DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are included in the prosecution.
Claim Rejections – 35 U.S.C. 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sloey at el. (US20180237501A1) hereinafter Sloey.
Regarding claims 1-20, Sloey is drawn to formulations of PCSK9-binding polypeptides that comprise N-acetyl arginine and have reduced viscosities when compared to formulations lacking N-acetyl arginine. Provided herein are also methods of formulating such compositions that are advantageous in that they conserve certain components. Such formulations comprising PCSK9-binding polypeptides can be administered to patients to treat and/or prevent PCSK9-related diseases, conditions, and disorders (abstract).
Sloey discloses there is a need in the art to reduce the viscosity of evolocumab- and other PCSK9-binding polypeptides-containing formulations with compounds that are more efficient than arginine [0007]. Sloey discloses a pharmaceutical composition comprising a PCSK9-binding polypeptide that selected from a monoclonal antibody [0009] and N-acetyl arginine [0021]. Sloey discloses pharmaceutical formulations include liquid, e.g., aqueous, solutions that can be directly administered, and lyophilized powders which can be reconstituted into solutions by adding a diluent before administration [0329]. Sloey discloses a derivative of arginine, N-acetyl arginine (NAR), efficiently reduces the viscosity of pharmaceutical compositions comprising high concentrations (greater than 100 mg/mL, such as 140 mg/mL and greater) of evolocumab more so than unacetylated arginine [0273].
Sloey discloses a method of preparing a PCSK9-binding polypeptide pharmaceutical composition comprising at least 140 mg/mL of PCSK9-binding polypeptide, comprising adding to a pharmaceutical composition comprising the PCSK9-binding polypeptide an effective amount of N-acetyl arginine, such that the viscosity of the pharmaceutical composition is reduced when compared to the pharmaceutical composition lacking the N-acetyl arginine [0137].
Sloey does not explicitly disclose each of the components of the composition in a single embodiment.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sloey, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Sloey discloses all the required components and Sloey discloses N-acetyl arginine, efficiently reduces the viscosity of pharmaceutical compositions comprising high concentrations of evolocumab more so than unacetylated arginine [0273]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615