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 .
Claims 45-58 are pending in the instant application. Claims 45-58 are rejected.
Information Disclosure Statement
The information disclosure statement filed on June 3, 2025 has been considered and a signed copy of form 1449 is enclosed herewith.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 45-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 3 of U.S. Patent No. 11,426,377. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 11,426,377 claims a similar method of treating pulmonary arterial hypertension comprising providing a kit comprising a titration package for enabling compliance with a regimen of changing dosage of medication over a period of time, wherein the medication is Compound 1, or a pharmaceutically acceptable salt, hydrate, or solvate thereof to the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to find the optimal dosing of Compound 1 for the quoted method. Thus, a prima facie case of obviousness has been established.
Claims 45-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 22 of U.S. Patent No. 11,826,337. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 11,826,337 claims a similar method of treating pulmonary arterial hypertension comprising providing a kit comprising a titration package for enabling compliance with a regimen of changing dosage of medication over a period of time, wherein the medication is Compound 1, or a pharmaceutically acceptable salt thereof to the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to find the optimal dosing of Compound 1 for the quoted method. Thus, a prima facie case of obviousness has been established.
Claims 45-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 2 of U.S. Patent No. 11,000,500. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 11,000,500 claims similar methods for the treatment of pulmonary arterial hypertension (PAH) in a patient to the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to find the optimal dosing of Compound 1 for the quoted methods. Thus, a prima facie case of obviousness has been established.
Claims 45-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 10,688,076. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 10,688,076 claims a similar method of determining an optimized dose for a patient in need of treatment of pulmonary arterial hypertension to the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to find the optimal dosing of Compound 1 for the quoted method. Thus, a prima facie case of obviousness has been established.
Claims 45-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 10,537,546. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 10,537,546 claims a similar method of treating pulmonary arterial hypertension to the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to find the optimal dosing of Compound 1 for the quoted method. Thus, a prima facie case of obviousness has been established.
Claims 45-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 12,239,627. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 12,239,627 claims a similar method of treating pulmonary arterial hypertension to the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the methods for treating pulmonary arterial hypertension (PAH) in a human of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to find the optimal dosing of Compound 1 for the quoted method. Thus, a prima facie case of obviousness has been established.
Conclusion
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
