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
`
`6980
`7590
`08/27/2015
`TROUTMANSANDERSLLP
`600 Peachtree Street
`Suite 5200
`Atlanta, GA 30308
`
`EXAMINER
`
`AKHOON, KAUSER M
`
`ART UNIT
`
`1642
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`08/27/2015
`
`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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`Office Action Summary
`
`Art Unit
`1642
`
`Application No.
`14/729,634
`
`Examiner
`KAUSER M. 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 0610312015.
`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: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) ~ 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. 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 20150811
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`Application/Control Number: 141729,634
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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.
`
`Priority
`
`Acknowledgment is made that this application is a continuation application 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 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 172-174, 190-196 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 shape and cured
`
`matrix ... cured by heated air .. .for 15 minute to about 8 hours." Instant claim 173 recites
`
`"wherein the heated air 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 both an apparatus and method. These
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`claims mix apparatus and method limitations (such as functions or actions of a user) are
`
`indefinite when the boundaries are unclear. A single claim which claims both an apparatus and
`
`the method steps of using the apparatus 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 190-196 and 199 are also rejected for being dependent on a rejected base claim.
`
`Applicant is requested to correct the deficiency.
`
`Claim Rejections- 35 USC§ 112, Fourth Paragraph
`
`The following is a quotation of 35 U.S.C. 112(d):
`
`(d) REFERENCE IN DEPENDENT FORMS.-Subject to subsection (e), a claim in
`dependent form shall contain a reference to a claim previously set forth and then specify
`a further limitation of the subject matter claimed. A claim in dependent form shall be
`construed to incorporate by reference all the limitations of the claim to which it refers.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), fourth paragraph:
`
`Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AlA)], a claim in dependent form
`shall contain a reference to a claim previously set forth and then specify a further
`limitation of the subject matter claimed. A claim in dependent form shall be construed to
`incorporate by reference all the limitations of the claim to which it refers.
`
`Claims 187, 188 and 189 are rejected under 35 U.S.C. ll2(d) or 35 U.S.C. ll2 (pre-
`
`AlA), 4th paragraph, as being of improper dependent form for failing to further limit the subject
`
`matter of the claim upon which it depends, or for failing to include all the limitations of the claim
`
`upon which it depends In the instant case, claims 187, 188 and 189 depends upon claim 170.
`
`Claim 187, 188 and 189 recites the limitation "wherein said tablet ... has a cracking force of..."
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`(claim 187), "where said tablet can be flattened to a thickness ... without breaking" (claim 188)
`and "wherein ... the same tablets are stored at 40 oc and 75% relative humidity ... release an
`amount of said oxycodone ... deviates ... by no more than about 10% points" (claim 189), these are
`
`inherent properties of the cured shaped tablet defined in claim 170 and not a further
`
`limitation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper
`
`dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that
`
`the dependent claim(s) complies with the statutory requirements.
`
`Claim 197 is 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.
`
`Claims 170-174 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 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%
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`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]). Thereby reading upon claims 170-171.
`
`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 172-17 4.
`
`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 Trademark Office is not equipped to
`
`conduct experimentation in order to determine whether Applicants' cured shaped tablets differs
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`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 § 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 190-196, 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
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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 190-196 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.
`
`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 170-187, 189-193 and 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 170-174 and 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 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.
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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. 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.
`
`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.
`
`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]).
`
`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 (CCPA 1955)
`
`Thereby meeting the limitations of claims 176-183.
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`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])
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`Application/Control Number: 141729,634
`Art Unit: 1642
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`Page 13
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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)
`
`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
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`opioid agonist (page 4, paragraph [0050]), which overlaps with the recited amount.
`
`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
`
`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.
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`Application/Control Number: 141729,634
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`Page 14
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`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).
`
`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 time wise extension of the "right to exclude" granted by a patent and to prevent possible
`
`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
`
`application claim is not patentably distinct from the reference claim(s) because the examined
`
`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 VanOrnum, 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: 141729,634
`Art Unit: 1642
`
`Page 15
`
`Effective January 1, 1994, a registered attorney or agent of record may sign a terminal
`
`disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CPR
`
`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.
`
`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.
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`Application/Control Number: 141729,634
`Art Unit: 1642
`
`Page 16
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Misook Yu can be reached on (571) 272-0839. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
`
`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
`
`like assistance from a USPTO Customer Service Representative or access to the automated
`
`information system, call800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/K. M.A./
`Examiner, Art Unit 1642
`
`/MISOOK YU/
`Supervisory Patent Examiner, Art Unit 1642
`
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`Application/Control No.
`
`14/729,634
`
`Examiner
`KAUSER M. AKHOON
`U.S. PATENT DOCUMENTS
`
`Name
`
`Bartholomaus et al.
`Wright et al.
`
`Applicant(s)/Patent Under
`Reexamination
`MCKENNA ET AL.
`Art Unit
`1642
`
`Page 1 of 1
`
`Classification
`
`424/010.1
`424/468
`
`Notice of References Cited
`
`Date
`MM-YYYY
`02-2005
`04-2003
`
`*
`*
`*
`
`Document Number
`Country Code-Number-Kind Code
`A US-2005/0031546
`B US-2003/0068375
`c US-
`D US-
`E US-
`F US-
`G US-
`H US-
`US-
`I
`US-
`J
`K US-
`L US-
`M US-
`
`*
`
`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
`
`Country
`
`Name
`
`Classification
`
`FOREIGN PATENT DOCUMENTS
`
`NON-PATENT DOCUMENTS
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
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`*
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`N
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`0
`p
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`Q
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`R
`s
`T
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`u
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`v
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`w
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`X
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`*A copy of th1s reference 1s not be1ng furnished w1th th1s Off1ce act1on. (See MPEP § 707.05(a).)
`Dates in MM-Y