APPLICATION NO.
`
`FILING DATE
`
`FIRST NAM < ) INVENTOR
`
`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
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/ 1 0/201 1
`
`ELECTRONIC
`
`10/500,354
`
`513
`
`7590
`
`06/10/2011
`
`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 2003
`
`Page 1 of 11
`
`SENJU EXHIBIT 2003
`MYLAN v. SENJU
`IPR2016-00626
`
`

`
`Application No.
`
`App|icant(s)
`
`10/500,354
`
`HIGASHIYAMA, MASAYO
`
`Office Action Summary
`
`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 laterthan three months after the mailing date ofthis communication, even iftimely filed, may reduce any
`earned patent term adjustment. See 37 CFR1.704(b).
`
`Status
`
`1)IZ Responsive to communication(s) filed on 19 May 2011.
`
`2a)I:| This action is FINAL.
`
`2b)IZ This action is non-final.
`
`3)I:l Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)IZ Claim(s) 1-10 12 and 13 is/are pending in the application.
`4a) 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
`
`9)|:l The specification is objected to by the Examiner.
`
`10)|:| The drawing(s) filed on j is/are: a)I:I accepted or b)I:l objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO—152.
`
`Priority under 35 U.S.C. § 119
`
`12)|:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119( )-(d) or (f).
`
`b)I:l Some * c)|:| None of:
`a)I:| All
`1.|:I Certified copies of the priority documents have been received.
`
`2.|:| Certified copies of the priority documents have been received in Application No.
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attach ment(s)
`
`4) D Interview Summary (PTO—4‘l3)
`Paper N0(s)/Mail Date. :-
`5) I:I NOIIC9 °f Informal P3197“ APPIICEIIIOIT
`6) D Other: :.
`
`1) D Notice of References Cited (PTO—892)
`2) I:I Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) D Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date :.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20110605-A
`
`Page 2 of 11
`
`

`
`Applicant(s)/Patent Under
`Reexamination
`
`HIGASHIYAMA, MASAYO
`
`Art Unit
`
`1611
`
`Application/Control No.
`
`Search NOTES
`
`10500354
`
`Examiner
`
`CHARLESWORTH RAE
`
`SEARCHED
`
`SEARCH NOTES
`
`-
`
`Updated searches
`
`Updated searches
`EAST search updated
`
`7/16/O8
`
`O4/16/O9
`4/2/10
`
`or
`BSF
`
`EAST search updated
`
`12/13/10
`
`BSF
`
`INTERFERENCE SEARCH
`
`US. Pateni and Trademark Office
`
`Part of Paper No.
`
`: 20110605-A
`
`Page 3 of 11
`
`

`
`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`DETAILED ACTION
`
`Continued Examination Under 37 CFR 1. 114
`
`1.
`
`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
`
`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 5/19/11
`
`has been entered.
`
`2.
`
`Claims 1-10, 12, and 13 are pending in this application. Claim 11 stands
`
`Status of Claims
`
`canceled.
`
`3.
`
`Claims 1-10, 12, and 13 are examined.
`
`Claim Rejections - 35 USC § 103
`
`4.
`
`The following is a quotation of 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.
`
`Page 4 of 11
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`

`
`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`5.
`
`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—pyridy|)methoxy]piperidino]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°/o 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
`
`excellent in antihistaminic activity and antiallergic activity, has little hygroscopicity and
`
`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).
`
`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
`
`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
`
`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
`
`Page 5 of 11
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`Page 4
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`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 salt/buffer functions as a viscosity
`
`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
`
`desired beneficial effect of the active agent in the eye, while simultaneously reducing
`
`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
`
`providing for a better contact and thus a controlled absorption of active agent into the
`
`eye (col. 2, lines 10-18).
`
`It would have been obvious to a person having ordinary skill in the art at the time
`
`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.
`
`Page 6 of 11
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`Page 5
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`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% in a light-stabilizing effective amount” (claim 10), and
`
`“light-stabilized with a water-soluble metal chloride at not less than 0.2 W/V°/o (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
`
`the viscosity reducing effect of the salt. Such amounts would necessarily be a light-
`
`stabilizing effective amount, as evidenced by App|icant’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.
`
`Page 7 of 11
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`Page 6
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`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
`
`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.
`
`6.
`
`Applicant's arguments filed 5/19/11 have been fully considered but they are not
`
`Response to Arguments
`
`persuasive.
`
`Applicant argues the combination of Kita and Lehmussaari would not have led to
`
`predictable results, adding that a person of ordinary skill in the art would not have been
`
`motivated to select a metal chloride from all of the salts and buffers disclosed in
`
`Lehmussaari and then manipulate the amount of salt and/or buffer to arrive at 0.2%
`
`w/v% from the “broad range" of 0.01-1 .5%. Applicant argues that the objective of
`
`adding a salt is different between the present application and Lehmussaari (pages 2-3
`
`of Remarks filed 5/19/11).
`
`This argument is not persuasive. Regarding the choice of metal chloride,
`
`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. Secondly, Applicant's amount of metal
`
`Page 8 of 11
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`

`
`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`Page 7
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`chloride in claim 1
`
`is not 0.2 w/v%, but rather 0.2 w/v% or more, which is actually
`
`broader than the range disclosed in Lehmussaari. Of the range disclosed in
`
`Lehmussaari, Lehmussaari teaches that its disclosed range functions to reduce
`
`viscosity, and thus it would be within the purview of the skilled artisan to manipulate the
`
`amount of viscosity reducing agent within said range, including amounts of 0.2 w/v% or
`
`more, by routine experimentation, in order to optimize the viscosity reducing effect of
`
`the viscosity reducing agent.
`
`It is noted that the prior art need not optimize amounts for
`
`the same reasons as Applicants. Applicants have not argued the criticality of the
`
`claimed range, or that amounts within the range of Lehmussaari but outside the claimed
`
`range of Applicants would not possess the properties claimed by Applicants.
`
`In response to Applicant’s arguments that the results in the specification
`
`demonstrate more stability with sodium chloride rather than a buffer, while Lehmussaari
`
`teaches a preferred use of a buffering salt to a metal chloride for appearance and
`
`storage purposes (page 3 of Remarks), it is noted that, while Lehmussaari does teach a
`
`preferred use of a buffer, it does not teach that a metal chloride may not be used, and
`
`therefore one skilled in the art would still consider a metal chloride to be useful, albeit
`
`perhaps not as preferred. However, 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). As noted above, 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.
`
`Page 9 of 11
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`

`
`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`Page 8
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`Therefore, it is the Examiner's position that the claims are rendered obvious.
`
`No claims are allowed at this time.
`
`Conclusion
`
`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—Thursday 9am-4pm
`
`EST.
`
`it attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Sharmila Landau can be reached on (571)272-0614. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`Page 10 of 11
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`

`
`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`Page 9
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`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 (toII—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 Hamal
`
`Primary Examiner, Art Unit 1632
`
`Page 11 of 11