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
This is a response to Applicant’s communication filed on May 19, 2026. Application No. 18/632,522, is a Divisional of U.S. Nonprovisional application No. 17/052,359, (issued as U.S. Patent No. 11,992,479), which is a 371 of PCT/EP2019/061283, filed May 2, 2019, and claims the benefit of U.S. Provisional Application No. 62/666,412, filed May 3, 2018, and claims foreign priority to European Patent Application No. EP 18176345.9, filed June 6, 2018. In a preliminary amendment filed August 23, 2024, Applicant cancelled claims 1-10 and 15, and added new claims 16-31. In an amendment filed September 9, 2025, Applicant cancelled claims 12, 14, 16-18, 21-30, and added new claims 32-45. Claims 11, 13, 19, 20, and 31-45 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 19, 2026, has been entered.
Rejection Maintained
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The rejection of claims 11, 13, 19, 20, and 31-45 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,822,332, is maintained for reasons made of record. Applicant argues that nothing in the '332 patent claims would lead a person of ordinary skill in the art to arrive at the instantly claimed pharmaceutical compositions requiring, e.g., the specified amounts of (R)-(+)-5-(p-cyanophenyl)-5,6,7,8-tetrahydroimidazolium[1,5- a]pyridine dihydrogen phosphate, where the specified amounts of the active ingredient surprisingly modulate plasma aldosterone with daily administration. Applicant’s argument has been fully considered and is not persuasive.
Applicant argues that the specified amounts of the active ingredient in a fix-unit dosage form provides for unexpected superior results. Yet Applicant provides no evidence that the present invention provides for such results. In this case, the attorney argument draws a conclusory statement. Applicant has not demonstrated the level of scientific enquiry required to demonstrate unexpected superior results, such as a head-to-head study. See MPEP 716.02. The arguments of counsel cannot take the place of evidence in the record. MPEP 2145. Attorney statements which are not evidence, as in this case, must be supported by an appropriate affidavit or declaration. (Id.)
In this case, Applicant has not provided the requisite scientific evidence to support its conclusory argument. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘332 patent encompass the same subject matter as claimed by the present invention. See specifically the ’332 patent, claims 11 and 17, for pharmaceutical compositions thereof.
It is suggested that Applicant file a Terminal Disclaimer over the ‘332 patent to obviate this rejection.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached on Monday - Friday, 9:00 a.m. -5:00 p.m..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIMOTHY R ROZOF/
Primary Examiner, Art Unit 1625
Prosecution Insights