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 1-19 are pending and are examined on the merits herein.
Priority
The application is a continuation of application 17/261927, now abandoned, filed on 1/21/2021, which is the National Stage entry of PCT/US2019/044261 filed on 7/31/2019, which claims priority to provisional application 62/713901, filed on 8/2/2018.
Information Disclosure Statement
The information disclosure statements (IDS) dated 7/31/2024 and 6/24/2026 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 17-19 are 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.
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2019/0062460A1, filed Aug 2017, PTO-892), in view of Liu et al. (US 2019/0062459A1, filed Aug 2017, PTO-892), further in view of Jia et al. (US 2018/0251575A1, filed March 2018, PTO-892), further in view of Cabri et al. (US 2019/0284308A1, filed March 2017, PTO-892).
Liu 460 discloses a process for isolating crystalline sugammadex sodium comprising dissolving sugammadex sodium (93 g) in water (3 ml) and methanol (480 ml) resulting in a suspension. The suspension mixture was heated to 65° C., the solution turned clear. The mixture was cooled slowly, where crystals formed after the temperature lowered to about 42-45° C. and stirred for 2 hr. The suspension was stirred for 2 h at 25° C., filtered and the cake was washed two times with a mixture of water and MeOH to obtain crystalline sugammadex sodium (75 g, yield 80.6%), HPLC purity: 99.3%. The crystalline sugammadex sodium was then dried in vacuo (15 mmHg), at 80° C. for 12 h. (¶0031-0032) Liu 460 discloses that the crystalline sugammadex sodium obtained has XRD data substantially the same as that of instant crystal form 6. (¶0017-0018) Liu et al. teaches that sugammadex sodium may be formulated as a pharmaceutical composition or medicament further comprising a pharmaceutically acceptable excipient. (¶0020-0021)
Liu 460 does not teach the claimed amounts of water and methanol in the crystallization process.
Liu 459 discloses a process for isolating crystalline sugammadex sodium comprising adding methanol (480 mL) to a solution of sugammadex sodium (174 g) in water (3 ml) resulting in crystallization. The suspension mixture was heated to 65° C., the solution turned clear. The mixture was cooled slowly. The crystals formed after the temperature lowered to about 42 to 45° C. and stirred for 2 hrs. The suspension was stirred for 2 hat 25° C., filtered and the cake was washed two time with a mixture of water and MeOH to obtain crystalline sugammadex sodium (140 g, yield 80.6%), HPLC purity: 99.3%.(¶0040)
Jia discloses a process for isolating crystalline sugammadex sodium comprising crude sugammadex sodium (10.0 kg) was dissolved in water (30 kg) and methanol (20 kg), treated with activated carbon (2.0 kg) and neutral Al2O3 (5.0 kg) at 50°C. for 30 mins. After filtering and washing with purified water (10.0 kg), the filtrate was heated to 50-55° C. under nitrogen and added methanol (40 kg) dropwise at the same temperature. After addition, the reaction system was slowly cooled to 25-30°C and stirred for 30 mins at the same temperature. The mixture was filtered and washed with 20 kg methanol, then dried at 60-65° C. for 24 hrs to obtain 6.3 kg white powder, yield: 63.0%. (¶0085)
Cabri discloses a process for isolating crystalline sugammadex sodium comprising sugammadex sodium (28 g) was dissolved in water (380 ml) and methanol (380 ml) at 20-30° C. To this solution activated carbon (2.8 g, 10% w/w) was added and stirred for 2 Hours at 20-30° C. The reaction mixture was filtered through celite and washed with methanol: water (1:1) (38 ml). The filtered solution was heated to 45-50° C. and methanol (2400 ml) was slowly added at the same temperature. The reaction mixture was then slowly cooled to 20-30° C. and stirred at the same temperature for 1 Hour. The reaction mass was filtered, washed with methanol (100 ml) and dried under vacuum at 60-65° C. for 15 Hours to give 24 g of sugammadex. The product had purity of 98.53 area-% HPLC. (¶0113)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the amounts of water and methanol in the crystallization process of Liu 460 could be varied within a range, thereby arriving at the instant invention. The obviousness of varying the amounts and ratios of water and methanol in a sugammadex sodium recrystallization process is demonstrated in the secondary references of Liu 459, Jia and Cabri. Collectively, the secondary references disclose a concentration range for water/sugammadex of 0.03 to 13 ml/g and a concentration range for methanol/sugammadex of 2.8-99 ml/g. The rationale for modifying Liu 460 in this manner is that the ranges in the collective secondary references overlap the ranges instantly claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). Moreover, a range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). The court stated that the "range" disclosed in multiple prior art patents is "a distinction without a difference" from previous range cases which involved a range disclosed in a single patent. Id.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1623
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