AITORNEY DOCKET NO. 244168.000007US10
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`)
`)
`) Group Art Unit: 1628
`)
`)
`) Examiner: Shirley V. GEMBEH
`)
`)
`) Confirmation No.: 2532
`)
`)
`
`In re Application of:
`
`Giorgio CALDERARI et al.
`
`Application No.: 13/902,132
`
`Filed: May 24, 2013
`
`For: LIQUID PHARMACEUTICAL
`FORMULATIONS OF
`PALONOSETRON
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`AMENDMENT AND RESPONSE TO OFFICE ACTION
`
`In reply to the Office Action mailed August 8, 2013, please amend the above-
`
`identified application as follows:
`
`Amendments to the Claims are reflected in the listing of claims in this paper
`
`and begin on page 2.
`
`Remarks/Arguments follow the amendment sections of this paper and begin on
`
`page 8.
`
`Dr. Reddy's Laboratories, ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1039
`
`Exh. 1039
`
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`)
`)
`) Group Art Unit: 1628
`)
`)
`) Examiner: Shirley V. GEMBEH
`)
`)
`) Confirmation No.: 2532
`)
`)
`
`In re Application of:
`
`Giorgio CALDERARI et al.
`
`Application No.: 13/902,132
`
`Filed: May 24, 2013
`
`For: LIQUID PHARMACEUTICAL
`FORMULATIONS OF
`PALONOSETRON
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`AMENDMENT AND RESPONSE TO OFFICE ACTION
`
`In reply to the Office Action mailed August 8, 2013, please amend the above-
`
`identified application as follows:
`
`Amendments to the Claims are reflected in the listing of claims in this paper
`
`and begin on page 2.
`
`Remarks/Arguments follow the amendment sections of this paper and begin on
`
`page 8.
`
`Dr. Reddy's Laboratories, ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1039
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 2 of 11
`
`AMENDMENTS TO THE CLAIMS:
`
`This listing of claims will replace all prior versions and listings of claims in the
`
`application:
`
`1-11. (Canceled)
`
`12.
`
`(Currently Amended) A method for reducing the likelihood of cancer
`
`chemotherapy-induced nausea and vomiting, comprising intravenously administering to
`
`a human in need thereof tAe Q pharmaceutical single-use. unit-dose formulation
`
`comprising a 5 ml sterile aqueous isotonic solution buffered at a pH of about 5.0 + 0.5,
`
`said solution of claim 10, comprising:
`
`about 0.05 mg/ml palonosetron hydrochloride based on the weight of its free
`
`about 41.5 mg/ml mannitol;
`
`about 0.5 mg/ml EDTA; and
`
`a citrate buffer.
`
`wherein said formulation
`
`is stable at 24 months when stored at room
`
`temperature. and
`
`wherein said intravenous administration to said human occurs before the start of
`
`the cancer chemotherapy.
`
`13.
`
`(Previously Presented) The method of claim 12, wherein said intravenous
`
`administration to said human occurs over a period of time of 10 to 60 seconds.
`
`14.
`
`(Previously Presented) The method of claim 12, wherein said intravenous
`
`administration reduces the likelihood of acute nausea and vomiting in said human.
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 3 of 11
`
`15.
`
`(Previously Presented) The method of claim 12, wherein said intravenous
`
`administration reduces the likelihood of delayed nausea and vomiting in said human.
`
`16.
`
`(New) A method for reducing the likelihood of cancer chemotherapy-
`
`induced nausea and vomiting, comprising intravenously administering to a human in
`
`need thereof a pharmaceutical single-use, unit-dose formulation comprising a 5 ml
`
`sterile aqueous isotonic solution buffered at a pH of about 5.0 ± 0.5, said solution
`
`comprising:
`
`about 0.05 mg/ml palonosetron hydrochloride based on the weight of its free
`
`base;
`
`from about 10 mg/ml to about 80 mg/ml mannitol; and
`
`from about 0.3 mg/ml to about 0.7 mg/ml EDTA;
`
`wherein said solution optionally comprises a citrate buffer,
`
`wherein said formulation
`
`is stable at 24 months when stored at room
`
`temperature, and
`
`wherein said intravenous administration to said human occurs before the start of
`
`the cancer chemotherapy.
`
`17.
`
`(New) The method of claim 16, wherein said intravenous administration to
`
`said human occurs over a period of time of 10 to 60 seconds.
`
`18.
`
`(New) The method of claim 16, wherein said intravenous administration
`
`reduces the likelihood of acute nausea and vomiting in said human.
`
`19.
`
`(New) The method of claim 16, wherein said intravenous administration
`
`reduces the likelihood of delayed nausea and vomiting in said human.
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 4 of 11
`
`20.
`
`(New) The method of claim 16, wherein said solution comprises from
`
`about 20 mg/ml to about 60 mg/ml mannitol.
`
`21.
`
`(New) The method of claim 20, wherein said solution comprises from
`
`about 40 mg/ml to about 45 mg/ml mannitol.
`
`22.
`
`(New) The method of claim 21, wherein said solution comprises about
`
`41 .5 mg/ml mannitol and about 0.5 mg/ml EDTA.
`
`23.
`
`(New) The method of claim 16, wherein said solution comprises a citrate
`
`buffer.
`
`24.
`
`(New) A method for reducing the likelihood of cancer chemotherapy-
`
`induced nausea and vomiting, comprising intravenously administering to a human in
`
`need thereof a pharmaceutical single-use, unit-dose formulation comprising a 5 ml
`
`sterile aqueous isotonic solution, said solution comprising :
`
`about 0.05 mg/ml palonosetron hydrochloride based on the weight of its free
`
`base;
`
`a tonicifying effective amount of mannitol; and
`
`from about 0.3 mg/ml to about 0.7 mg/ml EDTA;
`
`wherein said solution optionally comprises a citrate buffer and optionally has a
`
`pH of from about 5.0 ± 0.5,
`
`wherein said formulation
`
`is stable at 24 months when stored at room
`
`temperature, and
`
`wherein said intravenous administration to said human occurs before the start of
`
`the cancer chemotherapy.
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 5 of 11
`
`25.
`
`(New) The method of claim 24, wherein said intravenous administration to
`
`said human occurs over a period of time of 10 to 60 seconds.
`
`26.
`
`(New) The method of claim 24, wherein said intravenous administration
`
`reduces the likelihood of acute nausea and vomiting in said human.
`
`27.
`
`(New) The method of claim 24, wherein said intravenous administration
`
`reduces the likelihood of delayed nausea and vomiting in said human.
`
`28.
`
`(New) The method of claim 24, wherein said solution comprises a citrate
`
`buffer.
`
`29.
`
`(New) The method of claim 24, wherein said solution is buffered at a pH of
`
`about 5.0 ± 0.5.
`
`30.
`
`(New) The method of claim 24, wherein said solution comprrises from
`
`about 10 mg/ml to about 80 mg/ml mannitol.
`
`31.
`
`(New) The method of claim 30, wherein said solution comprrises from
`
`about 20 mg/ml to about 60 mg/ml mannitol.
`
`32.
`
`(New) The method of claim 32, wherein said solution comprises about
`
`41.5 mg/ml mannitol and about 0.5 mg/ml EDTA.
`
`33.
`
`(New) A method for reducing the likelihood of cancer chemotherapy-
`
`induced nausea and vomiting, comprising intravenously administering to a human in
`
`need thereof a pharmaceutical single-use, unit-dose formulation comprising a 5 ml
`
`sterile aqueous isotonic solution buffered at a pH of about 5.0 ± 0.5, said solution
`
`comprising:
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 6 of 11
`
`about 0.05 mg/ml palonosetron hydrochloride based on the weight of its free
`
`base; and
`
`a tonicifying effective amount of mannitol;
`
`wherein said solution optionally comprises one or a combination of a citrate
`
`buffer and a chelating agent,
`
`wherein said formulation
`
`is stable at 24 months when stored at room
`
`temperature, and
`
`wherein said intravenous administration to said human occurs before the start of
`
`the cancer chemotherapy.
`
`34.
`
`(New) The method of claim 33, wherein said intravenous administration to
`
`said human occurs over a period of time of 10 to 60 seconds.
`
`35.
`
`(New) The method of claim 33, wherein said intravenous administration
`
`reduces the likelihood of acute nausea and vomiting in said human.
`
`36.
`
`(New) The method of claim 33, wherein said intravenous administration
`
`reduces the likelihood of delayed nausea and vomiting in said human.
`
`37.
`
`(New) The method of claim 33, wherein said solution comprises a citrate
`
`buffer.
`
`38.
`
`(New) The method of claim 33, wherein said solution comprises a
`
`chelating agent.
`
`39.
`
`40.
`
`(New) The method of claim 38, wherein said chelating agent is EDTA.
`
`(New) The method of claim 39, wherein said solution comprises from
`
`about 0.3 mg/ml to about 0.7 mg/ml EDT A.
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 7 of 11
`
`41 .
`
`(New) The method of claim 33, wherein said solution comprises from
`
`about 10 mg/ml to about 80 mg/ml mannitol.
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 8 of 11
`
`REMARKS
`
`Claims 12-41 , as amended, are currently pending in this application. Claims 1-9
`
`were previously canceled, and claims 10 and 11 are canceled herein, all without
`
`prejudice or discllaimer. Claim 12 is amended herein and new claims 16-41 are added.
`
`Support for those amendments can be found
`
`throughout the priority document
`
`(Provisional Application No. 60/444,351 ), for example, at:
`
`-the abstract at page 21;
`
`-page 2, lines 3-6 and lines 24-29;
`
`-page 3, lines 1-5, lines 11-20;
`
`-page 3, line 21 to page 4, line 13;
`
`- page 4, I ines 19-21;
`
`-page 5, line 1 to page 6, line 2;
`
`- page 6, I ines 16-20;
`
`-page 6, line 21 to page 7, line 1;
`
`- page 7, line 29 to page 10, line 25;
`
`- page 11, lines 5-9;
`
`- Examples 1 and 2 on page 11;
`
`- Example 3 bridging pages 11-12;
`
`-Example 4 on page 12; and
`
`-original claims 1, 4, 5-8, 10, 12, 14-16, 18, 19, 21, 23, 25, 33, 34, 36, 38, 39,
`
`41-44,46-48,50, 51, and 54-57.
`
`Thus, the amendments do not add new matter.
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 9 of 11
`
`Applicant respectfully requests reconsideration of this application in view of the
`
`foregoing amendments and the following remarks.
`
`CLAIM REJECTIONS UNDER 35 U.S.C. § 112(b)
`
`Claims 10-15 were rejected under 35 U.S.C. § 112(b) as allegedly indefinite.
`
`(Office Action at pp. 2-3.) Specifically, the previously presented claims contained the
`
`term "means for making," which the Office identified as "an attempt to use a 'means'
`
`clause to recite a claim element as a means for performing a specified function." (!d. at
`
`p. 2.) According to the Office, however, "[t]he term 'making' has no functional! meaning,
`
`therefore it is confusing what Applicant is referring to." (/d. at p. 3.)
`
`Without acquiescing in any way to the rejection and solely to advance
`
`prosecution, Applicant has canceled claims 10 and 11 without prejudice or disclaimer,
`
`rendering the rejection moot with respect to those claims. In addition, Applicant notes
`
`that amended claim 12 and its dependent claims 13-15, as well as new claims 16-41, do
`
`not recite the phrase "means for making."
`
`For at least these reasons, Applicant respectfully requests that the Office
`
`withdraw the rejection under 35 U.S.C. § 112(b) and not apply it to the claims, as
`
`amended herein.
`
`PRIOR ART REJECTIONS
`
`A.
`
`Anticipation Rejection
`
`Claims 10 and 11 were rejected under 35 U.S.C. §102(b) as allegedly
`
`anticipated by WO 2004/073714 to Baroni et al. ("Baroni"). (Office Action at pp. 3-4.)
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 10 of 11
`
`Without acquiescing to the rejection, Applicant has canceled claims 10 and 11 without
`
`prejudice or disclaimer whatsoever, rendering this rejection moot.
`
`B.
`
`Obviousness Rejection
`
`Claims 12-15 were rejected under 35 U.S.C. § 103 as allegedly obvious over
`
`Baroni. (Office Action at pp. 4-7.) Applicant respectfully traverses this rejection as if it
`
`had been applied to the amended claims.
`
`Baroni is an International Application designating the United States. Baroni was
`
`filed on February 18, 2004, and was published under the Patent Cooperation Treaty on
`
`September 2, 2004.
`
`Baroni claims priority
`
`to U.S. Provisional Application
`
`No. 60/448,342, which was filed on February 18, 2003. Thus, Applicants assume,
`
`arguendo, that the 35 U.S.C. § 1 02(a)(2) effectively-filed date of the Baroni publication
`
`is February 18, 2003.
`
`The Preliminary Amendment sets forth that original claims 12-15 are fully
`
`supported, for purposes of enablement and written description support, by the priority
`
`document of the instant application (U.S. Application No. 60/444,351) ("the '351
`
`application"). And, as discussed above, the amendments to the claims herein are
`
`likewise fully supported in the '351 application. The '351 application was filed on
`
`January 30, 2003.
`
`Thus, claims 12-41 have an effective filing date of January 30, 2003. T hat date,
`
`of course, is prior to the assumed 35 U.S.C. § 102(a)(2) effectively-filed date of Baroni.
`
`Hence, Baroni is not prior art under 35 U .S.C. § 1 02(a )(2). Nor is it prior art under AlA
`
`35 U.S.C. § 102(a)(1), AlA 35 U.S.C. § 103, or pre-AlA 35 U.S.C. § 102(g). (Please see
`
`Exh. 1039
`
`
`
`U.S. Application No. 13/902,132
`Amendment and Response to Office Action
`October 9, 2013
`Page 11 of 11
`
`Choice of Law Section in the Preliminary Amendment, incorporated by reference
`
`herein.)
`
`Simply put, Baroni is not prior art to the currently pending claims. For at least
`
`these reasons, Applicant respectfully requests that the Office withdraw the rejection
`
`under 35 U.S.C. § 103.
`
`CONCLUSION
`
`In view of the foregoing amendments and remarks, Applicant respectfully
`
`requests reconsideration of this application and the timely allowance of the pending
`
`claims. Should the Examiner disagree or have any questions regarding this
`
`submission, the Applicant invites the Examiner to call the undersigned at 212.704.6105.
`
`Respectfully submitted,
`
`By:/Ciark G. Sullivan/
`Clark G. Sullivan
`Reg. No. 36,942
`
`Troutman Sanders LLP
`Chrysler Bldg, 405 Lexington Ave
`New York, NY 10174
`Phone: (212) 704-6000
`
`Exh. 1039
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