Exhibit 1020
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1020
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01799
`
`

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`
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`UNITED STATES PATENT AND TRADEMARK OEEICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trzuleinark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www usplo gov
`
`APPLICATION NO.
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`FILING 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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`13/895.124
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`05/15/2013
`
`S. George Kottayil
`
`INS 10763P00091US
`
`3808
`
`32ll6
`7590
`03/21/2014
`WOOD, PHILLIPS, KATZ, CLARK&MORTIMER
`500 W. MADISON STREET
`SUITE 1 1 30
`CHICAGO, IL 60661
`
`LANDsMAN,RoBERTs
`
`PAPER NUMBER
`
`ART UN”
`1647
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`NOT EICATION DATE
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`DELIVERY MODE
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`03/21/2014
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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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`PTOI.—90A (Rev. 04/07)
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`

`
`Application No.
`‘I3/895,124
`
`App|icant(s)
`KOTTAYIL ET AL.
`
`Office Action Summary
`
`AIA (First lnventorto File)
`Art unit
`Examiner
`figtus
`1647
`Robert Landsman
`-- The MAILING DA TE 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 Q MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1.136(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).
`
`In no event, however, may a reply be timely filed
`
`Status
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`1)IZI 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)|Zl 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
`Z; 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*
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`5)IXI Claim(s) fit is/are pending in the application.
`5a) Of the above claim(s) 2 and 3 is/are withdrawn from consideration.
`6)I:I Claim(s) j is/are allowed.
`7) Claim(s) 1 and 4 is/are rejected.
`8)I:I Claim(s) j is/are objected to.
`9)I:I Claim(s) j 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
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`participating intellectual property office for the corresponding application. For more information, please see
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`
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`if/index.'s , orsend an inquiry to PPI--lfeedbackflusgtogov.
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`:/.’www.usoto. ow atents/init events/'
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`htt
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`Application Papers
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`10)|:I The specification is objected to by the Examiner.
`11)I:I The drawing(s) filed on j is/are: a)I:I accepted or b)D 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:I 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.I:l Certified copies of the priority documents have been received.
`2.I:l Certified copies of the priority documents have been received in Application No. ?.
`3.I:l Copies of the certified copies of the priority documents have been received in this National Stage
`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)
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`1) D 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‘ .
`
`
`U.S. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
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`Part of Paper No./Mail Date 20140315
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`Office Action Summary
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`

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`Application/Control Number: 13/895,124
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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 and 4 are the subject of this Office Action.
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`2. Specification
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`A.
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`The objection to the specification has been Withdrawn in View of Applicants’ amendments
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`regarding trademarks.
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`3. Claim Rejections - 35 USC § 112, first paragraph — scope of enablement
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`A.
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`Claim 1 remains rejected for the reasons already of record on pages 2-3 of the Office Action
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`dated 1/10/14. Applicants‘ argue that paragraph [0043] limits the derivatives. This argument has been
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`considered, but is not deemed persuasive. The paragraph does not limit the compounds. It only states that
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`the derivatives include (i.e. comprises) these. Applicants argue that each of the analogues possess the
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`same backbone. While the Examiner will not extend the rejection to these compounds,
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`it
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`is not
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`predictable, nor is there guidance or working examples that derivatives other than non—fentanyl analogues
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`of paragraph [0043], or similarly structured compounds, would use the same backbone to achieve a size
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`of at least about 10 microns.
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`B.
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`Applicants addressed the potential rejection under 35 USC 112, first paragraph, regarding being
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`enabled only for various formulations. Since the clai111s are drawn only to compositions and not to
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`methods of treating, no rejection is being made. The issue would arise regarding methods of treating. It
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`appears from the specification that only certain concentrations of ETOH and PG would result in the
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`desired activity — in other words, altering these concentration/volumes, or substituting other compounds
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`for these, may result in an ineffective formulation (ETOH and PG can be considered “result—effective
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`variables”). Therefore, given the limited Working examples, it may not be predictable to a PI IOSITA how
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`to make and use the claimed formulations.
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`

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`Application/Control Number: 13/895,124
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`Art Unit: 1647
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`Page 3
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`4. Claim Rejections - 35 USC § 112, first paragraph — written description
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`A.
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`Claim 1 remains rejected for the reasons already of record on pages 3-4 of the Office Action
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`dated 1/10/14. Applicants‘ arguments and the EXaminer’s response is identical to that above regarding
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`enablement.
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`B.
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`Applicants addressed the potential rejection under 35 USC 112, first paragraph, regarding being
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`enabled only for various formulations. Their arguments, as well as the Examiner's response, is identical to
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`that above regarding enablement.
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`5. Claim Rejections - 35 USC § 112, second paragraph
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`The following is a quotation of 35 U.S.C. 112(b):
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`(b) CONCLUSION.—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.
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`The following is a quotation of 35 U.S.C. 112 (pre—AIA), second paragraph:
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`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.
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`A.
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`Claim 1 is confusing since it is drawn to a fentanyl formulation. However, the claim allows for
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`derivatives (including those of paragraph [0043]), which include compounds which are not fentanyl (e.g.
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`paragraph [0043] of the specification).
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`6. Claim Rejections - 35 USC § 102/103
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`A.
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`Claims 1 and 4 remain rejected under 35 USC 102/103 for the reasons already of record on page
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`8 of the Office Action dated 1/10/ 14. Applicants argue that the compositions of McCarty would not
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`necessarily form droplets with a mean diameter of at least about 10 microns. This argument has been
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`considered, but
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`is not deemed persuasive. Regarding the teaching of the nasal spray formulations,
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`Applicants argue that theses sprays are likely to have a smaller droplet size than those of the instant
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`invention. However, it is noted that it is possible for these sprays to contain droplets of at least about 10
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`microns. It is also noted that the claims recite "about 10 microns", which means that the droplet size could
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`

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`Application/Control Number: 13/895,124
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`Art Unit: 1647
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`Page 4
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`be less. If Applicants can provide evidence that nasal sprays (preferably opioid) commonly have a droplet
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`size below “about 10 microns” this rejection will be reconsidered.
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`B.
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`The rejections under Ross (2003) and Ross (2006) are withdrawn in View of Applicants’
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`arguments. However, new rejections under 35 USC 103 appear below.
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`7. Claim Rejections - 35 USC § 103
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`A.
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`Claims 1 and 4 are rejected under pre—AlA 35 U.S.C. 103(a) as being unpatentable over Ross
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`(US2003/0190290 — of record) in View of Whittle (U.S. Patent No. 6,946,150 - reference 7 on the 1449
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`dated 7/22/13). The claims and the teachings of Ross have been discussed previously. Applicants argue
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`that, while Ross teaches fentanyl formulations comprising ETOH and PG, the reference does not teach
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`discrete droplets of at least 10 microns.
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`However, Whittle does teach pharmaceutical formulations for sublingual use (colunm 2, lines 15-
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`17) and which have a droplet size of between 15 and 45 microns (column 4, lines 30-65). Whittle also
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`teaches the advantages of this droplet size as compared to those of 5-10 microns. The formulations of
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`Whittle also contain ETOH and PG (colunm 2, lines 35-40). The formulation of Whittle would inherently
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`produce opioids with the desired particle size ("at least about 10 microns”). Furthermore, the instantly
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`claimed ETOII/PG proportions are also taught by Whittle (colunm 5, lines 23-28). Therefore, Whittle
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`recognized ETOH and PG as result-effective variables.
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`B.
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`Claims 1 and 4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ross
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`(US2006/0062812 — of record) in view of Whittle. The claims, as well as the teachings of Ross and
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`Whittle have been discussed previously.
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`C.
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`Claims 1 and 4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McCarty
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`in view of Whittlc. The claims, as well as the teachings of Ross and Whittlc have been discussed
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`previously. In addition to that discussed above under 35 USC 102/103, Applicants further argue that
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`McCarty only exemplifies tablets. However, the disclosure does teach sublingual fentanyl formulations.
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`

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`Application/Control Number: 13/895,124
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`Art Unit: 1647
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`Page 5
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`This, combined with the teachings of Whittle, would provide the artisan with motivation of producing a
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`sublingual formulation with the desired droplet size.
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`8. Obviousness-Type Double Patenting
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`A.
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`All rejections are being held in abeyance as per Applicants’ request.
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`9. 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
`bc directed to Robert Landsman, Ph.D. Whosc 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 Landsmanl
`
`Primary Examiner, Art Unit 1647