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 .
Response to Amendment and Argument
The response filed on 7/13/26 has been entered.
Applicant’s arguments filed 7/13/26 have been fully considered but they are not deemed to be persuasive.
Claims 16-37 are pending in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed July 13, 2026. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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.
Claims 16-37 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 30 of U.S. Patent No. 12,138,256. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· The claims refer to a method of treating a cardiopulmonary disorder in a subject comprising administering to the subject, about 240 μg to about 4000 μg of a crystalline monohydrate compound 1 and the instant claims are to a formulation for inhalation comprising a dry powder blend, wherein the dry powder blend comprises:a) a crystalline monohydrate form of (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro- 4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino } -5,6,7,8-tetrahydroquinoline-2- carboxylic acid; andb) a lactose carrier comprising lactose monohydrate as a mixture of coarse lactose and fine lactose. The compound of the patented claims of compound 1 is the same as the compound formular of the instant claim 16 i.e., (5S)-{([2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4′-(trifluoromethyl)biphenyl-4-yl]methoxy)phenyl)ethyl]-amino}}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid with the same X-ray diffraction (see patented claims and instant claims. Therefore would have use the claims of the instant in practicing the patented method of treatment claims.
Although the patented claims did not recite a lactose carrier in the claims, nevertheless the specification when used as a dictionary teaches that a lactose blend was used with the compound (see col. 226). With regards to the lack of recitation of the method of treating a cardiopulmonary disorder , it would have been obvious to one of ordinary skill in the art to have used the instant claims in practicing the patented claimed invention with a reasonable expectation of success in doing so because claim 35 of the instant claims recites the method of treating a cardiopulmonary disorder.
With regards to the process recited in claim 34, when the specification is used as a dictionary, it teaches (see Fig. 84). Therefore one of ordinary skill in the art would have been motivated to use the patented claims in practicing the instant claimed invention with a reasonable expectation of success.
In view of the foregoing, the patented claims and the current application claims are obvious variations of each other.
Applicant argues that “Because the claims of the '256 patent do not recite a formulation, much less a specific formulation comprising a crystalline monohydrate form of Compound 1 and a dry powder blend comprising coarse lactose and fine lactose, a process for manufacturing the same, or methods of using the same, instant claims 16-35 are patentably distinct and would not have been obvious over claims 1-30 of the '256 patent. Applicant respectfully requests withdrawal of the rejection”
In response, Applicant’s argument have been considered and found unpersuasive because even though the patented claims fail to recitea lactose carrier and fails nonetheless the instat compositon also recites a method of method of treating a cardiopulmonary disorder, comprising administering to a subject in need the formulation of claim 16 wherein the cardiopulmonary disorder is selected from pulmonary arterial hypertension (PAH) and pulmonary hypertension (PH) associated with chronic lung disease (PH group 3) and the patented claims 20 and 30 recites the same method lacking a pharmaceutical carrier lactose. As stated previously the specification can be used as a dictionary and in so doing both the instant specification and the patented specification list lactose as the carrier 467 times in the patented specification and 493 times in the instant specification. The use of the composition is the same. Thus one of ordinary skill in the art would have used the specification in practicing the patented claims administering the composition to treat cardiopulmonary disorder. It would have been obvious to one of ordinary skill in the art to administer the composition with lactose as the excipient/carrier with a reasonable expectation of success because the compound is what does the treatment and not the lactose.
Claims 16 - 35 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 16 - 35of U.S. Patent Application No. 18779518. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims refer to a method of treating a cardiopulmonary disorder in a subject comprising administering to the subject, about 1000 μg of a crystalline monohydrate compound 1 and the instant claims are to a formulation for inhalation comprising a dry powder blend, wherein the dry powder blend comprises:a) a crystalline monohydrate form of (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro- 4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino } -5,6,7,8-tetrahydroquinoline-2- carboxylic acid; andb) a lactose carrier comprising lactose monohydrate as a mixture of coarse lactose and fine lactose. The compound of the patented claims of compound 1 is the same as the compound formular of the instant claim 16 i.e., (5S)-{([2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4′-(trifluoromethyl)biphenyl-4-yl]methoxy)phenyl)ethyl]-amino}}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid with the same X-ray diffraction (see patented claims and instant claims. Therefore would have use the claims of the instant in practicing the patented method of treatment claims.
Although the copending claims did not recite a lactose carrier in the claims, nevertheless the specification when used as a dictionary teaches that a lactose blend was used with the compound (see col. 226). With regards to the lack of recitation of the method of treating a cardiopulmonary disorder , it would have been obvious to one of ordinary skill in the art to have used the instant claims in practicing the patented claimed invention with a reasonable expectation of success in doing so because claim 35 of the instant claims recites the method of treating a cardiopulmonary disorder.
With regards to the process recited in claim 34, when the specification is used as a dictionary, it teaches (see Fig. 84). Therefore one of ordinary skill in the art would have been motivated to use the patented claims in practicing the instant claimed invention with a reasonable expectation of success.
In view of the foregoing, the copending claims and the current application claims are obvious variations of each other.
Applicant argues that the copending “do not recite a formulation, much less a specific formulation comprising Compound 1 and a dry powder blend comprising coarse lactose and fine lactose, a process for manufacturing the same, or methods of using the same.
In response, contrary to Applicants remarks and as stated above, both sets of claims do recite a method of treating a cardiopulmonary disorder with the compound of the same compound 1and the same as the compound formular of the instant claim 16 i.e., (5S)-{([2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4′-(trifluoromethyl)biphenyl-4-yl]methoxy)phenyl)ethyl]-amino}}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid, Thus to practice the claimed invention one of ordinary skill in the art would have been motivated to use the instant claims in practicing the copending claims with a reasonable expectation of success because as stated when the specification is used as a dictionary the copending specification it teaches the use of lactose 467 times therefore it would have been motivated to use lactose as a carrier/excipient to practice the copending invention.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 8/7/26
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