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
Preliminary amendment filed on 07/13/2023 is acknowledged. Claims 3-11 and 14 were amended and claim 15 was newly added. Claims 1-15 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.
Claim Rejections - 35 USC § 103
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.
Claims 1-8 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Goerlach-Doht et al. (US 2014/0017319 A1, published 01/16/2014, see 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). It is noted that Goerlah-Doht does not specifically use the term microcrystalline cellulose (CMM). However, Goerlach-Doht does describe the production of cellulose derivatives such as activating the cellulose by treatment with an alkali metal hydroxide and washing the product to remove by-products (paragraph 0021), which the same process used to describe the classical method for MCC production (instant specification page 1). Therefore, it would be reasonable to conclude that the particulate cellulose derivative would be MCC meeting the limitation of instant claim 1.
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).
Goerlach-Doht does not exemplify a microcrystalline cellulose (MCC).
It would have been prima facie obvious before the effective filing date of the claimed invention to utilize the method of producing a particulate cellulose derivative as taught by Goerlach-Doht to produce a microcrystalline cellulose to arrive at the instantly claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to utilize the method taught by Goerlach-Doht to produce a MCC because Goerlach-Doht teaches that the cellulose derivatives may be treated with alkali metal hydroxide which the same process used to describe the classical method for MCC production in the instant specification. One of ordinary skill in the art would have a reasonable expectation of success because Goerlach-Doht teaches that the particulate cellulose derivative may be treated with alkali metal hydroxide which would produce MCC.
Regarding instant claims 1-3, it would have been prima facie obvious before the effective filing date of the claimed invention to optimize the moisture content of the MCC 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 MCC to be from 20 to 75% or 50 to 70% and the mill-dried MCC to be less than 20% by weight because Goerlach-Doht teaches that the starting MCC moisture content can be 60-95% and the mill-dried MCC 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 before the effective filing date of the claimed invention to optimize the MCC 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 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 before the effective filing date of the claimed invention to utilize the cellulose produced from the method taught by Goerlach-Doht 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 cellulose produced from the method taught by Goerlach-Doht in a pharmaceutical because Goerlach-Doht teaches that the cellulose may be used in pharmaceutical applications such as medicines. 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
Claim 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, see PTO-892) as applied to claim 1 above, and further in view of Nguyen (US 7005514 B2, published 02/28/2006, see PTO-892).
Claim 1 is rejected as discussed above.
The teachings of Goerlach-Doht are discussed above.
Goerlach-Doht does 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 Goerlach-Doht with a flash dryer as taught by Nguyen in method of producing a particulate cellulose derivative 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 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.
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.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable 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, see PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a process for producing mill dried colloidal microcrystalline cellulose comprising the steps of providing colloidal MCC having a moisture content from 20 to 70 percent, based on the total weight of the moist colloidal MCC and mill-drying the moist colloidal MCC in a single device capable of milling and drying in combination. Hindi teaches that colloidal MCC is a type of MCC (page 21) and therefore the claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693