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
Pursuant to the amendment dated 05/27/2026, claims 1 was amended and claims 16-18 were newly added. Claims 1-18 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/EP2022/050567, filed on 01/12/2022 and claims benefit of provisional application 63/136,709 filed on 01/13/2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated 05/27/2026 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS document has been placed in the application file and the information therein has been considered as to the merits.
Withdrawn Rejections
Applicant’s amendment, filed on 05/27/2026, with respect to the rejection of claims 1-8 and 10-15 under 35 U.S.C. 103 as being unpatentable over Goerlach-Doht et al. (US 2014/0017319 A1, published 01/16/2014, PTO-892 dated 01/27/2026) has been fully considered and is persuasive. Goerlach-Doht does not teach MCC. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 05/27/2026, with respect to the rejection of claim 9 U.S.C. 103 as being unpatentable over Goerlach-Doht et al. (US 2014/0017319 A1, published 01/16/2014, PTO-892 dated 01/27/2026) as applied to claim 1 above, and further in view of Nguyen (US 7005514 B2, published 02/28/2006, PTO-892 dated 01/27/2026) has been fully considered and is persuasive. Goerlach-Doht does not teach MCC. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 05/27/2026, with respect to the Double Patenting rejection of claims over claims 1-3, 5, and 6 of copending Application No. 18/261,304 in view of Hindi (Nanoscience and Nanotechnology Research, published 02/2017, PTO-892 dated 01/27/2026) has been fully considered and is persuasive. Copending Application No. 18/261,304 has been amended to add the limitation of the produced mill dried colloidal MCC having a ratio of (initial viscosity):(24 h viscosity) measured as 2 weight-% dispersions in water at 20°C at a shear rate of 2.51 s-1 of at least 0.28 which is not a limitation taught by the instantly claimed or Hindi. The rejection is hereby withdrawn.
New and Modified Grounds of Rejection
Claims 1-8 and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Goerlach-Doht et al. (US 2014/0017319 A1, published 01/16/2014, PTO-892 dated 01/27/2026) and Suzuki et al. (European Journal of Pharmaceutics and Biopharmaceutics, published 11/30/1998, PTO-892).
Goerlach-Doht is drawn to a particulate cellulose derivative that is obtained in a process of grinding and drying a moist cellulose derivative which comprises the steps of providing a cellulose derivative having a moisture content from 60 to 95 percent, based on the total weight of the moist cellulose derivative, and grinding and partially drying the moist cellulose derivative in a gas-swept impact mill. The obtained particulate cellulose derivative has a high untapped bulk density and a good flowability (abstract). Goerlach-Doht teaches that a poor flowability can lead to problems in the manufacturing of dosage forms such as tablets. Problems can include increased variability in tablet weight or tablet crushing strength from tablet-to-tablet as well as variation in the amount of active ingredient incorporated into each dosage form. Poor particle flow can also lead to consolidation of the powder bed in processing equipment, such as storage bins and tablet press feed hoppers (paragraph 0004).
Regarding instant claim 2, Goerlach-Doht teaches that the moisture content of the cellulose derivative is typically reduced to 1 to 20 percent (paragraph 0027).
Regarding instant claim 4, 12, and 13, Goerlach-Doht teaches that the particulate cellulose derivative generally has a Carr index of 30 or less, preferably of 28 or less, more preferably of 25 or less (paragraph 0031).
Regarding instant claim 5, Goerlach-Doht teaches that the particulate cellulose derivative generally has a median Equivalent Projected Circle Diameter (EQPC) of less than 140 micrometers (paragraph 0036).
Regarding instant claim 6, Goerlach-Doht teaches that the particulate cellulose derivative generally has a median LEFI of from 60 to 350 micrometers (paragraph 0037).
Regarding instant claim 7, Goerlach-Doht teaches that microcrystalline cellulose preferably has a median particle diameter (DIFI) from 1 to 500 micrometers (paragraph 0044).
Regarding instant claim 10, Goerlach-Doht teaches that a dry cellulose derivative and a liquid, such as water, can be mixed in a compounder to a desired moisture content (paragraph 0023).
Regarding instant claims 14 and 15, the particulate cellulose derivative may be used in pharmaceutical applications, preferably in liquid suspensions comprising a cellulose derivative and a medicament, or solutions of the particulate cellulose derivative for the preparation of hard-shell capsules (paragraph 0039).
Regarding instant claim 16, Goerlach-Doht teaches gas flow rates from 52 to 67 mg3/kg based on the dry weight of cellulose derivative (paragraph 0027).
Regarding instant claims 17 and 18, Goerlach-Doht teaches a circumferential speed of the drying-grinding device is in a range from 35-140 m/s (paragraph 0026).
Goerlach-Doht does not teach that the cellulose derivative is a microcrystalline cellulose (MCC).
Suzuki is drawn to the study of the effect of crystallinity of MCC on the compatibility and dissolution of tablets (title). Suzuki teaches that MCC has MCC has been widely used as an additive for direct compression because of its good flowability and compatibility. Manufacturing conditions may affect the compatibility (page 225). MCC as well as the other additives is often pulverized in pharmaceutical processes, therefore it is important for assurance of the quality of drug products to clarify the effect of changes in physicochemical properties of MCC caused by pulverization on physical characteristics, such as granulation and compression and chemical characteristics, such as content uniformity and dissolution. Suzuki teaches that jet-milling did not change the crystallinity of the MCC (page 227). Suzuki further teaches that the rate of dissolution of acetaminophen MCC tablets is dependent on the crystallinity of MCC and not affected by the particle size of the MCC. As the degree of crystallinity of MCC may be a dominant factor in controlling the dissolution rate of directly compressed tablets including MCC the effect of the pulverization process on crystallinity is important (page 230).
It would have been prima facie obvious to combine the teachings of Goerlach-Doht and Suzuki before the effective filing date of the claimed invention by substituting the cellulose derivative in the method of producing cellulose of high bulk density and good flowability taught by Goerlach-Doht with the CMM taught by Suzuki to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill to substitute the cellulose derivate taught by Goerlach-Doht with the CMM taught by Suzuki, because Goerlauch-Doht teaches a process of producing a cellulose with good flowability that can be used for dosage forms such as tablets using a gas-swept impact mill and Suzuki teaches that MCC has good flowability that can be used for dosage forms such as tablets that maintains its crystallinity when processed by a jet mill which is a type of gas-swept mill. One of ordinary skill in the art would have a reasonable expectation of success because both Suzuki and Goerlach-Doht are directed to the same purpose of producing a cellulose with good flowability for tableting.
Regarding instant claims 1-3, it would have been prima facie obvious to combine the teachings of Goerlach-Doht and Suzuki before the effective filing date of the claimed invention by optimizing the moisture content of the MCC as taught by Suzuki for the method of producing a cellulose with high bulk density and good flowability as taught by Goerlach-Doht to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the moisture content of starting cellulose to be from 20 to 75% or 50 to 70% and the mill-dried cellulose to be less than 20% by weight because Goerlach-Doht teaches that the starting cellulose moisture content can be 60-95% and the mill-dried cellulose can be less than 20%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Regarding instant claims 4-7 and 12-14, it would have been prima facie obvious to combine the teachings of Goerlach-Doht and Suzuki before the effective filing date of the claimed invention by optimizing the MCC as taught by Suzuki to have a Carr Index up to 28, the EQPC to be up to 140 micrometers, the LEFI to be up to 350 micrometers, and the DIFI to be up to 500 micrometers for the method of producing a cellulose with high bulk density and good flowability as taught by Goerlach-Doht to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the Carr Index up to 28, the EQPC to be up to 140 micrometers, the LEFI to be up to 350 micrometers, and the DIFI to be up to 500 micrometers because Goerlach-Doht teaches that the Carr Index up to 28, the EQPC to be up to 140 micrometers, the LEFI to be up to 350 micrometers, and the DIFI to be up to 500 micrometers. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Regarding instant claims 14 and 15, it would have been prima facie obvious to combine the teachings of Goerlach-Doht and Suzuki before the effective filing date of the claimed invention by utilizing the MCC produced from the method taught by the combined teachings of Goerlach-Doht and Suzuki in a pharmaceutical to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to utilize the MCC produced from the method taught by the combined teachings of Goerlach-Doht and Suzuki in a pharmaceutical because Goerlach-Doht teaches that the cellulose may be used in pharmaceutical applications such as tablets and Suzuki shows that MCC that is processed by a jet mill maintains the MCC crystallinity and can be used for tablets. One of ordinary skill in the art would have a reasonable expectation of success because Goerlach-Doht teaches that the cellulose may be used in pharmaceutical applications such as medicines and dosage tablets and Suzuki shows that CMM that has been processed by a jet mill maintains the MCC crystallinity and can be used for tablets.
Regarding instant claims 16-18, it would have been prima facie obvious to combine the teachings of Goerlach-Doht and Suzuki before the effective filing date of the claimed invention by optimizing the gas flow rate to be from 52 to 67 mg3/kg based on the dry weight of cellulose and the gas-sept impact mill circumferential speed to be between 35-140 m/s as taught by Goerlach-Doht with a starting MCC as taught by Suzuki to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the gas flow rate to be from 52 to 67 mg3/kg based on the dry weight of cellulose derivative and the gas-sept impact mill circumferential speed to be between 35-140 m/s because Goerlach-Doht teaches that the gas flow rate to be from 52 to 67 mg3/kg based on the dry weight of cellulose and the gas-sept impact mill circumferential speed to be between 35-140 m/s. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Goerlach-Doht et al. (US 2014/0017319 A1, published 01/16/2014, PTO-892 dated 01/27/2026) Suzuki et al. (European Journal of Pharmaceutics and Biopharmaceutics, published 11/30/1998, PTO-892) as applied to claim 1 above, and further in view of Nguyen (US 7005514 B2, published 02/28/2006, PTO-892 dated 01/27/2026).
Claim 1 is rejected as discussed above.
The combined teachings of Goerlach-Doht and Suzuki are discussed above.
The combined teachings of Goerlach-Doht and Suzuki do not teach that the device capable of milling and drying in combination is a flash mill dryer.
Nguyen is drawn to process for producing microcrystalline cellulose comprised of the steps of contacting a paper grade pulp with an alkali hydrolysis agent, washing the hydrolyzed pulp and contacting the hydrolyzed pulp with an acid hydrolysis agent and washing the acid hydrolyzed product (claim 1). The process further comprises drying the product of the acid washing step (claim 20) wherein the drying step comprises milling flash drying (claim 22).
It would have been prima facie obvious before the effective filing date of the claimed invention to substitute the gas-swept dryer taught by the combined teachings of Goerlach-Doht and Suzuki with a flash dryer as taught by Nguyen in method of producing a MCC with good flowability as taught by the combined teachings of Goerlach-Doht and Suzuki to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to substitute the gas-swept dryer with a flash dryer as taught by Nguyen in the combination gas-swept impact mill taught by Goerlach-Doht. One of ordinary skill in the art would have a reasonable expectation of success because a simple substitution of the drying step for another would have resulted in the claimed invention, and the results would have been predictable because both forms of drying have been carried out on cellulose products.
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered in so much as they apply to the amended claims but they are not persuasive.
Applicant argues that Goerlach-Doht does not teach MCC. The argument is unpersuasive. In the newly amended rejection, Suzuki teaches that MCC has good flowability and can be processed using a jet mill and maintain the MCC crystallinity which is an important parameter that affects the dissolution properties of tablets. Therefore, it would have been prima facie obvious to substitute the MCC taught by Suzuki for the cellulose in the method for producing cellulose of high bulk density and good flowability that can be used in medicines such as tablets as taught by Goerlach-Doht.
Conclusion
No claims allowed.
This Office Action is non-final because it contains new grounds of rejection not necessitated by applicant’s amendment.
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/S.L.S./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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