UNITED STATES pATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/729,634
`
`06/03/2015
`
`William H. McKenna
`
`241957.000595
`
`8100
`
`05/24/2016
`7590
`6980
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`EXAMINER
`
`AKHOON, KAUSER M
`
`ART UNIT
`
`1642
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/24/2016
`
`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):
`j im.schutz@ troutmansanders .com
`ryan. schneider@ troutmansanders. com
`patents@ troutmansanders. com
`
`PTOL-90A (Rev. 04/07)
`
`KASHIV1038
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`Office Action Summary
`
`Art Unit
`1642
`
`Application No.
`14/729,634
`
`Examiner
`KAUSER AKHOON
`
`Applicant(s)
`MCKENNA ET AL.
`AlA (First Inventor to File)
`Status
`No
`-- The MAILING DATE 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 ;2 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`1 )~ Responsive to communication(s) filed on 1112312015 and 0211612015.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)~ This action is FINAL.
`2b)0 This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ;the restriction requirement and election have been incorporated into this action.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`Disposition of Claims*
`5)~ Claim(s) 170-199 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 170-199 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:ilvvww.uspto.gov!patents/init events/pph/index.jsp or send an inquiry to PPHfeedback(wuspto.oov.
`Application Papers
`1 0)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`Priority under 35 U.S.C. § 119
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)O All b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment{s)
`1) 0 Notice of References Cited (PT0-892)
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 11123/2015. 01/04/2016 and 03/03/2016.
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`Part of Paper No./Mail Date 20160216A
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`Application/Control Number: 141729,634
`Art Unit: 1642
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`Page 2
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`The present application is being examined under the pre-AlA first to invent provisions.
`
`DETAILED ACTION
`
`Claims 170-199 are currently pending.
`
`Withdrawn rejections
`
`Applicants' amendment and arguments filed 11/23/2015 and 02116/2016 are
`
`acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of
`
`record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
`
`Claims 172-174, 190-196 and 199 were rejected under 35 U.S.C. 112, second paragraph.
`
`Applicants' arguments were persuasive and the rejection has been withdrawn.
`
`Claims 187, 188 and 189 were rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-
`
`AlA), 4th paragraph. Applicants' arguments were persuasive and the rejection has been
`
`withdrawn.
`
`Information Disclosure Statement
`
`Applicant's Informational Disclosure Statements, filed on 11/23/2015, 01/04/2016 and
`
`03/03/2016 have been considered. The signed and initialed PTO 1449s have been mailed with
`
`this action.
`
`Declaration under- 37 CFR § 1.132
`
`The Affidavit under 37 CPR 1.132 filed 11/23/2015 is insufficient to overcome the
`
`rejection of claims 170-199 based upon Bartholomaus or Bartholomaus in view of Wright as set
`
`forth in the last Office action because: Applicant have amended claims to recite that high
`
`molecular weight polyethylene oxide is at least 79% by weight of the total weight of said
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`uncoated tablet for 10115/20/30 mg oxycodone and at least 65% by weight of the total weight of
`
`said uncoated tablet for 40/60/80 mg oxycodone would be present in the composition.
`
`However, the data presented is not commensurate in scope to that instantly claimed. The
`
`tablets for which the data is presented both have PEO of 80% or 96% and no data was presented
`
`for 65-79% and did not compare the claimed subject matter with the closest prior art, i.e.
`
`Bartholomaus et al. ("Bartholomaus", US Patent Publication No 2005/0031546). See MPEP
`
`716.02(e).
`
`As such the Affidavit does not have supportive data which would differentiate the
`
`compositions as taught by Bartholomaus in view of Wright with that instantly claimed.
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of pre-AlA 35 U.S.C. § 102
`
`(b) that forms the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless -
`
`(b) the invention was patented or described in a printed publication in this or a foreign
`country or in public use or on sale in this country, more than one year prior to the date of
`application for patent in the United States.
`
`Claims 170-174 and 187-199 stand rejected under pre-AlA 35 U.S.C. § 102(b) as
`
`being anticipated by Bartholomaus et al. ("Bartholomaus", US Patent Publication No
`
`2005/0031546).
`
`Applicants' claims are directed to a pharmaceutical table comprising oxycodone or
`
`pharmaceutically acceptable salt thereof with a high molecular weight polyethylene oxide with a
`
`MW from 4,000,000 or 7,000,000, said high molecular weight polyethylene oxide with a MW
`
`from 4,000,000 or 7 ,000,000, said high molecular weight polyethylene oxide is at least 65% or
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`79% by weight of the total weight of said uncoated tablet alone or in combination with the low
`
`molecular weight polyethylene oxide, these tablets being prepared by compression shaped and
`air cured with temperature at least 62 oc for a duration of at least 5 minutes.. Further, optional
`
`inclusion of additional components are interpreted as compositions that do not contain that
`
`component.
`
`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]). Bartholomaus teaches preparing his tablets by tableting
`(shaping) and heating at 80 oc under pressure for at least 15 seconds (page 10, paragraph
`
`[0117]). Thereby reading upon claims 170-170.
`
`Bartholomaus teaches his tablets are prepared accordingly to the procedure described in
`
`his Example 1, which teaches that the tablets were prepared by heating the mixture (80 °C) under
`
`pressure for at least 15 seconds of opioid with the polyethylene oxide, therefore reading upon
`
`instant claims 172-174. Further, it should be noted that claims 172-174 are product-by-process
`
`claims. Please note that in product-by-process claims, "once a product appearing to be
`
`substantially identical is found and a 35 U.S.C. 1021103 rejection [is] made, the burden shifts to
`
`the applicant to show an unobvious difference." MPEP 2113. This rejection under 35 U.S.C.
`
`102/103 is proper because the "patentability of a product does not depend on its method of
`
`production." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the
`
`Patent Office is not equipped to manufacture products by the myriad number of processes put
`
`before it and then obtain prior art products and make physical comparisons therewith." In re
`
`Brown, 459 F.2d 531,535, 173 USPQ 685,688 (CCPA 1972). Please note that the Patent and
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`Trademark Office is not equipped to conduct experimentation in order to determine whether
`
`Applicants' cured shaped tablets differs and, if so, to what extent, from that of the discussed
`
`reference. Therefore, with the showing of the reference, the burden of establishing non-
`
`obviousness by objective evidence is shifted to the Applicants. Thereby meeting the limitations
`
`of claims 172-17 4.
`
`With regard to claims 187-189, 197-199, which recite cracking force, flattened thickness
`
`ability, stability properties and density, these are considered physical properties inherent to the
`
`chemical composition.
`
`"Products of identical chemical composition cannot have mutually exclusive properties."
`
`A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the
`
`identical chemical structure, the properties applicant discloses and/or claims are necessarily
`
`present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
`
`MPEP § 2ll2.01 states, "Where the claimed and prior art products are identical or
`
`substantially identical in structure or composition, or are produced by identical or substantially
`
`identical processes, a prima facie case of either anticipation or obviousness has been established.
`
`In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433 (CCPA 1977). "When the PTO shows a
`
`sound basis for believing that the products of the applicant and the prior art are the same, the
`
`applicant has the burden of showing that they are not." In re Spada, 9ll F.2d 705, 709, 15
`
`USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by
`
`evidence showing that the prior art products do not necessarily possess the characteristics of the
`
`claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.
`
`v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985)."
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`Regarding claims 190-196, as a practical matter, the Patent Office is not equipped to
`
`manufacture products by the myriad number of processes put before it and then obtain prior art
`
`products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ
`
`685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to
`
`conduct experimentation in order to determine whether Applicants' extended release matrix
`
`formulation in tablet form differs and, if so, to what extent, from that of the discussed reference.
`
`Therefore, with the showing of the reference, the burden of establishing non-obviousness by
`
`objective evidence is shifted to the Applicants.
`
`Further, it should be noted that claims 190-196 are product-by-process claims. Please
`
`note that in product-by-process claims, "once a product appearing to be substantially identical is
`
`found and a 35 U.S.C. 1021103 rejection [is] made, the burden shifts to the applicant to show an
`
`unobvious difference." MPEP 2113. This rejection under 35 U.S.C. 1021103 is proper because
`
`the "patentability of a product does not depend on its method of production." In re Thorpe, 227
`
`USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to
`
`manufacture products by the myriad number of processes put before it and then obtain prior art
`
`products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ
`
`685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to
`
`conduct experimentation in order to determine whether Applicants' cured shaped tablets differs
`
`and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of
`
`the reference, the burden of establishing non-obviousness by objective evidence is shifted to the
`
`Applicants. Therefore the limitations of claims 190-196 are met.
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`Page 7
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`Thus, Claims 170-174 and 187-199 are anticipated by Bartholomaus under 35 U.S.C. §
`
`102(b).
`
`Response to Arguments:
`
`Applicant's arguments, filed 01/04/2016, have been fully considered but they are not
`
`deemed to be persuasive. Although applicants amended the claims to recite "said high molecular
`
`weight polyethylene oxide is at least 65% or 79% by weight of the total weight of said uncoated
`
`tablet alone or in combination with the low molecular weight polyethylene oxide" the limitations
`
`are met by Bartholomaus teaching that opiates are used for treatment of pain (page 1, paragraph
`
`[0002]) with 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]).
`
`Applicants argue unexpected density decrease when tablets are compression shaped then
`
`air cured. Whereas, Applicants assert that a tablet formed under heat and pressure, the density is
`
`increased.
`
`As discussed above, Bartholomaus teaches preparing his tablets by tableting (shaping)
`and heating at 80 oc where the powder mixture is pressed with a heated tool and pressure was
`maintained for at least 15 seconds (page 10, paragraph [0117]). Bartholomaus also discloses that
`
`the tablet demonstrates extended release ([0138]). Note that "at least 15 seconds" includes all the
`
`claimed curing time periods and that in the case where the claimed ranges "overlap or lie inside
`
`ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 I).
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`Page 8
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`Though Bartholomaus does not teach the claimed temperature and amount of time for
`
`curing the tablet, the workable amounts are readily determined by routine experimentation.
`
`"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to
`
`discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,
`
`456, 105 USPQ 233,235 (CCPA 1955)
`
`Applicants cite to Examples 13 and 22. Example 13 (page 38, paragraphs [0570-0573])
`prepares the tablets by compressing the blend (shaping) then heated and cured at 75 oc for 90
`minutes. Example 22 prepares the tablets by compressing the blend, molding under a
`temperature controlled press heated to 120 oc for 3 min under pressure. However, Bartholomaus
`blends are treated to pressing with heated tool (which had been previously heated to 80 °C) for at
`
`least 15 seconds under pressure. The claims do not exclude maintaining pressure during curing.
`
`Further, the data provided in the Declaration filed 11/23/2015 is not commensurate in
`
`scope to that instantly claimed. The tablets for which the data is presented both have PEO of
`
`80% or 96% and no data was presented for 54-79% and did not compare the claimed subject
`
`matter with the closest prior art, i.e. Bartholomaus et al. ("Bartholomaus", US Patent Publication
`
`No 2005/0031546). See MPEP 716.02(e). Additionally, evidence of secondary considerations,
`
`such as unexpected results or commercial success, is iiTelevant to 35 U.S.C. 102 rejections and
`
`thus cannot overcome a rejection so based, In re Hliggins, 488 F.2d 538, 543, 179 USPQ 421,
`
`425 (CCPA 19731. See :tviPEP 2131.04.
`
`The rejections are maintained.
`
`Claim Rejections - 35 USC § 103
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`Page 9
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`The following is a quotation of pre-AlA 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed
`or described as set forth in section 102 of this title, if the differences between the
`subject matter sought to be patented and the prior art are such that the subject
`matter as a whole would have been obvious at the time the invention was made to
`a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was
`made.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459
`
`(1966), that are applied for establishing a background for determining obviousness under 35
`
`U.S.C. 103(a) are summarized as follows:
`
`1.
`2.
`3.
`4.
`
`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating obviousness
`or nonobviousness.
`
`This application currently names joint inventors. In considering patentability of the
`
`claims under pre-AlA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the
`
`various claims was commonly owned at the time any inventions covered therein were made
`
`absent any evidence to the contrary. Applicant is advised of the obligation under 37 CPR 1.56 to
`
`point out the inventor and invention dates of each claim that was not commonly owned at the
`
`time a later invention was made in order for the examiner to consider the applicability of pre-
`
`AlA 35 U.S.C. 103(c) and potential pre-AlA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AlA
`
`35 U.S.C. 103(a).
`
`Claims 170-187, 189-193 and 199 stand rejected under 35 U.S.C. § 103(a) as being
`
`unpatentable over Bartholomaus et al. ("Bartholomaus", US Patent Publication No
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`Page 10
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`2005/0031546), ), as applied to claims 170-174 and 187-199 above, in view of Wright et al.
`
`("Wright", US Patent Publication No 2003/0068375).
`
`Claims 170-17 4 and 187-199 have been shown above to be anticipated by Bartholomaus.
`
`The discussion pertaining to Bartholomaus have been addressed at length above and the rational
`
`applies herein.
`
`Although, 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 [0 136]), Bartholomaus does not explicitly teach
`
`the specific combination of oxycodone or pharmaceutically acceptable salt thereof with a high
`
`molecular weight polyethylene oxide with a MW from 4,000,000 or 7,000,000, said high
`
`molecular weight polyethylene oxide is at least 65% by weight of the total weight of said
`
`uncoated tablet, further comprising coating, the specific dose forms or the percentage weight of
`
`the polyethylene oxide, additives (i.e. magnesium stearate, butylated hydroxytoluene, lactose,
`
`microcrystalline cellulose, hydroxypropyl cellulose.
`
`The specific combination of features claimed is disclosed within the broad generic ranges
`
`taught by the reference but such "picking and choosing" within several variables does not
`
`necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251,
`
`1262 (Fed. Circ. 1989). Where, as here, the reference does teach this specific combination of
`
`oxycodone or pharmaceutically acceptable salt thereof with a high molecular weight
`
`polyethylene oxide with a MW from 4,000,000 to 7,000,000, said high molecular weight
`
`polyethylene oxide is at least 60% by weight of the total weight of said uncoated tablet, further
`
`comprising a coating, anticipation cannot be found.
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`Page 11
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`That being said, however, it must be remembered that "[ w ]hen a patent simply arranges
`
`old elements with each performing the same function it had been known to perform and yields no
`
`more than one would expect from such an arrangement, the combination is obvious." KSR v.
`
`Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)).
`
`"[W]hen the question is whether a patent claiming the combination of elements of prior art is
`
`obvious," the relevant question is "whether the improvement is more than the predictable use of
`
`prior art elements according to their established functions." (/d.). Addressing the issue of
`
`obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out
`
`precise teachings directed to the specific subject matter of the challenged claim, for a court can
`
`take account of the inferences and creative steps that a person of ordinary skill in the art would
`
`employ." KSR at 1741. The Court emphasized that "[a] person of ordinary skill is ... a person of
`
`ordinary creativity, not an automaton." !d. at 1742.
`
`heating temperature of 62°C and duration of at least 5 minutes,
`Regarding the
`Bartholomaus teaches preparing his tablets by tabletting (shaping) and heating at 80 oc under
`pressure for at least 15 seconds (page 10, paragraph [0117]). Bartholomaus also discloses that
`
`the tablet demonstrates extended release ([0138]). Note that "at least 15 seconds" includes all the
`
`claimed curing time periods and that in the case where the claimed ranges "overlap or lie inside
`
`ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 I).
`
`Though Bartholomaus does not teach the claimed temperature and amount of time for
`
`curing the tablet, the workable amounts are readily determined by routine experimentation.
`
`"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to
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`Page 12
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`discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,
`
`456, 105 USPQ 233,235 (CCPA 1955)
`
`Wright teaches controlled release oral dosage forms (synonymous with extended release)
`
`an effective amount of a drug susceptible to abuse ( opioid analgesic) with a gelling agent
`
`(Abstract). Wright teaches opioid analgesics such as oxycodone (page 5, paragraph [0057],
`
`[0062]) and gelling agents such as polyethylene oxide (page 4, paragraph [0049]). Wright
`
`teaches the ratio of ratio of gelling agent to opioid agonist of from about 1 : 40 to about 40: 1 by
`
`weight, preferably from about 1 : 1 to about 30: 1 by weight, and more preferably from about 2:1
`
`to about 10: 1 by weight of the opioid agonist (page 4, paragraph [0050]). Wright teaches that
`
`the preferred embodiment of his oral dosage form is a tablet (page 7, paragraph [007 6]) and
`
`tablet are solid. Wright also teaches molecular weights of polyethylene oxides to (Examiner
`
`added emphasis):
`
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`(page
`
`13,
`
`paragraph [0150]). Wright teaches that the amount of opioid in the claimed composition may be
`
`about 75 ng to about 750 mg (page 5, paragraph [0056]). which overlap with the recited amount.
`
`Wright also teaches embodiments in which the opioid analgesic embodiments in which the
`
`opioid analgesic comprises oxycodone, the dosage form may include from about 2.5 mg to about
`
`320 mg oxycodone hydrochloride (page 5, paragraph [0058], specifically dosage of 10 mg, 20,
`
`KASHIV1038
`IPR of Patent No. 9,492,392
`
`

`

`Application/Control Number: 141729,634
`Art Unit: 1642
`
`Page 13
`
`mg, 40 mg or 80 mg oxycodone hydrochloride (page 5, paragraph [0063]). Wright teaches the
`
`ratio of gelling agent to opioid agonist of from about 1 : 40 to about 40: 1 by weight, preferably
`
`from about 1 : 1 to about 30: 1 by weight, and more preferably from about 2:1 to about 10: 1 by
`
`weight of the opioid agonist (page 4, paragraph [0050]), which overlaps with the recited amount.
`
`Therefore, it would have been obvious to one having ordinary skill in the art at the time
`
`of the instant invention to have prepared the Bartholomaus oxycodone hydrochloride and
`
`polyethylene oxide (MW 4,000,000 or 7,000,000) cured shaped tablets in the dosage amounts
`
`and percentage of polyethylene oxide as taught by Wright with a reasonable expectation of
`
`success. One having ordinary skill in the art would have been motivated to combine the teaching
`
`of Bartholomaus and Wright because Wright teaches formulations comprising the dosages are
`
`typical in oxycodone tablets and that adding a gelling agent such as polyethylene oxide in the
`
`amounts recited imparts a gel-like quality to the tampered dosage form (page 4, paragraph
`
`[0050]).
`
`Regarding claims 176-183, the instant claims recite various percentages of polyethylene
`
`oxide ("at least ... 79% or 65% or 80% or 85% or 90%"). Wright teaches the ratio of gelling
`
`agent to opioid agonist of from about 1 : 40 to about 40: 1 by weight, preferably from about 1 : 1
`
`to about 30: 1 by weight, and more preferably from about 2:1 to about 10: 1 by weight of the
`
`opioid agonist (page 4, paragraph [0050]), which overlaps with the recited amount.
`
`Wright and Bartholomaus do not explicitly teach the claimed amounts of the active
`
`ingredients with the percentage of polyethylene oxide in the dosage form, however, these
`
`workable amounts are readily determined by routine experimentation. "[W]here the general
`
`conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or
`
`KASHIV1038
`IPR of Patent No. 9,492,392
`
`

`

`Application/Control Number: 141729,634
`Art Unit: 1642
`
`Page 14
`
`workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,
`
`235 (CCPA 1955)
`
`Thereby meeting the limitations of claims 176-183.
`
`Further Bartholomaus teaches coating the tablet (page 9, paragraph [0107]). Meeting the
`
`limitation of claim 175.
`
`Regarding claims 184, Bartholomaus teaches compositions comprising magnesium
`
`stearate (page 9, paragraph [0099]).
`
`Regarding claim 185, Wright teaches butylated hydroxytoluene (page 14, paragraph
`
`[0153])
`
`Regarding claim 186, Bartholomaus teaches a dosage form comprising microcrystalline
`
`cellulose (page 5, paragraph [0047], claim 17)
`
`Therefore, selecting any of these amounts to little more than the selection of art-
`
`recognized components each according to their established functions under circumstances where
`
`the art expressly advocates their incorporation. All the claimed elements were known in the prior
`
`art and one skilled in the art could have combined the elements as claimed by known methods
`
`with no change in their respective functions, and the combination would have yielded predictable
`
`results to one of ordinary skill in the art at the time of the invention. (See KSR International Co.
`
`v. Teleflex, Inc., 82 USPQ2d 1385 (U.S. 2007)).
`
`Thus, given the teachings of the prior art and level of a person of ordinary skill in the art
`
`at the time of Applicant's invention one would have had a reasonable expectation of success in
`
`practicing the claimed invention. Therefore, the invention as a whole was prima facie obvious to
`
`KASHIV1038
`IPR of Patent No. 9,492,392
`
`

`

`Application/Control Number: 141729,634
`Art Unit: 1642
`
`Page 15
`
`one of ordinary skill in the art at the time the invention was made, as evidenced by the
`
`references.
`
`In the absence of any factual showing or unexpected results the presently claimed
`
`compositions are considered prima facie obvious over the prior art for the reasons stated above.
`
`In light of the forgoing discussion, the subject matter defined by the claims would have been
`
`obvious within the meaning of 35 USC§ 103(a).
`
`Response to Arguments:
`
`Applicant's arguments, filed 01/04/2016 have been fully considered but they are not
`
`deemed to be persuasive. The arguments regarding the claims have been addressed above and
`
`similarly applies herein. The rejections are maintained.
`
`Non-Statutory Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`grounded in public policy (a policy reflected in the statute) so