IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant:
`
`Serial No.:
`
`Ashley, Robert
`
`13/277,789
`
`Confirmation No:
`
`4179
`
`Filed:
`
`For:
`
`October 20, 2011
`
`Methods of
`Treating Acne
`
`Mail Stop Patent Application
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Examiner:
`
`Susan Tran
`
`Group Art Unit:
`
`1629
`
`Docket:
`
`Dated:
`
`512-53 DIV/CON II
`
`April 30, 2012
`
`Certificate of EFS-Web Transmission
`
`I hereby certify that this correspondence is being transmitted
`to the U.S. Patent and Trademark Office via the Office's
`electronic filing system on Aoril30 2012
`
`Carla Bcyan
`(Printed N arne)
`
`I carla bcyao/
`(Signature)
`
`Fifth Preliminary Amendment
`
`Sir:
`
`Applicant thanks Examiner Tran for her courteous consideration during a personal
`interview with the applicant's undersigned representative on April23, 2012. Applicant
`respectfully requests the instant Amendment be entered.
`
`Amendments to the Claims begin on page 2 of this paper.
`
`Remarks begin on page 5 of this paper.
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Galderma Laboratories, Inc.
`IPR2015-__
`Exhibit 1068
`
`Exh. 1068
`
`
`
`Applicant:
`
`Serial No.:
`
`Ashley, Robert
`
`13/277,789
`
`Confirmation No:
`
`4179
`
`Filed:
`
`For:
`
`October 20, 2011
`
`Methods of
`Treating Acne
`
`Mail Stop Patent Application
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Examiner:
`
`Susan Tran
`
`Group Art Unit:
`
`1629
`
`Docket:
`
`Dated:
`
`512-53 DIV/CON II
`
`April 30, 2012
`
`Certificate of EFS-Web Transmission
`
`I hereby certify that this correspondence is being transmitted
`to the U.S. Patent and Trademark Office via the Office's
`electronic filing system on Aoril30 2012
`
`Carla Bcyan
`(Printed N arne)
`
`I carla bcyao/
`(Signature)
`
`Fifth Preliminary Amendment
`
`Sir:
`
`Applicant thanks Examiner Tran for her courteous consideration during a personal
`interview with the applicant's undersigned representative on April23, 2012. Applicant
`respectfully requests the instant Amendment be entered.
`
`Amendments to the Claims begin on page 2 of this paper.
`
`Remarks begin on page 5 of this paper.
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Galderma Laboratories, Inc.
`IPR2015-__
`Exhibit 1068
`
`Exh. 1068
`
`
`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 2 of6
`
`Amendment to the Claims:
`
`This listing of claims will replace all prior versions, and listings, of claims in the application.
`
`Claims 1-20 (Cancelled).
`
`A method for treating papules and pustules of rosacea in a human in need
`21. (New)
`thereof, the method comprising
`administering orally to said human doxycycline, or a pharmaceutically acceptable salt
`thereof,
`in an amount that
`(i) is effective to treat the papules and pustules of rosacea;
`(ii) is 10-80% of a 50 mg dose of doxycycline; and
`(iii) results in no reduction of skin microflora during a six-month treatment, without
`administering a bisphosphonate compound.
`
`22. (New)
`monohydrate.
`
`The method according to Claim 21, wherein said doxycycline is doxycycline
`
`The method according to Claim 22, wherein said doxycycline monohydrate is
`23. (New)
`administered in an amount of 40 milligrams.
`
`The method according to Claim 23, wherein said doxycycline monohydrate is
`24. (New)
`administered by sustained release.
`
`A method according to Claim 24, wherein said doxycycline monohydrate is
`25. (New)
`administered once a day.
`
`The method according to Claim 22, wherein said doxycycline monohydrate is
`26. (New)
`administered in a dose of 20 mg twice a day.
`
`2
`
`Exh. 1068
`
`
`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 3 of6
`
`The method according to Claim 21, wherein said doxycycline, or a
`27. (New)
`pharmaceutically acceptable salt thereof, is administered in an amount which provides a
`serum concentration in the range of about 0.1 to about 0.8 11g/ml.
`
`A method for treating papules and pustules of rosacea in a human in need
`28. (New)
`thereof, the method comprising
`administering orally to said human doxycycline, or a pharmaceutically acceptable salt
`thereof,
`in an amount that
`(i) is effective to treat the papules and pustules of rosacea;
`(ii) is 40-80% of a 50 mg dose of doxycycline; and
`(iii) results in no reduction of skin microflora during a six-month treatment, without
`administering a bisphosphonate compound.
`
`29. (New)
`monohydrate.
`
`The method according to Claim 28, wherein said doxycycline is doxycycline
`
`The method according to Claim 29, wherein said doxycycline monohydrate is
`30. (New)
`administered in an amount of 40 milligrams.
`
`The method according to Claim 30, wherein said doxycycline monohydrate is
`31. (New)
`administered by sustained release.
`
`A method according to Claim 31, wherein said doxycycline monohydrate is
`32. (New)
`administered once a day.
`
`The method according to Claim 29, wherein said doxycycline monohydrate is
`33. (New)
`administered in a dose of 20 mg twice a day.
`
`3
`
`Exh. 1068
`
`
`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 4 of6
`
`The method according to Claim 28, wherein said doxycycline, or a
`34. (New)
`pharmaceutically acceptable salt thereof, is administered in an amount which provides a
`serum concentration in the range of about 0.1 to about 0.8 11g/ml.
`
`A method for treating papules and pustules of rosacea in a human in need
`35. (New)
`thereof, the method comprising
`administering orally to said human doxycycline, or a pharmaceutically acceptable salt
`thereof, in an amount of 40mg per day, wherein the amount results in no reduction of skin
`microflora during a six-month treatment, without administering a bisphosphonate compound.
`
`36. (New)
`monohydrate.
`
`The method according to Claim 35, wherein said doxycycline is doxycycline
`
`37. (New)
`The method according to Claim 36, wherein said doxycycline monohydrate is
`administered by sustained release.
`
`A method according to Claim 37, wherein said doxycycline monohydrate is
`38. (New)
`administered once a day.
`
`The method according to Claim 36, wherein said doxycycline monohydrate is
`39. (New)
`administered in a dose of 20 mg twice a day.
`
`The method according to Claim 35, wherein said doxycycline, or a
`40. (New)
`pharmaceutically acceptable salt thereof, is administered in an amount which provides a
`serum concentration in the range of about 0.1 to about 0.8 11g/ml.
`
`4
`
`Exh. 1068
`
`
`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 5 of6
`
`RE MARKS
`
`Claims 2-20 were previously cancelled. Claim 1 is presently cancelled. New Claims
`21-40 are presently added. Thus, Claims 21-40 are pending.
`
`Applicant thanks Examiner Tran for discussing the instant application during a
`personal interview with the applicant's undersigned representative on April23, 2012.
`
`During the interview, the applicant' s undersigned representative presented draft
`claims to the examiner. Suchclaimsare independent Claims 21, 28 and 35 presented in the
`instant Amendment. These claims are more defined than those allowed in the parent
`application, now US 7,232,572 (hereinafter "US'572").
`
`Claim 1 ofUS'572 recites a method for treating papules and pustules ofrosacea by
`the oral administration of a tetracycline compound, or its pharmaceutically acceptable salt, in
`an amount that is effective to treat the papules and pustules, but has substantially no antibiotic
`activity, the amount being 10-80% ofthe antibiotic amount. The amount is recited to result
`in no reduction of skin microflora during a six-month treatment.
`
`Similarly, the pending claims recite a method for treating papules and pustules of
`rosacea. However, in the pending claims, the tetracycline compound is defined as being
`doxycycline, or its pharmaceutically acceptable salt. The dose is expressed differently in
`each independent claim. The dose recited in Claim 21 is 10-80% of a 50 mg dose of
`doxycycline. The dose recited in Claim 28 is 40-80% of a 50 mg dose of doxycycline. The
`dose recited in Claim 35 is 40 mg. Support for these claims can be found throughout the
`specification, including for example, from page 9, line 27, to page 10, line 10, and page 15,
`lines 23-29. As in Claim 1 ofthe '572 patent, the amount of doxycycline administered results
`in no reduction of skin microflora during a six-month treatment.
`
`Since the pending claims are more defined than Claim 1 ofthe '572 patent, the instant
`claims are also allowable.
`
`5
`
`Exh. 1068
`
`
`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 6 of6
`
`Entry of this Amendment before examination on the merits is respectfully requested.
`If the examiner has any questions concerning this application, it is requested that the
`examiner contact applicant' s undersigned representative at the telephone number provided
`below.
`
`Respectfully submitted,
`
`/susan a. sipos/
`Susan A. Sipos
`Registration No.: 43,128
`Attorney for Applicant
`
`HOFFMANN & BARON, LLP
`6900 J ericho Turnpike
`Syosset, N ew Y ork 11791
`(516) 822-3550
`SAS
`
`376399
`
`6
`
`Exh. 1068
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