Notice of Allowability
`
`Application No.
`
`10/525,006
`Examiner
`
`Applicant(s)
`
`SAWA ET AL.
`Art Unit
`
`LAYLA SOROUSH
`
`1627
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOW ABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`1. [8J This communication is responsive to the response to arguments submitted on September 6. 2011.
`2. D 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.
`3. [8J The allowed claim(s) is/are 41,43-51,53-56,58-60 and 64-68.
`4. [8J Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`b) D Some*
`c) D None
`a) [8J All
`of the:
`1. [8J Certified copies of the priority documents have been received.
`2. D Certified copies of the priority documents have been received in Application No. __ .
`3. D 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)).
`* Certified copies not received: __ .
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`5. 0 A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PT0-152) which gives reason(s) why the oath or declaration is deficient.
`6. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`(a) D including changes required by the Notice of Draftsperson's Patent Drawing Review ( PT0-948) attached
`1) D hereto or 2) D to Paper No./Mail Date __ .
`(b) D including changes required by the attached Examiner's Amendment I Comment or in the Office action of
`Paper No./Mail Date __ .
`Identifying indicia such as the application number {see 37 CFR 1.84{c)) should be written on the drawings in the front {not the back) of
`each sheet. Replacement sheet{s) should be labeled as such in the header according to 37 CFR 1.121 {d).
`7. 0 DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. D Notice of References Cited (PT0-892)
`2. D Notice of Draftperson's Patent Drawing Review (PT0-948)
`3. D Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date __
`4. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`5. D Notice of Informal Patent Application
`6. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`7. [8J Examiner's Amendment/Comment
`
`8. [8J Examiner's Statement of Reasons for Allowance
`9. D Other __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-37 (Rev. 03-11)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20111129
`
`Page 1 of 239
`
`SENJU EXHIBIT 2005
`METRICS v. SENJU
`IPR2014-01041
`
`

`

`Application/Control Number: 10/525,006
`Art Unit: 1627
`
`Page 2
`
`An examiner's amendment to the record appears below. Should the changes
`
`and/or additions be unacceptable to applicant, an amendment may be filed as provided
`
`by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be
`
`submitted no later than the payment of the issue fee.
`
`Authorization for this examiner's amendment was given in a telephone interview
`
`with Warren Cheek on December 16, 2011. This application has been amended as
`
`follows:
`
`In claim 41, lines 3-4 after a hydrate thereof, insert- wherein the hydrate is at
`
`least one selected from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate -- .
`
`In claim 64, line 2-3 after a hydrate thereof, insert- wherein the hydrate is at
`
`least one selected from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate -- .
`
`Reasons for Allowance
`
`The following is an examiner's statement of reasons for allowance:
`
`The composition as claimed are found to be patentable over the prior art
`
`because the prior art does not teach or fairly suggest an aqueous liquid preparation
`
`consisting essentially of the following two components, wherein the first component is 2-
`
`amino-3-(4- bromobenzoyl)phenylacetic acid or a pharmacologically acceptable salt
`
`thereof, and the second component is tyloxapol wherein said liquid preparation is
`
`formulated for ophthalmic administration, and wherein when a quaternary ammonium
`
`compound is included in said liquid preparation, the quaternary ammonium compound is
`
`benzalkonium chloride.
`
`Page 2 of 239
`
`

`

`Application/Control Number: 10/525,006
`Art Unit: 1627
`
`Page 3
`
`The transitional phrase "consisting essentially of' limits the scope of a claim to
`
`the specified materials or steps "and those that do not materially affect the basic and
`
`novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52,
`
`190 USPQ 461, 463 (CCPA 1976) (emphasis in original).
`
`The closest prior arts of record, namely Yanni et al. and Desai et al. Yanni et al.
`
`teaches a composition comprising an active agent see specifically Preparation XV (3-
`
`benzoylphenylacetic acid derivatives, salts are known) in 0.01-0.5%, polysorbate 80 in
`
`0.01 %, benzalkonium chloride, disodium EDTA, monobasic sodium phosphate, dibasic
`
`sodium phosphate, sodium chloride, pH adjustment with NaOH and/or HCI, water.
`
`Desai et al. teach an ophthalmic composition comprising bromfenac (2-amino-3-(4-
`
`bromobenzoyl)phenylacetic acid) and its ophthalmically acceptable salts, esters, amides
`
`or prodrugs thereof (column 3, lines 13-29, claims 4 and 7) and polysorbates such as
`
`tweens and tyloxapol and further comprising boric acid buffer (column 2, lines 18-44).
`
`Applicants have found that tyloxapol is not equivalent to polysorbate 80 when
`
`combined with bromfenac. The present inventors have discovered that tyloxapol has an
`
`unexpected property in stabilizing an aqueous solution ofbromfenac in comparison with
`
`polysorbate 80. Please see the description of Experimental Example 1 and Table 1 on
`
`pages 14-16 of the specification. In the Experimental Example, the stability of an
`
`aqueous solution ofbromfenac was measured by storing the bromfenac solution with
`
`polysorbate 80 (see Comparison Example 1) and, separately, with tyloxapol (see A-02),
`
`under conditions of pH 7.0 at 60°C for 4 weeks. The remaining rate% of bromfenac was
`
`measured after the test. As shown in Table 1, only 51.3% ofbromfenac remained in the
`
`Page 3 of 239
`
`

`

`Application/Control Number: 10/525,006
`Art Unit: 1627
`
`Page 4
`
`aqueous solution when stored with polysorbate 80. In contrast, 73.8% of bromfenac
`
`remained in the aqueous solution when stored with tyloxapol. Thus the present
`
`inventors have found that tyloxapol has an unexpected stabilizing effect on an aqueous
`
`solution ofbromfenac in comparison to polysorbate 80. Therefore the present inventors
`
`have found that tyloxapol and polysorbate 80 are not equivalent compounds. Such
`
`unequivalency, and such remarkable effects, could not have been obvious to one skilled
`
`in the art from the cited references. For the foregoing reasons, it is respectfully
`
`submitted that the teachings of the cited references do not suggest the claimed
`
`bromfenac preparation as amended, nor the unexpected properties of the preparation.
`
`Additionally, Desai et al. teach that the problems with benzalkonium chloride and other
`
`quaternary ammonium compounds can be avoided by using certain polymeric
`
`quaternary ammonium compounds in combination with boric acid. Hence, an essential
`
`component of the Desai composition is a polymeric quaternary ammonium compound.
`
`However, the instant claims as amended require that, when the claimed liquid
`
`preparation includes a quaternary ammonium compound, the quaternary ammonium
`
`compound is limited to benzalkonium chloride. Thus the polymeric quaternary
`
`ammonium compounds disclosed in Desai et al. are excluded from the amended claims.
`
`Any comments considered necessary by applicant must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled "Comments on
`
`Statement of Reasons for Allowance."
`
`Page 4 of 239
`
`

`

`Application/Control Number: 10/525,006
`Art Unit: 1627
`
`Page 5
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Layla Soroush whose telephone number is (571 )272-
`
`5008. The examiner can normally be reached on 8:30a.m.-5:00p.m ..
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Sreenivasan Padmanabhan can be reached on (571 )272-0629. The fax
`
`phone number for the organization where this application or proceeding is assigned is
`
`571-273-8300.
`
`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.
`
`/SREENI PADMANABHAN/
`
`Supervisory Patent Examiner, Art Unit 1627
`
`Page 5 of 239
`
`

`

`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
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10/525,006
`
`03/28/2005
`
`Shirou Sawa
`
`2005_0232A
`
`1756
`
`11115/2011
`7590
`513
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`Suite 400 East
`Washington, DC 20005-1503
`
`EXAMINER
`
`SOROUSH, LAYLA
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/15/2011
`
`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 @wenderoth.com
`eoa@wenderoth.com
`
`PTOL-90A (Rev. 04/07)
`
`Page 6 of 239
`
`

`

`Applicant-Initiated Interview Summary
`
`Application No.
`
`10/525,006
`
`Examiner
`
`LAYLA SOROUSH
`
`Applicant(s)
`
`SAWA ET AL.
`
`Art Unit
`
`1627
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) LA YLA SOROUSH.
`
`(2) Sreeni Padmanabhan.
`
`(3) Warren Cheek.
`
`(4) __ .
`
`Type:
`
`Date of Interview: 01 September 2011.
`0 Telephonic 0 Video Conference
`1Z1 Personal [copy given to: 0 applicant
`Exhibit shown or demonstration conducted: 0 Yes
`If Yes, brief description: __ .
`
`0 applicant's representative]
`
`0No.
`
`Issues Discussed 0101 0112 0102 [8J1 03 OOthers
`(For each of the checked box(es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: a// claims of record.
`
`Identification of prior art discussed: Yanni.
`
`Substance of Interview
`(For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a
`reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc ... )
`
`Applicant argues - not necessarily is the claimed compound useful in the example
`Applicant will consider amending claims to Bromfenac and tvloxapol
`Applicant will deleter the method claims.
`
`Applicant recordation instructions: The formal written reply to the last Office action must include the substance of the interview. (See MPEP
`section 713.04 ). If a reply to the last Office action has already been filed, applicant is given a non-extendable period of the longer of one month or
`thirty days from this interview date, or the mailing date of this interview summary form, whichever is later, to file a statement of the substance of the
`interview
`
`Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of
`the substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the
`general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the
`general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.
`0 Attachment
`/Layla Soroush/
`Examiner, Art Unit 1627
`
`U.S. Patent and Trademark Off1ce
`PTOL-413 (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20110901
`
`Page 7 of 239
`
`

`

`Manual of Patent Examining Procedure (MPEP), Section 713.04, Substance of Interview Must be Made of Record
`A complete written statement as to the substance of any face-to-face, video conference, or telephone interview with regard to an application must be made of record in the
`application whether or not an agreement with the examiner was reached at the interview.
`
`Summary of Record of Interview Requirements
`
`Title 37 Code of Federal Regulations (CFR) § 1.1331nterviews
`Paragraph (b)
`
`In every instance where reconsideration is requested in view of an interview with an examiner, a complete written statement of the reasons presented at the interview as
`warranting favorable action must be filed by the applicant. An interview does not remove the necessity for reply to Office action as specified in §§ t. t t t, t. t 35. (35 U .S.C. t 32)
`
`37 CFR §t .2 Business to be transacted in writing.
`All business with the Patent or Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and
`Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to
`any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.
`
`The action of the Patent and Trademark Office cannot be based exclusively on the written record in the Office if that record is itself
`incomplete through the failure to record the substance of interviews.
`It is the responsibility of the applicant or the attorney or agent to make the substance of an interview of record in the application file, unless
`the examiner indicates he or she will do so. It is the examiner's responsibility to see that such a record is made and to correct material inaccuracies
`which bear directly on the question of patentability.
`
`Examiners must complete an Interview Summary Form for each interview held where a matter of substance has been discussed during the
`interview by checking the appropriate boxes and filling in the blanks. Discussions regarding only procedural matters, directed solely to restriction
`requirements for which interview recordation is otherwise provided for in Section 812.01 of the Manual of Patent Examining Procedure, or pointing
`out typographical errors or unreadable script in Office actions or the like, are excluded from the interview recordation procedures below. Where the
`substance of an interview is completely recorded in an Examiners Amendment, no separate Interview Summary Record is required.
`
`The Interview Summary Form shall be given an appropriate Paper No., placed in the right hand portion of the file, and listed on the
`"Contents" section of the file wrapper. In a personal interview, a duplicate of the Form is given to the applicant (or attorney or agent) at the
`conclusion of the interview. In the case of a telephone or video-conference interview, the copy is mailed to the applicant's correspondence address
`either with or prior to the next official communication. If additional correspondence from the examiner is not likely before an allowance or if other
`circumstances dictate, the Form should be mailed promptly after the interview rather than with the next official communication.
`
`The Form provides for recordation of the following information:
`-Application Number (Series Code and Serial Number)
`-Name of applicant
`-Name of examiner
`-Date of interview
`-Type of interview (telephonic, video-conference, or personal)
`-Name of participant(s) (applicant, attorney or agent, examiner, other PTO personnel, etc.)
`-An indication whether or not an exhibit was shown or a demonstration conducted
`-An identification of the specific prior art discussed
`An indication whether an agreement was reached and if so, a description of the general nature of the agreement (may be by
`attachment of a copy of amendments or claims agreed as being allowable). Note: Agreement as to allowability is tentative and does
`not restrict further action by the examiner to the contrary.
`-The signature of the examiner who conducted the interview (if Form is not an attachment to a signed Office action)
`
`It is desirable that the examiner orally remind the applicant of his or her obligation to record the substance of the interview of each case. It
`should be noted, however, that the Interview Summary Form will not normally be considered a complete and proper recordation of the interview
`unless it includes, or is supplemented by the applicant or the examiner to include, all of the applicable items required below concerning the
`substance of the interview.
`A complete and proper recordation of the substance of any interview should include at least the following applicable items:
`1) A brief description of the nature of any exhibit shown or any demonstration conducted,
`2) an identification of the claims discussed,
`3) an identification of the specific prior art discussed,
`4) an identification of the principal proposed amendments of a substantive nature discussed, unless these are already described on the
`Interview Summary Form completed by the Examiner,
`5) a brief identification of the general thrust of the principal arguments presented to the examiner,
`(The identification of arguments need not be lengthy or elaborate. A verbatim or highly detailed description of the arguments is not
`required. The identification of the arguments is sufficient if the general nature or thrust of the principal arguments made to the
`examiner can be understood in the context of the application file. Of course, the applicant may desire to emphasize and fully
`describe those arguments which he or she feels were or might be persuasive to the examiner.)
`6) a general indication of any other pertinent matters discussed, and
`7) if appropriate, the general results or outcome of the interview unless already described in the Interview Summary Form completed by
`the examiner.
`Examiners are expected to carefully review the applicant's record of the substance of an interview. If the record is not complete and
`accurate, the examiner will give the applicant an extendable one month time period to correct the record.
`
`Examiner to Check for Accuracy
`
`If the claims are allowable for other reasons of record, the examiner should send a letter setting forth the examiner's version of the
`statement attributed to him or her. If the record is complete and accurate, the examiner should place the indication, "Interview Record OK" on the
`paper recording the substance of the interview along with the date and the examiner's initials.
`
`Page 8 of 239
`
`

`

`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
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10/525,006
`
`03/28/2005
`
`Shirou Sawa
`
`2005_0232A
`
`1756
`
`11115/2011
`7590
`513
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`Suite 400 East
`Washington, DC 20005-1503
`
`EXAMINER
`
`SOROUSH, LAYLA
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/15/2011
`
`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 @wenderoth.com
`eoa@wenderoth.com
`
`PTOL-90A (Rev. 04/07)
`
`Page 9 of 239
`
`

`

`Office Action Summary
`
`Application No.
`
`10/525,006
`
`Examiner
`
`Applicant(s)
`
`SAWA ET AL.
`
`Art Unit
`
`1627
`LAYLA SOROUSH
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;2 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 t. t 36(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. § t33).
`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 t .704(b).
`
`Status
`
`1 )IZ! Responsive to communication(s) filed on 06 September 2011.
`2a)IZ! This action is FINAL.
`2b)0 This action is non-final.
`3)0 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)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.
`
`Disposition of Claims
`
`5)[8J Claim(s) 41.43-51.53-56.58-60 and 64-68 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8J Claim(s) 41.43-51.53-56.58-60 and 64-68 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`1 0)0 The specification is objected to by the Examiner.
`11 )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).
`12)0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`13)[8J Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)IZ! All b)O Some * c)O None of:
`1.[8J 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) 0 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: __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 03·11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20111102
`
`Page 10 of 239
`
`

`

`Application/Control Number: 10/525,006
`Art Unit: 1627
`
`Page 2
`
`DETAILED ACTION
`
`The response filed September 6, 2011 presents remarks and arguments
`
`submitted to the office action mailed May 6, 2011 is acknowledged.
`
`Applicant's arguments over the 35 U.S.C. 103 (a) rejection of claims 41,
`
`43-48, 50-51, 53-55, and 58-59 over as being unpatentable over Yanni et al.
`
`(5475034) in view of Guy et al.( 5540930) is not persuasive. Therefore, the
`
`rejection of record is herewith maintained.
`
`Applicant's arguments over the 35 U.S.C. 103 (a) rejection of claims 49,
`
`56, 60, and 64-68 over as being unpatentable over P Yanni et al. (5475034) and
`
`Guy et al. ( 5540930), as applied to claims 41-48, 50-51, 53-55, and 58-59, and
`
`further in view of Gamache et al. (WO 01 /15677) is not persuasive. Therefore,
`
`the rejection of record is herewith maintained.
`
`The ODP rejection is maintained for the reasons of record.
`
`The following rejections are made:
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 1 03(a) which forms the basis for
`
`all obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described
`as set forth in section 1 02 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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`Page 11 of 239
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`

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`Application/Control Number: 10/525,006
`Art Unit: 1627
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`Page 3
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`Claims 41, 43-48, 50-51, 53-55, and 58-59 are rejected under 35 U.S.C.
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`1 03(a) as being unpatentable over Yanni et al. (5475034) in view of Guy et al.(
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`5540930).
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`Yanni et al. teaches a composition comprising an active agent see
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`specifically Preparation XV (3-benzoylphenylacetic acid derivatives, salts are
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`known) in 0.01-0.5%, polysorbate 80 in 0.01 %, benzalkonium chloride,
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`disodium EDTA, monobasic sodium phosphate, dibasic sodium phosphate,
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`sodium chloride, pH adjustment with NaOH and/or HCI, water.
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`The reference fails to teach the specific elected second agent tyloxapol.
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`Guy et al. teaches non-ionic surfactant surface active agent include
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`polysorbate 80 and tyloxapol in 0.05-1 %.
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`It would have been obvious to one of ordinary skill in the art at the time of
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`the invention to interchange polysorbate 80 and tyloxapol. The motivation comes
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`from the teaching of Guy et al. that both compounds are non-ionic surfactant
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`surface active agents. Hence, a skilled artisan would have had reasonable
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`expectation of successfully producing a composition with similar efficacy and
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`results.
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`Claims 49, 56, 60, and 64-68 are rejected under 35 U.S.C. 1 03(a) as
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`being unpatentable over Yanni et al. (5475034) and Guy et al. ( 5540930), as
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`applied to claims 41-48, 50-51, 53-55, and 58-59, and further in view of
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`Gamache et al. (WO 01 /15677).
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`Yanni et al. and Guy et al. are as applied above.
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`Page 12 of 239
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`

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`Application/Control Number: 10/525,006
`Art Unit: 1627
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`Page 4
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`Yanni et al. and Guy et al. do not teach the specific buffer boric acid
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`and/or sodium borate/sodium tetraborate; thickners, polyvinylpyrrolidone;
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`stabilizer is sodium sulfite.
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`Gamache et al. teaches anti-inflammatory agents include bromfenac and
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`Moxifloxacin, viscosity building agents include, for example, polyvinyl alcohol,
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`polyvinyl pyrrolidone, methyl cellulose, hydroxypropyl methylcellulose,
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`hydroxyethyl cellulose, carboxymethyl cellulose, hydroxypropyl cellulose or other
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`agents known to those skilled in the art. An appropriate buffer system (e. g.,
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`sodium phosphate, sodium acetate or sodium borate) may be added to prevent
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`pH drift under storage conditions. Exemplified is an otic/nasal suspension:
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`Ingredient 1 B/1 D agonist 0.1-1.0% w/v, Moxifloxacin 0.3% w/v, Benzalkonium
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`Chloride 0.01% w/v, Edetate Disodium, USP 0.01% w/v, Sodium Chloride, USP
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`0.3% w/v, Sodium Sulfate, USP 1.2% w/v, Tyloxapol, USP 0.05% w/v,
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`Hydroxyethylcellulose 0.25% w/v, Sulfuric Acid and/or Sodium Hydroxide, NF q.
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`s., and purified water q. s. to 100%.
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`It would have been obvious to one of ordinary skill in the art at the time of
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`the invention to use the specific buffer boric acid and/or sodium borate/sodium
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`tetraborate; thickners, polyvinylpyrrolidone; stabilizer is sodium sulfite. The
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`motivation comes from the teaching of Gamache et al. that the anti-inflammatory
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`agents, viscosity building agents" and buffer systems are interchangeable.
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`Hence, a skilled artisan would have had reasonable expectation of successfully
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`producing a composition with similar efficacy and results.
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`Page 13 of 239
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`

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`Application/Control Number: 10/525,006
`Art Unit: 1627
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`Page 5
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`Double Patenting
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`Claims 41-51, 53-56, 58-60 and 64-68 are provisionally rejected on the
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`ground of nonstatutory obviousness-type double patenting as being unpatentable
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`over claims 1-43 of copending Application No. 11/755662.
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`Although the conflicting claims are not identical, they are not patentably
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`distinct from each other because the copending application contains claims
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`drawn to method of treating pain and/or inflammation associated with an ocular
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`condition, by administering the aqueous solutions of the instant claims. It would
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`have been obvious to one of ordinary skill in the art at the time of the invention to
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`use the formulations of the instant claims in the methods of the copending
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`application, since the claims recite that the formulations are eye drops, and the
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`instant abstract also teaches some of the conditions treated of the copending
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`application.
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`This is a provisional obviousness-type double patenting rejection because
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`the conflicting claims have not in fact been patented.
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`Response to Arguments
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`Applicant's main argument is that "Bromfenac is mentioned in Yanni in Table 1,
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`merely as a reference compound for comparison purposes with the novel amide
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`and ester derivatives of Yanni. It can be seen from the description of the anti-
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`inflammatory tests described in columns 13 and 14 that bromfenac was tested
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`merely in a 0.1% solution of the compound, and not in a pharmaceutical
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`composition." Examiner states Yanni clearly discloses a single topical dose of
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`0.1% drug solution/suspension comprising Bromfenac. The Examiners
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`Page 14 of 239
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`

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`Application/Control Number: 10/525,006
`Art Unit: 1627
`
`Page 6
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`contention is that the reference does not specify the specific components of the
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`comparative formulation (or in fact, the novel formulations) of the tests.
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`However, the Example of the ophthalmic composition disclosing 0.01-0.5% of an
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`active agent in a formulation renders obvious the use of the comparative
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`example- Bromfenac, in such a formulation.
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`The arguments are not persuasive and the rejection is made FINAL.
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`Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
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`Applicant is reminded of the extension of time policy as set forth in 37 CFR
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`1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action. In the event a first reply is filed
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`within TWO MONTHS of the mailing date of this final action and the advisory
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`action is not mailed until after the end of the THREE-MONTH shortened statutory
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`period, then the shortened statutory period will expire on the date the