DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment and Rebuttal Arguments
2. The amendments to the claims and rebuttal arguments filed on February 11, 2026 have been fully considered. The 35 USC 102 rejections over Noemi Cowan et al. and Kralova et al. are withdrawn.
3. The objections to claims 16, 18, 20, 22 and 23 are withdrawn.
4. New grounds of rejection are set forth in this office action.
Claim Rejections - 35 USC § 102
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.
5. Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shikiya et al. The reference has a publication date of 1990 which antedates the present claims having an effective filing date of February 13, 2019.
The reference teaches the treatment of strongyloidiasis with mebendazole and thiabendazole – claim 6. The treatment comprised of oral administration of mebendazole thrice daily for 5 days and then mebendazole twice daily for 9 days – separate and sequential administration as set forth in claim 14.
6. Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jisieike-Onuigbo et al. The reference has a publication date of 2011 which antedates the present claims having an effective filing date of February 13, 2019.
The reference teaches the treatment of infection with ciprofloxacin and mebendazole– claim 6. The treatment comprised of oral administration of mebendazole and ciprofloxacin – simultaneous and concurrent administration as set forth in claim 14.
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.
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.
7. Claim(s) 6, 8, 10, 11 and 13-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pantziarka et al. as applied to claims 6, 8, 10, 11 and 13-23 above, and further in view of CYP1A2.
Determining the scope and contents of the prior art
Patziarka et al. teaches the treatment of cancer by administration of mebendazole with cimetidine. The administration is sequential. The reference suggests possible synergies and that cimetidine increases mebendazole plasma levels.
Ascertaining the differences between the prior art and the claims at issue
The difference between the prior art and the present claims is that cimetidine is not claimed as a moderate or strong CYP1A2 inhibitor.
Resolving the level of ordinary skill in the pertinent art -considering objective evidence present in the application indicating obviousness
MPEP 2143 B provides basic requirements of prima facie case of obviousness including examples of rationale of the simple substitution of one known element for another to obtain predictable results. To reject a claim based on this rationale the following is considered below and applied to the present claims:
A finding that the prior art method differs from claimed method by the substitution of some component with another component
Patziarka et al. does not teach the combination of a moderate or strong CYP1A2 inhibitor with mebendazole for treatment. The prior art differs from the claims by substitution of one CYP1A2 inhibitor for another.
A finding that the substituted components and their functions were known in the art
CYP1A2 teaches various CYP1A2 inhibitors, of which various are within the scope of the present claims. For example, the reference cites ciprofloxacin, fluvoxamine, methoxsalen.
a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable
One of ordinary skill has the knowledge CYP1A2 inhibitors increases mebendazole plasma levels and provides possible synergies in the treatment of cancer. One of ordinary skill can substitute one known element for another, with results from substitution being predictable.
Regarding claims 14, 15, 17, 19 , 21, 23 the reference of Patziarka et al. teaches the sequential dosing of cimetidine followed by mebendazole.
For these reasons, the present claims are found to be prima facie obvious over the prior art.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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