DETAILED ACTION
Claims 1-3 are pending in the instant application.
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 .
Priority
This application is a continuation of U.S. Application No. 18/111,849, filed February 20, 2023, which is a continuation of U.S. Application No. 17/87 1,825, filed July 22, 2022, which is a continuation of U.S. Application No. 17/584,257, filed January 25, 2022, now abandoned, which is a continuation of U.S. Application No. 17/005,997, filed August 28, 2020, which is a continuation of U.S. Application No. 16/458,261, filed July 1, 2019, which claims priority to U.S.
Information Disclosure Statement
The information disclosure statement (IDS) submitted are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
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.
Claim Interpretation
Claims 1-3 include an antacid, Mg(OH)2 and ZnCO3. The specification states “Buffering agents: physiologically tolerated buffers to maintain pH in a desired range, such as sodium phosphate, bicarbonate, succinate, histidine, citrate and acetate, sulphate, nitrate, chloride, pyruvate. Antacids such as Mg(OH)2 and ZnCO3 may be also used. Buffering capacity may be adjusted to match the conditions most sensitive to pH stability” (page 35, lines 10-14). The examiner interprets buffering agents to include antacids routinely used in a pharmaceutical composition.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Neuwelt (US 2019/0160094 A1, Priority to 11/29/2017), Lichter et al. (US 2009/0306225 A1), Hacke (US 4399127, 1983), and Nutropin Depot (FDA Clean Package Insert, 1999).
Neuwelt discloses a method for eliminating or reducing ototoxicity in patients receiving a platinum based chemotherapeutic. In particular, reducing ototoxicity in pediatric patients. The methods include administering an effective amount of sodium thiosulfate to a patient in need thereof to reduce ototoxicity (Abstract). It is thought that platinum based chemotherapeutic agents, such as cisplatin, exert ototoxic effects by concentrating in the aural cavity of a patient. It is further contemplated that sodium thiosulfate (STS) can reduce the amount of platinum based chemotherapeutic agent in the aural cavity by binding to the agent and reducing its accumulation in the aural cavity. The concentration of cisplatin is reduced by about 50-100% compared to a pediatric patient receiving a platinum based chemotherapeutic without STS ([0088]). An effective amount of STS is an amount of STS which prevents, reduces, or inhibits ototoxicity in a pediatric patient receiving a platinum based chemotherapeutic. In some embodiments, the amount of STS administered is about 0.5 g/m2 to about 50 g/m2. ([0096]). It will be apparent to one of ordinary skill in the art that suitable modifications and adaptations to the compositions, formulations, methods can be made without departing from the scope of any embodiments or aspects thereof ([0110]). Neuwelt does not explicitly mention 0.3 M to about 0.6 M of STS, but as discussed above, one of ordinary skill in the art would routinely experiment with a concentration of STS suitable for reducing ototoxicity. And it would have been obvious to do so in this case as well since it is clearly a result-effective variable. Neuwelt discloses that STS was diluted with sterile water for injection ([0198]).
Neuwelt does not explicitly mention buffers.
Lichter describes compositions and methods for the treatment of otic disorders with immunomodulating agents and auris pressure modulators (Abstract). Any otic formulation described herein further comprise otoprotectants that reduce, inhibit or ameliorate the ototoxicity of agents such as chemotherapeutic agents; an example is sodium thiosulfate ([0612]). The pH of a composition can be adjusted by use of a buffer ([0648]); suitable pH adjusting agents or buffers include, but are not limited to acetate, bicarbonate, ammonium chloride, citrate, phosphate ([0650]), carbonate, succinate, borate ([0698]) as well as sodium hydroxide ([0763]). In some embodiments, the amount of buffer included is from about 0.005 M to about 0.2 M ([0651]).
Above references do not explicitly mention magnesium hydroxide.
Hacke discloses injectable oxyteracycline compositions comprising magnesium hydroxide (Abstract). Hacke discloses a stable, injectable antibiotic composition that includes a magnesium compound consisting of magnesium hydroxide (claim 1). One of ordinary skill in the art would immediately envisage that magnesium hydroxide can be included in a pharmaceutical composition.
Nutropin Depot package insert discloses that Nutropin Depot is a long-acting dosage form of recombinant human growth hormone. Each 13.5 mg 3 cc single-use vial of Nutropin Depot contains the active ingredient and zinc carbonate (pg 1). One of ordinary skill in the art would immediately envisage that zinc carbonate can be included in a pharmaceutical composition.
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined sodium thiosulfate with a pH adjusting and/or buffering agent such as magnesium hydroxide or zinc carbonate in a pharmaceutical composition. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claims 2-3, one of ordinary skill in the art would be motivated to include any and all routinely used pH adjusting agents and buffering agents within a pharmaceutical composition. And it would have been obvious to do so in this case as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615