Non Patent Literature
`
`Stevens_1995_Use_of_G|ucago
`n_to_Treat_Neonata|.pdf
`
`594ca9f894ea68517f510f4f9db35ff1df2505
`be
`
`2095868
`
`Non Patent Literature
`
`Swabrick_2002_Encyc|opedia_
`of_Pharmaceutica|_Techno|og
`y_. pdf
`
`281910
`
`ba76e
`550bdc1b2868a61207bd6589fbfd7ca5d09
`
`
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Information:
`
`Non Patent Literature
`
`Tsuchido_1987_Lysis_of_Baci||
`us_subti|is_Ce||s_by_G|ycero|.
`pdf
`
`3166784
`
`d39f
`a357d422b05fce16bfaf80f6b166989ea2d1
`
`Non Patent LIterature
`
`Tu rker_2004_Nasa|_route_and
`_drug_.pdf
`
`1be06a1417a09125decec785bd82ae5abb
`bd052c
`
`875630
`
`Non Patent LIterature
`
`Turton_1 996_A_ro|e_for_g|uca
`gon_|ike_.pdf
`
`8deb1d2bc5e294c8f7d5196507319b18c3a
`35564
`
`1073961
`
`Non Patent Literature
`
`US13495942_OA_10ct2013.pd‘ dede09f83a1dd271f69e618ed8f26b9d798
`323ad
`
`546105
`
`Non Patent Literature
`
`Vidal_2005_Making_sense_of_
`.
`antlsense_.pdf
`
`013941 198eca4158c56abcece7b1943c46ce
`bb8e4
`
`1315281
`
`Non Patent Literature
`
`.
`.
`Watanabe_2000_AntIbacterial
`Carbohyd rate_Monoesters.pdf 1dafe1b4450d02d4b7e581a012e6e526591
`(1 174
`
`2614493
`
`Non Patent Literature
`
`Weber_1984_Metabolism_of_o
`ra||y_.pdf
`
`891474d8dd14f3351acd4b067c3dc9ebb9 -
`1f408
`
`1325054
`
`Information:
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2801
`
`page 2801
`
`

`

`Non Patent LIterature
`
`Webpage_for_Anatrace_produ
`cts_of_Affymetrix_.pdf
`
`65cc6b535506c2b217edf91061df4ced74el
`bdaZ
`
`251292
`
`Non Patent Literature
`
`Yamamoto_1989_The_Ocu|ar_
`Route_for_Systemic_|nsulin_D
`e I ive ry. pdf
`
`5620625
`
`44de
`8:5158d55c3044989bf2f400bf69e8739046
`
`Non Patent Literature
`
`.
`.
`.
`.
`Yu_XInruI_2001_Tr|ptan_MedIc
`ament_and_.pdf
`
`973047
`
`2b529955d48494acc7547d8790ec7f368be
`29953
`
`Information:
`
`Information:
`
`Information:
`
`
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe 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
`lfa new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
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`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
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
`
`12/413,439
`
`03/27/2009
`
`Steve Cartt
`
`35401—7 16.201
`
`9049
`
`21971
`
`7590
`
`06/19/2014
`
`WILSON, SONSINLGOODRICMROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`MILLIGAN, ADAM c
`
`ART UNIT
`
`1612
`
`PAPER NUMBER
`
`
`
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`06/ 1 9/2014
`
`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.c0m
`
`PTOL—90A (Rev. 04/07)
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2803
`
`page 2803
`
`

`

`
`
`Applicant(s)
`Application No.
` 12/413,439 CARTT ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office ACtion summary
`
`1612ADAM C. MILLIGAN it?“
`
`-- 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 g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136(a).
`after SIX () 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
`
`1)IXI Responsive to communication(s) filed on 5/21/2012.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)lX| This action is non-final.
`a)I:| 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 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 Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)|XI 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)IZ| Claim(s) 20-24 27-36 38 and 40-53 is/are rejected.
`8)I:I Claim(s)_ is/are objected to.
`
`9)|:l Claim((s)
`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
`hit ://\va.usnto. ov/ atents/init events.) .h/index.
`
`
`
`‘3 , or send an inquiry to PF"l-ifeedback{<‘bLIsr).to.qov.
`
`
`
`Application Papers
`
`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).
`
`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:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some” c)I:I None of the:
`a)|:l All
`1.|:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`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.
`
`Attachment(s)
`
`3) D Interview Summary (PT0_413)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`—
`2) E InformatIon DIscIosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date 1Qg(11/16/2012), 39gs(4/15/20132,
`9
`5 10/29/2013 .
`
`AQUESTIVE EXHIBIT 1007 page 2804
`US. Patent and Trademark Office
`AQUESTIVE EXPHIBIT 19$?Dategoa‘lg)g? 2804
`PTOL-326 (Rev. 11-13)
`Part of Paper No
`610
`
`Office Action Summary
`
`

`

`Application/Control Number: 12/413,439
`
`Page 2
`
`Art Unit: 1612
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed 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 not reiterated 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 us. C. § 103
`
`The following is a quotation of 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 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 as follows:
`
`1.
`
`Determining the scope and contents of the prior art.
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2805
`
`page 2805
`
`

`

`Application/Control Number: 12/413,439
`
`Page 3
`
`Art Unit: 1612
`
`2.
`3.
`4.
`
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating
`obviousness or nonobviousness.
`
`This application currently names joint inventors.
`
`In considering patentability of
`
`the claims under 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.
`
`Claims 20-24, 27-36, 38 and 40-53 are rejected under 35 U.S.C. 103(a) as
`
`being unpatentable over Lehat (lntranasal 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 used to 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 phase is achieved (Sonne also
`
`teaches that co-solvent such as ethanol, benzyl alcohol, sesame oil or propylene glycol
`
`can be used in order to optimize the formulations bioadhesion, sprayability and viscosity
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2806
`
`page 2806
`
`

`

`Application/Control Number: 12/413,439
`
`Page 4
`
`Art Unit: 1612
`
`(col. 6, lines 47-53). When ethanol is used in the formulations, it may be used in an
`
`amount of 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 amount of about 44% (example18,
`
`col12, lines 37-51) or about 60% (example 16 at col.12, lines 10-17). d-tocopherol may
`
`be used in amounts of 20 to 99.9% (col.5, lines 56-61). The active ingredient should be
`
`present in an amount of 0.001% to 40% (col.5, lines 55-61). Diazepam may be present
`
`at about 5% by weight (example 11 at col. 11, lines 1-13). Preservative as well as odor
`
`masking compounds may be included in 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 be difficult 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 "[v]iscosity can be reduced by the addition of
`
`co-solvents such as ethanol (col.3, lines 65-66). Sonne teaches that “transmucosal
`
`delivery is preferred" (col.3, line 54) and "[n]asal...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 teaches that a co-solvent such as
`
`ethanol can be used in 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 amount of 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 found it obvious to
`
`AQUESTIVE EXHIBIT 1007
`
`AQUESTIVE EXHIBIT 1007 page 2807
`
`page 2807
`
`

`

`Application/Control Number: 12/413,439
`
`Page 5
`
`Art Unit: 1612
`
`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 amount from 0.01%
`
`to 1%.
`
`Meezan teaches that alkyl glycosidase is an absorption enhancer for drug
`
`administration (11150). 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. Meezan further teaches
`
`that the active ingredient for the nasal spray may be in the form of nanoparticles (1163).
`
`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 in a
`
`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 present the following arguments against the 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
`
`Page 6
`
`Art Unit: 1612
`
`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 ordinary skill 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, Lehat is 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 Sonne already teaches the inclusion of viatmin E, a
`
`penetration enhancer, a skilled artisan practicing the method of Sonne would have no
`
`reason to look anywhere else for penetration enhancers.
`
`Examiner disagrees. While Sonne teaches that 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
`
`Page 7
`
`Art Unit: 1612
`
`absorption. Meezan teaches that 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.
`
`No claims are allowed.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to ADAM MILLIGAN whose telephone number is (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 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). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`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
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`U.S. 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.
`
`Substitute for form 1449/PTO
`
`Application Number
`
`Complete ifKnown
`12/413,439
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`First Named Inventor
`
`(Use as many sheets as necessary)
`
`Art Unit
`
`_--n Attorney Docket Number
`
`03/27/2009
`Steve Cartt
`
`1612
`
`Mmgan Adam c.
`3 5401 -7 1 6.20 1
`
`U.S. PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MlVI-DD-YYYY
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`Document Number
`Number-Kind Code2 (ifknown)
`S- 2002-0110524 A1
`
`S- 2002-0141971 A1
`S- 2003-0017203 A1
`
`S- 2003-0040497 A1
`
`S- 2003-0087820 A1
`S- 2003-0100755 A1
`
`S- 2003-0118547 A1
`
`S- 2003-0118594 A1
`S- 2003-0158206 A1
`
`8/15/2002
`
`Cowan, S. M. L. et a1.
`
`10/3/2002 William H. Fre , II
`6/23/2003
`Crotts et a1.
`
`2/27/2003
`
`5/1/2003
`5/29/2003
`
`Teng et a1.
`
`Young et a1.
`Sham et a1.
`
`6/1/2303
`
`Vandenberg, G. W.
`
`6/26/2003
`8/21/2003
`
`Nag et a1.
`Billotte et a1.
`
`
`
`
`Examiner
`Initials*
`
`Cite
`No.1
`
`,_.
`
`PENN.
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`3.3.5.5.
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`
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`S- 2003-0170206 A1
`
`9/11/2003
`
`Rasmussen et al.
`
`S- 2004-0115135 A1
`S- 2004-0126358 A1
`
`S- 2004-0147473 A1
`
`S- 2004-0258663 A1
`S-2004-141923 A1
`S- 2005-0130260 A1
`
`6/17/2004
`7/1/2004
`
`7/29/2004
`
`Quay
`Warne et a1.
`
`Warriell, Jr.
`
`12/23/2004 Qua & El-Shaf
`07/22/2004 Dugger et a1.
`6/16/2005
`Linden et. a1.
`
`S- 2005-0234101 A1
`S- 2006-0045869 A1
`
`Stenkamp et a1.
`10/20/2005
`03/02/2006 Meezan et a1.
`
`S- 2006-0046969 A1
`
`3/2/2006
`
`Maggio, E. T.
`
`S- 2006-0106227 A1
`
`5/18/2006
`
`Reddy et a1.
`
`S- 2006-01473 86 A1
`S- 2007-0059254 A1
`
`07-06-2006 Wermling, D P
`3/15/2007
`Nikhilesh N. Sinh
`
`S- 2007-0098805 A1
`
`5/3/2007
`
`Gary G. Liversidge
`
`S- 2007-0298010 A1
`
`12/27/2007 Maggio, E. T.
`
`Edward T. Maggio
`10/30/2008
`S- 2008-0268032 A1
`10/15/2009 _—
`S-2009-0258865A1
`8/12/2010 _—
`LS-2010-0203119A1
`Date
`4
`[A m Mi“;
`n/
`Considered
`ga
`33
`06/11/2014
`*EXAMINER.‘ Initial ifreference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation ifnot in conformance and not considered. Include copy
`ofthis form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes ofUSPTO Patent Documents atW or MPEP
`901.04. 3Enter Office that issued the document1 by the two-letter code (WlPO Standard ST.3). 4For Japanese patent documents, the indication ofthe year ofthe reign ofthe Emperor must
`precede the serial number ofthe patent document. 5Kind of document by the appropriate symbols as indicated on the document under WlPO Standard ST.16 ifpossible. 6Applicant is 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 which is 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 Chieflnformation 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: Commissioner for Patents, PO. Box 1450, Alexandria, VA 22313-1450.
`Ifyoa need assistance in completing theform, call l-800—PTO-9199 (1-800- 786-9199) and select option 2.
`
`Attorney Docket No. 3 5401—716201
`
`_ 1 ,
`
`ALL REFERENCES CONSlQEEED EWWQEEEEIBSEBME®Q§B§HAMJ
`
`AQUESTIVE EXHIBIT 1007 page 2811
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`U.S. 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.
`
`Substitute for form 1449/PTO
`
`Application Number
`
`Complete ifKnown
`12/413,439
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`First Named Inventor
`
`(Use as many sheets as necessary)
`
`Art Unit
`
`_--n Attorney Docket Number
`
`03/27/2009
`Steve Cartt
`
`1612
`
`Mmgan Adam c.
`3 5401 -7 1 6.20 1
`
`Examiner
`Initials*
`
`Cite
`No.1
`
`U.S. PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MlVI-DD-YYYY
`Applicant of Cited Document
`
`Document Number
`Number-Kind Code (ifknown)
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`N 00
`
`S- 2010-0209485 Al
`S- 3,547,828
`
`Edward T Maggio
`8/19/2010
`12/15/1970 Mansfield et a1
`
`
`
`
`______________
`
`.bD.)
`
`______________
`
`(—1fliifl(—1
`
`N0.("if‘
`WWWwhackfliil 9/1/1989
`WU.)#0.)
`u.) .U‘.flit“ 1/1/1993
`WU.)«.68
`U.) 00
`
`s— 3,849,341
`
`S- 4.397951
`
`s— 4,748,158
`s— 4,868,289
`
`S- 4,921,838
`s— 5,182,258
`
`s- 5,192,528
`
`s— 5,236,707
`
`s— 5,268,461
`
`s— 5,308,531
`
`s- 5,317,010
`—
`s— 5,369,095
`s— 5,550,220
`
`s- 5,639,733
`
`s— 5,661,130
`
`S- 5,789,375
`
`S- 5,795,896
`
`S-5,817,634
`s- 5,955,425
`
`s— 6,004,574
`
`s— 6,254,854
`
`s— 6,316,410
`
`s— 6,395,300
`
`s— 6,482,834
`
`Cats1mpoolas et a1
`
`Radhakrishnan et a1.
`
`Shop et a1.
`
`Johns Patton
`
`11/19/1974
`
`8/9/1983
`
`5/31/1988
`
`5/1/1990
`
`3/3/1993
`
`847/1993
`
`12/7/1993
`5/3/1994
`
`5/31/1994
`
`11/29/1994
`
`8/27/1996
`
`8/26/1997
`
`4/14/1998
`8/4/1998
`
`8/18/1998
`
`9/29/1998
`
`10/1/1998
`
`12/21/1999
`
`7/3/2001
`
`11/13/2001
`
`5/28/2002
`
`9/20/2001
`
`
`...O.0..
`
`6/17/1997llWN
`4;:5.flit“s— 5,738,845
`ll9“.“
`4>4>90>]libs— 5,814,607
`4;.0flit“ 9/21/1999
`mmHO
`("F‘F‘
`mmWN
`LIIUI54%.ii
`
`Examiner
`
`rant 1/
`I
`-ii-
`'1‘
`3.,
`i
`LCD/11,2014
`tAaamtfisuagart/
`*EXAMINER.‘ Initial ifreference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation ifnot in conformance and not considered. Include copy
`ofthis form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes ofUSPTO Patent Documents atW or MPEP
`901.04. 3Enter Office that issued the document1 by the two-letter code (WlPO Standard ST.3). 4For Japanese patent documents, the indication ofthe year ofthe reign ofthe Emperor must
`precede the serial number ofthe patent document. 5Kind of document by the appropriate symbols as indicated on the document under WlPO Standard ST.16 ifpossible. 6Applicant is 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 which is 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 Chieflnformation 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: Commissioner for Patents, PO. Box 1450, Alexandria, VA 22313-1450.
`Ifyoa need assistance in completing theform, call l-800—PTO-9199 (1-800- 786-9199) and select option 2.
`
`Date
`
`Attorney Docket No. 3 5401—716.201
`
`_ 2 ,
`
`ALL REFERENCES CONSlQEEED EWWQEEEEIBSEBME®Q§B§IZAMJ
`
`AQUESTIVE EXHIBIT 1007 page 2812
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`U.S. 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.
`
`Substitute for form 1449/PTO
`
`Application Number
`
`Complete ifKnown
`12/413,439
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`First Named Inventor
`
`(Use as many sheets as necessary)
`
`Art Unit
`
`_--n Attorney Docket Number
`
`03/27/2009
`Steve Cartt
`
`1612
`
`Mean Adam c.
`3 5401 -7 1 6.20 1
`
`U.S. PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MlVI-DD-YYYY
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`Examiner
`Initials*
`
`Cite
`No.1
`
`Document Number
`Number-Kind Code (ifknown)
`_- US- 6,495,498
`_- US- 6,524,557
`U} 00
`-
`US 6 794 357
`
`0
`
`.
`
`1.
`
`0U}
`
`US- 6,932,962
`
`Us 6991785
`US-8 530 463
`
`12/17/2002
`2/25/2003
`9/21/2004
`
`8/23/2005
`
`Backstrom et a1.
`Backstrom et a1.
`
`1/31/2006 William H. Frey, 11
`09/10/2013
`
`
`
`Examiner
`Initials*
`
`Cite
`No.1
`
`Foreign Patent Document
`
`FOREIGN PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MlVI-DD-YYYY
`Applicant of Cited Document
`
`Pages, Columns, Lines,
`Where Relevant
`
`CountryCode ,Number,KindCode (lye/own) -_ Pasliesngizant
`_—EP-0396777 A1
`_—EP-1417972 A1
`JP1'151528(E“g“Sh _—Abstract and Claims)
`
`11/14/1990
`
`CO LTD
`
`5/12/2004
`
`COMPANY
`
`WO-1991-019481
`
`6/14/1989
`12/26/1991
`
`KOGYO KK
`
`WO-1994-05262 A1
`
`3/17/1994
`
`WO-1995-000151 A1
`w0—1995—31217 A1
`
`1/5/1995
`11/23/1995
`
`WO-2000-001390 A1
`
`01/13/2000
`
`WO-2003-055464
`
`07/10/2003
`
`F.H. FAUDLING & CO.
`LTD.
`UAB RESEARCH
`FOUNDATION
`
`RECORDATI S.A.
`CHEMICAL AND
`PHARMACEUTICAL
`COMPANY ET AL.
`BESINS
`INTERNATIONAL
`
`BELGIQUE ET AL.
`
`IIIIEII.
`
`I,
`/
`'55;
`'n .
`Examiner
`05/11/2014
`/Adam Mimgafil
`gimme
`*EXAMINER.‘ Initial ifreference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation ifnot in conformance and not considered. Include copy
`
`ofthis form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes ofUSPTO Patent Documents at www.mntopov or MPEP
`901.04. 3Enter Office that issued the document1 by the two-letter code (WIPO Standard ST.3). 4For Japanese patent documents, the indication ofthe year ofthe reign ofthe Emperor must
`precede the serial number ofthe patent document. 5Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 ifpossible. 6Applicant is 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 which is 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 ChiefInformation 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: Commissioner for Patents, PO. Box 1450, Alexandria, VA 22313-1450.
`Ifyoa need assistance in completing theform, call l-800—PTO-9199 (1-800- 786-9199) and select option 2.
`
`Date
`
`Attorney Docket No. 3 5401—716.201
`
`_ 3 L
`
`ALL REFERENCES CONSlDEEED EWWQEEEEIBSEBME®Q§B§UAMJ
`
`AQUESTIVE EXHIBIT 1007 page 2813
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`US. Patent and Trademark Office; US. 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.
`
`Substitute for form 1449/PTO
`
`Application Number
`
`Complete ifKnown
`12/413,439
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`_--n Attorney Docket Number
`
`Mmgan Adam c.
`3 5401-716.201
`
`Examiner
`Initials*
`
`Cite
`No.1
`
`71.
`
`Foreign Patent Document
`
`FOREIGN PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MlVI-DD- Y Y Y Y
`Applicant of Cited Document
`
`Country Code , Number , Kind Code (sznown)
`
`TRANSORAL
`
`Pages, Columns, Lines,
`Where RCleVaflt
`FI-
`es A- near
`Passages Or Relevant
`
`PHARMACEUTICALS,
`INC.
`WO-2005-018565 A2
`
`WO-2008-027395 A2
`Jazz Pharmaceuticals
`72.
`3/6/2008
`
`03/03/2005
`
`73.
`
`WO-2009-120933 A2
`
`10/01/2009
`
`Particle Sciences Inc.
`
`88-89, Vol. 13, No.4
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the 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),
`oublisher, cit and/or count Where oublished.
`
`Ahsan et al., "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
`Ahsan et a1., "Sucrose cocoate, a component of cosmetic preparations enhances nasal
`and ocular Hetide abso .tion", Int J Pharm, 2003; 251: 195-203
`Albert et a1., "Pharmacokinetics of diphenhydramine in man", J. Pharmacokinet,
`Biopharm., 3(3):159-170 (1975)
`Arnold et a1., "Correlation of tetradecylmal