DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Claim 1 is pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/10/2025 was considered by the examiner.
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.
Claim 1 is 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “grinding matrix” and then recites “grinding material” which is indefinite. It is unclear if the grinding matrix and the grinding material are the same or constitute a new product obtained from the process. For the purpose of examination the limitation is treated as the same ingredient.
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 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/960,703 (herein ‘703). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling a solid biologically active material and millable griding matrix whereas ‘703 recites a method for producing a blend containing nanoparticles and microparticles by dry milling solid biologically active material, sodium lauryl sulfate and a millable grinding matrix selected from lactose and mannitol to obtain particles having a median particle size less than 1000nm dispersed in the grinding material. Therefore, claim 1 is prima facie in view of claim 1 of application ‘703.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/794,997 (herein ‘997). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage whereas ‘997 claims a method of producing a composition by dry milling a solid biologically active material and millable griding matrix to produce particles of the active material dispersed in at least partially milled grinding matrix to make particles with volume fraction at or above 25 v/v%. Therefore, claim 1 are prima facie in view of claim 1 of application ‘997.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/377,330 (herein ‘330). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage whereas ‘330 recites a method of producing a compostion comprising dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage. Therefore, claim 1 is prima facie in view of claim 1 of application ‘330.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,735,450 (herein ‘450). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage whereas ‘450 claims a method for producing a composition comprising dry milling diclofenac acid, sodium lauryl sulfate and lactose in a mill to produce nanoparticles of diclofenac acid having a median particle size on a particles volume basis between 1,000nm and 25nm. Therefore, claim 1 is prima facie in view claim 1 of ‘450.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,808,751 (herein ‘751). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage whereas ‘751 claims a method for producing a composition comprising dry milling a biologically active compound, sodium lauryl sulfate and lactose in a mill to produce nanoparticles having an average sizes between 1,000nm and 75nm. Therefore, claim 1 is prima facie in view claim 1 of ‘751.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,095,496 (herein ‘496). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage whereas ‘496 claims a method for producing a composition comprising dry milling a biologically active compound, sodium lauryl sulfate and lactose in a mill to produce particles having a median particle size on a particles volume basis between 3,000nm and 25nm. Therefore, claim 1 is prima facie in view claim 1 of ‘496.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,849,111 (herein ‘111). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage whereas ‘111 claims a method for producing a composition comprising dry milling indomethacin, a grinding compound and a facilitating agent in a mill to produce particles of indomethacin having a median particle size on a particles volume basis between 3,000nm and 25nm. Therefore, claim 1 is prima facie in view claim 1 of ‘111.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,022,303 (herein ‘303). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage whereas ‘303 claims a method for producing a composition comprising dry milling a solid pharmaceutically active agent, a grinding matrix in a mill to produce particles having a median particle size on a particles volume basis between 50nm and 1,000nm. Therefore, claim 1 is prima facie in view claim 1 of ‘303.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,172,828 (herein ‘828). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage whereas ‘828 claims a method for producing a composition comprising dry milling indomethacin, a grinding compound and a facilitating agent in a mill to produce particles of indomethacin having a median particle size on a particles volume basis between 2,000nm and 25nm. Therefore, claim 1 is prima facie in view claim 1 of ‘828.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,103,456 (herein ‘456). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims a method of improving dissolution by dry milling solid biologically active material and a millable grinding matrix and is silent to volume fraction percentage whereas ‘456 claims a method for producing a composition comprising dry milling a biologically active compound, sodium lauryl sulfate and a grinding compound in a mill to produce nanoparticles having an average particle size between 1,000nm and 75nm. Therefore, claim 1 is prima facie in view claim 1 of ‘456.
Copending Applications
Applicants must bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim 1 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Barzegar-Jalali et al. (Enhancing Dissolution Rate of Carbamazepine via Cogrinding with Crospovidone and Hydroxypropylmethylcellulose, Iranian Journal of Pharmaceutical Research, 2007, 6 (3), pages 159-165).
Applicant claims a method of improving dissolution profile of a biologically active material comprising the steps of dry milling a solid biologically active material and a millable grinding matrix in a mill comprising a plurality of milling bodies, for a time period sufficient to produce particles of the biologically active material dispersed in an at least partially milled grinding material.
Barzegar-Jalali et al. disclose a method of increasing dissolution of carbamazepine by dry milling carbamazepine with either crospovidone or HPMC in rations of 1:1 to 1:10 by cogrinding in a ball mill containing balls of different diameters ranging from 8-20mm for 3 hours (page 160, Methods).
Claim 1 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Meiser et al. (WO 2008000042, published January 3, 2008; cited on 1/10/2025 SBO8).
Applicant claims a method of improving dissolution profile of a biologically active material comprising the steps of dry milling a solid biologically active material and a millable grinding matrix in a mill comprising a plurality of milling bodies, for a time period sufficient to produce particles of the biologically active material dispersed in an at least partially milled grinding material.
Meiser et al. discloses a method of dry milling raloxifene HCL in a mill comprising 10x10 mm steal balls with a lactose grinding compound for 15 minutes which has enhanced dissolution properites (page 85, F.). The dissolution profile showed improvement over a period of 180 minutes (Figure 29).
Conclusion
Claim 1 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached on Monday-Friday 9:00 am-5:30 pm.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
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