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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 March 2023 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 national stage entry of PCT/CN2020/127405. Claims 1-20 are currently pending and examined on the merits within.
Claim Rejections – 35 U.S.C. 103
3. 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.
4. Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. (U.S. Patent Application Publication No. 2018/0280392) in view of Yang et al. (CN106667952).
Zeng et al. teach 6-acetyl-8-cyclopentyl-5-methyl-2-(5-piperazine-1-yl-pyridine-2-yl amino group)-8H-pyrido[2,3-d]pyrimidine-7-one (palbociclib) or salt thereof, the salt comprising isethionate in a dosage form having good stability and excellent dissolution performance. See abstract. The composition comprises at least one of disintegrant, diluent, binder, surfactant, and lubricant, wherein the active is present in amounts of 10-80%, disintegrant in amounts of 1-25%, diluent in amounts of 10-80%, lubricants in amounts of 0.1-5%, surfactants in amounts of 0-5% and binders in amounts of 0-20%. See claim 3. The composition is prepared by a dry granulation process. See claim 12. Example 4 comprises microcrystalline cellulose, lactose, hydroxypropyl cellulose, crospovidone, croscarmellose sodium and/or magnesium stearate.
Zeng et al. do not teach angle of repose and tap density.
Yang et al. teach a composition comprising palbociclib in amounts of 27-28.5%, lactose (diluent) in amounts of 21-22.5%, microcrystalline cellulose (diluent) in amounts of 42.5-44%, sodium carboxymethyl starch (disintegrating agent) in amounts of 4.5 to 5.5%, silicon dioxide (glidant) in amounts of 0.5 to 0.8%, and magnesium stearate (lubricant) in amounts of 1.2 to 2%. See abstract. Table 16 shows an angle of repose of 24.9 and 34.3 with a tap density of 0.858, 0.863, and 0.854. Yang et al. teach raw materials with poor fluidity and strong static electricity of palbociclib, to be successfully prepared by dry granulation to prepare uniform particles, which largely depends on mixing step before the dry granulation. See Experimental Example 6.
It would have been obvious to one of ordinary skill in the art to modify the granulation process to control the angle of repose and tap density to increase fluidity resulting in more uniform particles. One would have been motivated, with a reasonable expectation of success to formulate a pharmaceutical composition which has good dissolution effect and a high dissolution rate, which is conducive to sufficient absorption and improves the efficacy as taught by Yang et al. See page 2. It would have been well within the purview of the skilled artisan to modify the order of steps, rate of reaction, and equipment used in the dry granulation process to achieve the optimal formulation with the desired properties since Yang et al. teach uniformity and fluidity are controlled by the order in which ingredients are combined.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/188973 (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. 18/188973 are directed to compositions comprising palbociclib isethionate and additional agents including diluents, disintegrants, glidants, and lubricants. The only difference lies in the fact that Application No. 18/188973 is directed to the composition, and the instant invention is directed to a method of making the composition. Thus the methods of the instant invention will result in the product of Application No. 18/188973. In addition, claim 19 of the instant application is also directed to a composition of palbociclib isethionate and auxiliary agents. Thus the two are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
7. No claims are allowed at this time.
8. 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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