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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on July 7, 2026. Claim(s) 1-18 are pending. Applicant’s cancellation of claims 25 and 26 obviates the outstanding election of species requirement. The species requirement is hereby withdrawn. Claims 1-18 are examined on the merits herein.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 11, 12, and 18 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 5, 6, 8, and 9-13 of US 12,709,606. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are drawn to 1-(5-(2-fluorophenyl)-4-methoxy-1-(6-methoxypyridin-3-yl)sulfonyl)-1H-pyrrole-3-yl)-N-methylmethanamine and salts and crystalline forms thereof. The patented claims are drawn to a method of treating gastrointestinal ulcers, gastrointestinal inflammatory diseases, or gastric acid-related diseases, the method comprising administering to a subject in need a therapeutically effective amount of a compound represented by Chemical Formula 2 or a pharmaceutically acceptable salt thereof. Patented Chemical Formula 2 embraces the compound of the instant claims, thereby anticipating the instant claims.
Claims 1, 2, 11, 12, and 18 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 5, 6, 8, and 9 of US 11,767,311. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are drawn to 1-(5-(2-fluorophenyl)-4-methoxy-1-(6-methoxypyridin-3-yl)sulfonyl)-1H-pyrrole-3-yl)-N-methylmethanamine and salts and crystalline forms thereof. The patented claims are drawn to a compound represented by Chemical Formula 2 or a pharmaceutically acceptable salt thereof. Patented Chemical Formula 2 embraces the compound of the instant claims, thereby anticipating the instant claims.
Claims 1, 2, 11, 12, and 18 are provisionally rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of application 18/710,749. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are drawn to 1-(5-(2-fluorophenyl)-4-methoxy-1-(6-methoxypyridin-3-yl)sulfonyl)-1H-pyrrole-3-yl)-N-methylmethanamine and salts and crystalline forms thereof. The copending claims are drawn to a compound represented by Chemical Formula 1 or a pharmaceutically acceptable salt thereof. Formula 1 embraces the compound of the instant claims apart from the deuterated methyl group on the N. One of ordinary skill in the art would have found it obvious to synthesize the deuterated analog of Formula I. Deuteration is a known strategy in medicinal chemistry to improve pharmacokinetics, safety, tolerability, and efficacy without altering potency or selectivity (Sun Pharm. Indus., Inc. v. Incyte Corp., No. 2019-2011, Fed. Cir. Aug. 22, 2023).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 11, 12, and 18 are provisionally rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8, 11-12, and 15-17 of application 18/720,436. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are drawn to 1-(5-(2-fluorophenyl)-4-methoxy-1-(6-methoxypyridin-3-yl)sulfonyl)-1H-pyrrole-3-yl)-N-methylmethanamine and salts and crystalline forms thereof. Claim 18 specifically recites the fumarate salt. The copending claims are drawn to the same compound represented by Chemical Formula 1, the fumarate salt thereof, methods of treatment thereof (claim 11 and 12), and methods of preparation thereof (claims 15-17). While the instant claims are drawn to the hydrochloride, succinate, and tartrate salts thereof, one of ordinary skill in the art at the time of filing would find it obvious to vary the salt form. One would be motivated to do so because it is obvious to form salts from known acids. In re Williams, 89 USPQ 396 (CCPA 1951). Additionally, it is well known in the art that salt formation provides a means of altering the physiochemical and biological characteristics of a drug without modifying its chemical structure.
Copending Chemical Formula 1 is obvious over the compound of the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 is dependent on claim 3 which claims a specific crystalline form, namely form 1. Claim 4 recites additional peaks present in the X-ray powder diffraction graph of form I. Because the specific form is recited in claim 3, the peaks are inherently present even though they are not explicitly recited. Therefore, claim 4 is not further limiting.
To overcome this rejection, Applicant may: 1) delete “form I” language from claim 3; 2) include the peaks of claim 4 into claim 3; or 3) delete claim 4.
The same rationale applies to claim 6. Applicant may: 1) delete “form II” language from claim 5; 2) include the peaks of claim 6 into claim 5; or 3) delete claim 6 to overcome this rejection.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 11, 12, and 18 are rejected under 35 U.S.C. 103 as being obvious over Yoon (US 2023/0192650).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Yoon teaches a compound of Chemical Formula 2 or a pharmaceutically acceptable salt thereof (claim 1; page 3, [0034]-[0039]).
PNG
media_image1.png
420
336
media_image1.png
Greyscale
Yoon specifically teaches 1-(5-(2-fluorophenyl)-4-methoxy-1-((6-methoxypyridin-3-yl)sulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine (claim 10).
Yoon teaches pharmaceutically acceptable salts thereof, however does not specifically teach the hydrochloride, succinate, and tartrate salts thereof, as required by the limitations of the instant claims.
One of ordinary skill in the art at the time of filing would find it obvious to vary the salt form. One would be motivated to do so because it is obvious to form salts from known acids. In re Williams, 89 USPQ 396 (CCPA 1951). Additionally, it is well known in the art that salt formation provides a means of altering the physiochemical and biological characteristics of a drug without modifying its chemical structure.
Based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Conclusion
Claims 1, 2, 4, 6, 11, 12, and 18 are not allowed.
Claims 3, 5, 7-10, and 13-17 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
Prosecution Insights