Prosecution Insights
Last updated: April 19, 2026
Application No. 18/261,499

METHOD OF PREPARATION OF CARBOXYMETHYL CELLULOSE HAVING IMPROVED STORAGE STABILITY

Non-Final OA §103
Filed
Jul 14, 2023
Examiner
BERRY, LAYLA D
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Nutrition & Biosciences USA 1, LLC
OA Round
1 (Non-Final)
66%
Grant Probability
Favorable
1-2
OA Rounds
2y 8m
To Grant
74%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
939 granted / 1427 resolved
+5.8% vs TC avg
Moderate +9% lift
Without
With
+8.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
44 currently pending
Career history
1471
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
34.8%
-5.2% vs TC avg
§102
20.0%
-20.0% vs TC avg
§112
23.3%
-16.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1427 resolved cases

Office Action

§103
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 . CONTINUING DATA This application is a 371 of PCT/EP2022/052025 01/28/2022 PCT/EP2022/052025 has PRO 63/143,145 01/29/2021 Election/Restriction REQUIREMENT FOR UNITY OF INVENTION As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e). When Claims Are Directed to Multiple Categories of Inventions: As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories: (1) A product and a process specially adapted for the manufacture of said product; or (2) A product and a process of use of said product; or (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or (4) A process and an apparatus or means specifically designed for carrying out the said process; or (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c). Restriction is required under 35 U.S.C. 121 and 372. This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted. Group I, claim(s) 1-10, drawn to a process of preparing carboxymethyl cellulose. Group II, claim(s) 11-17, drawn to carboxymethyl cellulose and compositions. The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of carboxymethyl cellulose, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of JP2015149929A (machine translation, cited on IDS). JP2015149929A teaches carboxymethyl cellulose prepared by treatment of cellulose in a mixed solvent of IPA and water in the presence of NaOH, followed by reaction with monochloroacetic acid and neutralization by acid, followed by pulverization. Paragraph [0025]. Claim 11 is a product-by-process claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). See MPEP 2113. In this instance, the product as claimed is one obtainable by the process of claim 1, but the process steps themselves are not required. During a telephone conversation with Jay Pattumudi on November 18, 2025, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-17 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. 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. 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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over JPH06206901A (machine translation, cited on IDS) in view of Kamide (US4579943A). JPH06206901A teaches a method wherein a solution of 1526 g of isopropyl alcohol and 96.4g of sodium hydroxide in 248 g of water (about 10% of the total reaction mixture) was added to a kneader and mixed for 90 minutes with 214 g of cellulose (about 9% of the total). A solution of monochloroacetic acid dissolved in 200 g of 90% isopropyl alcohol was added and reaction was maintained for 30 minutes. The mixture was neutralized with acetic acid and the mixture was placed in a twin-screw kneader for 10 minutes. The amount of CMC was 500 g (about 21% of the total reaction mixture). Page 4, Examples 1 and 2. Residual solvent and water in the CMC after etherification during the kneading step is important for obtaining the desired CMC [0006]. JPH06206901A is silent about the shear rate in the kneading step. Kamide teaches a conventional method for preparing carboxymethyl cellulose. In the solvent medium method, cellulose is converted to alkali cellulose and the alkali cellulose is reacted with monochloroacetic acid or sodium monochloroacetic acid. Means such as mechanical pulverization, compression, or shearing is customarily adopted to sufficiently mix the starting material and reactant. Paragraph bridging columns 1 and 2. Kamide also teaches that the solvents used for reaction include isopropanol and methanol. Column 7, lines 32-35. The amount of sodium hydroxide is 1 to 4 moles per mole of the glucose residue. Column 7, lines 41-46. It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the JPH06206901A process including claimed step d) during or after acid addition. JPH06206901A employs kneading using a twin-screw kneader after acid addition wherein the residual solvent and water is present, but is silent about the shear rate. Kamide teaches that shear is commonly employed for production of CMC in order to ensure all the components are sufficiently mixed. The skilled artisan would have carried out the neutralization step under shear in order to ensure sufficient mixing and neutralization. It would have been obvious to one of ordinary skill in the art at the time the application was filed to optimize reaction parameters such as shear rate using routine experimentation. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144. In this instance, the molar ratio of NaOH and anhydroglucose units of cellulose taught in the prior art overlaps with the claimed range. The amount of water used falls within the claimed range. The amount of carboxymethyl cellulose salt used in the prior art falls within the claimed range. The concentration of cellulose in step a) taught in the prior art falls within the claimed range. The skilled artisan would have optimized the shear rate using routine experimentation in order to ensure proper mixing and neutralization of the mixture. Regarding claim 6, JPH06206901A teaches reaction in IPA but not methanol. It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the JPH06206901A etherification reaction in a mixture of IPA and methanol because both solvents are known to be used in the reaction of cellulose with monohaloacetic acid. Regarding claims 9-10, JPH06206901A is silent about the viscosity of the obtained CMC. Claim scope is not limited by claim language that does not require steps to be performed or does not limit a claim to a particular structure, and a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” See MPEP 2106 and 2111.04. In this instance, claims 9-10 simply express the intended result of a process step positively recited. The title of the current application states a CMC having improved storage stability. Table 2 in the current specification compares Example 1 to Comparative Example A. Comparative Example A did not include high shear treatment and Example 1 was subjected to high shear treatment at a shear rate of 18850 s-1 for 2 minutes. No other comparison is made, so it is impossible to determine whether the result is commensurate in scope with the claim. MPEP 716.02(d) states that “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In this instance, there is one example at 18850 s-1 and one example without shear at all. It is impossible to determine whether the given results would be obtained at 800 s-1 as claimed, or in which range the results would be obtained. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F. 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. /LAYLA D BERRY/Primary Examiner, Art Unit 1693
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Prosecution Timeline

Jul 14, 2023
Application Filed
Nov 26, 2025
Non-Final Rejection — §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
66%
Grant Probability
74%
With Interview (+8.6%)
2y 8m
Median Time to Grant
Low
PTA Risk
Based on 1427 resolved cases by this examiner. Grant probability derived from career allow rate.

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