DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 11 May 2026 in which claim 12 was canceled, and claim 1 was amended to change the scope and breadth of the claims.
Claims 1-11 and 13-17 are pending in the current application and are examined on the merits herein.
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 .
Withdrawn Rejections
Applicant’s amendment, filed 11 May 2026, with respect to the rejection of claims 1-6 and 9-17 under 35 U.S.C. § 102(a)(1)/(a)(2), as being anticipated by Ohta et al. as evidenced by Ruike et al., has been fully considered and is persuasive.
Claim 1 has been amended to recite “wherein the compound represented by the General Formula (I) or the pharmaceutically acceptable salt thereof is administered at a dosage that results in a blood concentration of 30 µM or more”.
While Ohta et al. teach administering 20 mg/kg SQAP in Example VI, as well as an overall range of suitable doses, Ohta et al. do not expressly disclose administering SQAP in combination with an anti-cancer agent, wherein the SQAP is administered at a dosage that results in a blood concentration of 30 µM or more in the patient.
The rejection is hereby withdrawn.
Claim Objections
Claim(s) 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 11 May 2026 have been fully considered but they are not persuasive.
Applicant contends the data presented in the Specification show a particularly significant inhibitory effect was observed when the compound of General Formula (I) was administered at a dosage of 30 µM. Applicant argues this effect was found when the compound was administered together with doxorubicin.
The data presented in the Specification has been considered, but they do not appear to be commensurate in scope with the present claims. The examples are drawn towards combinations of SQAP (a compound that reads on General Formula (I)) with mitomycin C, doxorubicin, bleomycin, cisplatin, camptothecin, etoposide, taxol, and methyl methanesulfonate (MMS). However, Applicant’s examples drawn towards a combination of 30 µM SQAP, are limited to a combination with mitomycin C and doxorubicin. The present claims are drawn towards a combination of 30 µM SQAP and any anti-cancer agent.
See MPEP 716.02(d), “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.".
It is also noted the data presented in Table 2 is unreadable (the front is light gray, too small and blurry).
The rejection is hereby maintained.
Modified Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 11 May 2026, where the limitation in pending claim 1 as amended now have been changed. Therefore, rejections from the previous Office Action, dated 10 February 2026, have been modified and are listed below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 9-11 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ohta et al. (US Patent No. 7,973,145, cited in previous Office Action) in view of Kawakubo et al. (Bioscience, Biotechnology, and Biochemistry, 2021, vol. 85, no. 1, pp. 85-91, cited in previous Office Action) and further in view of Deb et al. (The Journal of Urology, 2011, vol. 186, pp. 2426-2433, cited in previous Office Action).
Ohta et al. disclose sulfoquinovosylacyl propanediol (SQAP) of formula (I) for treating tumors:
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, wherein R1 is an acyl residue of a fatty acid with 1-26 carbon atoms, Y is a number of 1, 2 or 3, M represents a hydrogen ion or a metal ion having a positive charge (abstract; claim 1 and 3). Exemplified salt forms include calcium and sodium (claims 4-6). Ohta et al. teach SQAP functions as a radiosensitizer, an antineoplastic agent or antitumor agent (claims 8 and 9). As a radiosensitizer, it may be combined with other radiosensitizers, antitumor agent, or other substance having pharmacological activity (col. 20:1-9). The composition may be administered to treat a human, a dog or a cat (col.22:9-16). Cancers that can be treated include prostate cancer (i.e. a solid tumor), as well as melanoma and lymphoma (col.19:52-65). Ohta et al. exemplify where R1 is a stearoyl group (example 1). The compound is administered at a dose of 0.001 to 100 mg/kg body weight via oral administration, 0.001 to 50 mg/kg body weight via injection, from 0.001 to 100 mg/kg body weight via transdermal administration, 0.001 to 50 mg/kg body weight via rectal administration, or about 0.001 to 3 wt.% solution via ocular instillation (col.20:54-61). Ohta et al. disclose an example of administering 2 mg/kg of the drug (example V-1; and other examples). They were also administered radiation treatment at a dose of 2 Gy on Day 1 and Day 4. Radiation is given over a period of one week to 6 months (col.21:1-17). Ohta et al. compare the properties of AQAP with 2mg/kg mitomycin C, wherein the mitomycin C serves as a positive control group (example VII-2).
Ohta et al. do not expressly disclose “wherein the compound…is administered at a dosage that results in a blood concentration of 30 µM or more (present claim 1). Ohta et al. do not expressly disclose wherein the anti-cancer agent is a DNA damaging agent (present claim 7).
Kawakubo et al. teach
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, which reads on the compound of formula (I), wherein R1 is a stearoyl group, herein after referred to as SQAP (p.86, fig. 1). They report SQAP is a radiosensitizing agent that makes tumor cells more sensitive to radiation therapy (abstract). They found SQAP induced the degradation of hypoxia-inducible factor-1α and then decreased the expression of histone deacetylase (HDAC1). Kawakubo et al. note HDAC inhibitors, such as sodium butyrate and trichostatin A (TSA), enhance the sensitivity of cancer cells to ionizing radiation (p.86, third para). HDAC inhibitors are useful in anticancer therapy because of their ability to inhibit angiogenesis, and HDACs have been shown to be upregulated in response to hypoxia (p.86, fourth para).
Deb et al. teach mitomycin C is a known DNA damaging agent, and valproic acid is a known histone deacetylate (HDAC) inhibitor (abstract). Deb et al. found the combination of mitomycin C with valproic acid appeared to synergistically treat human bladder cancer compared to each drug alone (abstract). The HDAC inhibitor potentiated the induction of cell death by mitomycin C in multiple bladder cancer cells (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer SQAP in doses ranging from 0.001 to 100 mg/kg body, including 20 mg/kg body weight, wherein the SQAP is administered in combination with an anti-cancer agent.
The skilled artisan would have been motivated to administer SQAP in doses ranging from 0.001 to 100 mg/kg body, including 20 mg/kg body weight, wherein the SQAP is administered in combination with an anti-cancer agent, because Ohta et al. expressly exemplify administering 20 mg/kg body weight of SQAP, and teach it can broadly be administered at a dose ranging from 0.001 to 100 mg/kg body weight. Furthermore, Ohta et al. teach it can be administered in combination with an antitumor agent, and radiation treatment.
Combining known therapies into a single therapy is a commonly applied method for identifying improved therapeutic outcomes with minimal adverse effect for the patient because each monotherapy is already known to be effective. Here, SPAQ functions as a radiosensitizing agent that can be used to treat a variety of cancers including in combination with radiation treatment, and a DNA damaging agent. Thus, the skilled artisan would have been motivated to combine the two drugs wherein they each produce different effects for the treatment of cancer. And, Ohta et al. teach SPAQ may be combined with additional radiosensitizing agents or antitumor agent.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
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 1-7, 9-11 and 13-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,440,505 in view of Kawakubo et al. (cited above) and further in view of Deb et al. (cited above).
The reference Patent is drawn towards administered the same SPAQ compound to treat cancer, including melanoma, adenocarcinoma, or squamous cell carcinoma at a dose of 0.5 mg/kg or more. Radiation is applied at a dose of 10 Gy or more after administering the SPAQ.
The reference Patent do not expressly disclose administering a DNA damaging agent (present claim 7).
Kawabuko et al. and Deb et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer SQAP in combination with mitomycin C to treat cancer.
According to MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Combining known therapies into a single therapy is a commonly applied method for identifying improved therapeutic outcomes with minimal adverse effect for the patient because each monotherapy is already known to be effective. Here, SPAQ functions as a radiosensitizing agent that can be used to treat a variety of cancers including in combination with radiation treatment, and a DNA damaging agent. Thus, the skilled artisan would have been motivated to combine the two drugs wherein they each produce different effects for the treatment of cancer.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Response to Arguments
Applicant's arguments filed 19 June 2024 have been fully considered but they are not persuasive.
Applicant has requested that the provisional rejections be held in abeyance until patentable subject matter is identified.
The obviousness double patenting rejections are hereby maintained.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
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