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 .
Election/Restrictions
Applicant’s election of Group II in the reply filed on 8/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 1-12, 16-18 are withdrawn from consideration for being directed to non-elected subject matter. Claims 13-15 and 19 are currently under examination.
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 13-15 and 19 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.
Regarding claim 13, the recitation of “at least one MR antagonist and at least one GR agonist having an enhanced binding affinity” renders the claim indefinite because it is unclear what this “enhanced binding affinity” is referring to. It is unclear whether it is referring to the MR antagonist, GR agonist, and whether it means it has enhanced binding to the receptor, an antibody, or other molecules. Moreover, it is unclear what the enhancement is comparing to. As such, the metes and bounds of the claim cannot be established.
Claims 14, 15 and 19 are rejected for same reason because they depend on claim 13 but does not remedy the indefiniteness.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 13-15 and 19 is/are rejected under 35 U.S.C. 102 (a1)(a2) as being anticipated by Farman (WO 2014/202744, IDS).
Farman teaches glucocorticoid and the mineralocorticoid receptor antagonist may be administered simultaneously to a subject, wherein the composition comprises both glucocorticoid and MR antagonist (page 17, lines 19-23). Therefore, the teaching from Farman anticipates the composition of claim 13.
Regarding claim 14-15 and 19, Farman teaches the pharmaceutical composition may be formulated as liquid preparation, gel, paste, powder, ointment, liposome, cream or lotion (page 18, lines 3-6).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CELINE X QIAN/Primary Examiner, Art Unit 1637
