EXHIBIT 1014 
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1014
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01797
`
`

`
`
`
`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.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`13/895,111
`
`05/15/2013
`
`S. George Kottayil
`
`INS10763P00101US
`
`1050
`
`32116
`7590
`11/21/2013
`WOOD, PHILLIPS, KATZ, CLARK&MORTIMER
`500 W. MADISON STREET
`SUITE 1 1 30
`CHICAGO, IL 60661
`
`LANDSMAN, ROBERT S
`
`1647
`
`PAPER NUMBER
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`11/21/2013
`
`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):
`
`docketing @Woodphillips.com
`
`PTOL—90A (Rev. 04/07)
`
`

`
`Application No.
`13/895,111
`
`App|icant(s)
`KOTTAYIL ET AL.
`
`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
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, 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)I:I Responsive to communication(s) filed on j
`I:I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`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
`
`; the restriction requirement and election have been incorporated into this action.
`
`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.
`
`Disposition of Claims
`5)IXI Claim(s) flis/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 III Claim s) j is/are allowed.
`s) E‘ is/are rejected.
`
`) _ is/are objected to.
`
`)_ 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
`
`
`
`://wwvv.us:>to. ow atents/init events/'
`if/index.‘$ orsend an inquiry to PPI--lfeedbackf,<%usj;)to.00)/.
`
`htt
`
`Application Papers
`
`10)IZI The specification is objected to by the Examiner.
`11)|Z| The drawing(s) filed on 5/15/13 is/are: a)lZl accepted or b)|: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).
`
`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)I:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`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
`
`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.
`
`Attach ment(s)
`
`1) E Notice of References Cited (PTO-892)
`3) D jntervjew summary (pTo-413)
`_
`_
`Paper No(s)/Mail Date. j
`2) E Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 7/22/13. 4) I:I Other‘ :-
`
`U.S. Patent and Trademark Office
`PTOL—326 (Rev. 08-13)
`
`Part of Paper No./Mail Date 20131116
`
`Office Action Summary
`
`

`
`Application/Control Number: 13/895,111
`
`Art Unit: 1647
`
`Page 2
`
`DETAILED ACTION
`
`The present application is being examined under the pre—AIA first to invent provisions.
`
`1. Formal Matters
`
`A.
`
`Claims 1-3 are pending and are the subject of this Office Action.
`
`2. Specification
`
`A.
`
`Trademarks should be capitalized wherever they appears and be accompanied by the generic
`
`terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature
`
`of the marks should be respected and every effort made to prevent their use in any manner which might
`
`adversely affect their validity as trademarks. Trademarks appear in at least paragraphs [00322], [00323]
`
`and [00325]. Trademarks are not even identified in [00330] and [0033l], for example.
`
`B.
`
`If applicable, the first line of the specification should be updated to reflect the status (e.g. “now
`
`U.S. Patent No.”, or “now abandoned”) of any parent applications. Similarly, though none could be
`
`found, any U.S. or Foreign Applications cited in the specification which have since issued should be
`
`updated with the corresponding Patent No.
`
`C.
`
`Though none could be found, any listing of references in the specification is not a proper
`
`information disclosure statement. 37 CFR l.98(b) requires a list of all patents, publications, or other
`
`information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be
`
`incorporated into the specification but must be submitted in a separate paper." Therefore, unless the
`
`references have been cited by the examiner on form PTO—892, they have not been considered.
`
`D.
`
`Though none could be found, Applicant is advised that embedded hyperlinks and/or other forms
`
`of browser—executable code are impermissible and require deletion. The attempt to incorporate subject
`
`matter into the patent application by reference to a hyperlink and/or other forms of browser—executable
`
`code is considered to be an improper incorporation by reference. See MPEP 608.0l(p), paragraph I
`
`regarding incorporation by reference.
`
`

`
`Application/Control Number: 13/895,111
`
`Art Unit: 1647
`
`Page 3
`
`E.
`
`Though no issues could be found, according to 37 CFR 1.821(d) (MPEP § 2422), Where the
`
`description or claims of a patent application discuss a sequence listing that is set forth in the "Sequence
`
`Listing" in accordance with paragraph (c) of this section, reference must be made to the sequence by use
`
`of the assigned identifier, in the text of the description or claims, even if the sequence is also embedded in
`
`the text of the description or claims of the patent application.
`
`F.
`
`The specification has not been checked to the extent necessary to determine the presence of all
`
`possible minor errors. Applicants’ cooperation is requested in correcting any errors of which Applicants
`
`may b6CO1T1€ E1WElI‘€
`
`.
`
`3. Claim Rejections - 35 USC § 112, first paragraph — scope of enablement
`
`The following is a quotation of 35 U.S.C. 112(a):
`
`(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and
`process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art
`to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best
`mode contemplated by the inventor or joint inventor of carrying out the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre—AIA), first paragraph:
`The specification shall contain a written description of the invention, and of the manner and process of making and
`using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or
`with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by
`the inventor of carrying out his invention.
`
`A.
`
`Claims 1-3 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while
`
`being enabling for the sublingual formulations of Table 50 (page 102 of the specification) (1) which are
`
`formulated for a spray and (2) which have the desired properties (and also limited a size of 10 microns),
`
`does not reasonably provide enablement for all formulations having said claimed properties. The
`
`specification does not enable any person skilled in the art to which it pertains, or with which it is most
`
`nearly connected, to make the invention commensurate in scope with these claims.
`
`In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404,
`
`the factors to be considered in
`
`determining whether a disclosure would require undue experimentation include (1)
`
`the quantity of
`
`experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence
`
`of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of
`
`those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
`
`

`
`Application/Control Number: 13/895,111
`
`Art Unit: 1647
`
`Page 4
`
`The breadth of the claims is excessive with regard to clain1ing all sublingual formulations having
`
`a Tmax of 1.28 +/— 0.60 hrs as Well as the claimed Cmax. Applicants have only provided guidance and
`
`working examples that the formulations disclosed in Table 50 (10 micron droplet size for use as a spray)
`
`act as claimed. Furthermore, given only this minimal guidance, is it predictable to one of ordinary skill in
`
`the art how to make other formulations which function as claimed.
`
`These factors lead the Examiner to hold that undue experimentation is necessary to practice the
`
`invention as claimed.
`
`4. Claim Rejections - 35 USC § 112, first paragraph — written description
`
`A.
`
`Claims 1-3 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which
`
`was not described in the specification in such a way as to reasonably convey to one skilled in the relevant
`
`art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
`
`These are genus claims. Applicants have only provided adequate written description that the
`
`formulations disclosed in Table 50 act as claimed (and are also limited a size of 10 microns for use as a
`
`spray). Other than the components and concentrations recited in Table 50, the specification and claims do
`
`not indicate what distinguishing attributes are shared by the members of the genus. Thus the scope of the
`
`claims includes numerous variants, and the genus is highly variant because a significant number of
`
`formulations genus members is permitted. The specification and claims do not provide any guidance as to
`
`What changes should be made to the formulations in Table 50.
`
`The general knowledge and level of skill in the art do not supplement the omitted description
`
`because specific, not general, guidance is what is needed. Since the disclosure fails to describe the
`
`common attributes or characteristics that identify members of the genus, and because the genus is highly
`
`variant, the formulations of Table 50, alone, are insufficient to describe the genus. One of skill in the art
`
`would reasonably conclude that the disclosure fails to provide a representative number of species to
`
`describe the genus. Thus, Applicant was not in possession of the claimed genus at the time the invention
`
`was made.
`
`

`
`Application/Control Number: 13/895,111
`
`Art Unit: 1647
`
`5. Claim Rejections - 35 USC § 102/103
`
`Page 5
`
`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 —
`
`(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.
`
`(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.
`
`The following is a quotation of pre—AIA 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 C0., 383 U.S. 1, 148 USPQ 459 (1966),
`
`that are applied for establishing a background for determining obviousness under pre—AIA 35 U.S.C.
`
`103(a) are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`2. Ascertaining the differences between the prior art and the claims at issue.
`3. Resolving the level of ordinary skill in the pertinent art.
`4. 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—AIA 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 CFR 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—AIA 35 U.S.C. 103(c) and potential pre—AIA 35
`
`U.S.C. 102(e), (f) or (g) prior art under pre—AIA 35 U.S.C. 103(a).
`
`

`
`Application/Control Number: 13/895,111
`
`Art Unit: 1647
`
`Page 6
`
`A.
`
`Claims 1-3 are rejected under pre—AIA 35 U.S.C. 102(e) as anticipated by or, in the alternative,
`
`under pre—AIA 35 U.S.C. 103(a) as obvious over McCarty (US 2007/0071806). The claims are drawn to
`
`sublingual formulations of fentanyl having various Tmax and Cmax values.
`
`McCarty teaches sublingual fentanyl formulations which include xylitol and propylene glycol as
`
`well as other alcohols (e.g. paragraphs [0002], [0035], [0093]). McCarty is silent with regard to Tmax and
`
`Cmax values.
`
`However, since the Office does not have the facilities for examining and comparing applicants‘
`
`formulation with the formulation of the prior art, the burden is on applicant to show a novel or unobvious
`
`difference between the claimed product and the product of the prior art (i.e., that the formulation of the
`
`prior art does not possess the same functional (and potentially structural) characteristics of the claimed
`
`formulation). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray, 10 USPQ
`
`2d 1922 1923 (PTO Bd. Pat. App. & Int.).
`
`Even if McCarty does not meet the limitations of the instant invention under 35 USC 103, it
`
`would have still been obvious at the time of the instant invention to have optimized the conditions to
`
`provide a formulation with a rapid/desired onset of action to reduce pain as quickly as possible. Where 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, 454, 105 USPQ 223,235, (CCPA
`
`1955)
`
`B.
`
`Claims 1-3 are rejected under pre—AIA 35 U.S.C. 102(b) as anticipated by or, in the alternative,
`
`under pre—AIA 35 U.S.C. 103(a) as obvious over Ross (US 2003/01900290). The claims are drawn to
`
`sublingual formulations of fentanyl having various Tmax and Cmax values. Ross teaches sublingual
`
`fentanyl formulations (e.g. Abstract, paragraphs [0003], [0015], page 3). Ross is silent with regard to
`
`Tmax and Cmax values.
`
`However, since the Office does not have the facilities for examining and comparing applicants‘
`
`formulation with the formulation of the prior art, the burden is on applicant to show a novel or unobvious
`
`difference between the claimed product and the product of the prior art (i.e., that the formulation of the
`
`prior art does not possess the same functional (and potentially structural) characteristics of the claimed
`
`formulation). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray, 10 USPQ
`
`2d 1922 1923 (PTO Bd. Pat. App. & Int.).
`
`

`
`Application/Control Number: 13/895,111
`
`Art Unit: 1647
`
`Page 7
`
`Even if Ross does not meet the lin1itations of the instant invention under 35 USC 103, it would
`
`have still been obvious at the time of the instant invention to have optimized the conditions to provide a
`
`formulation with a rapid/desired onset of action to reduce pain as quickly as possible. Where 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, 454, 105 USPQ 223,235, (CCPA 1955)
`
`6. 0bviousness- Type Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in
`public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise
`extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple
`assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue 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 Van Ornum, 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 CFR 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 reference 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. A
`terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
`The USPTO internet Web site contains terminal disclaimer forms which may be used. Please
`visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be
`used. A web—based eTern1inal Disclaimer may be filled out completely online using web—screens. An
`eTern1inal Disclaimer that meets all requirements is auto—processed and approved immediately upon
`submission.
`For
`more
`information
`about
`eTern1inal
`Disclaimers,
`refer
`to
`
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD—info—I.jsp.
`
`A.
`
`Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable
`
`over claims 1-3 of U.S. Patent No. 8,486,972. Although the claims at issue are not identical, they are not
`
`patentably distinct from each other because both sets of claims are drawn to sublingual fentanyl
`
`formulations.
`
`B.
`
`Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable
`
`over claims 1-20 of U.S. Patent No. 8,486,973. Although the claims at issue are not identical, they are not
`
`patentably distinct from each other because the instant claims are drawn to sublingual fentanyl
`
`

`
`Application/Control Number: 13/895,111
`
`Art Unit: 1647
`
`Page 8
`
`formulations, whereas the patent claims are drawn to methods of using these formulations. It would have
`
`been obvious at the time of the instant invention to have used the instant formulations since that is the
`
`disclosed intention, and a cornerstone of drug formulation.
`
`It is noted that the instant application is not a DIV of the patent (86 USPQ2d 1001 (Pfizer Inc. V.
`
`Teva Pharmaceuticals USA Inc.), U.S. Court of Appeals Federal Circuit, No. 2007-1271, Decided March
`
`7, 2008, 518 F3d 1353) and does, therefore, not receive safe harbor.
`
`7. Note
`
`A.
`
`It is noted that the parent application, 11/698,739 (to which the instant application is a CON)
`
`recites a Tmax of as low as 5 n1inutes. This falls outside the range of the instant claims, which would be
`
`as low as approximately 40 n1inutes (76 n1inutes — 36 n1inutes). However,
`
`it appears that both
`
`specifications disclose the same formulations.
`
`8. Conclusion
`
`A.
`
`No claim is allowable.
`
`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/
`
`Primary Examiner, Art Unit 1647