SSED rjl6[835 UAA'I!
`
`:
`
`U.S. UTIUTY Patent Application
`
`end
`
`ISSUE DATE
`
`AsslsttntEnmfr':/ . .,-rr. ,'"
`
`Prlnery Erarnlnr
`
`TERMINAL
`otsct_AtMER
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`1
`
`

`

`A TIORNEY'S DOCKET NUMBER
`2667 US F
`U.S. APPLICATION NO. (If known, see 37 CFR 1.5)
`
`I INTERNATIONAL FILING DATE
`
`September 20, 2007
`
`PRIORITY DATE CLAIMED
`September 28 2006
`
`PT0-1390 (Rev. 09-08)
`Approved for use through 2/28/2010. OMB 0651-0021
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`TRANSMITTAL LETTER TO THE UNITED STATES
`DESIGNATED/ELECTED OFFICE (DO/EO/US)
`CONCERNING A SUBMISSION UNDER 35 U.S.C. 371
`INTERNATIONAL APPLICATION NO.
`PCT/US2007/079094
`TITLE OF INVENTION
`SELF-PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS
`APPLICANT(S) FOR DO/EO/US
`ALCON RESEARCH, LTD.
`Applicant herewith submits to the United States Designated/Elected Office (DO/EO/US) the following items and other information:
`1. 0
`2. D
`3. D
`
`This is a FIRST submission of items concerning a submission under 35 U.S.C. 371.
`
`This is a SECOND or SUBSEQUENT submission of items concerning a submission under 35 U.S.C. 371.
`
`This is an express request to begin national examination procedures (35 U.S.C. 371 {f)). The submission must include items
`(5), {6), (9) and {21) indicated below.
`
`The US has been elected (Article 31).
`
`A copy of the International Application as filed (35 U.S.C. 371 (c}(2))
`a. D is attached hereto {required only if not communicated by the International Bureau}.
`b. D has been communicated by the International Bureau.
`c. 0
`is not required, as the application was filed in the United States Receiving Office (RO/US).
`An English language translation of the International Application as filed {35 U.S.C. 371 {c){2)).
`
`4. D
`5. [£]
`
`6. D
`
`7. 0
`
`a. D is attached hereto.
`b. D has been previously submitted under 35 U.S.C. 154(d){4).
`Amendments to the claims of the International Application under PCT Article 19 (35 U.S.C. 371 (c}(3))
`a. D
`b. D
`c. D
`0
`d.
`An English language translation of the amendments to the claims under PCT Article 19 (35 U.S.C. 371 (c)(3)).
`
`are attached hereto (required only if not communicated by the International Bureau).
`
`have been communicated by the International Bureau.
`
`have not been made; however, the time limit for making such amendments has NOT expired.
`
`have not been made and will not be made.
`
`8. D
`9. [{] An oath or declaration ofthe inventor(s) (35 U.S.C. 371 (c)(4)).
`
`10. D
`
`An English language translation of the annexes of the International Preliminary Examination Report under PCT
`Article 36 (35 U.S.C. 371(c)(5)).
`
`Items 11 to 20 below concern document(s) or information included:
`11. D
`12. D
`13. [{]
`
`An Information Disclosure Statement under 37 CFR 1.97 and 1.98.
`
`An assignment document for recording. A separate cover sheet in compliance with 37 CFR 3.28 and 3.31 is included.
`
`A preliminary amendment.
`
`14. D
`15. D
`16. D
`11. D
`18. D
`19. D
`
`An Application Data Sheet under 37 CFR 1.76.
`
`A substitute specification.
`
`A power of attorney and/or change of address letter.
`
`A computer-readable form of the sequence listing in accordance with PCT Rule 13ter.3 and 37 CFR 1.821- 1.825.
`
`A second copy of the published International Application under 35 U.S.C. 154(d)(4).
`
`A second copy of the English language translation of the international application under 35 U.S.C. 154(d)(4).
`
`Th1s collection of mformabon IS requ1red by 37 CFR 1.414 and 1.491-1 .492. The mformation IS reqUired to obtain or retam a b enef1t by the publ1c, w h1ch 1s to f1le (and by the
`USPTO to pro cess) an application. Confidentiality is governed by 35 U.S. C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 15 minutes to complete,
`including gathering information, preparing, and submitting the completed form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount
`of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S.
`Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Mail Stop PCT,
`Page 1 of 3
`Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`2
`
`

`

`PT0-1390 (Rev. 09-08)
`Approved for use through 2/28/2010. OMB 0651-0021
`l,J.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Pape!Work Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`ATTORNEY'S DOCKET NUMBER
`2667 US F
`
`U.S. APPLICATION NO. (if known, see 37 CFR 1.5) I INTERNATIONAL APPLICATION NO.
`
`PCT/US2007/079094
`
`20.
`
`Other items or information:
`
`The following fees have been submitted
`Basic national fee (37 CFR 1.492(a)) ........................................................ $330
`
`21.
`
`ILJ
`22. [2] Examination fee (37 CFR 1.492(c)}
`
`If the written opinion prepared by I SAlUS or the international preliminary examination report prepared
`by I PEA/US indicates all claims satisfy provisions of PCT Article 33(1)-(4) ............. $0
`All other situations ................................................................................................ $220
`
`[21
`Search fee (37 CFR 1.492(b))
`23.
`If the written opinion of the I SAlUS or the International preliminary examination report prepared by
`I PEA/US indicates all claims satisfy provisions of PCT Article 33(1)-(4) ................. $0
`Search fee (37 CFR 1.445(a)(2)} has been paid on the international application to the USPTO as an
`International Searching Authority .................................................................. . $100
`International Search Report prepared by an ISA other than the US and provided to the Office or
`previously communicated to the US by the lB .................................................... $430
`All other situations ............................................................................................. ... $540
`TOTAL OF 21 22 and 23 =
`D Additional fee for specification and drawings filed in paper over 100 sheets (excluding sequence
`listing in compliance with 37 CFR 1.821 (c) or (e) in an electronic medium or computer
`program listing in an electronic medium) (37 CFR 1.492(j)).
`The fee is $270 for each additional 50 sheets of paper or fraction thereof.
`
`Total Sheets
`
`Extra Sheets
`
`Number of each additional 50 or fraction
`thereof (round up to a whole number)
`
`RATE
`
`X$270
`/50 =
`- 100 =
`Surcharge of $130.00 for furnishing any of the search fee, examination fee, or the oath or declaration
`after the date of commencement of the national stage (37 CFR 1.492(h)).
`NUMBER EXTRA
`
`CLAIMS
`
`NUMBER FILED
`
`RATE
`
`CALCULATIONS
`$ 330.
`
`PTO USE ONLY
`
`$ 220.
`
`$ 430.
`
`$ 980.
`
`$
`
`$
`
`$
`
`$
`
`$
`
`$
`
`$
`
`$
`
`$
`
`$ 980.
`
`Total claims
`
`Independent claims
`
`-20 =
`
`-3=
`
`X $52
`
`X $220
`
`MULTIPLE DEPENDENT CLAIM(S) (if applicable)
`
`+ $390
`TOTAL OF ABOVE CALCULATIONS=
`D Applicant claims small entity status. See 37 CFR 1.27. Fees above are reduced by Y:z.
`SUBTOTAL=
`Processing fee of $130.00 for furnishing the English translation later than 30 months from the earliest
`+
`claimed priority date (37 CFR 1.492(i)).
`TOTAL NATIONAL FEE =
`
`Fee for recording the enclosed assignment (37 CFR 1.21 (h)). The assignment must be accompanied
`+
`by an appropriate cover sheet (37 CFR 3.28, 3.31). $40.00 per property
`
`$
`
`TOTAL FEES ENCLOSED =
`
`$
`Amount to be
`refunded:
`Amount to be
`charged
`
`$
`
`$ 980.
`
`Page 2 of 3
`
`3
`
`

`

`PT0-1390 (Rev. 09-08)
`Approved for use through 2/28/2010. OMB 0651-0021
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`a. 0
`b. 0
`
`A check in the amount of$ __________ to cover the above fees is enclosed.
`in the amount of$ _9_8_0_. ___ to cover the above fees.
`Please charge my Deposit Account No. 01 0682
`
`c. [{] The Commissioner is hereby authorized to charge any additional fees which may be required, or credit any overpayment to Deposit
`010682
`Account No.
`d. D Fees are to be charged to a credit card. WARNING: Information on this form may become public. Credit card information should not
`be included on this form. Provide credit card information and authorization on PT0-2038. The PT0-2038 should only be mailed or faxed
`to the USPTO. However, when paying the basic national fee, the PT0-2038 may NOT be faxed to the USPTO.
`
`ADVISORY: If filing by EFS-Web, do NOT attach the PT0-2038 form as a PDF along with your EFS-Web submission. Please be
`advised that this is not recommended and by doing so your credit card information may be displayed via PAIR. To protect your
`information, it is recommended paying fees online by using the electronic payment method.
`
`NOTE: Where an appropriate time limit under 37 CFR 1.495 has not been met, a petition to revive (37 CFR 1.137(a) or (b)) must be filed
`and granted to restore the International Application to pending status.
`
`SEND ALL CORRESPONDENCE TO:
`
`Alcon Research, Ltd.
`Scott A. Chapple, IP Legal
`6201 South Freeway
`Mail Code TB4-8
`Fort Worth, TX 76134-2099
`
`REGISTRATION NUMBER
`
`Page 3 of3
`
`4
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of: Alcon Research, Ltd. et al.
`
`Electronically Filed
`
`Serial No.: NYA
`
`Filed: March 19, 2009
`
`Examiner: NYA
`
`Group Art Unit: NY A
`
`For:
`
`SELF-PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS
`
`PRELIMINARY AMENDMENT
`
`Mail Stop PCT
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Please amend the application as follows:
`
`IN THE SPECIFICATION:
`
`Please add the following sentence below the title:
`
`This application claims priority as a 371 application from PCT/US2007/079094 filed on
`September 20, 2007, and claims priority from United States Serial No. 60/827,417, filed on
`September 28, 2006.
`
`Respectfully submitted,
`
`ALCON RESEARCH, LTD.
`
`Reg. No. 46,287
`
`March 19 2009
`Date
`
`Address for Correspondence:
`Scott A. Chapple
`Alcon Research, Ltd.
`6201 S. Freeway, Mail Code TB4-8
`Fort Worth, TX 76134-2099
`Phone: 817-615-5288
`Attorney Docket: 2667 US F
`
`5
`
`

`

`DECLARATION AND POWER OF ATTORNEY
`
`As a below named inventor, we hereby declare that:
`
`Our residence, post office address and citizenship are as stated below next to our
`
`names.
`
`We believe we are the original, first and joint inventors of the subject matter which is
`claimed and for which a patent is sought on the invention entitled:
`
`SELF PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS
`
`described and claimed herewith and further identified as Attorney Docket No. 2667 US F the
`specification of which (check one)
`is attached hereto.
`(X)
`) was filed by an authorized person on my behalf on ___ _ , as Application
`(
`Serial No.
`and was amended on
`(if applicable)
`
`We hereby state that we have reviewed and understand the contents of the above(cid:173)
`identified specification, including the claims as amended by any amendment referred to
`above.
`
`We acknowledge the duty to disclose information which IS known to me to be
`material to patentability as defined in Section 1.56.
`
`We hereby claim foreign priority benefits under Title 35, United States Code, Section
`119(a)-(d) or Section 365(b) of any foreign application(s) for patent or inventor's certificate,
`or Section 365(a) of any PCT international application which designated at least one country
`other than the United States, listed below and have also identified below any foreign
`application for patent or inventor's certificate having a filing date before that of the
`application on which priority is claimed:
`
`Prior Foreign Application(s):
`Application Number
`Country
`
`PCTIUS2007/079094
`
`us
`
`Filed
`(Month/Day/Year)
`09/20/2007
`
`Priority Claimed
`Yes
`No
`
`X
`
`6
`
`

`

`We hereby claim the benefit under 35 USC §119(e) of any United States provisional
`application(s) listed below.
`
`Prior Provisional Application(s):
`Application Number
`
`60/827,417
`
`Filed
`(Month/Day/Year)
`09/28/2006
`
`Priority Claimed
`Yes
`No
`
`X
`
`We hereby claim the benefit under Title 35, United States Code, Section 120 of any
`United States application(s), or Section 365(c) of any PCT international application designating
`the United States, listed below and, insofar as the subject matter of each of the claims of this
`application is not disclosed in the prior United States or PCT international application in the
`manner provided by the first paragraph of Title 35, United States Code, Section 112.
`I
`acknowledge the duty to disclose material information as defined in Title 3 7, Code of Federal
`Regulations, Section 1.56 which occurred between the filing date ofthe prior application and the
`national or PCT international filing date of this application:
`
`Prior U.S. Application(s):
`
`Application Number
`
`Filed
`(Month/Day/Year)
`
`Status: Patent,
`Pending,
`Abandoned
`
`We hereby declare that all statements made herein of my own knowledge are true and
`that all statements made on information and belief are believed to be true; and further that these
`statements were made with the knowledge that willful false statements and the like so made are
`punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States
`Code and that such willful false statements may jeopardize the validity of the application or any
`patent issued thereon.
`
`We hereby appoint those patent practitioners associated with Customer No. 26356 as
`my attorneys, with full power of substitution and revocation, to prosecute this application and
`to transact all business in the United States Patent and Trademark Office connected therewith.
`
`7
`
`

`

`Full name of Inventor:
`
`Masood A. Chowhan
`
`Address:
`
`Inventor's Signature:
`
`Date:
`
`Citizenship:
`
`3521 Lake Tahoe Drive
`Arlington, TX 76016
`
`w~Q~-
`
`United States
`
`Full name of Inventor:
`
`David J. Keith
`
`Address:
`
`508 Mill Creek Lane
`
`United States
`
`Inventor's Signature:
`
`Date:
`
`Citizenship:
`
`Address for Correspondence:
`Alcon Research, Ltd.
`Scott A. Chapple, IP Legal
`6201 South Freeway, TB4-8
`Fort Worth, TX 76134-2099
`Phone: 817-615-5288
`Docket No.: 2667 US F
`
`Customer No.: 26356
`
`8
`
`

`

`PATENT COOPERATION TREATY
`PCT
`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY
`(Chapter II of the Patent Cooperation Treaty)
`
`(PCT Article 36 and Rule 70)
`
`Applicant's or agenfs file reference
`2677FWO
`
`FOR FURTHER ACTION
`
`See Form PCTAPEA/416
`
`International application No.
`PCTAJS2007.079094
`
`International firing date (daytfnonth;jlear)
`20.09.2007
`
`Priority date (daytfnonth,Year)
`28.09.2006
`
`International Patent Classification (I PC) or national classification and IPC
`I NV. A61 K9JOO
`
`Applicant
`Alcon Research, Ltd.
`
`1.
`
`2.
`3.
`
`This report is the international preliminary examination report, established by this International Preliminary Examining
`Authority under Article 35 and transmitted to the applicant according to Article 36.
`This REPORT consists of a total of .1 sheets, including this cover sheet.
`This report is also accompanied by ANNEXES, comprising:
`a. D sent to the applicant and to the International Bureau) a total of sheets, as follows:
`D sheets of the description, claims and/or drawings which have been amended and are the basis of this report
`and/or sheets containing rectifications autftorized by this Authority (see Rule 70.16 and Section 607 of the
`Administrative Instructions).
`D sheets which supersede earlier sheets, but which this Authority considers contain an amendment that goes
`beyond the disclosure in the international application as filed, as indicated in item 4 of Box No. I and the
`Supplemental Box,
`, containing a
`(sent to the International Bureau only) a total of (indicate type and number of electronic carrier(s))
`sequence listing and/or tables related thereto, in electronic form only, as indicated in the Supplemental Box
`Relating to Sequence Listing (see Section 802 of the Administrative Instructions).
`
`b. D
`
`4.
`
`This report contains indications relating to the following items:
`
`Box No.I
`~
`D
`Box No. II
`D Box No. Ill
`D Box No. IV
`~ Box No. V
`
`Basis of the report
`Priority
`Non-establishment of opinion with regard to novelty, inventive step and industrial applicability
`Lack of unity of invention
`Reasoned statement under Article 35(2) with regard to novelty, inventive step or industrial
`applicability; citations and explanations supporting such statement
`D Box No. VI
`Certain documents cited
`0 Box No. VII Certain defects in the international application
`~ Box No. VIII Certain observations on the international application
`
`Date of submission of the demand
`
`Date of completion of this report
`
`2008-07-25
`
`Name and mailing address of the international
`preliminary examining authority:
`European Patent Office
`
`A\\\ D-80298 Munich
`J!/)J
`Tel. +49 89 2399 - 0 Tx: 523656 epmu d
`Fax: +49 89 2399 - 4465
`
`11.12.2008
`
`Authorized officer
`
`Kardas-Liorens, EyOp
`
`Telephone No. +49 89 2399-8652
`
`Form PCTAPEA/409 (Cover Sheet) (April2005)
`
`biL.V f'..U I.UUU
`
`IP LEGAL
`
`9
`
`

`

`INTERNATIONAL PRELIMINARY REPORT
`ON PATENTABILITY
`
`International application No.
`PCT !US2007 !079094
`
`Box No. I Basis of the report
`
`1. With regard to the language, this report is based on
`
`12:1
`
`the international application in the language in which it was filed
`
`D
`
`a translation of the international application into , which is the language
`of a translation furnished for the purposes of:
`international search (under Rules 12.3(a) and 23.1 (b))
`0
`0 publication of the international application (under Rule 12.4(a))
`internationalpreliminary examination (under Rules 55.2(a) andbr 55.3(a))
`0
`2. With regard to the elements* of the international application, this report is based on (replacement sheets which
`have been furnished to the receiving Office in response to an invitation under Article 14 are referred to in this
`report as "originally filed" and are not annexed to this report): ·
`
`Description, Pages
`
`1-28
`
`Claims, Numbers
`
`1-1 0
`
`as originally filed
`
`as originally filed
`
`0
`
`a sequence listing andbr any related table(s) -see Supplemental Box Relating to Sequence Listing
`
`3. 0
`
`The amendments have resulted in the cancellation of:
`0
`the description, pages
`0
`the claims, Nos.
`0
`the drawings, sheetsAigs
`0
`the sequence listing (specify):
`0 any table(s) related to sequence listing (specify):
`
`This report has been established as if (some of) the amendments annexed to this report and listed bf31ow
`4. 0
`had not been made, since they have been considered to go beyond the disclosure as filed, as indicated in the
`Supplemental Box (Rule 70.2(c)).
`D the description, pages
`0
`the claims, Nos.
`0
`the drawings, sheetsAigs
`0
`the sequence listing (specify):
`0 any table(s) related to sequence listing (specify):
`
`5. 0
`
`This opinion has been established taking into account the rectification of an obvious mistake authorized
`by or notified to this Authority under Rule 91 (Rule 70.2 (e)).
`
`Form PCTAPEA/409 (April2007)
`
`10
`
`

`

`INTERNATIONAL PRELIMINARY REPORT
`ON PATENTABILITY
`
`International application No.
`PCT !US2007 t079094
`
`Box No. V Reasoned statement under Article 35(2) with regard to novelty, inventive step or industrial
`applicability; citations and explanations supporting such statement
`
`1. Statement
`
`Novelty (N)
`
`Inventive step (IS}
`
`Yes:
`
`Claims
`
`No:
`
`Claims
`
`Yes:
`
`Claims
`
`No:
`
`Claims
`
`Industrial applicability (lA)
`
`Yes:
`
`Claims
`
`No:
`
`Claims
`
`2. Citations and explanations (Rule 70.7}:
`
`see separate sheet
`
`Box No. VIII Certain observations on the international application
`
`The following observations on the clarity of the claims, description, and drawings or on the question whether the
`claims are fully supported by the description, are made:
`
`see separate sheet
`
`Form PCTAPEA/409 (April 2007}
`
`11
`
`

`

`INTERNATIONAL PRELIMINARY
`REPORT ON PATENTABILITY
`(SEPARATE SHEET)
`
`International application No.
`
`PCT/US2007 /079094
`
`Re Item V
`Reasoned statement with regard to novelty, inventive step or industrial
`applicability; citations and explanations supp·orting such statement
`Novelty:
`A composition comprising a borate/polyol complex and zinc ions in the specified
`amounts as claimed in claim 1 is not disclosed in any one document cited in the search
`report.
`The subject-matter of independent claims 1 and 6 is therefore new (Article 33(2) PCT).
`
`Inventive Step:
`The present problem to be solved by the present invention is to provide an ophthalmic
`composition with the desired antimicrobial activity to satisfy the preservation efficacy
`requirements.
`This has been presently achieved by a composition comprising a borate/polyol complex
`>and zinc ions as claimed which demonstrates the desired effects as demonstrated in
`. present examples 4-6 in the claimed amounts of the actives.
`From none of the cited prior art documents it was obvious to a person skilled in the art
`to combine a borate/polyol complex with a zinc compound to achieve the desired
`technical effects in the presently claimed concentr:_ations.
`The relevant prior art documents 01 (US2002/0123482), 02 (US2005/129771) and 03
`(W095/13050) comprise zinc below (01 and D2) and above (03) the minimum amount
`·required in the ophthalmic composition which do not lead to the desired effects.
`Thus, the solution to the problem proposed in claim 1 and 6 of the present application is
`considered as involving an inventive step (Article 33(3) PCT).
`
`Re Item VIII
`Certain observations on the international application
`
`The wordings "having sufficient antimicrobial activity to satisfy USP preservative
`efficacy requirements" in claim 3 and 8 are not clear, since it is not clear how the
`"sufficient antimicrobial activity" and said "preservative efficacy requirements" have to
`be.
`Also from the wording "conventional antimicrobial preservative" in claims 4 and 9 it is
`not clear which preservatives are meant.
`
`Form PCT/Separate SheeV409 (Sheet 1) (EPO-April 2005)
`
`12
`
`

`

`r A TENT COOPERATION TREATY
`
`From the INTERNATIONAL SEARCHING AUTHORITY
`
`To:
`
`ALCON RESEARCH, LTD.
`Attn. Brown, Gregg c.
`6201 South Freeway
`TB 4-8
`Fort Worth TX 76134-2099
`ETATS-UNIS D'AMERIQUE
`
`RECEIVED
`APR 0 9 2008
`IP LEGAL
`
`r Applicant's or agent's file reference
`
`....-o
`
`rWO
`
`International application No.
`
`PCT/US2007/079094
`
`Applicant
`
`ALCON MANUFACTURING, LTD.
`
`PCT
`
`NOTIFICATION OF TRANSMITTAL OF
`THE INTERNATIONAL SEARCH REPORT AND
`THE WRITTEN OPINION OF THE INTERNATIONAL
`SEARCHING AUTHORITY, OR THE DECLARATION
`
`Date of mailing
`{day/monthlyeat).
`
`(PCT Rule 44.1)
`
`02/04/2008
`
`FOR FURTHER ACTION
`
`See paragraphs 1 and 4 below
`
`International filing date
`(day/month/year)
`
`~
`
`20/09/2007
`
`1. Ji]
`
`2.0
`3.o
`
`The applicant is hereby notified that the international search report and the written opinion of the International Searching
`Authority have been established and are transmitted herewith.
`Filing of amendments and statement under Article 19:
`The applicant is entitled, if he so wishes, to amend the claims of the International Application (see Rule 46}:
`When? The time limit for filing such amendments is normally two months from the date of transmittal of the
`International Search Report.
`Where? Directly to the International Bureau of WI PO, 34 chemin des Colombettes
`1211 Geneva 20, Switzerland, Fascimile No.: (41-22) 338.82.70
`For more detailed instructions, see the notes on the accompanying sheet.
`
`The applicant is hereby notified that no international search report will be established and that the declaration under
`Article 17(2}(a) to that effect and the written opinion of the International Searching Authority are transmitted herewith.
`With regard to the protest against payment of (an) additional fee(s) under Rule 40.2, the applicant is notified that:
`D
`D
`
`the protest together with the decision thereon has been transmitted to the International Bureau together with the
`applicant's request to forward the texts of both the protest and the decision thereon to the designated Offices.
`no decision has been made yet on the protest; the applicant will be notified as soon as a decision is made.
`
`4. Reminders
`Shortly after the expiration of 18 months from the priority date, the international application will be published by the
`International Bureau. If the applicant wishes to avoid or postpone publication, a notice of withdrawal of the international
`application, or of the priority claim, must reach the International Bureau as provided in Rules 90bis.1 and 90bis.3, respectively,
`before the completion of the technical preparations for international publication.
`The applicant may submit comments on an informal basis on the written opinion of the International Searching Authority to the
`International Bureau. The International Bureau will send a copy of such comments to all designated Offices unless an
`international preliminary examination report has been or is. to be established. These comments would also be made available to
`the public but not before the expiration ·of 30 months from the priority date.
`Within 19 months from the priority date, but only in respect of some designated Offices, a demand for international preliminary
`examination must be filed if the applicant wishes to postpone the entry into the national phase until 30 months from the priority
`date (in some Offices even later); otherwise, the applicant must, within 20 months from the priority date, perform the prescribed
`acts for entry into the national phase before those designated Offices.
`In respect of other designated Offices, the time limit of 30 months (or later) will apply even if no demand is filed within 19
`months.
`
`See the Annex to Form PCT/IB/301 and, for details about the applicable time limits, Office by Office, see the PCT Applicant's
`Guide, Volume II, National Chapters and the WI PO Internet site.
`
`Name and mailing address of the International Searching Authority
`
`~ European Patent Office, P.B. 5818 Patentlaan 2
`
`NL-2280 HV Rijswijk
`Tel. (+31-70) 340-2040, Tx. 31 651 epo nl,
`---==--Fax: (+31-70) 340-3016.
`
`Authorized officer
`Georg Hutterer
`
`/
`
`Form PCT/ISA/220 (October 2005)
`
`(See notes on accompanying sheet)
`
`13
`
`

`

`NOTES TO FORM PCT/ISA/220
`
`These Notes are intended to give the basic instructions concerning the filing of amendments under article 19. The
`Notes are based on the requirements of the Patent Cooperation Treaty, the Regulations and the Administrative Instructions
`under that Treaty. In case of discrepancy between these Notes and those requirements, the latter are applicable. For more
`detailed information. see also the PCT Applicant's Guide. a publication of WI PO.
`
`In these Notes. "Article", "Rule", and "Section" refer to the provisions of the PCT, the PCT Regulations and the PCT
`Administrative Instructions, respectively.
`
`INSTRUCTIONS CONCERNING AMENDMENTS UNDER ARTICLE 19
`
`The applicant has, after having received the international search report and the written opinion of the International
`Searching Authority, one opportunity to amend the claims of the international application. It should however be emphasized
`that, since all parts of the international application (claims,description and drawings) may be amended during the
`international preliminary examination procedure, there is usually no need to file amendments of the claims under Article 19
`except where, e.g. the applicant wants the latter to be published for the purposes of provisional protection or has another
`reason tor amending the claims before international publication. Furthermore, it should be emphasized that provisional
`protection is available in some States only (see PCT Applicant's Guide, Volume 1/A, Annexes B1 and B2).
`
`The attention of the applicant is drawn to the fact that amendments to the claims under Article 19 are not allowed where
`the International Searching Authority has declared, under Article 17(2), that no international search report would be
`established (see PCT Applicant's Guide, Volume 1/A, paragraph 296).
`
`What parts of the international application may be amended?
`
`Under Article 19, only the claims may be amended.
`
`During the international phase, the claims may also be amended (or further amended) under Article 34 before the
`International Preliminary Examining Authority. The description and drawings may only be amended under
`Article 34 before the International Examining Authority.
`
`Upon entry into the national phase, all parts of the international application may be amended under Article 28 or,
`where applicable, Article 41.
`
`When?
`
`Within 2 months from the date oUransmittal of the international search report or 16 months from the priority date,
`whichever time limit expires later. It should be noted, however, that the amendments will be considered as having
`been received on time if they are received by the International Bureau after the expiration of the applicable time
`limit but before the completion of the technical preparations for international publication (Rule 46.1 ).
`
`Where not to file the amendments?
`
`The amendments may only be filed with the International Bureau and not with the receiving Office or the
`International Searching Authority (Rule 46.2).
`
`Where a demand for international preliminary examination has been/is filed, see below.
`
`How?
`
`Either by cancelling one or more entire claims, by adding one or more new claims or by amending the text of one
`or more of the claims as filed.
`
`A replacement sheet must be submitted for each sheet of the claims which, on account of an amendment or
`amendments, differs from the sheet originally filed.
`
`All the claims appearing on a replacement sheet must be numbered in Arabic numerals. WhSre a claim is
`cancelled, no renumbering of the other claims is required. In all cases where claims are renumbered, they must be
`renumbered consecutively (Section 205(b)).
`
`The amendments must be made in the language in which the international application is to be published.
`
`What documents must/may accompany the amendments?
`
`Letter (Section 205(b)):
`
`The amendments must be submitted with a letter.
`
`The letter will not be published with the international application and the amended claims. It should not be
`confused with the "Statement under Article 19(1)" (see below, under "Statement under Article 19(1)").
`
`The letter must be in English or French, at the choice of the applicant. However, if the language of the
`international application is English, the letter must be in English; if the language of the international application
`is French, the letter must be in French.
`
`Notes to Form PCT/ISA/220 (first sheet) (October 2005)
`
`14
`
`

`

`PATENT COOPERATION TREATY
`
`PCT
`
`INTERNATIONAL SEARCH REPORT
`
`(PCT Article 18 and Rules 43 and 44)
`
`Applicant's or agent's file reference
`
`2677FWO
`International application No.
`
`PCT/US2007/079094
`Applicant
`
`ALCON MANUFACTURING,. LTD.
`
`FOR FURTHER
`ACTION
`International filing date (day/month/year)
`
`see Form PCT/ISA/220
`as well as, where applicable, item 5 below.
`
`(Earliest) Priority Date (day/month/year)
`
`20/09/2007
`
`28/09/2006
`
`This international search report has been prepared by this International Searching Authority and Is transmitted to the applicant
`according to Article 18. A copy is being transmitted to the International Bureau.
`
`This international search report consists of a total of
`4
`sheets.
`[KI
`It is also accompanied by a copy of each prior art document cited In this report.
`
`1 . Basis of the report
`a. With regard to the language, the international search was carried out on the basis of:
`the international application in the language in which it was filed
`a translation of the international application into
`, which is the language
`of a translation furnished for the purposes of international search (Rules 12.3(a) and 23.1(b))
`
`w
`D
`
`b. D
`c. D
`D
`D
`
`2.
`
`3.
`
`This international search report has been established taking into account the rectification of an obvious mistake
`authorized by or notified to this Authority under Rule 91 (Rule 43.6bis(a)).
`
`With regard to any n