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