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.
`
`14/729,660
`
`06/03/2015
`
`William H. McKenna
`
`241957.000596
`
`2426
`
`09111/2015
`7590
`6980
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`EXAMINER
`
`AKHOON, KAUSER M
`
`ART UNIT
`
`1642
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/1112015
`
`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)
`
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`Application No.
`14/729,660
`
`Applicant(s)
`MCKENNA ET AL.
`
`Examiner
`KAUSER M. AKHOON
`
`Art Unit
`1642
`
`Office Action Summary
`
`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 .J. MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR t. t 36(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. § t33).
`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 t .704(b).
`
`Status
`1 )~ Responsive to communication(s) filed on 06/03/2015.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)0 This action is FINAL.
`2b)~ 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://vvww.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to P~'Hfeedback(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) ~ Notice of References Cited (PT0-892)
`2) 0 Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date __ .
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. t t-t3)
`
`Office Action Summary
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`Part of Paper No./Mail Date 20t50825
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`Application/Control Number: 141729,660
`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 and under examination.
`
`Priority
`
`Acknowledgment is made that this application is a continuation of US patent application
`
`14/515,924, filed October 16,2014, which is a continuation of US patent application 13/803,132,
`
`filed March 14, 2013 (abandoned), US Patent Application No. 11/844,872, filed August 24,
`
`2007, which claims priority to US Provisional 60/840,244, filed August 25, 2006.
`
`Claim Objections
`
`Claim 172-173 is objected to for minor informalities. Claims recite " of about 62 about
`
`90 °C," claim needs add the term "to" after 62.
`
`Appropriate correction is requested.
`
`Claim Rejections- 35 USC§ 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`
`(b) The specification shall conclude with one or more claims particularly pointing
`out and distinctly claiming the subject matter which the inventor or a joint
`inventor regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`
`The specification shall conclude with one or more claims particularly pointing out
`and distinctly claiming the subject matter which the applicant regards as his
`invention.
`
`Claims 172-175, 180-186, 190-195, 197 and 199 are rejected under 35 U.S.C. 112,
`
`second paragraph, as being indefinite for failing to particularly point out and distinctly claim the
`
`subject matter which applicant regards as the invention. Instant claim 172 recites "wherein each
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`shape and cured matrix ... cured by heated air having a temperature of about 62 about 90 oc
`.. .for 15 minute to about 8 hours." Instant claim 173 recites "wherein the heated air
`
`Page 3
`
`temperature is from about 65 to 90° C .. . duration is about 15 minute to about 8
`
`hours ... cooling." Instant claim 17 4 recites "wherein said shaped tablet is coated at least one of
`
`before or after being cured." Claims 172-17 4 recite to two methods. These claims mix method
`
`of treating and method of making tablets limitations (such as functions or actions of a user) are
`
`indefinite when the boundaries are unclear. A single claim which claims method steps directed
`
`to method of treating and method of making is indefinite under 35 U.S.C. 112(b) or pre-AlA
`
`35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent
`
`Litigation, 639 F.3d 1303,97 USPQ2d 1737 (Fed. Cir. 20ll). Claims 172-174 has more than one
`
`interpretation and therefore is indefinite.
`
`Claims 175, 180-186, 190-195, 197 and 199 are also rejected for being dependent on a
`
`rejected base claim.
`
`Applicant is requested to correct the deficiency.
`
`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.
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`Claims 170-175 and 187-199 are 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 method of treating pain by administering a
`
`pharmaceutical tablet comprising an opioid 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, optional inclusion of additional components are interpreted as
`
`compositions that do not contain that component.
`
`Bartholomaus teaches 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 [0 136]). Bartholomaus teaches administration of his compositions (page 1, paragraph
`
`[0014]). The instant claims are using the same composition as Bartholomaus to perform the
`
`method as instantly claimed. Therefore, the treatment of pain by administering the same
`
`composition is inherent to the composition. Under the principles of inherency, if a prior art
`
`composition, in its normal and usual operation, would necessarily perform the method claimed,
`
`then the method claimed will be considered to be anticipated by the prior art composition. When
`
`the prior art device (composition) is the same as a device (composition) described in the
`
`specification for carrying out the claimed method, it can be assumed the device (composition)
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`will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed.
`
`Cir. 1986). MPEP 2112.02.
`
`Thereby reading upon claims 170-171 and 174-175.
`
`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 172-173.
`
`Further, it should be noted that claims 172-17 4 and 197 are directed to a method by
`
`administering a composition which is produced by a certain process, product-by-process. Claims
`
`170 and 171 also, i.e. "compression shaped and air cured" Please note that in product-by-process
`
`claims, "once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103
`
`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 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 170-17 4 and 197.
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`Further Bartholomaus teaches coating the tablet (page 9, paragraph [0107]). Meeting the
`
`limitations of claim 175.
`
`With regard to claims 187-189, 196 and 198-199, 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 § 2112.01 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, 911 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)."
`
`Regarding claims 190-195, 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
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`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 190-195 are directed to a method by administering
`
`a composition which is produced by a certain process, product-by-process. 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 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.
`
`Thus, Claims 170-174 and 187-199 are anticipated by Bartholomaus under 35 U.S.C. §
`
`102(b).
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`Claim Rejections- 35 USC§ 103
`
`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).
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`Claims 170-199 are rejected under 35 U.S.C. § 103(a) as being unpatentable over
`
`Bartholomaus et al. ("Bartholomaus", US Patent Publication No 2005/0031546), as applied
`
`to claims 170-175and 187-199 above, in view of Wright et al. ("Wright", US Patent
`
`Publication No 2003/0068375).
`
`As discussed above, 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 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,
`
`optional inclusion of additional components are interpreted as compositions that do not contain
`
`that component.
`
`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 [0136]), 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 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; the specific dose forms or the percentage weight of
`
`the polyethylene oxide; or specific additives (i.e. magnesium stearate, butylated hydroxytoluene,
`
`lactose, microcrystalline cellulose, hydroxypropyl cellulose).
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`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. Coming 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.
`
`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 17 41. The Court emphasized that "[a] person of ordinary skill is ... a person of
`
`ordinary creativity, not an automaton." !d. at 1742.
`
`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
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`(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):
`
`(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,
`
`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.
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`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 4,000,000-7,000,000) 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
`
`workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,
`
`235 (CCP A 1955)
`
`Thereby meeting the limitations of claims 17 6-183.
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`Application/Control Number: 141729,660
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`Page 13
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`Further Bartholomaus teaches coating the tablet (page 9, paragraph [0107]). Meeting the
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`limitations of claim 175.
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`Regarding claims 184, Bartholomaus teaches compositions comprising magnesium
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`stearate (page 9, paragraph [0099]).
`
`Regarding claim 185, Wright teaches butylated hydroxytoluene (page 14, paragraph
`
`[0153])
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`Regarding claim 186, Bartholomaus teaches a dosage form comprising microcrystalline
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`cellulose (page 5, paragraph [0047], claim 17)
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`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
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`art and one skilled in the art could have combined the elements as claimed by known methods
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`with no change in their respective functions, and the combination would have yielded predictable
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`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)).
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`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
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`practicing the claimed invention. Therefore, the invention as a whole was prima facie obvious to
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`one of ordinary skill in the art at the time the invention was made, as evidenced by the
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`references.
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`In the absence of any factual showing or unexpected results the presently claimed
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`compositions are considered prima facie obvious over the prior art for the reasons stated above.
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`Application/Control Number: 141729,660
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`In light of the forgoing discussion, the subject matter defined by the claims would have been
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`obvious within the meaning of 35 USC§ 103(a).
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`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 as to prevent the unjustified or
`
`improper timewise extension of the "right to exclude" granted by a patent and to prevent possible
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`harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection
`
`is appropriate where the conflicting claims are not identical, but at least one examined
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`application claim is not patentably distinct from the reference claim(s) because the examined
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`application claim is either anticipated by, or would have been obvious over, the reference
`
`claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re
`
`Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225
`
`USPQ 645 (Fed. Cir. 1985); In re Van Omum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re
`
`Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
`
`USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CPR 1.321(c) or 1.321(d) may
`
`be used to overcome an actual or provisional rejection based on a nonstatutory double patenting
`
`ground provided the conflicting application or patent either is shown to be commonly owned
`
`with this application, or claims an invention made as a result of activities undertaken within the
`
`scope of a joint research agreement.
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`Application/Control Number: 141729,660
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`Page 15
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`Effective January 1, 1994, a registered attorney or agent of record may sign a terminal
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`disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CPR
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`3.73(b).
`
`Application Nos.
`
`Due to the prolific nature of the portfolio, the Examiner will defer assessment of
`
`obviousness-type double patenting to the following co-pending applications and subject matter
`
`claimed in each application. Applicants are forewarned of the potential existence of
`
`obviousness-type double patenting with the present application. Although the claims at issue are
`
`not identical, they are not patentably distinct from each other because both instant and reference
`
`claims are drawn to the combination of an opioid (oxycodone hydrochloride) and polyethylene
`
`oxide
`
`13/333560 (US 8,808,740)
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`13/900873 (US 8,821,929)
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`13/900963 (US8,894,988)
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`13/901047 (US 8,846,086)
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`13/901078 (US 8,815,289)
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`13/901122 (US 8,834,925)
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`13/901218 (US 8,911,819)
`
`Process for preparing oxycodone HCl tablets with PEG
`000 and at least 79%
`of
`A tablet with opioid with first controlled release material
`(PEG) and shell with encasing core, a second portion
`with
`· · and second release material
`Process for preparing oxycodone HCl tablets with PEG
`4,000,000 and PEG amount by weight of composition
`and varied
`amounts.
`Oxycodone tablets with PEG 4,000,000 and PEG
`amount varied by weight of composition and varied
`rW>Jror>£1r>r>P amounts.
`
`Morphine tablets with PEG 4,000,000 and PEG amount
`varied by weight of composition and varied oxycodone
`amounts.
`Oxycodone tablets with PEG 4,000,000 and PEG
`amount varied by weight of composition and varied
`oxycodone amounts, with second PEG of MW less than
`000.
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`Application/Control Number: 141729,660
`Art Unit: 1642
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`Page 16
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`14/024367
`
`14/040535 (US 8,808,741)
`
`14/515855 (US 9.095.614)
`
`14/515857 (US 9,101,661)
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`14/515921 (US 9,095,615)
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`14/515924 (US 9,084,816)
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`14/729634
`14/729675
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`and a shell with opioid and PEG.
`Process for preparing hydrocodone with core and PEG
`and a shell with opioid and PEG.
`Method of treating pain by administering a tablet with
`oxycodone and PEG 4,000,000 with varied amount so
`oxycodone and percentage of PEG.
`Method of treating pain by administering a tablet with
`opioid and PEG 4,000,000 with varied amount so
`oxycodone and percentage of PEG.
`Process for preparing a tablet with opioid and Low MW
`PEG less than 1,000,000 with High MW PEG 7,000,000
`with at least PEG at 79% by weight.
`A tablet with opioid and Low MW PEG less than
`1,000,000 with High MW PEG 7,000,000 with at least
`PEG at 79% by weight, wherein the Low MW PEG is at
`least 22% and high MW PEG is at least 50%.
`A tablet with opioid and Low MW PEG less than
`1,000,000 with High MW PEG 7,000,000 with at least
`PEG at 79% by weight.
`Oxycodone tablets with PEG 4,000,000-7,000,000.
`Hydrocodone tablets with PEG 4,000,000-7,000,000.
`
`No claims are allowed.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to KAUSER M. AKHOON whose telephone number is (571)270-
`
`1026. The examiner can normally be reached on M-F 8:00AM-5:00PM.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Misook Yu can be reached on (571) 272-0839. The fax phone number for the
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`organization where this application or proceeding is assigned is 571-273-8300.
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