Prosecution Insights
Last updated: April 18, 2026
Application No. 18/568,436

A PROCESS FOR PRODUCING A METHYLCELLULOSE OR HYDROXYALKYL METHYLCELLULOSE

Non-Final OA §103§DP
Filed
Dec 08, 2023
Examiner
LEE, HOI YAN NMN
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Nutrition & Biosciences USA 1, LLC
OA Round
1 (Non-Final)
44%
Grant Probability
Moderate
1-2
OA Rounds
3y 5m
To Grant
99%
With Interview

Examiner Intelligence

Grants 44% of resolved cases
44%
Career Allow Rate
29 granted / 66 resolved
-16.1% vs TC avg
Strong +76% interview lift
Without
With
+76.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
84 currently pending
Career history
150
Total Applications
across all art units

Statute-Specific Performance

§101
2.8%
-37.2% vs TC avg
§103
40.2%
+0.2% vs TC avg
§102
17.4%
-22.6% vs TC avg
§112
17.4%
-22.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 66 resolved cases

Office Action

§103 §DP
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. DETAILED ACTION 2. Claims 1 – 15 are pending in this application and are examined on the merits herein. Applicant’s preliminary amendment, filed December 8, 2023, is entered, wherein claims 1 – 2 and 15 are original and claims 3 – 14 are amended. Priority 3. This application is a national stage application of PCT/EP2022/065168 , filed June 3, 2022, which claim benefit of foreign priority document EP21178171.1 , filed June 8, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. 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: i . Determining the scope and contents of the prior art. ii. Ascertaining the differences between the prior art and the claims at issue. iii. Resolving the level of ordinary skill in the pertinent art. iv. 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 1 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Swinehart (US2254249) in view of Balser et al. (US4438264) and Kitamura et al. (US2018/0273645A1) . a. Regarding claims 1 – 15 , Swinehart teaches a method for the manufacture of organo-soluble ethyl cellulose and other lower alkyl ethers of cellulose , specifically those wherein the substituting alkyl groups contain from 1 to 4 carbon atoms inclusive (page 1, Left Col., lines 1 – 5). Swinehart teaches the preferred method, wherein the method comprises immersing a cellulose sheet in a hot bath of concentrated caustic alkali, employing a caustic soda solution of from 67.5 to 80% , under conditions such that the cellulose is in contact with the alkali solution only long enough to absorb an amount of said solution which will yield an alkali cellulose, wherein the alkali/cellulose ratio is within the narrow range from 0.8 – 1.1/1 and the water/cellulose ratio is within the corresponding narrow range of from 0.28 – 0.38/1 (page 2, Right Col., lines 7 – 20). In one embodiment, the percentage of caustic soda concentration is 73.5% (page 3, Table 2) : . In another embodiment, the alkali solution is sodium hydroxide (page 3, Right Col., line 48). Swinehart teaches that the alkali cellulose is sealed in a reaction chamber with a large excess over the theoretical amount of ethyl chloride and the mixture is heated to a reaction temperature which may be within the range of from 60 to 150 ⁰C (page 2, Right Col., lines 24 – 29). Swinehart teaches that the amount of the alkali solution has been reduced to a concentration in the range from about 30 to about 50% during heating. The residual alkalinity at this stage is from about 1 to 8% of the total weight of the reaction mixture. Solid caustic alkali is then added to the reactor to bring the alkali solution in the vessel to a concentration of about 55 – 75%, thus bringing the total ratio of alkali to cellulose to a value varying from about 1.1/1 to about 3/1 (page 2, Right Col., lines 34 – 39). If enough alkali solution of less than 50% concentration is employed so that the cellulose fibers are uniformly penetrated and swollen by the alkali, there is always present, even after expressing excess aqueous alkali, sufficient water to make impractical the subsequent production of a uniform ether. Also, attempts which have been made to remove water during the etherification have proven both costly and inefficient , particularly since no material improvement in uniformity of the cellulose ether is obtained (page 1, Right Col., lines 6 – 13; lines 17 – 21). Swinehart further teaches that the ethyl cellulose is separated from the reaction mixture in known manner, washed and purified in accordance with standard practice (page 3, Left Col., lines 22 – 25). The ethyl cellulose can be obtained when the ethoxy content is at 34 to 40% (page 3, Left Col., line 49). However, Swinehart does not teach the mole of alkali hydroxide per mole of anhydroglucose units that is in contacted with cellulose. Swinehart does not teach the mole of methylating agent added per mole of anhydroglucose units in the cellulose. Swinehart does not teach the mole of hydroxyalkylating agent per mole of anhydroglucose units in the cellulose. Swinehart also does not teach the hydroxypropoxyl substitution. Balser et al. teach a process for the production of hydroxyethyl methyl cellulose by carrying out the alkalization and hydroxyethylation of the cellulose in liquid methyl chloride (Abstract) , wherein 1.2 to 1.4 mole of NaOH per mole of air-dry cellulose is used during alkalization (claim 2) , about 6 to 12 moles of liquid methyl chloride is used per mole of air-dry cellulose, and 3 to 5 moles of ethylene oxide per mole of air-dry cellulose (Col. 1, lines 57 – 58). Furthermore, Balser et al. teach that the MS in regard to OC 2 H 4 OH amounts to 1.65 and the hydroxyethyl content obtained may be adjusted as required in dependence upon the quantity of ethylene oxide used. Kitamura et al. teach a method for producing hydroxypropyl methyl cellulose (HPMC) having high hydroxypropoxy content, wherein the hydroxypropoxyl molar substitution is from 0.5 to 1.0 . The method comprises bringing the pulp into contact with alkali metal hydroxide solution to obtain a reaction product mixture containing alkali cellulose and reacting the alkali cellulose with an etherifying agent to obtain the crude HPMC (Abstract). The etherifying agent used is propylene oxide (para. [0007]). It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the method for the manufacture of organo-soluble lower alkyl ethers of cellulose as taught by Swinehart with the process for the production of hydroxyethyl methyl cellulose in view of Balser et al. because both references are directed to the etherification of alkali cellulose to produce substituted cellulose ethers and Balser et al. teach that methyl chloride and a hydroxyalkylating agent may be employed to obtain hydroxyalkyl methyl cellulose . It would have been obvious for one of ordinary skill in the art to substitute the ethyl chloride used as etherifying agent as taught by Swinehart with methyl chloride in view of Balser et al. to obtain the lower alkyl ether of cellulose, such as methylcellulose, because both references address the same field of cellulose ether manufacture and such substitution would have been expected to yield predictable results. It would have been obvious for one of ordinary skill in the art to modify the method of producing methyl cellulose or hydroxyethyl methyl cellulose as taught by Swinehart and Balser et al. into the method of producing hydroxypropyl methyl cellulose in view of Kitamura et al. because Kitamura et al. teach that hydroxypropyl methyl cellulose may be produced by reacting alkali cellulose with propylene oxide as the hydroxyalkylating agent, and further teach a hydroxypropoxyl molar substitution of from 0.5 to 1.0. One would have been motivated to substitute the ethylene oxide as taught by Balser et al. with propylene oxide in view of Kitamura et al. to obtain the known alternative hydroxyalkyl methyl cellulose because both hydroxyethyl and hydroxypropyl groups are known hydroxyalkylating agent introduced into cellulose through etherification of alkali cellulose and such substitution would have been expected to yield predictable results. Moreover, Kitamura et al. disclose the molar substitution range of 0.5 to 1.0 corresponds to approximately 15 to 26 wt.% hydroxypropoxyl , which falls within the ranges recited in claims 14 – 15. For the water content of the solid alkali hydroxide, Swinehart teaches that removal of water at the end of the production is costly and inefficient. One would have considered the disclosure of Swinehart and would have performed routine experimentation to discover the best water content of the solid alkali hydroxide for the optimal product characteristics. Moreover , the mole of methylating agent would have been no more than routine optimization of result-effective variables to obtain the desired substitution and product properties . With respect to claims 9 – 10, Swinehart explicitly teaches that solid caustic alkali is added to the reaction mixture to raise the alkali concentration in the vessel to about 55 – 75% and describes the stage-by-stage caustic soda concentrations in Table 2. Based on the disclosure, the amount of solid NaOH added between the end of the first stage and the beginning of the second stage is about 1.72 – 2.36 mol / mol AGU, which fall within the ranges recited in claims 9 – 10. Furthermore, one would have performed routine experimentation to discover the best methoxyl substitution for the optimal product characteristics based on the ethoxy substitution disclosed in Swinehart . One of ordinary skill in the art would have had a reasonable expectation to combine the teachings of Swinehart with the teachings in view Balser et al. and Kitamura et al. because all three references teach cellulose etherification through alkali cellulose, and each of the proposed modifications merely substitutes one known etherifying or hydroxyalkylating reagent for another known reagent used for producing a corresponding cellulose ether and these changes would have predictably yield the corresponding products. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claim s 1 – 4, 9 – 10, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/554,318 in view of Swinehart (US2254249) . a. Regarding 1 – 4, 9 – 10, and 13 , ‘318 teaches a process for preparing a methylcellulose , wherein the process comprising the steps of treating cellulose pulp with an alkalization agent at a temperature below 55 ⁰C; adding a methylating agent after the alkalization agent and reacting the alkalized cellulose with the methylating agent for 45 minutes or less; and wash the methylcellulose produced (claim 8). However, ‘318 does not teach contacting the first reaction mixture comprising alkali cellulose and methylating agent with solid alkali hydroxide having a water content of not more than 20 wt.% to obtain a second reaction mixture. ‘318 does not teach the isolating step. ‘318 does not teach the alkali hydroxide concentration and the mole of alkali hydroxide. Swinehart teaches a method for the manufacture of organo-soluble ethyl cellulose and other lower alkyl ethers of cellulose , specifically those wherein the substituting alkyl groups contain from 1 to 4 carbon atoms inclusive (page 1, Left Col., lines 1 – 5). Swinehart teaches the preferred method, wherein the method comprises immersing a cellulose sheet in a hot bath of concentrated caustic alkali, employing a caustic soda solution of from 67.5 to 80% , under conditions such that the cellulose is in contact with the alkali solution only long enough to absorb an amount of said solution which will yield an alkali cellulose, wherein the alkali/cellulose ratio is within the narrow range from 0.8 – 1.1/1 and the water/cellulose ratio is within the corresponding narrow range of from 0.28 – 0.38/1 (page 2, Right Col., lines 7 – 20). In one embodiment, the percentage of caustic soda concentration is 73.5% (page 3, Table 2): . In another embodiment, the alkali solution is sodium hydroxide (page 3, Right Col., line 48). Swinehart teaches that the alkali cellulose is sealed in a reaction chamber with a large excess over the theoretical amount of ethyl chloride and the mixture is heated to a reaction temperature which may be within the range of from 60 to 150 ⁰C (page 2, Right Col., lines 24 – 29). Swinehart teaches that the amount of the alkali solution has been reduced to a concentration in the range from about 30 to about 50% during heating. The residual alkalinity at this stage is from about 1 to 8% of the total weight of the reaction mixture. Solid caustic alkali is then added to the reactor to bring the alkali solution in the vessel to a concentration of about 55 – 75%, thus bringing the total ratio of alkali to cellulose to a value varying from about 1.1/1 to about 3/1 (page 2, Right Col., lines 34 – 39). If enough alkali solution of less than 50% concentration is employed so that the cellulose fibers are uniformly penetrated and swollen by the alkali, there is always present, even after expressing excess aqueous alkali, sufficient water to make impractical the subsequent production of a uniform ether. Also, attempts which have been made to remove water during the etherification have proven both costly and inefficient , particularly since no material improvement in uniformity of the cellulose ether is obtained (page 1, Right Col., lines 6 – 13; lines 17 – 21). Swinehart further teaches that the ethyl cellulose is separated from the reaction mixture in known manner, washed and purified in accordance with standard practice (page 3, Left Col., lines 22 – 25). The ethyl cellulose can be obtained when the ethoxy content is at 34 to 40% (page 3, Left Col., line 49). It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the process of preparing a methylcellulose as taught by ‘318 with the method of for the manufacture of organo-soluble ethyl cellulose and other lower alkyl ethers of cellulose, specifically those wherein the substituting alkyl groups contain from 1 to 4 carbon atoms inclusive in view of Swinehart because both references teach the methods for producing methylcellulose and both references teach performing the same alkalization and etherification to obtain the methylcellulose. For the water content of the solid alkali hydroxide, Swinehart teaches that removal of water at the end of the production is costly and inefficient. One would have considered the disclosure of Swinehart and would have performed routine experimentation to discover the best water content of the solid alkali hydroxide for the optimal product characteristics. With respect to claims 9 – 10, Swinehart explicitly teaches that solid caustic alkali is added to the reaction mixture to raise the alkali concentration in the vessel to about 55 – 75% and describes the stage-by-stage caustic soda concentrations in Table 2. Based on the disclosure, the amount of solid NaOH added between the end of the first stage and the beginning of the second stage is about 1.72 – 2.36 mol / mol AGU, which fall within the ranges recited in claims 9 – 10. Furthermore, one would have performed routine experimentation to discover the best methoxyl substitution for the optimal product characteristics based on the ethoxy substitution disclosed in Swinehart . One of ordinary skill in the art would have had a reasonable expectation to combine the teachings of ‘318 with the teachings in view Swinehart because both references teach cellulose etherification through alkali cellulose and the combination will yield predictable results. This is a provisional nonstatutory double patenting rejection. Conclusion No claim is found to be allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT HOI YAN LEE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT 571-270-0265 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Thursday 7:30 - 17:30 . 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, FILLIN "SPE Name?" \* MERGEFORMAT SCARLETT GOON can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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. /H.Y.L./ Examiner, Art Unit 1693 /SCARLETT Y GOON/ Supervisory Patent Examiner, Art Unit 1693
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Prosecution Timeline

Dec 08, 2023
Application Filed
Mar 30, 2026
Non-Final Rejection — §103, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
44%
Grant Probability
99%
With Interview (+76.0%)
3y 5m
Median Time to Grant
Low
PTA Risk
Based on 66 resolved cases by this examiner. Grant probability derived from career allow rate.

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