Docket No.: AGP-002C2
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Daniel J. Rader
`
`Application No.: 13/046,118
`
`Confirmation No.: 4237
`
`Filed: March 11, 2011
`
`Art Unit: 1629
`
`For: METHODS FOR TREATING DISORDERS OR
`DISEASES ASSOCIATED WITH
`HYPERLIPIDEMIA AND
`HYPERCHOLESTEROLEMIA WHILE
`MINIMIZING SIDE EFFECTS
`
`Examiner: K. E. Weddington
`
`AMENDMENT
`
`MSRCE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`This Response is being filed together with a Request for Continued Examination, and an
`
`Information Disclosure Statement.
`
`Amendments to the Claims begin on page 2 of this paper.
`
`Remarks begin on page 6 of this paper.
`
`CFAD Ex. 1039 (1 of 6)
`
`
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Daniel J. Rader
`
`Application No.: 13/046,118
`
`Confirmation No.: 4237
`
`Filed: March 11, 2011
`
`Art Unit: 1629
`
`For: METHODS FOR TREATING DISORDERS OR
`DISEASES ASSOCIATED WITH
`HYPERLIPIDEMIA AND
`HYPERCHOLESTEROLEMIA WHILE
`MINIMIZING SIDE EFFECTS
`
`Examiner: K. E. Weddington
`
`AMENDMENT
`
`MSRCE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`This Response is being filed together with a Request for Continued Examination, and an
`
`Information Disclosure Statement.
`
`Amendments to the Claims begin on page 2 of this paper.
`
`Remarks begin on page 6 of this paper.
`
`CFAD Ex. 1039 (1 of 6)
`
`
`
`Application No. 13/046,118
`Attorney Docket No.: AGP-002C2
`Amendment
`Page2of6
`
`AMENDMENTS TO THE CLAIMS
`
`What is claimed is:
`
`1.
`
`(Previously Presented) A method of treating a subject suffering from hyperlipidemia or
`
`hypercholesterolemia, the method comprising administering to the subject an effective amount of an
`
`MTP inhibitor, wherein said administration comprises at least three step-wise, increasing dose
`
`levels of the MTP inhibitor wherein a first dose level is from about 2 to about 13 mg/day, a second
`
`dose level is from about 5 to about 30 mg/day, and a third dose level is from about 10 to about 50
`
`mg/day; and wherein the MTP inhibitor is represented by:
`
`or a pharmaceutically acceptable salt thereof or the piperidine N-oxide thereof, and wherein each
`
`dose level is administered to the subject for about 1 to about 5 weeks.
`
`2.
`
`(Original) The method of claim 1 wherein the disorder is severe hypercholesterolemia.
`
`CFAD Ex. 1039 (2 of 6)
`
`
`
`Application No. 13/046,118
`Attorney Docket No.: AGP-002C2
`Amendment
`Page3 of6
`
`3.
`
`(Original) The method of claim 1 wherein one or more of Total Cholesterol, LDL, fasting
`
`triglycerides (TG), VLDL, lipoprotein (a) (Lp(a)), and apolipoproteins A-I, A-II, B, and E are
`
`reduced by at least 15%, compared to control levels.
`
`4.
`
`(Original) The method of claim 1 wherein one or more of Total Cholesterol, LDL, fasting
`
`triglycerides (TG), VLDL, lipoprotein (a) (Lp(a)), and apolipoproteins A-I, A-II, B, and E are
`
`reduced by at least 25%, compared to control levels.
`
`5.
`
`6.
`
`7.
`
`8.
`
`(Cancelled)
`
`(Original) The method of claim 1 wherein the MTP inhibitor is administered orally.
`
`(Cancelled)
`
`(Previously Presented) The method of claim 1 wherein said increasing dose levels further
`
`comprise a fourth dose level.
`
`9.
`
`(Previously Presented) The method of claim 1 wherein said increasing dose levels further
`
`comprise a fourth and a fifth dose level.
`
`10-12. (Cancelled)
`
`13.
`
`(Previously Presented) The method of claim 9 wherein said fourth dose level is from about
`
`20 to about 60 mg/day, and said fifth dose level is from about 30 to about 75_mg/day.
`
`14-25. (Cancelled)
`
`26.
`
`(Previously Presented) A method of treating a subject suffering from hyperlipidemia or
`
`hypercholesterolemia, the method comprising administering to the subject an effective amount of an
`
`CFAD Ex. 1039 (3 of 6)
`
`
`
`Application No. 13/046,118
`Attorney Docket No.: AGP-002C2
`Amendment
`Page4of6
`
`MTP inhibitor, wherein said administration comprises at least three step-wise, increasing dose
`
`levels of the MTP inhibitor wherein a first dose level is from about 2 to about 13 mg/day,
`
`administered to the subject for about 2 weeks; a second dose level is from about 5 to about 30
`
`mg/day, administered to the subject for about 2 weeks to about 4 weeks; and a third dose level is
`
`from about 10 to about 50 mg/day, administered to the subject for about 2 weeks to about 4 weeks;
`
`and wherein the MTP inhibitor is represented by:
`
`0
`
`or a pharmaceutically acceptable salt thereof or the piperidine N-oxide thereof.
`
`27.
`
`(New) A method of treating a subject suffering from hyperlipidemia or
`
`hypercholesterolemia, the method comprising administering to the subject an effective amount of an
`
`MTP inhibitor, wherein said administration comprises at least three step-wise, increasing dose
`
`levels of the MTP inhibitor wherein a first dose level is from about 2 to about 13 mg/day,
`
`administered to the subject for about 1 to about 12 weeks; a second dose level is from about 5 to
`
`about 30 mg/day, administered to the subject for about 4 weeks; and a third dose level is from about
`
`10 to about 50 mg/day, administered to the subject for about 4 weeks; and wherein the MTP
`
`inhibitor is represented by:
`
`CFAD Ex. 1039 (4 of 6)
`
`
`
`Application No. 13/046,118
`Attorney Docket No.: AGP-002C2
`Amendment
`PageS of6
`
`or a pharmaceutically acceptable salt thereof or the piperidine N-oxide thereof
`
`CFAD Ex. 1039 (5 of 6)
`
`
`
`Application No. 13/046,118
`Attorney Docket No.: AGP-002C2
`Amendment
`Page6of6
`
`REMARKS
`
`Claim 1-4, 6, 8, 9, 13, 26, are pending and have been found allowable. Claims 5, 7, 10-12,
`
`and 14-25 have been cancelled. New claim 27 has been added. Support for new claim 26 is found
`
`throughout the application as filed, including, for example, in original claims 1, 5, 13, and 17 and in
`
`paragraph 63 of the application as filed. No new matter has been added.
`
`Amendment of the originally filed claims, or cancellation of any claims should in no way be
`
`construed as an acquiescence, narrowing, or surrender of any subject matter. The amendments are
`
`being made not only to point out with particularity and to claim the present invention, but also to
`
`expedite prosecution of the present application. Applicant reserves the option to prosecute the
`
`originally filed claims further, or similar ones, in the instant or subsequently filed patent
`
`applications.
`
`Applicants submit this Request for Continued Examination in part to present additional
`
`claim 27.
`
`Any questions raised by this submission may be directed to the undersigned at (617) 570-
`
`3917. The Commissioner is hereby authorized to charge any underpayments, or credit any
`
`overpayments, to our Deposit Account No. 07-1700, Reference: AGP-002C2.
`
`Dated: September 25, 2013
`
`Respectfully submitted,
`
`/Theresa C. Kavanaugh/
`Theresa C. Kavanaugh
`Registration No.: 50,356
`GOODWIN PROCTER LLP
`Exchange Place
`Boston, Massachusetts 021 09
`(617) 570-1000
`Attorney for Applicant
`
`CFAD Ex. 1039 (6 of 6)
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