UNITED STA 1ES p A 1ENT 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
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
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`10/500,354
`
`06/30/2004
`
`Masayo Higashiyama
`
`2004_1016A
`
`2612
`
`513
`7590
`08/05/2008
`WENDEROTH, LIND & PONACK, L.L.P.
`2033 K STREET N. W.
`SUI1E 800
`WASHINGTON, DC 20006-1021
`
`EXAMINER
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`RAE, CHARLESWORTH E
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`ART UNIT
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`PAPER NUMBER
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`1611
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`MAIL DATE
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`DELIVERY MODE
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`08/05/2008
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`PAPER
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`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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`PTOL-90A (Rev. 04/07)
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`Page 1 of 9
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`SENJU EXHIBIT 2002
`MYLAN v. SENJU
`IPR2016-00626
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`

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`Office Action Summary
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`Application No.
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`Applicant(s)
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`10/500,354
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`Examiner
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`HIGASHIYAMA, MASAYO
`
`Art Unit
`
`1611
`CHARLESWORTH RAE
`-- The MAILING DATE 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 )IZ! Responsive to communication(s) filed on 08 Mav 2008.
`2a)[8J This action is FINAL.
`2b)0 This action is non-final.
`3)0 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.
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`Disposition of Claims
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`4)[8J Claim(s) 1-11 is/are pending in the application.
`4a) Of the above claim(s) 11 is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 1-10 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O 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 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
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`Priority under 35 U.S.C. § 119
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`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some* c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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)
`1) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
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`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
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`Part of Paper No./Mail Date 20080625
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`Page 2 of 9
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
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`Page 2
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`DETAILED ACTION
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`Acknowledgement is made of applicants' filing of the instant application as a
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`Request for Continued Examination (RCE) under 37 CFR 1.1114.
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`Applicant's statement that support for the claim amendment may be found in the
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`specification at page 8, lines 8-15, is acknowledged.
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`Status of the Claims
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`Claims 1-11 are currently pending in this application.
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`Claim 11 is withdrawn for examination purposes for being directed to non-elected
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`subject matter.
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`Claim 1-10 are currently under examination.
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`Amendment
`Claims 1 and 10 have been amended to specify that the metal chloride is
`a light-stabilizing agent.
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`Miscellaneous Comments
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`Applicant's request for a personal interview prior to this Office action is
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`acknowledged. However, the examiner made several attempts to schedule an interview
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`with applicant without any success. In view of the inability to schedule a timely
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`interview, this Office action is being issued.
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`Claim rejections- 35 USC 103(a)
`The following is a quotation of 35 U.S.C. 1 03(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`Page 3 of 9
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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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`(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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`This application currently names joint inventors. In considering patentability of
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`the claims under 35 U.S.C. 1 03(a), the examiner presumes that the subject matter of
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`the various claims was commonly owned at the time any inventions covered therein
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`were made absent any evidence to the contrary. Applicant is advised of the obligation
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`under 37 CFR 1 .56 to point out the inventor and invention dates of each claim that was
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`not commonly owned at the time a later invention was made in order for the examiner to
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`consider the applicability of 35 U.S.C. 1 03(c) and potential 35 U.S.C. 1 02(e), (f) or (g)
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`prior art under 35 U.S.C. 1 03(a).
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`Claims 1-10 are rejected under 1 03(a) as being unpatentable over Koida et al.
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`(JP 2001261553A, abstract only; already made of record), in view of Kita et al (US
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`Patent 6,307,052 81 ;already made of record), and Remington's (Remington's
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`Pharmaceutical Sciences. 1980; pages 1410-1419; already made of record).
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`It is noted that the light-stabilizing effect of the metal chloride salts encompassed
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`by the instant claims is deem to be a characteristic that is inseparable from the chemical
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`entity such that the light-stabilizing effect of said metal chloride salts is deemed to be
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`coextensive with the claimed aqueous liquid preparation. Thus, the amendment of
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`claims 1 and 10 to recite the light-stabilizing limitation does not confer patentability to
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`the applicant's claimed invention.
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`Koida et al. teach bepotastine (i.e. (S)-4-[4-[(4-chlorophenyl)(2-
`
`pyridyl)methoxy]piperidino] butyric acid) has optical purity and has markedly improved
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`Page 4 of 9
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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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`storage stability because of no occurrence of racemization (abstract). Claims 1, 4, 5,
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`and 10 recite said compound.
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`Koida et al. do not teach applicant's instant claimed aqueous liquid preparation
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`comprising bepotastine and a water-soluble metal chloride.
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`Kita et al. is added to show the general state of the art regarding aqueous
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`preparations comprising benzenesulfonate and a compound containing a 2-pyridyl
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`moiety having antihistaminic activity. Kita et al. teach that the benzenesulfonate and
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`benzoate of (S )-4-[4-[( 4-chlorophenyl )(2-pyridyl )methoxy]piperidino ]butanoic acid
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`possesses excellent antihistaminic and antiallergic agent activity (column 1, line 10 to
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`column 3, line 19). Kita et al. teach that the acid addition salt has little hydroscopicity
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`and excellent physiochemical stability so that it is a particularly suitable compound as a
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`medicine for allergic skin diseases, allergic rhinitis, sneeze, mucus, cough due to
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`respiratory inflammation such as a cold, and bronchial asthma (column 1, lines11-54 ).
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`Remington's Pharmaceutical Sciences (1980) is added to show the general state
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`of the art regarding the utilization of metal chlorides in aqueous pharmaceutical
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`preparations such as eye and nasal drops. Remington's teaches sodium chloride
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`equivalents of certain medicinals in aqueous solution (pages 1411, column 2, to 1419;
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`Appendix A; page 1419, Appendix B), which includes calcium chloride (page 1413),
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`potassium chloride (page 1417), sodium chloride (page 1418), benzalkonium
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`chloride (page 1413). Remington's teaches that besides water, certain other solvents
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`are frequently employed in nose drops, ear drops, and other preparations to be used in
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`various parts of the body (page 1410, column 2, second paragraph from the bottom).
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`Page 5 of 9
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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 instant claim limitations regarding the concentration of the metal chloride as recited
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`in claims 2, 4, and 10 (e.g. metal chloride concentration of 0.15-1.5 w/v%; acid addition
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`salt concentration of 0.1-2 w/v%; pH 4-8.5; (S)-4-[4-[(4-chlorophenyl)(2-
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`pyridyl)methoxy]piperidino] butyric acid monobenzenesulfonate and sodium chloride at
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`not less than 0.2 w/v% and not more than 0.8 w/v%) are reasonably construed to be
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`within the scope and skill of an artisan skilled in the art as these limitations represent
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`optimization in preparing a stable composition (pages 1411, column 2, to 1419;
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`Appendix A; page 1419, Appendix B). The pH range limitation of pH 4-8.5 as recited in
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`claim 7 is encompasses the pH range routinely considered to be the optimum pH for
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`aqueous preparations that are intended for use as eye drops.
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`It would have been obvious to one of ordinary skill at the time the invention was
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`made to formulate the instant compound in an aqueous solution comprising a metal
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`chloride. One would have been motivated to do so since Koida teaches similar
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`compounds have antihistamine activity and one would have reasonably assumed that
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`the instant compounds also have this acitivity. Further, one would have been motivated
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`to formulate the compounds in an aqueous solution since it is generally known in the art
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`to formulate anti-histamine agent into nasal and eye drops to relieve allergies and
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`Remington teaches that it is convention to formulation eye drops and nasal drops with
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`metal chlorides.
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`Thus, a person of ordinary skill in the art at the time the instant invention was
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`made would have deemed it obvious to create the instant claimed invention with a
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`reasonable predictability.
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`Page 6 of 9
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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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`Relevant Art of Record
`The below art reference made of record and relied upon is considered pertinent to
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`applicant's invention.
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`Onuki et al. (US Patent Application Pub. No. 2004/0147605;already made of
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`record) teach formulations comprising one or more antihistamine compound, including
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`bepotastine besilate (page 2, para 0017, line 11 ).
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`Himmelstein et al. (US Patent 5,599,534; already made of record) teach pH-
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`responsive reversible gelling compositions and liquid formulations for sustained delivery
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`of therapeutic or diagnostic agents suitable for use as drop or spray instillable or topical
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`drug delivery vehicles for drugs various drugs, including antihistamines and
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`decongestants (e.g. pyrilmaine, chlorpheniramine, tetrahydrazoline, antazonline),
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`which are particularly suitable for delivering pharmaceutical compounds to the ocular
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`environment due to clarity and lubricating properties of the gel (col. 5, lines 32-49 and
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`col. 8, line 51 to col. 9, line 9); flowable liquid forms of the composition are particularly
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`useful for pharmaceutical formulations to be applied by drops (e.g. eye drops) or sprays
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`(e.g. nasal sprays). See col. 7, lines 49-59; and col. 8, lines 29-34. Himmelstein et al.
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`teach that the pH preferably is within the physiological range between pH 2.5 and 7.5
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`(col. 6, lines 35-39).
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`Kabra (US Patent 6,331 ,540) teach a method of enhancing the stability of an
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`aqueous pharmaceutical composition containing fluoroquinolone and xantham gum and
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`the step of adding to the composition a water-soluble calcium salt in an amount of at
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`least 0.15% (w/w), such that the composition is homogenous and has a turbidity rating
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`Page 7 of 9
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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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`(NTU) < = 40 at room temperature (see cols. 5-6, including Table 3 and reference claim
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`1 ).
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Charlesworth Rae whose telephone number is 571-272-
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`6029. The examiner can normally be reached between 9 a.m. to 5:30p.m. Monday to
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`Friday.
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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 at 571-272-8373. The fax phone number
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`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
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`only. For more information about the PAIR system, see http:pair-direct.uspto.gov.
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`Should you have any questions on access to the Private PAIR system, contact the
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`Electronic Business Center (EBC) at 800-217-9197 (toll-free). If you would like
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`assistance from a USPTO Customer Service Representative or access to the
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`automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-
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`1000.
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`16 July 2008
`/C. R./
`Examiner, Art Unit 1611
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`Page 8 of 9
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`

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`Application/Control Number: 10/500,354
`Art Unit: 1611
`
`/Sharmila Gollamudi Landau/
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`Supervisory Patent Examiner, Art Unit 1611
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`Page 8
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`Page 9 of 9