UNITED STA TES p A TENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
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`12/553, 107
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`0910312009
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`Brian Ault
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`POZN.P0026US
`
`5949
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`10/09/2015
`
`7590
`108197
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. 1, Suite 200
`Austin, TX 78746
`
`EXAMINER
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`JUSTICE, GINA CHIEUN YU
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`ART UNIT
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`PAPER NUMBER
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`1617
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`NOTIFICATION DATE
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`DELIVERY MODE
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`10/09/2015
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address( es):
`docket@phiplaw.com
`
`PTOL-90A (Rev. 04/07)
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`MYLAN PHARMS. INC. EXHIBIT 1041 PAGE 1
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`

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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 2
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`The present application is being examined under the pre-AIA first to invent
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`provisions.
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`Continuation of No. 5:
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`Applicant's reply has overcome the following rejections:
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`1) Rejection made under 35 U.S.C. § 103 (a) over Hassan-Alin et al.
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`(Gastroenterology, 124 (4), 2003) in view of Plachetka (US 6926907 B2), which was
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`indicated in the previous Office action dated March 26, 2015;
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`2) Obviousness double patenting rejection made in view of claims 1-55 of US
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`Pat. No. 6926907 B2 in view of Hassan-Al in; and
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`3) Obviousness double patenting rejection made in view of claims 57-75 of
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`Application No. 14/045156 (now US Pat. No. 8852636).
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`Continuation of No. 12:
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`Claims 19, 29, 33, 34, 40, 42 and 45 remain rejected on the ground of
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`nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent
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`No. 8945621 B2 (previously cited as Application No. 12/822612). The rejection is
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`deemed proper and maintained for the reasons of record. Although applicant indicated
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`disagreement with the rejection, no specific reasons or explanation was given.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to GINA YU JUSTICE whose telephone number is
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`MYLAN PHARMS. INC. EXHIBIT 1041 PAGE 2
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`

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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 3
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`(571 )272-8605. The examiner can normally be reached on Monday through Friday,
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`from 9:00AM until 5:00 PM.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Johann Richter can be reached on 571-272-0646. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`/GINA YU JUSTICE/
`Primary Examiner, Art Unit 1617
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`MYLAN PHARMS. INC. EXHIBIT 1041 PAGE 3
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`

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`Advisory Action
`Before the Filing of an Appeal Brief
`
`Application No.
`121553, 107
`
`Examiner
`GINA YU JUSTICE
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`Applicant(s)
`AULT ET AL.
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`I AIA (First Inventor to File) Status
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`Art Unit
`1617
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`No
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`--The MAILING DATE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`THE REPLY FILED 25 September 2015 FAILS TO PLACE THIS APPLICATION IN CONDITION FOR ALLOWANCE.
`NO NOTICE OF APPEAL FILED
`1. 1:8:1 The reply was filed after a final rejection. No Notice of Appeal has been filed. To avoid abandonment of this application, applicant must timely file
`one of the following replies: (1) an amendment, affidavit, or other evidence, which places the application in condition for allowance;
`(2) a Notice of Appeal (with appeal fee) in compliance with 37 CFR 41.31; or (3) a Request for Continued Examination (RCE) in compliance with
`37 CFR 1.114 if this is a utility or plant application. Note that RCEs are not permitted in design applications. The reply must be filed within one of
`the following time periods:
`a) [gl The period for reply expires .Q_months from the mailing date of the final rejection.
`b) D The period for reply expires on: (1) the mailing date of this Advisory Action; or (2) the date set forth in the final rejection, whichever is later.
`In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of the final rejection.
`c) D A prior Advisory Action was mailed more than 3 months after the mailing date of the final rejection in response to a first after-final reply filed
`months from the mailing date of
`within 2 months of the mailing date of the final rejection. The current period for reply expires
`the prior Advisory Action or SIX MONTHS from the mailing date of the final rejection, whichever is earlier.
`Examiner Note: If box 1 is checked, check either box (a), (b) or (c). ONLY CHECK BOX (b) WHEN THIS ADVISORY ACTION IS THE
`FIRST RESPONSE TO APPLICANT'S FIRST AFTER-FINAL REPLY WHICH WAS FILED WITHIN TWO MONTHS OF THE FINAL
`REJECTION. ONLY CHECK BOX (c) IN THE LIMITED SITUATION SET FORTH UNDER BOX (c). See MPEP 706.07(f).
`Extensions of time may be obtained under 37 CFR 1.136(a). The date on which the petition under 37 CFR 1.136(a) and the appropriate
`extension fee have been filed is the date for purposes of determining the period of extension and the corresponding amount of the fee. The
`appropriate extension fee under 37 CFR 1.17(a) is calculated from: (1) the expiration date of the shortened statutory period for reply originally
`set in the final Office action; or (2) as set forth in (b) or (c) above, if checked. Any reply received by the Office later than three months after the
`mailing date of the final rejection, even if timely filed, may reduce any earned patent term adjustment. See 37 CFR 1.704(b).
`NOTICE OF APPEAL
`2. 1:8:1 The Notice of Appeal was filed on 25 September 2015. A brief in compliance with 37 CFR 41 .37 must be filed within two months of the
`date of filing the Notice of Appeal (37 CFR 41.37(a)), or any extension thereof (37 CFR 41.37(e)), to avoid dismissal of the appeal. Since
`a Notice of Appeal has been filed, any reply must be filed within the time period set forth in 37 CFR 41.37(a).
`AMENDMENTS
`3. D The proposed amendments filed after a final rejection, but prior to the date of filing a brief, will not be entered because
`a) D They raise new issues that would require further consideration and/or search (see NOTE below);
`b) D They raise the issue of new matter (see NOTE below);
`c) D They are not deemed to place the application in better form for appeal by materially reducing or simplifying the issues for
`appeal; and/or
`d) D They present additional claims without canceling a corresponding number of finally rejected claims.
`NOTE: __ . (See 37 CFR 1.116 and 41.33(a)).
`4. D The amendments are not in compliance with 37 CFR 1.121. See attached Notice of Non-Compliant Amendment (PTOL-324).
`5. [gl Applicant's reply has overcome the following rejection(s): See continuation sheet.
`6. D Newly proposed or amended claim(s) __ would be allowable if submitted in a separate, timely filed amendment canceling the non(cid:173)
`allowable claim(s).
`7. D For purposes of appeal, the proposed amendment(s): (a) D will not be entered, or (b) D will be entered, and an explanation of how the
`new or amended claims would be rejected is provided below or appended.
`AFFIDAVIT OR OTHER EVIDENCE
`8. D A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`9. D The affidavit or other evidence filed after final action, but before or on the date of filing a Notice of Appeal will not be entered because
`applicant failed to provide a showing of good and sufficient reasons why the affidavit or other evidence is necessary and was not earlier
`presented. See 37 CFR 1.116(e).
`1 O. D The affidavit or other evidence filed after the date of filing the Notice of Appeal, but prior to the date of filing a brief, will not be entered
`because the affidavit or other evidence failed to overcome g!! rejections under appeal and/or appellant fails to provide a showing of good
`and sufficient reasons why it is necessary and was not earlier presented. See 37 CFR 41.33(d)(1 ).
`11. D The affidavit or other evidence is entered. An explanation of the status of the claims after entry is below or attached.
`REQUEST FOR RECONSIDERATION/OTHER
`12. 1:8:1 The request for reconsideration has been considered but does NOT place the application in condition for allowance because:
`See continuation sheet.
`13. D Note the attached Information Disclosure Statement(s). (PTO/SB/08) Paper No(s). __
`14. D Other: __ .
`STATUS OF CLAIMS
`15. The status of the claim(s) is (or will be) as follows:
`Claim(s) allowed:
`Claim(s) objected to:
`Claim(s) rejected: 19, 29, 33, 34, 40, 42 and 45.
`Claim(s) withdrawn from consideration:
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`U.S. Patent and Trademark Office
`PTOL-303 (Rev. 08-2013)
`
`I
`Advisory Action Before the Filing of an Appeal Brief
`
`/GINA YU JUSTICE/
`Primary Examiner, Art Unit 1617
`
`Part of Paper No. 20151006
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`MYLAN PHARMS. INC. EXHIBIT 1041 PAGE 4
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