DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 28-45 are pending in this application.
Election/Restrictions
2. Applicant’s election without traverse of Group III drawn to a process of preparing a tartrate salt of 3-(1H-indole-5-yl)-5-[4-[(4-methyl-1-piperazinyl)methyl]phenyl]-1H-pyrrolo[2,3-b]pyridine in the reply filed on 06/16/2026 is acknowledged.
Double Patenting
3. 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.
4. Claims 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,479,541. Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and claims 1-4 of U.S. Patent No. 11,479,541. Said patent recites a tartrate salt and its preparation of tartrate salt that is the same as the instant case.
Claim Rejections - 35 USC § 103
5. 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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
6. Claims 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Val et al. J. Med. Chem. 2013, 56, 8032-8048 and further in view of Stahl et al., eds., Handbook of pharmaceutical salts. Properties, selection and use (Wiley-VCH, 2008), pages 265-327. The primary reference (Val et al.) teaches the following compound that is the same as applicants (see below).
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Said compound that is also known as URMC-099 is disclosed at page 3 of said reference.
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Applicants are claiming a process of preparing a tartrate salt of a known compound. Thus, the only difference between applicants and the prior art is the presence or absence of a specific addition salt (i.e. a tartrate salt) of the known compound.
The second reference (Stahl et al.) teaches numerous examples of salts, across a wide range of medicinal chemistry. Tartaric acid, Fumaric acid and phosphoric acid are disclosed as suitable salts at pages 266-267. Accordingly, the second references provide a “reasonable expectation of success”, and that is all the law requires, not a total predictability. See In re Clinton, 188 USPQ 365; In re Longi, 225 USPQ 645, 651; Alza Corp. v. Mylan Laboratories Inc., 80 USPQ2d 1001, 1006; In re Corkill, 771 F.2d 1496, 1500 ; Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 56 USPQ2d 1456; Merck & Co., Inc. v. Biocraft Labs., Inc., 10 USPQ2d 1843; In re Merck & Co., Inc., 231 USPQ 375; In re Rinehart, 189 USPQ 143; In re O'Farrell, 7 USPQ2d 1673.
The factual situation is thus largely the same as in Pfizer, Inc. v. Apotex, Inc. 82 USPQ2d 1321 which was directed to the amlodipine besylate drug. At the time of the invention, amlodipine was known as was the use of besylate anions. While the amlodipine besylate had the same therapeutic use, Pfizer discovered that the besylate (benzene sulphonate) form had a superior property. Pfizer’s argument that the results of forming amlodipine besylate would have been unpredictable, and therefore were nonobvious, was unpersuasive. The court rejected the notion that unpredictability could be equated with nonobviousness here, because there were only a finite number (53) of pharmaceutically acceptable salts to be tested for improved properties (e.g., non-stickiness, and improved stability) while at the same time having good solubility, and non-hygroscopicity. The court found that one of ordinary skill in the art looking to improve amlodipine would have looked to forming a salt of the compound with the group of potential salt-formers being a group of 53 anions already known to form pharmaceutically acceptable salts, which would be an acceptable number to provide ‘‘a reasonable expectation of success.’’ Indeed, the Court decision quoted unrefuted testimony that “part and parcel of pharmaceutically accepted was to look in pharmacopoeias and compendia” to find an anion having “precedence for use within the pharmaceutical industry” and that it “It would be logical to try” salts from the known list (page 1331). That other drugs which used the besylate salt did not have the same therapeutic use as amlodipine was called “unimportant, if not actually irrelevant” (page 1332). The Court further noted that “upon making a new acid addition salt, it was routine in the art to verify the expected physicochemical characteristics of each salt”, so that if “one skilled in the art would have had a reasonable expectation of success at the time the invention was made” one “merely had to verify that expectation” and learn of these properties (page 1335). Moreover, the Court found this “analogous to the optimization of a range or other variable within the claims that flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)…”
Since the primary reference teaches applicant’s claimed compound and the fact that Stahl et al. teaches a tartaric acid as a known salt, it is obvious to one skilled in the art at the time of the filing to make different salts of a known compound for a therapeutic purpose.
Information Disclosure Statement
7. Applicant’s Information Disclosure Statement, filed on 05/16/2026 and 11/05/2024 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624
June 24, 2026
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