DETAILED ACTION
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 .
Applicants' arguments, filed September 9, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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, 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 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.
Claim(s) 1 – 3, 6 and 12 – 19 were rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT05436652 (NCT’652; Version 3, dated September 21, 2022, cited on IDS) in view of Katz (US 2021/0393622). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed June 12, 2026 and those set forth herein.
Applicants traverse this rejection on the grounds that NTC’652 fails to teach or suggest no more than about 6 mg of clofutriben as recited in claim 1. Although Katz recites 20 and 30 mg among numerous exemplary prednisolone doses and separately identifies 6 mg as a possible dose of an HSD1 inhibitor, the selection of a fixed dose combination to exhibit reduced toxicity compared to prednisolone alone is not disclosed or identified. NTC’652 also does not disclose the SPI-62 dose and reports no toxicity outcome. The Examiner’s routine optimization rationale does not address the claimed invention as a whole and no evidence has been identified that the amount of prednisolone administrations with clofutriben was recognized as a results effective variable for simultaneously maintaining therapeutic efficacy and reducing toxicity relative to prednisolone alone. No reasonable expectation of success has been explained for arriving at the presently claimed range from the references’ broader disclosures to obtain the claimed comparative toxicity profile. The reported clinical results reported further rebut the predictability or inevitable consequence of combining these two drugs and arriving at the claimed efficacy and toxicity profile.
These arguments are unpersuasive. The combination of the two drugs is present in the clinical trial and at least overlapping dosage ranges are disclosed by the applied prior art. One of ordinary skill in the art would routinely optimize the dosages within those disclosed ranges. The rationale used in an obviousness rejection need not be the same as Applicants (see MPEP 2144(IV)) so explicit optimization of dosages to arrive at the claimed lowered toxicity for a combination of drugs taught in the prior art compared to prednisolone alone is not required to render the claimed amounts prima facie obvious. Please see MPEP 716.02 et seq. for a complete discussion of unexpected results. Amongst the topics discussed therein that the comparison should be with the closest prior art; Applicants bear the burden of explaining the evidence proffered in support of unexpected results, which includes what the expected results would be; and the evidence should be reasonably commensurate in scope with the claims. ¶ [0120] of the specification as filed states that cohorts 3 and 4 (in which the subject were given 20 or 30 mg of prednisolone with 6 mg of clofutriben) “demonstrated that doubling of the prednisolone dosage given with clofutriben (SPI-62) provides similar efficacy as prednisolone 10 mg, while maintaining the safety advantage over prednisolone itself” (emphasis added). This statement appears to suggest that the combination of 10, 20 or 30 mg prednisolone with 6 mg of clofutriben all behaved in a similar manner, which is not one what would expect for unexpected results relating to the claimed prednisolone dosage range of about 20 to about 150 mg of prednisolone as 10 mg falls outside this range. These results also do not address lower dosages of clofutriben (e.g., the about 1.2 or about 3 mg of claims 32 and 6). Therefore the evidence in the specification does not outweigh the prima facie case of obviousness.
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.
Applicants traverse the nonstatutory double patenting rejections on much the same grounds as discussed above, that none claim a fixed dose combination as claimed with reduced toxicity and 10 mg of prednisolone is outside the claimed range.
These arguments are unpersuasive. US’412 and US’242 claim broader ranges for the amounts of prednisolone that encompass amounts greater than 10 mg. The remaining rejections rely on Katz that as discussed previously and above discloses at least 20 mg and 30 mg doses of prednisolone that are sufficient to render obvious the range of amended claim 1. The evidence of unexpected results does not outweigh the prima facie case of obviousness as discussed above.
Claims 1 – 3, 6, 12 – 20 and 22 – 29 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of U.S. Patent No. 12,220,412. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed June 12, 2026 and those set forth herein.
Claims 1 – 3, 6, 12 – 20, 22 25, 28 and 29 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 9, 11 – 13, 15, 16, 25 – 27, 29, 32, 34, 36, 38, 39 and 47- 49 of copending Application No. 18/980,242 (reference application). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed June 12, 2026 and those set forth herein.
Claims 1 – 3, 6, 12 – 20, 22 25, 28 and 29 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 29 of U.S. Patent No. 12,734,155 as evidenced by Hwang et al. (Diabetes Metab Res Rev. 2014) in view of Katz (US 2021/0393622). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed June 12, 2026 and those set forth herein.
Note that since the mailing of the previous Office Action on June 12, 2026, Application No. 19/446,115 issued as U.S. Patent No. 12,734,155 on September 15, 2026. Therefore the provisional nonstatutory double patenting rejection is now a non-provisional nonstatutory double patenting rejection based on the issued patent.
Claims 1 – 3, 6, 12 – 20, 22 – 25, 28 and 29 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 18 of copending Application No. 19/446,127 as evidenced by Hwang et al. (Diabetes Metab Res Rev. 2014) in view of Katz (US 2021/0393622). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed June 12, 2026 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 3, 6, 12 – 20 and 22 – 29 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 70 - 89 of copending Application No. 19/209,346 as evidenced by Hwang et al. (Diabetes Metab Res Rev. 2014) in view of Katz (US 2021/0393622). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed June 12, 2026 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 3, 6, 12 – 20 and 22 – 29 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 25 of copending Application No. 19/446,144 as evidenced by Hwang et al. (Diabetes Metab Res Rev. 2014) in view of Katz (US 2021/0393622). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed June 12, 2026 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 3, 6, 12 – 20 and 22 – 29 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19/446,148 as evidenced by Hwang et al. (Diabetes Metab Res Rev. 2014) in view of Katz (US 2021/0393622). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed June 12, 2026 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
