Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
STATUS OF CLAIMS: Claims 31, 34-37, 39, 40, 42-45 and 47-50 are pending in this application.
Response to Arguments
Regarding Claim Rejections Under- 35 USC § 102
Applicant’s arguments, filed November 4, 2025, with respect to the rejection of claims under 35 USC § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration to Applicant’s amendment, a new ground of rejection is made herein below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 31, 34-37, 39, 40, 42-45 and 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over Yuanxin et al. (CN104116741).
Applicant claims the following:
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Yuanxin discloses a vilazodone solid dispersion comprising vilazodone, a carrier material and a surfactant. (See Abstract, entire document and Examples).
Yuanxin does not explicitly disclose a vilazodone solid dispersion wherein the surfactant is Span-20 and poloxamer 188.
Thus, Applicant’s vilazodone solid dispersion differs from Yuanxin by using a different surfactant (i.e., Span-20 and poloxamer 188) and a weight proportion of surfactant to vilazodone solid dispersion.
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings of Yuanxin to design a vilazodone solid dispersion to include a different surfactant and weight to obtain a different dispersion for bioavailability or dissolution. Yuanxin discloses a vilazodone solid dispersion comprising vilazodone, a carrier material and a surfactant and weight. It is well known in pharmaceutical chemistry that surfactants are crucial pharmaceutical excipients used to enhance drug solubility, stability and bioavailability by reducing interfacial tension, and act as emulsifiers, wetting agents, solubilizers in formulations and suspensions. Thus, choosing a different surfactant commonly known in pharmaceutical chemistry is common and obtained by routine experimentation. Thus, one skilled in the art looking for an alternative vilazodone solid dispersion would apply the vilazodone solid dispersion of Yuanxin to include a different surfactant and weight such as Span-20 and poloxamer 188 for bioavailability or dissolution by routine experimentation. All of the moieties are taught in the art. Therefore, Applicant’s vilazodone solid dispersion is an obvious alternative. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Yuanxin, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 31, 34-37, 39, 40, 42-45 and 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over IN 2012CH03815.
Applicant claims the following:
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IN 2012CH03815 discloses a vilazodone solid dispersion comprising vilazodone, a carrier material that is povidone or copovidone, and a surfactant. (See Abstract, entire document and Examples).
IN 2012CH03815 does not explicitly disclose a vilazodone solid dispersion wherein the surfactant is Span-20 and poloxamer 188, and a weight proportion of surfactant to vilazodone solid dispersion.
Thus, Applicant’s vilazodone solid dispersion differs from IN 2012CH03815 by using a different surfactant (i.e., Span-20 and poloxamer 188)
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings of IN 2012CH03815 to design a vilazodone solid dispersion to include a different surfactant to obtain a different dispersion for bioavailability or dissolution. IN 2012CH03815 discloses a vilazodone solid dispersion comprising vilazodone, a carrier material that is povidone or copovidone, and a surfactant. It is well known in pharmaceutical chemistry that surfactants are crucial pharmaceutical excipients used to enhance drug solubility, stability and bioavailability by reducing interfacial tension, and act as emulsifiers, wetting agents, solubilizers in formulations and suspensions. Thus, choosing a different surfactant commonly known in pharmaceutical chemistry is common and obtained by routine experimentation. Thus, one skilled in the art looking for an alternative vilazodone solid dispersion would apply the vilazodone solid dispersion of IN 2012CH03815 to include a different surfactant and weight such as Span-20 and poloxamer 188 for bioavailability or dissolution by routine experimentation. All of the moieties are taught in the art. Therefore, Applicant’s vilazodone solid dispersion is an obvious alternative. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of IN 2012CH03815, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 31, 34-37, 39, 40, 42-45 and 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over IN2013MU03458.
Applicant claims the following:
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IN2013MU03458 discloses a vilazodone solid dispersion comprising vilazodone, a carrier material that is povidone and copovidone, and a surfactant. (See Abstract, entire document and Examples).
IN2013MU03458 does not explicitly disclose a vilazodone solid dispersion wherein the surfactant is Span-20 and poloxamer 188, and a weight proportion of surfactant to vilazodone solid dispersion.
Thus, Applicant’s vilazodone solid dispersion differs from IN2013MU03458 by using a different surfactant (i.e., Span-20 and poloxamer 188)
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to modify the teachings of IN2013MU03458 to design a vilazodone solid dispersion to include a different surfactant and weight to obtain a different dispersion for bioavailability or dissolution. IN2013MU03458 discloses a vilazodone solid dispersion comprising vilazodone, povidone and co-povidone, and a surfactant. It is well known in pharmaceutical chemistry that surfactants are crucial pharmaceutical excipients used to enhance drug solubility, stability and bioavailability by reducing interfacial tension, and act as emulsifiers, wetting agents, solubilizers in formulations and suspensions. Thus, choosing a different surfactant commonly known in pharmaceutical chemistry is common and obtained by routine experimentation. Thus, one skilled in the art looking for an alternative vilazodone solid dispersion would apply the vilazodone solid dispersion of IN2013MU03458 to include a different surfactant and weight such as Span-20 and poloxamer 188 for bioavailability or dissolution by routine experimentation. All of the moieties are taught in the art. Therefore, Applicant’s vilazodone solid dispersion is an obvious alternative. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of IN2013MU03458, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Conclusion
Claims 31, 34-37, 39, 40, 42-45 and 47-50 are pending in this application. Claims 31, 34-37, 39, 40, 42-45 and 47-50 are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622