as being
`
`unpatentable over Kita in view of Lehmussaari is modified as follows:
`
`9.
`
`Claims 1, 3, 5-9, 12, 13, and 15 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Lehmussaari et al. (“Lehmussaari”, US Patent 5,795,913,
`
`previously cited) in view of Kita et al. (“Kita”, US Patent 6,307,052, previously
`
`cited) and optionally further in view of Araki et al. (“Araki”, WO 01/80858). US
`
`2003/0139436 is the national stage entry of WO 01/80858, and thus serves as an
`
`English translation of WO 01/80858; accordingly, relevant passages will be taken from
`
`the US '436 reference.
`
`Regarding claims 1 and 13, Lehmussaari teaches an ophthalmic composition in
`
`the form of a topical aqueous solution consisting essentially of an ophthalmologically
`
`active agent containing basic groups, an ion sensitive hydrophilic polymer containing
`
`acidic groups, and at least one salt selected from the group of inorganic salts and
`
`buffers in a total amount of from 0.01 to 2.0% by weight (abstract). The
`
`ophthalmologically active agent may be an antiallergic agent containing basic groups,
`
`including basic heterocycles, such as pyridine and piperidine (col. 4, lines 2-9). The
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`MYLAN EX. 1029, Page 5
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`Page 4
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`Art Unit: 1611
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`salt/buffer functions as a viscosity reducing agent; choices of salts include sodium
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`chloride and potassium chloride (col. 3, lines 45-50 and claim 5). Sodium chloride is
`
`exemplified in an amount of 0.9% w/v (Example 2), and therefore the skilled artisan
`
`would be sufficiently motivated to prepare the aqueous solution with sodium chloride,
`
`with a reasonable expectation of forming the ophthalmic composition. The composition
`
`is prepared by dissolving active ingredient(s) and inorganic salt(s) in sterile water,
`
`followed by mixing with a dispersion of the polymer in sterile water, to form a
`
`homogeneous solution (col. 5, lines 1-11). The composition is administered as a liquid
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`and obtains a desired beneficial effect of the active agent in the eye, while
`
`simultaneously reducing any discomfort in the patient’s eye, as compared to the
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`administration of a composition in gel form. The composition also provides for an
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`additional wetting effect while providing for a better contact and thus a controlled
`
`absorption of active agent into the eye (col. 2, lines 10-18).
`
`While Lehmussaari teaches the steps of preparing an aqueous preparation
`
`comprising an ophthalmic agent and sodium chloride, and teaches the ophthalmically
`
`active agent may be an antiallergic agent containing basic groups, including basic
`
`heterocycles, such as pyridine and piperidine, Lehmussaari does not specifically teach
`
`that the antiallergic agent is bepotastine. Lehmussaari also does not specifically teach
`
`that the amount of sodium chloride is a light-stabilizing effective amount (claim 1), or
`
`that the antiallergic agent is light-stabilized (claim 13).
`
`Kita teaches that the benzenesulfonic acid salt or benzoic acid salt of (S)-4-[4-
`
`[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butanoic acid (i.e., bepotastine) is
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`MYLAN EX. 1029, Page 6
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`Page 5
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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
`
`medicine. Kita et al also teach that its present invention relates to a medical
`
`composition containing the compound as an effective ingredient (see col. 1, lines 10-
`
`22).
`
`Araki teaches a stabilized liquid preparation having improved light stability,
`
`comprising an aqueous solution containing sitafloxacin and sodium chloride (abstract).
`
`The light stabilizing effect is enhanced with an increase of the sodium chloride
`
`concentration; a particularly high stabilizing effect is obtained at a sodium chloride
`
`concentration of 0.1% or higher (paragraph [0055]). The liquid preparation is suitable
`
`for systemic administration such as injections and drops, as well as topical
`
`administration such as liquids for external use and sprays (paragraph [0063]).
`
`It would have been obvious to a person having ordinary skill in the art at the time
`
`the invention was made to select bepotastine as the antiallergic agent in the preparation
`
`of Lehmussaari, with the reasonable expectation that the preparation thus prepared
`
`would be light—stabilized; thus arriving at the claimed invention. First, one skilled in the
`
`art would be motivated to select bepotastine as the antiallergic agent in the preparation
`
`of Lehmussaari because said compound provides the benefits of excellent
`
`antihistaminic activity and antiallergic activity, little hygroscopicity and excellent
`
`physicochemical stability, so that it is particularly suitable compound as a medicine, as
`
`taught by Kita. Additionally, Lehmussaari teaches that the ophthalmalogically active
`
`agent may be an antiallergic agent containing basic groups such as pyridine and
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`Page 6
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`piperidine, and the bepotastine compound taught by Kita contains both pyridine and
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`piperidine groups.
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`Regarding the limitations “a light—stabilizing effective amount” and “an active
`
`ingredient...which is light-stabilized”, it is noted that the composition of the combined
`
`references is drawn to the components as the claimed invention, i.e., a solution
`
`comprising water, a water-soluble metal chloride, and an ophthalmically active agent
`
`(i.e., an antiallergy agent, such as bepotastine).
`
`It is also noted that the amount of
`
`active agent taught by Lehmussaari is preferably in the range of 0.1 to 0.5% by weight
`
`(col. 4, lines 32-35), which falls within the range taught for the active agent in the
`
`claimed invention (see page 5, lines 1-9 of specification), and the amount of metal
`
`chloride is from 0.01 to 2.0% (abstract), with an amount of 0.9% exemplified, which is
`
`comparable to that of the claimed invention (see page 5, lines 17-20 of specification).
`
`Therefore, since the composition of the combined references comprises the same
`
`components in comparable amounts, the skilled artisan would reasonably expect the
`
`resultant aqueous preparation to have the same effect, i.e., to be light-stabilized, absent
`
`evidence to the contrary. Optionally additionally, since Araki teaches that sodium
`
`chloride is known to improve light stability of other active agents (such as sitafloxacin) in
`
`aqueous preparations, the skilled artisan would reasonably expect the amount of
`
`sodium chloride in Lehmussaari to impart a light—stabilizing effect to the composition of
`
`the combined references, and thus be a “light-stabilizing effective amount”, absent
`
`evidence to the contrary.
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`Page 7
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`Art Unit: 1611
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`Regarding the amount of metal chloride (claims 1, 13, and 15), Lehmussaari
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`teaches an amount of buffer/salt from 0.01 to 2.0% by weight (col. 2, lines 65-67) which
`
`functions to reduce the viscosity, which is favorable for both efficacy and ease of
`
`application (col. 3, lines 35-40), and Araki teaches that the light stabilizing effect is
`
`enhanced with an increase of the sodium chloride concentration, wherein a particularly
`
`high stabilizing effect is obtained at a sodium chloride concentration of 0.1% or higher
`
`(paragraph [0055]) . These ranges overlap those of the claimed invention; one skilled in
`
`the art would be motivated to manipulate the amount of salt from within said ranges,
`
`including the ranges claimed, by routine experimentation, in order to optimize properties
`
`of the resultant composition, such as viscosity as taught by Lehmussaari, and/or light-
`
`stabilizing effect as taught by Araki.
`
`Regarding the choice of metal chloride (claims 3, 12, and 15) Lehmussaari
`
`teaches six choices of buffer/salt, two of which are sodium chloride and potassium
`
`chloride (col. 3, lines 45-50), and exemplify sodium chloride as the salt present in the
`
`composition (col. 5, Example 2).
`
`Regarding claims 5, 6, and 15, Kita teaches the benzenesulfonic acid salt of
`
`bepotastine (col. 1, lines 11-13).
`
`Regarding claim 7, Lehmussaari teaches that the pH of the composition is
`
`suitably from 5 to 8 (col. 3, lines 59-60), which is within Applicant's range.
`
`Regarding the limitation that the composition is an eye drop (claims 8 and 13),
`
`Lehmussaari teaches that its invention is an easy-to-use eye drop formulation with
`
`improved patient compliance (col. 2, lines 3-5).
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`Page 8
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`Art Unit: 1611
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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
`
`composition of the combined references are suitable for use in the nose, said
`
`composition would be capable of use as a nasal drop.
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`Response to Arguments and Declaration
`
`10.
`
`Applicant's arguments and Declaration filed 14 September 2012 have been fully
`
`considered but they are not persuasive.
`
`Applicant first argues that the composition of Lehmussaari requires the presence
`
`of an ion sensitive, hydrophilic polymer having viscosity, such as Carbopol, to control
`
`the formation of the polymer film on the cornea of the eye, but Carbopol is degraded by
`
`light, citing the Chemical Abstract reference dated January 3, 1972 (cited in the IDS
`
`filed September 14, 2012). Applicant asserts that the Carbopol polymer would
`
`materially affect the basic and novel characteristics of the preparation because it would
`
`introduce a component that degrades in light into a solution that is designed to “light-
`
`stabilize” bepotastine by using a water-soluble metal chloride. (See Applicant's
`
`Remarks, filed 14 September 2012, page 5, and Declaration filed 14 September 2012,
`
`Section I).
`
`This argument is not persuasive. While Applicant's evidence teaches Carbopol
`
`polymers, such as those taught in Lehmussaari, degrade in the presence of light,
`
`Applicant's evidence does not show that such a polymer, when present in the
`
`composition of the combined references, would cause the composition to not be light-
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`Page 9
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`Art Unit: 1611
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`stable. Thus, it is not clear that such a polymer would affect the basic and novel
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`characteristics of the claimed composition.
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`It is further noted that both carbopol and
`
`bepotastine contain reactive carboxyl groups; therefore, one of ordinary skill in the art
`
`would reasonably expect that a compound (such as sodium chloride) which light-
`
`stabilizes bepotastine would also light—stabilize carbopol, absent evidence to the
`
`contrary.
`
`Examiner’s note: objective evidence presented which shows that carbopol
`
`degrades in the presence of light and sodium chloride (i.e., is not light-stabilized by a
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`metal chloride such as sodium chloride) would be sufficient to overcome the rejection.
`
`Applicant then argues that the Lehmussaari reference provides no teaching that
`
`varying the salt concentration would be helpful for light-stabilization or viscosity
`
`optimization. Applicant argues that Lehmussaari teaches that the amount of polymer,
`
`rather than the viscosity of the composition, is important from the point of view of
`
`obtaining good absorption of drug into the eye. Applicant asserts that one skilled in the
`
`art would not have recognized that the amount of salt is a result—effective variable.
`
`(See
`
`Remarks, page 6).
`
`This argument is not persuasive. While Lehmussaari teaches the amount of
`
`polymer is important in terms of absorption of the active ingredient (col. 2, lines 19-23),
`
`Lehmussaari also teaches that it is important to control the viscosity of the composition,
`
`both from the view point of efficacy of the product in the target site, and of ease of
`
`application (col. 3, lines 38-46). Therefore, one skilled in the art would, in fact, be
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`motivated to manipulate the amount of salt from within the range taught by Lehmussaari
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`by routine experimentation, in order to optimize the viscosity of the composition.
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`Applicant also argues that, in Experimental Example 1 of the specification,
`
`Formulation 2 comprising 0.1 W/V°/o of sodium chloride fails to light-stabilize bepotastine
`
`besilate, while Formulations 3-6 comprising 0.2 to 1.18 W/V°/o of a metal chloride provide
`
`a light—stabilizing effect. (See Remarks, page 6).
`
`Applicant’s data in the specification has been fully considered, but is not
`
`sufficient for overcoming the rejection. While Applicant's data shows an optimal range
`
`in which sodium, potassium, or calcium chloride impart a light—stabilization effect to a
`
`bepotastine-containing composition (Example 1 of specification), the range of amounts
`
`now claimed (i.e., 0.2 to 1.2% w/v) still sufficiently overlaps that of Lehmussaari (0.01 to
`
`2.0%, with an amount of 0.9 W/V°/o exemplified; see Example 2) and Araki (0.01°/o to
`
`0.5%; see Table 1 and paragraph [0101]) that one skilled in the art would still arrive at
`
`such a range by routine experimentation, and would be motivated to do so in order to
`
`optimize the viscosity of the composition, as taught by Lehmussaari (which would
`
`necessarily be a light—stabilizing effective amount), and/or to light-stabilize the
`
`composition, as taught by Araki.
`
`Applicant further argues that sitafloxacin (the compound in the composition of
`
`Araki) has a completely different chemical structure, and has completely different
`
`chemical properties as compared to bepotastine. Applicant asserts there are no
`
`common chemical groups in the two compounds that would suggest they share any
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`similar activity or have any similar properties. (See Remarks, pages 7-8, and
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`Declaration, Section llA).
`
`This argument is not persuasive. Both sitafloxacin and bepotastine contain the
`
`same reactive groups (carboxyl, chloro), and therefore one skilled in the art would
`
`reasonably expect that a compound (such as sodium chloride) which light-stabilizes
`
`sitafloxacin would also light-stabilize bepotastine, absent evidence to the contrary.
`
`Applicant further argues that the Araki reference is silent on the suppression of
`
`coloration and precipitation, while the specification demonstrates when an aqueous
`
`bepotastine solution free of sodium chloride was subjected to light irradiation, the
`
`solution turned black green, and a precipitate was produced. Applicant asserts that a
`
`person of ordinary skill in the art with the goal of reducing or eliminating this
`
`phenomenon would not refer to the teachings Araki, because the reference provides no
`
`description regarding coloration and precipitation. (See Remarks, page 9, and
`
`Declaration, Section IIB).
`
`This argument is not persuasive. Araki teaches that, in the presence of sodium
`
`chloride, sitafloxacin in aqueous solution is prevented from decomposing on irradiation,
`
`and reductions in light transmission of an aqueous solutions sitafloxacin solution are
`
`suppressed (paragraph [0005]). Since reductions in light transmission would be
`
`attributable to the presence of precipitates in solution, one skilled in the art would
`
`reasonably expect that the presence of sodium chloride suppresses precipitation of a
`
`precipitate, absent evidence to the contrary.
`
`it is further noted that independent claims
`
`1 and 13 do not require suppression of coloration or precipitation, only that sodium
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`MYLAN EX. 1029, Page 13
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`Page 12
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`chloride is present in a “light-stabilizing effective amount” (claim 1), or that bepotastine
`
`or a salt thereof is light-stabilized (claim 13), which limitations are met by the
`
`combination of references.
`
`Therefore, it is the Examiner’s position that the claims are rendered obvious.
`
`11.
`
`Claim 14 is allowed.
`
`Allowable Subject Matter
`
`Conclusion
`
`12.
`
`Claims 1, 3, 5-9, 12, 13, and 15 are rejected.
`
`13.
`
`Claim 14 is allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to BARBARA FRAZIER whose telephone number is
`
`(571)270-3496. The examiner can normally be reached on Monday-Friday 9am-2:30pm
`
`EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Daniel Sullivan can be reached on (571)272-0779. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-8300.
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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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`If you would like assistance from a
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`BSF
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`/Daniel M Sullivan/
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`Supervisory Patent Examiner, Art Unit 1611
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`MYLAN EX. 1029, Page 15
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`MYLAN Ex. 1029, Page 15