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
Claims 1-16 are pending.
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 for producing MCC.
Group II, claim(s) 11-16, drawn to an MCC product.
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 MCC, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Tan (US 20130090391 A1, 2013). Tan teaches a dried colloidal microcrystalline cellulose product. See Example 4, paragraph [0059]. The product was prepared by extrusion followed by drying and not by mill-drying in a single device. Claims 11-16 are product-by-process claims, and the patentability of the product depends on the product itself and not how it was made.
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. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-16 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7-10 are drawn to the process of claim 1, wherein the colloidal MCC provided in step a) “is obtained by” a process. Because the claims do note recite an active step regarding the preparation of colloidal MCC provided in step a), it is unclear whether an active step for producing the colloidal MCC is required, or whether the “is obtained by” is a product-by-process limitation directed to the colloidal MCC of step a).
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 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 40% was mixed with CMC in a ratio of 85:15 parts by weight and passed through an extruder. The resulting product was spray dried. Example 3 [0057]. The colloidal MCC:CMC composition has 42% solids content [0037]. 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.
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 1-10 are provisionally rejected 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 (US 20130090391 A1, 2013).
The ‘296 application claims a process for producing mill dried MCC by providing MCC having a moisture content of 20-75 percent and mill-drying the moist MCC in a single device which is gas-swept impact mill or a flash mill dryer (claims 1, 8, and 9). The produced MCC has a moisture content of less than 20% by weight (claim 2). The MCC provided in the first step has a moisture content of 50-70% (claim 3). EQPC is up to 400 micrometers. LEFI is up to 400 micrometers. DIFI is up to 400 micrometers. Claims 5-7.
The ’396 MCC was not colloidal MCC and was not mixed with CMC.
Tan teaches stabilizing colloidal MCC. See abstract. Colloidal MCC is prepared using a protective colloid such as CMC which is added during attrition, and facilitates re-dispersion following drying [0005]. The viscosity was at least 1000 cps at 2.6% solids (claim 9).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to add CMC in the ‘296 process as a protective colloid, thus preparing colloidal MCC, because the CMC is protective and facilitates re-dispersion after drying. The ‘396 claims do not recite a viscosity, but Tan teaches a colloidal MCC which has a viscosity of at least 1000 cps at 2.6% solids. The skilled artisan would have optimized the viscosity based on Tan’s teaching to obtain a product having the desired viscosity depending on its intended use.
This is a provisional nonstatutory double patenting rejection.
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.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693