DETAILED ACTION
Claims 1-4, 6, 8-9, 11-23, submitted on 08 August 2024, are pending in the application. Claims 16-23 are withdrawn. Claims 1-4, 6, 8-9 and 11-15 are under examination in the instant Office Action.
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 .
Election/Restrictions
Claims 16-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08 August 2026.
Applicant’s election without traverse of Group I (claims 1-4, 6, 8-9 and 11-15) in the reply filed on 08 August 2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 6, and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the carboxylic acid coupling agent" in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim. There is a lack of antecedent basis on the fact that claim 1 does not recite the use of a carboxylic acid coupling agent. Claim 1 does mention the use of a base, however, the use of a coupling agent is mentioned in claim 3. The Examiner would suggest amending claim 4 to be dependent on claim 3 to overcome the instant rejection.
Regarding claim 4, the phrase "preferably" after “1,1’-carbonyldiimidazole” in lines 5-6 of the claim renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 is rejected because it is dependent on a currently cancelled claim and thus its metes and bounds are unclear. Based on the past claim set submitted 15 December 2023, and in view of the Applicant Arguments/Remarks filed on 07 August 2024, the Examiner would suggest amending claim 6 to be dependent on instant claim 4 to overcome the instant rejection.
Regarding claim 6, the phrase "preferably" after “…or a salt thereof” in line 2 of the claim renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 13, the phrase "e.g." found in line 8 on page 4 of the claims renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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:
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 1-4, 6, 8-9, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chand et al. (WO 2021/053476 A1).
Chand teaches a method of preparing diroximel fumarate by reacting ethylene carbonate with succinimide, in the presence of a base, to form hydroxyethyl succinimide (paragraph 107). The hydroxyethyl succinimide was then reacted with monomethyl fumarate to form diroximel fumarate (paragraph 14).
Claim 2 is rejected as Chand teaches that the intermediate compound is not isolated (paragraph 112).
Claims 3-4, 6, 8-9 and 11-12 are rejected as Chand teaches that the reaction between hydroxyethyl succinimide and monomethyl fumarate takes place in the presence of a coupling agent, wherein the coupling agent is N-(3-dimethylaminopropyl)-N’-ethylcarbodiimide hydrochloride (paragraph 72). Chand also teaches wherein the coupling agent could be selected from ((benzotriazol-1-yloxy) tripyrrolidinophosphonium hexafluorophosphate) (a phosphonium reagent), N-[(5-Chloro-3-oxido-1H-benzotriazol-1-yl)-4- morpholinylmethylene]-N-methylmethanaminium hexafluorophosphate (an aminium reagent), propylphosphonic anhydride and 4-(4,6-dimethoxy-1,3,5-triazin-2-yl)-4- methylmorpholinium tetrafluoroborate (paragraph 71). Additionally, it’s taught that the reaction occurs in the presence of a base that could be selected from dimethylaminopyridine (DMAP) or diazabicyclo[5.4.0]undec-7-ene (DBU) (paragraph 77).
For the above reasons, claims 13-14 are also rejected as Chand discloses an identical method of preparation of diroximel fumarate.
Regarding claim 15, Chand teaches Example 3, which teaches the preparation of diroximel fumarate by reacting the monomethyl fumarate with hydroxyethyl succinimide in the presence of DMAP and EDC*HCl in dichloromethane solvent (paragraph 145). While Chand used dichloromethane as the solvent, this reference also teaches that the solvent could be acetone (paragraph 130). Therefore, it can be seen that substituting dichloromethane with acetone is merely a simple and obvious substitution.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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