EXHIBIT 1017 
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1017
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01797
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`

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`INSl0763P00l0lUS
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re Application of:
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`S. George Kottayil
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`Serial No.:
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`13/895,111
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`Filed: May 15, 2013
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`Sublingual Fentanyl Spray
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`Examiner:
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`Robert S Landsman
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`Group Art Unit:
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`1647
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`Confirmation No.:
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`1050
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`AMENDMENT
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`Commissioner for Patents
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`P.O. Box 1450
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`Alexandria, VA 223 l3-1450
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`Madam:
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`Responsive to the Office Action mailed March 24, 2014, please amend the above-
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`identified application as indicated below.
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`If any fees are incurred as a result of the filing of this paper, authorization is given to charge
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`Deposit Account No. 23-0785.
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`Amendment of the Claims begin on page 2 of this paper.
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`Remarks begin on page 3 of this paper.
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`Page 1 of 6
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`

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`Response to Office Action mailed March 24, 2014
`Serial No. 13/895,111
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`Amendment to the Claims
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`1.
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`(Currently amended) A sublingual formulation comprising from about 0.001% to about
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`15% by weight an—effeetive—ameu=&t—ef fentanyl, from about 20% to about 60% by weight
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`ethanol and from about 4% to about 6% by weight propylene glycol, at—least—ene
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` , the formulation providing a mean Tmax of about
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`1.28+/-0.60 hours when a dose is administered sublingually to humans.
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`2.
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`(Currently amended@5Fhe—sublingual fomulation comprising from about
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`0.001% to about 15% by weight fentanyl, from about 50% to about 60% by weight ethanol, and
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`from about 4% to about 6% by weight propylene glycol, which provides a plasma concentration
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`after administration to humans selected from the group consisting of: about 60% of the mean
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`Cm, in about 10 minutes, about 86% of the mean Cm, by about 20 minutes and a combination
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`thereof.
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`3.
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`(Original)The sublingual formulation of claim 1, that when administered to humans
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`provides a plasma concentration that is greater than about 80% of the mean Cmax for about 2
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`hours.
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`4.
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`(Previously presented) A sublingual spray formulation comprising 400 mcg dose of
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`fentanyl which provides one or more mean pharmacokinetic values selected from the group
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`consisting of: AUC1ast 4.863 +/-1.70821 hr*ng/mL, AUCjnf 5.761 +/- 1.916 hr*ng/mL, and
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`AUCeX[rap 10.26 +/- 5.66%, when administered to humans.
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`5.
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`(Previously presented) A sublingual spray formulation comprising a dose of fentanyl
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`which provides a substantially dose proportional mean AUC1ast based on a mean AUC1ast of about
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`4.863 +/-1.70821 hr*ng/mL for a 400 mcg fentanyl dose when administered to humans.
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`6.
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`(Previously presented) A sublingual spray formulation comprising a 400 mcg dose of
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`fentanyl which provides a mean F(AUC1ast) of about 0.721 +/- 0.199 ng/mL when administered
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`to humans.
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`Page 2 of 6
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`

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`Response to Office Action mailed March 24, 2014
`Serial No. 13/895,111
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`REMARKS
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`Claims 1-6 are pending. Claims 1 and 2 have been amended. Support for the
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`amendments to claim 1 and 2 can be found in paragraphs [00122] and [00124] and table 50 and
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`52 of the specification.
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`35 U.S.C. § 112 Rejections
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`The rejection under 35 U.S.C. § 112, first paragraph, for claims 1-3 failing to comply
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`with the enablement requirement or the written description requirement because the specification
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`does not reasonably provide enablement for or description of all sublingual formulations “(l)
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`which are formulated for a spray and (2) which have the desired properties” has been withdrawn.
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`The Office Action asserts that this rejection may be reinstated if Applicants overcome the prior
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`art rejections.
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`Applicants anticipatorily and respectfully traverse the reinstatement of these rejections.
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`Claims 1 and 2 have been amended to include specific concentration ranges for the components
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`of the composition. The formulations disclosed in the instant specification (Table 50 and Table
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`52) fully enable and disclose compositions comprising fentanyl, ETOH and PG within the
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`specific claimed concentration ranges that provide the claimed Tmax and Cmax values.
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`Paragraphs [00122] and [00124] of the instant specification describe the claimed concentration
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`ranges and paragraphs [0048], [0049] and [0057] describe the claimed Tmax and Cmax values in
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`general. Thus, applicants respectfully request that these rejections be withdrawn.
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`35 U.S.C. § 102 Rejection
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`Ross
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`Claims
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`1-3 stand rejected under
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`l02(a) as anticipated by or Ross et al. U.S.
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`2006/0062812. Regarding claim 1, the Office Action asserts that Ross teaches a sublingual
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`fentanyl formulation having a Tmax of either 2 hours or 1.5 hours. Regarding claim 2, the
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`Office Action asserts that Ross teaches that plasma concentrations start to fall just 30 minutes
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`after administration, therefore, it would be expected that the levels would be approximately 60%
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`of Cmax in 10 minutes and 86% of Cmax in 20 minutes.
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`Page 3 of 6
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`

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`Response to Office Action mailed March 24, 2014
`Serial No. 13/895,111
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`Applicants respectfully traverse this rejection. Amended claims 1 and 2 comprise a
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`specific concentration of fentanyl, ethanol (“ETOH”) and propylene glycol (“PG”) that are not
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`taught in Ross and thus, Ross does not anticipate instant claims 1-3. Accordingly, Applicants
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`request withdrawal of this rejection.
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`Palmer
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`Claim 1
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`stands rejected under
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`l02(a) as being anticipated by Palmer et al. U.S.
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`2012/0035216. The Office Action asserts that Palmer teaches formulations #59 and #62 which
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`are sublingual tablets that have a Tmax of 45 minutes and 50 minutes, respectively.
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`Applicants respectfully traverse this rejection. The instant application claims priority to
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`U.S. application No. 11/698,739 which was filed on 1/25/2007 and U.S. Provisional Application
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`No. 60/762,057. Palmer was not published until 2/9/2012 and thus is not prior art under l02(a).
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`Assuming for the sake of argument that Palmer was l02(a) prior art, amended claim 1 comprises
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`a specific concentration of fentanyl, ETOH and PG that are not taught in Palmer and thus,
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`Palmer does not anticipate instant claim 1. Accordingly, Applicants request withdrawal of this
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`rejection.
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`35 U.S.C.
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`103
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`Claims 1-3 remain rejected under 35 U.S.C. § 103 for being obvious over McCarty U.S.
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`2007/0071806 or Ross. The Office Action asserts that if view of Applicant’s argument that a
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`person having ordinary skill in the art (“PHOSITA”) would have been able to routinely produce
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`formulations meeting the instant claims, even though only one is disclosed, it would have also
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`been obvious to vary the formulas taught in McCarty or Ross to reach the claimed formulations.
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`Applicants respectfully traverse this rejection. The formulations disclosed in the instant
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`specification (Table 50 and Table 52) fully enable and disclose compositions comprising
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`fentanyl, ETOH and PG within the specific claimed concentration ranges that provide the
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`claimed Tmax and Cmax values. Paragraphs [00122] and [00124] of the instant specification
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`describe the claimed concentration ranges and paragraphs [0048], [0049] and [0057] describe the
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`claimed Tmax and Cmax values in general.
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`Thus, a PHOSITA,
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`in light of the instant
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`specification, would not have to endure undue experimentation to enable the claims. No
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`Page 4 of 6
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`

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`Response to Office Action mailed March 24, 2014
`Serial No. 13/895,111
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`formulation of McCarty even contains fentanyl, ETOH and PG. Further, McCarty does not teach
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`or suggest that the claimed concentrations of fentanyl, ETOH and PG, alone or in combination
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`would be an effective sublingual formulation or that these formulations would provide any
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`particular Tmax or Cmax value. Thus, the teachings of McCarty would not make obvious to a
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`PHOSITA the claimed sublingual formulations.
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`Ross does not disclose a formulation that contains fentanyl, ETOH and PG. Where a
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`skilled artisan merely pursues "known options" from "a finite number of identified, predictable
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`solutions," the resulting invention is obvious under Section 103. KSR, 550 U.S. 398, 421 (2007).
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`Where, however, a defendant urges an obviousness finding by "merely throw[ing] metaphorical
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`darts at a board" in hopes of arriving at a successful result, but "the prior art gave. . .no direction
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`as to which of many possible choices is likely to be successful," courts should reject "hindsight
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`claims of obviousness." In re Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009) (quoting In re
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`0'FarrelZ, 853 F.2d 894, 903 (Fed. Cir. 1988)). No example in Ross teaches the use of ETOH
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`and PG together in a sublingual fentanyl formulation. A PHOSITA would endure undue
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`experimentation to arrive at the instant claimed formulations, because there is no suggestion in
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`Ross that such a formulation would be an effective sublingual formulation. Further, Ross does
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`not teach or suggest a single sublingual formulation that contains fentanyl, ETOH and PG in the
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`claimed concentrations that provides the claimed Tmax and Cmax values. Thus, a PHOSITA
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`would have to undergo an excessive amount of experimentation without any direction as to
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`which of the many choices would likely be successful. Accordingly, Applicants request
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`withdrawal of these rejections.
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`Double Patenting
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`The Office Action rejected claims 1-6 on the ground of nonstatutory obviousness-type
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`double patenting over claims 1-3 of U.S. Patent No. 8,486,973 and/or claims 1-20 of U.S. Patent
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`No. 8,486,973. Additionally, claims 1-6 are provisionally rejected on the grounds of
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`nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application
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`No. 13/895,123.
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`In response, Applicants respectfully request that this rejection be held in abeyance until
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`the instant application is deemed to have allowable subject matter but for the double-patenting
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`rej ection.
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`Page 5 of 6
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`

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`Response to Office Action mailed March 24, 2014
`Serial No. 13/895,111
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`Conclusion
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`None of McCarty, Ross or Palmer teach or makes obvious a sublingual fentanyl
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`formulation having the claimed specific concentrations of fentanyl, ETOH, PG or the claimed
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`Tmax or Cmax values. Applicants respectfully submit
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`that
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`the pending claims 1-6 are
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`patentable. Accordingly, reconsideration of the rejections and allowance of the application are
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`requested. Should the Examiner have any questions concerning the above, he is respectfully
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`requested to contact the undersigned at the telephone number listed below.
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`Respectfully submitted,
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`Date: April 15, 2014
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`/Steven F. Weinstock/
`Steven F. Weinstock, Registration No. 30,117
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`WOOD, PHILLIPS, KATZ,
`CLARK & MORTIMER
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`500 West Madison Street, Suite 1130
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`Chicago, IL 60662-2511
`Tel.: (312) 876-2110
`Fax.: (312) 876-2020
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`Page 6 of 6
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`

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`Electronic Acknowledgement Receipt
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`International Application Number:
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`Title of Invention:
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`SUBLINGUAL FENTANYL SPRAY
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`First Named Inventor/Applicant Name:
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`Application Type:
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`Utilnty under 35 USC111(a)
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`Payment information:
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`File Listing:
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`Document
`Number
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`Document Description
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`File Size(Bytes)/
`Message Digest
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`Pages
`Multi
`Part /.zip (if appl.)
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`Information:
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`Amend ment/Req. Reconsideration-After
`Non-Final Reject
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`|NS101US_Response_to_Office
`_Action.pdf
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`fcf669223c1a84c8ce84b8aafd2fa019acb0c
`d6d
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`Total Files Size (in bytes)
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`98479
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`Document code: WFEE
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`United States Patent and Trademark Office
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`Sales Receipt for Accounting Date: 04/22/2014
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`NHENSLEY
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`SALE #00000004 Mailroom Dt: 04/15/2014
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`230785
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`13895111
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`APP“°a“°” Or Docket Number
`13/895,111
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`FI“”9 Dale
`05/15/2013
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`I:I MULTIPLE DEPENDENT CLAIM PRESENT (37 CFR1.16(j))
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`04/15/2014
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