DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/20/2025 has been entered.
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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devouassoux et al (US 9,248,229, hereafter Dev) in view of Wang (US 2020/0172635).
Regarding claims 1 and 2, Dev discloses an injection formulation comprising: a medical container 3 having an oxygen-permeable container (Col.7 ll 41-43) that is filled with a solution (Col.6 ll 21); and a poorly oxygen-permeable packaging container 1 (Col.8 ll 8-11), wherein (i) the medical container is accommodated and sealed in the poorly oxygen-permeable packaging container together with an oxygen absorber 2 (fig 2); or (ii) the medical container is accommodated and sealed in the poorly oxygen-permeable packaging container purged with an inert gas (Col.12 ll 59-60).
While Dev substantially discloses the invention as claimed, it does not disclose the solution is a sugammadex sodium aqueous solution containing sugammadex sodium as an effective component and sterilized with high-pressure steam.
Wang discloses the use of a sugammadex sodium as it is known as a muscle relaxant reversal agent (¶4). It is also known to be unstable to oxygen (¶5), Wang attempts to manufacture the material with inert gas in an oxygen free environment (¶41).
Dev discloses using gas/steam sterilization (Col.7 ll 56). It takes one of ordinary skill in the art to determine the pressure of steam needed to properly sterilize the device.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Dev such that the solution is a sugammadex sodium aqueous solution containing sugammadex sodium as an effective component and sterilized with high-pressure steam (made of an inert gas) as taught by both Dev and Wang as part of customizing the solution for a particular intended use (muscle relaxant reversal agent) and allowing for sterilization without introducing oxygen to known oxygen sensitive material.
Regarding claim 3, while Dev and Wang substantially disclose the invention as claimed, they do not disclose wherein a sugammadex sodium concentration of the sugammadex sodium aqueous solution is 50 to 200 mg/mL.
However, both Application (specification dated 2/11/2022 ¶2) and Wang (¶4) disclose using the sugammadex sodium as a muscle relaxant reversal agent. It requires routine skill in the art to determine appropriate dosing to achieve the goal of muscle relaxant reversal agent. It would have been obvious to one of ordinary skill in the art, at the time of filing, to determine an appropriate solution concentration, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (in this case usage as a muscle relaxant reversal agent). In re Aller, 105 USPQ 233 (CCPA 1955).
Regarding claims 4 and 5, wherein the medical container is a syringe (Col.1 ll 53), the oxygen- permeable container is a resin outer cylinder that constitutes the syringe, and wherein the resin is polypropylene or a cyclic polyolefin (Col.6 ll 51).
Regarding claim 6, wherein the syringe has a gasket made of an elastomer (Col.6 ll 53-54).
Regarding claim 7, wherein the elastomer is butyl rubber or a thermoplastic elastomer (Col.6 ll 56).
Regarding claim 8, while Dev and Wang substantially disclose the invention as claimed, they do not disclose wherein an oxygen permeability of a material that forms the oxygen-permeable container is 50 cm3/m2-day-atm (120 pm) or more when measured at 23 °C and 90%RH.
Dev does not disclose which particular materials achieve this goal, but has substantial overlap in materials disclosed (Applicant ¶42 and Dev Col.6 ll 44-55). Dev also discloses the use of an oxygen-permeable material (Col.7 ll 41-55).
It would have been obvious to one of ordinary skill in the art, at the time of filing to modify Dev such that an oxygen permeability of a material that forms the oxygen-permeable container is 50 cm3/m2-day-atm (120 pm) or more when measured at 23 °C and 90%RH as suggested by Dev itself to allow for sterilization of the syringe contents.
Regarding claim 9, wherein an oxygen permeability of a material that forms the poorly oxygen-permeable packaging container is 1.0 cm3/m2-day-atm or less when measured at 23 °C and 90%RH (Col.8 ll 24-26; the examiner notes that Applicant has added specific temperatures and relative humidity where Dev has none on this particular value, but is seen as teaching this value regardless of the conditions, whether hotter or cooler or more or less humid, as its entire goal is to minimize oxygen in the device).
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive.
The examiner agrees on the fundamental difference in interpretation of Wang. Applicant argues after reviewing the state of the art, ordinarily skilled artisans would discover that thioether bonds are widely considered to be stable to oxidation by molecular oxygen at room temperature and thus Dev’s packaging would not be required. The examiner disagrees and maintains the rejection absent further evidence. Based upon Wang, there is a reasonable expectation of success (which could be verified by routine experimentation) that removing oxygen during storage conditions would help prevent degradation at storage conditions based upon the thioether bond’s exposure mentioned in Wang.
Applicant argues on page 4 that none of the compounds listed in Dev as unstable to oxygen have the thioether group. The examiner does not dispute this, only that one viewing Dev would consider other compounds known to be unstable to oxygen as candidates (such as disclosed by Wang).
Applicant argues on pages 4 and 5 that Wang is drawn to purifying sugamadex and uses a substantial amount of heat, said heat being the catalyst for the oxidation susceptibility and not representative of conditions exposed to during storage. While the examiner certainly agrees that it is notoriously well-known in the art that higher heat/energy is often required to break bonds and also increases the rate of reaction, there only has to be a reason one would suspect the substance is susceptible to oxygen at lower temperatures (even if it is a slower reaction than at higher temperatures).One could then perform routine experimentation to determine if it’s true or not. Based upon Wang, there is a reasonable expectation of success (which could be verified by routine experimentation) that removing oxygen during storage conditions would help prevent degradation at storage conditions based upon the thioether bond’s exposure mentioned in Wang.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783