Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10 January 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. The instant application is a continuation of Application 17/461,713 (currently abandoned) filed 30 August 2021, which is a continuation of Application 16/016,443 (now U.S. Patent 11,103,456) filed 22 June 2018, which is a continuation of Application 14/461,594 (currently abandoned) filed 18 August 2014, which is a continuation of Application 12/306,948 (now U.S. Patent 8,808,751) filed 7 December 2009, which is a national stage entry of PCT/AU07/00910 filed 29 June 2007. Claim 1 is currently pending. Claims 2-51 have been cancelled. Claim 1 is examined on the merits within.
Abstract Objections
3. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract comprises fewer than 50 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawing Objections
4. The disclosure is objected to because of the following informalities: numerous figures are not labeled correctly. For example, Figures 2, 6, 7, 12, 15, 23, and 24 do not have the axes labeled. Appropriate correction is required.
Claim Rejections – 35 U.S.C. 102
5. 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.
6. Claim 1 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Verhoff et al. (U.S. Patent Application Publication No. 2002/0047058).
Regarding instant claim 1, Verhoff et al. disclose a process for preparing a synergetic commixture comprising small particles of a solid substrate and small particulates of a first material of a desired size, said process comprising the steps of providing to the milling chamber of a media mill a contents comprising a pre-mix of a solid substrate, a fluid carrier, a plurality of milling bodies of a first material and a plurality of milling bodies of a second material; operating said media mill to grind said solid substrate and degrade at least a portion of said milling bodies of first material to produce a dispersion in said fluid carrier comprising a synergetic commixture of small particulates of said first material and small particles of said solid substrate having a desired size equal to or less than a size Sp; separating said dispersion from any residual milling body, piece of milling body, and solid substrate having a size larger than Sp; and optionally removing said fluid carrier from said dispersion to form a dry synergetic commixture comprising said particles and said small particulates; wherein the milling bodies of said first material are fractured and eroded by the milling bodies of said second material, the milling bodies of said second material are essentially resistant to fracture and erosion in the milling process, and Sp is smaller than the size of the milling bodies of the second material. See claim 1. The solid substrate is a poorly water soluble or water insoluble drug such as ibuprofen, diclofenac, naproxen, or indomethacin. See paragraph [0256]. The "fluid" material is a liquid for wet milling and gas for dry milling. See paragraph [0144]. The desired particle size is less than 500 nm. See claim 23.
Thus the instant claim is anticipated by Verhoff et al.
7. Claim 1 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Samejima et al. (U.S. Patent No. 5,202,129).
Regarding instant claim 1, Samejima et al. disclose a process for micronizing a slightly soluble drug characterized by subjecting a mixture of said drug and a sugar to high speed stirring comminution or impact comminution in order to produce a micronized drug. See abstract. Samejima et al. disclose that ultrafine particles of a slightly-soluble drug, whose average diameter is less than about 2 to 3 micrometers, preferably less than 1 micrometer, can easily be obtained by grinding the drug in the presence of a grinding aid such as sugar or sugar alcohol. See column 2, lines 43-49. Samejima et al. disclose that the sugar or sugar alcohol can be used alone, or as a mixture of two more of these compounds. Examples of sugar include xylitol, mannitol, sorbitol, arabinose, ribose, xylose, glucose, mannose, galactose, sucrose, lactose, and the like. See column 3, lines 19-32. Tables 1 and 2 show examples of particle sizes of compositions of biologically active compound and sugar which have undergone milling. The sizes range from 0.1 to 0.53 um. Grinding can be completed with the aid of two stainless steel balls (milling bodies). See Example 1.
Thus the instant claim is anticipated by Samejima et al.
Double Patenting
8. 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.
9. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,103,456.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 11,103,456 are directed to methods of making nanoparticles of a biologically active compound by dry milling. The only difference lies in the fact that U.S. Patent 11,103,456 includes sodium lauryl sulfate, a specific grinding compound, and a specific particle size range. Thus, the invention of U.S. Patent 11,103,456 is in effect a "species” of the "generic" invention of the instant application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant application is anticipated by U.S. Patent 11,103,456, they are not patentably distinct.
10. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 8,808,751.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 8,808,751 are directed to methods of making nanoparticles of a biologically active compound by dry milling. The only difference lies in the fact that U.S. Patent 8,808,751 further includes sodium lauryl sulfate, lactose anhydrous or lactose monohydrate, and a specific size range. Thus, the invention of U.S. Patent 8,808,751 is in effect a "species” of the "generic" invention of the instant application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant application is anticipated by U.S. Patent 8,808,751, they are not patentably distinct.
11. Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 83-96 and 99-100 of copending Application No. 16/985,150 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application No. 16/985,150 are directed to methods of making nanoparticles of a biologically active compound by dry milling. The only difference lies in the fact that Application 16/985,150 includes a step of mechanochemical synthesis during dry milling. Thus, the invention of Application 16/985,150 is in effect a "species” of the "generic" invention of the instant application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant application is anticipated by Application 16/985,150, they are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
12. No claims are allowed at this time.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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