REMARKS
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`Favorable reconsideration is respectfully requested in view of the foregoing amendments
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`and following remarks.
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`Applicants express their sincere appreciation to the Examiner for her courtesy and helpful
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`assistance provided to the Applicants' undersigned representative and representative Dr. Toan
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`Vo during the telephone interview held on September 18, 2013.
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`The foregoing amendments are presented according to the discussion with the Examiner,
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`and for the reasons discussed during the interview, are believed to overcome all grounds of
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`rejection.
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`I.
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`INFORMALITIES
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`In item 5 and 7 of the Office Action summary page, it is respectfully requested that the
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`pending claims be corrected to claims 19-48.
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`In item 12 of the Office Action summary page, it is respectfully requested that the claim
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`of foreign priority be acknowledged, and receipt of the certified copy of the priority document be
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`acknowledged, which copy is present in the Image File Wrapper.
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`II.
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`SUPPORT FOR AMENDED CLAIMS
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`Claims 19,27 and 32 are amended to specify that "the first component is the sole
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`pharmaceutical active ingredient contained in the preparation;". This amendment is supported
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`by page 7 (lines 14-17) and page 13 (lines 11-13) of the specification, which teaches that the
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`claimed preparation may be prepared with 2-amino-3-( 4-bromobenzoyl)phenylacetic acid or a
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`pharmacologically acceptable salt thereof or a hydrate thereof (hereinafter "bromfenac"), and
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`with "other same or different kind of active ingredients" so long as the purpose of the present
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`invention is achieved. Thus, a preparation containing bromfenac as the sole active ingredient is
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`clearly taught by the specification.
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`The amendment is further supported by the Examples of the specification which teach
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`compositions having bromfenac as the sole pharmaceutical active ingredient contained in the
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`preparation. The first specific composition taught in the specification is found in Experimental
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`Example 1 (pages 14-15). The sole pharmaceutical active ingredient contained in the preparation
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`is Sodium 2-amino-3-( 4-bromobenzoyl)phenylacetate, i.e. bromfenac.
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`9
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`The second specific composition taught in the specification is found in Experimental
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`Example 2 (pages I6-I8). The sole pharmaceutical active ingredient contained in the preparation
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`is Sodium 2-amino-3-( 4-bromobenzoyl)phenylacetate, i.e. bromfenac.
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`The third specific composition taught in the specification is found in Example I (page
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`2I). The sole pharmaceutical active ingredient contained in the preparation is Sodium 2-amino-
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`3-( 4-bromobenzoyl)phenylacetate 3/2 hydrate, i.e. bromfenac.
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`The fourth specific composition taught in the specification is found in Example 2 (page
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`22). The sole pharmaceutical active ingredient contained in the preparation is Sodium 2-amino-
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`3-( 4-bromobenzoyl)phenylacetate 3/2 hydrate, i.e. bromfenac.
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`The fifth and final specific composition taught in the specification is found in Example 3
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`(page 23). The sole pharmaceutical active ingredient contained in the preparation is Sodium 2-
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`amino-3-( 4-bromobenzoyl)phenylacetate 3/2 hydrate, i.e. bromfenac.
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`In summary, a preparation containing bromfenac as the sole active ingredient is clearly
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`taught by the specification. Thus, the amendment to claims I9, 27 and 32 is clearly supported by
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`the specification.
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`A minor error has been corrected in claim 25 which is evident from claim 3I.
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`Claims 44-48 are amended to specify the preservative efficacy standard ofEP-criteria B
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`of the European Pharmacopoeia, which is explicitly supported on page 20, last line, to page 2I of
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`the specification. Thus, the claims are amended to recite "as follows:
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`viable cell counts ofbacteria (S. aureus. P.aeruginosa) 24 hours and 7 days after
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`inoculation decrease to not more than Ill 0 and not more than Ill 000, respectively, and
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`thereafter, the cell count levels off or decreases; and
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`viable cell count of fungi (C. albicans. A. niger) I4 days after inoculation decreases to
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`not more than Ill 0, and thereafter, the cell count keeps the same level as that of I4 days after
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`inoculation".
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`III. REJECTION OF CLAIMS 44-48 UNDER 35 U.S.C. 112
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`Claims 44-48 are rejected under 35 U.S.C. II2, second paragraph, as being indefinite for
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`the recitation of the standard ofEP-criteria B of the European Pharmacopoeia.
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`This ground of rejection is deemed to be overcome by the foregoing amendments.
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`IO
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`IV.
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`REJECTION OF CLAIMS 19, 21-24, 26, 28-30, 32, 34-36, 38, 40-42 and 44-48
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`UNDER 35 U.S.C. § 103(a) BASED UPON GAMACHE
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`A. Claims 19, 21-24, 32, 34-36, 38, 40-42, 44 and 46-48
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`Claims 19, 27 and 32 now recite that the preparation comprises the first component, 2-
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`amino-3-( 4-bromobenzoyl)phenylacetic acid or a pharmacologically acceptable salt thereof or a
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`hydrate thereof (i.e. "bromfenac"), as the sole pharmaceutical active ingredient contained in the
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`preparation.
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`Gamache does not teach or suggest any preparation comprising bromfenac as the sole
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`pharmaceutical active ingredient.
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`Gamache teaches only compositions that must contain 5-HT1D and/or 5-HT1B receptor
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`agonists. Gamache's compositions may contain additional pharmaceutical active ingredients.
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`Gamache does not teach or suggest any composition comprising bromfenac as the sole
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`pharmaceutical active ingredient.
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`Thus, Gamache does not teach or suggest claims 19, 27 or 32 as amended. Accordingly,
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`Gamache fails to teach or suggest claims 21-24, 34-36, 38, 40-42, 44 and 46-48 which are
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`dependent upon claims 19 and 32.
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`Consequently, Gamache does not render these claims obvious.
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`B.
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`Claims 26, 28-30 and 45
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`Claim 26 recites that "said stable liquid preparation is formulated for ophthalmic
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`administration; and wherein the stable aqueous liquid preparation is characterized in that greater
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`than about 90% of the original amount of the first component remains in the preparation after
`storage at about 60 oc for 4 weeks."
`Gamache does not teach or suggest any preparation comprising bromfenac and tyloxapol,
`wherein greater than 90% of the original amount of bromfenac remains after storage at 60 oc for
`4 weeks.
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`Gamache disclosed generally that anti-inflammatory drugs, such as bromfenac or others,
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`may be used in a composition including any surfactants "known to those skilled in the art,"
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`including polysorbate 80. However, Gamache did not recognize the problem that bromfenac
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`degrades rapidly in the presence of polysorbate 80, a surfactant "known to those skilled in the
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`11
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`art" (according to Gamache), as Applicant demonstrated in the grandparent application Serial
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`No. 10/525,006.
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`Applicant recognized this problem and surprisingly found that the degradation of
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`bromfenac could be avoided by specifically including tyloxapol in the preparation.
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`Thus, the preparation of claim 26, and its dependent claims, are not obvious from
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`Gamache.
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`V.
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`REJECTION OF CLAIMS 20, 27, 33, and 39 UNDER 35 U.S.C. § 103(a) OVER
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`GAMACHE IN VIEW OF DESAI
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`Claim 20 is dependent upon independent claim 19. As pointed out above, claim 19 is
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`nonobvious over Gamache because Gamache does not teach or suggest any composition wherein
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`bromefenac is the sole pharmaceutical active ingredient. Therefore, adding Desai to show the
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`use of benzalkonium chloride still does not overcome the deficiency of Gamache. Therefore,
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`claim 20 is nonobvious over Gamache in view of Desai.
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`Claim 27 is amended to recite that bromfenac is the sole pharmaceutical active ingredient
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`in the preparation. As pointed out above, claim 27 is nonobvious over Gamache because
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`Gamache does not teach or suggest any composition wherein bromefenac is the sole
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`pharmaceutical active ingredient. Therefore, adding Desai to show the use of benzalkonium
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`chloride still does not overcome the deficiency of Gamache. Therefore, claim 27 is nonobvious
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`over Gamache in view of Desai.
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`Claims 33 and 39 are dependent upon independent claim 32. As pointed out above, claim 32
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`is nonobvious over Gamache because Gamache does not teach or suggest any composition
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`wherein bromfenac is the sole pharmaceutical active ingredient. Therefore, adding Desai to
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`show the use of benzalkonium chloride still does not overcome the deficiency of Gamache.
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`Moreover, all Desai's experiments include mannitol, which is excluded from the compositions of
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`present claims 33 and 39. Therefore, the combination of Gamache and Desai does not teach or
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`suggest any composition wherein bromfenac is the sole pharmaceutical active ingredient and
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`wherein mannitol is excluded. Consequently, claims 33 and 39 are nonobvious over Gamache in
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`view of Desai.
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`12
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`VI.
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`REJECTION OF CLAIMS 25, 31, 37 AND 43 UNDER 35 U.S.C. § 103(a) OVER
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`GAMACHE IN VIEW OF OGAWA AND DE BRUIJU
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`Claim 25 is dependent upon independent claim 19. As pointed out above, claim 19 is
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`nonobvious over Gamache because Gamache does not teach or suggest any composition wherein
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`bromefenac is the sole pharmaceutical active ingredient. Therefore, adding Ogawa and De
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`Bruiju to show the use of sodium tetraborate, sodium sulfite, polyvinylpyrrolidone and boric acid
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`does not overcome the deficiency of Gamache. Therefore, claim 25 is nonobvious over
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`Gamache in view of Ogawa and De Bruiju.
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`Claim 31 is dependent upon independent claim 26. As pointed out above, claim 26 is
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`nonobvious over Gamache because Gamache does not teach or suggest any preparation
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`comprising bromfenac and tyloxapol, wherein greater than 90% of the original amount of
`bromfenac remains after storage at 60 oc for 4 weeks. Therefore, adding Ogawa and De Bruiju to
`show the use of sodium tetraborate, sodium sulfite, polyvinylpyrrolidone and boric acid does not
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`overcome the deficiency of Gamache. Therefore, claim 31 is nonobvious over Gamache in view
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`of Ogawa and De Bruiju.
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`Claim 37 is dependent upon independent claim 32. As pointed out above, claim 32 is
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`nonobvious over Gamache because Gamache does not teach or suggest any composition wherein
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`bromefenac is the sole pharmaceutical active ingredient. Therefore, adding Ogawa and De
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`Bruiju to show the use of sodium tetraborate, sodium sulfite, polyvinylpyrrolidone and boric acid
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`does not overcome the deficiency of Gamache. Therefore, claim 37 is nonobvious over Gamache
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`in view of Ogawa and De Bruiju.
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`Claim 43 is dependent upon independent claim 32. As pointed out above, claim 32 is
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`nonobvious over Gamache because Gamache does not teach or suggest any composition wherein
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`bromefenac is the sole pharmaceutical active ingredient. Therefore, adding Ogawa and De
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`Bruiju to show the use of sodium tetraborate, sodium sulfite, polyvinylpyrrolidone and boric acid
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`does not overcome the deficiency of Gamache. Therefore, claim 43 is nonobvious over
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`Gamache in view of Ogawa and De Bruiju.
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`VII. DOUBLE PATENTING REJECTIONS
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`All claims are rejected on the ground of nonstatutory double patenting as being
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`unpatentable over claims ofU.S. Patent No. 7,829,544, U.S. Patent No. 8,129,431, U.S. Serial
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`No. 11/755,662 and U.S. Serial No. 13/353,653.
`13
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`

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`A. U.S. Patent No. 7,829,544, U.S. Patent No. 8,129,431, and U.S. Serial No.
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`13/353,653
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`Without acquiescing to the grounds of rejection, there are submitted herewith a Terminal
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`Disclaimer over U.S. Patent No. 7,829,544, U.S. Patent No. 8,129,431, and U.S. Serial No.
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`13/353,653.
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`B. U.S. Serial No. 111755,662
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`Regarding the provisional double patenting rejection over U.S. Serial No. 11/755,662, the
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`rejection is deemed to be overcome by the submission of a Letter of Express Abandonment filed
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`in the '662 application by the attorney of record on October 18, 2013 and the undersigned
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`representative on October 22, 2013.
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`Accordingly, the double patenting grounds of rejection are deemed to be overcome.
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`VIII. CONCLUSION
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`In view of the foregoing, it is believed that each ground of rejection has been overcome,
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`and that the application is now in condition for allowance.
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`Applicant respectfully submits that claims 19-48 are patentable over the prior art. A
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`favorable action on the merits is solicited.
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`WMC/dlk
`Washington, D.C. 20005-1503
`Telephone (202) 721-8200
`Facsimile (202) 721-8250
`October 22, 2013
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`Res)(~c~fully submitted,
`tvvarren M.
`Bt:heek, Jr./
`Warren M. Cheek
`Registration No. 33,367
`Attorney for Applicant
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`Digitally signed by /Warren M. Cheek,
`Jr./
`DN: cn=/Warren M. Cheek, Jr./, o, ou,
`email=wcheek@wenderoth.com, c=US
`Date: 2013.10.22 15:39:25 -04'00'
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