UNITED STATES PATENT 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.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`12/811,737
`
`07/06/2010
`
`Federico Stroppolo
`
`3504-108
`
`1929
`
`6449
`7590
`02/14/2012
`ROTHWELL,FIGG,ERNST&MANBECK,P.C.
`1425 K STREET, N.W.
`SUITE 800
`
`ALLEY, GENEVIEVE S
`
`1617
`
`02/ 14/2012
`
`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):
`PTO-PAT-Email@rfem.c0m
`
`PTOL—90A (Rev. 04/07)
`
`Bass and Spangenberg
`Bass and Spangenberg
`Exhibit 1008
`Exhibit 1008
`
`

`
`Office Action Summary
`
`Application No.
`
`App|icant(s)
`
`12/811,737
`
`STROPPOLO ET AL.
`
`Examiner
`GENEVIEVE s. ALLEY
`
`A“ Unit
`1617
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1.136(a).
`In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`—
`— Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)I:l Responsive to communication(s) filed on
`
`2a)I:I This action is FINAL.
`
`2b)IXl This action is non—final.
`
`3)I:l 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)I:l Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)IZl Claim(s) 1 is/are pending in the application.
`
`5a) Of the above claim(s) 10 and 11 is/are withdrawn from consideration.
`
`6 I:l Claim s) j is/are allowed.
`
`s) flis/are rejected.
`
`s) £9 is/are objected to.
`
`)
`
`are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`
`11)|:| The drawing(s) filed on j is/are: a)I:| accepted or b)I:l objected to by the Examiner.
`
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`12)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`13)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`a)|:I All
`
`b)I:l Some * c)I:I None of:
`
`1.|:I Certified copies of the priority documents have been received.
`
`2.|:I Certified copies of the priority documents have been received in Application No. _.
`
`3.|:I Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) IX] Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) IX] Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 07/06/10.
`U.S. Patent and Trademark Office
`
`4) El Interview Summary (PTO-413)
`Paper N°(5)/Ma" DaTe- E
`5) I:I Notice of informal Patent Application
`6) D Other:
`.
`
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20120208
`
`

`
`Application/Control Number: 12/811,737
`
`Page 2
`
`Art Unit: 1617
`
`DETAILED ACTION
`
`This action is in response to papers filed November 10, 2011. Applicants’
`
`response to the restriction requirement of October 19, 2011 has been entered. No
`
`claims were cancelled, amended, or newly added. Currently claims 1-11 are pending in
`
`the application
`
`Election/Restrictions
`
`Applicants’ election of Group I (claims 1-9) drawn to an orally disintegrating tablet
`
`with speckled appearance, is acknowledged.
`
`Because Applicants did not distinctly and specifically point out the supposed
`
`errors in the restriction requirement, the election has been treated as an election without
`
`traverse (MPEP § 818.03 (a)).
`
`As the requirement for restriction is deemed proper, it is maintained and hereby
`
`made FINAL. Please note that after a final requirement for restriction, the Applicants, in
`
`addition to making any response due on the remainder of the action, may petition the
`
`Commissioner to review the requirement. Petition may be deferred until after final
`
`action on or allowance of claims to the invention elected, but must be filed not later than
`
`appeal. A petition will not be considered if reconsideration of the requirement was not
`
`requested. (See § 1.181.).
`
`Claims 10-11 are hereby withdrawn from further consideration by the Examiner,
`
`pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no
`
`allowable generic or linking claim. The instant claims have been examined
`
`

`
`Application/Control Number: 12/811,737
`
`Page 3
`
`Art Unit: 1617
`
`commensurate with the scope of the elected invention. Applicants timely responded to
`
`the restriction requirement in the reply filed November 10, 2011.
`
`Accordingly, claims 1-9 are under current examination.
`
`Claim Objections
`
`{Claims 1-9 are objected to because of the following informalities: The
`
`independent claim lacks the article “A” and the dependent claims lack the article “The”
`
`at the beginning of each claim. See MPEP 608.01 (n)(lV).§
`
`
`
`. H.-‘W ‘.-
`..~“\
`
`
`Claim 9 is objected to because of the following informalities:
`
`incomplete unit.
`
`Claim 9 recites “...wherein the colored granules are present in an amount from about
`
`0.1 w/w to about 30% w/w.” The claim objection can be obviated by amending the claim
`
`to recite “...wherein the colored granules are present in an amount from about 0.1 w/w
`
`to about 30% w/w per tablet.” Appropriate correction is required.
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in
`the United States.
`
`

`
`Application/Control Number: 12/811,737
`
`Page 4
`
`Art Unit: 1617
`
`Claims 1-4 and 8 are rejected under 35 U.S.C. 102(b) as being anticipated by
`
`Martino et al. (US 2003/0180357).
`
`Claims 1-4 and 8 encompass an orally disintegrating tablet with speckled
`
`appearance comprising colored granules of a water-soluble sugar (e.g., mannitol in 0.1 —
`
`50% w/w) in admixture with a pharmaceutically acceptable carrier.
`
`Martino et al. teach a pharmaceutical tablet suitable for peroral or intraoral
`
`administration, for example for delivery of a drug contained in the core of the tablet to a
`
`subject (oral limitation of claim 1;Abstract). Martino et al. disclose that the tablet has a
`
`speckled appearance that renders the tablet readily identifiable (limitation of claim 1 ;
`
`Abstract).
`
`In [0011], Martino et al. state that the intraoral route refers to administration
`
`by placement of the tablet in the mouth of the subject, where the tablet disintegrates
`
`and/or dissolves, so that absorption of the drug typically occurs at least in part via the
`
`oral mucosa (limitation of claim 1). These tablets comprise a water-soluble sugar such
`
`as mannitol (granular) in 50-90% by weight and a magnesium stearate carrier
`
`(limitations of claims 1-4 and 8; [0060] and [0071]).
`
`In a particular embodiment,
`
`granular mannitol and dye (cherry shade #1632, Crompton and Knowles) were blended
`
`in a high shear mixer for 2 minutes or until homogenously mixed prior to adding other
`
`ingredients and forming the tablet (color limitation of claim 1; [0085]). Martino et al.
`
`teach that this method produced a tablet that had an attractive high gloss appearance
`
`with cherry red speckles [0092].
`
`Therefore, by teaching all the limitations of claims 1-4 and 8, Martino et al.
`
`anticipate the instant invention as claimed.
`
`

`
`Application/Control Number: 12/811,737
`
`Page 5
`
`Art Unit: 1617
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`Claims 1-4 and 8-9 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over Martino et al. (US 2003/0180357).
`
`The teachings of Martino et al. are applied as above for claims 1-4 and 8.
`
`Claim 9 encompasses an orally disintegrating tablet with speckled appearance
`
`comprising colored granules of a water-soluble sugar (1 -30% w/w) in admixture with a
`
`pharmaceutically acceptable carrier.
`
`Regarding the concentration of granules as specified in claim 9, MPEP 2144.05
`
`states:
`
`Generally, differences in concentration or temperature will not support the
`
`patentability of subject matter encompassed by the prior art unless there is
`
`evidence indicating such concentration or temperature is critical. “[W]here the
`
`general conditions of a claim are disclosed in the prior art, it is not inventive to
`
`discover the optimum or workable ranges by routine experimentation.” In re Aller,
`
`220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
`
`Furthermore, Martino et al. teach that relatively large particles will tend to
`
`produce a speckled pattern having larger blocks of color than will be produced by
`
`smaller particles [OO61]. The Applicants‘ specification provides no evidence that the
`
`

`
`Application/Control Number: 12/811,737
`
`Page 6
`
`Art Unit: 1617
`
`selected concentration in claim 9 was not due to routine optimization and/or that the
`
`results should be considered unexpected compared to the prior art.
`
`It would have been
`
`obvious to a person of ordinary skill in the art at the time of the invention to combine
`
`these teachings and alter the concentration of water-soluble sugar granules. One of
`
`ordinary skill in the art would have been motivated to change the concentration as this
`
`could be expected to be affect the appearance of the tablet.
`
`Thus, the claimed invention was prima facie obvious at the time the invention
`
`was made.
`
`Claims 1-9 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Martino et al. (US 2003/0180357), in view of Pettersson et al. (US 2004/0213855).
`
`The teachings of Martino et al. are applied as above for claims 1-4 and 8-9.
`
`Claims 5-7 encompass an orally disintegrating tablet with speckled appearance
`
`comprising colored granules of a water-soluble sugar in admixture with a
`
`pharmaceutically acceptable carrier, wherein the granules have a particle size of 10-
`
`1200, or 200-800 or 300-500 um.
`
`Although Martino et al. teach an orally administered, disintegrating tablet with
`
`speckled appearance comprising granular mannitol in 50-90% (by weight), a dye and a
`
`magnesium stearate carrier as described above, they do not teach the particle size of
`
`the granular mannitol. However, the use of granular mannitol with a particle size
`
`between 300 and 500 um (limitations of claims 5-7) in a tablet were known and routinely
`
`used in the prior art. For example, Pettersson et al. disclose a disintegrating tablet
`
`

`
`Application/Control Number: 12/811,737
`
`Page 7
`
`Art Unit: 1617
`
`comprising granular mannitol with a particle size from 250 to 450 um and a magnesium
`
`stearate [OO59]. Based on these teachings, it would have been obvious to one of
`
`ordinary skill in the art to use a granular size between 250 and 450 pm to achieve the
`
`predictable result of obtaining a composition suitable for oral administration of drugs.
`
`Thus, the claimed invention was prima facie obvious at the time the invention
`
`was made.
`
`Claims 1-9 are not allowed.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to GENEVIEVE S. ALLEY whose telephone number is
`
`(571)270-1111. The examiner can normally be reached on Monday through Friday
`
`7:30AM to 5:00PM EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`

`
`Application/Control Number: 12/811,737
`
`Page 8
`
`Art Unit: 1617
`
`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.
`
`GENEVIEVE S ALLEY
`
`Examiner, Art Unit 1617
`
`/Ileana Popa/
`Primary Examiner, Art Unit 1633
`
`

`
`Notice of References Cited Examiner
`
`Application/Control No.
`
`12/811737
`
`GENEVIEVE s. ALLEY
`U.S. PATENT DOCUMENTS
`
`App|icant(s)/Patent Under
`Reexamination
`STROPPOLO ET AL.
`Art Unit
`
`1617
`
`Page 1 °C1
`
`Document Number
`Country Code—Number— Kind Code
`
`Date
`MM -YYYY
`
`Classification
`
`424/465
`
`424/489
`
`A
`
`US-2003/0180357
`
`09-2003
`
`Martino et al.
`
`US-2004/0213855
`
`10-2004
`
`Pettersson et al.
`
`c:c:c:c:c:c:c:c:c:c:c:C”C”C”C”C”C”C”C”C”C”C”
`
`FOREIGN PATENT DOCUMENTS
`
`Document Number
`Country Code—Number—Kind Code
`
`Date
`Mix/|.YYYY
`
`Country
`
`C3'a55”l°a“°"
`
`
`————
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`— U
`
`*A copy of this reference is not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM—YYYY format are publication dates. Classifications may be US or foreign.
`U.S. Patent and Trademark Office
`
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20120208
`
`

`
`t28t 173'?’ ~ GAL}: 1617
`Receipt date: O’?/06/2610
`PTO/SB/08a (01-10)
`Doc code: IDS
`h 07/31/2012. OMB 0651-0031
`th
`df
`A
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`.
`.
`.
`.
`Us. Patent and ,,a§§§;’;fk O?%;',:.eU_§",J3£I5PARTMENT OF COMMERCE
`Doc description: Information Disclosure Statement (IDS) Filed
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
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`————
`
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
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`NON-PATENT LITERATURE DOCUMENTS
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`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), vo|ume—issue number(s),
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`
`EFS Web 2.1.17
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`ALL REFERENCES COi\IS§{3EREI3 EXCEPT WHERE LINEII} THROUGH.
`
`/GA./’
`
`

`
`Receit date: 0'?/06/2010
`
`t28t 173'?’ ~ GAL}: 1617
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`Attorney Docket Number
`
`3504-108
`
` T
`English language translation is attached.
`
`If you wish to add additional non-patent literature document citation information please click the Add button
`
`EXAMINER SIGNATURE
`
`Examiner Signature
`
`/Genevieve Alley/'
`
`Date Considered
`
`02/O8/2012
`
`*EXAM|NER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`
`1 See Kind Codes of USPTO Patent Documents at www.LJ§PTQ.GOV or MPEP 901.04. 2 Enter office that issued the document, by the two-letter code (WIPO
`Standard ST.3).
`3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. 5 Applicant is to place a check mark here i
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`ALL REFERENCES COE\lS§{3EREE3 EXCEPT WHERE UNEED THRQUGH.
`
`/GA./’
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Page 1 of 1
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, V'
`'nia 22313-1450
`www.uspto.go
`
`CONFIRMATION NO. 1929
`
`GROUP ART UNIT ATTORN'\|lEg DOCKET
`3504-108
`
`BIB DATA SHEET
`
`SERIAL NUMBER
`12/811,737
`
`FILINgIA9l_I‘E 371(c)
`07/06/2010
`
`RULE
`
`APPLICANTS
`
`Federico Stroppolo, Mezzovico, SWITZERLAND;
`Shahbaz Ardalan, Mezzovico, SWITZERLAND;
`
`~k~k~k~k~k~k~k~k*~k~k~k**~k~k~k**~k~k***~k
`
`This application IS a 371 Of PCT/EP09/51055 01/30/2009
`which claims benefit 01 61/026,249 02/05/2008
`
`*************************
`
`~k~k
`
`**
`
`** IF REQUIRED, FOREIGN FILING LICENSE GRANTED **
`07/27/2010
`
`:|YesBNo
`Forei9nPrioriwcIaimed
`35 USC 119(a—d) conditions met :I Yes D No
`V 'f' d
`d
`/GENEVIEVES
`9"“ a”
`ALLEY,
`Acknow|edged
`Examiner's Signature
`
`ADDRESS
`
`Allowance
`D Met after
`
`STATE on
`
`SHEETS
`
`TOTAL
`
`INDEPENDENT
`
`__
`
`SWITZERLAND
`
`0
`
`11
`
`1
`
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`1425 K STREET, N.W.
`SUITE 800
`WASHINGTON, DC 20005
`UNITED STATES
`
`ORALLY DISINTEGRATING TABLETS WITH SPECKLED APPEARANCE
`
`FEES: Authorit has been iven in Pa er
`
`'F:;"E'I;NEcIV':E'E[,E No.
`
`y to chargeg/credit DEIEOSIT ACCOUNT
`
`II All Fees
`
`31.16 Fees (Filing)
`
`3 ‘-17 Fees (P‘°CeSS‘“9 Ext 01 “me
`
`for following:
`
`II 1.18 Fees (Issue)
`
`II Other
`
`II Credit
`
`BIB (Rev. 05/07).
`
`

`
`Application/Control No.
`
`5e3I'Ch NOTES
`
`12811737
`
`Applicant(s)/Patent Under
`Reexamination
`
`STROPPOLO ET AL.
`
`
`
`Art Unit
`
`1617
`
`Examiner
`
`GENEVIEVE S ALLEY
`
`SEARCHED
`
`SEARCH NOTES
`
`2
`
`INTERFERENCE SEARCH
`
`
`
`/G.S.A./
`Examiner.Ar1 Unit 1617
`
`US. Patent and Trademark Office
`
`Part of Paper No.
`
`: 20120208
`
`

`
`
`
`
`
`EAST Search History
`
`EAST Search History
`
`EAST Search History (Prior Art)
`
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`
`
`
`
`
`
`
`
`
`
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`
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`
`
`mannitol WITH granuI$
`EUS-PGPUB; USPAT; USOCR;
`2012/02/08;
`3
`§FPRS; EPO; JPO;
`WI TH tablet
`20 : 52
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`DERWENT
`
`
`US—PGPUB; USPAT; USOCR;
`L1 WITH (particle ADJ
`3
`§FPRS; EPO; JPO;
`§size)
`.................................................................................................................................................................................................................................-
`3
`DERWENT
`
`§US—PGPUB; USPAT; USOCR;
`§"3555144"
`3
`§FPRS; EPO; JPO;
`3
`.....................................................................................................................................................................................
`DERWENT
`
`
`
`
`
`
`
`
`
`
`§US—PGPUB; USPAT; USOCR;
`tablet WITH
`3
`§FPRS; EPO; JPO;
`§disintegrat$
`.................................................................................................................................................................................................................................-
`3
`DERWENT
`
`
`
`
`
`US—PGPUB; USPAT; USOCR;
`§manitoI WITH color
`3
`§FPRS; EPO; JPO;
`3
`« ““““““““« xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxfl xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx‘ \x\\\\\\\\\\\\\\\\\\\\\\\‘ \\\\\\\\\\\\\\\\\\\E xxxxxxxxxxxxxxxxxxxxxxxxx\
`DERWENT
`
`
`
`
`§USPGPUB; USPAT; USOCR;
`§sucrose WITH color
`3
`§FPRS; EPO; JPO;
`3
`« ““““““““« xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxfl xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx‘ \x\\\\\\\\\\\\\\\\\\\\\\\‘ \\\\\\\\\\\\\\\\\\\E xxxxxxxxxxxxxxxxxxxxxxxxx\
`DERWENT
`
`§USrPGPUB; USPAT; usoca;
`3
`§FPRS; EPO; JPO;
`\\\\\\\\\\A \\\\\\\\\\\\\\\\A KKKKKKKKKKKKKKKKKK\\KKKKKKKKKKKKKK\\\\\\\\\\\\\\\\\\\\\\\A KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKI KK\\\\\\\\\\\\\\\\\\\\\\\l \\\\\\\\\\\\\\\\\\\\‘ KKKKKKKKKKKKKKKKKKKKKKKKK\.
`§DERWENT
`
`3
`
`
`
`
`
`§tabIet with speckI$
`3
`
`§stroppoIo—f$.in.
`3
`................
`
`...........
`
`§US~PGPUB; USPAT; usoca;
`§FPRS; EPO; JPO;
`§DERWENT
`
`EUSPGPUB; USPAT; usoca;
`
`3
`§FPRS; EPO; JPO;
`........................................................é ................................................................l .........................l ...................$ ..........................l
`§DERWENT
`
`EUS-PGPUB; USPAT; USOCR;
`§ardaIan—S$.in.
`3
`IFPRS; EPO; JPO;
`\ ...........\ ................\ ........................................................¢ ................................................................: .........................: ....................~ ..........................:
`§DERWENT
`
`‘u<<<<<<<<<<<<<<<<<~<.<.<.<.<.<.<.<.<.<.<.<.<.<.<’
`
`<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.‘
`
`‘u<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<<<<<<<’
`
`‘u<<<<<<<<<<<<<<<<<~<.<.<.<.<.<.<.<.<.<.<.<.<.<.<’
`
`<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.‘
`
`‘u<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<<<<<<<’
`
`
`
`§S‘|O AND table
`
`§USrPGPUB; USPAT; USOCR;
`§FPRS; EPO; JPO;
`\ ‘“““““\ ‘“““““““‘\ <.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.\
`<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.N‘.<.N‘.<.N‘.<.<.<.<.<.<.<.<.<.<.<.<-<-<-<-<-<-<-<-<-<-<-<3
`EDERWENT
`
`
`US—PGPUB; USPAT; USOCR;
`§FPRS; EPO; JPO;
`\ ‘“““““\ ‘“““““““‘\ <.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.\
`<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.<.N‘.<.N‘.<.N‘.<.<.<.<.<.<.<.<.<.<.<.<-<-<-<-<-<-<-<-<-<-<-<3
`DERWENT
`
`
`
`
`
`
`
`US—PGPUB; USPAT; USOCR;
`§FPRS; EPO; JPO;
`
`KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKxx
`DERWENT
`
`EUS-PGPUB; USPAT; USOC '
`gtablet with dots
`§FPRS; EPO; JPO;
`\ \\\\\\\\\\\\ \\\\\\\\\\\\\\\\\ \\\\\\\\\\\\\\\KKKKKK\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ xxK\\\\K\\\\KKxxxKK\\\\K\\\\K\\\\KKxxxKK\\\\\\\\\\\\\\\\\\\\\\\\é uuuuuuuuuuuu: \\\\\\\\\\\\\\\\\\\\ \\\\\\\\\\\\\\\\\\\\\\\\\\é
`DERWENT
`
`§S13 AND pharmaceutic$ §US~PGPUB; USPAT; USOCR;
`§FPRS; EPO; JPO;
`.................................................................................................................................................................................................................................-
`DERWENT
`
`
`
`
`
`
`3
`
`
`
`§US—PGPUB; USPAT; USOCR;
`§FPRS; EPO; JPO;
`
`§S‘|O AND tablet
`
`§(sugar OR sucrose or
`§mannitoI) NEAR9
`
`file:///CI/Users/galley/D0cuments/e—Red%2OF01der/12811737/EASTSearchHist0ry.12811737_Accessib1eVersi0n.htm[2/8/2012 10:45: 24 PM]
`
`
`
`

`
`
`
`
`
`EAST Search History
`
`\ \\\\\\\\\\Q \\\\\\\\\\\\\\\Q \\\KK\\\KKKKKKKKKKKKKKKKKKKKKKKKK\\\\\\\\\\\\\\\\\\\\\\\Q KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK\\\\\\\\\\\\\\\\\\\\\\\\KJ K\\\\\\\\\\\\\\\\\\\\\\\J KKKKKKKKKKKKK1‘
`
`
`
`
`
`
`
`
`mannitol WITH spot$
`US—PGPUB; USPAT; USOCR; §ADJ
`§2o12/01/31$
`§FPRS; EPO; JPO;
`§12:58
`
`
`................................................................................................................................................................................................................................e
`
`
`DERWENT
`
`
`§(424/‘|O.3).OCLS.
`US-PGPUB; USPAT; USOCR; §OR
`§FPRS; EPO; JPO;
`
`
`................................................................................................................................................................................................................................e
`DERWENT
`
`
`§S18 AND speck|$
`§US- PGPUB; USPAT; USOCR;
`§FPRS; EPO; JPO;
`.....................................................................................................................................................................................
`§DERWENT
`
`§US~PGPUB; USPAT; USOCR;
`§FPRS; EPO; JPO;
`
`................................................................................................................................................................................................................................g
`§DERWENT
`
`
`
`
`
`
`(424/10.2).OCLS.
`
`US PGPUB; USPAT; usoca;
`§s22 AND speck$
`§FPRS; EPO; JPO;
`s
`111111111‘. \\\\\\\\\\\\\\\\« 111‘1111‘1111‘1111‘1111‘1111‘1111‘\\\\\\\\\\\\\\\\\\\\\\\« KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK\\\\\\\\\\\\\\\\\\\\\\\‘ KK\\\\\\\\\\\\\\\\\\\\\\\‘ \\\\\\\\\\\\\\\\\\\£ KKKKKKKKKKKKKKKKKKKKKKKKKu
`DERWENT
`
`
`US PGPUB; USPAT; usoca;
`§s1s AND spotted
`§FPRS; EPO; JPO;
`s
`« ‘“““““““« AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA‘“““““““““““« ‘u‘u‘u‘u‘ufi‘ufl‘:‘u‘u‘u‘u‘u‘ufl‘:‘ufl‘:‘u‘u‘u‘u‘u‘ufl‘:‘ufl‘:‘u‘u‘ufl‘:‘ufl‘:‘u‘u‘u‘-‘u‘-‘u‘u‘-‘u<u‘-‘u‘-‘u‘u‘-‘u<u‘-‘u‘<‘-‘u‘-‘u‘ AA“““““““““““‘- ““““““““““‘ xxxxxxxxxxxxxxxxxxxxxxxxx‘-
`DERWENT
`
`
`US PGPUB; USPAT; usoca;
`§FPRS; EPO; JPO;
`s
`
`
`111111111‘. \\\\\\\\\\\\\\\\« 111‘1111‘1111‘1111‘1111‘1111‘1111‘\\\\\\\\\\\\\\\\\\\\\\\« KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK\\\\\\\\\\\\\\\\\\\\\\\‘ KK\\\\\\\\\\\\\\\\\\\\\\\‘ \\\\\\\\\\\\\\\\\\\£ KKKKKKKKKKKKKKKKKKKKKKKKKu
`DERWENT
`
`
`
`
`
`
`
`
`gus PGPUB; USPAT; USOCR;
`§s22 AND spot$
`3
`§FPRS; EPO; JPO;
`3
`\ ...........‘ ................‘ ........................................................é ................................................................l .........................l ...........
`§DERWENT
`
`we PGPUB; USPAT; USOCR;
`Esugar WITH speck|$
`‘
`§FPRS; EPO; JPO;
`\ ..........¢ ...............¢ ........................................................¢ ................................................................: .........................: ...................a ..........................:
`§DERWENT
`
`§USrPGPUB; USPAT; USOCR;
`$825 NOT S15
`§FPRS; EPO; JPO;
`
`\ ..........¢ ...............¢ ........................................................¢ ................................................................: .........................: ...................a ..........................:
`§DERWENT
`
`
`
`
`
`
`
`
`
`
`EUS-PGPUB; USPAT; USOCR;
`§Spotted tablet
`§FPRS; EPO; JPO;
`3
`
`\ 222222222‘; \\\\\\\\\\\\\\\$ \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\$ \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\: \\\\\\\\\\\\\\\\\\\\\\\\: \\\\\\\\\\\\\\\\\\\‘ \\\\\\\\\\\\\\\\\\\\\\\\\\:
`DERWENT
`
`
`
`§Speck|ed tablet
`§US- PGPUB; USPAT; USOCR;
`§FPRS; EPO; JPO;
`\ 222222222‘; \\\\\\\\\\\\\\\$ \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\$ \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\: \\\\\\\\\\\\\\\\\\\\\\\\: \\\\\\\\\\\\\\\\\\\‘ \\\\\\\\\\\\\\\\\\\\\\\\\\:
`DERWENT
`
`
`2/ 8/ 2012 10:45:13 PM
`
`C:\ Users\ ga|ley\ Documents\ EAST\Workspaces\12811737.wsp
`
`file:///CI/Users/galley/D0cuments/e—Red%2OF01der/12811737/EASTSearchHist0ry.12811737_Accessib1eVersi0n.htm[2/8/2012 10:45: 24 PM]