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
Election of Species and Status of the Claims
Applicant’s election of “compound 17” as the “single composition that selectively inhibits Akt3” in the response filed on October 17th 2025 is acknowledged. Claims 1-5 and 8-22 are pending. Claims 2, 4-5, 12, 15-20, and 22 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable (Note that claims 2 and 12 are directed towards a composition containing active agents other than compound 17). Claims 1, 3, 8-11, 13-16, and 21 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on March 28th 2025, October 8th 2024, May 5th 2024, March 11th 2024, November 22nd 2023, and August 11th 2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and its dependent claims 8-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
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.
Claims 1, 3, 8-11, 13-16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Khleif (U.S. Patent No. 10,342,868 issued on July 9th 2019) in view of Mehta-Shah (Mehta-Shah et al. Adult T-Cell Leukemia/Lymphoma. JOP 13, 487-492(2017)).
Claims 1, 3, 13-16, and 21 are directed towards the treatment of adult T-cell leukemia/lymphoma (ATLL)via the administration of applicant’s elected species,
PNG
media_image1.png
112
260
media_image1.png
Greyscale
.
Khleif teaches the same compound (Khleif, col. 12, compound 18) as an AKT3 inhibitor for the treatment of leukemias and lymphomas (Khleif, col. 28).
Khleif does not explicitly state that the leukemia/lymphoma is ATLL, but one of ordinary skill in the art would have a reasonable expectation of success in treating ATLL with the above compound, because the leukemias/lymphomas treated by Khleif match the characteristic profile with ATLLs. Specifically of interest, Khleif defines the compound as being useful for the treatment of infections, including human T-lymphotrophic virus (HTLV) (Khleif, col. 28). Notably, this infection is described in the art as being the primary cause of ATLL. See Mehta-Shah:
“Adult T-cell lymphoma/leukemia (ATL) is a rare lymphoproliferative neoplasm of mature CD4+ CD25+ T cells caused by infection with the retrovirus human T-lymphotropic virus type 1 (HTLV-1)”
[Mehta-Shah, pg. 487]
“ATL remains a rare T-cell lymphoma caused by infection with HTLV-1.”
[Mehta-Shah, pg. 491]
As one of one of ordinary skill in the art would have a reasonable expectation of treating leukemia caused by HTLV-1 infection via administration of applicant’s compound (see Khleif) and would recognize such a leukemia as ATLL (see Mehta-Shah), , claims 1, 3, 13-16, and 21 are prima facie obvious.
Claim 8 requires that the ATLL of claim 1 is caused by HTLV-1, and is prima facie obvious for the same reasons as claim 1.
Claim 9 requires that, in the method of claim 1, the immune suppressive function reduced is either nTreg or iTreg. As Khleif teaches the reduction of each of nTreg and iTreg (Khleif, col. 3), claim 9 is prima facie obvious.
Claim 10 limits the immune suppressive function of nTreg in claim 9 to be the secretion of one or more anti-inflammatory cytokines, which is also taught by Khleif (Khleif, col. 3), rendering claim 10 prima facie obvious.
Claim 11 limits the anti-inflammatory cytokines of claim 10 to IL10, TGF-beta, or a combination thereof. Khleif teaches each of these anti-inflammatory cytokines (Khleif, col. 3), and claim 11 is prima facie obvious.
Nonstatutory 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, 8-11, 13-16, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,292,978. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches the reduction of suppressive immune response and treatment of hematologic cancers (thus encompassing ATLL) via administration of a composition that comprises applicant’s elected species.
Claims 1-3, 8-11, 13-16, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,525,049. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches the treatment of hematologic cancers (thus encompassing ATLL) via administration of a composition that comprises applicant’s elected species.
Claims 1-3, 8-11, 13-16, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,013,735 in view of Mehta-Shah (Mehta-Shah et al. Adult T-Cell Leukemia/Lymphoma. JOP 13, 487-492(2017)). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches the treatment of infectious diseases caused by virus via administration of a composition that comprises applicant’s elected species. Such viruses are said to include HTLV (reference patent, col. 29), which is known in the art to cause ATLL (Mehta-Shah, pg. 487).
Claims 1-3, 8-11, 13-16, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,342,868. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons stated in the above 103 rejection.
Claims 1-3, 8-11, 13-16, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,588,966. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches the treatment of hematologic cancers (thus encompassing ATLL) via administration of a composition that comprises applicant’s elected species.
Claims 1-3, 8-11, 13-16, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,980,878. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches the treatment of hematologic cancers (thus encompassing ATLL) via administration of a composition that comprises applicant’s elected species.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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 Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629