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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/KR2022/001195, filed 01/24/2022, which claims the priority benefit of KOREA, REPUBLIC OF Application No. 10-2021-0077327, filed 06/15/2021, and KOREA, REPUBLIC OF Application No. 10-2021-0077326, filed 06/15/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/12/2023, 02/25/2026, and 04/27/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II, Claim 24 with a species election of compound SB-B002 in the reply filed on 04/27/2026 is acknowledged.
In accordance with the 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 (see MPEP 803.02). 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 reexamined.
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 reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP 803.02, the Examiner will determine whether the entire scope of the claims is patentable.
Applicants' elected species
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makes a contribution over the prior art of record. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Status of the Application
Claims 1-2, 4, 6, 8, 10, 13, 15, 17-18, 20-22, and 24-29 are pending. Claim 24 has been amended. Claims 1-2, 4, 6, 8, 10, 13, 15, 17-18, and 20-22 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 3, 5, 7, 9, 11-12, 14, 16, 19 and 23 have been cancelled by applicant without prejudice or disclaimer. Claims 25-29 have been added. Claims 24-29 are examined herein insofar as they read on the elected invention and species.
Claim Objections
Claim 24 is objected to because of the following informalities: the structure of formula 1 does not show the ion charge of the P atom clearly. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 24-25, 27-29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by IDS reference Skulachev (US 2013/0072463 A1).
Skulachev teaches compound SkQ1 as a derivative of structure I which can be used for efficient preventing and therapy of all types of cancer alone or in combination with other forms of cancer therapy Such as chemotherapy and/or irradiation, and/or antibody therapy [0065]. Skulachev’s disclosed structure of SkQ1 [0049] anticipates the structural limitations of applicants compound of formula 1 where L is a 10 carbon chain and A is an =O and Me substituted cycloalkyl. See MPEP 2112.01.
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Skulachev’s SkQ1 (Left) Applicants Formula I (Right)
Claim Rejections - 35 USC § 103
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.
Claims 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Teixiera (Disruption of mitochondrial function as mechanism for anti-cancer activity of a novel mitochondriotropic menadione derivative, pgs. 123-139).
The instant claims are directed to a method of treating cancer or ocular disease by administering a compound of formula I to a subject in need thereof.
Teixeira et al. teach the compound of MitoK3 which satisfies the structural limitations of formula 1 of the instant claims where L is a 10 carbon chain and A is
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. Teixeira teaches MitoK3 caused dose-dependent toxicity effects on tumour MCF-7 and non-tumour MCF-12A cells with an IC50 in the sub micromolar range of 0.42 µM and 0.76 µM, respectively and that the data suggest that MitoK3 is more toxic to cancer cells than to non-cancer cells, with the largest differences obtained for lung cancer cells (para. 3.3, pg. 128). Teixeira also discloses “Our data suggest that the efficacy of traditional cancer therapies could be improved if tumors were “metabolically sensitized” with a compound (p.e. MitoK3) that specifically affects on mitochondrial metabolism of cancer cells (through mitochondrial destabilization and/or by interference with mitochondrial redox processes) prior to treatment with ROS-based cancer therapies” (Introduction, pg. 124, r. column).
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Teixeira’s MitoK3compound (Left) Applicants Formula 1 (Right)
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the instant application, to administer a compound of MitoK3 for the treatment of cancer in a subject in need thereof because Teixeira disclosed MitoK3 displayed desirable results in treating lung cancer in a patient wherein the cancerous cells were targeted over the non-cancerous cells in lung cancers.
Examiner notes the limitations of a compound capable of binding to TRAP1 and competes with SB-TM2 and to a client binding site (CBS) of TRAP1 and inhibits binding between TRAP1 and a client protein would be inherent in a compound with the same structure See MPEP 2112.01.
A person of ordinary skill in the art would have been motivated to administer the compound of MitoK3 to a patient with cancer because Teixeira disclosed MitoK3 targeted lung cancer cells preferably over non-cancerous cells and that MitoK3 when administered as a co-therapy, improved the efficacy of traditional cancer therapies. Therefore, a skilled artisan would have had a reasonable expectation of success in treating a subject with cancer by administering an effective amount of a compound of MitoK3.
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 24-26 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-8 of U.S. Patent No. 12,545,695 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the compound of formula I of the instant claims used in a method of treating cancer or ocular disease would be obvious over the reference claims which discloses a derivative of formula 1 as compound of formula 3. Reference formula 3 is taught as treating neovascular ocular diseases of choroidal neovascular disease, retinal neovascular disease, subretinal neovascular disease, corneal neovascular disease, iris neovascular disease and neovascular glaucoma and diabetic retinopathy, retinopathy of prematurity, and retinal vein occlusion. Reference compound of formula 3 satisfies the structural limitations of the instant claims where
L is a (CH2)10 , and A is the subgroup
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Conclusion
All claims are rejected, no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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