IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Application of:
`
`Klaus DUGI, et al
`
`Art Unit:
`
`1629
`
`U.S. Appln. No.
`
`12/946,193
`
`Examiner:
`
`K. WEDDINGTON
`
`U.S. Filing Date:
`
`November 15, 2010
`
`Confirm. No.:
`
`9433
`
`Title of Invention:
`
`USES OF DDP—IV INHIBITORS
`
`Docket No.:
`
`01—2051—1—C1
`
`VIA EFS Web
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`RESPONSE UNDER 37 C.F.R.
`
`1.111
`
`Sir:
`
`This paper is responsive to a nonfinal office action having a notification date of
`
`October 29, 2012 in connection with the above—identified patent application. A response to
`
`the office action was initially due three (3) months from the notification date of the office
`
`action, that is, by January 29, 2013. Accordingly, filed concurrently herewith is a Petition
`
`for Extension of Time to extend the time for responding to the office action by three (3)
`
`months, such that it expires on April 29, 2013.
`
`Petition for Extension of Time begins on page 2 of this paper.
`
`Amendments to the Claims begin on page 3 of this paper.
`
`Remarks begin on page 7 of this paper.
`
`MYLAN Ex. 1016, Page 1
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`MYLAN Ex. 1016, Page 1
`
`

`
`U.S. Application No.: 12/946,193
`Response to Nonfinal Office Action dated October 29, 2012
`
`PETITION FOR EXTENSION OF TIME
`
`Applicants’ agent hereby petitions for a three (3) month extension of time under 37
`
`C.F.R. § 1.136, to extend the time for responding to the October 29, 2012 office action
`
`such that expires on April 29, 2012. The fee required under 37 C.F.R. § 1.17(a) in
`
`connection with this petition will be paid during electronic filing Via the Revenue
`
`Accounting and Management System.
`
`MYLAN Ex. 1016, Page 2
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`MYLAN Ex. 1016, Page 2
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`

`
`U.S. Application No.: 12/946,193
`Response to Nonfinal Office Action dated October 29, 2012
`
`Amendments to the Claims:
`
`This listing of claims will replace all prior versions and listings of claims in the
`
`application:
`
`Listing of Claims:
`
`Claims 1-55. (Cancelled).
`
`56.
`
`(Previously presented) A method of treating type II diabetes mellitus comprising
`
`administering to a patient in need thereof a pharmaceutically effective oral amount of 1-
`
`[(4-methyl-quinazolin-2-yl)methyl] -3 —methyl—7—(2—butyn— 1-yl)-8-(3-(R)-amino-piperidin-1-
`
`yl)-xanthine, and a pharmaceutically effective amount of metformin, which is from 300 mg
`
`to 1000 mg once or twice a day, or delayed—release metformin in a dose of 500 mg to 1000
`
`mg once or twice a day or 500 mg to 2000 mg once a day.
`
`57.
`
`(Previously presented) The method according to claim 56, wherein the
`
`pharmaceutically effective oral amount of 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-
`
`7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is an oral daily dose of from 2.5
`
`mg to 10 mg.
`
`58.
`
`(New) The method according to claim 56, wherein the 1-[(4—methyl—quinazolin—2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of from 0.5 mg to 50 mg.
`
`59.
`
`(New) The method according to claim 56, wherein the 1-[(4—methyl—quinazolin—2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of from 2.5 mg to 10 mg.
`
`60.
`
`(New) The method according to claim 56, wherein the 1-[(4—methyl—quinazolin—2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of 0.5 mg, 1 mg, 2.5 mg, 5 mg or 10 mg.
`
`MYLAN Ex. 1016, Page
`
`MYLAN Ex. 1016, Page 3
`
`

`
`U.S. Application No.: 12/946,193
`Response to Nonfinal Office Action dated October 29, 2012
`
`61.
`
`(New) The method according to claim 56, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 -methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of 1 mg, 2.5 mg or 5 mg.
`
`62.
`
`(New) The method according to claim 56, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 -methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of 2.5 mg or 5 mg.
`
`63.
`
`(New) The method according to claim 56, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 -methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of from 2.5 mg to 50 mg.
`
`64.
`
`(New) The method according to claim 56, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 -methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral daily dose of 5 mg.
`
`65.
`
`(New) A method of treating type 2 diabetes or pre-diabetes comprising
`
`administering to a patient in need thereof a therapeutically effective oral dose of 1-[(4-
`
`methyl-quinazolin-2-yl)methyl] -3 -methyl-7-(2-butyn-1-yl)-8-(3 -(R)-amino-piperidin-1-yl)-
`
`xanthine in combination with a therapeutically effective dose of metformin, which is 500
`
`mg, 850 mg or 1000 mg metformin as a single dose with a total daily dose of metformin of
`
`500-2850 mg, or which is 500 mg, 1000 mg, 1500 mg or 2000 mg metformin in delayed
`
`release form.
`
`66.
`
`(New) The method according to claim 65, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 -methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of from 0.5 mg to 50 mg.
`
`67.
`
`(New) The method according to claim 65, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 -methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of from 2.5 mg to 10 mg.
`
`MYLAN Ex. 1016, Page 4
`
`MYLAN Ex. 1016, Page 4
`
`

`
`U.S. Application No.: 12/946,193
`Response to Nonfinal Office Action dated October 29, 2012
`
`68.
`
`(New) The method according to claim 65, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of 0.5 mg, 1 mg, 2.5 mg, 5 mg or 10 mg.
`
`69.
`
`(New) The method according to claim 65, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of 1 mg, 2.5 mg or 5 mg.
`
`70.
`
`(New) The method according to claim 65, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of 2.5 mg or 5 mg.
`
`71.
`
`(New) The method according to claim 65, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral dosage of from 2.5 mg to 50 mg.
`
`72.
`
`(New) The method according to claim 65, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is
`
`administered in an oral daily dose of 5 mg.
`
`73.
`
`(New) A method of treating type II diabetes mellitus comprising administering to a
`
`patient in need thereof a pharmaceutically effective oral amount of 1-[(4-methyl-
`
`quinazolin-2-yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin- 1-yl)-
`
`xanthine which is an oral daily dose of from 2.5 mg to 10 mg, and a pharmaceutically
`
`effective amount of metformin.
`
`74.
`
`(New) A method of treating type II diabetes mellitus comprising administering to a
`
`patient in need thereof a pharmaceutically effective oral amount of 1-[(4-methyl-
`
`quinazolin-2-yl)methyl] -3 —methyl—7—(2—butyn— 1 -yl)-8-(3 -(R)-amino-piperidin-1-yl)-
`
`xanthine which is an oral daily dose of 5 mg, and a pharmaceutically effective amount of
`
`metformin.
`
`MYLAN Ex. 1016, Page 5
`
`MYLAN Ex. 1016, Page 5
`
`

`
`U.S. Application No.: 12/946,193
`Response to Nonfinal Office Action dated October 29, 2012
`
`75.
`
`(New) A method of treating type 2 diabetes or pre-diabetes comprising
`
`administering to a patient in need thereof a therapeutically effective oral dose of 1-[(4-
`
`methyl-quinazolin-2-yl)methyl] -3 —methyl—7—(2—butyn— 1-yl)-8-(3 —(R)—amino—piperidin— 1 —yl)-
`
`xanthine in combination with a therapeutically effective dose of metformin, wherein the 1-
`
`[(4-methyl-quinazolin-2-yl)methyl]-3—methyl—7—(2—butyn-1—yl)-8-(3-(R)-amino-piperidin-
`
`1-yl)-xanthine is administered in an oral dosage of from 0.5 mg to 50 mg.
`
`76.
`
`(New) The method according to claim 75, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn— 1 -yl)-8-(3—(R)—amino—piperidin— 1 -yl)-xanthine is
`
`administered in an oral dosage of from 2.5 mg to 50 mg.
`
`77.
`
`(New) The method according to claim 75, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn— 1 -yl)-8-(3—(R)—amino—piperidin— 1 -yl)-xanthine is
`
`administered in an oral dosage of from 2.5 mg to 10 mg.
`
`78.
`
`(New) The method according to claim 75, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn— 1 -yl)-8-(3—(R)—amino—piperidin— 1 -yl)-xanthine is
`
`administered in an oral dosage of 0.5 mg, 1 mg, 2.5 mg, 5 mg or 10 mg.
`
`79.
`
`(New) The method according to claim 75, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn— 1 -yl)-8-(3—(R)—amino—piperidin— 1 -yl)-xanthine is
`
`administered in an oral dosage of 1 mg, 2.5 mg or 5 mg.
`
`80.
`
`(New) The method according to claim 75, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn— 1 -yl)-8-(3—(R)—amino—piperidin— 1 -yl)-xanthine is
`
`administered in an oral dosage of 2.5 mg or 5 mg.
`
`81.
`
`(New) The method according to claim 75, wherein the 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 —methyl—7—(2—butyn— 1 -yl)-8-(3—(R)—amino—piperidin— 1 -yl)-xanthine is
`
`administered in an oral daily dose of 5 mg.
`
`MYLAN Ex. 1016, Page
`
`MYLAN Ex. 1016, Page 6
`
`

`
`U.S. Application No.: 12/946,193
`Response to Nonfinal Office Action dated October 29, 2012
`
`REMARKS
`
`Claims 40, 56 and 57 were pending in the subject application. In this Amendment
`
`Applicants have cancelled claim 40 and added new claims 58-81. Claims 56-81 are now
`
`pending in the subject application.
`
`Support for new claims 58-81 can be found in the original specification at, for
`
`example, page 4, paragraph 4; and Examples 11 and 13.
`
`No new matter is added by this amendment, and Applicants respectfully request its
`
`entry.
`
`I.
`
`Non-statutory Double Patent Rejection of Claims 40, 56 and 57
`
`The Examiner rejected claim 40 on the ground of nonstatutory obviousness-type
`
`double patenting as allegedly being unpatentable over claims 2, 5-7 and 9 of U.S. Patent
`
`No. 8,119,648; and claim 36 of U.S. Patent No. 8,178,541 for the reasons set forth in the
`
`office action.
`
`The Examiner further rejected claims 40, 56 and 57 on the ground of nonstatutory
`
`obviousness-type double patenting as allegedly being unpatentable over claims 5, 8, 12,
`
`14, 20 and 21 of U.S. Patent No. 8,232,281.
`
`Applicants note that claim 40 has been cancelled, thereby rendering the Examiner’s
`
`rejections of that claim moot.
`
`Applicants will address the obviousness-type double patenting rejection of claims
`
`56 and 57 when the claims are otherwise in condition for allowance. Nevertheless,
`
`Applicants request that the Examiner reconsider the double-patenting rejection in View of
`
`the arguments presented below in Section III of this paper.
`
`II.
`
`Anticipation Rejection of Claim 40
`
`The Examiner rejected claim 40 under 35 U.S.C. § 102(b) as allegedly being
`
`anticipated by US Patent Application Publication No. 2004/0097510 A1 to Himmelsbach
`
`et al. (“Himmelsbach et al.”) for the reasons set forth in the office action. Applicants note
`
`that claim 40 has been cancelled, thereby rendering the Examiner’s anticipation rejection
`
`of that claim moot.
`
`MYLAN Ex. 1016, Page 7
`
`MYLAN Ex. 1016, Page 7
`
`

`
`U.S. Application No.: 12/946,193
`Response to Nonfinal Office Action dated October 29, 2012
`
`III.
`
`Obviousness Rejection of Claims 40, 56 and 59
`
`The Examiner rejected claims 40, 56 and 57 under 35 U.S.C. § 103(a) as allegedly
`
`being obvious over Himmelsbach et al. for the reasons set forth in the office action. In
`
`particular, the Examiner states that Himmelsbach et al. relates to the use of a combination
`
`comprising 1- [(4—methyl—quinazolin—2—yl)methyl] —3—methyl—7—(2—butyn— 1 —yl)—8—(3 —(R)—
`
`amino—piperidin—1—yl)—xanthine and metformin for the treatment of type II diabetes
`
`mellitus.” The Examiner further states that “[t]he instant invention differs from the cited
`
`reference in that the cited reference does not teach the dosage ranges for each individual
`
`agent of the instant combination is administered to a said patient in need of thereof.” The
`
`Examiner asserts that “those skilled in the art would have readily optimized effective
`
`dosages and concurrent administration dosage forms (oral) as determined by good medical
`
`practice and the clinical condition of the individual patient. Regardless of the manner of
`
`administration, the specific dose may be calculated according to body weight, body surface
`
`area or organ size.” The Examiner further states that “[f]urther refinement of the
`
`calculations necessary to determine the appropriate dosage for treatment involving each of
`
`the above mentioned formulation is routinely made by those skilled in the art and is within
`
`the ability of tasks routinely performed by them without undue experimentation.”
`
`Applicants traverse.
`
`As noted above, claim 40 has been cancelled, thereby rendering the Examiner’s
`
`rejection of that claim moot.
`
`As taught in the specification of the subject ‘193 application, “the combination of a
`
`DPP—IV inhibitor with metformin leads to a significantly greater reduction in the fasting
`
`glucose and/or non—fasting glucose and/or the HbA1c value than either the DPP IV
`
`inhibitor alone or metformin alone.” Applicants refer to the Prescribing Information and
`
`Patient Information for TRADJENTA® (linagliptin) having a revision date of 9/2012
`
`(“Prescribing Information”) which is enclosed with the IDS filed concurrently with this
`
`amendment. Section 14 of the Prescribing Information discusses the results of clinical
`
`studies involving linagliptin monotherapy (Section 14.1) and linagliptin/metformin
`
`combination therapy (Section 14.2). Table 6 of the Prescribing Information contains the
`
`results of a 24-week study in which patients were treated with a (a) placebo, (c) linagliptin
`
`or metformin monotherapy, or (c) linagliptin/metformin combination therapy. As shown
`
`MYLAN Ex. 1016, Page 8
`
`MYLAN Ex. 1016, Page 8
`
`

`
`U.S. Application No.: 12/946,193
`Response to Nonfinal Office Action dated October 29, 2012
`
`in Table 6 and discussed in Section 14.1 of the Prescribing Information, “[i]nitial therapy
`
`with the combination of linagliptin and metformin provided significant improvements in
`
`A1C, and fasting plasma glucose (FPG) compared to placebo, to metformin alone, and to
`
`linagliptin alone (Table 6, Figure 1).” As shown in Table 6, the percentage of patients
`
`achieving A1C of less than 7% was much greater when the patients were administered a
`
`linagliptin/metformin combination (2.5 mg linagliptin twice daily and either 500 mg or
`
`1000 mg metformin twice daily), than when patients were treated only with linagliptin
`
`monotherapy or metformin monotherapy. Likewise, the fasting plasma glucose (FPG)
`
`levels of patients receiving the linagliptin/metformin combination therapy (2.5 mg
`
`linagliptin twice daily and either 500 mg or 1000 mg metformin twice daily), decreased
`
`much more than the FPG levels of patients treated only with linagliptin monotherapy or
`
`metformin monotherapy (see Section 14.1 and Table 6 of the Prescribing Information).
`
`In summary, the Prescribing Information shows that significant improvements in
`
`A1C and FPG were achieved using 2.5 mg linagliptin twice daily and either 500 mg or
`
`1000 mg metformin twice daily. Therefore, even if Himmelsbach et al. teach a
`
`combination of linagliptin and metformin, one skilled in the art would not have plainly
`
`expected or predicted that the specific dosage amounts of linagliptin and metformin in a
`
`combination therapy as recited in claims 56 and 57 of the subject ‘ 193 application would
`
`provide the (clinically and therapeutically) significant improvements A1C and FPG as
`
`reported in the clinical study section of the Prescribing Information. Therefore, claim 56
`
`and 57 of the subject application are not obvious over Himmelsbach et al. for at least this
`reason.
`
`In view of the above, Applicants submit that claims 56 and 57 are not obvious over
`
`Himmelsbach et al. (claim 40 having been cancelled), and request that the rejection of
`
`these claims under 35 U.S.C. § 103(a) be withdrawn.
`
`MYLAN Ex. 1016, Page 9
`
`MYLAN Ex. 1016, Page 9
`
`

`
`U.S. Application No.: 12/946,193
`Response to Nonfinal Office Action dated October 29, 2012
`
`CONCLUSION
`
`Applicants respectfully request prompt consideration of the pending claims and
`
`allowance of the application. No additional fee is believed due. However, if any
`
`additional fee is due, the Examiner is authorized to charge the fee to Applicants’ Deposit
`
`Account No. 02-2955.
`
`If a telephonic or personal interview is deemed necessary to expedite the examination
`
`of the instant application, the Examiner is kindly requested to contact the undersigned at the
`
`telephone number listed below.
`
`Respectfully submitted,
`
`/David L. Kershner/
`David L. Kershner
`
`Attorney for Applicant(s)
`Reg. No. 53,112
`
`Patent Department
`Boehringer Ingelheim Corp.
`900 Ridgebury Road
`P.O. Box 368
`
`Ridgefield, CT 06877
`Tel.:
`(203) 798-5469
`Fax: (203)798-4408
`
`Date: April 26, 2013
`
`10
`
`MYLAN Ex. 1016, Page 10
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`MYLAN Ex. 1016, Page 10
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`

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`INFORMATION DISCLOSURE
`
`First Named Inventor
`
`Klaus DUGI
`
`Application Number
`
`Filing Date
`
`12946193
`
`2010-11-15
`
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`Art Unit
`Examiner Name
`
`| 1629
`K. WEDDINGTON
`
`Attorney Docket Number
`
`|01—2051—1—C1
`
`E).(‘?m*iner Cite
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`EFS web2.1.17
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`MYLAN Ex. 1016, Page 11
`
`MYLAN Ex. 1016, Page 11
`
`

`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`12946193
`
`Filing Date
`2010-11-15
`First Named Inventor
`Klaus DUGI
`A“ Unit
`| 1629
`Examiner Name
`K WEDDINGTON
`Attorney Docket Number
`| 01 -2051 —1—C1
`
`TRADJENTA. Highlights of Prescribing Information (Revised 9/2012)
`
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`Standard ST.3). 3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST_16 if possible.
`5 Applicant is to place a check mark here it‘
`English language translation is attached.
`
`EFsweb2.1.17
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`MYLAN Ex. 1016, Page 12
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`MYLAN Ex. 1016, Page 12
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`

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`INFORMATION DISCLOSURE
`
`First Named Inventor
`
`Klaus DUGI
`
`Application Number
`
`12946193
`
`Filing Date
`
`2010-11-15
`
`STATEMENT BY APPLICANT
`_
`_
`( Not for submission under 37 CFR 1.99)
`
`Art Unit
`Examiner Name
`
`| 1629
`K. WEDDINGTON
`
`Attorney Docket Number
`
`| 01 -2051 —1—C1
`
`CERTIFICATION STATEMENT
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate se|ection(s):
`
`|:I
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`II
`
`|:| See attached certification statement.
`
`|:| The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`
`A certification statement is not submitted herewith.
`
`SIGNATURE
`
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Signature
`NamelPrint
`
`53112
`
`Date WW-MM-00>
`Registration Number
`
`2°13-04-26
`
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the
`public which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR
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`
`EFsweb2.1.17
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`MYLAN Ex. 1016, Page 13
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`MYLAN Ex. 1016, Page 13
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`

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`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
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`The information provided by you in this form will be subject to the following routine uses:
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`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act
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`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
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`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
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`EFS Web 2.1.17
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`MYLAN Ex. 1016, Page 14
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`MYLAN Ex. 1016, Page 14
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`

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`Electronic Patent Application Fee Transmittal
`
`Filing Date:
`
`15-Nov-2010
`
`Title of Invention:
`
`USES OF DPP—IV INHIBITORS
`
`;
`
`Utility under 35 USC111(a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`
`USD($)
`
`Basic Filing:
`
`Miscellaneous Filing
`
`Patent Appeals and Interference:
`
`Post-Allowance-and-Post Issuance
`
`Extension-of-Time:
`
`!N Ex“‘I°616 age 1‘é°°
`
`-
`
`MYLAN Ex. 1016, Page 15
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`

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`Miscellaneous:
`
` S“:-S1-;(t$a)| in
`
`Total in USD (S)
`
`MYLAN Ex. 1016, Page 16
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`MYLAN Ex. 1016, Page 16
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`

`
`Electronic Acknowledgement Receipt
`
`m—
`
`Title of Invention:
`
`USES OF DPP—IV INHIBITORS
`
`I
`
`Payment information:
`
`yes—
`Submitted with Payment
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application a
`
`—Auth°“zedUser
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.16 (National application filing, search, and examination fees)
`
`MYLAN Ex. 1016, Page 17
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`

`
`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
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`Charge any Additional Fees required under 37 C.F.R. Section 1.20 (Post Issuance fees)
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`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
`
`File Listing:
`
`Document
`Number
`
`Document Description
`
`File Size(Bytes)/
`Message Digest
`
`Pages
`Multi
`Part /.zip (if appl.)
`
`01-2051-I-C1-2013-O4-26
`
`Response-OA.pdf
`
`d56b4d60f1696e893eda85c303697223655
`08c0b
`
`Multipart Description/PDF files in .zip description
`
`Amendment/Req. Reconsideration-After Non-Final Reject
`
`Extension ofTime
`
`Information Disclosure Statement (IDS)
`Form (SB08)
`
`01-2051-1-C1-2013-04-26-|DS-
`SB08.pdf
`
`775047
`
`60cbcbd4d048097df3173fc0494c9df68ed ‘
`b862
`
`Information:
`
`A U.S. Patent Number Citation ora U.S. Publication Number Citation is required in the Information Disclosure Statement (IDS) form for
`autoloading of data into USPTO systems. You may remove the form to add the required data in order to correct the Informational Message if
`you are citing U.S. References. Ifyou chose not to include U.S. References, the image ofthe form will be processed and be made available
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`Documents or Non Patent Literature will be manually reviewed and keyed into USPTO systems.
`
`Non Patent Literature
`
`Tradjenta-2011.pdf
`
`391755
`
`5dd615bfd6702ef6d394ea402400d5daef9
`498e1
`
`Information:
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`5193c2d4b169d7e378223379d769265bd7
`6f8f6f
`
`MYLAN Ex. 1016, Page 18
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`MYLAN Ex. 1016, Page 18
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`

`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`lfa new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
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`National Stage of an International Application under 35 U.S.C. 371
`lfa timely submission to enter the national stage of an international application is compliant with the conditions of 35
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`
`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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`
`MYLAN Ex. 1016, Page 19
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`MYLAN Ex. 1016, Page 19
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`

`
`Document code: WFEE
`
`United States Patent and Trademark Office
`
`Sales Receipt for Accounting Date: 05/06/2013
`
`AJOHNSO1
`
`Mailroom Dt: 04/26/2013
`SALE #00000001
`01
`FC : 1201
`840.00 DA
`02
`FC : 1202
`480.00 DA
`
`022955
`
`12946193
`
`MYLAN Ex. 1016, Page 20
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`MYLAN Ex. 1016, Page 20
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`

`
`PTO/SB/O6 (09-11)
`Approved for use through 1/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`PATENT APPLICATION FEE DETERMINATION RECORD
`Substitute for Form PTO-875
`
`APP“°a“°” Or Docket Number
`12/946,193
`
`FI“”9 Dale
`1 1/15/2010
`
`I:I T0 be Mailed
`
`APPLICATION AS FILED — PART I
`
`(Column 2)
`
`FOR
`
`NUMBER FILED
`
`ENTITY:
`
`IXI LARGE I:| SMALL El MICRO
`
`I:| BASIC FEE
`37CFR1.16a, b,or c
`
`I:I SEARCH FEE
`37CFR1.16k,
`
`i,or m
`
`D EXAMINATION FEE
`(37 CFR1.16( ), (p), or (q))
`TOTAL CLAIMS
`37 CFR1.16i
`INDEPENDENT CLAIMS
`37 CFR 1.16 h
`
`U/;:PCL;g§T'gNS'ZE
`I
`'
`ls”
`
`WA
`
`WA
`
`N/A
`
`.
`”"”“5 2°=
`
`If the specification and drawings exceed 100 sheets
`I
`th
`I"
`t'
`'
`f
`d
`'
`310
`155
`;°