page 2801
`
`:
`.
`Watanabe_2000_Antibacterial
`Carbohydrate_Monoesters.pdf Idafe1b4450d02d4b7e581a012e6e526591
`C1174
`
`Non Patent Literature
`
`Non Patent Literature
`
`Weber_1984_Metabolism_of_o
`rally_.pdf
`
`1325054
`
`891474d8dd 14f335 1acd4b067c3dc9ebb9ey
`1f408
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2801
`
`Non Patent Literature
`
`Stevens_1995_Use_of_Glucago
`n_to_Treat_Neonatal.pdf
`
`594ca9f894.ea685 17f5 10f4f9db35ff1 df2505}
`be
`
`2095868
`
`Non Patent Literature
`
`Swabrick_2002_Encyclopedia_
`of_Pharmaceutical_Technolog
`y_.pdf
`
`281910
`
`ba76e
`550bdc1b2868a61207bd6589fbofd7casd09
`
`Non Patent Literature
`
`Tsuchido_1987_Lysis_of_Bacill
`us_subtilis_Cells_by_Glycerol.
`pdf
`
`3166784
`
`d39f
`a357d422b05fce1 6bfaf80f6b166989ea2d1
`
`Non Patent Literature
`
`Turker_2004_Nasal_route_and
`_drug_.pdf
`
`875630
`
`1be06a1417a09125decec785bd82ae5abb
`bd052c
`
`Non Patent Literature
`
`Turton_1996_A_role_for_gluca
`gon_like_.pdf
`
`1073961
`
`8deb1d2bc5e294c8f7d5 1965073 19b18c3al
`35564
`
`Non Patent Literature
`
`US13495942_OA_10ct2013.pdf
`
`546105
`
`dede09f83a1dd271f69e61 8ed8f26b9d798
`323ad
`
`Non Patent Literature
`
`Vidal_2005_Making_sense_of_
`:
`antisense_.pdf
`
`1315281
`
`0b941198eca4158c56abcece7b1943c46ce
`bb8e4
`
`2614493
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`

`

`Non Patent Literature
`
`Webpage_for_Anatrace_produ
`cts_ofAffymetrix_.pdf
`
`251292
`
`65cc6b535506c2b21 7edf91061dfaced74e1}
`bda2
`
`Information:
`
`Information:
`
`Non Patent Literature
`
`Yamamoto_1989_The_Ocular_
`Route_for_Systemic_Insulin_D
`elive ry. pdf
`
`5620625
`
`44de
`8c5158d55c3044989bf2F400bf69e8739046
`
`Non Patent Literature
`
`.
`.
`,
`Yu_Xinrui_2001_Triptan_Medic
`ament_and_.pdf
`
`973047
`
`2b529955d48494acc7547d8790ec7f368be
`29953
`
`the application.
`
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105)will be issued in due course, subject to prescriptions concerning
`national security, and the date shownon this AcknowledgementReceiptwill establish the international filing date of
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`This AcknowledgementReceipt evidences receipt on the noted date by the USPTOofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable.It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
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`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shownonthis
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`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2802
`
`page 2802
`
`

`

`
`
`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.
`
`
`
`
`CONFIRMATIONNO.
`
`12/413,439
`
`03/27/2009
`
`Steve Cartt
`
`35401-716.201
`
`9049
`
`21971
`
`7590
`
`06/19/2014
`
`WILSON, SONSINI, GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`MILLIGAN, ADAM C
`
`ART UNIT
`
`1612
`
`PAPER NUMBER
`
`
`
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/19/2014
`
`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):
`patentdocket@ wsgr.com
`
`PTOL-9OA @ev. 407)
`
`AQUESTIVE EXHIBIT 1007 page 2803
`AQUESTIVE EXHIBIT 1007
`page 2803
`
`

`

`
`Application No.
`Applicant(s)
`12/413,439
`CARTT ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`ADAM C. MILLIGAN
`1612
`No
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
`Period for Reply
`
`Office Action Summary
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 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, evenif 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
`1) Responsive to communication(s) filed on 5/21/2012.
`L] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filedon___
`2a)L] This action is FINAL.
`2b)X] This action is non-final.
`3)L] An election was made bythe applicant in responseto a restriction requirementset forth during the interview on
`
`; the restriction requirement and election have been incorporated into this action.
`4)L] Sincethis application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordancewith the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
` 9
`
`Disposition of Claims*
`
`5)K] Claim(s) 20-24,27-36,38 and 40-53 is/are pending in the application.
`
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6)L] Claim(s)___is/are allowed.
`
`7) Claim(s) 20-24,27-36,38 and 40-53 is/are rejected.
`8)L] Claim(s)___ is/are objectedto.
`
`9)L] Claim(s)
`are subjectto 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
`nito:/www. uspte.dovi
`
`atenis/init events/peh/index.jsp or send an inquiry to PPHfeedback@uspto.dov.
`
`
`
`
`
`
`Application Papers
`10) The specification is objected to by the Examiner.
`
`11) The drawing(s) filed on
`is/are: a)[_] accepted or b)[_] 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)L] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)LJ All
`b)[] Some** c)L] None ofthe:
`1.) Certified copies of the priority documents have been received.
`2.L] Certified copies of the priority documents have been received in Application No.
`3.L] Copies of the certified copies of the priority documents have been receivedin 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)
`1) C Notice of References Cited (PTO-892)
`;
`;
`2) X Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 79(11/16/2012), 3pgs(4/15/2013),
`'s (10/29/20 13).
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`;
`;
`Office Action Summary
`
`3) TC Interview Summary (PTO-413)
`Paper No(s)/Mail Date.
`Oo Other
`AQUESTIVE EXHIBIT 1007 page 2804
`AQUESTIVE EXHIBIT 1007pateARse 2804
`Part of Paper No
`610
`
`

`

`Application/Control Number: 12/413,439
`Art Unit: 1612
`
`Page 2
`
`The present application is being examined underthe pre-AlA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`A requestfor continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), wasfiled in this application after final rejection. Since this
`
`application is eligible for continued examination under 37 CFR 1.114, and the fee set
`
`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
`
`5/21/2012 has been entered.
`
`Applicants’ arguments, filed 5/21/2012, have been fully considered. Rejections
`
`and/or objections notreiterated from previous office actions are hereby withdrawn. The
`
`following rejections and/or objections are either reiterated or newly applied. They
`
`constitute the complete set presently being applied to the instant application.
`
`Claim Rejections — 35 U.S.C. § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousnessrejections setforth in this Office action:
`
`(a) A patent maynot be obtained though the invention is not identically disclosed or described as
`set forth in section 102 ofthistitle, 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 obviousat the time the
`invention was made to a person having ordinaryskill 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 asfollows:
`
`1.
`
`Determining the scope and contentsof the prior art.
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2805
`
`page 2805
`
`

`

`Application/Control Number: 12/413,439
`Art Unit: 1612
`
`Page 3
`
`2.
`3.
`4.
`
`Ascertaining the differences betweenthe prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinentart.
`Considering objective evidence presentin the application indicating
`obviousness or nonobviousness.
`
`This application currently namesjoint inventors.
`
`In considering patentability of
`
`the claims under 35 U.S.C. 103(a), the examiner presumesthat the subject matter of
`
`the various claims was commonly ownedat the time any inventions covered therein
`
`were made absent any evidenceto the contrary.
`
`Claims 20-24, 27-36, 38 and 40-53 are rejected under 35 U.S.C. 103(a) as
`
`being unpatentable over Lehat (Intranasal midazolam for childhood seizures, The
`
`Lancet, vol.352, August 22, 1998 — See IDS dated 10/29/2013) in view of Sonne (U.S.
`
`6,193,985- See IDS dated 9/16/2009) and Meezan (U.S. 2006/0046962).
`
`Lehat teaches diazepam is widely usedto treat acute seizures in adults and
`
`children and that intranasal administration of benzodiazepine compounds has been
`
`demonstrated as an effective way to manage acute childhood seizures (Abstract).
`
`Lehat does not teach suitable excipients for the formulation.
`
`Sonne teaches tocopherol compositions for the delivery of biologically active
`
`agents which are only sparingly soluble in water (col. 1, lines 7-13), such as diazepam
`
`(col. 1, lines 7-14). One particular nasal formulation contains 5g of diazepam, 44 g
`
`Tenox GT2 (70%tocopherol), 5 g Vitamin E TPGS, 1.45 g Pluronic and 0.1g
`
`benzalkonium chloride (example 1 at col. 7, lines 32-45). In preparing the formulation,
`
`the ingredients are heated slowly until a homogeneous phaseis achieved (Sonnealso
`
`teaches that co-solvent such as ethanol, benzyl alcohol, sesame oil or propylene glycol
`
`can be usedin orderto optimize the formulations bioadhesion, sprayability and viscosity
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2806
`
`page 2806
`
`

`

`Application/Control Number: 12/413,439
`Art Unit: 1612
`
`Page 4
`
`(col. 6, lines 47-53). When ethanol is used in the formulations, it may be used in an
`
`amountof about 11% by weight of the formulation (See example 3 at col.8, lines 28-43).
`
`When sesame oil is used, it may be used in an amountof about 44% (example18,
`
`col12, lines 37-51) or about 60% (example 16 at col.12, lines 10-17). a-tocopherol may
`
`be used in amountsof 20 to 99.9%(col.5, lines 56-61). The active ingredient should be
`
`present in an amountof 0.001%to 40%(col.5, lines 55-61). Diazepam maybe present
`
`at about 5% by weight (example 11 at col. 11, lines 1-13). Preservative as well as odor
`
`masking compounds maybeincludedin the (col.7, lines 4-12). The composition may be
`
`in the form of a spray formulation (col. 6, lines 28-35). In general, administration to the
`
`nose can bedifficult because of the limited volume which is acceptable for the nose,
`
`which is about 100uL (col.7, lines 25-30). Sonne teaches that the “compositions of the
`
`invention may be used directly as a solution of bioactive agents in the tocopherol
`
`solvent”(col.3, lines 60-61) and that the "[vJiscosity can be reduced by the addition of
`
`co-solvents such as ethanol (col.3, lines 65-66). Sonne teachesthat “transmucosal
`
`delivery is preferred” (col.3, line 54) and "[njasal...administrations are particularly
`
`preferred” (col.3, lines 58-59). The compositions of the invention may contain from 1-
`
`99.99% tocopherol (col.5, lines 55-57). Sonne also teachesthat a co-solvent such as
`
`ethanol can be usedin order to optimize the formulations bioadhesion, sprayability and
`
`viscosity (col. 6, lines 47-53). When ethanol is used in the formulations, ethanol may be
`
`present in an amountof about 11%by weight of the formulation (See e.g. example 3 at
`
`col.8, lines 28-43). Thus, one of ordinary skill in the art would have foundit obvious to
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2807
`
`page 2807
`
`

`

`Application/Control Number: 12/413,439
`Art Unit: 1612
`
`Page 5
`
`nasally administer a composition that contains only tocopherol or tocotrienol, an alcohol
`
`and optionally one or more alkyl glycosides.
`
`Sonne does not teach the addition of a alkyl glycoside in an amountfrom 0.01%
`
`to 1%.
`
`Meezan teachesthat alkyl glycosidase is an absorption enhancerfor drug
`
`administration (150). Specifically, Meezan demonstrates that the addition of 0.25%of
`
`alkyl glycoside can increase drug absorption from about 3%bioavailabilty to about 90%
`
`bioavailability when the drug is administered via a nasal spray. Meezanfurther teaches
`
`that the active ingredient for the nasal spray maybe in the form of nanoparticles (63).
`
`Meezan does not teach using a benzodiazapine active ingredient.
`
`It would have been obvious to one of ordinary skill in the art treating seizures by
`
`oral administration of benzodiazepines as taught by Lehat to administer the drug ina
`
`benzodiazepine nasal formulation such as that taught by Sonne. In doing so, it would
`
`have been obvious adminsiter the formulation as nanoparticles comprising alkyl
`
`glycoside in order to increase absorption, and thus the bioavailability, of the active
`
`ingredient as taught by Meezan.
`
`Applicants presentthe following arguments againstthe rejection.
`
`Applicants argue that because the instant claims are to a solution which excludes
`
`water and oil.
`
`Examiner disagrees. A solution can be one phase of a composition which
`
`comprises multiple phases such as the emulsion compositions exemplified by Sonne.
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2808
`
`page 2808
`
`

`

`Application/Control Number: 12/413,439
`Art Unit: 1612
`
`Page 6
`
`The instant claims recite a method of treating...comprising...administering... a
`
`pharmaceutical solution... consisting of... 1 to 20 mg of a benzodiazepine drug, one or
`
`more natural or synthetic tocopherols or tocotrienols... one or more alcohols or glycols,
`
`... and one or more alkyl glycosides. Thus, while the solution is limited by the phrase
`
`“consisting of’, the use of the term “comprising” permits additional steps in the method.
`
`Such additional steps could include, for example, administration of an oil or water
`
`phase. Thus, the instant claims do not exclude the presence of water and oil as
`
`Applicants have alleged.
`
`Applicants argue that Sonne is silent with regard to treating a person having a
`
`seizure disorder, and thus one of ordinaryskill in the art would not be motivated to use
`
`the composition of Sonne to treat a person having a seizure disorder.
`
`Examiner disagrees. The rejection is not based on one reference alone, but a
`
`combination of references. Here, Lehatis relied upon for supplying the motivation to
`
`administer a benzodiazepine to a patient having a seizure disorder.
`
`Applicants argue that one of ordinary skill in the art would have no motivation to
`
`combine Sonne with Meezan. Since Sonnealready teachesthe inclusion of viatmin E, a
`
`penetration enhancer, a skilled artisan practicing the method of Sonne would have no
`
`reason to look anywhereelse for penetration enhancers.
`
`Examiner disagrees. While Sonne teachesthat penetration enhancers may be
`
`included in the formulation, Sonne does not specifically state that they improve
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2809
`
`page 2809
`
`

`

`Application/Control Number: 12/413,439
`Art Unit: 1612
`
`Page 7
`
`absorption. Meezan teachesthat the inclusion of an alkyl glycoside can drastically
`
`improve absorption. Thus, one of ordinary skill in the art making the formulation of
`
`Sonne would find it obvious to include an alkyl glycoside in order to improve the
`
`absorption as taught by Meezan.
`
`Conclusion
`
`No claims are allowed.
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to ADAM MILLIGAN whosetelephone numberis (571)270-
`
`7674. The examiner can normally be reached on M-F 9:00-5:00 EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Fred Krass can be reached on (571)272-0580. The fax phone numberfor
`
`the organization wherethis 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 accessto 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 automatedinformation
`
`system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/ADAM C MILLIGAN/
`
`Primary Examiner, Art Unit 1612
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2810
`
`page 2810
`
`

`

`
`
`
`repre}ReNTR|oO
`S- 2004-0115135 Al
`6/17/2004
`aic
`12.|Us. 2004-0126358 Al
`PB.
`BR]
`ale S- 2004-0147473Al
`| S- 2004-0258663 Al
`__|
`US-2004-141923 Al
`alr
`ale
`x}
`ale
`NLR©]oO
`
`|||||||||||
`
`twN&Ne) wn
`
`—
`
`wo
`
`S- 2006-0147386 Al
`
`07-06-2006
`
`S- 2007-0059254 Al
`
`S- 2007-0098805 Al
`
`S- 2007-0298010 Al
`
`S- 2008-0268032 Al
`||26.|US- 2009-0258865Al|10/15/2009|Carttetal|
`Cc
`||27.|us-2010-0203119Al8/12/2010[Leaneetal|
`dam
`Miliga
`Cotered
`06/11/2014
`Examiner
`/Adam Millaan/
`Date
`;
`*EXAMINER:Initialifreference considered, whether or not citation is in conformance with MPEP 609. Draw line through citationifnot in conformance and not considered. Include copy
`ofthis form with next communication to applicant.
`'Applicant’s uniquecitation designation number(optional). "See Kinds Codes ofUSPTO Patent Documentsat www.usoto.gov or MPEP
`901.04. *Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). “For Japanese patent documents, the indication ofthe year ofthe reign ofthe Emperor must
`precedethe serial numberofthe patent document. *Kind of document by the appropriate symbolsas indicated on the document under WIPO Standard ST.16 ifpossible. °Applicantis to place a
`check mark here ifEnglish language Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public whichis to file (and by the USPTO to process) an
`application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering, preparing, and submitting the
`completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount oftime you require to complete this form and/or suggestions for
`reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`ifyou need assistance in completing theform, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`Attorney Docket No. 35401-716.201
`
`-1l-
`
`ALL REFERENCES CONSIDERED FE MUARSSWHE BRHIRET007 R@abse eBITA.M_/
`
`AQUESTIVE EXHIBIT 1007 page 2811
`
`US- 2003-0170206 Al
`
`S- 2005-0130260 Al
`
`6/16/2005
`
`US- 2005-0234101 Al
`S- 2006-0045869 Al
`
`S- 2006-0046969 Al
`
`S- 2006-0106227Al
`
`03/02/2006
`
`PTO/SB/08a (07-09)
`Approved for use through 07/3 1/2012. OMB 0651-0031
`USS. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons required to respond to a collection of information unless it contains a valid OMB control number.
`Complete ifKnown
`12/413,439
`03/27/2009
`Steve Cartt
`Art Unit
`1612
`Examiner Name
`Milligan, Adam C.
`|Sheet=|1dfof| Attorney Docket Number|35401-716.201
`
`Substitute for form 1449/PTO
`INFORMATION DISCLOSURE
`STATEMENTBY APPLICANT
`(Use as many sheets as necessary)
`
`Application Number
`Filing Date
`
`Examiner
`
`Cite
`No.!
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`
`Document Number
`Number-Kind Code‘ (ifknown)
`S-2002-0110824 Al
`
`U.S. PATENT DOCUMENTS
`Publication Date
`Nameof Patentee or
`
`Pages, Columns, Lines, Where
`RelevantPassages or Relevant
`Figures Appear
`
`ia
`
`S- 2002-0141971 Al
`
`S- 2003-0017203 Al
`
`6/23/2003
`
`S- 2003-0040497 Al
`
`S- 2003-0087820 Al
`
`S- 2003-0100755 Al
`
`5/29/2003
`
`S- 2003-0118547 Al
`
`S- 2003-0118594 Al
`
`S- 2003-0158206 Al
`
`|||||||||||||
`
`GIaelcicic|cicicicic
`
`___|
`
`-_|
`
`

`

`U.S. PATENT DOCUMENTS
`Publication Date
`Nameof Patentee or
`
`Document Number
`Number-Kind Code® (ifknown)
`S- 2010-0209485 Al
`
`8/19/2010
`
`Pages, Columns, Lines, Where
`RelevantPassages or Relevant
`Figures Appear
`
`Cite
`No.!
`No oO
`ny|S
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`wo]GoBY]vw
`we“|:
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`Ww]Go]GoSy=|s:
`Wo}Go}Go]GoSO]90]I]S
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`12/15/1970
`11/19/1974
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`Catsimpoolaset al
`
`Radhakrishnanet al
`
`Shoji et al
`
` a
`
`
`PTO/SB/08a (07-09)
`Approved for use through 07/3 1/2012. OMB 0651-0031
`USS. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons required to respond to a collection of information unless it contains a valid OMB control number.
`Complete ifKnown
`12/413,439
`03/27/2009
`Steve Cartt
`Art Unit
`1612
`Examiner Name
`Milligan, Adam C.
`|Sheet=|2ofof| Attorney Docket Number|35401-716.201
`
`Substitute for form 1449/PTO
`INFORMATION DISCLOSURE
`STATEMENTBY APPLICANT
`(Use as many sheets as necessary)
`
`Application Number
`Filing Date
`
`Examiner
`Initials*
`
`|||p
`
`e|||p
`
`e||
`
`S- 3,547,828
`S- 3,849,341
`S- 4,397,951
`5/31/1988
`S- 4,748,158
`9/1/1989
`S- 4,868,289
`5/1/1990
`S- 4,921,838
`1/1/1993
`S- 5,182,258
`3/3/1993
`S- 5,192,528
`U
`8/17/1993
`S- 5,236,707
`| U
`12/7/1993
`S- 5,268,461
`pe U
`5/3/1994
`S- 5,308,531
`||40.|us-5,317,010
`5/31/1994
`S- 5,317,010
`| U
`—
`S- 5,369,095
`11/29/1994
`| U
`WS
`S- 5,550,220
`8/27/1996
`pe
`S- 5,639,733
`6/17/1997
`zBFY!
`S- 5,661,130
`8/26/1997
`ayo
`S- 5,738,845
`4/14/1998
`S- 5,789,375
`8/4/1998
`PIN
`
`S- 5,795,896 8/18/1998|Léfroth et al
`
`S- 5,814,607 9/29/1998|John S. Patton
`A©
`S- 5,817,634
`10/1/1998
`wa
`S- 5,955,425
`9/21/1999
`S- 6,004,574
`12/21/1999
`wn
`S- 6,254,854
`wa we
`aqic
`__|
`US- 6,316,410
`54.|US- 6,395,300|5/28/2002|Straubetal|Cd
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`|55.|us-6,482,834|9/20/2001|Spada,APcta.|
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`a|c
`
`Cc
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`Examiner
`
`Agi44}
`:
`Arar Maiti
`06/11/2014
`‘Adam Milligan/
`*EXAMINER:Initialifreference considered, whether or not citation is in conformance with MPEP 609. Draw line through citationifnot in conformance and not considered. Include copy
`ofthis form with next communication to applicant.
`'Applicant’s uniquecitation designation number(optional). "See Kinds Codes ofUSPTO Patent Documentsat www.usoto.gov or MPEP
`901.04. *Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). “For Japanese patent documents, the indication ofthe year ofthe reign ofthe Emperor must
`precedethe serial numberofthe patent document. *Kind of document by the appropriate symbolsas indicated on the document under WIPO Standard ST.16 ifpossible. °Applicantis to place a
`check mark here ifEnglish language Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public whichis to file (and by the USPTO to process) an
`application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering, preparing, and submitting the
`completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount oftime you require to complete this form and/or suggestions for
`reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`ifyou need assistance in completing theform, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`Date
`
`Attorney Docket No. 35401-716.201
`
`-2-
`
`ALL REFERENCES CONSIDERED FE QUARSSWHE BRHIRET007 R@abe 2B12A.M_/
`
`AQUESTIVE EXHIBIT 1007 page 2812
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/3 1/2012. OMB 0651-0031
`USS. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons required to respond to a collection of information unless it contains a valid OMB control number.
`Complete ifKnown
`12/413,439
`03/27/2009
`Steve Cartt
`Art Unit
`1612
`Examiner Name
`Milligan, Adam C.
`|Sheet=|3Cfof| Attorney Docket Number|35401-716.201
`
`Substitute for form 1449/PTO
`INFORMATION DISCLOSURE
`STATEMENTBY APPLICANT
`(Use as many sheets as necessary)
`
`Application Number
`Filing Date
`
`Cite
`
`Examiner
`
`U.S. PATENT DOCUMENTS
`Pages, Columns, Lines, Where
`Publication Date
`Nameof Patentee or
`RelevantPassages or Relevant
`MM-DD-YYYY
`Document Number
`Figures Appear
`Number-Kind Code® (ifknown)
`
`||56.|US-6,495,498|12/17/2002|Niemiecetal.|
`P|57.|us-6,524,557|2/25/2003|Backstrometal.|
`|58.|Us-6,794,357_|9/21/2004|Backstrometal.|
`||59.|us-6,932,962 8/23/2005|Backstrometal.|
`|60.us-6,991,785|1/31/2006|WilliamFrey,|
`|ot.|US-8530,463foptov2013|Cant
`
`Examiner
`Initials*
`
`Cite
`No.!
`
`Foreign Patent Document
`
`FOREIGN PATENT DOCUMENTS
`Publication Date
`Nameof Patentee or
`MM-DD-YYYY
`Applicant of Cited Document
`
`Pages, Columns, Lines,
`Where Relevant
`
`
`
`tttis|
`
`(ifknown) ae PassagesOF}Relevant
`a CountryCode’—Number’—KindCode’
`SYtiowermarinaLeo|
`Tress|sano[cowie|
`ON[tstecrmcims|sano|Roovowe [
`Abstract and Claims) 6/14/1989|KOGYO KK
`
`6[WO-1991-019481|1296/1991[ALLERGANING|
`
`
`
`EP-0396777 Al 11/14/1990|COLTD
`
`
`
`EP-1417972 Al 5/12/2004|COMPANY
`
`
`
`WO-1994-05262 Al 3/17/1994|LTD.
`UAB RESEARCH
`FOUNDATION
`1/5/1995
`WO-1995-000151 Al
`—
`
`68.|WO-1995-31217 Al 11/23/1995
`RECORDATIS.A.
`CHEMICAL AND
`PHARMACEUTICAL
`COMPANYET AL.
`BESINS
`WO-2003-055464 07/10/2003|INTERNATIONAL
`BELGIQUEET AL.
`
`WO-2000-001390 Al
`
`01/13/2000
`
`
`
`Examiner
`
`;
`f
`AATHT
`nen
`06/41/2014
`/Adam Milligan:
`*EXAMINER:Initialifreference considered, whether or not citation is in conformance with MPEP 609. Draw line through citationifnot in conformance and not considered. Include copy
`
`ofthis form with next communication to applicant.
`'Applicant’s uniquecitation designation number(optional). "See Kinds Codes ofUSPTO Patent Documentsat www.usoto.gov or MPEP
`901.04. *Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). “For Japanese patent documents, the indication ofthe year ofthe reign ofthe Emperor must
`precedethe serial numberofthe patent document. *Kind of document by the appropriate symbolsas indicated on the document under WIPO Standard ST.16 ifpossible. °Applicantis to place a
`check mark here ifEnglish language Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public whichis to file (and by the USPTO to process) an
`application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering, preparing, and submitting the
`completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount oftime you require to complete this form and/or suggestions for
`reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`ifyou need assistance in completing theform, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`Date
`
`Attorney Docket No. 35401-716.201
`
`-3-
`
`ALL REFERENCES CONSIDERED FE QUARSSIWHE BRHIRBT007 R@abe 2B1ZA.M_/
`
`AQUESTIVE EXHIBIT 1007 page 2813
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/3 1/2012. OMB 0651-0031
`USS. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons required to respond to a collection of information unless it contains a valid OMB control number.
`Complete ifKnown
`12/413,439
`03/27/2009
`
`Application Number
`
`Substitute for form 1449/PTO
`INFORMATION DISCLOSURE
`STATEMENTBY APPLICANT
`(Use as many sheets as necessary)
`
`1612
`Milian, Adan
`|Sheet=|4ofof| Attorney Docket Number|35401-716.201
`
`Examiner
`Initials*
`
`Cite
`No.!
`
`Foreign Patent Document
`
`Country Code* — Number’ — Kind Code’
`
`(ifknown)
`
`FOREIGN PATENT DOCUMENTS
`Publication Date
`Nameof Patentee or
`MM-DD-YYYY
`Applicant of Cited Document
`
`Pages, Columns, Lines,
`Where Relevant
`pp
`Passages Or Relevant
`
`TRANSORAL
`71.
`03/03/2005|PHARMACEUTICALS,
`WO-2005-018565 A2
`INC.
`WO-2008-027395 A2
`Jazz Pharmaceuticals
`
`3/6/2008
`
`72.
`
`
`
`73. 10/01/2009|Particle Sciences Inc.WO-2009-120933 A2
`
`
`
`Examiner
`Initials*
`
`J
`
`79.
`
`NON PATENT LITERATURE DOCUMENTS
`Include nameofthe author (in CAPITAL LETTERS),title of the article (when appropriate), title of the
`item (book, magazine, journal, serial, symposium, catalog,etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`Ahsanetal., "Effects of the permeability enhancers, tetradecylmaltoside and dimethyl-
`B-cyclodextrin, on insulin movement acress human bronchial epithelial cells", European
`Journal of Pharmaceutical. Sciences, 2003; 20: 27-34
`Ahsanetal., "Sucrose cocoate, a component of cosmetic preparations enhances nasal
`and ocular peptide absorption", Int J Pharm, 2003; 251: 195-203
`Albert et al., "Pharmacokinetics of diphenhydramine in man", J. Pharmacokinet,
`Biopharm., 3(3):159-170 (1975)
`Arnold et al., "Correlation of tetradecylmaltoside induced increases in nasal peptide
`drug delivery with morphological changes in nasal eithelial cells", J. Pharm. Sci.
`93(9):2205-2213 (2004)
`
`Beam etal., "Blood, Brain, Cerebrospinal Fluid Concentrations of Several Antobiotics
`in Rabbits with Intact and Inflamed Meninges", Antimicrobal Agents and
`Chemotherapy, December 1977, pp 710-716
`
`
`
`|||eathecion:pp12GoorySSaPeeelensCalbiochem, pp. 1-42 (2001)
`pS|Birkett et al., "Bioavailability and First Pass Clearance", Australian Prescriber, 1991,
`
`82.
`
`Examiner
`
`Date
`
`pp. 14-16, Vol. 14
`Birkett et al., "How Drugs are Cleared by the Liver", Australian Prescriber, 1990, pp.
`88-89, Vol. 13, No. 4
`ion
`4
`Winan/
`{
`06/11/2014
`jAdam Milligan
`*EXAMINER:Initialifreference considered, whether or not citation is in conformance with MPEP 609. Draw line through c