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 .
Status of the Claims
Applicant’s remarks and amendments filed on December 18, 2023 have been fully considered.
Newly added claims 8 – 14 are pending and rejected.
Claims 1 – 7 have been cancelled.
Priority
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46
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 18, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 8 – 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holdstock et al., J Am Soc Nephrol (2016), 27(4), pp. 1234-1244 as evidenced by Pagels et al., Health and Quality of Life Outcomes (2012), 10 (71), pp. 1-11, both cited in IDS dated December 18, 2023.
Holdstock et al. teaches four-week studies of a hypoxia-inducible factor-prolyl hydroxylase inhibitor, GSK1278863 (also known as daprodustat). See, e.g., Abstract. Holdstock states “[a]dvanced CKD (chronic kidney disease) is frequently associated with anemia and its pathogenesis is multifactorial, inclusive of a relative deficiency of erythropoietin (EPO)”. See, e.g., pp. 1234, 1st paragraph. Holdstock et al. report the results of two phase 2a trials, including assessing the “hemoglobin dose response, safety, and tolerability of a 4-week administration of GSK1278863, including a study in anemic patients with CKD who were not dialysis dependent and were not currently receiving rhEPO (nondialysis study)”. See, e.g., pp. 1235, 4th paragraph.
The prior art would have anticipated the instant claims as presented below:
Claim 8, directed to a method for reducing fatigue in a human subject with anemia associated with chronic kidney disease, which method comprises administering to said subject, daprodustat or a pharmaceutically acceptable salt thereof, wherein the human subject is not on dialysis. The limitation “for reducing fatigue” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires daprodustat for reducing fatigue in a human subject with anemia associated with chronic kidney disease, but does not impart any specific limitations to the structure. Based on the teachings of Holdstock et al., daprodustat is capable of reducing fatigue in a human subject with anemia associated with chronic kidney disease.
With respect to claim 9, Holdstock et al. teaches that the human subject with anemia has a hemoglobin concentration ranging from 9.91 + 0.57 g/dL (Placebo) to 10.08 + 0.72 g/dL (5 mg of GSK1278863), which is < 11 g/dL at baseline, as claimed in claim 9. See, e.g., Table 2.
With respect to claim 10, Holdstock et al. conducted primary and secondary efficacy assessments, which included “modeled change in hemoglobin from baseline over 4weeks of treatment” and “change in high-sensitivity C-reactive protein (hsCRP)”. See, e.g., pp. 1242, 2nd paragraph. Pagels et al. further teach that “HRQoL (Health-related Quality of Life) dimensions deteriorated significantly across CKD stages, with the lowest scores in CKD 5”. See, e.g., pp. 7, 2nd paragraph., Pagels et al. further note that C-reactive proteins (CRP) and cardiovascular disease (CVD) “were the most important predictors of impaired HRQoL”. See, e.g., Abstract. Pagels shows that a number of patients with CKD stages 2-5 all have CRP levels at 5-10 mg/L and a significant number of patients have CRP levels > 10 mg/L (see, e.g., Table 2), which is > 6.60, as claimed in claim 10.
With respect to claims 11 – 14, the limitations only define the conditions when “fatigue is reduced”. The conditions are still only defining the intended use/outcome and do not provide any specific guidelines/ active steps that are required for the method of reducing fatigue in the subject. Thus, the limitations are not given patentable weight towards the scope of the claims. As discussed in claim 8, the intended use only requires daprodustat for reducing fatigue in a human subject with anemia associated with chronic kidney disease, but does not impart any specific limitations to the structure. Based on the teachings of Holdstock et al., daprodustat is capable of reducing fatigue in a human subject with anemia associated with chronic kidney disease. Further, Pagels et al. also teach that the study of 535 patients in CDK stages 2-5 were assessed for HRQoL (Health-Related Quality of Life) through the SF-36 questionnaire. See, e.g., pp. 2, 2nd paragraph. In order to provide patentable weight for the limitations, Applicant may amend the claims to clearly indicate that these observations are required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626