Docket No.: 241957.000595
`(TRACK 1)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`William H. McKenna et al.
`
`Application No.: 14/729,634
`
`Filed: June 3, 2015
`
`Customer No. 06980
`
`Confirmation No.: 8100
`
`Art Unit: 1642
`
`For: TAMPER RESISTANT DOSAGE FORMS
`
`Examiner: AKHOON, Kauser M.
`
`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 2 of this paper.
`
`Remarks/arguments begin on page 8 of this paper.
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`Application No. 14/729,634
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`Docket No.: 241957.000595
`(TRACK 1)
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`AMENDMENTS TO THE CLAIMS
`
`The following listing of claims replaces all previous claims, and listings of claims, in the
`application.
`
`1-169. (Cancelled)
`
`170,
`
`(Currently Amended) A cured shaped 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 al least about 62 o 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_. aH:d 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 aH:--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:
`said high molecular weight polyethylene oxide is at least W 54 % by weight of
`the total weight of said uncoated tablet;
`the total combined \veight of said high and low molecular weight polyethylene
`oxide, if present, is at least W lQ % by weight of the total weight of said uncoated tablet;
`and
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`said tablet provides a twice-daily extended release ta-blet of s-affi-oxycodone or
`pharmaceutically acceptable salt thereof from said tablet.
`
`(Previously Presented) A cured shaped tablet as defined in claim 170, wherein
`171.
`said oxycodone or pharmaceutical salt thereof comprises at least 5 % by weight, based upon the
`total weight of said uncoated tablet.
`
`(Currently Amended) A cured shaped tablet as defined in claim 170, wherein each
`172.
`shaped and cured matrix has been cured by heated air having a temperature of about 62 o C to
`about 90 o C for a duration of about 15 minutes to about 10 hours, and then is subsequently
`cooled.
`
`(Currently Amended) A cured shaped tablet as defined in claim 172, wherein said
`173.
`heated air temperature is from about 65 o C to about 90 o 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 o
`C.
`
`(Previously Presented) A cured shaped tablet as defined in claim 170, wherein
`174.
`said shaped tablet is coated at least one of before or after being cured.
`
`(Previously Presented) A cured shaped tablet as defined in claim 173, wherein
`175,
`one or both of said first matrix and second matrix further comprise a coating.
`
`(Previously Presented) A cured shaped tablet as defined in claim 170, wherein,
`176.
`said second matrix is not present, said oxycodone or pharmaceutically acceptable salt thereof is
`provided in a dose 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.
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`(Previously Presented) A cured shaped tablet as defined in claim 170, wherein,
`177.
`said second 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 cured shaped tablet as defined in claim 176, wherein
`178.
`said low molecular weight polyethylene oxide is not present.
`
`(Previously Presented) A cured shaped tablet as defined in claim 177, wherein
`179.
`said low molecular weight polyethylene oxide is not present.
`
`(Previously Presented) A cured shaped tablet as defined in claim 174, wherein the
`180.
`total 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 cured shaped tablet as defined in claim 174, wherein the
`181.
`total 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.
`
`(Previously Presented) A cured shaped tablet as defined in claim 174, wherein the
`182.
`total 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 cured shaped tablet as defined in claim 174, wherein the
`183.
`total 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 cured shaped tablet as defined in claim 174, wherein
`184.
`said tablet further comprises magnesium stearate.
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`(Previously Presented) A cured shaped tablet as defined in claim 184, wherein
`185.
`said tablet further comprises butylated hydroxytoluene.
`
`(Previously Presented) A cured shaped tablet as defined in claim 184, wherein
`186.
`said tablet further comprises at least one of lactose, microcrystalline cellulose and hydroxypropyl
`cellulose.
`
`(Previously Presented) A cured shaped tablet as defined in claim 170, wherein
`187.
`said tablet, 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 cured shaped tablet as defined in claim 170, wherein
`188.
`said tablet can 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.
`
`189.
`(Previously Presented) A cured shaped tablet according to claim 170, wherein,
`after a 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 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 cured shaped tablet as defined in claim 172, wherein
`190.
`said air temperature during curing exhibits a plateau profile.
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`(Previously Presented) A cured shaped tablet as defined in claim 173, wherein
`191.
`said air temperature during curing exhibits a plateau profile.
`
`(Previously Presented) A cured shaped tablet as defined in claim 172, wherein
`192.
`said air temperature during curing exhibits a parabolic or triangular profile.
`
`(Previously Presented) A cured shaped tablet as defined in claim 173, wherein
`193.
`said air temperature during curing exhibits a parabolic or triangular profile.
`
`(Previously Presented) A cured shaped tablet as defined in claim 172, wherein
`194.
`curing is by convection and said air temperature is measured as a mean exhaust temperature of a
`convection curing device.
`
`(Previously Presented) A cured shaped tablet as defined in claim 172, wherein
`195.
`curing is by convection at atmospheric pressure and said air temperature is measured as a mean
`exhaust temperature of a convection curing device.
`
`(Previously Presented) A cured shaped tablet as defined in claim 173, wherein
`196.
`curing is by convection at atmospheric pressure and said air temperature is measured as a mean
`exhaust temperature of a convection curing device.
`
`(Previously Presented) A cured shaped tablet as defined in claim 188, wherein
`197.
`said tablet, 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 cured shaped tablet as defined in claim 170 wherein
`198.
`said cured shaped tablet has a density that is at least about 1 % lower than the density of said
`shaped tablet prior to curing.
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`Application No. 14/729,634
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`Docket No.: 241957.000595
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`(Previously Presented) A cured shaped tablet as defined in claim 173 wherein
`199.
`said cured shaped tablet has a density that is at least about 1 % lower than the density of said
`shaped tablet prior to curing.
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`Application No. 14/729,634
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`Docket No.: 241957.000595
`(TRACK 1)
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`Remarks
`
`This Amendment is in response to the Office Action dated August 27, 2015. Claims 170-
`199 are pending and have been rejected. Claims 170, 172, and 173 are amended. The
`amendments are supported by the Specification or are editorial changes to make the claims
`clearer, and do not present new matter. See, e.g.,~ 0204 (curing temperature),~ 0217 (curing
`time),~ 0820, Example 25, (% HMW PEO), ~ 0415, Example 4.2, (% LMW PEO).
`
`Applicants thank the Examiner and her Primary Examiner for the courtesies extended
`during the interview on November 12, 2015. 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 the rejections under 35 U.S.C. ~ 112 would be withdrawn based
`upon the arguments presented below.
`
`I. Rejections Under 35 U.S.C. § 112
`
`A. Product & Method- Claims 172-174, 190-196 and 199
`
`Claims 172-174 are rejected under 35 U.S.C. § 112 because, according to the Examiner,
`they "recite both an apparatus and method." Office Action, at 2. Claims 190-196 and 199 are
`rejected because they depend from claims 172-174. Specifically, the Examiner states that
`"[t]hese claims mix apparatus and method limitations (such as functions or actions of a user)"
`and are indefinite because they have "more than one interpretation." !d. at 3. The Examiner
`relies on In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d
`1737 (Fed. Cir. 2011), which provides that "[a] single claim which claims both an apparatus and
`the method steps of using the apparatus is indefinite .... " Id. at 3 (emphasis added).
`Respectfully, the rejection is misplaced because the claims do not encompass "functions
`or actions of a user" nor any steps of "using" the claimed pharmaceutical tablet.
`Amended claim 170 provides, inter alia, a pharmaceutical tablet that compnses a
`compression shaped and then cured matrix and optionally comprises a coating. Dependent
`claims 172 and 173 provide that "each shaped and cured matrix has been cured by heated air" for
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`specified times and temperatures "and then is subsequently cooled." Dependent claim 174
`provides that the tablet "is coated at least one of before or after being cured." The person of
`ordinary skill in the art would not mistake any of these claims as requiring method steps for
`using the tablet.
`In Katz, 639 F.3d at 1318, there was confusion about whether a claimed computer system
`having a certain input means ("interface means ... wherein ... individual callers digitally enter
`data") was directly infringed when the computer system was made or sold (a system capability),
`or was infringed only when a user actually used the input means (a user action). There is no such
`confusion here. Claims 172-174 are not means-plus-function claims, they do not specify a user
`action, and they do not fall within the rationale of Katz.
`Claims 172-174 are not indefinite, nor are dependent claims 190-196 and 199. The
`rejection of these claims under 35 U.S.C. § 112 should be withdrawn.
`
`B. Inherent Properties- Claims 187-189.
`
`Dependent claims 187, 188 and 189 are rejected under 35 U.S.C. § 112 because,
`according to the Examiner, they do not limit the subject matter of the claims from which they
`depend. Each rejected claim depends from claim 170, and specifies a tablet property that is not
`recited in claim 170.
`First, the Applicant responds that the Examiner did not provide support for the presumed
`inherency of the properties in the dependent claims (cracking, penetration, flattening, and
`stability). See MPEP § 2112 (IV) ("In relying upon the theory of inherency, the examiner must
`provide a basis in fact and/or technical reasoning to reasonably support the determination that the
`allegedly inherent characteristic necessarily flows from the teachings of the applied prior art."). 1
`Second, claim 170 provides a genus of pharmaceutical tablets that encompasses different
`embodiments, e.g., in size, shape, composition, and structure. These embodiments are not all
`"physically the same" and there is no reason why they "must have the same properties." MPEP §
`
`1 MPEP § 2112 concerns prior art that may inherently disclose subject matter that is not literally
`described. Here, the Examiner has applied inherency to claim differentiation. The principles
`addressed in MPEP § 2112 should apply equally in both contexts.
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`2112.01 (II). Each of shaping and curing can be performed under different conditions, e.g., of
`time and temperature. The matrix and the tablet can have different sizes, shapes, and weights.
`The amounts of opioid and PEO can vary, so long as the tablet is at least 54 % high molecular
`weight PEO as claimed. The claims may also "comprise" other components, such as excipients,
`which may alter the properties of the tablet.
`Likewise, the ability of a pharmaceutical tablet to resist each of cracking, penetration, and
`flattening, and its storage stability, will vary according to parameters of size, shape, composition,
`structure and conditioning. The properties required by each of dependent claims 187, 188, and
`189 are not inherent in all of the tablet embodiments encompassed by independent claim 170.
`The rejection of claims 187, 188 and 189 under 35 USC§ 112 should be withdrawn.
`
`II. Rejections Under 35 U.S.C. § 102
`Claims 170-174 and 187-199 are rejected as anticipated by Bartholomaus, US
`2005/0031546. According to the Examiner, Bartholomaus teaches a tablet comprising 20 mg
`(13.3% by wt of the tablet) oxycodone hydrochloride and 110 mg (73.3% by wt of the tablet)
`polyethylene oxide of molecular weight 7,000,000 (page 11, paragraph [0136]). These tablets
`were treated by heating (80° C) the opioid and PEO under pressure for at least 15 seconds.
`Office Action, at 4-5 (citing Example 1 of Bartholomaus ). The Examiner presumes that these
`tablets are the same as in rejected claims 170-174, and that product-by-process limitations in
`claims 172-174 and 190-196 make no difference. !d. at 5-7. Claims 187-189 and 197-199,
`"which recite cracking force, flattened thickness ability, stability properties and density" are
`rejected because "these are considered physical properties inherent to the chemical composition."
`!d. at 6. In these circumstances, evidence of a non-obvious difference can overcome a
`presumption that a claimed composition and a prior art composition are the same. !d. at 6, 7.
`The pharmaceutical tablets of the present claims have a compression shaped and then air
`cured structure. The density of the claimed tablets is decreased, whereas experiments show that
`the density of a tablet formed under heat and pressure is increased. The density decrease in the
`claimed tablets is a matter of degree across the claimed tablets. This is not necessarily the same
`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~~ [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,
`magnesium stearate was added with additional blending, and the blend was compressed on a
`tablet press to a target weight of 150 mg. These tablets contained 10, 15, 20, 30 and 40 mg of
`oxycodone HCl and from 72 to 92% PEO. Id. at~~ [00560-561]. The compressed tablets were
`loaded into a coating pan and cured under specified conditions, including 30, 60 and 90 minutes
`at 75 o C (counting the ramp up time from 70-75 o C). This was followed by cooling and coating
`the tablets. !d. at ~~ [0561-0577]. The density of the cured tablets decreased, compared to
`uncured tablets, as reported in Table 13.6 (column 42). The density decreased to a different
`degree, depending on the amounts of oxycodone and PEO, and on the curing time. For a 90
`minute curing time, the density decrease ranged from -0.846 to -2.986 percent. !d.
`By comparison, molded tablets that were made under heat and pressure have a density
`increase. See~~ [0741; 0754-0767] and Table 22.1. In Example 22, tablets were prepared "using
`the compositions as described in Example 13, and amending the manufacturing process of
`Example 13 insofar that the tablets were subjected to a molding step instead of a curing step." !d.
`at~ [0741]. Instead of loading the tablets into a coating pan, they "were placed between two
`heated plates which were preheated to 120° C. and then compressed at a pressured [sic] setting of
`1000 kg and held for 3 minutes. The molten tablets were cooled to room temperature prior to
`density measurement." !d. at~ [0752]. The density of the molded tablets increased, compared to
`unmolded tablets, and ranged from+ 1.227% to +3.647%.
`The Applicant submitted additional density data in the March 27, 2015 Declaration of
`Richard 0. Mannion Under 37 C.P.R. § 1.132. This Declaration was filed in several prior
`applications, which are now patented. See, Serial Nos. 14/515,857 (US 9,101,661); 14/515,855
`(US 9,095,614); 14/515,924 (US 9,084,816); and 14/515,921 (9,095,615). A copy from SN
`14/415,857 is provided with this Response. The Declaration provides data for tablets having the
`opioid hydrocodone bitartrate and 7,000,000 MW PEO.
`Cured tablets, as in claims 170-174, have an unexpected density decrease, and the
`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
`in claims 187-189 and 197-199 (cracking, flattening, stability, and density) are not inherent, as
`shown here and in Sec. I(B), above. Respectfully, this rejection should be withdrawn.
`
`III. Rejections Under 35 U.S.C. § 103
`Claims 170-187, 189-193 and 199 are rejected under 35 U.S.C. § 103(a) as being
`unpatentable over Bartholomaus, as applied to claims 170-174 and 187-199 above, in view of
`Wright et al. ("Wright", US Patent Publication No 2003/0068375). Wright is cited to show that
`high MW PEO is suitable as a gelling agent in a pharmaceutical composition comprising an
`opioid, and according to the Examiner the claimed amounts of opioid and PEO are deemed to be
`readily determined by routine experimentation. Magnesium stearate and microcrystalline
`cellulose are found in Bartholomaus, and butylated hydroxy toluene is found in Wright. Office
`Action at 9, 11-13.
`This rejection, like the rejection above, should be withdrawn in view of the unexpected
`density results. Combining Wright with Bartholomaus does not provide the compression shaped
`and then air cured tablets of the invention and does not provide the surprising decrease in density
`(See § II, above).
`
`IV. Double Patenting
`The Applicant will address any obviousness-type double-patenting issues that remain,
`upon an indication of allowable claims.
`
`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
`.
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`Respectfully submitted,
`TROUTMAN SANDERS LLP
`/Joseph R. Robinson/
`Joseph R. Robinson
`Registration No. 33,448
`
`875 Third Avenue
`New York, NY 10022
`Phone: 212-7 04-6000
`Facsimile: 212-704-6288
`
`Please recognize our Customer No. 06980
`as our correspondence address.
`
`Date: November 18, 2015
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