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 .
DETAILED ACTION
Claims 1 – 5, 7 – 13, and 16 – 22 are pending in this application. Applicant’s amendment, submitted July 9, 2025, is entered, wherein claims 1, 5, 7 – 10, 12 – 13, and 16 – 19 are amended, claims 20 – 22 are new, and claims 6 and 14 – 15 are canceled.
Priority
This application is a national stage application of PCT/EP2021/050520, filed January 13, 2021, which claims benefit of foreign priority document EP20382142.6, filed February 28, 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of group I, claims 1 – 5, 7 – 13, and 16 – 20, drawn to a process for removing water-miscible organic solvents from Sugammadex or its salts, filed July 9, 2025, is acknowledged. The newly added claims 21 – 22 depend from claim 1. Therefore, claims 1 – 5, 7 – 13, and 16 – 22 are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/16/2022 and 10/05/2023 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 8 – 10, 12 – 13, 16 – 17, and 19 – 20 are objected to because of the following informalities:
Claim 1, line 3, “which” should read “, wherein”.
Claim 1, line 4, “the” should be inserted immediately before “salt thereof”.
Claims 8, 12 – 13, and 19 – 20, line 2, “the” should be inserted immediately before “salt thereof”.
Claims 9 and 16 , lines 2 – 3, “the” should be inserted immediately before “salt thereof”.
Claim 10 and 17, lines 3 and 5, “the” should be inserted immediately before “salt thereof”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 5, 7 – 13, and 16 – 22 are rejected under 35 U.S.C. 103 as being unpatentable over Racz et al. (WO2020/028448A1, published on February 6, 2020) in view of Buchlovic et al. (WO2019/193198A1).
Regarding claims 1 – 5, 7 – 13, and 16 – 22, Racz et al. teach solid state forms of sugammadex sodium, processes for preparation thereof (para. [0001]). Form 9 of sugammadex sodium can be prepared by a process comprising maintaining crystalline form 6 of sugammadex sodium at a relative humidity of about 50% to about 100% (para. [0070]). The solution of the sugammadex sodium in water in combination with methanol is provided at the temperature of from about 50 ⁰C to 80 ⁰C (para. [0042]). In a preferred process according to any embodiment of the present process, the suspension is stirred for a suitable period of time (para. [0052]). The crystalline form 6 of sugammadex sodium may be a hydrate form. Typically, it has water content from about 7% to 15% (w/w) (para. [0039]). The drying is performed at a temperature of about 55 ⁰C under vacuum (para. [0042]) or the drying may be conducted at a temperature of about 40 ⁰C to 80 ⁰C (para. [0056]). Racz et al. teach that the solid state of sugammadex sodium according to the disclosure may have advantageous properties, such as low content of residual solvents (para. [0025]. The crystalline sugammadex sodium may be anhydrous, wherein it does not contain more than about 1% (w/w) of either water or organic solvents as measured by TGA (para. [0034]).
However, Racz et al. do not teach the at least one of the water-miscible organic solvents is ethanol.
Buchlovic et al. teach a process for the preparation of a solid form sugammadex comprising (a) suspending sugammadex in a solvent mixture comprising an aliphatic alcohol, water, and an alkylacetate; (b) isolating the solid form of sugammadex, wherein the aliphatic alcohol can be methanol or ethanol (page 3, lines 11 – 16).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute methanol used in the process of obtaining solid state forms of sugammadex sodium as taught by Racz et al. with ethanol used in preparing solid form sugammadex in view of Buchlovic et al. because both references teach the preparation of obtaining solid form sugammadex or the salt thereof, thereby, yielding predictable results. Racz et al. do not explicitly teach sugammadex sodium in anhydrous form. However, Racz et al. suggest that sugammadex sodium may be obtained in the anhydrous form based on the disclosure. Although the content of residual solvents are not disclosed explicitly, Racz et al. state that the invention is able to provide a solid state sugammadex sodium with a low content of residual solvents. With the drying step at a temperature of 40 – 80 ⁰C under vacuum, it is expected that the content of residual solvents, such as ethanol, would be minimized. For the water content of the sugammadex sodium, one would have performed routine experimentation to discover the best water content for the optimal crystalline properties. Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to substitute methanol used in the process of obtaining solid state forms of sugammadex sodium as taught by Racz et al. with ethanol used in preparing solid form sugammadex in view of Buchlovic et al. because Racz et al. teach the process of obtaining solid state forms of sugammadex sodium using methanol and Buchlovic et al. teach that the process may be done with methanol or ethanol, suggesting that ethanol will yield the same result.
Conclusion
No claim is found to be allowable.
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/H.Y.L./Examiner, Art Unit 1693
/JONATHAN S LAU/Primary Examiner, Art Unit 1693