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 the Claims
Per Applicant’s amendment to the claims, submitted on 07/06/2026, claims 1, 7-8, 13-16, and 18-19 are amended, claims 9 and 11 are canceled, and claims are newly added. Currently, claims 1-8, 10, 12-22 are pending in the instant application.
Claim Interpretation - Withdrawn
Interpretation of claim 8 under 35 USC 112(f):
In light of Applicant’s amendment to the claims, the requirement for claim interpretation is hereby withdrawn. Claim 8 has been amended to remove the term “step”.
Claim Rejections - 35 USC § 112 Second Paragraph – Withdrawn
Rejections of claims 1, 8, and 15:
In light pf Applicant’s amendments to the claims, the rejections are hereby withdrawn. Claims 1, 8, and 15 have been amended to remove the previously indicated indefinite language.
Claim Rejections - 35 USC § 112 Second Paragraph – Maintained
Rejections of claims 12-14 and 16:
Applicant’s amendment to the claims is not sufficient to overcome the rejections. The rejections of claims 12-14 and 16 are hereby maintained.
With regards to claim 12, the dependency for the claim has been shifted to the method claim of 18, however this does not ameliorate the indefiniteness of the claim. The claim as currently recited remains drawn to an intended use of a composition, and does not further limit the material process of claim 18 or the composition used in said process.
With regards to claim 13, the dependency for the claim has been shifted to the method claim of 18, however this does not ameliorate the indefiniteness of the claim for the same reasons as claim 12. As the instant claim appears to be drawn towards subtypes of cancer being treated, this rejection may be overcome by amending claim 13 to further limit the “cancer” recited in claim 18 rather than the medicament used.
With regards to claim 14, the dependency for the claim has been shifted to the method claim of 18, however this does not ameliorate the indefiniteness of the claim. The claim as currently recited remains drawn to an intended use of a composition, and does not further limit the material process of claim 18 or the composition used in said process.
With regards to claim 16, the dependency for the claim has been shifted to the method claim of 18, however this does not ameliorate the indefiniteness of the claim. The claim as currently recited remains drawn to an intended use of a composition, and does not further limit the material process of claim 18 or the composition used in said process.
Claim Rejections - 35 USC § 112 – New Grounds of Rejection
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 15, 21-22 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 15 is indefinite for reciting “for treating cancer, and/or for preventing cancer metastasis, and/or for preventing cancer recurrence, and/or for decreasing resistance to the additional therapy b) in a subject”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. The instant claim is drawn to a material product comprising two components, namely a compound of claim 1 and an additional therapy, wherein said therapy is immunotherapy, chemotherapy and /or radiotherapy. Because the instant claim is drawn to such a material product, the indicated recitation is considered as not further limiting because it is directed towards an intended use or result of the combination.
Claim 21 is indefinite for reciting “wherein the subject is a human suffering from a cancer and resistant to chemotherapy”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. Claim 15 to which to the instant claim depends upon, is drawn to a composition of matter (i.e., a “product”).
Claim 22 is indefinite for reciting “wherein the cancer is selected from [each of the recited cancers]”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. Claim 10 to which the instant claim depends upon is drawn to a composition of matter (i.e., a medicament comprising a compound of claim 1). Claim 10 provides no mention of cancer, and accordingly, the instant claim provides improper antecedence to said claim.
Claim Rejections - 35 USC § 103 – Maintained
Rejections of claims 1-8, 10, 15, and 17-19:
Applicant’s arguments are not persuasive. Accordingly, the rejections are hereby maintained. Applicant puts forth two general arguments in support of the instant claims being non-obvious over Chen (previously referenced) and Mai (previously referenced):
The combination of Chen and Mai do not teach or suggest compounds of claim 1
The compounds of the instant invention provide unexpected results over narasin and salinomycin derivatives
With regards to element (i), Applicant contends that neither Chen nor Mai address the core problem to be solved by the instant invention. Namely, the treatment and/or prevention of resistant cancer. However, this argument is not aligned with the scope of the claims. Specifically, claims 17-19 each recite a method for treating or preventing “a cancer”. While the teachings of Chen are directed towards breast cancer cells and Mai is directed towards cancer stem cells, each individually and when combined, falls within the breadth of the claims. Applicant further indicates that one of ordinary skill in the art would not have been motivated to apply the C20 amination of salinomycin to the structure of narasin due to conformational differences between the two compounds. More specifically, that the cited work of Antoszczak (Eur. J. Med, Chem. 166, 48-64, 2019) viewed through the lens of Rodriguez (2022) indicates that the additional methyl group at the C4 position on narasin alters the conformation of the compound itself and its derivatives, compared to salinomycin (Remarks page 12). While Examiner does not explicitly deny Applicant’s supposition with regards to the cited works, Rodriguez cannot be used as a reference to rebut the rejection because the work itself was published after the effective filing date of the instant application, and therefore would not have been available at the time of invention.
With regards to element (ii), Applicant purports to have demonstrated unexpected results over narasin and salinomycin analogs. In support of said results, Applicant references experimental data found in Rodriguez (J. Am. Chem. Soc. 2022, 144, 11536-11545). While the data and general contents of the Rodriguez reference are not contested, it cannot be used as a rebuttal to the outstanding rejection or evidence of unexpected results. Firstly, Rodriguez appears to have been published after the earliest effective filing date of the instant application. Secondly, Rodriguez does not appear to have been previously disclosed (see IDS). Thirdly, no evidence of unexpected results was provided in the initial submission of the specification. The data relied upon by Applicant to support the argument regarding unexpected results are tied to the Rodriguez reference rather than any experimental data previously disclosed. Due to the aforementioned reasons, the Rodriguez reference cannot be accepted as evidence against the outstanding rejections. Accordingly, the rejections are hereby maintained.
Applicant, if desired, is permitted to submit supplementary data for consideration through the submission of a Declaration/Affidavit traversing the rejections. Currently, the Rodriguez reference cannot be considered due to the above reasons, but also because the relationship between said reference and the instant application is unclear, outside of partially shared authorship. As the instant Office Action will be considered final, any further submissions traversing the outstanding rejections must be provided alongside a Request for Continued Examination.
Claim Rejections - 35 USC § 103 – New Grounds of Rejection
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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (previously referenced) in view of Mai (previously referenced).
Claim 20 further limits claim 1 wherein R1 and R2 are different.
As iterated in the rejection of claim 1, Mai teaches a moiety NR1R2 wherein R1 is H and R2 is C3 alkynyl. As the corresponding R groups are different from one another, the instant claim is obvious for the same reasons as claim 1.
Conclusion
Claims 1-8, 10, and 12-22 are rejected.
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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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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