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 .
Terminal Disclaimer
The terminal disclaimer filed on 02/27/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11,801,237; 11,185,535; 11,576,903 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 1-3, 5-7, 9-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Flynn et al. US 8,940,756, in view of Fry et al. US 2014/0296267 A1.
Flynn teaches a c-KIT compound for the treatment of disease including gastrointestinal stromal tumor, cell cancer, skin cancer and the like. See abstract and column 5. The claimed compound can be found in a number of examples, specifically example 30. Compound in amorphous and having purity of at least 98% is found in columns 20-22. Compound formulated into oral pharmaceutical form is found in columns 22-24.
The only deficiency in the Flynn reference is the specific oral pharmaceutical composition comprising the claimed solid dispersion or the intra and extra granular.
Fry teaches an oral composition comprising compound useful for the treatment of cancer. The oral composition comprising solid dispersion as claimed. See claims and paragraphs 0142-0200. The solid dispersion can be formulated into tablet comprising the claimed intra and extra granular. See Examples 13-15. Fig. 13 shows the release rate of at least 80% between 30-60 minutes.
Thus, it would have been prima facie obvious to one of ordinary skills in the art at the time the invention was made to prepare an oral tablet comprising the claimed c-KIT compound with the expectation to obtain a tablet comprising compound useful for the treatment of GIST. This is because Fry teaches tablet comprising solid dispersion and compound useful for the treatment of cancer is known in the art, and this is because Flynn teaches the desirability for incorporating the c-KIT compound into any ordinary oral dosage form useful for the treatment of cancer.
Claims 1-3, 5-7, 9-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Flynn et al. US 8,940,756, in view of Asgharnejad et al. 6,123,964.
Flynn teaches a c-KIT compound for the treatment of disease including gastrointestinal stromal tumor, cell cancer, skin cancer and the like. See abstract and column 5. The claimed compound can be found in a number of examples, specifically example 30. Compound in amorphous and having purity of at least 98% is found in columns 20-22. Compound formulated into oral pharmaceutical form is found in columns 22-24.
The only deficiency in the Flynn reference is the specific oral pharmaceutical composition comprising the claimed solid dispersion or the intra and extra granular.
Asgharnejad teaches a tablet composition comprising an amorphous form of a compound useful for the treatment of cancer. The solid comprises intra and extra excipients. See Examples and claims.
Thus, it would have been prima facie obvious to one of ordinary skills in the art at the time the invention was made to prepare an oral tablet comprising the claimed c-KIT compound with the expectation to obtain a tablet comprising compound useful for the treatment of cancer. This is because Asgharnejad teaches tablet comprising solid dispersion and compound useful for the treatment of cancer is known in the art, and this is because Flynn teaches the desirability for incorporating the c-KIT compound into any ordinary oral dosage form useful for the treatment of cancer.
Claims 1-3, 5-7, 9-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Flynn et al. US 8,940,756, in view of Lee et al. EP 2827900 B1, in view of Asgharnejad et al. 6,123,964.
Flynn teaches a c-KIT compound for the treatment of disease including gastrointestinal stromal tumor, cell cancer, skin cancer and the like. See abstract and column 5. The claimed compound can be found in a number of examples, specifically example 30. Compound in amorphous and having purity of at least 98% is found in columns 20-22. Compound formulated into oral pharmaceutical form is found in columns 22-24.
The only deficiency in the Flynn reference is the specific oral pharmaceutical composition comprising the claimed solid dispersion.
Lee teaches an amorphous solid dispersion for use in the treatment of brain cancer. The solid dispersion comprises 25%-35% by weight of active compound and dispersion polymer such as HPMCAS. See abstract, pages 7-8, and paragraph 0060. The solid dispersion is in the form of tablet comprising pharmaceutically acceptable carrier is found in paragraph 0062.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to include the amorphous compound in a solid dispersion in view of the teaching of Lee with the expectation of at least similar result. This is because both references teach the use of a water insoluble therapeutic compound desirable for cancer treatment.
Flynn further does not teach the claimed intra and extra granular.
Asgharnejad teaches a tablet composition comprising an amorphous form of a compound useful for the treatment of cancer. The solid comprises intra and extra excipients. See Examples and claims.
Thus, it would have been prima facie obvious to one of ordinary skills in the art at the time the invention was made to prepare an oral tablet comprising the claimed c-KIT compound with the expectation to obtain a tablet comprising compound useful for the treatment of cancer. This is because Asgharnejad teaches tablet comprising solid dispersion and compound useful for the treatment of cancer is known in the art, and this is because Flynn teaches the desirability for incorporating the c-KIT compound into any ordinary oral dosage form useful for the treatment of cancer.
Response to Arguments
Applicant's arguments filed 02/27/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims are commensurate in scope with the findings of the Declaration of Ehab Hamed filed with U.S.S.N. 17/504,133, made of record on September 2, 2022 ("Hamed Declaration"), which is incorporated by reference into the present response. In particular, all compositions as claimed require an active drug loading commensurate with the 8.25% loading of the compound represented by Formula (I) as presented in the Hamed Declaration. Applicant submits that the findings of the Hamed Declaration support the surprising nature of the claimed invention for at least the reasons described below. Fry discloses a solid dispersions of ARRY-380 at various high weight loadings (e.g., specifically 30, 50, or 60 weight percent in Examples 1-11). See, more particularly, Paragraphs [0229]-[0249] of Fry. Examples 13-16 of Fry (Paragraphs [0256]-[0264]) include a total25 percent drug loading, which represents an amount orders of magnitude higher than required in the instant claims. See Paragraph 7 of the Hamed Declaration. Further, ARRY-380 is a compound having drastically different properties, including solubility, as compared to the claimed Formula I compound. Id. In other words, a person of ordinary skill in the art, would not have recognized that the formulations of the cited references, e.g., Fry, could teach or suggest the instantly claimed HMPCAS formulation. Applicant notes that using the required loading amounts of Fry for example, would have resulted in an inoperable formulation where the compound represented by Formula (I) would simply precipitate from such a HPMCAS solid dispersion. A side-by-side comparison of Fry with the instant claimed invention shows unexpected and significant differences. See Table 1 of the Hamed Declaration. While the instant claims relate to a total drug loading of 8.25%, in stark contrast, formulations of Fry (Examples 13-16 of Fry) have a total drug loading of 25%, which is three (3) times as much weight of drug than the claimed formulations.
However, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., all compositions as claimed require an active drug loading commensurate with the 8.25% loading of the compound represented by Formula (I) as presented in the Hamed Declaration) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claims Allowable
Claims 4, 8, 12 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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
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 on Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615