WO 95/31217
`
`PCT/EP95/01835
`
`EHARMASQQLQQX ;
`
`E
`
`a.
`
`1
`
`1
`
`.
`
`:
`
`Preparations containing CNS active and muscle relaxing
`
`drugs such as diazepam and midazolam were tested in a
`
`pharmacodynamic model in rabbits.
`
`The model consists of the following tests:
`
`I§£L_l:
`
`-
`
`Hind legs to one side and the rabbit must stay in
`
`this position even after a firm tip with a finger
`
`on the hip.
`
`The test is immediately repeated with
`
`both legs placed on the other side.
`
`IEEL_2:
`
`-
`
`Hind legs stretched out backwards and the rabbit
`
`must stay in this position even after a firm tip
`
`with a finger on the hip.
`
`IEEL_3:
`
`—
`
`The rabbit must stay in a supine position, when
`
`placed in such a position.
`
`After administration of the formulations (i.n., oral or
`
`i.v.) the rabbits were exposed to the three tests
`
`approximately once per minute until positive
`
`pharmacodynamic response, and thereafter every 2
`
`minutes.
`
`The total test period was 20 minutes after
`
`i.n. and i.v. administration and 30 minutes after
`
`peroral administration.
`
`The time elapsed from administration until the first
`
`positive response in test 1 was used to compare the
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2101
`
`page 2101
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`

`

`WO 95/31217
`
`PCT/EP95/01835
`
`-27-
`
`onset of action of the different formulations.
`
`SIHDX_l
`
`This pharmacodynamic study compared the nasal
`
`formulation of Example 8
`
`(C) containing 5% of diazepam
`
`to a commercially available diazepam formulation,
`
`Stesolido 2mg tablet, Dumex (D). The study was run in 8
`
`rabbits in a randomized cross-over study. The rabbits
`
`were tested for pharmacodynamic response as described
`
`previously, but the test period was 30 minutes after
`
`peroral administration to be sure to obtain a
`
`pharmacodynamic effect.
`
`Formulation C was given intranasally (i.n.) with a
`
`laboratory pipette. Each rabbit was held in a supine
`
`position during and one minute after i.n. dosing in one
`
`nostril.
`
`The rabbits received a volume
`
`equivalent to
`
`2.5 mg diazepam. After each administration the actual
`
`dose received is calculated by subtraction of the weight
`
`of the pipette before and after administration. Only
`applications determined to 80% (2 mg diazepam) were
`accepted.
`
`Formulation D was given as an oral administration using
`
`a stomach pump. The tablet was dissolved in 5 ml water
`
`immediately before administration. The tube was rinsed
`
`with 10 ml water.
`
`The time to onset of pharmacodynamic response in test 1
`
`is $i5_minutgfi
`
`(median, n=7 ) using formulation C
`
`and 12*g_minutes (median, n=8) using formulation D.
`
`SIHDX_Z
`
`This pharmacokinetic study compared the nasal
`
`formulation of Example 8
`
`(C) containing 5% of diazepam
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2102
`
`page 2102
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`

`

`WO 95/31217
`
`PCT/EP95/01835
`
`_ 28 _
`
`to a commercially available diazepam formulation,
`Stesolid® 2mg tablet, Dumex (D). The study was run in 8
`
`rabbits in a randomized cross-over study.
`
`.
`
`Formulation C was given intranasally (i.n.) as described
`
`in study 1.
`
`Formulation D was given by oral administration as
`
`described in study 1 using a stomach pump.
`
`Blood samples from the ear-vein were taken before
`
`administration (time = O) and at 2, 5, 10, 15, 30, 45,
`
`60, 75, 90, 120, 180 and 240 minutes.
`
`Serum was analyzed for diazepam and the metabolite,
`
`desmethyldiazepam using Gas Chromatografy (GC).
`
`The limit of detection was Sng/ml for both substances.
`
`The pharmacokinetic parameters found for diazepam were
`
`twm = 23 minutes (median, n=6), Cmax = 68.2 ng/ml
`
`(median, n=6) after administration of formulation C and
`
`tmax = 45 minutes (median, n=6), Cmax = 9.7 ng/ml
`
`(median, n=6) after administration of formulation D.
`
`Figures 1 and 2
`
`illustrate the mean serum
`
`concentrations of diazepam and desmethyldiazepam after
`
`administration of formulations C and D.
`
`EIUDX_1
`
`This pharmacodynamic study compared Example 8(C)
`
`containing 5% of diazepam with Example 19 (E) containing
`
`2.5% of midazolam. The study was using 6 rabbits.
`
`Formulations C and E were given intranasally (i.n.) with
`
`a laboratory pipette. Each rabbit was held in a supine
`position during and one minute after i.n. dosing in one
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2103
`
`page 2103
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`

`

`WO 95/31217
`
`PCT/EP95/01835
`
`..
`
`2 9 _
`
`nostril.
`
`The rabbits received a volume equivalent to
`
`2.5 mg diazepam or 1.25 mg midazolam, respectively.
`
`After each administration the actual dose received was
`
`calculated by subtraction of the weight of the pipette
`
`before and after administration. Only doses equivalent
`
`to 80% were accepted.
`
`The time to onset of pharmacodynamic response in test 1
`
`was 3*l_minntes (median, n=6) using formulation C
`
`containing diazepam and 2Ԥ_Eunutes (median, n=6) using
`
`formulation E containing midazolam.
`
`Emmi;
`
`l
`
`.
`
`.‘
`
`.
`
`1
`
`.
`
`The investigation was carried out in order to estimate
`
`irritation after nasal application of 10 mg of diazepam;
`
`100 mg of the preparation from Example 8 in each
`
`nostril.
`
`6 volunteers,
`
`3 male and 3 female participated in the
`
`trial.
`
`The investigator inspected both nostrils macroscopically
`
`for local irritation at the following times:
`
`Immediately
`
`after medication, at 30 minutes, and 1, 2, 4, and 6
`
`hours.
`
`In one volunteer the macroscopic inspection showed light
`
`blush of both nostrils immediately after medication.
`
`None of the six volunteers had local irritation of the
`
`nostrils 30 minutes after application, see table 2.
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2104
`
`page 2104
`
`

`

`W0 95/312 17
`
`PCT/EP95/01835
`
`_ 30 _
`
`CONCLUS ION
`
`The total results of the trial have shown that
`
`preparation of Example 8 does not cause unacceptable
`irritation of the nostrils.
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2105
`
`page 2105
`
`

`

`WO 95/31217
`
`PCT/EP95/01835
`
`Table 2.
`
`_ 31 -
`
`Individual local irritation of the nostrils after intranasal
`
`administration of 10 mg diazepam,
`
`(Example 8)
`
`Local irritation
`
`Imme—
`
`diately
`after
`
`medication
`
`R: right nostril
`L: left nostril
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2106
`
`page 2106
`
`

`

`wo 95/31217
`
`'
`
`PCT/EP95/01835
`
`Slams
`
`1.
`
`Use of a tocopherol or a derivative thereof as a
`
`solvent and/or emulsifier for substantially insoluble
`
`or sparingly soluble biologically active agents.
`
`2.
`
`Use as claimed in claim 1 in the manufacture of
`
`pharmaceutical compositions.
`
`3.
`
`A composition for delivery of a substantially
`
`insoluble or sparingly soluble biologically active
`
`agent, comprising said agent dissolved in a tocopherol
`or a derivative thereof.
`
`4.
`
`A composition as claimed in claim 3 wherein the
`
`tocopherol is u—tocopherol or an ester thereof.
`
`5.
`
`A composition as claimed in claim 3 or claim 4 in
`
`a form suitable for transmucosal,
`
`topical, enteral or
`
`parenteral application.
`
`6.
`
`A composition as claimed in claim 5,
`
`in a form
`
`suitable for intranasal, vaginal or rectal application
`
`or for administration via the oral cavity.
`
`7.
`
`A composition as claimed in any one of claims 1 to
`
`6 in the form of an emulsion.
`
`8.
`
`A composition as claimed in claim 7, additionally
`
`comprising an emulsifying agent.
`
`9.
`
`A composition as claimed in claim 8, wherein the
`
`emulsifying agent is a tocopherol derivative.
`
`10.
`
`A composition as claimed in claim 9, wherein the
`
`emulsifying agent is a tocopherol ester.
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2107
`
`page 2107
`
`

`

`WO 95/31217
`
`PCT/EP95/01835
`
`-33-
`
`11.
`
`A composition as claimed in claim 10, wherein the
`
`emulsifying agent is Vitamin E TPGS.
`
`12. A composition suitable for delivery of
`
`substantially insoluble or sparingly soluble
`
`biologically active agents, comprising a tocopherol or
`
`a derivative thereof, and an emulsifier.
`
`13. A composition as claimed in claim 12, wherein the
`
`emulsifier is Vitamin E TPGS.
`
`14. A composition as claimed in any of claims 3 to 13,
`
`further comprising one or more additional components
`
`selected from solvents, surfactants, stabilizers,
`
`bioadhesive polymers, preservatives, and odour— or
`
`taste—masking agents.
`
`15. A composition as claimed in any one of claims 3 to
`
`14, wherein the biologically active agent is a
`
`benzodiazepine or an anti-mycotic.
`
`16. A composition as claimed in claim 15, wherein the
`
`biologically active agent is diazepam, midazolam or
`miconazole.
`
`17.
`
`A composition as claimed in any one of claims 3 to
`
`16, wherein the content of the tocopherol or derivative
`
`thereof is from 1 to 99.99% (w/w).
`
`18. A composition as claimed in claim 17, wherein the
`
`content of the tocopherol or derivative thereof is from
`
`20 to 99.99% (w/w).
`
`19.
`
`A composition as claimed in claim 17, wherein the
`
`content of the tocopherol or derivative thereof is from
`
`40 to 99.99% (w/w).
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2108
`
`page 2108
`
`

`

`WO 95/31217
`
`PCT/EP95/01835
`
`_ 34 _
`
`20.
`
`A method of preparing a composition for delivery
`
`of a substantially insoluble or sparingly soluble
`
`biologically active agent, said method comprising
`
`dissolving said agent in an amount of a tocopherol or a
`
`derivative thereof, sufficient to dissolve said agent.
`
`21. A method as claimed in claim 20, further
`
`comprising forming an emulsion of said
`
`tocopherol/biologically active agent solution, by
`
`mixing with an aqueous phase.
`
`22.
`
`A method as claimed in claim 21, wherein the
`
`emulsification step is performed in the presence of an
`
`emulsifying agent.
`
`23. A method as claimed in claim 22, wherein the
`
`emulsifying agent is Vitamin E TPGS.
`
`24. Use of a tocopherol or a derivative thereof for
`
`the preparation of a composition as claimed in any one
`of claims 3 to 18.
`
`25. A method of treatment of a human or non—human
`
`animal subject by delivery of a substantially insoluble
`
`or sparingly soluble biologically active agent, said
`
`method comprising administering to said subject a
`
`composition as defined any one of claims 3 to 11 or 14
`to 18.
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2109
`
`page 2109
`
`

`

`WO 95/31217
`
`PCT/EP95/01835
`
`l / 2
`
`100
`
`80
`
`+Desmethyl-diazepam
`+ Diazepam
`
`
`
`0
`
`60
`
`120
`
`180
`
`240
`
`300
`
`Time (min)
`
`EU)
`
`50
`
`'C
`
`OU
`
`Fig. 1
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2110
`
`page 2110
`
`

`

`WO 95/31217
`
`PCT/EP95/01835
`
`2/2
`
`+ Diazepam
`
`~fi~ Desmethyi-diazepam
`
`Time (min)
`
`120
`
`180
`
`240
`
`300
`
`—L O
`
`r:
`E\
`c»
`s:v
`
`o'c
`
`oO
`
`Fig. 2
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2111
`
`page 2111
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`lntemal
`
`l Application No
`
`PCT/EP 95/01835
`
`
`
`. CLASSIFICATION OF SUBJECT MATTER
`
`EPC 6
`A61K47/22
`A61K9/00
`A61K9/48
`
`According to lntemational Patent Classification (IPC) or to both national classification and [PC
`
`
`8. FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by clam'ficauon symbols)
`IPC 6
`A61K
`
`
`
`
` Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`
`
`
`
`
`
`
`
`
`
`
`Electronic data base consulted during the international search (name of data base and, where practical, search terms used)
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Citation of document, with indication. where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`W0,A,89 03689 (THE LIPOSOME COMPANY) 5 May
`1989
`see the whole document
`
`W0,A,92 13531 (EASTMAN KODAK COMPANY) 20
`August 1992
`see the whole document
`
`
`
`
`
`
`
`DATABASE WPI
`Section Ch, Week 9437,
`Derwent Publications Ltd., London, GB;
`Class 302, AN 94-302691
`& WO,A,94 20143 (FUJISAWA PHARM CO LTD) 15
`September 1994
`see abstract
`
`
`
`
`
`
`
`
`
`
`
`E Patent family members are listed in annex.
`l
`,
`.
`l
`.
`T later document published after the international filing date
`or priority date and not in conflict with the application but
`-
`a
`»
`-
`'A" document defining the general state of the art which is not
`Etc;:13)liiii'iderstand the pnnCiple or theory underlying the
`conSidered to be of particular relevance
`
`'X' document of particular relevance; the claimed invention
`'E' earlier document but published on or after the international
`cannot be considered novel or cannot be considered to
`filing date
`
`
`involve an inventive step when the document is taken alone
`'L' dment which maymizhdoubfion priogity drainms‘)hor
`'Y' document of
`-
`.
`-
`,
`-
`w 'c is cite to esta is
`e pu ication
`te o ano er
`
`particular relevance the claimed invention
`,
`.
`‘
`cannot be considered to involve an inventive step when the
`“mm“ or other specml "33°" (as specn'ied)
`‘
`‘
`.
`
`document is combined With one or more other such docu-
`'0' document referring to an oral disclosure, use, exhibition or
`
`merits, such combination being obvious to a person skilled
`other means
`
`'P' document published prior to the inteman'onal filing date but
`1" the art.
`'&' document member of the same patent family
`later than the priority date claimed
`
` Date of mailing of the international search report
`Date of the actual completion of the international search
`
`27. ll]. 35
` 19 October 1995
`
`Authorized officer
`
`Name and mailing address of the ISA
`
`European Patent Office, P.B. 58l8 Patentlaan 2
`Ni. - 2280 HV' Rijswijk
`
`
`
`Tel. (+3l-70) 340-2040, Tx. 31651epo nl,
` Ventura Amat, A
`Fax: (+ 31-70) 340-30l6
`
`
`Form PCT/ISAJZIO (second sheet) (July 1992)
`AQUESTIVE EXHIBIT 1004 page 2112
`
`D Further documents are listed in the continuation of box C.
`' SpeCial categories of cited documents :
`
`
`
`
`
`
`
`
`
`
`,
`
`AQUESTIVE EXHIBIT 1004
`
`page 2112
`
`

`

`INTERNATIONAL SEARCH REPORT
`Imormauon on patent family members
`
`
`[mm-nan
`Application No
`
`PCT/EP 95/01835
`
`Publication
`date
`
`
`
`Patent family
`member(s)
`
`CA-A-
`DE-A-
`DE-T-
`EP-A,B
`JP-T-
`
`1333360
`3883246
`3883246
`0382779
`3500651
`5364631
`
`Patent document
`cited in search report
`
`Publication
`date
`
`W0-A-8903689
`
`05-05-89
`
`
`
`
`
`
`
`
`
`
`
`
`
`W0-A-9213531
`5179122
`12-01-93
`2079325
`12-08-92
`CA-A-
`
`
`0524308
`27-01-93
`
`
`06-12-94
`16-09-93
`02-12-93
`22-08-90
`14-02-91
`15-11-94
`
`
`
`Form PCT/[SHIN] (patch! family mnax) (July 1992)
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2113
`
`page 2113
`
`

`

`Electronic Acknowledgement Receipt
`
`International Application Number: —
`
`Title of Invention:
`
`ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS
`
`First Named Inventor/Applicant Name:
`
`
`
`Application Type:
`
`Utillty under 35 USC111(a)
`
`Payment information:
`
`a_e 2114
`
`.
`
`.
`
`File Size(Bytes)/
`
`Multi
`
`Pages
`
`Transmittal Letter
`
`Neurelis_35401_716_501_Tran
`_O9_13_2013.pdf
`
`152501
`
`4:016169b0b7872b25f3e7f1ad0b65c5f5ef
`bb21
`
`A O UESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2114
`
`File Listing:
`
`Document
`
`Informatiom
`
`

`

`Information Disclosure Statement (IDS)
`Form (SBOS)
`
`NeureIis_35401_716_501_IDS_
`09_13_2013.pdf
`
`173256
`
`bb30beebdb53bb70d3c7d68eade1d27f11
`e9a494
`
`Information.
`
`This is not an USPTO supplied IDS fiIIabIe form
`
`Foreign Reference
`
`WOO9120933.pdf
`
`Information:
`
`Information:
`
`Information:
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`Information:
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`179941 ef30d4b1 d2eeae1 1 6239db41 862a!
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`1029387
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`f9af283fa0a266521e0804dafcb3d28e1ffa8
`351;)
`
`2531930
`
`(c1ac6f7ec36019fb57024616d5bc68c07a4
`1bac
`
`Foreign Reference
`
`WO9531217.pdf
`
`Non Patent Literature
`
`AU2009228093_OA_19JUL201
`3.pdf
`
`3a88c58d2573d880c604744d25a11abfe4f‘
`c4a6
`
`519659
`
`Non Patent Literature
`
`EPO97239065_ESR_O9JUN2013.
`pdf
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`399408
`
`c54355fa3e1ca24b31b47be395ba396fc525
`9858
`
`Non Patent Literature
`
`JP2010507633_OA_09JUL2013.
`pdf
`
`105893
`
`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2115
`
`page 2115
`
`

`

`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
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
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`lfa timely submission to enter the national stage of an international application is compliant with the conditions of 35
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`the application.
`
`New International Application Filed with the USPTO as a Receiving Office
`lfa new international application is being filed and the international application includes the necessary components for
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`AQUESTIVE EXHIBIT 1004
`
`AQUESTIVE EXHIBIT 1004 page 2116
`
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`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Attorney Docket No. 35401-716501
`PATENT
`
`Inventor:
`
`Steve Cartt
`
`Group Art Unit:
`
`1612
`
`Serial Number:
`
`13/495,942
`
`Examiner:
`
`Milligan, Adam C.
`
`Filing Date:
`
`6/13/2012
`
`CONFIRMATION NO:
`
`7399
`
`Title: ADMINSTRATION OF
`BENZODIAZEPINES COMPOSITIONS
`
`
`
`FILED ELECTRONICALLY ON: September 13, 2013
`
`Commissioner for Patents
`PO. Box 1450
`Alexandria VA 22313-1450
`
`INFORMATION DISCLOSURE STATEMENT
`
`UNDER 37 CFR §1.97
`
`Madam:
`
`An Information Disclosure Statement along With attached PTO/SB/O8 is hereby submitted. A
`
`copy of each listed publication is submitted, if required, pursuant to 37 CFR §§1.97-1.98, as indicated
`
`below.
`
`The Examiner is requested to review the information provided and to make the information of
`
`record in the above-identified application. The Examiner is further requested to initial and return the
`
`attached PTO/SB/O8 in accordance With MPEP §609.
`
`The right to establish the patentability of the claimed invention over any of the information
`
`provided herewith, and/or to prove that this information may not be prior art, and/or to prove that this
`
`information may not be enabling for the teachings purportedly offered, is hereby reserved.
`
`This statement is not intended to represent that a search has been made or that the information
`
`cited in the statement is, or is considered to be, prior art or material to patentability as defined in §1.56.
`
`A.
`
`IXI 37 CFR §I.97(b). This Information Disclosure Statement should be considered by the Office
`because:
`
`D
`
`(1)
`
`It is being filed Within 3 months of the filing date of a national application and is
`other than a continued prosecution application under §1.53(d);
`
`__ OR __
`
`D
`
`2
`
`g
`y
`It is bein filed Within 3 months of entr of the national stage as set forth in
`§1.491 in an international application;
`
`Attorney Docket No. 35410-716501
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`- l -
`
`580287271.D0CX
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`AQUESTIVE EXHIBIT 1004
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`AQUESTIVE EXHIBIT 1004 page 2117
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`page 2117
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`__ OR __
`
`IXI
`
`(3)
`
`It is being filed before the mailing of a first Office action on the merits;
`
`__ OR __
`
`D
`
`(4)
`
`It is being filed before the mailing of a first Office action after the filing of a
`request for continued examination under §1.114.
`
`B. D 37 CFR §I.97(c). Although this Information Disclosure Statement is being filed after the period
`specified in 37 CFR §I.97(b), above, it is filed before the mailing date of the earlier of (1) a final
`office action under §1.113, (2) a notice of allowance under §1.311, or (3) an action that otherwise
`closes prosecution on the merits, this Information Disclosure Statement should be considered because
`it is accompanied by one of:
`
`D
`
`a statement as specified in §1.97(e) provided concurrently herewith;
`
`__ OR __
`
`D
`
`a fee of $180.00 as set forth in §1.17(p) authorized below, enclosed, or included with the
`payment of other papers filed together with this statement.
`
`C. D 37 CFR §I.97(d). Although this Information Disclosure Statement is being filed after the mailing
`date of the earlier of (1) a final office action under §1.113 or (2) a notice of allowance under §1.311,
`it is being filed before payment of the issue fee and should be considered because it is accompanied
`by:
`
`i.
`
`a statement as specified in §1.97(e);
`
`—— AND ——
`
`ii.
`
`a fee of $180.00 as set forth in §1.17(p) is authorized below, enclosed, or included
`with the payment of other papers filed together with this Statement.
`
`D. El 37 CFR §I.97(e). Statement.
`
`D
`
`A statement is provided herewith to satisfy the requirement under 37 CFR §§1.97(c);
`
`-- AND/OR --
`
`D
`
`A statement is provided herewith to satisfy the requirement under 37 CFR §§1.97(d);
`
`-- AND/OR --
`
`D
`
`A copy of a dated communication from a foreign patent office clearly showing that the
`information disclosure statement is being submitted within 3 months of the filing date on
`the communication is provided in lieu of a statement under 37 C.F.R. § 1.97(e)(1) as
`provided for under MPEP 609.04(b) V.
`
`E. D Statement Under 37 C.F.R. §I.704(d). Each item of information contained in the information
`disclosure statement was first cited in a communication from a foreign patent office in a counterpart
`application that was received by an individual designated in § l.56(c) not more than thirty (30) days
`prior to the filing of this information disclosure statement. This statement is made pursuant to the
`requirements of 37 C.F.R. §1.704(d) to avoid reduction of the period of adjustment of the patent term
`for Applicant(s) delay.
`
`F.
`
`IXI 37 CFR §I.98(a)(2). The content of the Information Disclosure Statement is as follows:
`
`I:I
`
`Copies of each of the references listed on the attached Form PTO/SB/08 are enclosed
`herewith.
`
`Attorney Docket No. 35410-716501
`
`- 2 -
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`580287271.DOCX
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`AQUESTIVE EXHIBIT 1004
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`AQUESTIVE EXHIBIT 1004 page 2118
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`page 2118
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`

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`__ OR __
`
`IZI
`
`IXI
`
`I:I
`
`Copies of US. Patent Documents (issued patents and patent publications) listed on the
`attached Form PTO/SB/O8 are NOT enclosed.
`
`-- AND/OR --
`
`Copies of Foreign Patent Documents and/or Non Patent Literature Documents listed on
`the attached Form PTO/SB/O8 are enclosed in accordance with 37 CFR §l.98 (a)(2).
`
`-- AND/OR --
`
`Copies of pending unpublished U.S. patent applications are enclosed in accordance with
`37 CFR §l.98(a)(2)(iii).
`
`G. D 37 CFR §I.98(a)(3). The Information Disclosure Statement includes non-English patents and/or
`references.
`
`I:I
`
`Pursuant to 37 CFR §l.98(a)(3)(i), a concise explanation of the relevance of each patent,
`publication or other information provided that is not in English is provided herewith.
`
`I:I
`
`D
`
`Pursuant to MPEP 609(B), an English language copy of a foreign search report is
`submitted herewith to satisfy the requirement for a concise explanation where
`non-English language information is cited in the search report.
`
`__ OR __
`
`A concise explanation of the relevance of each patent, publication or other
`information provided that is not in English is as follows:
`
`I:I
`
`Pursuant to 37 CFR §l.98(a)(3)(ii), a copy of a translation, or a portion thereof, of the
`non-English language reference(s) is provided herewith.
`
`H. D 37 CFR §I.98(d). Copies of patents, publications and pending US. patent applications, or other
`information specified in 37 CFR. § l.98(a) are not provided herewith because:
`
`I:I
`
`to 37 CFR §l.98(d)(l) the information was previously submitted in an
`Pursuant
`Information Disclosure Statement, or cited by examiner, for another application under
`which this application claims priority for an earlier effective filing date under 35 U.S.C.
`120.
`
`Application in which the information was submitted:
`
`Information Disclosure Statement(s) filed on:
`
`AND
`
`D
`
`The information disclosure statement submitted in the earlier application complied with
`paragraphs (a) through (c) of 37 CFR §l.98.
`
`Attorney Docket No. 35410-716501
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`- 3 -
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`580287271.DOCX
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`AQUESTIVE EXHIBIT 1004
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`AQUESTIVE EXHIBIT 1004 page 2119
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`page 2119
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`

`

`I.
`
`IXI Fee Authorization. The Commissioner is hereby authorized to charge the above-referenced fees
`
`of $0.00 and charge any additional
`fees or credit any overpayment associated With this
`communication to Deposit Account No. 23-2415 (Docket No.35401-716.501 !.
`
`Respectfully submitted,
`
`WILSON SONSINI GOODRICH & ROSATI
`
`/MattheW V. Grumblingz
`By:
`Matthew V. Grumbling, Attorney for Applicant
`Reg. No. 44,427
`
`Dated: 9/1 1/2013
`
`650 Page Mill Road
`Palo Alto, CA 94304-1050
`
`(650) 493-9300
`Customer No. 021971
`
`Attorney Docket No. 35410-716501
`
`- 4 -
`
`580287271.DOCX
`
`AQUESTIVE EXHIBIT 1004
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`AQUESTIVE EXHIBIT 1004 page 2120
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`page 2120
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`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
`
`13/495,942
`
`06/13/2012
`
`Steve Cartt
`
`35401—716501
`
`7399
`
`21971
`
`7590
`
`10/01/2013
`
`WILSON, SONSINLGOODRICMROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`MILLIGAN, ADAM c
`
`ART UNIT
`
`1612
`
`MAIL DATE
`
`10/01/2013
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`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.
`
`PTOL—90A (Rev. 04/07)
`
`AQUESTIVE EXHIBIT 1004
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`AQUESTIVE EXHIBIT 1004 page 2121
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`page 2121
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`

`
`Application No.
`Applicant(s)
`
` 13/495,942 CARTT ET AL.
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1612ADAM C. MILLIGAN [SENS
`
`-- 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 3 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 () 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)IZI Responsive to communication(s) filed on 9/6/2013.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|ZI This action is non-final.
`2a)|: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)|:| 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 Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)IZI Claim(s) 1-65 is/are pending in the application.
`5a) Of the above claim(s) 23-56 and 60-65 is/are withdrawn from consideration.
`
`is/are allowed.
`6)I:I Claim(s)
`7)|Z| Claim(s) 1 -22 and 57-59 is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
`
`
`are subject to restriction and/or election requirement.
`9)I:I Claim((s)
`* 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
`\WIIW.LIsct0. ov/ atentS/init events/
`
`
`
`hit
`:i/
`h/index.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)I:l 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:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:l All
`
`b)|:l Some * c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`3.|:| 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)
`
`1) D Notice of References Cited (PTO-892)
`
`3) D Interview Summary (PTO-413)
`
`Paper N°ISI/Ma" Date' —
`PTO/SB/Os
`t
`1
`St
`I
`D'
`1'
`r
`2 IZI I
`)
`4) I:I Other:
`a emen (s) (
`Isc osure
`n orma Ion
`)
`Paper No(s)/Mai| Date 6Qgsj4/15/2013j, 19g19/13/2013j.
`
`U 8 Patent and Trademark Office
`PtoL-sze (Rev. 08-13)
`
`AQUESTIVE EXHIIBJSIP ALWDatepanglZZ
`
`AQUESTIVE EXHIBIT 1004 page 2122
`
`Office Action Summary
`
`

`

`Application/Control Number: 13/495,942
`
`Page 2
`
`Art Unit: 1612
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`Election/Restrictions
`
`Applicant’s election of Group I, claims 1-22 and 57-59, in the reply filed on
`
`9/6/2013 is acknowledged. Because Applicant did not distinctly and specifically point
`
`out the supposed errors in the restriction requirement, the election has been treated as
`
`an election without traverse (MPEP § 818.03(a)).
`
`Claims 23-56 and 60-65 are withdrawn from further consideration pursuant to 37
`
`CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable
`
`generic or linking claim.
`
`Claim Rejections — 35 us. C. § 1 12 - 2"" Paragraph
`
`The following is a quotation of 35 U.S.C. 112(b):
`
`(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.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`
`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.
`
`Claims 10-12, 17, 19 and 57-59 are rejected under 35 U.S.C. 112(b) or
`
`35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly
`
`point out and distinctly claim the subject matter which the inventor or a joint inventor, or
`
`for pre-AIA the applicant regards as the invention.
`
`AQUESTIVE EXHIBIT 1004
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`AQUESTIVE EXHIBIT 1004 page 2123
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`

`Application/Control Number: 13/495,942
`
`Page 3
`
`Art Unit: 1612
`
`Claims 10-12, 17, and 57-59 include values in parenthesis. It is not clear whether
`
`the values in parentheses are part of the claimed invention. lf Applicants intend the
`
`values to be limiting on the respective claims, Examiner suggests removing the values
`
`from the parentheses.
`
`Similarly, regarding claim 19, the phrase "such as" renders the claim indefinite
`
`because it is unclear whether the limitations following the phrase are part of the claimed
`
`invention. See MPEP § 2173.05(d).
`
`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.
`2.
`3.
`4.
`
`Determining the scope and contents of the prior art.
`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 join