IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Application of:
`
`Klaus DUGI, et al
`
`Art Unit:
`
`1629
`
`U.S. Appln. No.
`
`14/161,007
`
`Examiner:
`
`K. WEDDINGTON
`
`U.S. Filing Date:
`
`January 22, 2014
`
`Confirm. No.:
`
`4052
`
`Title of Invention:
`
`USES OF DDP—IV INHIBITORS
`
`Docket No.:
`
`01—2051—US—3
`
`VIA EFS Web
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`RESPONSE TO FINAL OFFICE ACTION
`
`Sir:
`
`This paper is responsive to a final office action having a notification date of April
`
`16, 2015 in connection with the above—identified patent application and is being filed
`
`concurrently with a request for continued examination. A response to the final office
`
`action is initially due three (3) months from the notification date of the office action, that
`
`is, by July 16, 2015. Accordingly, this response is timely filed.
`
`Amendments to the Claims begin on page 2 of this paper.
`
`Remarks begin on page 6 of this paper.
`
`MYLAN Ex. 1017, Page 1
`
`MYLAN Ex. 1017, Page 1
`
`

`
`U.S. Application No.: 14/161,007
`Response to Final Office Action dated April 16, 2015
`Attorney Docket No.: 01—2051—US—3
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims will replace all prior versions and listings of claims in the
`
`application:
`
`Listing of Claims:
`
`Claims 1-14 (Cancelled).
`
`15.
`
`(Previously presented) A method of treating type 2 diabetes comprising
`
`administering to a patient in need thereof 1—[(4-methyl—quinazolin—2—yl)methyl]—3—methyl—
`
`7—(2—butyn—1—yl)—8—(3—(R)—amino—piperidin—1—yl)—Xanthine, or a therapeutically active salt
`
`thereof,
`
`in an oral dosage of 2.5 mg or 5 mg
`
`wherein the dose of metformin is 100 mg to 500 mg or 200 mg to 850 mg (1-3 times a
`
`day), or 300 mg to 1000 mg once or twice a day, or as 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,
`or
`
`wherein the dose of metformin is 500 mg, 850 mg or 1000 mg as a single dose with a total
`
`daily dose of metformin of 500-2850 mg, or 500 mg, 1000 mg, 1500 mg or 2000 mg
`
`metformin in delayed release form,
`or
`
`wherein the dose of metformin is 500 mg to 1000 mg.
`
`16.
`
`(Cancelled)
`
`17.
`
`(Previously presented) The method according to claim 15, wherein 1—[(4—methyl—
`
`quinazolin—2—yl)methyl] -3 —methyl—7—(2—butyn— 1 —yl)—8—(3 —(R)—amino—piperidin— 1—yl)—
`
`xanthine and metformin are administered orally in the form of a fixed combination.
`
`18.
`
`(Previously presented) The method according to claim 17, wherein the fixed
`
`combination is a tablet or capsule.
`
`MYLAN Ex. 1017, Page 2
`
`MYLAN Ex. 1017, Page 2
`
`

`
`U.S. Application No.: 14/161,007
`Response to Final Office Action dated April 16, 2015
`Attorney Docket No.: 01-2051-US-3
`
`19.
`
`(Previously presented) The method according to claim 17, wherein the fixed
`
`combination is a tablet.
`
`Claims 20-23.
`
`(Cancelled)
`
`24.
`
`(Previously presented) The method according to claim 17, wherein the dosage of
`
`1- [(4-methyl-quinazolin-2-yl)methyl] -3 —methyl—7—(2—butyn-1-yl)-8-(3-(R)-amino-
`
`piperidin-1-yl)-xanthine is 2.5 mg.
`
`25.
`
`(Previously presented) The method according to claim 17, wherein the dosage of
`
`1- [(4-methyl-quinazolin-2-yl)methyl] -3 —methyl—7—(2—butyn-1-yl)-8-(3-(R)-amino-
`
`piperidin-1-yl)-xanthine is 5 mg.
`
`26.
`
`(Cancelled)
`
`27.
`
`(Previously presented) The method according to claim 17, wherein metformin is
`
`provided in a dose of 100 mg to 500 mg or 200 mg to 850 mg (1-3 times a day), or 300 mg
`
`to 1000 mg once or twice a day, or as 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.
`
`28.
`
`(Previously presented) The method according to claim 17, wherein the dose of
`
`metformin is 500 mg, 850 mg or 1000 mg as a single dose with a total daily dose of
`
`metformin of 500-2850 mg, or 500 mg, 1000 mg, 1500 mg or 2000 mg metformin in
`
`delayed release form.
`
`29.
`
`(Previously presented) The method according to claim 17, wherein the amount of
`
`metformin is 500 mg to 1000 mg.
`
`30.
`
`(Previously presented) The method according to claim 17, wherein the amount of
`
`metformin is 500 mg.
`
`MYLAN Ex. 1017, Page 3
`
`MYLAN Ex. 1017, Page 3
`
`

`
`U.S. Application No.: 14/161,007
`Response to Final Office Action dated April 16, 2015
`Attorney Docket No.: 01-2051—US—3
`
`31.
`
`(Previously presented) The method according to claim 17, wherein the amount of
`
`metformin is 850 mg.
`
`32.
`
`(Previously presented) The method according to claim 17, wherein the amount of
`
`metformin is 1000 mg.
`
`33.
`
`(Cancelled)
`
`34.
`
`(Cancelled)
`
`35.
`
`(Previously presented) A method of treating type 2 diabetes comprising
`
`administering twice daily to a patient in need thereof 1-[(4-methyl-quinazolin-2-
`
`yl)methyl] -3 -methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-Xanthine in an oral
`
`dosage of 2.5 mg in fixed combination with metformin in an amount of 500 mg to 1000
`
`mg.
`
`36.
`
`(Previously presented) An oral tablet formulation comprising 1—[(4-methyl-
`
`quinazolin-2-yl)methyl] -3 -methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-
`
`Xanthine in an amount of 2.5 mg or 5 mg optionally in combination with metformin, and
`
`an pharmaceutically acceptable carrier or diluent.
`
`37.
`
`(Previously presented) The oral tablet according to claim 36, containing 500 mg to
`
`1000 mg metformin.
`
`38.
`
`(Previously presented) A method of treating type 2 diabetes comprising
`
`administering to a patient in need thereof 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-
`
`7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in a daily oral amount of 5 mg
`
`the form of a fixed combination, wherein metformin is administered in a dose of 100 mg to
`
`500 mg or 200 mg to 850 mg (1-3 times a day), or 300 mg to 1000 mg once or twice a day,
`
`or as 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.
`
`MYLAN Ex. 1017, Page 4
`
`MYLAN Ex. 1017, Page 4
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`

`
`U.S. Application No.: 14/161,007
`Response to Final Office Action dated April 16, 2015
`Attorney Docket No.: 01-2051-US-3
`
`39.
`
`(Previously presented) A method of treating type 2 diabetes comprising
`
`administering to a patient in need thereof 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-
`
`7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in a daily oral amount of 5 mg
`
`and metformin, the form of a fixed combination, wherein the dose of metformin is 500 mg,
`
`850 mg or 1000 mg as a single dose with a total daily dose of metformin of 500-2850 mg,
`
`or 500 mg, 1000 mg, 1500 mg or 2000 mg metformin in delayed release form.
`
`40.
`
`(Previously presented) A method of treating type 2 diabetes comprising
`
`administering to a patient in need thereof 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-
`
`7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in a daily oral amount of 5 mg
`
`and metformin, the form of a fixed combination, wherein the amount of metformin is 500
`
`mg to 1000 mg.
`
`41.
`
`(Previously presented) The method according to claim 15, wherein 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 a daily oral amount of 5 mg.
`
`42.
`
`(Previously presented) A method of treating type 2 diabetes comprising
`
`administering to a patient in need thereof the oral tablet of claim 36, wherein the daily 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 administered to said patient is 5 mg.
`
`43.
`
`(New) The method according to claim 24, wherein 1-[(4—methyl—quinazolin—2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-Xanthine in a dosage
`
`of 2.5 mg is administered twice daily.
`
`44.
`
`(New) The method according to claim 25, wherein 1-[(4—methyl—quinazolin—2-
`
`yl)methyl] -3 —methyl—7—(2—butyn—1-yl)-8-(3-(R)-amino-piperidin-1-yl)-Xanthine in a dosage
`
`of 5mg is administered once daily.
`
`MYLAN Ex. 1017, Page 5
`
`MYLAN Ex. 1017, Page 5
`
`

`
`U.S. Application No.: 14/161,007
`Response to Final Office Action dated April 16, 2015
`Attorney Docket No.: 01-2051-US—3
`
`REMARKS
`
`Claims 15, 17-19, 24, 25, 27-32, 35-42 were pending in the subject application. In
`
`this amendment Applicants have added new claims 43 and 44. Claims 15, 17-19, 24, 25,
`
`27-32, 35-44 are now pending in the subject application.
`
`New claims 43 and 44 depend from claims 24 and 25, respectively, and further
`
`specify that 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 a twice daily dose (claim 43) or once
`
`daily dose (claim 44). Support for new claims 43 and 44 can be found in the original
`
`specification at, for example, page 14, first paragraph.
`
`No new matter is added by this amendment, and Applicants respectfully request its
`
`entry.
`
`I.
`
`Non-statutory Double Patenting Rejections
`
`A.
`
`Rejection of Claim 15 over Claims 1-9 of U.S. Patent No. 8,119,648 B2
`
`The Examiner rejected claim 15 on the ground of nonstatutory obviousness-type
`
`double patenting as allegedly being unpatentable over claims 1-9 of U.S. Patent No.
`
`8,119,648 B2 for the reasons set forth in the previous office action at pages 2-4 (“the
`
`November 19, 2014 office action”). In the November 19, 2014 office action, the Examiner
`
`stated that “the claims at issue are not identical, they are not patentably distinct from each
`
`other because the only difference between the patented claims and the present claim lies in
`
`that in the present claims, the addition of metformin with the 1-[(40methyl-quinazolin-2-
`
`yl)methyl] -3 -methyl-7-(2-butyn-1-yi)-8-(3-(R)-amino-piperidin-1-yl)-xanthine. The
`
`present claim would anticipate the patented claims because the patented claims recite
`
`‘comprising’ and thus opens the claims to the inclusion of metformin.”
`
`Applicants traverse. Claims 1-9 of the ‘648 patent relate inter alia to a method of
`
`treating type II diabetes mellitus comprising administering a pharmaceutically effective
`
`amount of 1- [(4-methyl-quinazolin-2-yl)methyl] -3-methyl-7-(2-butyn- 1 -yl)-8-(3 -(R)-
`
`amino-piperidin-1-yl)-xanthine to a patient in need thereof. The Examiner asserts that the
`
`term “comprising” in the claims 1-9 of the ‘648 patent “opens the claims to the inclusion
`
`of metformin.” However, even if the term “comprising” in claims 1-9 of the ‘648 patent
`
`includes metformin as stated by the Examiner, none of claims 1-9 of the ‘648 patent
`
`MYLAN Ex. 1017, Page 6
`
`MYLAN Ex. 1017, Page 6
`
`

`
`U.S. Application No.: 14/161,007
`Response to Final Office Action dated April 16, 2015
`Attorney Docket No.: 01—2051—US—3
`
`specifies the oral dosage of 2.5 mg or 5 mg of 1-[(4—methyl—quinazolin—2—yl)methyl]-3-
`
`methyl—7—(2—butyn—1—yl)—8—(3—(R)—amino—piperidin—1—yl)—xanthine nor do they recite the
`
`specific daily dosage amounts metformin, nor that the metformin can be administered to
`
`the patient either once, twice or three times a day. Thus, the patented claims do not
`
`anticipate the present claims. Further, as already discussed in the previous responsive
`
`amendment filed on February 18, 2015, the Prescribing Information and Patient
`
`Information for TRADJENTA® (linagliptin) having a revision date of 9/2012
`
`(“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, 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
`
`would provide the (clinically and therapeutically) significant improvements in A1C and
`
`FPG as reported in the clinical study section of the Prescribing Information.
`
`At least in view of these unexpected clinical properties, Applicants respectfully
`
`submit that the rejection based on obviousness—type double patenting as to the ‘648 patent
`
`has been overcome. See Eli Lilly v. Teva Parenteral Medicines, Inc., 689 F.3d 1368, 1382
`
`(Fed. Cir. (2012) (“The district court's categorical repudiation of Lilly's evidence [of
`
`unexpected clinical properties and commercial success] was therefore erroneous. When
`
`offered, such evidence should be considered; a fact—finder must withhold judgment on an
`
`[obviousness—type double patenting] challenge until it has considered all relevant evidence,
`
`including that relating to the objective considerations.”)
`
`B.
`
`Rejection of Claims 15, 17-19, 24, 25, 27-32 and 35-42 over Claims 1-9
`of U.S. Patent No. 8,178,541 B2
`
`The Examiner rejected claims 15, 17-19, 24, 25, 27-32 and 35-42 on the ground of
`
`nonstatutory obviousness—type double patenting as allegedly being unpatentable over
`
`claims 15, 32, 35, 36, 39, 41 and 45 of U.S. Patent No. 8,178,541 B2 for the reasons set
`
`forth on pages 4-5 of the November 19, 2014 office action. In the November 19, 2014
`
`office action the Examiner states that “[a]lthough the claims at issue are not identical, they
`
`are not patentably distinct from each other because the present application teaches a
`
`method for treating type 2 diabetes with a composition comprising 1—[(4—methyl—
`
`quinazolin—2—yl)methyl] -3 —methyl—7—(2—butyn— 1 —yi)—8—(3 —(R)—amino—piperidin— 1—yl)—
`
`MYLAN Ex. 1017, Page 7
`
`MYLAN Ex. 1017, Page 7
`
`

`
`U.S. Application No.: 14/161,007
`Response to Final Office Action dated April 16, 2015
`Attorney Docket No.: 01—2051—US—3
`
`xanthine and metformin, and the patented application teaches a method for treating type II
`
`diabetes or obesity with 1-[(4—methyl—quinazolin—2—yl)methyl]—3—methyl—7—(2—butyn—1—yi)—
`
`8—(3—(R)—amino—piperidin—1—yl)—xanthine and another therapeutic agent such as metformin.”
`
`The Examiner asserts that “the patented application teaches the present application's instant
`
`combination for the treatment of type 2 diabetes.”
`
`Applicants traverse. Claims 15, 32, 35, 36, 39, 41 and 45 of the ‘541 patent relate
`
`inter alia to a method of treating type II diabetes mellitus comprising administering a
`
`phannaceutically effective 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 phannaceutically effective
`
`amount of metformin to a patient in need thereof. The Examiner asserts that “the patented
`
`application teaches the present application's instant combination for the treatment of type 2
`
`diabetes.” However, even if claims 15, 32, 35, 36, 39, 41 and 45 of the ‘541 patent recite a
`
`combination therapy of 1—[(4—methyl—quinazolin—2—yl)methyl]—3—methyl—7—(2—butyn—1—yl)—
`
`8—(3—(R)—amino—piperidin—1—yl)—xanthine and metformin, none of those claims of the ‘541
`
`patent specify the oral dosage of 2.5 mg or 5 mg of 1—[(4—methyl—quinazolin—2—yl)methyl]—
`
`3—methyl—7—(2—butyn—1—yl)—8—(3—(R)—amino—piperidin—1—yl)—xanthine nor do they recite the
`
`specific daily dosage amounts metformin, nor that the metformin can be administered to
`
`the patient either once, twice or three times a day. As noted above, 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. 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 would provide the (clinically and therapeutically) significant
`
`improvements in A1C and FPG as reported in the clinical study section of the Prescribing
`
`Information based on claims 15, 32, 35, 36, 39, 41 and 45 of the ‘541 patent.
`
`In summary, Applicants submit that these unexpected clinical properties have
`
`overcome the obviousness—type double patenting rejection in accordance with Eli Lilly v.
`
`Teva Parenteral Medicines, Inc. Therefore, Applicants request that the obviousness type-
`
`double patenting rejection as to the ‘541 patent be withdrawn.
`
`C.
`
`Rejection of Claims 15-40 over Claims 1-26 of U.S. Patent No. 8,673,927
`B2
`
`MYLAN Ex. 1017, Page 8
`
`MYLAN Ex. 1017, Page 8
`
`

`
`U.S. Application No.: 14/161,007
`Response to Final Office Action dated April 16, 2015
`Attorney Docket No.: 01-2051—US—3
`
`The Examiner rejected claims 15-40 on the ground of nonstatutory obviousness-
`
`type double patenting as allegedly being unpatentable over claims 1-26 of U.S. Patent No.
`
`8,673,927 B2 for the reasons set forth in the present office action. Applicants note that
`
`claims 15, 17-19, 24, 25, 27-32, 35-42 are presently pending in the subject application
`
`Submitted herewith is a Terminal Disclaimer as to the ‘927 patent. Applicants
`
`submit that the submission of this Terminal Disclaimer fully addresses the Examiner's
`
`obviousness-type double-patenting rejection of pending claims 15, 17-19, 24, 25, 27-32,
`
`35-42 as to the ‘927 patent.
`
`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: July 10, 2015
`
`MYLAN Ex. 1017, Page 9
`
`MYLAN Ex. 1017, Page 9
`
`

`
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`PATENT APPLICATION FEE DETERMINATION RECORD
`substitute for Form PTo-375
`
`Aeetteattett or Docket Number
`14/161,007
`
`Ftttttg Date
`01/22/2014
`
`III To be Mailed
`
`ENTITY:
`
`IZI LARGE |:| SMALL |:| MICRO
`
`APPLICATION AS FILED — PART I
`
`(Column 2)
`
`FOR
`
`NUMBER FILED
`
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`
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`37 CFR1.16i
`INDEPENDENT CLAIMS
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`I:I MULTIPLE DEPENDENT CLAIM PRESENT (37 CFR1.16(j))
`* If the difference in column 1 is less than zero, enter “0" in column 2.
`
`APPLICATION AS AMENDED — PART II
`
`(Column 3)
`
`PRESENT EXTRA
`
`ADDITIONAL FEE (sis)
`
`07/10/2015
`
`CLAIMS
`REMAINING
`AFTER
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`
`(Column 2)
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`
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`AMENDMENT
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`** If the “Highest Number Previously Paid For” IN THIS SPACE is less than 20, enter “20".
`*** If the “Highest Number Previously Paid For" IN THIS SPACE is less than 3, enter
`The “Highest Number Previously Paid For" (Total or Independent) is the highest number found in the appropriate box in column 1.
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`ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`LI E
`/MAFHSSA BLY-|-HER/
`
`MYLAN Ex. 1017, Page 10
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`MYLAN Ex. 1017, Page 10