IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant
`
`Robert A. Ashley
`
`Examiner:
`
`Blessing Fubara
`
`Serial No.:
`
`10/474,240
`
`Group Art Unit:
`
`1613
`
`Confirmation No:
`
`1971
`
`Docket:
`
`512-47 PCT/US/RCE III
`
`Filed:
`
`For:
`
`October 3, 2003
`
`Dated:
`
`December 22, 2010
`
`Controlled Delivery of
`Tetracycline Compounds
`and Tetracycline
`Derivatives
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Certificate ofEFS-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 December 22, 2010
`
`CarlaB an
`(Printed Name)
`
`Signature: /carla bryan/
`
`Amendment in Response to September 9, 2010 Final Office Action and
`
`Substance of Interview
`
`Sir:
`
`In reply to the September 9, 2010 Final Office Action, applicant respectfully
`
`submits a Request for Continued Examination along with the following Amendment for
`
`entry into the above-identified application.
`
`Amendments to the Specification: None.
`
`Amendments to the Claims:
`
`Begin on page 2.
`
`Remarks:
`
`Begin on page 3.
`
`1
`
`
`
`Applicant
`
`Robert A. Ashley
`
`Examiner:
`
`Blessing Fubara
`
`Serial No.:
`
`10/474,240
`
`Group Art Unit:
`
`1613
`
`Confirmation No:
`
`1971
`
`Docket:
`
`512-47 PCT/US/RCE III
`
`Filed:
`
`For:
`
`October 3, 2003
`
`Dated:
`
`December 22, 2010
`
`Controlled Delivery of
`Tetracycline Compounds
`and Tetracycline
`Derivatives
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Certificate ofEFS-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 December 22, 2010
`
`CarlaB an
`(Printed Name)
`
`Signature: /carla bryan/
`
`Amendment in Response to September 9, 2010 Final Office Action and
`
`Substance of Interview
`
`Sir:
`
`In reply to the September 9, 2010 Final Office Action, applicant respectfully
`
`submits a Request for Continued Examination along with the following Amendment for
`
`entry into the above-identified application.
`
`Amendments to the Specification: None.
`
`Amendments to the Claims:
`
`Begin on page 2.
`
`Remarks:
`
`Begin on page 3.
`
`1
`
`
`
`Applicant: Robert A. Ashley
`Serial No. 10/474,240
`Filing Date: October 3, 2003
`Docket No.: 512-47 PCT/US/RCE III
`Page 2 of5
`
`Amendment to the Claim:
`
`This listing of claims replaces all prior versions, and listings, of claims in the application.
`
`Claims 1-81. (Cancelled).
`
`82. (Currently Amended)
`
`A controlled release pharmaceutical composition comprising
`
`capsule consisting ofbeadlets, wherein the beadlets consist of:
`
`a.
`
`b.
`
`doxycycline, and
`
`a controlled release agent, wherein the controlled release agent
`
`consists of a com-bination of is either:
`
`______ 1"'-'. __ an instantaneous-release agent and or
`
`-------=2=.--a polymeric and/or biodegradable delayed-release agent;-..
`
`c.
`
`at least one pharmaceutical excipient other than a controlled
`
`release agent,
`
`'tvherein the composition is a capsule; and
`
`wherein the capsule consists ofbeadlets having the instantaneous-release agent and
`
`beadlets having the delayed release agent,
`
`wherein the doxycycline is physically associated with the controlled-release agents agent
`
`to provide a release-profile in a human upon administration whereby the human is treated
`
`with doxycycline at a dose substantially without antibiotic activity, and
`
`wherein the dose provides a serum level of about 0.4 to 0.8 )lg/ml over a period of 12 to
`
`24 hours.
`
`Claim 83. (Cancelled).
`
`2
`
`
`
`Applicant: Robert A. Ashley
`Serial No. 10/474,240
`Filing Date: October 3, 2003
`Docket No.: 512-47 PCT/US/RCE III
`Page 3 of5
`
`REMARKS
`
`Claims 1-81 and 83 were previously cancelled. Thus, Claim 82 is pending.
`
`Substance of Interview
`
`Applicant wishes to thank Examiner Blessing Fubara for taking the time to
`
`discuss the outstanding Office Action and for her courtesy during the December 9, 2010
`
`personal interview with the undersigned. (Note, the Interview Summary erroneously
`
`indicates that the interview took place on December 8, 2010.)
`
`Applicant's representative discussed proposed amendments of pending Claim 82
`
`with the examiner. In the Interview Summary, the examiner summarizes the subject
`
`matter of the proposed Claim 82. In particular, the subject matter is described as being a
`
`capsule wherein:
`
`[T]he capsule consists of two types ofbeadlets,
`
`one type ofbeadlet consisting of doxycycline and an instantaneous release
`
`agent and an excipient other than a controlled release agent; and
`
`the other type ofbeadlet consisting of doxycycline and a delayed release
`
`agent and an excipient other than a controlled release agent.
`
`In the present amendment, Claim 82 has, in fact, been amended to recite all the
`
`above elements. Support for these amendments can be found throughout the
`
`specification, including, for example, page 15, lines 20-22; the paragraph bridging pages
`
`9 and 10; and page 8, lines 23-28.
`
`3
`
`
`
`Applicant: Robert A. Ashley
`Serial No. 10/474,240
`Filing Date: October 3, 2003
`Docket No.: 512-47 PCT/US/RCE III
`Page 4 of5
`
`Thus, the only controlled release agents present in the capsules recited in
`
`amended Claim 82 are an instantaneous release agent and a delayed release agent. The
`
`capsules recited in Claim 82 cannot include a prolonged release agent.
`
`In the Interview Summary, the examiner states that the proposed amendments of
`
`Claim 82 "appear to overcome the prior art of record having prolonged and delayed, or
`
`prolonged and instantaneous release agents (Valorose and Saslawski)."
`
`To further elaborate, during the interview, applicant's representative explained
`
`that, unlike amended Claim 82, both Valorose and Saslawski reguire a prolonged release
`
`agent in their compositions. The following chart summarizes such explanation.
`
`Instantaneous
`Release Agent
`
`Prolonged
`Release Agent
`
`Delayed
`Release Agent
`
`Claim 82
`
`Saslawski
`
`Valorose
`
`YES
`
`YES
`
`NO
`
`NO
`
`YES
`
`YES
`
`YES
`
`YES
`
`YES
`
`In particular, Saslawski (US 6,372,255) discloses a composition comprising an
`
`immediate release agent and a prolonged release agent, and another composition which,
`
`in addition to an immediate release agent and a prolonged release agent, also includes a
`
`delayed release agent. (See abstract of Saslawski.) Thus, all the compositions of
`
`Saslawski require a prolonged release agent.
`
`4
`
`
`
`Applicant: Robert A. Ashley
`Serial No. 10/474,240
`Filing Date: October 3, 2003
`Docket No.: 512-47 PCT/US/RCE III
`Page 5 of5
`
`Similarly, Valorose (US 4,837,030) discloses a composition that requires a
`
`prolonged release agent. That is, Valorose discloses a composition comprising a
`
`prolonged release agent and a delayed release agent. (See col. 2, lines 50-56, and col. 3,
`
`lines 19-24 of Valorose.)
`
`As indicated in the Interview Summary, Golub et al. (US 5,837,696) does not
`
`teach any type of controlled release agent.
`
`Thus, as the examiner acknowledged in the Interview Summary, the proposed
`
`amendments of Claim 82 appear to overcome the prior art of record.
`
`Finally, to address the examiner's concern, the last phrase of Claim 82 has been
`
`amended to include a period of time as follows: "wherein the dose provides a serum level
`
`of about 0.4 to 0.8 )lg/ml over a period of 12 to 24 hours." Support for this amendment is
`
`found on page 4, lines 29-30, of the specification.
`
`In view of the amendment and remarks set forth above, applicant respectfully
`
`submits that the application is now in condition for allowance, which action is earnestly
`
`solicited. The examiner is respectfully requested to contact applicant's attorney at the
`
`telephone number indicated below with any questions or comments.
`
`Respectfully submitted,
`
`/susan a. sipos/
`Susan A. Sipos
`Registration No.: 43,128
`Attorney for Applicant
`
`HOFFMANN & BARON, LLP
`6900 Jericho Turnpike
`Syosset, New York 11791
`( 516) 822-3550
`
`346238
`
`5
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