DETAILED ACTION
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 .
Claims
Claim Rejections - 35 USC § 103 - Obviousness
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.
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.
1) Claims 1-6 and 8-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (CN 101467987) in view of JP 3375518 (JP 518’).
Zhou et al. disclose lidocaine carbonate injection. The injection is made by adding lidocaine hydrochloride for injection 106.6 g, sodium bicarbonate 35 g, and water 5 Liters (meeting the water amounts of the instant claims) (page 2). The composition comprises 5% lidocaine (about 20 mg/ml) and 60% water for injection. An aqueous sodium bicarbonate solution is mixed with the lidocaine hydrochloride water solution, and adjusted to a pH value in the range of 7.5 to 6.0 with carbon dioxide gas. The composition is stored in a sterilized ampoule. The composition is a colorless transparent liquid. The composition is stored in an ampoule (meeting glass container).
Zhou et al. differ from the instant claims insofar as they do not disclose carbon dioxide case in a headspace.
JP 518’ discloses injection that use gas in the headspace of the container. The injections comprise sodium bicarbonate ions. Carbon dioxide may be used in the containers in order to provide a stable injectable preparation containing fewer particles. The carbon dioxide comprises 2 to 35% by volume.
It would have been obvious to one of ordinary skill in the art to have used carbon dioxide when storing the preparations of Zhou motivated by the desire to help stabilize the composition.
In regards to a buffer or pH adjuster, sodium bicarbonate is both.
In regards to the amount of carbon dioxide, carbon dioxide is used as a stabilizing agent, thus, making it a result effective variable. It would have been in the relative skill of one of ordinary skill in the art to have adjusted the amount of carbon dioxide in the headspace of the container of Zhou motivated by the desire to effectively stabilize the injectable composition when being stored.
In regards to the internal volume, it would be reasonable to conclude that the volume determines how much of the composition may held. Therefore it would have been obvious to one of ordinary skill in the art to have used a container with a certain volume motivated by the desire to hold a certain amount of the composition for delivering to a patient.
In regards to the properties of claims 13-18, the composition comprises substantially the same amounts of sodium bicarbonate and lidocaine hydrochloride. Therefore one of ordinary skill in the art would reasonably conclude that the liquid would have the stability recited by the instant claims. Further the compositions are ready to use or ready to administer.
In regards to claim 20, the compositions do not comprise any of the recited components.
The carbon dioxide inhibits particles. Therefore it is reasonable conclude that combination of Zhou in view of JP 518” would lead to not more than 100 particles.
2) Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (CN 101467987) in view of JP 3375518 (JP 518’) in further view of Liu (CN 106692120).
Zhou et al. in view of JP 518’ is discussed above and differs from the instant claims insofar as it does not disclose sodium chloride.
Liu discloses lidocaine hydrochloride pharmaceutical compositions. The composition may comprise sodium chloride as a pharmaceutically acceptable auxiliary materials. Sodium chloride is used to adjust the osmotic pressure.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added sodium chloride to the compositions of Zhou et al. in view of JP 518’ because it is suitable for compositions comprising lidocaine.
The sodium chloride is used to adjust the osmotic pressure making it a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of sodium chloride when adding to the composition of Zhou et al. in view of JP 518’ the routine experimentation to arrive at the desired osmotic pressure.
Claims 1-23 are rejected.
No claims allowed.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612