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 .
DETAILED ACTION
Election/Restriction
CONTINUING DATA
This application is a 371 of PCT/EP2022/050564 01/12/2022
PCT/EP2022/050564 has PRO 63/136,707 01/13/2021
This office action is in response to Applicant’s amendment submitted April 13, 2026. Claims 1-19 are pending.
During a telephone conversation with Ryan Douglas on November 10, 2025, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-10. Claims 11-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant’s amendment is sufficient to overcome the rejection of claims 7-10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
The provisional rejection of claims 1-10 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/261,296 in view of Tan is withdrawn because the reference application does not claim producing the product recited in amended claim 1.
The following new rejections were necessitated by Applicant’s amendment and/or new references cited on an IDS.
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 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan (US 20130090391 A1, 2013) in view of Goerlach-Doht (US 20140017319A1, 2014).
Tan teaches an example wherein MCC wetcake at a solids content of 45% (moisture content 55%) was mixed with two different CMCs in a ratio of 88:8:4 parts by weight and passed through an extruder. The resulting product was spray dried. The initial viscosity was 3100 cps and the 24 hour viscosity was 5050 cps, for a ratio of 0.45. Example 6 [0064]. The colloidal MCC:CMC composition has 42% solids content [0037]. In example 6 [0065], the ratio of viscosities was 0.61. The viscosity was at least 1000 cps at 2.6% solids (claim 9), which converts to at least 1000 mPa-s. The product is used in food products (claim 19) or pharmaceutical or chemical formulations (claim 21). Either extrusion or milling are both suitable attrition methods [0022].
Tan does not teach that the MCC was mill-dried in a single device capable of milling and drying in combination.
Goerlach-Doht teaches particulate cellulose derivatives prepared by providing a cellulose derivative having a moisture content of 60-95% and grinding and drying in a gas-swept impact mill. See abstract. The product has good flowability [0010]. The product is used in pharmaceuticals [0040]. The product has EQPC of less than 140 micrometers [0011], LEFI of 60-350 micrometers [0037], and a median particle diameter from 1-500 micrometers [0044].
It would have been obvious to one of ordinary skill in the art at the time the application was filed to dry Tan’s composition using a gas-swept impact mill because milling and drying may be done simultaneously using a gas-swept impact mill as taught by Goerlach-Doht for particulate cellulose derivatives. The use of the gas-swept impact mill provides the product in one step instead of two separate extrusion and drying steps, and the product has good flowability. Simple substitution of one drying/milling (or extrusion) step for another would have resulted in the claimed invention, and the results would have been predictable because both forms of drying/milling have been carried out on cellulose products. The skilled artisan would have prepared MCC having the claimed EQPC, LEFI, and DIFI because Tan’s product is used for pharmaceuticals and cellulose products used in pharmaceuticals have a suitable EQPC, LEFI, and DIFI which are the same as or overlap with the claimed amounts. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05.
Response to Arguments
Applicant argues that Tan does not demonstrate that the combination of references suggests a method of producing MCC having the claimed ratio of initial viscosity : 24 hour viscosity. This argument is not persuasive because Tan’s products meet the claim limitations regarding viscosity.
Applicant argues that the claimed process surprisingly produces mill dried colloidal microcrystalline cellulose that exhibits a smaller change in viscosity over 24 hours compared to the prior art product Avicel. This argument is not persuasive because the prior art process is also capable of producing colloidal MCC having the smaller change in viscosity over 24 hours.
Claim(s) 1-10 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (WO 2018/236965 A1, cited on IDS) in view of Goerlach-Doht (US 20140017319A1, 2014, previously cited by the examiner).
Yang teaches a process for preparing colloidal MCC. MCC particles contain about 40-92% of the composition and a polysaccharide comprises 8-50% of the composition and an attrition agent comprises 0.01-10% of the composition. Paragraph [00010]. The MCC wetcake has about 25-60% water [00032]. Attrition is accomplished by extrusion [00038] followed by spray drying or other methods of drying [00039]. Sample A of colloidal MCC/Manucol DM were prepared in a Readco extruder at a ratio of 89/11 with 1 wt% citric acid. The initial viscosity was 1030 and the 24-hour viscosity was 1040 (0.99). Sample B (without citric acid) had an initial viscosity of 520 and a 24-hour viscosity of 525 (0.99) [00066]. The compositions are useful in pharmaceutical formulations [0002].
Yang does not teach that the MCC was mill-dried in a single device capable of milling and drying in combination.
Goerlach-Doht teaches particulate cellulose derivatives prepared by providing a cellulose derivative having a moisture content of 60-95% and grinding and drying in a gas-swept impact mill. See abstract. The product has good flowability [0010]. The product is used in pharmaceuticals [0040]. The product has EQPC of less than 140 micrometers [0011], LEFI of 60-350 micrometers [0037], and a median particle diameter from 1-500 micrometers [0044].
It would have been obvious to one of ordinary skill in the art at the time the application was filed to dry Yang’s composition using a gas-swept impact mill because milling and drying may be done simultaneously using a gas-swept impact mill as taught by Goerlach-Doht for particulate cellulose derivatives. The use of the gas-swept impact mill provides the product in one step instead of two separate extrusion and drying steps, and the product has good flowability. Simple substitution of one drying/milling (or extrusion) step for another would have resulted in the claimed invention, and the results would have been predictable because both forms of drying/milling have been carried out on cellulose products. The skilled artisan would have prepared MCC having the claimed EQPC, LEFI, and DIFI because Yang’s product is used for pharmaceuticals and cellulose products used in pharmaceuticals have a suitable EQPC, LEFI, and DIFI which are the same as or overlap with the claimed amounts. The claimed ratio 0.99 is very close to “from 1 to 2.2” in claim 19. 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. MPEP 2144.05.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on April 13, 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 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
Prosecution Insights