Docket No.: 241957.000596
`(TRACK 1)
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`William H. McKenna et al.
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`Customer No. 06980
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`Application No.: 14/729,660
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`Confirmation No.: 2426
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`Filed: June 3, 2015
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`Art Unit: 1642
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`For: TAMPERRESISTANTDOSAGEFORMS
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`Examiner: AKHOON, KAUSER M.
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`AMENDMENT
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`MS Amendment
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`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
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`Prior to examination on the merits, please amend this U.S. patent application as follows.
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`Amendments to the Claims begin on page 3 of this paper.
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`Remarks/arguments begin on page 7 of this paper.
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`2606929lvl
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`Docket No.: 241957.000596
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`AMENDMENTS TO THE CLAIMS
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`The following listing of claims replaces all previous claims, and listings of claims, in the
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`application.
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`1-169. (Cancelled)
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`170,
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`(Currently Amended) A method of treating pain comprising administering to a
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`patient in need thereof a pharmaceutical tablet comprising:
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`(1) at least a first compression shaped and then air cured matrix, wherein said
`curing is by heated air having a temperature of at least about 62 ° C for a duration of at
`least about 5 minutes, said matrix comprising oxycodone or a pharmaceutically
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`acceptable salt thereof in combination with at least one high molecular weight
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`polyethylene oxide having, based on rheological measurements, an approximate
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`molecular weight selected from the group consisting of 4,000,000,_ aftti 7,000,000, and a
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`combination thereof, and optionally further comprising at least one low molecular weight
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`polyethylene oxide having, based on rheological measurements, an approximate
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`molecular weight of less than 1,000,000;
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`(2) optionally a second air cured matrix compnsmg a&-oxycodone or a
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`pharmaceutically acceptable salt thereof in combination with at least one low molecular
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`weight polyethylene oxide having, based on rheological measurements, an approximate
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`molecular weight of less than 1,000,000; and
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`(3) optionally a coating, wherein in said tablet:
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`said high molecular weight polyethylene oxide is at least eG 54 % by weight of
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`the total weight of said uncoated tablet;
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`the total combined weight of said high and low molecular weight polyethylene
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`oxide, if present, is at least eG lQ% by weight of the total weight of said uncoated tablet;
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`and
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`said tablet provides a twice-daily extended release tahlet of said oxycodone or
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`pharmaceutically acceptable salt thereof
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`171.
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`(Previously Presented) A method as defined in claim 170, wherein said
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`oxycodone or pharmaceutical salt thereof comprises at least 5 % by weight, based upon the total
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`weight of said uncoated tablet.
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`(Currently Amended) A method as defined in claim 170, wherein each shaped and
`172.
`cured matrix has been cured by heated air having a temperature of about 62 ° C to about 90 ° C
`for a duration of about 15 minutes to about 10 hours, and then is subsequently cooled.
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`(Currently Amended) A method as defined in claim 172, wherein said heated air
`173.
`temperature is from about 65 ° C to about 90 ° C, said duration is about 15 minutes to about 8
`hours, and said cooling comprises exposure to an air temperature of less than about 62 ° C.
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`174.
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`(Previously Presented) A method as defined in claim 170, wherein said shaped
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`tablet is coated at least one of before or after being cured.
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`175,
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`(Previously Presented) A method as defined in claim 173, wherein one or both of
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`said first matrix and second matrix further comprise a coating.
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`176.
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`(Previously Presented) A method as defined in claim 170, wherein, said second
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`matrix is not present, the dosage amount of oxycodone is selected from 10 mg, 15, mg, 20 mg,
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`and 30 mg, and the total combined weight of said high and low molecular weight polyethylene
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`oxide is at least 79 %by weight of the total weight of said uncoated tablet.
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`177.
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`(Previously Presented) A method as defined in claim 170, wherein, said second
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`matrix is not present, the dosage amount of oxycodone is selected from 40 mg, 60 mg, and 80
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`mg, and the total combined weight of said high and low molecular weight polyethylene oxide is
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`at least 65 % by weight of the total weight of said uncoated tablet.
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`178.
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`(Previously Presented) A method as defined m claim 176, wherein said low
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`molecular weight polyethylene oxide is not present.
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`179.
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`(Previously Presented) A method as defined m claim 177, wherein said low
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`molecular weight polyethylene oxide is not present.
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`180.
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`(Previously Presented) A method as defined in claim 174, wherein the total
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`combined weight of said high and low molecular weight polyethylene oxide is at least 65 %by
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`weight, based upon the total weight of said uncoated tablet.
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`181.
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`(Previously Presented) A method as defined in claim 174, wherein the total
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`combined weight of said high and low molecular weight polyethylene oxide is at least 80 %by
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`weight, based upon the total weight of said uncoated tablet.
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`182.
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`(Previously Presented) A method as defined in claim 174, wherein the total
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`combined weight of said high and low molecular weight polyethylene oxide is at least 85 %by
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`weight, based upon the total weight of said uncoated tablet.
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`183.
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`(Previously Presented) A method as defined in claim 174, wherein the total
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`combined weight of said high and low molecular weight polyethylene oxide is at least 90 %by
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`weight, based upon the total weight of said uncoated tablet.
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`184.
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`(Previously Presented) A method as defined in claim 174, wherein said tablet
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`further comprises magnesium stearate.
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`185.
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`(Previously Presented) A method as defined in claim 184, wherein said tablet
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`further comprises butylated hydroxytoluene.
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`186.
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`(Previously Presented) A method as defined in claim 184, wherein said tablet
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`further comprises at least one of lactose, microcrystalline cellulose and hydroxypropyl cellulose.
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`187.
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`(Previously Presented) A method as defined in claim 170, wherein said tablet,
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`when subjected to an indentation test, has at least one of (i) a cracking force of at least 110 N;
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`and (ii) a penetration depth to crack distance of at least 1.0 mm.
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`188.
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`(Previously Presented) A method as defined in claim 170, wherein said tablet can
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`be flattened to a thickness that is no more than about 60% of the initial tablet thickness without
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`breaking; and said flattened tablet swells upon exposure to water or ethanol.
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`189.
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`(Previously Presented) A method according to claim 170, wherein, after a
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`plurality of at least 100 of the same tablets are stored at 40° C and 75% relative humidity for at
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`least 3 months, a set of at least ten of said stored tablets, on average, when measured in a USP
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`Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 o
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`C., in the absence of an added stabilizer, release an amount of said oxycodone or pharmaceutical
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`salt thereof, after 1 hour, 4 hours, and 12 hours, that deviates from an initial dosage amount of
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`said oxycodone or pharmaceutical salt thereof by no more than about 10% points.
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`190.
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`(Previously Presented) A method as defined in claim 172, wherein said air
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`temperature during curing exhibits a plateau profile.
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`191.
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`(Previously Presented) A method as defined m claim 173, wherein said air
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`temperature during curing exhibits a plateau profile.
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`192.
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`(Previously Presented) A method as defined in claim 172, wherein said air
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`temperature during curing exhibits a parabolic or triangular profile.
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`193.
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`(Previously Presented) A method as defined in claim 173, wherein said air
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`temperature during curing exhibits a parabolic or triangular profile.
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`194.
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`(Previously Presented) A method as defined in claim 172, wherein curing is by
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`convection and said air temperature is measured as a mean exhaust temperature of a convection
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`curing device.
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`195.
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`(Previously Presented) A method as defined in claim 173, wherein curing is by
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`convection and said air temperature is measured as a mean exhaust temperature of a convection
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`curing device.
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`196.
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`(Previously Presented) A method as defined in claim 188, wherein said tablet,
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`when subjected to an indentation test, has at least one of (i) a cracking force of at least 110 N;
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`and (ii) a penetration depth to crack distance of at least 1.0 mm.
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`197.
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`(Previously Presented) A method as defined in claim 173, wherein curing is by
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`convection and said air temperature is measured as a mean exhaust temperature of a convection
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`curing device.
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`198.
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`(Previously Presented) A method as defined in claim 170 wherein said cured
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`shaped tablet has a density that is at least about 1 %lower than the density of said shaped tablet
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`prior to curing.
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`199.
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`(Previously Presented) A method as defined in claim 173 wherein said cured
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`shaped tablet has a density that is at least about 1 %lower than the density of said shaped tablet
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`prior to curing.
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`Remarks
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`This Amendment is in response to the Office Action dated September 11, 2015. Claims
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`170-199 are pending and have been rejected. Claims 170, 172, and 173 are amended. The
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`amendments are supported by the Specification or are editorial changes to make the claims
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`clearer, and do not present new matter. See, e.g., ~ 0204 (curing temperature), ~ 0217 (curing
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`time),~ 0820, Example 25, (% HMW PEO), ~ 0415, Example 4.2, (% LMW PEO).
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`Applicants thank the Examiner and her Primary Examiner for the courtesies extended
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`during the interview on November 12, 2015. All claims of related application Serial No.
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`14/729,634 were discussed as were the pending rejections and the prior art relied upon by the
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`Examiner in the Office Action of August 27, 2015. Agreement was reached that the rejections
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`under 35 U.S.C. ~ 112 would be withdrawn in that application, and similar rejections in this
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`related application would also be withdrawn, based upon the arguments presented below.
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`I. Rejections Under 35 U.S.C. § 112
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`A Product & Method- Claims 172-174, 190-196 and 199
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`Claims 172-174 are rejected under 35 U.S.C. § 112 because, according to the Examiner,
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`they "recite both an apparatus and method." Office Action, at 2. Claims 190-196 and 199 are
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`rejected because they depend from claims 172-174. Specifically, the Examiner states that
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`"[t]hese claims mix method of treating and method of making limitations (such as functions or
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`actions of a user)" and are indefinite because they have "more than one interpretation." Id at 3.
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`The Examiner relies on In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303,
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`97 USPQ2d 1737 (Fed. Cir. 2011), which provides that "[a] single claim which claims both an
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`apparatus and the method steps of using the apparatus is indefinite .... " Id. at 3 (emphasis
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`added).
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`Respectfully, the rejection is misplaced because the claims unambiguously encompass
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`methods of treatment comprising administering a specified pharmaceutical composition. All of
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`the claims require using the claimed pharmaceutical tablet. There is no claim that ambiguously
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`provides for making the composition but without requiring such use.
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`Amended claim 170 provides, inter alia, a method of treating pam compnsmg
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`administering to a patient in need thereof a pharmaceutical tablet that comprises a compression
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`shaped and then cured matrix and optionally comprises a coating. All of the other claims depend
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`from claim 170 and all of them are for a method of treatment. The person of ordinary skill in the
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`art would not mistake any of these claims as claiming only the method of making the tablet itself,
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`without requiring its use in the specified method of treatment. Furthermore, features of a
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`composition can properly be claimed using product-by-process terms. See, MPEP 2173 .05(p );
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`Office Action at 5.
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`In Katz, 639 F.3d at 1318, there was confusion about whether a claimed computer system
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`having a certain input means ("interface means ... wherein ... individual callers digitally enter
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`data") was directly infringed when the computer system was made or sold (a system capability),
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`or was infringed only when a user actually used the input means (a user action). There is no such
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`confusion here. Claims 172-174 are not means-plus-function claims, they unambiguously specify
`a required action (administration of the tablet), and they do not fall within the rationale of Katz. 1
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`Claims 172-174 are not indefinite, nor are dependent claims 190-196 and 199. The
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`rejection of these claims under 35 U.S.C. § 112 should be withdrawn.
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`II. Rejections Under 35 U.S.C. § 102
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`Claims 170-175 and 187-199 are rejected as anticipated by Bartholomaus, US
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`2005/0031546. According to the Examiner, Bartholomaus teaches a tablet comprising 20 mg
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`(13.3% by wt of the tablet) oxycodone hydrochloride and 110 mg (73.3% by wt of the tablet)
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`polyethylene oxide of molecular weight 7,000,000 (page 11, paragraph [0136]). These tablets
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`were treated by heating (80° C) the opioid and PEO under pressure for at least 15 seconds.
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`Office Action, at 4-5 (citing Example 1 of Bartholomaus ). The Examiner presumes that these
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`tablets are the same as in rejected claims 170-175, and that product-by-process limitations in
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`claims 172-173 and 190-196 make no difference. Id. at 5-7. Claims 187-189, 196, and 198-199,
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`1 Katz dealt with an apparatus versus its method of use. Here, the Applicant understands that the
`Examiner has extended to Katz to address an alleged confusion between a method of use and a method of
`manufacture. Office Action at 3. However, there is no such confusion anyway, because all of the claims
`require that the specified tablet, once made, must be used in the claimed method of treatment.
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`"which recite cracking force, flattened thickness ability, stability properties and density" are
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`rejected because "these are considered physical properties inherent to the chemical composition."
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`Id. at 6. In these circumstances, evidence of a non-obvious difference can overcome a
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`presumption that a claimed composition and a prior art composition are the same. Id. at 6, 7.
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`The pharmaceutical tablets of the present claims have a compression shaped and then air
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`cured structure. The density of the claimed tablets is decreased, whereas experiments show that
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`the density of a tablet formed under heat and pressure is increased. The density decrease in the
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`claimed tablets is a matter of degree across the claimed tablets. This is not necessarily the same
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`for all tablets encompassed by the claims and is not inherent.
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`The Specification (US 2009/0081290) discloses that a cured product of the invention has
`a decrease in density. See ,m [0231-0236; 0299; 0581-0595] and Tables 13.6, 14.6, and 25.5. In
`representative Example 13, oxycodone HCl and PEO WSR 301 (4,000,000 MW) were blended,
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`magnesium stearate was added with additional blending, and the blend was compressed on a
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`tablet press to a target weight of 150 mg. These tablets contained 10, 15, 20, 30 and 40 mg of
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`oxycodone HCl and from 72 to 92% PEO. Id. at~~ [00560-561]. The compressed tablets were
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`loaded into a coating pan and cured under specified conditions, including 30, 60 and 90 minutes
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`at 75 o C (counting the ramp up time from 70-75 o C). This was followed by cooling and coating
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`the tablets. Id at ~~ [0561-0577]. The density of the cured tablets decreased, compared to
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`uncured tablets, as reported in Table 13.6 (column 42). The density decreased to a different
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`degree, depending on the amounts of oxycodone and PEO, and on the curing time. For a 90
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`minute curing time, the density decrease ranged from -0.846 to -2.986 percent. Id
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`By comparison, molded tablets that were made under heat and pressure have a density
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`increase. See~~ [0741; 0754-0767] and Table 22.1. In Example 22, tablets were prepared "using
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`the compositions as described in Example 13, and amending the manufacturing process of
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`Example 13 insofar that the tablets were subjected to a molding step instead of a curing step." Id
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`at~ [0741]. Instead of loading the tablets into a coating pan, they "were placed between two
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`heated plates which were preheated to 120° C. and then compressed at a pressured [sic] setting of
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`1000 kg and held for 3 minutes. The molten tablets were cooled to room temperature prior to
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`density measurement." Id. at~ [0752]. The density of the molded tablets increased, compared to
`unmolded tablets, and ranged from + 1.227% to + 3. 64 7%.
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`The Applicant submitted additional density data in the March 27, 2015 Declaration of
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`Richard 0. Mannion Under 37 C.F.R. § 1.132. This Declaration was filed in several prior
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`applications, which are now patented. See, Serial Nos. 14/515,857 (US 9,101,661); 14/515,855
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`(US 9,095,614); 14/515,924 (US 9,084,816); and 14/515,921 (9,095,615). A copy from SN
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`14/415,857 is provided with this Response. The Declaration provides data for tablets having the
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`opioid hydrocodone bitartrate and 7,000,000 MW PEO.
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`Cured tablets, as in claims 170-174, have an unexpected density decrease, and the
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`product-by-process limitations in claims 172-174 and 190-196 do make a difference, at least
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`because tablet density varies according to the composition and curing conditions. The properties
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`in claims 187-189 and 196, 198-199 (cracking, flattening, stability, and density) are not inherent,
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`as shown here and in Sec. I(B), above. Respectfully, this rejection should be withdrawn.
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`III. Rejections Under 35 U.S.C. § 103
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`Claims 170-199 are rejected under 35 U.S.C. § 103(a) as being unpatentable over
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`Bartholomaus, as applied to claims 170-175 and 187-199 above, in view of Wright et al.
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`("Wright", US Patent Publication No 2003/0068375). Wright is cited to show that high MW
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`PEO is suitable as a gelling agent in a pharmaceutical composition comprising an opioid, and
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`according to the Examiner the claimed amounts of opioid and PEO are deemed to be readily
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`determined by routine experimentation. Magnesium stearate and microcrystalline cellulose are
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`found in Bartholomaus, and butylated hydroxy toluene is found in Wright. Office Action at 9,
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`11-13.
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`This rejection, like the rejection above, should be withdrawn in view of the unexpected
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`density results. Combining Wright with Bartholomaus does not provide the compression shaped
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`and then air cured tablets of the invention and does not provide the surprising decrease in density
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`(See § II, above).
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`IV. Double Patenting
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`The Applicant will address any obviousness-type double-patenting issues that remain,
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`upon an indication of allowable claims.
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`Conclusion
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`This application is believed to be in condition for allowance. If any issues remain that
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`may be addressed by an Examiner's amendment or a supplementary amendment, or if the
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`Examiner has any concerns that would benefit from an interview with Applicants' representative,
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`the Examiner is respectfully requested to contact the undersigned.
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`The Commissioner is authorized to charge any deficiency or credit any excess in the fees
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`to Deposit Account No. 20-1507 of Customer No. 06980
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`.
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`Respectfully submitted,
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`TROUTMANSANDERSLLP
`
`/Joseph R. Robinson/
`
`Joseph R. Robinson
`Registration No. 33,448
`
`875 Third Avenue
`New York, NY 10022
`Phone: 212-704-6000
`Facsimile: 212-704-6288
`
`Please recognize our Customer No. 06980
`as our correspondence address.
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`Date: December 11, 2015
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