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 .
Applicants' arguments, filed May 12, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Response to Arguments
The Examiner submits that although Zhou does not disclose carbon dioxide in a headspace, JP 518’ provides motivation as to why one of ordinary skill in the art would want to use carbon dioxide in a headspace of a lidocaine composition in an ampule. One would want to stabilize a pharmaceutical composition by preventing precipitation of particles. Further although Zhou discloses other methods of stabilization, one of ordinary skill in the art would recognize the advantage of adding an additional layer of protection for the composition. Although JP 518’ does not disclose lidocaine, one of ordinary skill in the would use its teachings and apply them to other pharmaceutical compositions. One would recognize that stabilization of a composition that may form particles may also be applied to other composition with the same problems. In regards to the glass containers, JP 518’ was used to for its disclosure of stabilization with nitrogen, not material of the storage container. In regards to not forming particles in glass containers, one of ordinary skill in the art would recognize that over time, a pharmaceutical composition may start to form particles. One of ordinary skill in the art would provide components that would prevent any precipitation or break down. In regards to gas space, the gas space would be the space above the solution in the ampule. In regards to the amendment, ampules for lidocaine compositions are usually made of glass and the term ampule often refers to glass containers. In regards to the amount of particles, not only does the method of making the solutions of Zhou decrease the formation of particles, the addition of carbon dioxide to the headspace of the ampule of Zhou would also reduce particles. Therefore one would reasonably conclude that less than 100 particles are formed after storage. JP 518’ was used for it disclosure of carbon dioxide and that carbon dioxide may be used to stabilize pharmaceutical compositions. Therefore the rejection is maintained.
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.
Response to Arguments
The Examiner submits that Liu cures the deficiencies of Zhou in view of JP 518’ by disclosing the amount of sodium chloride. Therefore, it would have been obvious to 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’ to arrive at the desired osmotic pressure.
Conclusion
Claims 1-23 are rejected.
No claims allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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