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 .
Claim Status
Claim listing filed on July 7, 2025 is pending. Claims 13, 16, and 23-48 are canceled. Claims 1, 6-8, 12, and 20-21 are amended. Claims 1-12, 14-15, and 17-22 are examined upon their merits.
Information Disclosure Statement
The information disclosure statement filed on May 21, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections and Rejections
Applicant’s amendments to the specification have overcome all objections of record, and the specification objections are withdrawn.
The rejections of claims 1-6, 9-11, 14-15, and 17-22 under 35 U.S.C. 112(b) as being indefinite are withdrawn in view of applicant’s amendments. In particular, Claim 1 now recites wherein the administration of the UBE2N inhibitor results in a therapeutic effect which makes it clear that the method of treatment is not directed to a prophylactic effect.
The rejections of claims 1-12, 14-15, and 17-22 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement are withdrawn in view of applicant’s amendments. In particular, amended Claim 1 is now directed to a method of treating wherein treatment results in a therapeutic effect, not a prophylactic effect.
Claim Objections (Maintained)
Claim 6 is objected to because of the following informalities: The chemical name “1-(4-methylphenyl)-3-[(6-methyl-1H-benzimidazol- 2-yl) sulfanyl]prop-2-en-1-one” is still repeated twice in the list of UBE2N inhibitors. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (Maintained)
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.
Claims 7-8 and 12 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 7 still recites “decreases one or more markers of viability,” and “decreases” is on record as being indefinite due to relative terminology (MPEP § 2173.05(b)). Note, the amendment “relieves one or more symptoms” in Claim 7 overcomes the previous indefinite relative terminology. “Relieves” is not defined in the specification, and the broadest reasonable interpretation is that the UBE2N inhibitor eliminates the symptoms completely or lessens the severity of the symptoms wherein any change in severity (even a non-significant change) is encompassed by “relieves.” Claim 8 is rejected due to its dependence on Claim 7.
Claim 12 still recites “resensitizes” which is on record as being indefinite relative terminology (MPEP § 2173.05(b)). No clarifying amendments have been made to define the objective boundaries of “resensitizes.”
Claim Rejections - 35 USC § 103 (Maintained)
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 1-11, 14-15, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Starczynowski WO 2018/081361 (IDS 07/06/2023) and further in view of Smith WO 2018/081738 (IDS 07/06/2023). Note, both WO applications were published on May 3, 2018, and are not prior art exceptions.
Applicant's arguments filed July 7, 2025 have been fully considered but they are not persuasive.
Applicant argues that the rejection fails to make a prima facie case of obviousness because the references in combination fail to supply at least one element common to all of the claims in consideration. However, the applicant failed to distinctly and specifically point out the supposed errors in the Examiner’s action as is required in a complete response (MPEP § 714.02). Therefore, this argument does not warrant a complete response and is not persuasive.
Applicant argues that Starczynowski is silent about AML subtypes, and Smith is silent about UBE2N inhibitors. However, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references (MPEP § 2145.IV).
Applicant argues that the rejection implies that any type of AML responsive to IRAK4 or IRAK1 inhibitors should also be responsive to UBE2N inhibitors but the specification demonstrates that this is not the case. The specification does not teach any examples of therapeutically administering IRAK4 or IRAK1 inhibitors, so there is no evidence to support this argument.
Applicant argues that there are many factors involved in immune signaling and inhibition of one signaling cascade is not functionally equivalent to inhibition of another signaling cascade even if downstream components are shared among pathways. It is of record that IRAK inhibitors and UBE2N inhibitors effect the same signaling cascade (as shown in Smith Figure 12A). Smith further teaches that TRAF6 and IRAK1 are interacting proteins wherein phosphorylated IRAK1 binds to and activates TRAF6 resulting in NF-κB activation (paragraph [0055]; art cited solely to reply to Applicant’s argument and not as a new grounds of rejection). Therefore, IRAK1 inhibitors are understood to directly decrease activity of TRAF6 and NF-κB which is the same mechanism by which Starczynowski teaches that UBE2N inhibitors treat AML (of record). Therefore, the mechanistic connection between UBE2N and IRAK inhibitors is not between different complex signaling cascades but between three proteins in one signaling cascade that are known to directly interact with one another.
Applicant argues that the specification describes in vitro and in vivo experiments that support that the UBE2N inhibitors have therapeutic effects in the M4 and M5 AML subtypes wherein Starczynowski and Smith do not teach these experimental results. Applicant is reminded that absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. “Good science and useful contributions do not necessarily result in patentability.” PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007). MPEP § 2145. M4 and M5 AML subtypes are in reference to the standard French-American-British (FAB) classification system wherein AML is classified into eight subtypes (M0-M7). Because Starczynowski teaches administering UBE2N inhibitors to treat AML, there is an understanding that UBE2N inhibitors are likely to have a degree of therapeutic effect across the eight known AML subtypes. The mechanistic teachings of Smith demonstrate why UBE2N inhibitors are likely to have therapeutic effect in M4 and M5 AML subtypes specifically. The combined teachings of Starczynowski and Smith teach a degree of predictability that one of ordinary skill would have found to be reasonable.
Claims 1 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Starczynowski WO 2018/081361 (IDS 07/06/2023) in view of Smith WO 2018/081738 (IDS 07/06/2023) as applied to Claims 1-11, 14-15, and 17-22 above, and further in view of Guerra et al. Best Pract Res Clin Haematol. May 2019 (of record) as evidenced by Dana-Farber 2025 (of record).
Applicant's arguments filed July 7, 2025 have been fully considered but they are not persuasive. Applicant argues that the secondary references fail to cure the alleged defects in Starczynowski and Smith. The arguments directed to Starczynowski and Smith are addressed above, and the rejections are maintained.
Conclusion
No claim is allowed.
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 SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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