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 18/017,422
Claims 1-16 are currently pending.
Priority
Instant application 18/017,422, filed 1/23/2023, claims priority as follows:
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The certified foreign priority application was not submitted as a translated document in English. Therefore, priority cannot be granted for claims 1-16 as the Examiner cannot execute the claim-by-claim analysis per MPEP § 2152.01. Thus, the effective filing date of claims 1-16 is the PCT filing date, 7/22/2021.
Information Disclosure Statement
All references from the IDS submitted on 6/12/2023 have been considered unless marked with a strikethrough.
Objection to Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figures 1 and 2 are not able to be interpreted as they are pixelated and illegible. It is unclear what atoms correspond to what color in the crystal structure. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Objection to Specification
The disclosure is objected to because of the following informalities: The amended version of the specification and the clean version of the specification were submitted in the same file. Though the Examiner appreciates the two versions, they need to be submitted as separate files.
Additionally, the figures embedded in the amended and clean versions of the specification are pixelated and illegible. Specifically, the figures on pages 4, 9, 12, 15, 19 of the amended version and the figures on pages 25, 31, 33, 36, 40, and 41 of the clean version are not able to be interpreted.
Appropriate correction is required.
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.
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. See the double patenting rejections below. Claims 1-6 and 9-10 read on the elected and expanded species. Claims 7-8 and 11-16 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.
Claim Interpretation
Claim 10 recites an intended use after the preamble of a pharmaceutically acceptable salt or pharmaceutical composition. The intended use of a salt or composition is not given patentable weight, and therefore the claim is currently being interpreted as the respective salt or composition.
Claim Objections
Claim 1 is objected to because of the following informalities: The image of formula 1 is pixelated. Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
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.
Claim 10 is 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.
Claims 1 and 9, the parent claims from which claim 10 depends, recite a pharmaceutically acceptable salt or pharmaceutical composition according to claim 1. Claim 10 recites the pharmaceutically acceptable salt or pharmaceutical composition for use as a medicament, which is merely an intended use of the salt or composition already recited by claims 1 and 9. Accordingly, claim 10 is essentially a duplicate of claims 1 and 9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 9-10 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 9-10 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 9-10 are rejected. Claims 7-8 and 11-16 are withdrawn.
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.
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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