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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/12/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4 and 8-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 4 and 8-15 fail to further limit the subject matters recited in claim 1 for the following reasons:
Claim 2 recited a subject matter that is the same as the last wherein clause in claim 1;
Claim 4 recited the limitation “the intragranular components including” in line 2, which broaden the scope of the intragranular in view of the transitional language “including”. Note: claim 1 recited “intragranular components consisting of”;
Claim 8 recited the exact same subject matter as recited in claim 7;
Claim 9 recited the limitation “wherein the tablet contains” in lines 1-2, which broaden the scope of the claim in view of the transitional language “contains”. Note: claim 8 recited “tablet consists of”; and
Claims 12 and 13 recited the limitation “wherein the tablet comprises” in lines 1-2, which broaden the scope of the claim in view of the transitional language “comprises”. Note: claim 11 depends from claim 8 that recited “tablet consists of”.
In view of the above reasons, and for examining purpose, the claims are interpreted to recite tablet comprising, an intragranular comprising, and an extragranular comprising.
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 1-4, 7-15, 28-40 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Samec et al. WO 2020/102302 A1, in view of Holdstock et al. J Am Soc Nephrol 27:1234-1244 and Shyam et al. CA 3015399 C
Samec teaches a crystalline form of non-solvated daprodustat (Crystalline Form 1) having an X-ray powder diffraction falling within the claimed range. See abstract, pages 3-7, and Figs. Samec further teaches combining the crystalline form of daprodustat with at least one pharmaceutically acceptable excipient to obtain tablet dosage form. See pages 12-16. Method for treating a subject suffering from anemia is found in page 3.
Samec does not teach tablet comprising dosing amount of daprodustat.
Holdstock teaches a method for treating anemia comprising orally administering solid composition comprising HIF-PH inhibitor GSK1278863 in a dosing amount 0.5 mg, 2 mg, or 2mg for 4 weeks. See abstract.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to, by routine experimentation select a dosing amount of daprodustat that falls within the claimed range in view of the teaching of Holdstock. This is because Holdstock teaches orally administering daprodustat in the claimed dosing amount for the same treatment desired by the present inventor is known in the art, namely, orally administering 0.5 mg, 2 mg or 5 mg GSK1278863 showed effective alternative for managing anemia. See Holdstock pages 1234-1241.
Samec further does not teach tablet comprising the intra and extra granular compositions recited in the claims.
Shyam teaches a pharmaceutical composition/formulation for improving or preventing progression of chronic kidney disease (CKD) caused due to inflammation and/or Klotho under expression. See Abstract. The pharmaceutical composition can be formulated in the form of tablets, capsules, granules, powder, sachets, suspension, solution, modified release formulations, topical formulations, etc. The formulations of the present invention comprise suitable excipients such as diluents, disintegrants. binders, solubilizing agent, lubricants, glidants, solvents etc. In a preferred embodiment, the pharmaceutical composition/formulation according to the present invention can be formulated for oral administration. For oral administration, the solid pharmaceutical compositions can be in the form of, but not limited to, tablets, capsules, pills, hard capsules filled with liquids or solids, soft capsules, powders or granules, sachet, etc. The compositions may further comprise pharmaceutically acceptable excipients. See page 15. The intragranular and extragranular of the present claims can be found in the Examples.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation select a tableting method in view of Shyam with the expectation to obtain a tablet dosage form useful for oral delivery of active agents useful for the treatment of conditions related to chronic kidney disease. This is because Shyamn teaches a tableting process useful for a wide variety of active agents including drugs useful for the treatment of kidney disease, this is because Shyam teaches tableting method using intragranular and extragranular similar to that of the present invention is known known in the art to have tensile strength useful for the delivery of a wide variety of active agents, and this is because Samec teaches the use of tablet and solid tablet excipients known in the art.
Response to Arguments
Applicant’s arguments filed 03/12/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Claims
Claim 41 is 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.
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