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. Claim Status Claims 1-17 were filed on 1/4/2023. Priority The instant application was filed 1/4/2023 and does not claim priority to any earlier filed applications. Claim Objections Claims 6 -9 are objected to because of the following informalities: In line 2 of claim 6 , the word “is” should be deleted and replaced by –are--. In line 2 of claim 6 , the indefinite article –a—should be inserted before the limitation “C 1 -C 24 alkyl group”. In line 4 of claim 7 , the first instance of the word “is” should be deleted and replaced by –and--. In the third line of text in claim 8 , the word “is” should be deleted and replaced by –are--. In the third line of text in claim 9 , the word “is” should be deleted and replaced by –are--. Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 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 7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 7 recites “R 4 is an alkyl group, acyl is an alkyl or aryl acyl group; wherein the methylene group may be substituted with an alkyl group in the total sum of alkyl groups; and the number of total carbons of methylene groups and R 4 is at least 14”. There are two issues with this limitation. First it is not clear if i) R 4 is alkyl group, alkyl acyl group, or aryl acyl group or if ii) R 4 is an alkyl group; wherein acyl is an alkyl or aryl acyl group. Option ii) would refer back to the limitation “acyl-N(CH 2 ) m (CH 2 ) n ” in line 3 of claim 7 . The second issue with the claim is that it is not clear what “the total sum of alkyl groups” refers to. The final limitation of the claim requires a “number of total carbon atoms of methylene groups and R 4 is at least 14”, however there is no discussion of a “total sum of alkyl groups”. 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 (i.e., changing from AIA to pre-AIA) 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. 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. Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiong ( CN 102516105 , published on 6/27/2012 , of record in the IDS filed on 7/18/2024 ) in view of Fiorini ( US4413142 , published on 11/1/1983) . An English translation of Qiong is provided with the instant OA. The Applicant claims a process for the production of L-carnitine, comprising: Mixing L-carnitinenitrile chloride and optionally alkali chloride with hydrochloric acid to form a solution of L-carnitine hydrochloride, ammonium chloride, and optionally, alkali chloride; Cooling the solution of step (a) to precipitate the ammonium chloride and optionally, alkali chloride; Separating the precipitated ammonium chloride and optionally alkali chloride of step (b) to yield a solution of L-carnitine hydrochloride; and Isolating the L-carnitine from the solution of step (c). Qiong is directed toward a preparation method of L-carnitine hydrochloride. See abstract. In example 1 , Qiong teaches mixing L-carnitinenitrile chloride with hydrochloric acid to form a solution of L-carnitine hydrochloride and ammonium chloride. Qiong teaches that the solution is cooled to 0°C to precipitate ammonium chloride, which is then removed by filtration to yield a solution of L-carnitine hydrochloride. See lines 148-156 of the translation and scheme in [0015] of the patent. Fiorini teaches a method for preparing L-carnitine. See abstract. Fiorini teaches that the final step in the process is the neutralization of L-carnitine acid chloride (L-carnitine hydrochloride) to produce and isolate L-carnitine. The neutralization can be carried out with an ion-exchange resin in the OH form or a solution of a strong base such as ammonium hydroxide. Fiorini further teaches removing ammonium chloride from the neutralized product. See col. 3, line 51-col. 4, line 55. Qiong does not explicitly teach a step of neutralizing the L-carnitine hydrochloride to prepare and isolate L-carnitine from the final solution, as required by instant step (d) of claim 16 . It would have been prima facie obvious for the skilled artisan to combine the teachings of Qiong and Fiorini to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the invention. A person of ordinary skill would have been motivated to neutralize the L-carnitine hydrochloride obtained at the end of the process of Qiong and isolate L-carnitine because such is explicitly taught by Fiorini . L-Carnitine is active as both the betaine and the hydrochloride salt. See col. 1, lines 1-39 of Fiorini and lines 20-28 of the translation of Qiong . Therefore, combining one known predictable process with another will produce L-carnitine from its hydrochloride salt. Also see MPEP 2143(I)(A). Allowable Subject Matter Claims 1-5 and 10-15 are allowed. Claims 6-9 are objected to for containing informalities, but are otherwise free from the prior art. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Claim 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action. Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: the closest prior art to the process of claims 1-15 and 17 is the process described in Fiorini ( US4413142 , published on 11/1/1983), which is the reference applied to the 35 USC 103 rejection of claim 16 above. Fior ini teaches a method for preparing L-carnitine. See abstract. Fiorini teaches that the final step in the process is the neutralization of L-carnitine acid chloride (L-carnitine hydrochloride) to produce and isolate L-carnitine. The neutralization can be carried out with an ion-exchange resin in the OH form or a solution of a strong base such as ammonium hydroxide. See col. 3, line 51-col. 4, line 55. Fiorini does not teach or suggest substituting a strong ionic base (ammonium hydroxide) or an ion-exchange resin in the OH form for an organic base for the neutralization of L-carnitine hydrochloride to L-carnitine. This deficiency is not cured by the prior art. No other prior art teaches or suggests substituting an organic base for those disclosed in Fiorini . Further, the examples on p. 15-20 of the specification as filed show that when an organic base is employed in the neutralization reaction that the process beneficially produces less salts that need to be addressed during the isolation and purification of the L-carnitine. The examples also teach that there is no epimerization of L-carnitine under the disclosed conditions. Desalting is a known problematic step in the synthesis of L-carnitine and the prior art does not appear to contemplate addressing this issue through use of an organic base . Also see p. 4, final paragraph to p. 5, third full paragraph. Therefore, the instantly claimed process appears to be free from the prior art. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT AMY C BONAPARTE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-7307 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 11-7 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /AMY C BONAPARTE/ Primary Examiner, Art Unit 1692