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 .
Status of the Claims.
Claims 16-23 and 26-33 are pending.
Applicants’ arguments filed on 09/23/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 09/23/2026, have been fully considered. Applicants have amended claims 16-23 and 26-33. Applicants have cancelled claims 24-25 and 34-35. Therefore, claims 16-23 and 26-33 are subject of the Office action below.
Non-Statutory Obviousness-Type Double Patenting
Maintained/New Grounds of Rejection Necessitated by Applicants’ Amendments
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.
Claims 16-23 and 26-33 (inadvertently recited in the previous office action as claims 16-43) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,138,256 (‘256 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and claims of the ‘256 patent are similarly drawn to a method of treating a cardiopulmonary disorder in a subject, with a crystalline compound 1:
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For example, the claims of the instant invention (e.g., claim 16 and 21) are drawn to a method for treating pulmonary hypertension associated with interstitial lung disease in a subject in need thereof, with about 1000 µg (claim16) or about 2000 µg (claim 26) of compound 1, whereas the claims of the ‘256 patent (e.g., claims 1, 18-19) are drawn to a method for treating a cardiopulmonary disorder (e.g., pulmonary hypertension with idiopathic interstitial pneumonia) in a subject in need thereof, with about 240 µg to about 4000 µg of compound 1.
The claimed “about 240 µg to about 4000 µg of compound 1” of the ‘256 patent encompasses the “about 1000 µg or about 2000 µg of compound 1” of the instant claims. Accordingly, one skilled in the art would have envisaged a method for treating pulmonary hypertension associated with interstitial lung disease (a cardiopulmonary disorder) in a subject in need thereof, with “about 1000 µg or about 2000 µg of compound 1”, in the ‘256 patent claims.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Response to Applicants’ Arguments/Remarks
Applicants argue alleging that the instant claims are non-obvious over claims of the ‘256 patent because the claims of the ‘256 patent fail to recite “about 1000 µg or about 2000 µg of compound 1” (see pages 5-6 of Remarks).
Response
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because the claimed “about 240 µg to about 4000 µg of compound 1” of the ‘256 patent encompasses the “about 1000 µg or about 2000 µg of compound 1” of the instant claims. Accordingly, one skilled in the art would have envisaged a method for treating pulmonary hypertension associated with interstitial lung disease (a cardiopulmonary disorder) in a subject in need thereof, with the “about 1000 µg or about 2000 µg of compound 1”, in the ‘256 patent claims.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Conclusion
No claim is allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
