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 .
DETAILED ACTION
Status of 18/017,422
Claims 1-9, 14, and 17 are currently pending.
Priority
Instant application 18/017,422, filed 1/23/2023, claims priority as follows:
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The Examiner acknowledges the submission of the certified, translated foreign priority document of 4/28/2026. Thus, the instant claims can be granted the effective filing date of 7/22/2020.
Information Disclosure Statement
All references from the IDS submitted on 6/12/2023 have been considered unless marked with a strikethrough.
Response to Applicant Arguments/Amendments
The amendment filed 4/28/2026 has been entered. Claim 1 has been amended. Claims 10-13 and 15-16 have been cancelled, and claim 17 has been added but is not considered new matter.
In the Non-Final dated 1/28/2026, the drawings were objected to as they were pixelated and illegible, and it was unclear what atoms correspond to what color in the crystal structures. In response, Applicant has submitted corrected drawings in color, which overcomes the objection. Thus, the objection is withdrawn.
The specification was objected to in the Non-Final dated 1/28/2026 for pixelated and illegible images, and for the submission of the combined amended and clean files. Upon the submission of the two separate files with corrected images, the objection is overcome and withdrawn.
Claim 1 was objected to in the Non-Final dated 1/28/2026 for a pixelated and illegible image. In response, Applicant has submitted a new claim set with a sharper image, which overcomes the objection. Thus, the objection is withdrawn.
Claim 10 was rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends in the Non-Final dated 1/28/2026. Upon the cancellation of claim 10, the rejection is overcome and withdrawn.
In the Non-Final dated 1/28/2026, claims 1-6 were provisionally rejected over the claims of copending Application No. 17/426,047 and claims 1-6 and 9-10 were provisionally rejected over the claims of copending Application No. 18/017,416 on the ground(s) of nonstatutory double patenting. Applicants arguments have been considered, particularly with respect to Table 4 of the instant disclosure, but are not considered persuasive because the instant claims do not require a crystalline form only a salt. Table 4 does not teach that no salt is formed; but rather no crystalline salt is isolated. Based on the rejection, a salt would be present when the acid and base are mixed. Currently, the instant claims do not require the salt to be isolated or crystalline as they are drafted now, and thus, the rejections are maintained. The rejections have been updated to reflect the claim changes.
This argument does not apply to the provisional rejection of claims 1-3, 6, and 9-10 on the ground(s) of nonstatutory double patenting over the claims of copending Application No. 18/017,421 (herein after the ‘421 application) because the claims of the ‘421 application recite the fumarate salt of the compound of instant formula I. The Examiner notes that the applications were filed on the same date, and thus MPEP § 804(I)(B)(1)(b)(ii) applies. Applicant requested that the double patenting rejection be held in abeyance until the ‘421 application issues as a patent or the present application is indicated to be otherwise in condition for allowance. This request is acknowledged. However, Applicant is reminded that the Office cannot hold a rejection in abeyance and “[i]n order to be entitled to reconsideration or further examination, the applicant or patent owner must reply to the Office action. The reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner's action and must reply to every ground of objection and rejection in the prior Office action.” Because Applicant has failed to present an amendment or argument that overcomes the present rejection, the provisional rejection is maintained. Any future submissions that fail to address the merits of the non-statutory double patenting rejection might be deemed to be non-responsive. The claims rejected have been updated to reflect Applicant’s changes to the instant claims.
Election/Restriction
Applicant’s election of Group I, claims 1-6 and 9-10, drawn to pharmaceutically acceptable salts of a compound represented by formula 1 and compositions thereof, without traverse, in the reply filed 9/25/2025 is acknowledged. Applicant’s election of the fumarate salt of a compound of formula 1 in the same reply filed 9/25/2025, without traverse, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
In the Non-Final rejection dated 1/28/2026, the elected species was searched and double patenting rejections were identified. During the search, evidence for the expanded species of the hydrochloride salt was also identified, but was overcome upon Applicants arguments regarding the unpredictability of salt formation. The double patenting were not overcome, and thus claims 1-6 and 9 read on the elected species. Claims 7-8, 14, and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
MAINTAINED REJECTIONS
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 1-3, 6, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13-14, 21-23, and 26 of copending Application No. 18/017,421 (herein after the ‘421 application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘421 application recite the fumarate salt of the compound of instant formula 1 in a 1:1 ratio, and the corresponding crystal data.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 9-11, and 23-31 of copending Application No. 17/426,047 (herein after the ‘047 application) in view of Sekhon (Sekhon, BS. ARS Pharmaceutica, 2009, 50(3), 99-117). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘047 application recite a compound represented by formula I:
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or a pharmaceutically acceptable salt thereof. Instant formula 1 anticipates a compound of formula I of the ‘047 application when R1 is H, R2 is isopropyl, R3 is H, m is 1, n is 0, R4 and R5 form =O together, Y---X is
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where R6 is C1 alkyl, R7 is H, R8 is H, R9 is H, L is
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, G is a 6 membered aryl substituted by one R11, and R11 is a halogen.
It would have been prima facie obvious for one of ordinary skill to formulate the specific AKT inhibitor of instant formula 1 as the pharmaceutically acceptable fumarate or hydrochloride salt because according to Sekhon (Sekhon, BS. ARS Pharmaceutica, 2009, 50(3), 99-117), co-crystallization is a known technique for optimizing drug properties of pharmaceuticals. The reference Sekhon teaches that the formation of co-crystals in pharmaceuticals is considered a better alternative (abstract), and specifically teaches fumarate salts (page 102, last paragraph and page 107, second paragraph) and hydrochloride salts as examples (page 105, third paragraph).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 19-26 of copending Application No. 18/017,416 (herein after the ‘416 application) in view of Sekhon (Sekhon, BS. ARS Pharmaceutica, 2009, 50(3), 99-117). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘416 application recite a compound represented by formula I-0:
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or a pharmaceutically acceptable salt thereof. Instant formula I anticipates a compound of formula I of the ‘416 application when R is C3 alkyl and X is CH2.
It would have been prima facie obvious for one of ordinary skill to formulate the specific AKT inhibitor of instant formula I as the pharmaceutically acceptable fumarate or hydrochloride salt because according to Sekhon (Sekhon, BS. ARS Pharmaceutica, 2009, 50(3), 99-117), co-crystallization is a known technique for optimizing drug properties of pharmaceuticals. The reference Sekhon teaches that the formation of co-crystals in pharmaceuticals is considered a better alternative (abstract), and specifically teaches fumarate salts (page 102, last paragraph and page 107, second paragraph) and hydrochloride salts as examples (page 105, third paragraph).
Further, with respect to the unit dosage limitation of 5 mg to 400 mg calculated as a free base, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the amount of free base recited in the claims of the ‘416 application because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of compounds to treat AKT protein kinase-mediated diseases. The concentration of compounds in the formulation is a result effective parameter that will affect the physical properties of the final composition and is a parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-6 and 9 are rejected. Claims 7-8, 14, and 17 are withdrawn.
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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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