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 .
Applicant’s amendments filed 3/26/2026 have been entered.
Claims 3-8, 10-29 are pending.
Claims 21-29 have been added in the amendments filed 3/26/2026.
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.
Claim 3-6, 16-18, 21-25, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 30, 31, 33 of copending Application No. 17/614,652 (‘652) (reference application) in view of Gould, International Journal of Pharmaceutics, 33 (1986) 201-217. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘652 teaches a pharmaceutical acceptable salt of the herein claimed compound (see claim 27 and 30). ‘652 does not expressly teach the specific acid salts of the compounds recited in the claims.
Gould teaches salt formation provides a means of altering the physiochemical and resultant biological characteristics of a drug without modifying its chemical structure (see page 201, col.1, first paragraph). Gould teaches that one of the most common acid salt as HCl salt, sulfate salt, and Isothionate salt (2-hydroxyethyl sulfonate), among many other salts (see page 202, Table 1). Although potential problem may occur, it seems formulating HCl salt would be the first move. And if problem arises, selecting other salts would be warranted (see page 204, col. 1, fourth paragraph).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate an acid salt of the herein claimed compounds of formula (II).
One of ordinary skill in the art would have been motivated to formulate an acid salt of the herein claimed compounds as producing HCl salt would be reasonably expected to improve the formulating process, stability, or solubility of the compound of formula (II). Furthermore, the mixing and reacting the acid with the free base to form the salt would be considered obvious as being within the purview of skilled artisans. In addition, adjusting the number of acid is obvious as the compound has more than one place to be ionizable. This is considered obvious as being within the purview of skilled artisan.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 7-8, 10-15, 19-20, and 26-28 are allowed.
Response to Arguments
Applicant's arguments filed 3/23/2026 averring the cited prior art’s failure to teach the benefits of forming a salt since the free base of the compound as being non-soild, have been fully considered but they are not persuasive. The examiner notes that Gould does not expressly teach that the free base must be in a solid form. As the matter of fact, the salt formation/selection process is a way to make free base to become completely chemically stable, non-hygroscopic, not cause processing problems, and dissolve quickly from solid dosage form., according to Gould (see page 203, col. 1, second paragraph). In other words, altering the forms using salt formation in order to improve the physical and/or chemical properties that the API would be able to be formulated into a pharmaceutical dosage form. Therefore, the use of salt formation in oily chemical compounds expected and reasonable ways to solve such problem.
Applicant's arguments filed 3/23/2026 averring the presence of unexpected benefits of formic salt, have been considered, but are not found persuasive. The examiner notes that it is applicant’s burden to demonstrate unexpected results over the prior art. See MPEP 716.02, also 716.02 (a) - (g). Furthermore, the unexpected results should be demonstrated with evidence that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Moreover, evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972). In the instant case, the formic acid salt of the instant compounds improves the bioavailability and Cmax compared to the free base. Although applicant labels it as unexpected benefits, it is not clear if it is indeed unexpected. Forming salt could increase the solubility of a compound in the magnitude of 100’s, depending on the compound itself (see for example, Gould, page 207, col. 2, Table at the bottom). The increase of the solubility of the free base (0.008% w/v) to the diacetate salt (1.8% w/v) is more than 200-fold. Increasing in solubility in general will improve the absorption of the drug. Since there is only one data point – formate salt, it is not clear if the increase in bioavailability and Cmax are indeed unexpected.
Furthermore, even if there is unexpected benefits by forming formate salt, the showing is not commensurate with the scope of the salts recited in the claims. Therefore, possessing the teachings of the cited prior art, one of ordinary skill in the art would have been motivated to synthesize a salt for the herein claimed compound.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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