Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
Status of Application
1. Applicants’ arguments/remarks filed 23 March 2026 are acknowledged. Claims 1 and 52-53 are currently pending. Claims 2-51 have been cancelled. Claims 52-53 are newly added. Claim 1 is amended. Claims 1 and 52-53 are examined on the merits within.
Withdrawn Objections/Rejections
2. Applicants’ arguments, filed 23 March 2026, with respect to the objections have been fully considered and are persuasive. The objections of the abstract and drawings have been withdrawn. The 35 U.S.C. 102(b) Rejections of Verhoff et al. and Samejima have been withdrawn in view of the claim amendments. However, upon further consideration, a new 35 U.S.C. 103 rejection is made in view of Verhoff et al. and Samejima. The Obviousness Double Patenting Rejection of Application 16/985,150 has been withdrawn in view of the abandonment.
New Rejections
Claim Rejections – 35 U.S.C. 103
3. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
4. Claims 1 and 52-53 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Verhoff et al. (U.S. Patent Application Publication No. 2002/0047058) in view of Samejima eta l. (U.S. Patent No. 5,202,129).
Regarding instant claims 1 and 52, Verhoff et al. teach 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. Suitable surface active substances when the solid comprises a pharmaceutical include sodium lauryl sulfate. See paragraph [0211]. Milling or grinding media include steel in spherical beads, rods, etc. See paragraphs [0105-0106]. Milling media bodies range from 1 mm to 5 mm. See paragraph [0107].
Regarding instant claim 53, milling time is usually between 1 to 15 hours. See paragraph [0157].
Verhoff et al. do not teach milling bodies consisting only of steel balls.
Samejima et al. teach 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. teach 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.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use steel balls as the only milling bodies in the process of Verhoff et al. because Samejima teach two steel balls effectively grinds biologically active compounds to sizes between 0.1 to 0.53 um. One would have been motivated, with a reasonable expectation of success, to effectively reduce the size of the particles in the formulation.
Double Patenting
5. 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.
6. Claims 1 and 52-53 are 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 a specific grinding compound. 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.
7. Claims 1 and 52-53 are 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 lactose anhydrous or lactose monohydrate. 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.
Response to Arguments
Applicants’ arguments filed 23 March 2026 have been fully considered but they are not persuasive.
8. Applicants argued, “The present claims describe a process in which the only milling bodies are stainless steel. Verhoff disclose two different milling media bodies and does not teach sodium lauryl sulfate.”
In response to applicants’ arguments, Verhoff et al. teach that suitable surface active substances when the solid comprises a pharmaceutical include sodium lauryl sulfate. See paragraph [0211]. With regards to milling bodies, the prior art of Samejima was provided to make obvious the use of only steel balls.
Thus this rejection is maintained.
9. Applicant has requested that the provisional rejections be held in abeyance until patentable subject matter is identified. However, this request cannot be considered, especially in view that no patentable subject matter has yet been identified.
The obviousness double patenting rejections are hereby maintained.
Conclusion
10. Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
11. No claims are allowed at this time.
12. 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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