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 .
Status of Claims and Response to Amendments
The amendments filed March 20, 2026 have been acknowledged and entered. Claims 10-18 and 21-32 are pending.
Election/Restriction
The present examination is based on Applicant’s election without traverse of Group II (presently claims 10-18 and 21-32) and the species of cancer corresponding to myeloma in the reply filed on November 6, 2025.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Claim Objections
Claims 11-18 and 21-22 are 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.
The statement of reasons for indicating allowable subject matter are provided below.
Maintained Rejections
Claim Rejections - 35 USC § 103
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over by Durusu et al. (Leukemia Research 2017, 55, 33-40)(hereinafter “Durusu”).
The reasons for this rejection were set forth in the previous Office Action mailed December 22, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed March 20, 2026 have been fully considered but they are not persuasive.
Applicant argues the cell line studied in Durusu teaches a specific multiple myeloma cell line,
U266, has a missense mutation on the TP53 gene in conjunction with a deletion of the
chromosome l 7p allele, resulting in loss of wild-type p53 function. Thus, not only are the
findings of Durusu applicable only to a subpopulation of multiple myeloma (i.e. those patients
harboring a TP53 mutation and a deletion of chromosome 17) and therefore cannot replicate the
dynamics of mono- versus biallelic subclone populations, but the findings of Durusu also cannot
recapitulate multiple myeloma with different and/or co-occurring mutations (i.e. multiple
myeloma that results from mutations in KRAS, etc.). Even more importantly, Durusu cannot model multiple myeloma that has become drug-resistant as provided in the pending claims (pages 8-9 of remarks)
These arguments are not found persuasive for the reason that the cell line studied by Durusu is a myeloma cell line and is intended to be a model system of the disease. A person of ordinary skill in the art can appreciate that model systems are meant to simulate a given disease and do not necessary represent all possible forms of a disease. In the present case, the fact that clofazimine has an anticancer effect in a myeloma cell line would have provided motivation to attempt to use the compound in a method of treating myeloma. As per drug resistance, Durusu teaches drug resistance remains the major cause of mortality in myeloma, that clofazimine has been previously shown to inhibit a Multi Drug Resistance Protein, and that there is evidence that clofazimine has therapeutic potential in drug resistant malignancies (page 39, discussion). The combined teachings that clofazimine has anticancer activity in myeloma, drug resistance is a problem in myeloma, and that clofazimine has therapeutic potential in drug resistant malignancies would have provided motivation to one of ordinary skill in the art to treat a drug-resistant myeloma as is claimed. Moreover, the evidence that clofazimine has an anticancer effect in myeloma in combination with the knowledge in the art that clofazimine has therapeutic potential in drug resistant malignancies would have provided the person of ordinary skill in the art with a reasonable expectation of success. Examiner thus respectfully disagrees with Applicant’s argument that Durusu does not teach or suggest the pending claim limitations and also does not provide a suggestion or motivation with any expectation of success to a person of ordinary skill in the art to develop a method of treating a drug-resistant multiple myeloma in a subject, as claimed.
The rejection is still deemed proper and thus maintained.
Allowable Subject Matter
Claims 11-18 and 21-22 are objected to but otherwise allowable as indicated above.
Claims 23-32 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Applicant’s arguments that a person of ordinary skill in the art would appreciate that the combination of drugs is not predictable a priori from either single-agent data or a combination regime with different drugs (page 9 of remarks) is found persuasive. In view of Durusu, it would not have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to combine clofazimine with a proteasome inhibitor or an immunomodulatory drug to treat drug-resistant myeloma as is claimed, or to use clofazimine to treat myeloma resistant to proteasome inhibitor(s) or immunomodulatory drugs as is claimed.
Conclusion
Claim 10 is rejected. Objection is made to claims 11-18 and 21-22. Claims 23-32 are 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.
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April 8, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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