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, 7-11 and 13 are currently pending in the instant application. Applicants have amended claims 1, 7 and 13 and cancelled claims 2-6, 12, 14 and 15 in an amendment filed on November 10, 2025. Claims 1 and 13 are rejected and claims 7-11 are considered allowable in this Office Action.
I. Response to Arguments/Remarks
Applicant’s arguments, filed November 10, 2025 with respect to the rejection of claims 1-13 and 15 under 35 USC 103 as being unpatentable over Mathad, et al. (WO 2015/044965 A1) have been fully considered but are not found to be persuasive. Applicants have provided data in the form of arguments which should be presented in a declaration.
Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984), or otherwise presented during prosecution. See, e.g., MPEP §§ 714 to 716 et seq. However, arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
The Examiner has maintained the rejection with regards to claims 1 and 13. “When claiming a purer form of a known compound, it must be demonstrated
that the purified material possess properties and utilities not possessed by the
unpurified material”. Ex parte Reed, 1.35 U.S.P.Q. 34, 36 (P.O.B.A. 1961), on
reconsideration.
Applicants’ amendment to claim 7 has overcome the 103 rejection of claims 7-11 as being unpatentable over Mathad, et al. (WO 2015/044965 A1). The rejection with regards to claims 7-11 have been withdrawn.
II. Rejection(s)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. § 103(a) that forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
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 and 13 are rejected under 35 U.S.C. § 103 as being unpatentable over Mathad, et al. (WO 2015/044965 A1). It is well established that “Pure compositions are unpatentable over impure compositions (compounds) if the utility is the same”. In re Crosley 72 USPQ 499, In re Merz 1938 CD 728.
Applicants claim
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710
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The Scope and Content of the Prior Art (MPEP §2141.01)
The Mathad, et al. reference teaches a crystalline form of mirabegron, a pharmaceutical composition comprising this compound and a method of preparing mirabegron
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774
701
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665
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(see pages 6-8)
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Mathad, et al. and the instant invention is that the applicants are claiming the well-known compound that is substantially free of specific impurities whereas the prior art teaches the compound but does not teach the specific impurities of the compound. So the difference would be a pure composition vs. an less impure composition (compounds).
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
It is well established that “Pure compositions are unpatentable over impure compositions (compounds) if the utility is the same”. In re Crosley 72 USPQ 499, In re Merz 1938 CD 728. Mathad, et al. teaches the compound
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which is well known throughout the prior art. Applicants have not prepared a novel compound over the prior art. Applicants compound (IA) has the same utility as the prior art’s compound. The only difference is that Applicants have developed a process for preparing the well-known compound in a purer form that is substantially free of the specified impurities whereas the prior art is silent on the specific impurity. It is well within one of ordinary skill in the art to obtain a purer form of a compound when being used as a pharmaceutical. The motivation to optimize the compounds of Mathad, et al. would be to prepare pharmaceutical compounds that are useful as a beta-3 adrenergic receptor agonist used for the treatment of urinary frequency or urgency associated with overactive bladder. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to optimize the compounds of Mathad, et al. for the purpose of having a purer form to use in a pharmaceutical composition.
III. Conclusion
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is (571)272-9043. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached on (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626