r
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`of 1995.
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`Approved for us© through 03/31/2008.
`OMB 0651-0031
`U.S. Patent and Tradema*
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`reouifad it comains
`a
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`no
`
`Application Number
`
`10/927,857
`
`Filing Date
`
`First Named Inventor
`
`August 27,
`
`2004
`
`Andrew Acheampong
`
`Reduction Ad
`Under the Panaworit
`Request
`for
`Continued Examination (RCE)
`Transmittal
`
`Address to:
`Mail Stop RCE
`Commissioner for Patents
`P.O. Box 1450
`^Alexandria. VA 22313-1450
`17618(AP)
`Attorney Docket Number
`
`
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`for Continued
`Examination
`(RCE)
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`or
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`See (not
`2.
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`amendments
`enclosed
`with
`the
`RCE
`applicant does
`not
`wish
`to
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`
`have unentered amendment(s)
`amendmenl(s).
`
`Art Unit
`
`Examiner Name
`
`1654
`
`Mancela M. Cordero
`
`Garcia
`
`Instruction on page
`
`y
`
`37
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`
`0429
`
` EXHIBIT 1005 (PART 3 OF 3)
`
`

`
`Docket No. 17618(AP)
`
`Serial No. 10/927,857
`
`TRADEMARK
`IN THE UNITED STATES PATENT AND
`Applicant: Acheampong et al
`Examiner: Marcela M. Cordero Garcia
`
`OFFICE
`
`Serial No.: 10/927,857
`
`Group Art Unit: 1654
`
`Filed: August 27, 2004
`
`Confirmation No.: 2409
`
`For: METHODS OF PROVIDING
`THERAPEUTIC EFFECTS USING
`CYCLOSPORIN COMPONENTS
`
`Customer No.: 051957
`
`Response
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`above-referenced
`The Applicants request continued examination of the
`application, thereby withdrawing
`their pending
`
`appeal. They submit with this paper a
`list of amended
`claims
`at
`
`page Remarks follow at page 3. 2.
`
`
`1
`
`0430
`
`

`
`Docket No. 17618(AP)
`
`Serial No. 10/927,857
`
`CLAIMS
`claims will
`
`replace
`
`all
`
`previous
`
`versions
`
`The following
`listing of
`presented in this application:
`
`1.-40 (Canceled).
`
`41. (New) A composition
`a
`of
`eye
`an
`treating
`for
`glycerin,
`Pemulen,
`oil,
`comprising cyclosporin A,
`castor
`
`amount less than 0.05% by weight;
`the cyclosporin A
`is
`in an
`weight;
`the Pemulin is in amount equal to or greater
`than
`1.0%
`by
`the glycerin is in amount equal to or
`less
`than 1.0%
`by
`weight;
`and wherein the
`ratio of
`cyclosporin
`A
`to
`
`castor 0.04.
`oil
`
`human
`and
`
`is
`
`or
`water,
`
`less
`
`2
`
`0431
`
`

`
`Docket No. 17618(AP)
`
`Serial No. 10/927,857
`
`REMARKS
`The applicants have
`history
`prosecution
`reviewed
`the
`have
`and co-pending application no.
`11/897,177,
`and
`purpose of this
`
`request
`for
`continued
`
`to is examination those errors to
`
`attention of the examiner,
`to
`file
`IDS,
`and
`to
`
`an
`
`of
`
`found The
`bring
`the
`submit
`
`the
`significant
`
`new
`
`The Ding reference and obviousness
`The present application describes
`Composition II
`is as
`follows:
`Present Application
`
`two
`
`compositions
`
`at
`
`Example
`
`Cyclosporin A
`Castor Oil
`Polysorbate 80
`Pemulin®
`Glycerine
`NaOH
`Purified water
`
`PH
`Ratio cyclosporin
`to castor oil
`
`Composition II
`0.05 %
`1.25 %
`1.00 %
`0.05 %
`2.20 %
`qs
`qs
`7.2-7.6
`
`0.04
`
`of
`
`the
`
`claims
`
`that
`
`the
`
`the
`rejected
`claims
`No.
`
`5,474,979 The Ding (the
`
`1D,
`and
`1E
`the
`
`under
`
`35
`"Ding
`compositions
`
`Composition II fell within
`presented for prosecution.
`July 2, 2007, the Office
`
`In a final action dated
`U.S.
`Patent
`U.S.C. § 103
`in view of
`reference discloses at Examples
`1B,
`following page.
`
`the
`
`scope
`
`3
`
`0432
`
`

`
`Docket No. 17618(AP)
`
`Serial No. 10/927,857
`
`Ding Reference
`
`Example 1B
`0.40 %
`5.00 %
`1.00 %
`0.05 %
`2.20 %
`qs
`qs
`7.2-7.6
`
`Example 1D
`0.05 %
`0.625 %
`1.00 %
`0.05 %
`2.20 %
`qs
`qs
`7.2-7.6
`
`Example 1E
`0.05 %
`0.625 %
`1.00 %
`0.05 %
`2.20 %
`qs
`qs
`7.2-7.6
`
`0.08
`
`0.08
`
`0.08
`
`Cyclosporin A
`Castor Oil
`Polysorbate 80
`Pemulin®
`Glycerine
`NaOH
`Purified water
`PH
`Ratio cyclosporin
`to castor oil
`
`The only difference between Composition
`the
`of
`II
`that
`is
`Examples 1D and 1E of
`the Ding
`reference,
`The only difference between
`1E
`cyclosporin, and Example
`has
`less
`castor
`oil.
`has
`Composition II and Example
`1B,
`is
`that
`Example
`1B
`the same
`castor
`castor oil, although both
`compositions
`have
`cyclosporin
`and
`amount
`proportion. Stated differently, Composition
`II
`has
`the
`same
`oil
`Example 1E,
`the same amount
`of
`castor
`as
`Example
`of cyclosporin
`to castor oil
`as
`Example
`1B.
`As shown on the
`following
`page,
`compositions are otherwise
`the
`same.
`
`present
`Example
`
`the
`
`less
`
`1D,
`
`4
`
`0433
`
`

`
`Docket No. 17618(AP)
`
`Serial No. 10/927,857
`
`the Ding
`Compositions of
`Composition II of
`the
`
`reference
`present
`
`compared
`application
`
`to
`
`Ding et al.
`Example 1B
`0.20 %
`A
`5.00 %
`1.00 %
`0.05 %
`2.20 %
`qs
`qs
`7.2-7.6
`0 04
`
`Ding et al.
`Example 1D
`0.10 %
`1.250 %
`1.00 %
`0.05 %
`2.20 %
`Qs
`Qs
`7.2-7.6
`0.08
`
`Ding et al.
`Example 1E
`0.05 %
`0.625 %
`1.00 %
`0.05 %
`2.20 %
`qs
`qs
`7.2-7.6
`0.08
`
`Cyclosporin
`Castor Oil
`Polysorbate 80
`Pemulin®
`Glycerine
`NaOH
`Purified water
`
`PH
`cyclosporin :
`castor oil
`
`Composition II
`
`0.05 %
`1.250 %
`1.00 %
`0.05 %
`2.20 %
`qs
`qs
`7.2-7.6
`0.04
`
`between
`the
`
`of
`the
`
`compositions
`application
`skill
`in
`
`of
`
`disclosed
`were
`
`the
`Ding
`cyclosporine
`envisage
`
`The Office argued
`the
`differences
`the
`that
`present
`of
`compositions
`the
`Ding reference and
`ordinary
`one
`It would have been obvious to
`composition
`the invention was made
`to modify
`the
`decreasing
`or
`oil
`increasing the amount of
`castor
`readily
`art
`would
`the
`in
`concentration.
`. . .
`[0]ne
`skilled
`been
`motivated
`claimed composition. The skilled artisan would have
`Ding
`et
`al.
`do so because
`the compositions
`taught
`by
`pharmaceutical emulsion
`consisting
`of
`between
`about
`0.05%
`about
`0.40% by weight cyclosporin A
`and
`
`0.625 between about 5.0%
`
`and
`castor oil. . . There would
`have
`been
`a
`reasonable
`expectation
`success, given
`that compositions
`with
`higher
`amount
`of
`a
`encompassed by
`the Ding
`et
`al.
`claims
`and
`because
`of cyclosporine/hydrophobic components
`to
`below
`0.08
`was
`Ding et al.
`Office action dated July 2,
`
`to
`
`teach
`an
`
`optimizing
`taught
`
`2007,
`
`at
`
`4-5
`
`
`
`(parenthetical omitted).
`
`text
`
`5
`
`0434
`
`

`
`Docket No. 17618(AP)
`
`Serial No. 10/927,857
`
`modify
`
`of
`
`of
`
`of
`
`the
`
`obvious to
`been
`have
`it would
`that
`The applicants concede
`II
`at
`Composition
`arrive
`to
`1A-1E of the Ding
`reference
`insignificant. One need only use
`the
`cyclosporin concentration
`The differences are
`Example 1E
`(0.05%),
`the
`castor
`oil
`concentration
`of
`Example 1D
`remaining ingredients of
`those
`
`examples. As the examiner correctly observes,
`one
`ordinary skill in the art
`"would
`readily
`
`a such envisage" composition, especially
`
`
`in
`view of Example 1B: having
`selected
`0.05%
`as of cyclosporin, the
`
`
`concentration
`Example 1B (wherein
`the
`
`ratio cyclosporin to castor oil of
`
`is 0.04)
`teaches
`that
`concentration of castor oil should
`be
`1.250%
`
`(0.05% The
`/1.250%
`applicants concede
`that
`
`in making selection (0.05% cyclosporin this
`
`and
`1.250%
`castor oil) there would have
`been
`a
`reasonable
`expectation
`of
`differences between Examples
`1A-1E and Composition
`II
`are
`too
`otherwise.
`The formulation of Composition
`reference, and the Office
`should
`suggesting otherwise, whether
`in
`11/897,177.
`
`squarely
`is
`II
`any
`disregard
`this
`application
`
`within
`statements
`or
`in
`
`teaching
`the
`the
`by
`co-pending
`
`the
`
`Ding
`
`cyclosporin
`The Ding reference and 0.05%
`distinguish
`to
`attempted
`Counsel for
`the applicants
`
`therapeutically effective compositions
`any
`arguing that it does not
`disclose
`comprising less
`than 0.10%
`
`cyclosporin. That argument
`
`is in error. It urges an
`interpretation of
`the Ding
`reference
`that
`the
`applicants
`Below is an example of
`counsel's
`argument. It should be disregarded,
`
`should all other statements
`
`
`in filed connection with
`this application
`or
`application no. 11/897,177
`in support
`of
`this argument:
`There is absolutely no
`
`indication in Ding that a therapeutically effective
`less
`dosage of cyclosporin can
`be
`achieved
`at
`a
`concentration
`the
`0.1%. Indeed, the apparent
`failure
`of
`Ding
`to
`even
`test
`bioavailability of composition
`1E
`(at
`0.05%
`cyclosporin
`having
`
`not
`
`do
`as
`co-pending
`
`6
`
`0435
`
`

`
`Docket No. 17618(AP)
`
`Serial No. 10/927,857
`
`A
`could
`of
`
`as
`not
`less
`
`cyclosporin to
`
`0.1%
`of
`
`to
`
`at
`
`filed March
`
`7,
`
`2008
`
`("Amended Appeal
`
`Brief),
`
`it as
`filed
`examiner
`
`a
`
`is
`
`on
`but
`were
`
`0.05%)
`
`cyclosporin
`of
`amount
`the
`[than]
`less
`[than] half or
`et
`al.
`Ding
`that
`compositions A-D) demonstrates
`A
`dosages
`predict that compositions
`containing cyclosporin
`alternatively, that
`0.1% would be
`therapeutically
`effective,
`or
`composition 1E
`failed
`to
`deliver
`a
`therapeutic
`level
`of
`interest. Either possibility must
`lead
`the
`conclusion
`ocular tissues of
`that therapeutically effective
`compositions
`having
`less
`than
`cyclosporin A . . . were unpredictable
`the
`priority
`date
`application. . . .
`Amended appeal brief
`(emphasis omitted).
`dismissing
`this argument,
`of
`little
`thought
`The examiner
`
`evidentiary support." Examiner's Answer
`any
`statement.
`. . provided without
`May 28, 2008 ("Examiner's Answer"). The applicants concede
`that
`the
`correct.
`Counsel for the applicants
`advanced case based not on evidence a
`
`
`had
`that
`Examples
`1A-1D
`states
`speculation: the Ding
`reference
`Example
`1E
`(cyclosporin
`that
`bioavailability;
`it does not
`state
`supposedly
`ocular bioavailability; hence,
`this
`clearly indicate[s]
`. . .
`
`that Ding et al. did not expect
`of Example 1E
`is therapeutically
`effective,
`composition 1E did not
`deliver
`therapeutic
`the tissues of
`interest."
`Amended Appeal Brief,
`at 16.
`negative It is the
`
`unfounded
`an
`on
`Counsel's argument was
`based
`because
`Ding et
`that
`equivalent of arguing,
`for
`example,
`al.
`one
`should
`expect them
`that
`compositions are chemically
`stable,
`explode; that
`
`because they fail
`to state
`that
`their
`compositions are not radioactive,
`they
`are
`that
`radioactive; or
`that because
`nowhere
`do
`Ding
`state
`et
`al.
`not give a patient x-ray vision, that one may
`conclude
`that
`the
`compositions
`
`that
`or
`
`the
`Ding
`levels
`
`7
`
`composition
`was
`
`of
`
`aware
`cyclosporin
`
`implication.
`fail
`to
`
`0436
`
`

`
`Docket No. 17618(AP)
`
`Serial No. 10/927,857
`
`above
`
`evidence,
`
`a patient to see through walls. Counsel's logic elevates speculation
`and permits one
`to draw
`any
`
`conclusion, matter how
`
`no incredible.
`reason
`any
`Counsel for the applicants
`has
`not
`identified
`using
`ineffective
`compositions of
`the Ding
`reference
`would
`be
`a
`composition comprising
`less than 0.10%. The Ding reference expressly
`discloses
`0.05% cyclosporin;
`it describes
`its
`
`and testing; it claims its use. As the examiner
`
`aptly points out:
`applications
`in
`used
`was
`1E
`the composition of Example
`
`1-4
`were It is clear that
`used.
`in Examples
`eyes since the
`formulations
`that
`eye
`indicates
`application of such compositions
`to
`the
`be
`therapeutically
`pharmaceutical composition
`is expected
`to
`it would
`not
`with respect to, e.g., dry
`eye
`and
`because
`bioactive
`function.
`pharmaceutical composition without
`having
`a
`Examiner's Answer, at 9
`(parenthetical
`
`omitted). text The applicants concede
`
`that
`the examiner is correct.
`
`"there is absolutely no
`
`that that
`In sum, the notion
`indication in Ding that a
`of
`cyclosporin can
`therapeutically effective dosage
`be
`achieved
`less than 0.1%"
`(Amended Appeal
`Brief,
`at
`13)
`is
`incorrect.
`It improperly
`characterizes the Ding
`reference,
`and
`the
`Office
`should
`this application or
`in or
`made in support of
`that
`characterization,
`whether
`in
`pending application no. 11/897,177.
`
`cyclosporin
`
`to
`
`to
`
`effective
`be
`
`at
`
`disregard
`
`co­
`
`Claim amendments
`the
`amended
`have
`applicants
`the
`foregoing,
`In view of
`the
`
`
`animal comprising or cyclosporin A,
`human
`of
`a
`eye
`composition for
`treating an
`wherein
`water,
`and
`castor oil, Pemulen, glycerin,
`the cyclosporin A
`is
`in an
`
`amount less than 0.05% by weight;
`weight;
`the Pemulin is in amount equal to or greater
`than
`1.0%
`by
`the glycerin is in amount equal to or
`less
`than 1.0%
`by
`weight;
`and wherein the
`ratio of
`cyclosporin
`A
`to
`
`castor 0.04.
`oil
`
`less
`
`is
`
`claims
`
`8
`
`0437
`
`

`
`Docket No. 17618(AP)
`
`Serial No. 10/927,857
`
`Information Disclosure Statement
`the
`of I present application describes the
`Composition II of Example
`
`
`
`in
`of Restasis®, a treatment
`for
`
`
`dry Restasis® has been on eye.
`sale
`States since approximately April,
`2003. The applicants submit with
`
`this
`with the prescribing
`information
`
`that Restasis is sold with.
`
`formulation
`the
`United
`paper
`an
`
`IDS
`
`The Commissioner is hereby authorized to charge any fees required or
`necessary for the filing, processing or entering of this paper or any of the enclosed
`papers, and to refund any
`overpayment,
`to
`deposit
`account
`
`01-0885.
`
`Date: June 15,2009
`
`Respectfully submitted
`
`/JOEL B. GERMAN/
`
`JOEL B. GERMAN
`Attorney of Record
`Registration Number 48,676
`
`inquiries and
`Please direct all
`Joel B. German, Esq.
`Allergan, Inc.
`2525 Dupont Drive, T2-7H
`Irvine, California 92612
`Tel: (714)246-4920 Fax: (714)246-4249
`
`correspondence
`
`to:
`
`9
`
`0438
`
`

`
`17618(AP)
`
`IN THE UNITED STATES PATENT AND
`OFFICE
`TRADEMARK
`Applicant: Acheampong et al
`Examiner: Marcela M. Cordero Garcia
`
`Serial No.: 10/927,857
`
`Group Art Unit: 1654
`
`Filed: August 27, 2004
`
`Confirmation No.: 2409
`
`For: METHODS OF PROVIDING
`THERAPEUTIC EFFECTS USING
`CYCLOSPORIN COMPONENTS
`INFORMATION DISCLOSURE STATEMENT
`
`Customer No.: 051957
`
`for Patents
`Commissioner
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Dear Sir:
`
`In accordance with the provisions of 37 C.F.R. 1.56, 1.97, and 1.98, the
`attention of
`
`the Patent and Trademark is hereby directed Office
`
`to
`the
`documents
`listed on the attached form PTO-SB/O8b (formerly 1449).
`It is respectfully
`requested that the documents be expressly considered during the prosecution of
`this application, and that the documents be made of record therein and appear
`among the "References Cited"
`on
`any
`patent
`to
`issue
`
`therefrom.
`
`to
`pursuant
`material
`be
`While these documents may
`
`disclosure is not intended to constitute an admission that the documents are
`The filing of this Statement should not be
`art in regard to this invention,
`construed to mean that a search has been conducted or that no other material
`documents or information exists.
`Please do not hesitate to contact the
`undersigned should any questions
`arise
`regarding
`this
`Statement.
`
`37
`prior
`
`0439
`
`

`
`Docket No. 17618(AP)
`Serial No. 10/927,857
`
`The Commissioner is hereby authorized to charge any fees required or
`necessary for the filing
`processing or entering of this paper or any of the
`enclosed papers, and
`to refund
`any
`overpayment,
`to
`deposit
`
`account
`
`Respectfully submitted
`
`/JOEL B. GERMAN/
`
`JOEL B. GERMAN
`Attorney of Record
`Registration Number 48,676
`correspondence
`to:
`
`Date: June 15, 2009
`
`inquiries and
`Please direct all
`Joel B. German, Esq.
`Allergan, Inc.
`2525 Dupont Drive, T2-7H
`Irvine, California 92612
`Tel: (714)246-4920 Fax: (714)246-4249
`
`2
`
`0440
`
`

`
`
`FORM PTO-1449 U.S. DEPARTMENT OF
`COMMERCE ATTY. DOCKET NO.
`PATENT AND TRADEMARK
`OFFICE
`17618(AP)
`
`SERIAL NO.
`10/927,857
`
`SHEET 1 OF 1
`
`INFORMATION DISCLOSURE STATEMENT
`BY APPLICANT
`
`(USE SEVERAL SHEETS
`
`IF
`
`NECESSARY)
`
`APPLICANT
`Andrew Acheampong
`
`FILING DATE
`August 27, 2004
`
`U.S. PATENT DOCUMENTS
`
`GROUP
`1654
`
`EXAMINER
`INITIAL
`
`DOCUMENT NUMBER
`
`DATE
`
`NAME
`
`CLASS
`
`SUBCLASS
`
`FILING DATE
`(IF APPROPRIATE)
`
`EXAMINER
`INITIAL
`
`DOCUMENT NUMBER
`
`DATE
`
`COUNTRY
`
`CLASS SUBCLASS
`
`TRANSLATION
`
`YES
`
`NO
`
`FOREIGN PATENT
`
`DOCUMENTS
`
`EXAMINER
`INITIAL
`
`OTHER DOCUMENTS
`
`(INCLUDING AUTHOR,
`
`
`
`TITLE, DATE, PERTINENT PAGES, ETC.)
`
`Restasis Product Information Sheet
`
`- 5
`
`pages
`
`EXAMINER
`
`DATE CONSIDERED
`
`609; DRAW LINE
`IS CITATION IN CONFORMANCE WITH MPEP
`
`
`"EXAMINER: INITIAL IF CITATION CONSIDERED, WHETHER OR NOT
`
`CONFORMANCE AND NOT CONSIDERED, INCLUDE COPY OF THIS FORM WITH NEXT COMMUNICATION TO APPLICANT.
`
`THROUGH
`
`
`
`CITATION IN
`
`IF
`
`NOT
`
`0441
`
`

`
`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`10927857
`
`27-Aug-2004
`
`Title of Invention:
`
`Methods of
`
`providing
`
`
`
`therapeutic effects using
`
`cyclosporin
`
`components
`
`First Named Inventor/Applicant
`
`Name:
`
`Andrew Acheampong
`
`Filer:
`
`Joel B. German/Bonnie
`
`Ferguson
`
`Attorney Docket Number:
`
`17618(AP)
`
`Filed as Large Entity
`
`Utility under 35 USC 111 (a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total
`USD($)
`
`in
`
`Basic Filing:
`
`Pages:
`
`Claims:
`
`Miscellaneous-Filing:
`
`Petition:
`
`Patent-Appeals-and-lnterference:
`
`Post-Allowance-and-Post-lssuance:
`
`Extension-of-Time:
`
`0442
`
`

`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total
`USD($)
`
`in
`
`Miscellaneous:
`
`Request
`
`for
`
`continued
`
`examination
`
`1801
`
`1
`
`810
`
`810
`
`Total in USD ($)
`
`810
`
`0443
`
`

`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`5514219
`
`10927857
`
`International
`
`Application Number:
`
`Confirmation Number:
`
`2409
`
`Title of Invention:
`
`Methods of
`
`providing
`
`
`
`therapeutic effects using
`
`cyclosporin
`
`components
`
`First Named Inventor/Applicant
`
`Name:
`
`Andrew Acheampong
`
`Customer Number:
`
`51957
`
`Filer:
`
`Joel B. German/Bonnie
`
`Ferguson
`
`Filer Authorized By:
`
`Joel B. German
`
`Attorney Docket Number:
`
`17618(AP)
`
`Receipt Date:
`
`Filing Date:
`
`15-JUN-2009
`
`27-AUG-2004
`
`Time Stamp:
`
`13:10:38
`
`Application Type:
`
`Utility under
`
`35
`
`USC 111(a)
`
`Payment information:
`
`Submitted with Payment
`
`Payment Type
`
`Payment was successfully
`
`
`
`received in RAM
`
`RAM confirmation Number
`
`Deposit Account
`
`Authorized User
`
`File Listing:
`
`Document
`Number
`
`yes
`
`Deposit Account
`
`$810
`
`8198
`
`010885
`
`Document Description
`
`File Name
`
`File Size( Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(ifappl.)
`
`0444
`
`

`
`1
`
`Request
`
`for
`
`Continued
`(RCE)
`
`Examination
`17618-RCETransmittal.pdf
`
`97684
`
`no
`
`1
`
`4d5c7fcb4a0d82d1f95115e5d8edf8029dea
`8515
`
`Warnings:
`
`This is not
`
`a USPTO supplied
`
`RCE SB30
`
`form.
`
`Information:
`
`2
`
`Warnings:
`
`Information:
`
`17618Response061509.pdf
`
`yes
`
`9
`
`85651
`
`7574bdab3fe4d177ac5a965e4c4d82d58d6
`b2ca8
`
`Multipart Description/PDF
`
`
`
`files in .zip description
`
`Document Description
`
`Start
`
`End
`
`Amendment/Argument
`
`after
`
`
`
`Notice Appeal
`
`of
`
`Claims
`
`Applicant Arguments/Remarks
`
`
`
`Made in an Amendment
`
`1
`
`2
`
`9
`
`1
`
`2
`
`3
`
`61819
`
`3
`
`Transmittal
`
`Letter
`
`17618-IDS-Trans6-15-09.pdf
`
`no
`
`2
`
`f288731 d605943f65b093d25fd169d4b11 e
`70263
`
`Warnings:
`
`Information:
`
`4
`
`Information
`
`Disclosure
`Filed (SB/08)
`
`Statement
`
`(IDS)
`17618-1449-6-15-09.pdf
`
`64544
`
`no
`
`1
`
`el 8bf4cb6923fc83eb6c1 c5cc9dfb2f768b7
`dcc7
`
`Warnings:
`
`Information:
`
`This is not
`
`an
`
`
`
`USPTO supplied IDS fillable
`
`form
`
`be
`large. The pages should
`
`the in PDF is too
`
`size
`The page
`
`Image File Wrapper
`
`and may affect
`subsequent
`processing
`
`
`
`
`
`
`
`x 8.5 If this PDF is submitted, 11 or the pages will be resized upon entry A4.
`
`
`
`
`
`
`
`into the
`
`5
`
`NPL Documents
`
`RestasisProductlnfoSheetsb.pdf
`
`no
`
`5
`
`62345
`
`604160268435ab09d0183919a20f9a4d97b
`b6f79
`
`Warnings:
`
`Information:
`
`6
`
`Fee Worksheet
`
`(PTO-875)
`
`fee-info.pdf
`
`no
`
`2
`
`30217
`
`5c9ada3462d7ed1 bl a4406fb9e125008e04
`e6ac4
`
`Warnings:
`
`Information:
`
`Total Files Size (in bytes):
`
`402260
`
`0445
`
`

`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of
`characterized by the applicant, and including page counts, where applicable.
`It
`Post Card, as described in MPEP 503.
`
`the indicated documents,
`
`
`serves as evidence of receipt similar
`
`to a
`
`New Applications Under 35 U.S.C. 111
`includes the necessary components for a filing date (see 37 CFR
`
`If a new application is being
`filed and the application
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement
`Receipt will establish the filing date of the application.
`
`National Stage of an International
`Application under 35 U.S.C. 371
`If a timely submission
`to enter
`the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements
`a Form PCT/DO/EO/903
`indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`includes the necessary components for
`
`If a new international application
`is being
`filed and the international application
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International
`Application Number
`and of the International Filing Date (Form PCT/RO/105) will be issued in due course, subject
`to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish
`the international
`filing date of
`the application.
`
`0446
`
`

`
`Under the Paperwork
`Reduction
`PATENT APPLICATION
`FEE
`Substitute
`for Form
`
`Act
`of
`1995,
`DETERMINATION
`PTO-875
`
`(07-06)
`PTO/SB/06
`OMB 0651-0032
`1/31/2007.
`through
`for use
`Approved
`U.S.
`DEPARTMENT
`U.S. Patent and
`Trademark
`Office;
`
`are it
`
`required displays
`no to a collection
`
`of
`
`persons information
`unless
`RECORD
`Number Filing Date 1""
`10/927,857
`Application or Docket
`
`08/27/2004 EH To be Mailed
`
`APPLICATION AS FILED - PART I
`(Column 1)
`
`(Column 2)
`
`SMALL ENTITY •
`
`OR
`
`OTHER THAN
`SMALL ENTITY
`
`FOR
`
`NUMBER FILED
`
`NUMBER EXTRA
`
`RATE ($)
`
`FEE ($)
`
`RATE ($)
`
`FEE ($)
`
`• BASIC FEE
`(37 CFR 1.16(a),
`
`• SEARCH FEE
`(37 CFR 1.16(k),
`
`(b),
`
`or
`
`(c))
`
`(i),
`
`or
`
`(m))
`
`FEE
`(p),
`
`• EXAMINATION
`(37 CFR 1.16(0),
`TOTAL CLAIMS
`(37 CFR 1.16(1))
`INDEPENDENT CLAIMS
`(37 CFR 1.16(h))
`
`or
`
`(q))
`
`N/A
`
`N/A
`
`N/A
`
`minus 20 =
`
`minus 3 =
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`X $
`
`X $
`
`N/A
`
`N/A
`
`N/A
`
`OR
`
`X $
`
`X $
`
`•APPLICATION SIZE FEE
`(37 CFR 1.16(s))
`
`CLAIM
`
`PRESENT
`
`(37
`
`due
`
`exceed
`size
`for
`thereof.
`CFR
`
`100
`
`fee
`each
`
`See
`1.16(s).
`
`CFR
`
`1.16(j))
`
`
`
`zero, TOTAL
`
`TOTAL
`
`drawings
`and
`If the specification
`application
`the
`sheets of paper,
`small
`entity)
`is $250 ($125
`for
`additional 50 sheets
`or
`fraction
`35 U.S.C. 41(a)(1)(G)
`and
`37
`D MULTIPLE DEPENDENT
`* If the difference
`in
`column
`
`1
`
`
`
`is enter "0"
`
`in
`
`
`
`less column
`
`2.
`
`than
`
`APPLICATION AS
`
`(Column 1)
`
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`
`06/15/2009
`
`(37 CFR
`
`
`
`AMENDED PART II -
`
`
`
`(Column 2)
`
`(Column 3)
`
`SMALL ENTITY
`
`OR
`
`OTHER THAN
`SMALL ENTITY
`
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`PRESENT
`EXTRA
`
`RATE ($)
`
`ADDITIONAL
`FEE ($)
`
`RATE ($)
`
`ADDITIONAL
`FEE ($)
`
`X $52=
`
`I—
`z
`LU
`2
`O
`z
`LU
`2 <
`
`* 1
`
`TOtal
`1.16(1))
`Independent
`* 1
`(37 CFR 1.16(h))
`l~l Application Size Fee
`I I FIRST PRESENTATION
`
`Minus
`
`Minus
`
`- 36
`
`,„3
`
`= 0
`
`= 0
`
`(37 CFR
`
`1.16(s))
`
`OF
`
`MULTIPLE
`
`DEPENDENT
`
`(Column 1)
`
`(Column 2)
`
`(Column 3)
`
`X $
`
`x $
`
`CLAIM
`
`TOTAL
`ADD'L
`FEE
`
`OR
`
`OR
`
`X $220=
`
`(37
`
`OR
`
`CFR
`
`OR
`
`TOTAL
`ADD'L
`FEE
`
`0
`0
`
`0
`
`1.160))
`
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`PRESENT
`EXTRA
`
`RATE ($)
`
`ADDITIONAL
`FEE ($)
`
`RATE ($)
`
`ADDITIONAL
`FEE ($)
`
`Minus
`
`Minus
`
`(37 CFR
`
`1.16(s))
`
`x $
`
`X $
`
`OR
`
`OR
`
`X $
`
`X $
`
`OF
`
`MULTIPLE
`
`DEPENDENT
`
`CLAIM
`
`(37
`
`OR
`
`CFR
`
`1.160))
`
`(37 CFR
`
`I—
`Z
`TOtal
`LU
`1.16(1))
`2 Independent
`Q
`(37 CFR 1.16(h))
`Z
`l~l Application Size Fee
`LU
`2 I I FIRST PRESENTATION
`<
`
`is
`1
`column
`in
`* If the entry
`Previously
`** If the "Highest Number
`Previously
`*** If the
`"Highest
`Number
`The "Highest Number
`Previously
`Paid
`by
`is
`information
`This collection of
`governed
`process) an application.
`Confidentiality
`application
`preparing, and
`submitting
`the completed
`suggestions
`require to complete
`this
`form
`and/or
`Alexandria,
`1450,
`Department of Commerce,
`P.O.
`Box
`Patents,
`for
`ADDRESS. SEND TO: Commissioner
`P.O. Box 1450, Alexandria, VA
`If you need assistance
`in completing
`the
`form,
`
`less
`Paid
`Paid
`For"
`required
`is
`
`the
`than
`IN
`For"
`For" 3, enter "3".
`
`(Total
`
`37
`by
`
`for
`
`form
`
`column
`
`is
`
`is
`
`the
`
`The
`122 gathering,
`
`
`
`the
`
`reducing
`
`this
`22313-1450.
`
`USPTO.
`
`Time
`
`burden,
`DO
`
`and
`
`select
`
`option
`
`VA
`22313-1450.
`call
`1-800-PTO-9199
`
`TOTAL
`ADD'L
`FEE
`entry
`Legal Instrument
`THIS
`/Kim Downing/
`THIS
`
`IN
`
`OR
`
`TOTAL
`ADD'L
`FEE
`in
`Examiner:
`SPACE
`SPACE
`
`or
`
`35
`to
`
`CFR
`
`Independent) is
`1.16.
`
`U.S.C.
`
`0447
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`a
`1
`$
`
`II
`
`'gj
`
`VVTOFCO
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`DX 1450
`P.O. Bo
`dria, Virginia 22313-1450
`Alexan
`to.gov
`www.usp
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO. CONFIRMATION NO.
`
`10/927,857
`
`08/27/2004
`
`Andrew Acheampong
`
`17618(AP)
`
`2409
`
`7590
`
`51957
`
`ALLERGAN, INC.
`2525 DUPONT DRIVE, T2-7H
`IRVINE, CA 92612-1599
`
`06/16/2009
`
`EXAMINER
`
`CORDERO GARCIA, MARCELA M
`
`ART UNIT
`
`PAPER NUMBER
`
`1654
`
`MAIL DATE
`
`06/16/2009
`
`DELIVERY MODE
`
`PAPER
`
`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.
`
`PTOL-90A (Rev. 04/07)
`
`0448
`
`

`
`UNITED STATES PATENT AND TRADEMARK
`
`OFFICE
`
`PATENT
`BEFORE THE BOARD OF
`AND INTERFERENCES
`
`APPEALS
`
`Ex parte ANDREW ACHEAMPONG, DIANE TANG-LIU,
`JAMES N. CHANG and DAVID
`F.
`POWER
`
`Appeal 2009-005649
`Application 10/927,857
`Technology Center 1600
`
`Mailed: June 16, 2009
`
`Before STEVEN J. BARTLETT, Appeals
`
`Program Manager.
`
`ORDER DISMISSING APPEAL
`
`and
`a
`
`a
`Request
`
`such
`
`further
`
`is
`to
`
`dismissed.
`the
`Examiner
`
`for
`
`On March 9, 2009, Appeal No. 2009-005649 was assigned
`Docketing Notice was mailed. On June 15, 2009, Appellants
`filed
`for Continued Examination (RCE).
`Accordingly, it
`is
`ORDERED that the appeal
`This application is returned
`may be appropriate.
`If there are any questions pertaining
`Board of Patent Appeals and Interferences
`
`to
`at
`
`this Order, please contact the
`
`571-272-9797.
`
`0449
`
`

`
`Appeal 2009-005649
`Application 10/927,857
`
`SJB
`
`ALLERGAN, INC.
`2525 DUPONT DRIVE, T2-7H
`IRVINE CA 92612-1599
`
`2
`
`0450
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`a
`1
`$
`3k
`
`VVTOFCO
`
`II
`
`'gj
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER
`FOR
`PATENTS
`DX 1450
`P.O. Bo
`dria, Virginia 22313-1450
`Alexan
`to.gov
`www.usp
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED
`
`INVENTOR
`
`ATTORNEY DOCKET
`
`NO. CONFIRMATION NO.
`
`10/927,857
`
`08/27/2004
`
`Andrew Acheampong
`
`17618(AP)
`
`2409
`
`7590
`
`51957
`
`ALLERGAN, INC.
`2525 DUPONT DRIVE, T2-7H
`IRVINE, CA 92612-1599
`
`09/01/2009
`
`EXAMINER
`
`CORDERO GARCIA, MARCELA
`
`M
`
`ART UNIT
`
`PAPER NUMBER
`
`1654
`
`MAIL DATE
`
`DELIVERY MODE
`
`09/01/2009
`
`PAPER
`
`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.
`
`PTOL-90A (Rev. 04/07)
`
`0451
`
`

`
`Application No.
`
`Applicant(s)
`
`10/927,857
`
`Examiner
`
`MARCELA M.CORDERO
`GARCIA
`appears
`
`on
`
`ACHEAMPONG ET AL.
`
`Art Unit
`
`1654
`
`the
`
`cover
`
`sheet
`
`with
`
`Office Action Summary
`
`— The MAILING DATE of this communication
`Period for Reply
`PERIOD
`A SHORTENED STATUTORY
`FROM
`WHICHEVER
`IS LONGER,
`available
`- Extensions of
`time may
`be
`the
`mailing
`after SIX
`(6) MONTHS
`from
`above,
`If NO period
`for
`reply
`is specified
`-
`or
`to
`reply within
`the
`set
`- Failure
`
`
`Any reply
`received
`by
`the
`
`later Office three months after
`earned patent term
`adjustment. See 37 CFR 1.704(b).
`Status
`
`FOR REPLY
`THE
`MAILING
`under
`
`the In no event, however,
`date
`of
`
`IS
`
`the
`extended
`
`than the
`mailing
`
`maximum
`period
`date
`
`
`
`a
`
`SET MONTH(S) OR THIRTY TO
`
`DATE
`OF
`
`provisions may
`reply
`this
`statutory
`for
`
`of
`
`(35 U.S.C. §
`this
`
`EXPIRE DAYS,
`(30)
`
`THIS COMMUNICATION.
`37 timely
`
`filed
`
`will
`will,
`
`even
`
`be
`of
`communication.
`
`period communication.
`
`reply 133).
`communication,
`
`Responsive
`1
`on
`filed
`to communication(s)
`2b)E3 This action
`is FINAL.
`2a)• This action
`in
`is
`condition for
`Since this application
`closed in accordance with
`the
`practice
`
`15
`is non-final.
`allowance
`under
`
`Ex
`
`June
`
`2009.
`
`except
`parte
`
`for
`Quayle,
`
`formal
`
`1935
`
`Disposition of Claims
`4)^3 Claim(s) 41_
`in
`is/are pending
`4a) Of the above claim(s)
`5)0 Claim(s)
`is/are allowed.
`6® Claim(s) 41_ is/are rejected.
`
`?)• Claim(s)
`is/are objected
`8)0 Claim(s)
`are subject
`to
`
`application.
`the
`is/are withdrawn
`from
`
`consideration.
`
`to.
`restriction
`
`and/or
`
`election
`
`requirement.
`
`Application Papers
`9)KI The specification
`Examiner.
`the
`by
`to
`is objected
`the Examiner.
`filed
`
`on is/are: a)^ accepted or b)^ objected to by
`10)0
`The drawing(s)
`Applicant may not request th