Prosecution Insights
Last updated: April 19, 2026
Application No. 18/090,005

PROCESS FOR PRODUCING L-CARNITINE

Non-Final OA §102§103§112
Filed
Dec 28, 2022
Examiner
BONAPARTE, AMY C
Art Unit
1692
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Carnitech LLC
OA Round
3 (Non-Final)
80%
Grant Probability
Favorable
3-4
OA Rounds
2y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants 80% — above average
80%
Career Allow Rate
584 granted / 734 resolved
+19.6% vs TC avg
Strong +24% interview lift
Without
With
+23.8%
Interview Lift
resolved cases with interview
Typical timeline
2y 2m
Avg Prosecution
40 currently pending
Career history
774
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
33.3%
-6.7% vs TC avg
§102
15.7%
-24.3% vs TC avg
§112
32.8%
-7.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 734 resolved cases

Office Action

§102 §103 §112
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 and 5-8 were amended in the response filed on 7/14/2025. Claims 1-15 are currently pending and under examination. Claim Interpretation In claims 5-8, the process steps of making the solution of L-carnitinenitrile are enclosed within a “wherein” clause and are recited using only product by process language (is prepared/produced by). Therefore, the process steps are only considered to the extent that they limit the structure of the solution. In contrast, see the phasing of the steps in claims 12-15, which are included within “further comprising” language and recite actively required process steps. See MPEP 2111.04 and MPEP 2113. This is the same interpretation on p. 2 of the OA dated 1/15/2025. Withdrawn Claim Objections The Applicant’s amendments, filed on 7/14/2025, are persuasive to overcome the objections of record on p. 2-3 of the OA dated 1/15/20125. Therefore, the objections are withdrawn. Withdrawn Claim Rejections - 35 USC § 112(b) The Applicant’s amendments, filed on 7/14/2025, are persuasive to overcome the rejections of record on p. 3-4 of the OA dated 1/15/20125. Therefore, the rejections are withdrawn. Withdrawn Claim Rejections - 35 USC § 102 The Applicant amended step (a) of claim 1 to require “adding an oxidant to a colored solution of L-carnitinenitrile chloride and residual cyanide to decolorize and to remove residual cyanide”. These amendments, in combination with the arguments on p. 5-6 of the response filed 7/14/2025 are persuasive to overcome the 35 USC 102 rejection of record of claim(s) 1-3, 5-9, and 11 as being anticipated by Ohashi (JPH01287065A, published on 11/17/1989, including a machine generated English language translation) as evidenced by Changzhou (CN108727221A, published on 11/2/2018, including a machine generated English language translation) and KR940009936B1 (published on 10/19/1994, including machine generated English language translation) on p. 4-9 of the OA dated 1/15/2025. Though the evidentiary references suggest that the method of Ohashi should produce a colored solution of L-carnitine nitrile chloride and residual cyanide, the combination of the references does not mean that both characteristics are necessarily present. Nor does the combination of the references necessarily teach that the hydrogen peroxide of Ohashi decolorizes and removes residual cyanide from the product. Therefore, the rejection is withdrawn. Also see MPEP 2112(IV). Maintained Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. See p. 9-24 of the OA dated 1/15/2025 regarding the rejections of record. Claim(s) 1-3 and 5-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Changzhou (CN108727221A, published on 11/2/2018, including a machine generated English language translation, of record) in view of KR940009936B1 (published on 10/19/1994, including machine generated English language translation, of record) and Ohashi (JPH01287065A, published on 11/17/1989, including a machine generated English language translation, of record). Applicant Claims A process for the production of L-carnitine, comprising: (a) adding an oxidant to a colored solution of L-carnitinenitrile chloride and residual cyanide to decolorize and to remove residual cyanide; (b) optionally isolating the L-carnitinenitrile chloride from the solution of step (a); and (c) converting the L-carnitinenitrile chloride of step (a) or step (b) to L-carnitine. Determining the Scope and Content of the Prior Art (MPEP §2141.01) Changzhou discloses a preparation of levocarnitine (L-carnitine) intermediate: L-3-cyano-2-hydroxypropyltrimethylammonium chloride (L-carnitinenitrile chloride). Se abstract and claims. The method comprises aminating (S)-epoxychloropropane with trimethylamine hydrochloride to obtain L-3-chloro-2-hydroxypropyltrimethylammonium chloride and then carrying out cyanation with sodium cyanide to obtain L-carnitinenitrile chloride. Changzhou further teaches that after the aminating reaction, the reaction system is handled using complexing agent, preferably phytic acid. Changzhou teaches that after cyanation, the reaction system is handled using an adsorbent, preferably activated carbon. The complexing agent is added to improve the color of the L-3-chloro-2-hydroxypropyltrimethylammonium chloride (referred to as L-quaternary ammonium salts throughout Changzhou) solution and to reduce impurities therein. The adsorbent is added after cyanation to improve the color of the L-carnitinenitrile chloride solution (referred to as L-nitrile compounds throughout Changzhou) and to reduce the impurities therein. See abstract and claims. Thus, Changzhou teaches the overall product-by-process steps recited in claims 5, 6, and 8, as illustrated by the scheme on p. 2 of the specification as filed. Changzhou further teaches that L-carnitinenitrile chloride can be obtained as a solid in the examples, therefore an L-carnitinenitrile solution obtained using the method of claim 7 could also be used. See experimental procedure on p. 2 of the translation. Therefore, though the process steps in claims 5-8 are only interpreted to the extent that they further limit the composition of the L-carnitinenitrile solution, as Changzhou teaches the same method of preparation, then it is assumed that the compositions of the L-carnitine solutions of Changzhou are equivalent to those claimed and include any impurities derived from said methods of preparation. Also see MPEP 2113. Changzhou further teaches that NaCN, the cyanation agent, is used in excess in the preparation reaction, such that residual cyanide ions are expected to be present in the crude L-carnitinenitrile chloride solution prior to being treated with an adsorbent. See reaction procedure on p. 2 of the translation, wherein the limiting reagent is 1.40 mol of S-epoxychloropropane as compared to 1.53 mol of NaCN. Thus, Changzhou establishes that the disclosed two step method for preparing L-carnitinenitrile chloride is known to produce discolored reaction solutions which include impurities, including residual cyanide ions. Changzhou further teaches that both the color of the solutions and the purity level of the solutions can be improved by using a complexing agent after the amination step and an adsorbent step after the cyanation step. See abstract; the second and third paragraphs on p. 2 of the translation, and the examples and Tables 1-5 on p. 2-3 of the translation. The “miscellaneous content” in the Tables refers to impurities present. Changzhou additionally teaches that the intended use of the purified L-carnitinenitrile chloride is in the production of L-carnitine (levocarnitine), which corresponds to step (c) of claim 1. See first paragraph on p. 2 of the translation. KR940009936B1 teaches a recovery process for recovering organic acids (RCOOH) from aqueous NaCN. The process comprises treating a mixture of NaCN and the organic acid with hydrogen peroxide (H2O2, an oxidant-claims 1-3) in water in order to decompose NaCN. See abstract and claims. KR940009936B1 teaches that the NaCN is oxidatively decomposed according to the following equations: PNG media_image1.png 82 266 media_image1.png Greyscale . See top of p. 3 of the patent. Ohashi is directed toward obtaining carnitine without causing formation of salts in a large amount, by reacting carnitinenitrile chloride with a catalytic amount of a basic substance and aqueous hydrogen peroxide (an oxidant of claims 1-3). See abstract and claims. Claim 3 of Ohashi: PNG media_image2.png 286 356 media_image2.png Greyscale Claims 3-5 of Ohashi teach that the carnitinenitrile chloride is a compound of formula (III) and that carnitine is a compound of formula (I). The examples teach that racemic (d,l) carnitinenitrile chloride is employed in a solution with water as a solvent, therefore, L-carnitine is present in the carnitinenitrile chloride solution. See p. 3-4 of the translation. Additionally, examples 38-41 (see original patent and tp. 3-4 of the translation) teach the use of a solution of carnitinenitrile chloride consisting of L-carnitinenitrile chloride. Ohashi teaches that the oxidant hydrogen peroxide, when in the presence of a basic substance, produces carnitine over a two-step hydrolysis reaction. The reaction proceeds through amide intermediate (II): PNG media_image3.png 210 690 media_image3.png Greyscale . See claim 4 and examples. The reactions of examples 1-15 (summarized in Table 1 on p. 6 of the patent) and 16-20 (summarized inTable 2 on p. 6 of the patent) teach that the product of the reaction comprises a mixture of product carnitine (I), residual carnitinenitrile chloride (III), and partially hydrolysed amide intermediate (II). Top of Table 1 of Ohashi, wherein col. 4-6 teach the relative amounts of compounds (I), (II), and (III) present in the product: PNG media_image4.png 236 732 media_image4.png Greyscale Top of Table 2 of Ohashi, wherein col. 3-5 teach the relative amounts of compounds (I), (II), and (III) present in the product: PNG media_image5.png 206 764 media_image5.png Greyscale Therefore, the examples of Ohashi meet the limitations of the instant claims when step (b) remains optional and step (c) can take place concurrently with step (a). Ohashi teaches that the carnitinenitrile chloride (II) is prepared by reacting epichlorohydrin and trimethylamine hydrochloride to produce 3-chloro-2-hydroxypropyltrimethylammonium chloride, and then cyanating it using sodium cyanide. See the tenth paragraph on p. 2 of the translation. This preparation method corresponds to the product-by-process steps recited in claims 5, 6, and 8, and the process of Changzhou. Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.02-03) Changzhou does not explicitly teach a process wherein an oxidant is added to a solution of L-carnitinenitrile chloride to decolorize and remove residual cyanide. However, Changzhou does teach that if the L-carnitinenitrile chloride is produced according to the product-by-process steps of claims 5, 6, and 8 (which all describe the same overall process occurring in one or multiple stages), that the crude L-carnitinenitrile chloride solution obtained therefrom will be discolored and contain impurities including residual NaCN. Changzhou teaches removing said impurities and improving the color of the solutions through the use of complexing agents and adsorbents. KR940009936B1 teaches that hydrogen peroxide, an oxidant, is known to safely decompose NaCN in aqueous solution. KR940009936B1 does not explicitly teach the use of hydrogen peroxide to treat a solution of L-carnitinenitrile chloride. Ohashi teaches that the addition of at least an equimolar amount of hydrogen peroxide to an aqueous solution of L-carnitinenitrile chloride under basic conditions can facilitate the hydrolysis of L-carnitinenitrile chloride to L-carnitine. Ohashi does not explicitly teach that the hydrogen peroxide can decolorize and remove residual cyanide. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Changzhou, KR940009936B1, and Ohashi to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the claimed invention. A person of ordinary skill would have been motivated to use hydrogen peroxide as an oxidant to purify a crude mixture of L-carnitinenitrile chloride because replacing or combining one known purification method with another is prima facie obvious. Changzhou teaches the need for purification of L-carnitinenitrile chloride solutions when they are obtained from the reaction between epichlorohydrin, trimethylammonium hydrochloride, and NaCN in any combination of steps. Changzhou further teaches that both adsorbents and complexing agents are known to reduce impurities and improve the color of L-carnitinenitrile chloride solutions. KR940009936B1 teaches that hydrogen peroxide is known to oxidatively decompose NaCN, an impurity in the solution of L-carnitinenitrile chloride of Changzhou, in the presence of water. Therefore, the skilled artisan would be motivated to either replace the adsorbents and/or complexing agents of Changzhou with hydrogen peroxide or to include a further purification step with hydrogen peroxide in the process of Changzhou to predictably obtain a pure solution of L-carnitinenitrile chloride. Changzhou also teaches that L-carnitinenitrile chloride is an intermediate in the production of pharmaceutically valuable L-carnitine. Ohashi additionally provides support for the use of hydrogen peroxide as a purification agent because hydrogen peroxide can also facilitate the hydrolysis of L-carnitinenitrile chloride to L-carnitine. Therefore, the hydrogen peroxide would not be expected to adversely affect the L-carnitinenitrile chloride. Further, the overall synthesis of L-carnitine could be simplified because a single reagent could be employed to both purify a crude L-carnitinenitrile chloride solution and then facilitate its transformation to L-carnitine. Therefore, improving the purity of an intermediate in the synthesis of L-carnitine by including a hydrogen peroxide treatment step will also predictably improve the purity of the final L-carnitine commercial product, thus increasing the value of the L-carnitine product while increasing the efficiency of the process. Also see MPEP 2143(A) and (B). Regarding claims 9 and 10, examples 1-15 of Ohashi are carried out at a molar ratio of carnitinenitrile chloride (10 mmol) : hydrogen peroxide (20 mmol) of 1:2 or 200% molar of H2O2 based on carnitinenitrile chloride to produce L-carnitine. See p. 3 of the translation. This value falls within the limitations of claim 9. KR940009936B1 teaches that 1 mole of H2O2 is required to decompose 1 mole of NaCN as evidenced by the reaction scheme. Therefore, if the skilled artisan only desired to remove residual NaCN from the crude L-carnitinenitrile chloride solution as in KR940009936B1, as opposed to hydrolysing the L-carnitinenitrile chloride to form L-carnitine in Ohashi, then the skilled artisan would be motivated to employ a substoichiometric amount of hydrogen peroxide, as compared to L-carnitinenitrile chloride, in the addition step such that only enough is added to predictably decompose all of the residual NaCN. Also see MPEP 2144.05. Regarding claim 11, examples 1-15 of Ohashi first stir all the reactants for 1 hour at room temperature then the reaction is heated to 40C (below the boiling point of water) for 2 hours. See p. 3 of the translation. Similarly, KR940009936B1 teaches that the preferred range is 20-70C which falls within the claimed range. See p. 2 of the translation and MPEP 2144.05. Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Changzhou (CN108727221A, published on 11/2/2018, including a machine generated English language translation, of record) in view of KR940009936B1 (published on 10/19/1994, including machine generated English language translation, of record) and Ohashi (JPH01287065A, published on 11/17/1989, including a machine generated English language translation of record), as applied to claims 1-3 and 5-11 above and further in view of Brown (US2006/0100457, published on 5/11/2006, of record). Applicant Claims Applicant claims the method of claim 1, wherein the oxidant is sodium hypochlorite. Determining the Scope and Content of the Prior Art (MPEP §2141.01) The combination of Changzhou, KR940009936B1, and Ohashi teach the use of hydrogen peroxide as an oxidant. Brown is directed toward a process for production of gamma-cyhalothrin of formula (I). See abstract. Brown teaches that the process comprises the following steps: PNG media_image6.png 338 348 media_image6.png Greyscale PNG media_image7.png 394 346 media_image7.png Greyscale . See [0004]. In [0032], Brown teaches that the production of compound (II) includes the use of sodium cyanide (NaCN) and that residual cyanide was destroyed with sodium hydrochlorite liquor at the end fo the reaction. Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.02-03) The combination of Changzhou, KR940009936B1, and Ohashi does not explicitly teach that sodium hypochlorite can be substituted for hydrogen peroxide as the oxidant. This deficiency is cured through the teachings of Brown. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Changzhou, KR940009936B1, Ohashi, and Brown to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the instant invention. A person of ordinary skill would have been motivated to replace hydrogen peroxide with sodium chlorite because both are known to decompose residual NaCN. Therefore, replacing one known equivalent with another is prima facie obvious and predictable. Also see MPEP 2143(B). Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Changzhou (CN108727221A, published on 11/2/2018, including a machine generated English language translation, of record) in view of KR940009936B1 (published on 10/19/1994, including machine generated English language translation, of record) and Ohashi (JPH01287065A, published on 11/17/1989, including a machine generated English language translation, of record), as applied to claims 1-3 and 5-11 above and further in view of Cavazza (US6372940, published on 4/16/2002, of record in the IDS filed on 7/25/2024). Applicant Claims Applicant claims the method of claim 1, further comprising the production of L-carnitine L-tartrate or L-carnitine fumarate by reacting L-carnitine with either L-tartaric acid or fumaric acid, respectively. Determining the Scope and Content of the Prior Art (MPEP §2141.01) The combination of Changzhou, KR940009936B1, and Ohashi teaches the production of L-carnitine. Cavazza is directed toward process for the preparation of non-hygroscopic salts of L-carnitine. Cavazza teaches that the process comprising heating a mixture comprising L-carnitine with fumaric acid or tartaric acid. See abstract and claims. Cavazza teaches L-tartaric acid in claim 1. Cavazza further teaches that fumarate and tartrate salts of L-carnitine have ideal properties for oral pharmaceutical formulations. See col. 1, lines 1-30. Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.02-03) The combination of Changzhou, KR940009936B1, and Ohashi does not explicitly teach forming the claimed salts of L-carnitine. This deficiency is cured through the teachings of Cavazza. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Changzhou, KR940009936B1, Ohashi, and Cavazza to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the instant invention. A person of ordinary skill would have been motivated to produce L-carnitine-L-tartrate and L-carnitine fumarate from L-carnitine according to the claimed methods because Cavazza teaches that these are known methods to produce the desired salts, which have ideal properties to prepare pharmaceutical oral formulations of L-carnitine. Therefore, combing the preparation method of L-carnitine of Changzhou, KR940009936B1, and Ohashi with the salt formation process of Cavazza will predictably produce the claimed commercially valuable salts. Also see MPEP 2143(A). Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Changzhou (CN108727221A, published on 11/2/2018, including a machine generated English language translation) in view of KR940009936B1 (published on 10/19/1994, including machine generated English language translation, of record) and Ohashi (JPH01287065A, published on 11/17/1989, including a machine generated English language translation, of record), as applied to claims 1-3 and 5-11 above and further in view of Kramer (US2015/0166466, published on 6/18/2015, of record in the IDS filed on 7/25/2024). Applicant Claims Applicant claims the method of claim 1, further comprising the production of acetyl-L-carnitine hydrochloride or propionyl-L-carnitine hydrochloride by reacting L-carnitine with either acetyl chloride or propionyl chloride, respectively. Determining the Scope and Content of the Prior Art (MPEP §2141.01) The combination of Changzhou, KR940009936B1, and Ohashi teaches the production of L-carnitine. Kramer is directed toward process for the preparation of salts of carnitine, including salts of acetyl-L-carnitine and propionyl-L-carnitine. See abstract. Kramer teaches that the hydrochloride salts of acetyl-L-carnitine and propionyl-L-carnitine can be prepared by reacting L-carnitine with acetyl chloride and propionyl chloride, respectively. See [0031]: PNG media_image8.png 558 358 media_image8.png Greyscale . Kramer further teaches that acetyl/propionyl-L-carnitine salts have increased bioavailability as compared to L-carnitine. See [0003-0006]. Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.02-03) The combination of Changzhou, KR940009936B1, and Ohashi does not explicitly teach forming the claimed derivatives of L-carnitine. This deficiency is cured through the teachings of Kramer. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Changzhou, KR940009936B1, Ohashi, and Kramer to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the instant invention. A person of ordinary skill would have been motivated to produce acetyl/propionyl-L-carnitine from L-carnitine according to the claimed methods because Kramer teaches that these are known methods to produce the desired derivatives, which have greater bioavailability than L-carnitine. Therefore, combing the preparation method of L-carnitine of Changzhou, KR940009936B1, and Ohashi with the derivative formation process of Kramer will predictably produce the claimed commercially valuable derivatives for use in supplements. Also see MPEP 2143(A). Response to Applicant Arguments On p. 5-6 of the response filed 7/14/2025, the Applicant argues the following against the 35 USC 102 rejection of record: “This application discloses and claims a method for providing a solution to a long-time industrial problem that was described in Changzhou art, i.e., the solution of L-carnitinenitrile chloride produced from trimethylamine hydrochloride, sodium cyanide, and epichlorohydrin is colored and contains residual sodium cyanide. Ohashi describes the use of hydrogen peroxide (an oxidant) to convert L-carnitinenitrile to L-carnitinamide, and then to L-carnitine. Thus, Ohashi teaches the use of hydrogen peroxide to destroy L-carnitinenitrile, not to prepare L-carnitinenitrile. Ohashi is silent about the color of the solution and does not address the issue of removing cyanide. Changzhou describes the reaction of trimethylamine hydrochloride, epichlorohydrin, and sodium cyanide to produce a solution of L-carnitinenitrile chloride that is colored and contains residual sodium cyanide, the long-time industrial problem. Changzhou described the use of an absorbent to clarify the solution and to reduce the color of the solution. Changzhou is silent on the issue of cyanide. KR '936 describes the use of hydrogen peroxide to destroy sodium cyanide in the presence of organic acid, not in the presence of L-carnitinenitrile chloride. KR '936 is silent on the issue of decoloring. Neither the individual references nor their combination in any way suggest the present process i.e., that an oxidant (such as hydrogen peroxide) can be used to prepare L- carnitinenitrile chloride of improved quality by decolorizing a colored solution of L- carnitinenitrile and to remove residual cyanide.” While the Applicant does not appear to specifically address the 35 USC 103 rejections of record, it is presumed that the arguments presented above are also intended to address the 35 USC 103 rejections. With respect to the 35 USC 103 rejections, this argument has been fully considered but is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the rejection: “A person of ordinary skill would have been motivated to use hydrogen peroxide as an oxidant to purify a crude mixture of L-carnitinenitrile chloride because replacing or combining one known purification method with another is prima facie obvious. Changzhou teaches the need for purification of L-carnitinenitrile chloride solutions when they are obtained from the reaction between epichlorohydrin, trimethylammonium hydrochloride, and NaCN in any combination of steps. Changzhou further teaches that both adsorbents and complexing agents are known to reduce impurities and improve the color of L-carnitinenitrile chloride solutions. KR940009936B1 teaches that hydrogen peroxide is known to oxidatively decompose NaCN, an impurity in the solution of L-carnitinenitrile chloride of Changzhou, in the presence of water. Therefore, the skilled artisan would be motivated to either replace the adsorbents and/or complexing agents of Changzhou with hydrogen peroxide or to include a further purification step with hydrogen peroxide in the process of Changzhou to predictably obtain a pure solution of L-carnitinenitrile chloride. Changzhou also teaches that L-carnitinenitrile chloride is an intermediate in the production of pharmaceutically valuable L-carnitine. Ohashi additionally provides support for the use of hydrogen peroxide as a purification agent because hydrogen peroxide can also facilitate the hydrolysis of L-carnitinenitrile chloride to L-carnitine. Therefore, the hydrogen peroxide would not be expected to adversely affect the L-carnitinenitrile chloride. Further, the overall synthesis of L-carnitine could be simplified because a single reagent could be employed to both purify a crude L-carnitinenitrile chloride solution and then facilitate its transformation to L-carnitine. Therefore, improving the purity of an intermediate in the synthesis of L-carnitine by including a hydrogen peroxide treatment step will also predictably improve the purity of the final L-carnitine commercial product, thus increasing the value of the L-carnitine product while increasing the efficiency of the process. Also see MPEP 2143(A) and (B).” Changzhou teaches that crude L-carnitinenitrile solutions commonly contain excess cyanide ions and are discolored. Changzhou also teaches that the solutions can be purified by treatment with complexing agents and/or adsorbents. KR ‘936 teaches that the hydrogen peroxide step of Otashi can purify and transform L-carnitinenitrile chloride to L-carnitine. Therefore, the combination of references teaches replacing one predictable purification with another (MPEP 2143B) or adding an additional predictable purification step comprising an oxidant to an existing purification process (MPEP 2143A). Either modification of the process of Changzhou will predictably lead to purified L-carnitinenitrile and L-carnitine products. With further respect to KR ‘936, it is noted that L-carnitine is an organic acid, which is produced by hydrolysis of carnitinenitrile and is the desired end product of Changzhou, Otashi, and the instantly claimed process. Therefore, the rejection stands for the reasons of record. Conclusion 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 AMY C BONAPARTE whose telephone number is (571)272-7307. The examiner can normally be reached 11-7. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. 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
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Prosecution Timeline

Dec 28, 2022
Application Filed
Jan 10, 2025
Non-Final Rejection — §102, §103, §112
Jul 14, 2025
Response Filed
Aug 13, 2025
Final Rejection — §102, §103, §112
Oct 20, 2025
Request for Continued Examination
Oct 21, 2025
Response after Non-Final Action
Dec 02, 2025
Non-Final Rejection — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
80%
Grant Probability
99%
With Interview (+23.8%)
2y 2m
Median Time to Grant
High
PTA Risk
Based on 734 resolved cases by this examiner. Grant probability derived from career allow rate.

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