DETAILED ACTION
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 .
Applicant’s reply and amendment filed 12/22/2025, are acknowledged. Claims 1-27 and 29 are pending.
Response to Arguments
Applicant’s arguments regarding the chemical differences between apalutamide and taxanes and Yoon’s failure to exemplify any tablet with an excess of 80% w/w solid dispersion with have been fully considered and are persuasive. See Reply at pages 11-12.
Withdrawal of Claim Rejections
Any previous rejection not reiterated herein has been withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4-15 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (WO2022/060969A1).
Regarding claims 1 and 2, Zhou et al. teaches a pharmaceutical combination comprising Compound A and a second therapeutically active agent in the same dosage form and in the same solid dispersion formulation. See para. [0021]. The second therapeutically active agent may be apalutamide. See paras. [0025] and [0246]. Zhou et al. further teaches that combination may be in a tablet composition wherein either of the compounds is about 10% to about 70% of the tablet composition. See para. [0030]. Moreover, Zhou et al. teaches that “[i]n one embodiment, the composition comprising the solid dispersion of the therapeutically active agent is about 30% to about 90% by weigh of the total composition.” Para. [0197]. Zhou et al. also teaches that the solid dispersion comprises HPMCAS. See para. [0104].
Regarding claim 4, Zhou et al. teaches “an amount of the second therapeutically active agent per a dosage form is about 5 mg to about 300 mg.” Para. [0208].
Regarding claims 5 and 6, Zhou et al. teaches “the ratio of the therapeutically active agent to the at least one polymer or polymeric carrier is about 5: 1 to about 1:40, about 4:l to about 1:20, about 3:l to about 1:10, or about 2:l to about 1:5, including all values and subranges therebetween.” Para. [0199].
Regarding claim 7, Zhou et al. teaches “apalutamide is amorphous.” Para. [0248].
Regarding claim 8, Zhou et al. teaches “the solid dispersion is a supersaturated solid solution.” Para. [0186].
Regarding claim 9, Zhou et al. teaches “(HPMCAS) has a grade L, M, H, LF, MF, HF, LG, MG, and/or HG.” Para. [0191].
Regarding claim 10, Zhou et al. teaches “the solid dispersion formulation is formed by solvent evaporation, hot-melt extrusion or spray drying dispersion.” Para. [0019].
Regarding claims 11 and 12, Zhou et al. teaches “[c]ompressed tablets may be prepared by compressing in a suitable machine the active ingredient in a free flowing form such as a powder or granules, optionally mixed with a binder . . . lubricant” (claim 15). Para. [0283].
Regarding claim 13, Zhou et al. teaches “silicified microcrystalline cellulose,” para. [0245], colloidal silicon dioxide as a glidant, see para. [0290], magnesium stearate as a lubricant, see para. [0291], and croscarmellose sodium as a disintergrant. See para. [0289].
Regarding claim 14, Zhou et al. teaches both intragranular and extragranular forms. See para. [0230].
Regarding claim 29, Zhou et al. teaches a method for treating cancer, comprising administering the claimed composition. See para. [0064].
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (WO2022/060969A1).
Teachings of Zhou et al. are discussed above.
Regarding claim 3, Zhou et al. does not teach “wherein the tablet comprises about 960 mg of the solid dispersion.”
However, Zhou et al. does provide guideposts from which one of ordinary skill in the art would arrive at a tablet comprising about 960 mg of a solid dispersion. First, Zhou et al. teaches “an amount of Compound A per one tablet or one capsule is between about 5 mg and about 1000 mg. is between about 100 mg and about 1000 mg.” Para. [0207]. Second, Zhou et al. also teaches that “a daily dosage amount of apalutamide is about 50 mg to about 500 mg” and “is provided in one tablet or capsule.” Para. [0241]. Thirdly, Zhou et al. teaches that Compound A and apalutamide are about 10% to about 70% by weight of the composition. See para. [0250]. It would have been prima facie obvious to one of ordinary skill in the art based on these disclosures to arrive at tablet comprising about 960 mg of the solid dispersion given that “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over as applied to claims 1, 2, 4-15 and 29 above, and further in view of Bertels et al. (US 2019/0216829).
Teachings of Zhou et al. are discussed above.
Regarding claims 26 and 27, Bertels et al. teaches “a pharmaceutical formulation comprising a pharmaceutically acceptable carrier, abiraterone acetate and a solid dispersion, said solid dispersion comprising ARN-509 and a polymer selected from HPMCAS, a poly(meth)acrylate copolymer, and mixtures thereof.” Para. [0015]. The pharmaceutical formulation may be a tablet. See para. [0014]. Bertels et al. teaches preparing a process for preparing the tablet which involves a suitable solvent mixture of dichloromethane and methanol. See paras. [0126]-[0131] and [0147].
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the teaching of Zhou et al. and Bertels et al. and arrive at the claimed invention. It would have been prima facie obvious to one of ordinary skill in the art to combine the references and have a reasonable expectation of success in combination because both references teach the use of solid dispersions of apalutamide and HPMCAS in making tablets. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”)
Claim Objections
Claims 16-19 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.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or suggest a tablet comprising the combination of an intragranular phase, as claimed, and extragranular phase, as claimed, wherein the solid dispersion is present at equal or greater than 80 w/w % relative to the total weight of the tablet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614