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 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 06/16/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/16/2026 have been fully considered but they are not persuasive. Applicant again addresses the compound cinacalcet, from the previous final office action the difference between the prior art teachings of Masayuki and the compound cinacalcet was addressed in that of the compound be used as a reference and not indicating Masayuki teaches cinacalcet, thus applicant’s argument is moot. Applicant argues examiner is stating the conversion of dosage amount to concentration. Applicant is conflating examiners example to be of concentration but is of dosage amount used on an adult human in which is taught by the prior art of Masayuki which reads to the dosage claims of 14-15 of claimed invention.
Applicant additionally argues the pH of 7.2 taught by the prior art is not claimed pH range of 6.0-7.0 which is “a result-effective variable in influencing the amount of decomposition products IB and IC”. It is noted from applicant’s specification (para. 0099) the limitation of decomposition IB greater than IC is when the pH is 8.0 or less and Tables 8-9 fails on the contrary does not show decomposition IB greater than IC at the claimed 5 to 25°C for 3 to 30 months.
Applicant has added claim 37, no new matter was added. Claims 1-5, 8-10, 14-20, 23-24 and 28-37 is pending. Claims 1-5, 8-10, 14-20, 23-24 and 28-37 is now evaluated on its merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 8-10, 14-20, 23-24 and 28-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1 and 30 recite the limitation of “wherein the amount of decomposition product IB is greater than the amount of decomposition product IC when stored at 5°C to 25°C for 3 months to 30 months”. Applicant is not enabled for this limitation as per applicants’ specification decomposition product IB is not greater than the amount of decomposition product IC in all of the claimed temperature ranges for the claimed pH range. This is exemplified by Tables 8-9 of applicants’ specification
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1022
617
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. Of specific example at 5°C decomposition 1C is greater than 1B when stored for 30 months. Thus, applicant is not enabled for the claimed limitation and claims 2-5, 8-10, 14-20, 23-24, 28-29 and 31-37 are equally rejected as being dependent from claims 1 and 30 therefore carrying the same limitation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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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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