DETAILED ACTIONStatus 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 1-26 are pending.
Claim Interpretation
Regarding claims 13-18, the claimed pharmaceutical formulation is drawn to product claims and therefore the intended use of the formulation, “which is reconstituted with a diluent before intramuscular or subcutaneous administration” does not carry patentable weight over the teachings of the prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 14 is indefinite for reciting “wherein the diluent comprises at least one selected from the group consisting of carboxymethylcellulose sodium, mannitol, sodium chloride, sodium hydroxide, polysorbate, acetic acid, sodium dihydrogen phosphate monohydrate, and disodium phosphate heptahydrate”, and claim 14 depends from claim 13 which recites the pharmaceutical formulation is reconstituted with a diluent before intramuscular or subcutaneous injection, and this phrase in claim 14 is unclear because sodium chloride, sodium dihydrogen phosphate monohydrate, and disodium phosphate heptahydrate are solids and it is unclear if the diluents of claim 14 are supposed to be aqueous solutions comprising one of sodium chloride, sodium dihydrogen phosphate monohydrate, and disodium phosphate heptahydrate in order to be used as a reconstitution diluent.
Appropriate correction is required.
Claim Rejections - 35 USC §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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
on sale or otherwise available to the public before the effective filing date of the claimed
invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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 1-26 are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein et al. (US20050069591A1) hereinafter Bernstein.
Regarding claims 1-26, Bernstein is drawn to pharmaceutical formulations and methods are provided for the sustained delivery of a pharmaceutical agent to a patient by injection, by oral administration or by topical administration. The injectable formulation includes porous microparticles which comprise a pharmaceutical agent and a matrix material, wherein upon injection of the formulation a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles for at least 24 hours (abstract and claims 1-20). Berstein discloses the pharmaceutical agent is levothyroxine sodium [0083]. Berstein discloses the matrix material comprises a biocompatible synthetic polymer poly(lactide-co-glycolide) [0012].
Berstein discloses to deliver sustained release microparticulate pharmaceutical agents, compounds must be precisely formulated to ensure that they deliver the correct amount of pharmaceutical agent over the appropriate amount of time. This requires control of key factors such as geometric particle size and density and compatibility with select delivery devices and pharmaceutically acceptable carriers [0004].
Bernstein discloses a method is provided for delivering a pharmaceutical agent to a patient comprising administering to the patient by injection a sustained release pharmaceutical formulation which comprises porous microparticles which comprise a pharmaceutical agent and a matrix material, wherein upon injection of the formulation a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles into the patient for at least 24 hours. Exemplary routes/sites of injection include subcutaneous, intramuscular administration [0014].
Bernstein discloses methods are provided for making an injectable formulation for administration and sustained release of pharmaceutical agent. In a preferred embodiment, the method comprises the steps of: dissolving a matrix material in a volatile solvent to form a solution; adding a pharmaceutical agent to the solution to form an emulsion, suspension, or second solution; and removing the volatile solvent from the emulsion, suspension, or second solution to yield porous microparticles which comprise the pharmaceutical agent and the matrix material, wherein upon injection of the formulation a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles for at least 24 hours. In one embodiment, the method further comprises combining one or more surfactants with the solution. In one embodiment, the method further comprises combining the microparticles with a pharmaceutically acceptable vehicle for injection [0016]. Bernstein discloses methanol [0156] and dichloromethane [0168].
Bernstein does not explicitly disclose wherein the formulation has a theoretical levothyroxine loading of at least 1.5% w/w.
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 Bernstein, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Berstein discloses to deliver sustained release microparticulate pharmaceutical agents, compounds must be precisely formulated to ensure that they deliver the correct amount of pharmaceutical agent over the appropriate amount of time. This requires control of key factors such as geometric particle size and density and compatibility with select delivery devices and pharmaceutically acceptable carriers [0004], thus one of ordinary skill in the art would have reasonably expected success in arriving at a theoretical levothyroxine loading of at least 1.5% w/w. 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