To the European Patent Office
`
`Europaisches
`Pam“
`European
`Patentomce
`Office européen
`
`“5 “eve“
`
`Entry into the European phase
`(EPO as designated or elected Office)
`
`European application number
`EP12801372.9
`
`PCT application number
`PCT/US2012/042311
`
`PCT publication number
`WO2012174158
`
`Applicant's or representative's reference
`EPA-124 519
`
`International Filing Date
`13.06.2012
`
`International Searching Authority (ISA)
`US
`
`International Preliminary Examining Authority (IPEA)
`not applicable
`
`1. Applicant
`Indications concerning the applicant(s) are contained in the international
`publication or were recorded by the International Bureau after the international
`publication.
`Changes which have not yet been recorded by the International Bureau are set
`out here:
`
`I:
`
`2. Representative
`This is the representative who will be listed in the Register of European Patents
`and to whom notifications will be made
`
`Representative 1
`
`Name: WICHMANN Hendrik
`
`Company: Wuesthoff & Wuesthoff Patent- und
`Rechtsanwaelte
`
`Address of place of business: Schweigerstr. 2
`
`81541 Muenchen,
`
`Germany
`
`Telephone: 089-62 18 00-0
`
`Fax: 089 / 621800-15
`
`e-mail: wuesthoff@wuesthoff.de
`
`3. Authorisation
`An individual authorisation is attached.
`
`A general authorisation has been registered under No:
`
`A general authorisation has been filed, but not yet registered.
`
`The authorisation filed with the EPO as PCT receiving Office expressly includes
`the European phase.
`
`4. Request for examination
`Examination ofthe application under Art. 94 EPC is hereby requested. The
`examination fee is being (has been, will be) paid.
`Request for examination in an admissible non-EPO language:
`
`
`
`|_|l—lflWVII—IVII—l
`
`The applicant waives his right to be asked under Rule 70(2) EPC whether he
`
`wishes to proceed further with the application.
`
`5. Copies
`Additional copies of the documents cited in the supplementary European search
`report are requested.
`Number of additional sets of copies
`
`6. Documents intended for proceedings before the EPO
`
`Number of claims on entry into the European phase:
`
`65
`
`6.1 Proceedings before the EPO as designated Office (PCT I) are to be based on
`the following documents:
`the application documents published by the International Bureau (with all claims,
`description and drawings), where applicable with amended claims under Art. 19
`PCT
`
`EPA-124 519
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0251
`
`page 0251
`
`

`

`unless replaced by the amendments attached.
`
`D
`
`Where necessa/y, c/ar/ficat/ons should be attached as ‘Other documents‘
`6.2 Proceedings before the EPO as elected Office (PCT II) are to be based on the
`following documents:
`the documents on which the international preliminary examination report is based,
`including any annexes
`unless replaced by the amendments attached.
`
`Where necessa/y, c/ar/ficat/ons should be attached as ‘Other documents‘
`lfthe EPO as International Preliminary Examining Authority has been supplied
`with test reports, these may be used as the basis of proceedings before the EPO.
`6.3 A copy of the results ofthe search carried out by the authority with which the
`previous application(s) whose priority is claimed was (were) filed is attached (R.
`141(1) EPC).
`6.4 The applicant waives his right to the communication under Rules 161(1) or (2)
`and 162 EPC.
`
`7. Translations
`
`Translations in one of the official languages of the EPO (English, French, German)
`are attached as crossed below:
`
`* in proceedings before the EPO as des/gnated or e/ected Ofi‘ice (PCT/ + ii):
`Translation of the international application (description, claims, any text in the
`drawings) as originally filed, of the abstract as published and of any indication
`under Rule 13bis.3 and 13bis.4 PCT regarding biological material
`Translation of the priority application(s) (to be filed only at the EPO's request,
`Rule 53(3) EPC)
`It is hereby declared that the international application as originally filed is a
`complete translation of the previous application (Rule 53(3) EPC)
`* /n addit/on, in proceedings before the EPO as des/gnated Ofi‘ice (P077):
`Translation of amended claims and any statement under Art. 19 PCT, ifthe
`claims as amended are to form the basis for the proceedings before the EPO
`(see Section 6).
`* /n addit/on, in proceedings before the EPO as e/ected Ofi‘ice (PCT ii):
`H
`Translation of annexes to the international preliminary examination report
`
` HmmWWHmmmm
`
` U
`
`WWWWW
`EDD
`
`8. Biological material
`The invention uses and/or relates to biological material deposited under Rule 31
`EPC.
`
`The particulars referred to in Rule 31(1)(c) EPC (if not yet known, the depositary
`institution and the identification reference(s)) [number, symbols, etc.] of the
`depositor) are given in the international publication or in the translation submitted
`in Section 7 on:
`
`page(s) / line(s)
`The receipt(s) of deposit issued by the depositary institution
`is (are) enclosed.
`
`will be filed later.
`
`9. Nucleotide and amino acid sequences
`The international application discloses nucleotide and/or amino acid sequences.
`
`9.1 The sequence listing was filed under Rule 5.2(a) PCT, orfurnished to the
`EPO as ISA under Rule 13ter.1(a) PCT, or is otherwise available to the EPO, in
`computer-readable format in accordance with WIPO ST.25.
`9.2
`
`The sequence listing is attached in computer-readable format in accordance with
`WIPO Standard ST.25
`
`The sequence listing is attached in PDF format.
`
`Waiver of the right to an undertaking from the requester pursuant to Rule 33(2)
`EPC attached.
`
`The sequence listing does not include matter which goes beyond the content of
`
`the application as filed.
`
`10. Designation fees
`
`EPA-124 519
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0252
`
`page 0252
`
`

`

`All the contracting states party to the EPC at the time of filing of the international E
`patent application and designated in the international application are deemed to
`be designated (see Article 79(1) EPC).
`The following states, which were contracting states to the EPC at the time of filing
`of the international application, are designated:
`AL AT BE BG CH&LI CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LT LU
`
`LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
`
`11. Extension of the European patent
`This application is deemed to be a request to extend the European patent
`application and the European patent granted in respect of it to all the
`non-contracting states to the EPC designated in the international application and
`with which extension agreements are in force on the date on which the
`international application is filed. However, the extension only takes effect if the
`prescribed extension fee is paid.
`
`|:|
`
`It is currently intended to pay the extension fee for the following states:
`
`Note: Under the automatic debiting procedure, extension fees will only be debited
`for states indicated here, unless the EPO is instructed otherwise before expiry of the
`
`period for payment.
`
`12. List of enclosed documents
`
`Description of document
`Original file name
`Assigned file name
`
`
`
`13. Mode of payment: Debit from deposit account
`
`E
`
`
`
`Currency
`
`EU R
`
`The European Patent Office is hereby authorised, to debit from the deposit
`account with the EPO any fees and costs indicated on the fees page.
`
`Deposit account number
`28000226
`
`Account holder
`Wuesthoff & Wuesthoff
`14. Any refunds should be made to the following EPO deposit account:
`E
`
`Number and account holder
`Wuesthoff & Wuesthoff
`
`28000226
`
`15. Fees
`
`Factor/reducti
`Fee schedule
`Amount to be paid
`
`on applied
`
`
`
`
`
`15-1
`
`15-2
`
`15-3
`
`15-4
`
`15-5
`
`15-6
`
`15-7
`
`002 Fee for a European search - Applications filed on/after
`01.07.2005
`
`005e Designation fee - For all contracting States designated for
`applications filed on/after 01.04.2009
`
`006 Examination fee - For applications filed on/after 01.07.2005
`
`015 Claims fee - For the 16th to the 50th claim
`
`15e Claims fee - For the 51st and each subsequent claim
`
`020 Filing fee - entry EP phase - online
`
`520 Additional filing fee for the 36th and each subsequent page
`- entry into EP phase
`
`Total:
`
`
`
`-190
`
`1
`
`1
`
`0
`
`0
`
`1
`
`42
`
`1 165.00
`
`555.00
`
`975.00
`
`55500
`
`1 555.00
`
`1 55500
`
`225.00
`
`555.00
`
`115.00
`
`14.00
`
`EUR
`
`0.00
`
`0.00
`
`115.00
`
`588.00
`
`3 788.00
`
`16. Annotations —’—
`
`17. Signature(s) of applicant(s) or representative
`
`Mflnchen
`
`07 January 2014
`
`/Dr. Hendrik Wichmann, European Patent
`
`Attorney/
`
`(Representative)
`
`Place:
`
`Date:
`
`Signed by:
`
`Capacity:
`
`EPA-124 519
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0253
`
`page 0253
`
`

`

`Table for section 6 of Form 1200.3
`
`In accordance with the Notice from the European Patent Office dated 26 January 2009 concerning the 2009 fee structure (OJ EPO 2009, 118,
`and Guidelines for Examination in the EPO, April 2009, A-Ill, 13.2), the amount of the additional fee (Art. 2, item 1a, Rules relating to Fees) for
`the pages of this European patent application is calculated as follows:
`
`Documents intended for proceedings before the EPO (R. 159 (1) (b) EPC) and for calculating the additional fee
`(Art. 2, item 1a, RFees):
`
`Page(s) from to
`NugZZOf
`
`
`
`Description:
`International application as published
`1_65
`65
`
`
`C|aims;
`International application as published
`66-71
`6
`
`
`Drawings:
`International application as published
`1/5_5/5
`5
`
`
`
`Abstract:
`
`Default count: one page
`
`1
`
`
`Total number of pages
`77
`
`
`Fee-exempt pages (Art. 2, item 1a, RFees)
`
`-35
`
`Number of pages to be paid for
`
`(x 14 EUR per page)
`
`
`
`Total amount payable 588 E U R
`
`
`
`EPA-124 519
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0254
`
`page 0254
`
`

`

`Europfiisches
`Pateiata mt
`European
`Patent Office
`
`des brevets
`
`Office auropéen
`
`Acknowledgement of receipt
`
`We hereby acknowledge receipt of the form for entry into the European phase (EPO as designated or elected Office) as follows:
`
`Submission number
`
`2510119
`
`PCT application number
`
`PCT/US2012/042311
`
`EP application number
`
`128013729
`
`Date of receipt
`
`07 January 2014
`
`Receiving Office
`
`European Patent Office, The Hague
`
`Your reference
`
`EPA-124 519
`
`package-data.me
`
`ep-euro-pct.Xml
`
`
`
`Applicant
`
`Country
`
`Documents submitted
`
`application-body.xml
`
`epf1200.pdf (4 p.)
`
`Submitted by
`
`CN=Beate Meiners 24076
`
`Method of submission
`
`Date and time
`receipt generated
`
`Message DigeSt
`
`07 January 2014, 13:34 (CET)
`
`9B:D4:E4:9A:F1:A1:EA:F8:BA:B4:4F:E7:22:C3:65:41:AF:B2:DD:19
`
`Correction by the EPO of errors in debit instructions filed by eOLF
`Errors in debit instructions filed by eOLF that are caused by the editing of Form 1038E entries or the continued use of outdated
`software (all forms) may be corrected automatically by the EPO, leaving the payment date unchanged (see decision T 152/82,
`OJ EPO 1984, 301 and point 6.3 ffADA, Supplement to OJ EPO 10/2007).
`
`/European Patent Office/
`
`AQUESTIVE EXHIBIT 1040
`Acknowledgement of receipt - application number PCT/USZO12/042311
`
`AQUESTIVE EXHIBIT 1040 page 0255
`
`page 0255
`Page 1 of 1
`
`

`

`Europiisches
`Patentamt
`
`
`
`Empean
`Patent Office
`i
`,
`; n
`3335121?“
`
`
`
`MITCHNICK, Mark
`80 Three Mile Harbor Drive
`
`East Hampton, NY 11937
`ETATS-UNIS D'AMERIQUE
`
`European Patent Office
`Postbus 5818
`
`2280 HV RIJSWIJK
`NETHERLANDS
`Tel. +31 (0)70 340-2040
`Fax +31 (0)70 340-3016
`
`this communication:
`
`Tel.:+31 (0)70 340 45 OO
`
`Date
`24.01 .1 4
`
`Reference
`
`Applicant/Proprietor
`
`Application No./Patent No.
`
`
`
`Hale BioPharma Ventures, LLC
`
`Notification of the data mentioned in Rule 19(3) EPC
`
`In the above-identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`PRIORITY
`
`: US/14.06.11/ USP201161497017
`: US/13.12.11/ USP201161570110
`
`TITLE
`
`:ADMINISTRATION OF BENZODIAZEPINE
`
`DESIGNATED STATES
`
`:AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE
`IS IT LI LT LU LV MG MK MT NL NO PL PT Ro RS SE SI SK SM
`TR
`
`Receiving Section
`
`Q?»
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`’00
`(9557a
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`
`EPO Form 1204 12.07
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0256
`
`page 0256
`
`

`

`Europiisches
`Patentamt
`
`
`
`Empean
`Patent Office
`i
`,
`; n
`3335121?“
`
`
`
`MEDEIROS, David
`212 Crown Circle
`
`South San Francisco, CA 94080
`ETATS-UNIS D'AMERIQUE
`
`European Patent Office
`Postbus 5818
`
`2280 HV RIJSWIJK
`NETHERLANDS
`Tel. +31 (0)70 340-2040
`Fax +31 (0)70 340-3016
`
`this communication:
`
`Tel.:+31 (0)70 340 45 00
`
`Date
`24.01 .1 4
`
`Reference
`
`Applicant/Proprietor
`
`Application No./Patent No.
`
`
`
`Hale BioPharma Ventures, LLC
`
`Notification of the data mentioned in Rule 19(3) EPC
`
`In the above-identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`PRIORITY
`
`: US/14.06.11/ USP201161497017
`: US/13.12.11/ USP201161570110
`
`TITLE
`
`:ADMINISTRATION OF BENZODIAZEPINE
`
`DESIGNATED STATES
`
`:AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE
`IS IT LI LT LU LV MG MK MT NL NO PL PT RO RS SE SI SK SM
`TR
`
`Receiving Section
`
`Q?»
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`EPO Form 1204 12.07
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0257
`
`page 0257
`
`

`

`Europiisches
`Patentamt
`
`
`
`mpg,"
`Patent Office
`1
`,
`.
`3335121?“
`
`,,
`
`
`
`
`
`LOXLEY, Andrew
`126 Market Street 5
`
`Philadelphia, PA 19106
`ETATS-UNIS D'AMERIQUE
`
`European Patent Office
`Postbus 5818
`
`2280 HV RIJSWIJK
`NETHERLANDS
`Tel. +31 (0)70 340-2040
`Fax +31 (0)70 340-3016
`
`this communication:
`
`Tel.:+31 (0)70 340 45 00
`
`Date
`24.01 .1 4
`
`Application No./Patent No.
`
`Reference
`
`Applicant/Proprietor
`
`Hale BioPharma Ventures, LLC
`
`
`
`Notification of the data mentioned in Rule 19(3) EPC
`
`In the above-identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`PRIORITY
`
`: US/14.06.11/ USP201161497017
`: US/13.12.11/ USP201161570110
`
`TITLE
`
`:ADMINISTRATION OF BENZODIAZEPINE
`
`DESIGNATED STATES
`
`:AL AT BE BG CH CY 02 DE DK EE ES FI FR GB GR HR HU IE
`IS IT LI LT LU LV MG MK MT NL NO PL PT Ro RS SE SI SK SM
`TR
`
`Receiving Section
`
`Q12)
`3°
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`EPO Form 1204 12.07
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0258
`
`page 0258
`
`

`

`Europiisches
`Patentamt
`
`
`
`mp“,
`Patent Office
`1
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`3335121?“
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`
`
`
`
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`
`
`GWOZDZ, Garry, Thomas
`432 Pine Street
`
`Jim Thorpe, PA 18229
`ETATS-UNIS D'AMERIQUE
`
`European Patent Office
`Postbus 5818
`
`2280 HV RIJSWIJK
`NETHERLANDS
`Tel. +31 (0)70 340-2040
`Fax +31 (0)70 340-3016
`
`this communication:
`
`Tel.:+31 (0)70 340 45 00
`
`Date
`24.01 .1 4
`
`Application No./Patent No.
`
`Reference
`
`Applicant/Proprietor
`
`Hale BioPharma Ventures, LLC
`
`
`
`Notification of the data mentioned in Rule 19(3) EPC
`
`In the above-identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`PRIORITY
`
`: US/14.06.11/ USP201161497017
`: US/13.12.11/ USP201161570110
`
`TITLE
`
`:ADMINISTRATION OF BENZODIAZEPINE
`
`DESIGNATED STATES
`
`:AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE
`IS IT LI LT LU LV MG MK MT NL NO PL PT Ro RS SE SI SK SM
`TR
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`Receiving Section
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`
`EPO Form 1204 12.07
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0259
`
`page 0259
`
`

`

`Europiisches
`Patentamt
`
`
`
`Empean
`Patent Office
`,
`,
`;
`3335121?“
`
`,,
`
`
`
`MAGGIO, Edward, T.
`16870 W. Bernardo Drive Suite 390
`
`San Diego, CA 92127
`ETATS-UNIS D'AMERIQUE
`
`European Patent Office
`Postbus 5818
`
`2280 HV RIJSWIJK
`NETHERLANDS
`Tel. +31 (0)70 340-2040
`Fax +31 (0)70 340-3016
`
`this communication:
`
`Tel.:+31 (0)70 340 45 00
`
`Date
`24.01 .1 4
`
`Application No./Patent No.
`
`Reference
`
`Applicant/Proprietor
`
`Hale BioPharma Ventures, LLC
`
`
`
`Notification of the data mentioned in Rule 19(3) EPC
`
`In the above-identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`PRIORITY
`
`: US/14.06.11/ USP201161497017
`: US/13.12.11/ USP201161570110
`
`TITLE
`
`:ADMINISTRATION OF BENZODIAZEPINE
`
`DESIGNATED STATES
`
`:AL AT BE BG CH CY 02 DE DK EE ES FI FR GB GR HR HU IE
`IS IT LI LT LU LV MG MK MT NL NO PL PT RO RS SE SI SK SM
`TR
`
`Receiving Section
`
`Q?»
`3°
`w
`
`+3
`5
`:5
`“2»
`’00
`(9557a
`04/78 00100
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`‘2
`a(0
`
`g.0
`£2
`m
`s?
`.30}
`'5
`
`EPO Form 1204 12.07
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0260
`
`page 0260
`
`

`

`Europiisches
`Patentamt
`
`
`
`mpg,"
`Patent Office
`1
`,
`.
`3335121?“
`
`,,
`
`
`
`
`
`CARTT, Steve
`3260 Whipple Road
`Union City, CA 94587
`ETATS-UNIS D'AMERIQUE
`
`European Patent Office
`Postbus 5818
`
`2280 HV RIJSWIJK
`NETHERLANDS
`Tel. +31 (0)70 340-2040
`Fax +31 (0)70 340-3016
`
`this communication:
`
`Tel.:+31 (0)70 340 45 00
`
`Date
`24.01 .1 4
`
`Application No./Patent No.
`
`Reference
`
`Applicant/Proprietor
`
`Hale BioPharma Ventures, LLC
`
`
`
`Notification of the data mentioned in Rule 19(3) EPC
`
`In the above-identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`PRIORITY
`
`: US/14.06.11/ USP201161497017
`: US/13.12.11/ USP201161570110
`
`TITLE
`
`:ADMINISTRATION OF BENZODIAZEPINE
`
`DESIGNATED STATES
`
`:AL AT BE BG CH CY 02 DE DK EE ES FI FR GB GR HR HU IE
`IS IT LI LT LU LV MG MK MT NL NO PL PT RO RS SE SI SK SM
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`9232 Bernardo Lakes Drive
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`ETATS-UNIS D'AMERIQUE
`
`European Patent Office
`Postbus 5818
`2280 HV RIJSWIJK
`NETHERLANDS
`Tel. +31 (0)70 340-2040
`Fax +31 (0)70 340-3016
`
`this communication:
`
`Tel.:+31 (0)70 340 45 00
`
`Date
`24.01 .1 4
`
`Reference
`
`Applicant/Proprietor
`
`Application No./Patent No.
`
`
`
`Hale BioPharma Ventures, LLC
`
`Notification of the data mentioned in Rule 19(3) EPC
`
`In the above-identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`PRIORITY
`
`: US/14.06.11/ USP201161497017
`: US/13.12.11/ USP201161570110
`
`TITLE
`
`:ADMINISTRATION OF BENZODIAZEPINE
`
`DESIGNATED STATES
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`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0262
`
`page 0262
`
`

`

`Europilsches
`
` Patcntamt
`
`European
`Patent Office
`,
`33331:?”
`
`LOXLEY, Andrew
`126 Market Street 5
`
`Philadelphia, PA 19106
`ETATS-UNIS D'AMERIQUE
`
`European Patent Office
`POSthS 5818
`
`2280 HV RIJSWIJK
`#EITH3E1RI6A703DSS O 2040
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`
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`
`late
`24.01 .14
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`Application No./Patent No.
`I
`_ 128013729 - 1453 PCT/US2012042311
`
`‘ -p Ican 'roprletor
`
`Hale BioPharma Ventures, LLC
`
`'
`
`Notification of the data mentioned in Rule 19(3) EPC
`
`In the above-identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`PRIORITY
`
`: US/14.06.11/ USP201161497017
`: US/13.12.11/ USP20116157011O
`
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`3260 Whipple Road
`Union City, CA 94587
`ETATS-UNIS D'AMERIQUE
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`European Patent Office
`Postbus 5818
`2280 HV RIJSWIJK
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`24.01 .1 4
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`
`Application NolPatent No.
`
`_ 128013729 - 1453 PCT/US2012042311
`
`Hale BioPharma Ventures, LLC
`
`Notification of the data mentioned in Rule 19(3) EPC
`
`In the above—identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`‘ PRIORITY
`
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`
`: US/14.06.11/ USP201161497017
`:US/13.12.11/ USP201161570110
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`AQUESTIVE EXHIBIT 1040 page 0265
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`AQUESTIVE EXHIBIT 1040 page 0266
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`Europilsches
`
` Patentamt
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`
`MAGGIO, Edward, T.
`16870 W. Bernardo Drive Suite 390
`
`San Diego, CA 92127
`ETATS-UNIS D'AMERIQUE
`
`European Patent Office
`Postbus 5818
`2280 HV RIJSWIJK
`'IF‘EITHIEERbANDS
`e . +
`70 340-2040
`Fax +31 E0370 340-3016
`
`this communication:
`
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`24.01.14
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`
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`
`
`
`
`Hale BioPharma Ventures, LLC
`
`Notification Of the data mentioned in Rule 19(3) EPC
`
`In the above-identified patent application you are designated as inventor/co-inventor.
`Pursuant to Rule 19(3) EPC the following data are notified herewith:
`
`DATE OF FILING
`
`: 13.06.12
`
`PRIORITY
`
`: US/14.06.11/ USP201161497017
`2 US/13.12.11/ USP201161570110
`
`TITLE
`
`:ADMINISTRATION OF BENZODIAZEPINE
`
`DESIGNATED STATES
`
`'
`
`:AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE
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`AQUESTIVE EXHIBIT 1040 page 0267
`
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`
`
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`

`

`
`
`532333;?“
`European
`Patent Office
`Office européen
`des brevets
`
`
`
`
`
`
`
`
`
`
`
`Wichmann, Hendrik
`Wuesthoff & Wuesthoff
`
`Schweigerstrasse 2
`81541 MUnchen
`ALLEMAGNE
`
`European Patent Office
`80298 MUNICH
`GERMANY
`
`Questions about this communication ?
`Contact Customer Services at www.epo.org/contact
`
`Date
`
`26.03.14
`
`Reference
`EPA-124 519
`
`Application No./Patent No.
`
`12801372.9 - 1453 / 2720699 PCT/US2012042311 Applicant/Proprietor
`
`Hale BioPharma Ventures, LLC
`
`Communication of European publication number and information on the application of
`Article 67(3) EPC
`
`The provisional protection under Article 67(1) and (2) EPC in the individual Contracting States becomes
`effective only when the conditions referred to in Article 67(3) EPC have been fulfilled (for further details,
`see information brochure of the European Patent Office "National Law relating to the EPC" and additional
`information in the Official Journal of the European Patent Office).
`
`Pursuant to Article 153(3) EPC the publication under Article 21 PCT of an international application for
`which the European Patent Office is a designated or elected Office takes the place of the publication of a
`European patent application.
`
`The bibliographic data of the above-mentioned Euro-PCT application will be published on 23.04.14 in
`Section H of the European Patent Bulletin. The European publication number is 2720699.
`
`In all future communications to the European Patent Office, please quote the application number plus
`Directorate number.
`
`Receiving Section
`
`Q?»
`3°
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`
`EPO Form1219
`
`03.11
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0269
`
`page 0269
`
`

`

`PATENT COOPERATION TREATY
`
`PCT
`
`INTERNATIONAL PRELIIVIINARY REPORT ON PATENTABILITY
`
`(Chapter I of the Patent Cooperation Treaty)
`
`(PCT Rule 44bis)
`
`Applicant’s or agent’s file reference
`35401-716602
`
`FOR FURTHER ACTION
`
`See item 4 below
`
`International application No.
`PCT/US2012/042311
`
`International filing date (day/month/year)
`13 June 2012 (13.06.2012)
`
`Priority date (day/month/year)
`14 June 2011 (14.06.2011)
`
`International Patent Classification (8th edition unless older edition indicated)
`See relevant information in Form PCT/ISA/237
`
`Applicant
`HALE BIOPHARMA VENTURES, LLC
`
`This international preliminary report on patentability (Chapter I) is issued by the International Bureau on behalf of the
`International Searching Authority under Rule 44 bis.1(a).
`
`This REPORT consists of a total of 8 sheets, including this cover sheet.
`
`In the attached sheets, any reference to the written opinion of the International Searching Authority should be read as a
`reference to the international preliminary report on patentability (Chapter I) instead.
`
`This report contains indications relating to the following items:
`
`Box \0. I
`
`Basis of the report
`
`
`
`
`
`Box
`
`Box
`
`Box
`
`Box
`
`Box
`
`Box
`
`Box
`
`. II
`
`Priority
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Non-establishment of opinion with regard to novelty, inventive step and industrial
`applicability
`
`Lack of unity of invention
`
`Reasoned statement under Article 35(2) with regard to novelty, inventive step or
`industrial applicability; citations and explanations supporting such statement
`
`Certain documents cited
`
`Certain defects in the international application
`
`Certain observations on the international application
`
`
`
`The International Bureau will communicate this report to designated Offices in accordance with Rules 44bis.3(c) and 93bis.1
`but not, except where the applicant makes an express request under Article 23(2), before the expiration of 30 months from
`the priority date (Rule 44bis .2).
`
`The International Bureau of WIPO
`34, chemin des Colombettes
`1211 Geneva 20, Switzerland
`
`Date of issuance of this report
`25 March 2014 (25.03.2014)
`
`AnthOHZEd officer
`
`.
`.
`.
`Llngfel Bal
`
`Facsimile No. +41 22 338 82 70
`
`Form PCT/IB/373 (January 2004)
`
`e-mail: pt02.pct@wipo.int
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0270
`
`page 0270
`
`

`

`
`
`
`PALO ALTO, CA 94304
`
`
`
`
`
`
`Date of mailing
`(day/monlh/year)
`31 AU G 20 12
`
`
`Applicant’s or agent’s file reference
`
`.
`
`FOR FURTHER ACTION
`
`PCT/USZO12IO42311 31.08.2012
`
`From the
`INTERNATIONAL SEARCHING AUTHORITY
`
`PATENT COOPERATION TREATY
`
`
`
`To; MATTHEW v. GRUMBLING
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`
`PCT
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`(PCT Rule 43bis.1)
`
`
`
`35401 -71 6.602
`
`See paragraph 2 below
`
`International application No.
`
`International filing date (day/month/year)
`
`Priority date (day/month/year)
`
`13 June 2012 (13.06.2012)
`
`PCT/US12/42311
`
`International Patent Classification (IPC) or both national classification and IPC
`IPC(8) - A01 N 43/62; A61K 31/55 (2012.01)
`
`
`USPC - 514/220-221
`
`Applicant HALE BIOPHARMA VENTURES, LLC
`
`
`14 June 2011 (14.06.2011)
`
`I. This opinion contains indications relating to the following items:
`[X Box No. I
`Basis of the opinion
`
`E] Box No. II
`
`Priority
`
`Box No.
`
`Non—establishment of opinion with regard to novelty, inventive step and industrial applicability
`
`Box No. IV Lack of unity of invention
`
`Box No. V
`
`Reasoned statement under Rule 43bis.l(a)(i) with regard to novelty, inventive step or industrial applicability;
`citations and explanations supporting such statement
`
`Box No. VI
`
`Certain documents cited
`
`Box No. VII Certain defects in the international application
`
`Box No. VIII Certain observations on the international application
`
`2. FURTHER ACTION
`
`If a demand for international preliminary examination is made, this opinion will be considered to be a written opinion of the
`International Preliminary Examining Authority (“IPEA”) except that this does not apply where the applicant chooses an Authority
`other than this one to be the IPEA and the chosen IPEA has notified the International Bureau under Rule 66.l bis(b) that written
`opinions of this International Searching Authority will not be so considered.
`
`If this opinion is, as provided above, considered to be a written opinion of the IPEA, the applicant is invited to submit to th IPEA
`a written reply together, where appropriate, with amendments, before the expiration of 3 months from the date of mailing of Fom
`PCT/ISA/220 or before the expiration of 22 months from the priority date, whichever expires later.
`
`For further options, see Form PCT/ISA/220.
`
`PCT Helpdesk: 571272-4300
`
`Name and mailing address of the ISA/US Date of completion of this opinion
`Mail Stop PCT, Attn: ISA/US
`C
`'
`'
`f Pt
`I
`pmlff'fisetifiefafigia, Virginia 223134450
`Facsimile No. 571 -273-3201
`
`‘0 AUQUSt 201?- (1003-2012)
`
`Authorized officer:
`
`Lee W. Young
`
`PCT osp; 571-272-7774
`
`Form PCT/ISA/237 (cover sheet) (July 20] l)
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0271
`
`page 0271
`
`

`

`PCT/USZO12I042311 31.08.2012
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
` International application No.
`
`PCT/US 12/42311
`
`Box No. I
`
`Basis of this opinion
`
`
`
`
`
`1. With regard to the language, this opinion has been established on the basis of:
`[E the international application in the language in which it was filed.
`I:
`a translation of the international application into
`
`which is the. language of a
`
`
`
`
`translation fumished for the purposes of international search (Rules 12.3(a) and 23.1(b)).
` 2. D This opinion has been established taking into account therectification of an obvious mistake authorized by or notified
`
` 3. With regard to any nucleotide and/or amino acid sequence disclosed in the international application, this opinion has been
`
`
`established on the basis ofa sequence listing filed or furnished:
`(means)
` a.
`
`on paper
`
` in electronic form
`
`to this Authority under Rule 91 (Rule 43 bis. 1(a))
`
` in the international application as filed
`
`I:
`together with the international application in electronic form
`
`
`subsequently to this Authority for the purposes of search
`
` 4. D In addition, in the case that more than one version or copy of a sequence listing has been filed or furnished, the required
`statements that the information in the subsequent or additional copies is identical to that in the application as filed or
`
`does not go beyond the application as filed, as appropriate, were fumished.
`
`5. Additional comments:
`
`
`
`Form PCT/ISN237 (BOX NO- I) (July 201 1)
`
`AQUESTIVE EXHIBIT 1040
`
`AQUESTIVE EXHIBIT 1040 page 0272
`
`page 0272
`
`

`

`PCT/USZO12IO42311 31.08.2012
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/US 12/423“
`
`Box No. 111
`
`Non-establishment of opinion with regard to novelty, inventive step and industrial applicability
`
`The questions whether the claimed invention appears to be novel, to involve an inventive step (to be non obvious), or to be indistrially
`applicable have not been examined in respect of:
`'
`
`D the entire international application.
`
`m claims Nos. 63-65
`
`because:
`
`El
`
`the said international application, or the said claims Nos.
`subject matter which does not require an international search (speczfv):
`
`relate to the following
`
`I: See Supplemental Box for further details.
`
`V'
`M the description, claims or drawings (indicate particular elements below) or said claims Nos. 63-65
`are so unclear that no meaningful opinion could be formed (specifiz):
`Claims 63-65 are improper multiple dependent claims because they are dependent claims and are not drafted in accordance with the
`second and third sentences of Rule 6.4(a).
`
`El
`
`the claims, or said claims Nos.
`by the description that no meaningful opinion could be formed (specifil):
`
`are so inadequately supported
`
`E no international search report has been established for said claims Nos. 5355
`
`E]
`
`the applicant did not, within the prescribed time limi
`a meaningful opinion could not be