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 .
Applicant's response to the previous Office action, dated February 12, 2026, has been received. By way of this submission, Applicant has amended claim 1.
Claims 1-3, 5-8, 11-12, 14-15, 17-18, 22, 25-26, 35-37, 49-50, 53-55, 58-60, and 70-72 are pending in the application. Claims 2-3, 5, 14-15, 17-18, 36-37, 58-60, and 70-72 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed July 25, 2024.
Claims 1, 6-8, 11-12, 22, 25-26, 35, 49-50, and 53-55 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated September 12, 2025.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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. 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.
Claims 1, 6-8, 11-12, 22, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Allen (US20170100370A1) in view of Callens (J Exp Med. 2010 Apr 12;207(4):731-50).
Applicant argues that the method taught by Allen requires large doses of intravenous ascorbate, well in excess of what is recited in the claims as amended, and that Allen teaches that oral ascorbate is unable to reach therapeutic plasma levels, and is therefore not suitable as an anti-cancer agent. Applicant further argues that Allen and Callens are technically incompatible with each other, as Callens teaches that chemotherapy is unsuitable for the treatment of myeloid leukemia. Applicant asserts that the teachings of Allen are drawn to combinations of ascorbate and EDTA, which relies on a pro-oxidant mechanism to enhance cytotoxicity via oxidative stress, whereas Callens teaches a protective approach, in which vitamin D3 and iron-chelating agents act synergistically to induce cellular differentiation rather than pro-oxidant cytotoxicity.
Applicant's arguments have been considered fully but are not found to be persuasive.
Claim 1 as amended recites the limitation of "optionally, at least one antioxidant, vitamin, or essential mineral". The administration of vitamins such as Vitamin C is still optional. Applicant's amendment to the claims has not changed this limitation. The amended clause of claim 1 recites "...provided that if vitamin C is administered, it is orally administered at a dose of no more than 50 grams in a single day." (emphasis added). If vitamin C is not administered, this clause does not limit the method at all.
Callens teaches that chemotherapy is the traditional method of treating AML, though Callens also acknowledges the limitations of this therapy (page 733, left column, second paragraph). Callens also teaches that iron chelators may act as either pro- or anti-oxidants (page 738, left column, second and third paragraph). Callens also teaches that iron chelators have also been proposed for several years as an alternative anti-cancer therapy and effectively induce cell growth arrest and apoptosis in cancer cells in vitro and in vivo (page 734, right column).
Callens is relied upon in teaching that both chemotherapy and iron chelation are known for treatment of AML. Callens does not draw conclusions as to how ascorbate may impact AML treatment. It is noted that Applicant's specification does not provide any suggestions as to the mechanism of how metal chelation may influence chemotherapy, nor how the addition of broadly any antioxidant, vitamin, or essential mineral to such a combination may further provide a synergistic benefit.
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). MPEP 2123. Applicant's argument that Callens is not compatible with Allen is based upon an unreasonably narrow reading of Callens.
It is also noted that previous treatments with chemotherapy prior to administration with a metal chelator are within the scope of the claims (see instant claim 22).
This rejection is therefore maintained.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Allen and Callens as applied to claim 1 above, and further in view of Fridle (Leuk Lymphoma. 2017 May;58(5):1068-1075).
Applicant argues that the teachings of Fridle do not overcome the alleged deficiencies of Allen and Callens. This is not found persuasive, for reasons described supra.
This rejection is therefore maintained.
Claims 49-50 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Allen and Callens as applied to claim 1 above, and further in view of Huff (Int J Occup Environ Health. 2007; 13(2):202-212).
Applicant argues that the teachings of Huff do not overcome the alleged deficiencies of Allen and Callens. This is not found persuasive, for reasons described supra.
This rejection is therefore maintained.
Claims 54 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Allen and Callens as applied to claim 1 above, and further in view of Wolf (Arch Biochem Biophys. 2007 Feb 1;458(1):24-32).
Applicant argues that the teachings of Wolf do not overcome the alleged deficiencies of Allen and Callens. This is not found persuasive, for reasons described supra.
This rejection is therefore 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 PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER JOHANSEN/Examiner, Art Unit 1644