Bass and Spangenberg
`Exhibit 1012
`
`Page 1 of 15
`
`

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`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
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`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any Change Ofaddress)
`
`7590
`6449
`ROTHWELL, FIGG,
`
`03/20/2013
`&
`
`607 14th Street’ N'W'
`SUITE 800
`WASHINGTON, DC 20005
`
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`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`V
`_
`‘D°P°“‘°”““°>
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`INV001Federico Stroppolo
`07/06/2010
`12/811,737
`TITLE OF INVENTION: ORALLY DISINTEGRATING TABLETS WITH SPECKLED APPEARANCE
`
`3504- 108
`
`1929
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$ 1780
`
`$3 00
`
`$0
`
`$2080
`
`06/20/2013
`
`ALLEY, GENEVIEVE S
`
`1617
`
`424- 010200
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
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`3 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/ 122) attached.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/811,737
`
`07/06/2010
`
`INV001Federico Stroppolo
`
`3504-108
`
`1929
`
`6449
`
`7590
`
`03/20/2013
`
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th Street, N.W.
`sum 800
`WASHINGTON, DC 20005
`
`ALLEY, GENEV -VES
`
`1617
`
`DATE MAILED: 03/20/2013
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(application filed on or after May 29, 2000)
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`The Patent Term Adjustment to date is 43 day(s). If the issue fee is paid on the date that is three months after the
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`PTOL—85 (Rev. 02/11)
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`Page 4 of 15
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`

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`Page 5 of 15
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`Page 5 of 15
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`

`
`Application No.
`
`App|icant(s)
`
`12/811,737
`
`STROPPOLO ET AL.
`
`GENEVIEVE S. ALLEY
`
`1617
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL—85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. IX This communication is responsive to December 12 2012.
`
`2. I] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`; the restriction
`
`3. IX! The allowed cIaim(s) is/are Q. As a result of the allowed cIaim(s), 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
`httaz.//‘www.us to. ow‘ atents/init events/'
`h/indexfis or send an inquiry to PPI-Ifeedbackf usgtogov .
`
`4. I] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119( )—(d) or (f).
`
`a) D All
`
`b) I:I Some*
`
`c) I:I None
`
`of the:
`
`1. I:I Certified copies of the priority documents have been received.
`
`2. El Certified copies of the priority documents have been received in Application No.
`
`3. El 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( )).
`
`* Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE” of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. I:I CORRECTED DRAWINGS ( as “replacement sheets”) must be submitted.
`
`I:I
`
`including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`Paper No./Mail Date
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6. I] DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. I] Notice of References Cited (PTO—892)
`
`2. I] Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date
`3. I:I Examiner’s Comment Regarding Requirement for Deposit
`of Biological Material
`4. IX Interview Summary (PTO—413),
`Paper No./Mail Date 03/13/13.
`
`5. IX] Examiner’s Amendment/Comment
`
`6. IX] Examiner’s Statement of Reasons for Allowance
`
`7. El Other
`
`/GENEVIEVE S ALLEY/
`EXamiF1eF,AF’EUF1i’E1617
`
`/Fereydoun G Sajjadi/
`Supervisory Patent Examiner, Art Unit 1617
`
`U.S. Patent and Trademark Office
`
`PTOL-37 (Rev. 09-12)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20130312
`
`Page 6 of 15
`
`Page 6 of 15
`
`

`
`_
`_
`_
`_
`Examiner-Initiated Interview Summary
`
`12/811,737
`_
`Examiner
`
`STROPPOLO ET AL.
`_
`Art Unit
`
`Application No.
`
`App|icant(s)
`
`
`
`GENEVIEVE s. ALLEY 1617
`
`All participants (applicant, app|icant’s representative, PTO personnel):
`
`(1) GENEVIEVE S. ALLEY.
`
`(2) —
`
`Date of Interview: 12 March 2013.
`
`(3)
`
`.
`
`(4):-
`
`Type:
`
`I:I Video Conference
`IX] Telephonic
`I] Personal [copy given to: El applicant
`
`El applicant’s representative]
`
`Exhibit shown or demonstration conducted:
`If Yes, brief description: E.
`
`[I Yes
`
`IX] No.
`
`IZI112 I:|102 I:|103 I:IOthers
`I:I101
`Issues Discussed
`(For each of the checked box(es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: 1-11.
`
`Identification of prior art discussed:
`
`Substance of Interview
`(For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a
`reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc...)
`
`The Examiner indicated that claims 1 -9 were in condition for allowance. However, claims 10 and 11 would be reiected
`under 112, 2" paragraph; claims 10 and 11 provide for the use of ‘indentifying an orally disintegrating tablet” but,
`since the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant
`is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps
`delimiting how this use is actually practiced. The Examiner indicated that an issue of allowance for claims 1-9 could
`
`be filed if claims 10 and 11 were canceled in an Examiner's amendment. Monica Kitts authorized the cancelation of
`claims 10 and 11..
`
`Applicant recordation instructions:
`
`If is not necessary for applicant to provide a separate record of the substance of interview.
`
`Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of
`the substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the
`general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the
`general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.
`
`I:| Attachment
`/GENEVIEVE S ALLEY/
`Examiner, Art Unit 1617
`
`U.S. Patent and Trademark Office
`
`PTOL-413B (Rev. 8/11/2010)
`
`
`
`Interview Summary
`
`Paper No. 20130312
`
`Page 7 of 15
`
`Page 7 of 15
`
`

`
`Application/Control Number: 12/811,737
`
`Page 2
`
`Art Unit: 1617
`
`DETAILED ACTION - ALLOWANCE
`
`Continued Examination Under 37 CFR 1.114
`
`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 December 12, 2012 has been entered.
`
`Claim Status
`
`Applicants’ response of December 12, 2012, to the final Office action dated September
`
`12, 2012 has been entered. Claim 1 has been amended and no claims have been newly added or
`
`newly canceled.
`
`This application is in condition for allowance except for the presence of claims 10 and 11
`
`directed to a method of identifying an orally disintegrating tablet, which was non—elected.
`
`Claims 10 and 11 are canceled (see Examiner’s Amendment below).
`
`Accordingly, claims 1-9 are pending in the application.
`
`Withdrawn Claim Rejections
`
`The rejection of claims 1-4 and 8 under 35 U.S.C. §102(b) as being anticipated by
`
`Martino et al. (US 2003/0180357; published: September 25, 2003; of record); claim 1-4, 8 and 9
`
`under 35 U.S.C. §103 as being unpatentable over Martino et al. (US 2003/0180357; published:
`
`Page 8 of 15
`
`Page 8 of 15
`
`

`
`Application/Control Number: 12/811,737
`
`Page 3
`
`Art Unit: 1617
`
`September 25, 2003; of record); and claims 1-9 under 35 U.S.C. §103 as being unpatentable over
`
`Martino et al. (US 2003/0180357; published: September 25, 2003; of record), in View of
`
`Pettersson et al. (US 2004/0213855; published: October 28, 2004; of record) are hereby
`
`withdrawn in View of the claim amendments filed on December 12, 2012; specifically, claim 1
`
`amendment that requires the speckles to comprise colored granules of water—soluble sugar, not
`
`taught by the cited prior art.
`
`Examiner ’s Amendment
`
`An examiner’s amendment to the record appears below. Should the changes and/or
`
`additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR
`
`1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the
`
`payment of the issue fee.
`
`Authorization for this examiner’s amendment was given in a telephone interview with
`
`Monica Kitts on March 12, 2013 (See Interview Summary: March 12, 2013).
`
`Claims 10 and 11 have been canceled.
`
`Reasons for Allowance
`
`The following is an examiner’s statement of reasons for allowance:
`
`The prior art fails to teach or reasonably suggest an orally disintegrating tablet, wherein
`
`colored granules of sugar provide a speckled appearance. The closest prior art of record is
`
`Martino et al. (US 2003/0180357; of record), which teaches a tablet with a speckled appearance,
`
`wherein the tablet comprises mannitol (i.e., a water—soluble sugar) and dye particles; however,
`
`Page 9 of 15
`
`Page 9 of 15
`
`

`
`Application/Control Number: 12/811,737
`
`Page 4
`
`Art Unit: 1617
`
`the speckles comprise solid particles of dye ([0061]) and not colored granules of a water—soluble
`
`sugar. As indicative by the method of preparing the abovementioned tablet (mannitol and dye
`
`are blended in a high— shear mixer for 2 minutes), the granules of sugar are not colored. The solid
`
`particles of dye are merely blended with the mannitol and therefore, the dye does not coat or
`
`attach to the mannitol (i.e., the mannitol is not colored by the dye particles).
`
`Any comments considered necessary by applicant must be submitted no later than the
`
`payment of the issue fee and, to avoid processing delays, should preferably accompany the issue
`
`fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for
`
`Allowance.”
`
`Claims 1-9 are allowed.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to GENEVIEVE S. ALLEY Whose telephone number is (571)270-
`
`1l11. The examiner can normally be reached on Monday through Friday 7:30AM to 5:00PM
`
`EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Fereydoun Sajjadi can be reached on 571-272-3311. 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
`
`Page 10 of 15
`
`Page 10 of 15
`
`

`
`Application/Control Number: 12/811,737
`
`Page 5
`
`Art Unit: 1617
`
`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.
`
`/GENEVIEVE S ALLEY/
`
`Examiner, Art Unit 1617
`
`/Fereydoun G Sajjadi/
`
`Supervisory Patent Examiner, Art Unit 1617
`
`Page 110115
`
`Page 11 of 15
`
`

`
`Application/Control No.
`
`Search NOTES
`
`12811737
`
`Applicant(s)/Patent Under
`Reexamination
`
`STROPPOLO ET AL.
`
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`GENEVIEVE S ALLEY
`
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`
`/G.S.A./
`Examiner.Art Unit 1617
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`U.S. Patent and Trademark Office
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`03/12/13
`03/12/13
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`Part of Paper No.
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`: 20130312
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`Page 12 of 15
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`Page 12 of 15
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`1III“I“I|HI|HII“I"WI I1
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`GENEVIEVE S ALLEY
`
`1617
`
`Issue Classification 12811737
`
`STROPPOLO ET AL.
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`Svmb°'
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`US ORIGINAL CLASSIFICATION
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`INTERNATIONAL CLASSIFICATION
`
`Version
`
`A
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`49/00 2006.01.01
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`O.G. Print Figure
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`‘
`CROSS REFERENCE S
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`/GENEVIEVE S ALLEY/
`
`Examiner.Art Unit 1617
`
`(Assistant Examiner)
`/FEREYDOUN G SAJJAD|/
`Supervisory Patent Examiner.Art Unit 1617
`
`(Primary Examiner)
`U.S. Patent and Trademark Office
`
`03/13/13
`
`(Date)
`
`Total Claims Allowed:
`9
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`03/13/2013
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`O.G. Print C|aim(s)
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`(Date)
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`1
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`“One
`Part of Paper No. 20130312
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`Page 13 of15
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`Page 13 of 15
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`

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`Issue Classification 12811737
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`STROPPOLO ET AL.
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`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
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`GENEVIEVE S ALLEY
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`/GENEVIEVE S ALLEY/
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`“One
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`03/13/13
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`(Date)
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`Total Claims Allowed:
`9
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`03/13/2013
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`O.G. Print C|aim(s)
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`O.G. Print Figure
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`Examiner.Art Unit 1617
`
`(Assistant Examiner)
`/FEREYDOUN G SAJJAD|/
`Supervisory Patent Examiner.Art Unit 1617
`
`(Primary Examiner)
`U.S. Patent and Trademark Office
`
`(Date)
`
`1
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`Part of Paper No. 20130312
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`Page 14 of15
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`Issue Classification 12811737
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`STROPPOLO ET AL.
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`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`11||1|H1|1|H||11|1|H1||H1|1||||1111|| "1
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`GENEVIEVE S ALLEY
`
`1617
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`E
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`Claims renumbered in the same order as presented by applicant
`
`[I
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`E]
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`T.D
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`Final
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`Original
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`Final
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`Original
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`Final
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`Original
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`Final
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`Original
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`Final
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`Original
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`Final
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`Original
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`Final
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`Original
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`Final
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`Original
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`/GENEVIEVE S ALLEY/
`
`
`
`Examiner.Art Unit 1617
`
`(Assistant Examiner)
`/FEREYDOUN G SAJJAD|/
`Supervisory Patent Examiner.Art Unit 1617
`
`(Primary Examiner)
`U.S. Patent and Trademark Office
`
`03/13/13
`
`(Date)
`
`Total Claims Allowed:
`9
`
`03/13/2013
`
`O.G. Print C|aim(s)
`
`O.G. Print Figure
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`(Date)
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`1
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`“One
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