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 .
Response to Arguments
Applicant's arguments filed 09/26/2025 have been fully considered but they are not persuasive. Examiner agrees with applicants assertion that cinacalcet is a different structural compound as to claimed invention, however teachings of Masayuki reads to the compound of claimed invention. Applicant additionally argues as to dosage being different from concentration in which applicant agrees and it is noted from the teachings of Masayuki the CaSR agonist of compound 6 had the same activity against hyperparathyroidism as another CaSR agonist of cinacalcet at a concentration of 0.1 mg/kg. Thus it would have been obvious to have compound 14 (claimed invention) at a concentration of 0.1 mg. Applicant additionally has not addressed the 7.2 pH taught by Masayuki being obvious to claimed invention pH. For the above reasons the 103 rejections over Masayuki is maintained.
Applicant’s arguments, see page 9, with respect to the 112b rejection of claim 3 for pH adjusters not falling within the claimed range have been fully considered and are persuasive. The 112b rejection of claim 3 has been withdrawn.
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, 8-10, 14-19, 23-24 and 28-35 are rejected under 35 U.S.C. 103 as being unpatentable over Masayuki et al. (JP 2013063971 A).
Regarding claims 1-4, 8-10, 14-19, 23-24 and 28-35, Masayuki teaches an intravenous method for treating secondary hyperparathyroidism under maintenance dialysis (claim 2) comprising (2S) -2-amino-3-{[(3-chloro-2-methyl-5-sulfophenyl) carbamoyl] amino} propanoic acid at a dosage amount of 0.001 mg to 10 mg per kg (relevant to claims 24, 31) (example 14) (claimed invention shown in specification para.5). Masayuki further teaches example 14 (claimed invention) in example test I and III is dissolved in an Assay Buffer (146 mM NaCl, 5 mM KCl, 1 mM MgS, 1 mg / ml Glucose, 20 mM HEPES), resulting in a pH of 7.2 (relevant to claims 8-10, 17, 23). The compounds taught by Masayuki further includes carrier of “calcium phosphate” (relevant to claims 2-4, 18-19).
The intravenous administration during maintenance dialysis the preferred timing for administration is “30 minutes before to immediately before the end of dialysis” and maintenance dialysis “ refers to hemodialysis usually performed three times a week for patients with impaired renal function such as renal failure” (relevant to claim 16). Masayuki further teaches “In the case of intravenous administration, for example, a single dose is preferably 0.001 mg to 10 mg per kg body weight, and more preferably 0.01 mg to 0.5 mg per kg body weight” (relevant to claims 14-15). In example II, of which compound No. 1 was administered intravenously to rats at 0.1 mg to decrease serum iPTH, Masayuki teaches is approximately “equal to cinacalcet” as a preventive or therapeutic agent for hyperparathyroidism (relevant to claims 1, and 28-35).
To the extent of compound 14 at 0.1 mg, it would have been obvious to administer compound 14 (claimed invention) at the same concentration of 0.1 mg to have the same therapeutic effect as compound 6. Both compounds are used for the same purpose of agents for hyperparathyroidism and derived from the same parent compound, thus one would use the same concentration of 0.1 mg.
To the extent that it can take for decomposition products to arise, it would only be a matter of time before Masayuki’s composition developed the inherent 1B and 1C decomposition products – this is supported by the data in table 6 showing that 1B and 1C developed after 1 month at a pH of 7. Masayuki fails to teach how old the intravenous composition is or for how long it had been stored. However, it would have been obvious to have conducted stability testing on Masayuki’s composition in order to determine its shelf-life. It also would have been obvious to have stored Masayuki’s composition should one have desired a ready-to-use dialysis treatment composition for those suffering from secondary hyperparathyroidism. For it is known in the art that to mass produce a stable therapeutic, most medications are stored at a controlled room temperature of 5° to 25° C and storage over a period of time is routine which would have produced decomposition products 1B and 1C.
Additionally, it would have been obvious to someone of ordinary skill in the art at the time of filling to have administer compound 14 intravenously with the limitations of pH adjusters, concentration amount and tonicity agents taught by Masayuki to an adult to treat secondary hyperparathyroidism under maintenance dialysis. One would have been motivated to do so from the teachings of Masayuki on the similar structure of compound 1 and compound 2, thus having similar properties on the effect of iPTH and based off the dosage amounts for intravenous administration an adult human weighing 50 kg to 100 kg would be calculated to be from 0.05 to .01 mg falling in the range limitations of claims 14-15 and concentration amount of 0.1 mg. There would be a reasonable expectation of success with treating secondary hyperparathyroidism under maintenance dialysis in adults with the cinacalcet taught by Masayuki at a concentration range of 0.01 to 5 mg/ml.
Masayuki teaches the medicinal composition having a pH of 7.2 but not having a pH from 6.0 to 7.0. Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have administered the medicinal composition having a pH from 6.0 to 7.0. One would have been motivated to do so because the claimed range of 6.0 to 7.0 is close to the prior art teachings of Masayuki of 7.2, hence been prima facie obvious to the claimed range per MPEP 2144.05 I “ Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0)”. There would be expectation of the medicinal composition taught by Masayuki with to a pH of 7.3 to have the same properties of claimed invention with a pH from 6.0 to 7.0.
Claims 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Masayuki et al. (JP 2013063971 A) in view of Shikamura et al. (US Patent No. 20150366969 A1).
The teachings of Masayuki et al. are set forth in the above 103 rejection of claims 1-4, 8-10, 14-19, 23-24 and 28-35 is incorporated herein by reference. Masayuki et al. does not teach the medical composition comprising pH adjusters of disodium hydrogen phosphate hydrate or sodium dihydrogen phosphate.
Regarding claims 5 and 20, Shikamura teaches a clear and stable aqueous liquid composition comprising pH buffers and adjusters of phosphate hydrate, sodium dihydrogen phosphate and HEPES (para. 0034) to achieve a general pH range of 6.0 to 8.6 (para. 0032). Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have used phosphate hydrate or sodium dihydrogen phosphate to the medicinal composition of Masayuki to achieve the desired claimed pH range. One would have been motivated to do so because Masayuki teaches HEPES as a buffer to reach the desired pH of 7.3 and Shikamura teaches phosphate hydrate, sodium dihydrogen phosphate and HEPES are known in the art to be pH adjusters and buffers to reach a desired pH in ranges of 6.0 to 8.6. There would be a reasonable expectation of success with achieving a pH within the desired claimed range with the pH adjuster of phosphate hydrate or sodium dihydrogen phosphate taught by Shikamura to the medicinal composition taught by Masayuki.
Allowable Subject Matter
Claim 36 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.
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.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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