DETAILED 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 .
Claims 1-15 are pending in the instant application. Claims 1, 5, 7, 8, 10, and 15 are rejected. Claims 2-4, 6, 9, and 11-14 are objected.
Information Disclosure Statements
The information disclosure statements filed on June 3, 2024, August 1, 2024, September 16, 2024, and January 2, 2025 have been considered and signed copies of form 1449 are enclosed herewith.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 7, 8, 10, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/033702 A1.
WO 2021/033702 A1 discloses a process for the preparation of a calcium salt of {4-[5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}acetic acid or MRE-269 (see example 8 on page 12), using an EtOH/water mixture as a solvent and a 1 molar eq. of calcium hydroxide. MRE-269, calcium hydroxide and EtOH/water were added to a vial and mixed at 50 ºC for 2 days; after cooling to room temperature, the solids were isolated by vacuum filtration and dried. Therefore, a process for the manufacturing of calcium; {4-[5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}acetate of the claims wherein the first calcium source is added in an amount of 1 mol per mol {4-[5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}acetic acid; solvent (a) is an organic solvent mixed with water; and wherein the organic solvent in solvent (a) is ethanol is anticipated by the reference. The product obtained by the process of the claims is also anticipated by the reference.
It is noted that “[e]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Therefore, it is recommended by the examiner that clam 15 be canceled.
It is also noted that the process of claim 1 involves the step of optionally (emphasis added) re-slurrying the isolated solid product in a solution of a second calcium source in a solvent (b) at a temperature in the range of 20ºC to 85ºC and this step is not limiting to the process. Therefore, it is recommended by the examiner that the word “optionally” be deleted from the claim.
Claim Objections
Claims 2-4, 6, 9, and 11-14 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622