12/811,737
`
`6449
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`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
`
`ATTORNEY DOCKET NO.
`
`CONF <MATION NO.
`
`07/06/2010
`
`Federico Stroppolo
`
`3504-108
`
`1929
`
`7590
`
`09/12/2012
`
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th Street, N.W.
`SUITE 800
`WASHINGTON, DC 20005
`
`EXAMINER
`
`ALLEY, GENEVIEVE S
`
`ART UNIT
`
`1617
`
`PAPER NUMBER
`
`* ICATION DATE
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`DELIVERY MODE
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`09/12/2012
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`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 1010
`Exhibit 1010
`
`

`
`Office Action Summary
`
`Application No.
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`App|icant(s)
`
`12/811,737
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`STROPPOLO ET AL.
`
`Examiner
`GENEVIEVE s. ALLEY
`
`Art 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
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`1)|Xl Responsive to communication(s) filed on 14 May 2012.
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`2a)IXI This action is FINAL.
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`2b)I:I This action is non—final.
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`3)|:l An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:l Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`5)|XI Claim(s) 1 is/are pending in the application.
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`5a) Of the above claim(s) 10 and 11 is/are withdrawn from consideration.
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`6)I:I Claim(s) j is/are allowed.
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`7)|Xl Claim(s)1;£9is/are rejected.
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`8)I:I Claim(s) _ is/are objected to.
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`9)|:l Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`10)|:l The specification is objected to by the Examiner.
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`11)I:I The drawing(s) filed on j is/are: a)I:I accepted or b)I:I 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).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`12)|:l The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`13)|:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
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`a)I:I All
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`b)I:I Some * c)I:l None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.I:I Certified copies of the priority documents have been received in Application No. j.
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`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) El Notice of References Cited (PTO-892)
`2) El Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) El Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date
`.
`U.S. Patent and Trademark Office
`
`4) El Interview Summary (PTO-413)
`Paper N°(3)/Ma“ DaT9- L
`5) I:I Notice Of Inform-3' Patent APPIICaTI0“
`6) X Other: search history.
`
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20120829A
`
`

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`Application/Control Number: 12/811,737
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`Page 2
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`Art Unit: 1617
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`DETAILED ACTION
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`Claim Status
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`Applicants’ response of May 14, 2012, to the non-final Office action dated
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`February 14, 2012 has been entered. Claims 1-10 have been amended and claims 10
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`and 11 have been previously withdrawn. Accordingly, claims 1-11 are pending in the
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`application and claims 1-9 are under current examination.
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`Withdrawn Claim Objection/Rejections
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`The objections to claims 1-9 for minor informalities are hereby withdrawn in view
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`of the claim amendments filed on May 14, 2012.
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(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.
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`Claims 1-4 and 8 remain rejected under 35 U.S.C. 102(b) as being anticipated by
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`Martino et al. (US 2003/0180357; published: Sep. 25, 2003; of record).
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`Claims 1-4 and 8 encompass an orally disintegrating tablet with speckled
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`appearance comprising colored granules of a water-soluble sugar (e.g., mannitol in 0.1 -
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`50% w/w) in admixture with a pharmaceutically acceptable carrier.
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`

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`Application/Control Number: 12/811,737
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`Page 3
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`Art Unit: 1617
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`Martino et al. teach a pharmaceutical tablet suitable for peroral or intraoral
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`administration, for example for delivery of a drug contained in the core of the tablet to a
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`subject (oral limitation of claim 1 ; Abstract). Martino et al. disclose that the tablet has a
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`speckled appearance that renders the tablet readily identifiable (limitation of claim 1 ;
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`Abstract).
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`In [0011], Martino et al. state that the intraoral route refers to administration
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`by placement of the tablet in the mouth of the subject, where the tablet disintegrates
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`and/or dissolves, so that absorption of the drug typically occurs at least in part via the
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`oral mucosa (limitation of claim 1). These tablets comprise a water—soluble sugar such
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`as mannitol (granular) in 50-90% by weight and a magnesium stearate carrier
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`(limitations of claims 1-4 and 8; [0060] and [0071]).
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`In a particular embodiment,
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`granular mannitol and dye (cherry shade #1632, Crompton and Knowles) were blended
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`in a high shear mixer for 2 minutes or until homogenously mixed prior to adding other
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`ingredients and forming the tablet (color limitation of claim 1; [0085]). Martino et al.
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`teach that this method produced a tablet that had an attractive high gloss appearance
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`with cherry red speckles [0092].
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`Therefore, by teaching all the limitations of claims 1-4 and 8, Martino et al.
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`anticipate the instant invention as claimed.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 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
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`

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`Application/Control Number: 12/811,737
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`Page 4
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`Art Unit: 1617
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`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`Claims 1-4 and 8-9 remain rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Martino et al. (US 2003/0180357; published: Sep. 25, 2003; of
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`record).
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`The teachings of Martino et al. are applied as above for claims 1-4 and 8.
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`Claim 9 encompasses an orally disintegrating tablet with speckled appearance
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`comprising colored granules of a water-soluble sugar (1 -30% w/w) in admixture with a
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`pharmaceutically acceptable carrier.
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`Regarding the concentration of granules as specified in claim 9, MPEP 2144.05
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`states:
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`Generally, differences in concentration or temperature will not support the
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`patentability of subject matter encompassed by the prior art unless there is
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`evidence indicating such concentration or temperature is critical. “[W]here the
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`general conditions of a claim are disclosed in the prior art, it is not inventive to
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`discover the optimum or workable ranges by routine experimentation.” In re Aller,
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`220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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`Furthermore, Martino et al. teach that relatively large particles will tend to
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`produce a speckled pattern having larger blocks of color than will be produced by
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`smaller particles [OO61]. The Applicants‘ specification provides no evidence that the
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`selected concentration in claim 9 was not due to routine optimization and/or that the
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`results should be considered unexpected compared to the prior art.
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`It would have been
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`obvious to a person of ordinary skill in the art at the time of the invention to combine
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`

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`Application/Control Number: 12/811,737
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`Page 5
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`Art Unit: 1617
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`these teachings and alter the concentration of water-soluble sugar granules. One of
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`ordinary skill in the art would have been motivated to change the concentration as this
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`could be expected to affect the appearance of the tablet.
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`Thus, the claimed invention was prima facie obvious at the time the invention
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`was made.
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`Claims 1-9 remain rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Martino et al. (US 2003/0180357; published: Sep. 25, 2003; of record), in view of
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`Pettersson et al. (US 2004/0213855; published: Oct. 28, 2004; of record).
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`The teachings of Martino et al. are applied as above for claims 1-4 and 8-9.
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`Claims 5-7 encompass an orally disintegrating tablet with speckled appearance
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`comprising colored granules of a water-soluble sugar in admixture with a
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`pharmaceutically acceptable carrier, wherein the granules have a particle size of 10-
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`1200, or 200-800 or 300-500 um.
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`Although Martino et al. teach an orally administered, disintegrating tablet with
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`speckled appearance comprising granular mannitol in 50-90% (by weight), a dye and a
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`magnesium stearate carrier as described above, they do not teach the particle size of
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`the granular mannitol. However, the use of granular mannitol with a particle size
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`between 300 and 500 um (limitations of claims 5-7) in a tablet were known and routinely
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`used in the prior art. For example, Pettersson et al. disclose a disintegrating tablet
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`comprising granular mannitol with a particle size from 250 to 450 um and a magnesium
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`stearate [0059]. Based on these teachings, it would have been obvious to one of
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`

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`Application/Control Number: 12/811,737
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`Page 6
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`Art Unit: 1617
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`ordinary skill in the art to use a granular size between 250 and 450 pm to achieve the
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`predictable result of obtaining a composition suitable for oral administration of drugs.
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`Thus, the claimed invention was prima facie obvious at the time the invention
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`was made.
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`Response to Arguments
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`Applicants’ arguments have been fully considered, but are not found persuasive.
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`Applicants argue that Martino et al. fails to describe “colored granules of a water-
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`soluble sugar; specifically, that the process of Martino et al. of “homogenous mixture of
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`mannitol and dye” does not result in colored granules of a water-soluble sugar
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`(Remarks: p. 5, 2”’ 1]).
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`In response, Martino et al. describe the process of tablet formation by first
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`blending granular mannitol and dye in a high—shear mixer for 2 minutes or until
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`homogenously mixed ([0084-0085]). This blending process will necessarily produce
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`smaller granules (e.g., it could produce a sugar powder) that is colored with the dye
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`(e.g., colored with cherry shade #1632 dye) ([0084-0085]). The instant specification
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`does not provide a special definition for granules and therefore, any particle (with any
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`particle size) would encompass the term "granule” recited in instant claim 1.
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`Applicants also, argue that the present invention does not require a coating for a
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`speckled appearance, but rather is speckled due to the presence of "colored granules of
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`water-soluble sugar" (Remarks: p. 5, 3“ 1]).
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`

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`Application/Control Number: 12/811,737
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`Page 7
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`Art Unit: 1617
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`In response, such features are not commensurate with the scope of the instant
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`claims. For example, claim 1
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`is directed solely to an orally disintegrating tablet with
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`speckled appearance comprising colored granules of a water-soluble sugar in admixture
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`with a pharmaceutically acceptable carrier as opposed to being directed to how the
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`speckled appearance on the tablet is produced. That is, as written, the claim only
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`requires a speckled appearance and does not require the speckles to comprise colored
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`sugar granules.
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`Applicants argue that Pettersson et al. fail to remedy the deficiencies of Martino
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`et al.; that is, Pettersson et al. fail to describe, teach or suggest "colored granules of a
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`water-soluble sugar" (Remarks: p. 6, 2”" 1]).
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`In response, the argument is not material to the instant rejection because, as
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`indicated in the above rejection, the teachings of Martino et al. are relied upon for the
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`claim 1 limitations of "colored granules of a water-soluble sugar".
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`Claims 1-9 are not allowed.
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`Conclusion
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`

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`Application/Control Number: 12/811,737
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`Page 8
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`Art Unit: 1617
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the mailing date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to GENEVIEVE S. ALLEY whose telephone number is
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`(571)270-1111. The examiner can normally be reached on Monday through Friday
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`7:30AM to 5:00PM EST.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone
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`number for the organization where this application or proceeding is assigned is 571 -
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`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`

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`Application/Control Number: 12/811,737
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`Page 9
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`Art Unit: 1617
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`/GENEVIEVE S ALLEY/
`
`Examiner, Art Unit 1617
`
`/Ileana Popa/
`Primary Examiner, Art Unit 1633
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`

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`EAST Search History
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`EAST Search History
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`EAST Search History (Prior Art)
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`O12/O8/30§
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`§stroppo|o-f$.in.
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`8/30/2012 1:40:39 PM
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`C:\ Users\ galley\ Documents\ EAST\ Workspaces\ 12811737.wsp
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`file:///CI/Users/galley/Documents/e—Red%2OF01der/12811737/EASTSearchHist0ry.12811737_Accessib1eVersi0n.htm[8/30/2012 1:40:52 PM]
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`

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`Application/Control No.
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`Search NOTES
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`12811737
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`Applicant(s)/Patent Under
`Reexamination
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`STROPPOLO ET AL.
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`
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`Art Unit
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`1617
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`Examiner
`
`GENEVIEVE S ALLEY
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`SEARCHED
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`SEARCH NOTES
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`‘
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`INTERFERENCE SEARCH
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`/G.S.A./
`Examiner.Art Unit 1617
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`
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`U.S. Patent and Trademark Office
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`Pan of Paper No.
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`: 20120829A