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 .
DETAILED ACTION
This action is in response to a request for continued examination received July 18th, 2026.
Status of Claims
Claims 38 and 43-53 are pending in the instant application.
Claims 1-37 and 39-42 have been canceled.
Claims 50-53 stand withdrawn.
Election/Restriction
As noted in the final rejection mailed April 20th, 2026, Applicant elected in a reply received November 30th, 2025 in response to a restriction requirement mailed October 24th, 2025 without traverse Group I and a species election of a single species of a compound of formula I as
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Pursuant to this restriction requirement, Claims 50-53 stand withdrawn.
Terminal Disclaimer
The terminal disclaimer filed on July 18th, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted over U.S. Application No. 18/845,613 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
Applicant has traversed the rejection of Claims 38-49 under 35 U.S.C. 112(a). Applicant’s cancellation of Claims 39-42 renders the rejection thereof moot.
Applicant traverses the rejection based on their disclosure, exemplified in Example 1-14 of the instant disclosure, teaching the efficacy of berberine in treating tumors with low or no NNMT expression. While the examiner is persuaded that Applicant has sufficiently demonstrated enablement for the treatment of tumors with low or no expression of NNMT gene, it is noted that treatment of said tumors is not wholly distinct from the treatment of tumors defined by tissue classification, as tumors classified by traditional morphology classification may still encompass species thereof with low or no NNMT expression. This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 38-48 under 35 U.S.C. 102(a)(1). Applicant’s cancellation of Claims 39-42 renders the rejection thereof moot. This rejection is hereby withdrawn.
In accordance with the Terminal Disclaimer, as noted above, the provisional rejection of Claims 38-49 as being unpatentable over copending Application No. 18/845,613 are hereby withdrawn.
Applicant’s amendment is sufficient to overcome the provisional rejection of Claims 38-49 on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/862,584. Applicant’s cancellation of Claims 39-42 renders the rejection thereof moot. This rejection is hereby withdrawn.
Claim Objections
Claims 38 and 43 are objected to because of the following informalities:
Claim 38 presently reads “A method for treating tumor…” The examiner is interpreting this as “A method for treating a tumor.”
Similarly, at Claim 43, “wherein the tumor is human tumor” is interpreted as “wherein the tumor is a human tumor”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 38 and 43-49 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 38 recites the limitation "the tumor cell" in the seventh line of the claim. There is insufficient antecedent basis for this limitation in the claim, as the method is drawn to treating a tumor, not a tumor cell.
Additionally, Claim 38 recites the following species as a compound of formula I:
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Each of these six species possess a positively charged nitrogen, but are not charge-balanced with an anion. Compounds must be charge neutral.
Dependent Claims 43-49 do not correct this lack of antecedent basis, and therefore are also rendered indefinite.
Claim 43 is indefinite due to the recitation of the limitation “the expression comprises…” Claim 38, from which Claim 43 depends, recites “expression of NNMT gene”, and “expression of DNA methylase”, “expression of UHRF1”. Claim 43 is indefinite as to which expression is further limited by the aforementioned limitation.
Claim 49 recites the limitation "renal carcinoma cell comprises renal carcinoma Wilms cell". There is insufficient antecedent basis for this limitation in the claim, as Claim 48, from which Claim 49 depends recites “renal carcinoma” and “renal carcinoma Wilms”. This rejection can be overcome by amending the fifth line of the claim to read “the renal carcinoma comprises renal carcinoma Wilms”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 38 and 43-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et. al. (“Different mechanisms involved in the berberine-induced antiproliferation effects in triple-negative breast cancer cell lines”, Journal of Cellular Biochemistry, 2019; hereinafter referred to as Lin).
At the abstract, Lin teaches berberine (BBR) is known to be effective at inhibiting cell proliferation in various cancer cells.
Beginning at the Last Paragraph of Page 13535 through the First Paragraph at Page 13537, Lin teaches BBR was administered to the MDA-MB-453 cell line, and resulted in “significant cell growth inhibition”. Such inhibition is illustrated at Page 13542 at Figure 7(A).
Lin is silent with respect to the expression of NNMT gene in MDA-MB-453 cell line. At Page 46, Second Paragraph under Example 6, the instant specification identified MDA-MB-453 as a cell line with low expression of NNMT.
To emphasize, the prior art is silent with respect to the MDA-MB-453 cell line having low expression of NNMT gene. However, treating a tumor with low or no NNMT gene expression will inevitably flow from the teachings of Lin, since the same compound, berberine, is being administered to the same cell line that was later identified to have low or no NNMT expression. In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “low or no NNMT expression”, by practicing the method taught by Lin, administering berberine to treat a tumor, one will also be “treating a tumor with low no NNMT expression,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage in treating tumors with low or no NNMT expression of the method taught by the prior art.
MPEP 2112, I., states, “”[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Such is the case here. Applicant explains the relative effectiveness of administering berberine to the MDA-MB-453 cell line by identifying this cell line has low NNMT expression. Administering berberine to the MDA-MB-453 cell line, however, was already known to be effective in the prior art, as taught by Lin. Therefore, discovering why this cell line is more sensitive to treatment by administering berberine relative to other cell lines does not make this patentable over the prior art. In other words, Lin teaches administering berberine to inhibit the MDA-MB-453 cell line, and doing so reads on the instant Claims 38 and 43-47.
Conclusion
Claims 38 and 43-49 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624
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