EXHIBIT 1016 
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1016
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01797
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`

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`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
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`APPLICATION NO.
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`F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF {MATION NO.
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`13/895,111
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`05/15/2013
`
`S. George Kottayil
`
`INS10763P00101US
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`1050
`
`32116
`7590
`03/24/2014
`WOOD, PHILLIPS, KATZ, CLARK&MORTIMER
`500 W. MADISON STREET
`SUITE 1 1 30
`CHICAGO, IL 60661
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`LANDSMAN, ROBERT S
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`1647
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`PAPER NUMBER
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`NOT *ICATION DATE
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`DELIVERY MODE
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`03/24/2014
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on aboVe—indicated "Notification Date" to the
`following e—mail address(es):
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`docketing @Woodphillips.com
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`PTOL—90A (Rev. 04/07)
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`

`
`Application No.
`13/895,111
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`App|icant(s)
`KOTTAYIL ET AL.
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`Office Action Summary
`
`AIA (First lnventorto File)
`Art unit
`Examiner
`iltgtus
`1647
`Robert Landsman
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`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).
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`In no event, however, may a reply be timely filed
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`—
`—
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`Status
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`1)IXI Responsive to communication(s) filed on 3/6/14.
`I:I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)lXl This action is non—final.
`2a)I:l This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)I:I 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.
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`Disposition of Claims*
`5)IXI Claim(s)1;6is/are pending in the application.
`5a) Of the above claim(s) j is/are withdrawn from consideration.
`6)I:I Claim(s) j is/are allowed.
`7)IZI Claim(s)1;6is/are rejected.
`8)I:I Claim(s) _ is/are objected to.
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`_ are subject to restriction and/or election requirement.
`I
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
`if/index.‘s
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`
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`://www.us:>to. ow atents/init events/'
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`, orsend an inquiry to PPI--lfeedbackf,<13usj;),togov.
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`htt
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`Application Papers
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`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I 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).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`Priority under 35 U.S.C. § 119
`12)I:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
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`b)I:l Some** c)I:l None of the:
`a)|:l All
`1.|:l Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No. j
`3.I:| Copies of the certified copies of the priority documents have been received in this National Stage
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`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.
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`Attach ment(s)
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`1) E Notice of References Cited (PTO-892)
`3) D jntervjew summary (pTo-413)
`_
`_
`Paper No(s)/Mail Date. j
`2) D Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 4) I:I Other: j‘ .
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`
`U.S. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
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`Part of Paper No./Mail Date 20140317
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`Office Action Summary
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`

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`Application/Control Number: 13/895,111
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`Art Unit: 1647
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`Page 2
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`DETAILED ACTION
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`The present application is being examined under the pre—AIA first to invent provisions.
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`1. Formal Matters
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`A.
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`Claims 1-6 are pending and are the subject of this Office Action.
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`2. Specification
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`A.
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`The amendment to the specification has been withdrawn in View of Applicants‘ amendments.
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`3. Claim Rejections - 35 USC § 112, first paragraph — scope of enablement
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`A.
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`The rejection of claims 1-3 under 35 USC 112, first paragraph, has been withdrawn.
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`It appears
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`that Treatment A (Table 52) is the only one meeting the claimed limitations. However, though Examples
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`1-6 do not appear to meet the claimed lin1itations, Applicants‘ argument that a PHOSITA would be able to
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`produce such a formulation is persuasive.
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`The claims are not lin1ited to liquid formulations. However, in view of the rejections below under
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`35 USC 102 and 103, this enablement rejection is being withdrawn. However, if Applicants are able to
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`overcome the prior art rejections, this enablement rejection may be reinstated.
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`4. Claim Rejections - 35 USC § 112, first paragraph — written description
`{\
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`The rejection of claims 1-3 under 35 USC 112, first paragraph, has been withdrawn. The
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`reasoning is seen above regarding scope of enablement.
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`5. Claim Rejections - 35 USC § 102
`The following is a quotation of the appropriate paragraphs of pre—AIA 35 U.S.C. 102 that form
`the basis for the rejections under this section made in this Office action:
`A person shall be entitled to a patent unless —
`(a) the invention was known or used by others in this country, or patented or described in a printed
`publication in this or a foreign country, before the invention thereof by the applicant for a patent.
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`

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`Application/Control Number: 13/895,111
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`Art Unit: 1647
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`Page 3
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`(e) the invention was described in (1) an application for patent, published under section 122(b), by
`another filed in the United States before the invention by the applicant for patent or (2) a patent granted
`on an application for patent by another filed in the United States before the invention by the applicant
`for patent, except that an international application filed under the treaty defined in section 351(a) shall
`have the effects for purposes of this subsection of an application filed in the United States only if the
`international application designated the United States and was published under Article 21(2) of such
`treaty in the English language.
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`A.
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`Claims 1 and 2 are rejected under pre—AIA 35 U.S.C. 102a as being anticipated by Ross et al.
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`(US2006/0062812 — reference 27 on the 1449 dated 7/22/13). The claims have been discussed previously.
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`Regarding claim 1, Ross teaches a sublingual fentanyl formulation which has a Tmax of either 2 hrs
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`(Patient 2 of Table 1) or 1.5 hrs (Patient 5 of Table 1). This meets the limitations of "about 1.28 +/— 0.60
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`hrs). The Examiner has determined that 1.28 hrs +/— 0.60 hrs is equal to “about” 76 minutes +/— 36
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`minutes, Which is a range of “about” 40 minutes to 112 minutes.
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`Regarding claim 2, Ross teaches that plasma concentrations start to fall just 30 n1inutes after
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`administration (paragraph [0126]). Therefore, given that the maximum concentration in some cases would
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`occur at 30 minutes, it would be expected that the levels would be approximately 60% of Cmax in 10
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`minutes and 86% of Cmax in 20 minutes.
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`B.
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`Claim 1
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`is rejected under pre—AIA 35 U.S.C. 102a as being anticipated by Palmer et al.
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`(US2012/0035216). The claims have been discussed previously. It is noted that the claims are not lin1ited
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`to liquid preparations.
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`Palmer teaches formulations #59 and #62, which are sublingual tablets, have a Tmax of 45
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`minutes and 50 minutes, respectively. Again, the Examiner has determined that 1.28 hrs +/— 0.60 hrs is
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`equal to “about” 76 minutes +/— 36 minutes, which is a range of “about” 40 minutes to 112 minutes.
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`Though Figure 6 appears to show a very rapid rise to Cmax, this is for sufentanyl. A case cannot be made
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`that fentanyl will produce the same results.
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`6. Claim Rejections - 35 USC § 103 (previously 102/103)
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`A.
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`Claims 1-3 remain rejected under 35 USC 103 for the reasons already of record on page 6 of the
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`Office Action dated 11/21/13. Applicants argue that McCarty does not teach the claimed Tmax, Cmax
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`and AUC values, nor would it have been obvious to have produced such formulations.
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`

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`Application/Control Number: 13/895,111
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`Art Unit: 1647
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`Page 4
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`These arguments have been considered, but are not deemed persuasive. The rejections
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`under 35 USC 112,
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`first paragraph, both enablement and written description, have been
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`withdrawn in View of Applicants’ arguments that a PHOSITA would have been able to routinely
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`produce formulations meeting the instant claims, even though only one is disclosed (Formulation
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`A). However, here that Applicants are stating that it would not have been obvious for McCarty,
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`who teaches sublingual formulations, to have optimized their conditions in order to produce the
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`desired sublingual formulations. Therefore, given the fact that Applicants argue the obviousness
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`of a PHOSITA in producing the formulations, it would have been obvious for McCarty to do the
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`same. No result effective variables are recited in the claims. Where the general conditions of a claim
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`are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine
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`experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955)
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`B.
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`Claims 1-3 remain rejected under 35 USC 103 for the reasons already of record on pages 6-7 of
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`the Office Action dated 11/21/13. Applicants arguments are similar to that for McCarty. These arguments
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`are not persuasive for the same reasons. Paragraphs [0015], [0016] and [0017] of Ross clearly state the
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`advantages of producing such sublingual formulations.
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`C.
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`Claims 1-3 are rejected under pre—AIA 35 U.S.C. 102b as being anticipated by Ross et al.
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`(US2006/0062812 — reference 27 on the 1449 dated 7/22/13). The claims have been discussed previously.
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`Ross teaches sublingual fentanyl
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`formulations (paragraphs
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`[0014],
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`[0018]—[0021],
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`[0036],
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`[0037],
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`[0055]). Given the teachings of Ross, it would have been obvious for a PHOSITA to have produced a
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`formulation meeting the claimed limitations. The rationale is the same for that above regarding McCarty.
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`7. 0bvi0usness- Type Double Patenting
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`A.
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`As per Applicants‘ request, the rejection over U.S. Patent Nos. 8,486,972 and 8,486,973 are being
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`held in abeyance. Newly added claims 4-6 are also rejected as being obvious over each of these patents.
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`

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`Application/Control Number: 13/895,111
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`Art Unit: 1647
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`Page 5
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`B.
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`Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being
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`unpatentable over claims 1-4 of copending Application No. 13/895,123. Although the claims at issue are
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`not identical, they are not patentably distinct from each other because both are drawn to sublingual
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`fentanyl formulations.
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`This is a provisional nonstatutory double patenting rejection because the patentably indistinct
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`claims have not in fact been patented.
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`8. Conclusion
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`A.
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`No claim is allowable.
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`Advisory information
`Any inquiry concerning this communication or earlier communications from the examiner should
`be directed to Robert Landsman, Ph.D. whose telephone number is (571) 272-0888. The examiner can
`normally be reached M—F 8 AM — 6 PM (eastern).
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`Joanne Hama, can be reached at 571-272-2911. 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).
`
`/Robert Landsman/
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`Primary Examiner, Art Unit 1647