Docket No.: 241957.000596
`(TRACK 1)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`William H. McKenna et al.
`
`Application No.: 14/729,660
`
`Filed: June 3, 2015
`
`Customer No. 06980
`
`Confirmation No.: 2426
`
`Art Unit: 1642
`
`For: TAMPERRESISTANTDOSAGEFORMS
`
`Examiner: AKHOON, KAUSER M.
`
`SUPPLEMENTAL AMENDMENT
`
`MS Amendment
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
`
`Prior to examination on the merits, please amend this U.S. patent application as follows.
`
`Amendments to the Claims begin on page 3 of this paper.
`
`Remarks/arguments begin on page 8 of this paper.
`
`KASHIV1037
`IPR of Patent No. 9,492,393
`
`
`(TRACK 1)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`William H. McKenna et al.
`
`Application No.: 14/729,660
`
`Filed: June 3, 2015
`
`Customer No. 06980
`
`Confirmation No.: 2426
`
`Art Unit: 1642
`
`For: TAMPERRESISTANTDOSAGEFORMS
`
`Examiner: AKHOON, KAUSER M.
`
`SUPPLEMENTAL AMENDMENT
`
`MS Amendment
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
`
`Prior to examination on the merits, please amend this U.S. patent application as follows.
`
`Amendments to the Claims begin on page 3 of this paper.
`
`Remarks/arguments begin on page 8 of this paper.
`
`KASHIV1037
`IPR of Patent No. 9,492,393
`
`
`
`Docket No.: 241957.000596
`(TRACK 1)
`
`AMENDMENTS TO THE CLAIMS
`
`The following listing of claims replaces all previous claims, and listings of claims, in the
`application.
`
`1-169. (Cancelled)
`
`(Currently Amended) A method of treating pain comprising administering to a
`170,
`patient in need thereof a pharmaceutical tablet comprising:
`(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
`acceptable salt thereof in combination with at least one high molecular weight
`polyethylene oxide having, based on rheological measurements, an approximate
`molecular weight selected from the group consisting of 4,000,000, 7,000,000, and a
`combination thereof, and optionally further comprising at least one low molecular weight
`polyethylene oxide having, based on rheological measurements, an approximate
`molecular weight of less than 1,000,000;
`(2) optionally a second air cured matrix compnsmg oxycodone or a
`pharmaceutically acceptable salt thereof in combination with at least one low molecular
`weight polyethylene oxide having, based on rheological measurements, an approximate
`molecular weight of less than 1,000,000; and
`(3) optionally a coating,
`wherein in said tablet:
`(i) said oxycodone or pharmaceutically acceptable salt thereof is provided in a
`dose selected from the group consisting of 10 mg, 15, mg, 20 mg, and 30 mg;
`the total combined weight of said low molecular weight polyethylene oxide, if
`present, and said high molecular weight polyethylene oxide is at least 79% by weight of
`the total weight of said tablet, excluding the weight of any coatings; and
`
`2
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`KASHIV1037
`IPR of Patent No. 9,492,393
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`
`
`Docket No.: 241957.000596
`(TRACK 1)
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`said high m:oleeular weight polyethyleHe mcide is at least 54 % by weight of the
`total weight of said uHeoated tablet;
`said low molecular weight polyethylene oxide, if present, is at least 10 % by
`weight of the total weight of said uncoated tablet, excluding the weight of any coatings;
`aHti or
`
`(ii) said oxycodone or pharmaceutically acceptable salt thereof is provided in a
`dose selected from the group consisting of 40 mg, 60 mg, and 80 mg;
`the total combined weight of said low molecular weight polyethylene oxide, if
`present, and said high molecular weight polyethylene oxide is at least 65 %by weight of
`the total weight of said tablet, excluding the weight of any coatings; and
`said low molecular weight polyethylene oxide, if present, is at least 10 % by
`weight of the total weight of said tablet, excluding the weight of any coatings; and
`said tablet provides a dosage form for twice-daily extended release administration
`of-saffi. oxycodone or pharmaceutically acceptable salt thereof
`
`(Previously Presented) A method as defined in claim 170, wherein said
`171.
`oxycodone or pharmaceutical salt thereof comprises at least 5 % by weight, based upon the total
`weight of said uncoated tablet.
`
`(Previously Presented) A method as defined in claim 170, wherein each shaped
`172.
`and 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.
`
`(Previously Presented) 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.
`
`(Previously Presented) A method as defined in claim 170, wherein said shaped
`174.
`tablet is coated at least one of before or after being cured.
`
`3
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`KASHIV1037
`IPR of Patent No. 9,492,393
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`Docket No.: 241957.000596
`(TRACK 1)
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`(Previously Presented) A method as defined in claim 173, wherein one or both of
`175,
`said first matrix and second matrix further comprise a coating.
`
`(Previously Presented) A method as defined in claim 170, wherein, said second
`176.
`matrix is not present, the dosage amount of oxycodone is selected from 10 mg, 15, mg, 20 mg,
`and 30 mg, and the total combined weight of said high and low molecular weight polyethylene
`oxide is at least 79 %by weight of the total weight of said uncoated tablet.
`
`(Previously Presented) A method as defined in claim 170, wherein, said second
`177.
`matrix is not present, the dosage amount of oxycodone is selected from 40 mg, 60 mg, and 80
`mg, and the total combined weight of said high and low molecular weight polyethylene oxide is
`at least 65 % by weight of the total weight of said uncoated tablet.
`
`(Previously Presented) A method as defined m claim 176, wherein said low
`178.
`molecular weight polyethylene oxide is not present.
`
`(Previously Presented) A method as defined m claim 177, wherein said low
`179.
`molecular weight polyethylene oxide is not present.
`
`(Previously Presented) A method as defined in claim 174, wherein the total
`180.
`combined weight of said high and low molecular weight polyethylene oxide is at least 65 %by
`weight, based upon the total weight of said uncoated tablet.
`
`(Previously Presented) A method as defined in claim 174, wherein the total
`181.
`combined weight of said high and low molecular weight polyethylene oxide is at least 80 %by
`weight, based upon the total weight of said uncoated tablet.
`
`4
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`IPR of Patent No. 9,492,393
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`Docket No.: 241957.000596
`(TRACK 1)
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`(Previously Presented) A method as defined in claim 174, wherein the total
`182.
`combined weight of said high and low molecular weight polyethylene oxide is at least 85 %by
`weight, based upon the total weight of said uncoated tablet.
`
`(Previously Presented) A method as defined in claim 174, wherein the total
`183.
`combined weight of said high and low molecular weight polyethylene oxide is at least 90 %by
`weight, based upon the total weight of said uncoated tablet.
`
`(Previously Presented) A method as defined in claim 174, wherein said tablet
`184.
`further comprises magnesium stearate.
`
`(Previously Presented) A method as defined in claim 184, wherein said tablet
`185.
`further comprises butylated hydroxytoluene.
`
`(Previously Presented) A method as defined in claim 184, wherein said tablet
`186.
`further comprises at least one of lactose, microcrystalline cellulose and hydroxypropyl cellulose.
`
`(Previously Presented) A method as defined in claim 170, wherein said tablet,
`187.
`when subjected to an indentation test, has at least one of (i) a cracking force of at least 110 N;
`and (ii) a penetration depth to crack distance of at least 1.0 mm.
`
`(Previously Presented) A method as defined in claim 170, wherein said tablet can
`188.
`be flattened to a thickness that is no more than about 60% of the initial tablet thickness without
`breaking; and said flattened tablet swells upon exposure to water or ethanol.
`
`(Previously Presented) A method according to claim 170, wherein, after a
`189.
`plurality of at least 100 of the same tablets are stored at 40° C and 75% relative humidity for at
`least 3 months, a set of at least ten of said stored tablets, on average, when measured in a USP
`Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 o
`
`5
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`IPR of Patent No. 9,492,393
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`Docket No.: 241957.000596
`(TRACK 1)
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`C., in the absence of an added stabilizer, release an amount of said oxycodone or pharmaceutical
`salt thereof, after 1 hour, 4 hours, and 12 hours, that deviates from an initial dosage amount of
`said oxycodone or pharmaceutical salt thereof by no more than about 10% points.
`
`(Previously Presented) A method as defined in claim 172, wherein said air
`190.
`temperature during curing exhibits a plateau profile.
`
`(Previously Presented) A method as defined m claim 173, wherein said air
`191.
`temperature during curing exhibits a plateau profile.
`
`(Previously Presented) A method as defined in claim 172, wherein said air
`192.
`temperature during curing exhibits a parabolic or triangular profile.
`
`(Previously Presented) A method as defined in claim 173, wherein said air
`193.
`temperature during curing exhibits a parabolic or triangular profile.
`
`(Previously Presented) A method as defined in claim 172, wherein curing is by
`194.
`convection and said air temperature is measured as a mean exhaust temperature of a convection
`curing device.
`
`(Previously Presented) A method as defined in claim 173, wherein curing is by
`195.
`convection and said air temperature is measured as a mean exhaust temperature of a convection
`curing device.
`
`(Previously Presented) A method as defined in claim 188, wherein said tablet,
`196.
`when subjected to an indentation test, has at least one of (i) a cracking force of at least 110 N;
`and (ii) a penetration depth to crack distance of at least 1.0 mm.
`
`6
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`KASHIV1037
`IPR of Patent No. 9,492,393
`
`
`
`Docket No.: 241957.000596
`(TRACK 1)
`
`(Previously Presented) A method as defined in claim 173, wherein curing is by
`197.
`convection and said air temperature is measured as a mean exhaust temperature of a convection
`curing device.
`
`(Previously Presented) A method as defined in claim 170 wherein said cured
`198.
`shaped tablet has a density that is at least about 1 %lower than the density of said shaped tablet
`prior to curing.
`
`(Previously Presented) A method as defined in claim 173 wherein said cured
`199.
`shaped tablet has a density that is at least about 1 %lower than the density of said shaped tablet
`prior to curing.
`
`7
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`KASHIV1037
`IPR of Patent No. 9,492,393
`
`
`
`Docket No.: 241957.000596
`(TRACK 1)
`
`Remarks
`
`This Amendment is in further response to the Office Action dated August 27, 2015 and
`further amends the claims submitted in the previous response. Claims 170-199 are pending and
`have been rejected. Claim 170 is amended here. The amendments are supported by the
`Specification and do not present new matter.
`Applicants thank the Examiner, her Primary Examiner, and her Group Director for the
`courtesies extended during the telephone interview on February 10, 2016. All claims were
`discussed as were the pending rejections and the prior art relied upon by the Examiner in the
`Office Action of August 27, 2015. Agreement was reached that claim 170 would be presented as
`currently amended and that appropriate terminal disclaimers would be provided.
`
`Conclusion
`This application is believed to be in condition for allowance. If any issues remain that
`may be addressed by an Examiner's amendment or a supplementary amendment, or if the
`Examiner has any concerns that would benefit from an interview with Applicants' representative,
`the Examiner is respectfully requested to contact the undersigned.
`The Commissioner is authorized to charge any deficiency or credit any excess in the fees
`to Deposit Account No. 20-1507 of Customer No. 06980
`.
`
`Respectfully submitted,
`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.
`
`Date: February 16, 2016
`
`8
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`KASHIV1037
`IPR of Patent No. 9,492,393
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