APPLICATION NO.
`
`FILING DATE
`
`FIRST NAM < ) INVENTOR
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`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.0 Box 1450
`Alexandria, Virginia 22313- I450
`Www.uspto gov
`
`06/3 0/2004
`
`Masayn Higashiyama
`
`2004_l 01 6A
`
`2612
`
`EXAMINER
`
`FRAZIER. BARBARA s
`
`ART UNIT
`1511
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`PAPER NUMBER
`
`NOTIFICATION DATE
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`DELIVERY MODE
`
`11/3 0/201 1
`
`ELECTRONIC
`
`10/500,354
`
`513
`
`7590
`
`11/30/2011
`
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`Suite 400 East
`
`Washington, DC 20005-1503
`
`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.co1n
`eoa@ wenderoth.com
`
`PTOL—9OA (Rev. 04/07)
`
`SENJU EXHIBIT 2004
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`Page 1 of 10
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`SENJU EXHIBIT 2004
`MYLAN v. SENJU
`IPR2016-00626
`
`

`
`Office Action Summary
`
`Application No.
`
`App|icant(s)
`
`10/500,354
`
`Examiner
`
`BARBARA FRAZIER
`
`HIGASHIYAMA, MASAYO
`
`-- 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 bythe 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 CFR1.704(b).
`
`Status
`
`1)lZ Responsive to communication(s) filed on 12 September 2011.
`
`2b)I:l This action is non-final.
`This action is FINAL.
`An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`j; the restriction requirement and election have been incorporated into this action.
`
`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 Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)IZ Claim(s) 1-10 12 and 13 is/are pending in the application.
`5a) Of the above Claim(s)
`is/are withdrawn from consideration.
`
`1-10 12 and 13 is/are rejected.
`
`is/are objected to.
`are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`
`11)|:I The drawing(s) filed on j is/are: a)I:I accepted or b)|: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).
`
`12)|:l 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
`
`13)|:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119( )—(d) or (f).
`
`a)|:| All
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`b)I:l Some * c)I:l None of:
`Certified copies of the priority documents have been received.
`
`Certified copies of the priority documents have been received in Application No. _
`
`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)
`
`4) D Interview Summary (PTO-413)
`Papef N0(3)/Ma” DaTe- j
`5) I:I NOIICE‘ Of Inf0rm3I Patent APPIICETIOII
`6) D Other:
`.
`
`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
`.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20111122
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`Page 2 of 10
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
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`DETAILED ACTION
`
`Status of Claims
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`1.
`
`Claims 1-10, 12, and 13 are pending in this application. Claim 11 stands
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`canceled.
`
`2.
`
`Claims 1-10, 12, and 13 are examined.
`
`Claim Rejections - 35 USC § 103
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`3.
`
`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:
`
`(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.
`
`4.
`
`Claims 1-10, 12, and 13 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Kita et al (US Patent 6,307,052, previously cited) in view of
`
`Lehmussaari et al (US Patent 5,795,913).
`
`The claimed invention, as amended, is drawn to an aqueous liquid preparation
`
`comprising, in an aqueous solution, an active ingredient consisting of ( )-(S)-4-[4-[(4-
`
`chlorophenyl)(2-pyridyl)methoxyjpiperidino]butyric acid (i.e., bepotastine) or a
`
`pharmaceutically acceptable acid addition salt thereof, and a water-soluble metal
`
`chloride in a light stabilizing effective amount of 0.2 w/v% or more (see claim 1).
`
`Kita et al teach 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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`Page 3 of 10
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
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`Page 3
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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-
`
`22).
`
`While Kita et al teach a medical composition comprising bepotastine, Kita et al do
`
`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.
`
`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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`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). The salt/buffer functions as a viscosity
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`reducing agent; choices of salts include sodium chloride and potassium chloride (col. 3,
`
`lines 45-50 and claim 5). The composition is administered as a liquid and obtains a
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`desired beneficial effect of the active agent in the eye, while simultaneously reducing
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`any discomfort in the patient’s eye, as compared to the administration of a composition
`
`in gel form. The composition also provides for an additional wetting effect while
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`providing for a better contact and thus a controlled absorption of active agent into the
`
`eye (col. 2, lines 10-18).
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`Page 4 of 10
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
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`Page 4
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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
`
`aqueous solution of Lehmussaari et al; thus arriving at the claimed invention. One
`
`skilled in the art would be motivated to do so because the aqueous solution of
`
`Lehmussaari et al provides the benefits of better contact and controlled absorption of
`
`active agent into the eye, as well as additional wetting effect, as taught by Lehmussaari
`
`et al (col. 2, lines 10-18). One would reasonably expect success from the use of the
`
`formulation of Lehmussaari et al to formulate the medical composition of Kita et al
`
`because Lehmussaari et al teaches that the opthalmalogically active agent may be an
`
`antiallergic agent containing basic groups such as pyridine and piperidine, and Kita et al
`
`teach that its compounds have excellent antiallergic activity, and contain both pyridine
`
`and a piperidine groups.
`
`Regarding the limitations, “a water-soluble metal chloride in a light-stabilizing
`
`effective amount of 0.2 w/v% or more” (claim 1), “sodium chloride at not less than 0.2
`
`w/v% and not more than 0.8 w/v°/3 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),
`
`as well as other particular amounts claimed (claims 2, 4, and 13), Lehmussaari 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). This range overlaps 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
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`Page 5 of 10
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
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`Page 5
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`the viscosity reducing effect of the salt. Such amounts would necessarily be a light-
`
`stabilizing effective amount, as evidenced by Applicant's specification (e.g., see page 2,
`
`line 27 — page 3, line 10).
`
`Regarding the choice of metal chloride (claims 3, 10, and 12) Lehmussaari et al
`
`teach 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 and 6, Kita et al teach the benzenesulfonic acid salt of
`
`bepotastine (col. 1, lines 11-13).
`
`Regarding claim 7, Lehmussaari et al teach 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, 10 and
`
`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).
`
`Regarding the limitation that the composition is a nasal drop (claim 9), said
`
`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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`5.
`
`Applicant's arguments filed 6/10/11 have been fully considered but they are not
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`Response to Arguments
`
`persuasive.
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`Page 6 of 10
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
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`Page 6
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`Applicant argues the ion sensitive, hydrophilic polymer of Lehmussaari, such as
`
`Carbopol, would materially affect the basic and novel characteristics of the aqueous
`
`liquid preparation of the claimed invention, citing WO 2009/142950 (“WO ‘950”), which
`
`teaches a higher NTU value for an aqueous solution of Carbomer (i.e., Carbopol) and
`
`sodium chloride, as compared to the same solution which does not include sodium
`
`chloride.
`
`This argument is not persuasive.
`
`It is first noted that App|icant’s specification
`
`teaches that other same or different kinds of efficacious ingredients may be added
`
`appropriately as long as the object of the present invention is not impaired (page 6, lines
`
`22-25 of the specification).
`
`It is also noted that the W0 ‘95O patent has a publication
`
`date of 26 November 2009 and a filing date of 12 May 2009, both of which are well past
`
`the filing date of the instant application (30 June 2004). Applicant has not indicated any
`
`teaching in the specification which teaches the polymer of Lehmussaari would materially
`
`affect the basic and novel characteristics of the claimed invention, or would impair the
`
`object of the present invention, or that the basic and novel characteristics of the claimed
`
`invention exclude ion sensitive hydrophilic polymers from the "efficacious ingredients”
`
`which may be included in the composition. Lehmussaari teaches hydrophilic polymers,
`
`such as Carbopol, are useful with ophthalmologically active agents and salts in
`
`ophthalmic compositions. Therefore, at the time the invention was made, it still would
`
`have been obvious for a person having ordinary skill in the art to formulate the medical
`
`composition of Kita et al with the aqueous solution of Lehmussaari et al; thus arriving at
`
`the claimed invention.
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`Page 7 of 10
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
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`Page 7
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`Even if the teachings of the W0 ‘950 patent were applicable, it is noted that the
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`W0 ‘950 patent only teaches a higher NTU when the aqueous solution comprises only
`
`carbopol and sodium chloride; however, when other ingredients are added, such as
`
`povidone, the NTU value decreases. Lehmussaari teaches solutions of Carbopol and
`
`sodium chloride are, in fact, suitable as ophthalmic compositions (e.g., see Example 2),
`
`and therefore one skilled in the art would reasonably expect success from formulating
`
`formulate the medical composition of Kita et al with the aqueous solution of
`
`Lehmussaari et al.
`
`In response to Applicant’s arguments that Lehmussaari teaches that "for
`
`appearance and storage purposes, the use of a buffering salt is preferred to the use of
`
`e.g. sodium or potassium chloride as the viscosity reducing agent", it is noted that
`
`Lehmussaari specifically names only six viscosity reducing agents, the first two named
`
`being metal chlorides (col. 3, lines 45-50), and therefore one skilled in the art would
`
`clearly envisage the use of a metal chloride. Even if a buffering salt may be preferred,
`
`disclosed examples and preferred embodiments do not constitute a teaching away from
`
`a broader disclosure or nonpreferred embodiments.
`
`In re Susi, 440 F.2d 442, 169
`
`USPQ 423 (CCPA 1971).
`
`In response to Applicants arguments that the references do not teach or suggest
`
`the light—stability or the light—stabi|ization of a drug, it is noted that the amounts of
`
`buffer/salt of Lehmussaari (used to control viscosity) overlap those of the claimed
`
`invention, such that one skilled in the art would be motivated to manipulate the amount
`
`of salt from within said ranges, including the ranges claimed, by routine
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`Page 8 of 10
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`Page 8
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`experimentation, in order to optimize the viscosity reducing effect of the salt. Such
`
`amounts would necessarily be a light—stabilizing effective amount, as evidenced by
`
`Applicant's specification (e.g., see page 2, line 27 — page 3, line 10). Applicant has not
`
`pointed to any evidence demonstrating the criticality of the claimed range of amounts for
`
`providing a light—stabilizing effect, or that amounts falling within the amounts of
`
`Lehmussaari but outside those of the claimed invention do not provide a light—stabilizing
`
`effect.
`
`Therefore, it is the position of the Examiner that the claims are rendered obvious.
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`Conclusion
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`No claims are allowed at this time.
`
`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR1.136( ).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action.
`
`In the event a first reply is filed within
`
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`
`mailed until after the end of the THREE—MONTH shortened statutory period, then the
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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 mailing date of this final action.
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`Page 9 of 10
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
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`Page 9
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`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.
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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.
`
`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.
`
`BSF
`
`/Joanne Hama/
`
`Primary Examiner, Art Unit 1632
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`Page 10 of 10