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
Response to Amendment/Arguments
Regarding Claim Rejections Under - 35 USC §§ 102 & 112
Applicant’s arguments with respect to claims rejected under 35 USC §§ 102 & 112 have been considered and persuasive. Thus, the rejections under 35 USC §§ 102 & 112 have been withdrawn.
However, a new ground of rejection is entailed 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 1-47 (including claims dependent thereon or relate back to other claims) are rejected under 35 U.S.C. 103 as being unpatentable over Grunenberg et al., (US Pub. 20150038514).
Applicants claim a method for preparing a liquid pharmaceutical composition comprising a sodium salt of letermovir of formula (I) by the following steps:
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Additionally, Applicant claims methods of a lyophilizate, pharmaceutical compositions, processes and methods of treatment using said compositions and lyophilizate.
Additionally, in the dependent claims, Applicant claims the following:
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Grunenberg discloses methods for preparing liquid pharmaceutical compositions comprising a sodium salt of letermovir of formula (I) by the similar steps of Applicant’s methods, and Grunenberg discloses pharmaceutical compositions, processes and methods of treatment using said compositions. (See pages 1-8 and 16-17).
Grunenberg does not discloses the concentration (i.e., a concentration in the range of from 20 to 100mg/mL with respect to letermovir free base) and choices of excipients such as polyalkoxy compounds, mannitol, HCl and sucrose.
Thus, Applicant’s preparation methods and compositions provide alternative pharmaceutical compositions comprising a sodium salt of letermovir by using a different concentration and different commonly known excipients.
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the teachings of Grunenberg with commonly known preparation methods in chemistry such as changing the concentrations and changing commonly known excipients, such as polyalkoxy compounds, mannitol, sucrose, and HCl (which are common practices) by using routine experimentation. Moreover, freeze-drying an obtained solution to provide a lyophilizate is also a common chemistry method that is commonly known in the art by using routine experimentation. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, confronted with providing an alternative pharmaceutical composition comprising a sodium salt of letermovir, would be motivated to modify the teachings of Grunenberg by customary practices in the art of modifying the concentration and modifying the excipients by using routine experimentation to obtain the alternative pharmaceutical composition comprising a sodium salt of letermovir . See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Grunenberg, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Conclusion
Claims 1-47 are pending in this application. Claims 1-47 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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