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 .
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,529,351 (‘351). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘531 patent discloses a method of treating a disorder in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of an immediate release composition comprising (a) an amorphous solid dispersion comprising dasatinib in an amount of from about 17% w/w to about 21% w/w and copovidone in an amount of from about 38% w/w to about 42% w/w; (b) mannitol in an amount of from about 11% w/w to 15% w/w; (c) at least one gas generating agent comprising sodium bicarbonate in an amount of from about 10% w/w to about 14% w/w; (d) crospovidone in an amount of from about 6% w/w to about 10% w/w; (e) at least one acidic pH modifier comprising fumaric acid in an amount of from about 2% w/w to about 6% w/w; (f) sodium stearyl fumarate in an amount of from about 0.1% w/w to about 4% w/w; and (g) colloidal silicon dioxide in an amount of from about 0.1% w/w to about 1% w/w; wherein the stated amounts are based on the total weight of the composition; wherein the tablet optionally comprises a coating layer; wherein the mole ratio of the at least one gas generating agent to the at least one acidic pH-modifier ranges from about 4:1 to about 1:4; and wherein a dasatinib dose of 100 mg provides an AUC.sub.(0-24h)fed/AUC.sub.(0-24h)fasted ratio of from about 95% to about 100%, wherein AUC.sub.(0-24h)fed corresponds to the least-squares geometric mean of the AUC.sub.(0-24h) in fed patients and wherein AUC.sub.(0-24n)fasted corresponds to the least-squares geometric mean of the AUC.sub.(0-24h) in fasted patients, wherein said proliferative disorder is newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase; adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. See Claims 1 and 4.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘351 patent. This is because the ‘351 patent discloses an invention similar to that of the present invention, namely, A method of treating a disorder in a patient in need thereof, comprising administering a therapeutically effective amount of dasatinib to the patient, wherein said proliferative disorder is newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase; adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18/064,383 (‘383). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘383 application discloses a method of treating a disorder in a patient in need thereof, comprising administering a therapeutically effective amount of dasatinib to the patient, wherein said proliferative disorder is newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase; adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+CML with resistance or intolerance to prior therapy including imatinib; and adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. The composition comprising: (a) particles comprising (i) dasatinib in an amount of about 10% by weight to about 70% by weight of the particles; and (ii) at least one polymeric stabilizing and matrix-forming component; (b) at least one disintegrant agent in an amount of about 4% by weight to about 16% by weight; (c) at least one gas generating agent in an amount of about 8% by weight to about 22% by weight; and (d) at least one acidic pH modifier in an amount of about 2% by weight to about 6% by weight. See Claims 1 and 10. Crospovidone is found in claim 8. Solid dispersion is found in claim 2.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘383 application. This is because the ‘383 application discloses an invention similar to that of the present invention, namely, A method of treating a disorder in a patient in need thereof, comprising administering a therapeutically effective amount of dasatinib to the patient, wherein said proliferative disorder is newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase; adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wertz et al. US 2021/236489 A1, in view of Shu et al. US 2016/0038496 A1.
Wertz teaches a method of treatment involving the administration of a pharmaceutical composition comprising an amorphous solid dispersion ("ASD") of dasatinib. See abstract. Amorphous dasatinib having less than 1% crystalline is found in paragraphs 0112-0115. Tablet comprising amorphous dasatinib and one or more pharmaceutically acceptable additives including sodium bicarbonate, crospovidone, and the like is found in paragraphs 0134-0150. The claimed pharmacokinetic properties are found in paragraphs 0173-0179 and 0185-0190. The claimed dasatinib dosing is found in paragraph 0171. Co-administering with a gastric acid reducing agent in found in paragraphs 0180-0184.
Wertz is only deficient in the sense that Wertz does not teach the amounts of additives that fall within the claimed range.
Shu teaches a tablet composition comprising colloidal silicon dioxide, sodium stearyl fumarate, and crospovidone. See paragraphs 0047-0057. Tablet further comprises copovidone and mannitol is found in paragraphs 0128 and 0183. The claimed amounts of the additives are disclosed also in the Examples.
Thus, it would have been obvious to one of ordinary skills in the art at the time the invention was made to, by routine experimentation include the additives disclosed in the Shu reference with the expectation to obtain a tablet comprising dasatinib useful in the art. This is because Shu teaches tablet comprising the claimed additives useful for the delivery of dasatinib is known in the art.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615