DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 11-24) in the reply filed on 7/6/2026 is acknowledged.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/6/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/7/2023 and 8/22/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 11 and 17 are objected to because of the following informalities:
On line 6 of claim 11, “form” should read “from” to correct a minor typographical error.
Claim 17 should end in a period
Appropriate correction is required.
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.
Claim(s) 11-15 and 17-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pennington et al. (US 2018/0117249; hereafter Pennington).
In regard to claim 11, Pennington discloses a method to reduce abnormal cell populations in a primate, the method comprising: inducing a hypoglycemic condition in a primate having abnormal cells within a target BGL range by way of infusion, controlled by a controller, of at least insulin (see par. [0052]-[0057], [0067], [0101], [0132]); monitoring vital signs of the primate with one or more sensors (320, 340; see par. [0101]) each of which monitor a physiological aspect of the primate including at least BGL and is in signal communication with the controller (see par. [0101] and [0103]); wherein the controller receives data inputs form the sensors and at least in part uses that input data to one of maintain the primate's BGL within a target hypoglycemic BGL range and alter the target hypoglycemic BGL range or lower threshold for the hypoglycemic BGL based on the received sensor data (see at least par. [0056]-[0057], [0094], [0096], and [0131]-[0133]); and, wherein abnormal cells cellular membranes are made more susceptible to the influx of orally or intravenously administered cocktail components by way of the hypoglycemic condition (see par. [0048]-[0053]).
In regard to claim 12, Pennington discloses wherein the abnormal cells are one of cancerous and senescent (see at least par. [0053]).
In regard to claim 13, Pennington discloses wherein the abnormal cells have more insulin receptors then normal cells (see at least par. [0051]).
In regard to claim 14, Pennington discloses wherein the abnormal cells have more transferrin receptors then normal cells (cancer cells have more transferrin receptors than normal cells).
In regard to claim 15, Pennington discloses wherein the sensor data is one of BGL, oxygen saturation, heart rate, blood pressure, galvanic skin response, temperature, EEG, ECG, and pupillary response (see Fig. 5; par. [0073], [0101], [0103], and [0109]).
In regard to claim 17, Pennington discloses wherein the cocktail is administered orally and includes at least, quercetin (and analogs thereof),and dasatinib (see par. [0184]-[0185] and [0256]).
In regard to claim 18, Pennington discloses wherein the cocktail is administered intravenously and contains at least one of quercetin, Cisplatine, Mitomycine, carboplatin, vinorelbine 5-FU, Gemcitabine, Docetaxel, Bee Propolis, plant alkaloids, antitumor antibiotics, antimetabolites, topoisomerase inhibitors, mitotic inhibitors, nitrosoureas , tocotrienols azithromycin, Sirolimus (Rapamycin), Nav-Gal and Navitoclax, Artemisia, hydrogen, oxyhydrogen, vitamin C, Curcuminoid, cannabinoids, y- Tocotrienols, romidepsin, zolinza (vorinostat), belinostat (also known as PXD101), farydak, panobinostat), ricolinostat (also known as ACY-1215) and citarinostat (also known as ACY-241) and anthracyclines (see par. [0256]-[0257]).
In regard to claim 19, Pennington discloses wherein the active agents in dasatinib is less than 50% the maximum tolerated dose (MTD) (see par. [0169]-[0170]).
In regard to claim 20, Pennington discloses wherein the active agents in dasatinib is less than 50% the minimum effective dose (MED) (see par. [0169]-[0170]).
In regard to claim 21, Pennington discloses wherein the active agents in the cocktail are less than 50% the minimum effective dose (MED) (see par. [0169]-[0170]).
In regard to claim 22, Pennington discloses wherein the active agents in the cocktail are less than 25% the minimum effective dose (MED) (see par. [0169]-[0170]).
In regard to claim 23, Pennington discloses the method further comprising the controller (710) raises BGL in the primate by way of infusion of at least glucose to maintain the target hypoglycemic BGL range for the primate (see par. [0125]).
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.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pennington in view of D’Agostino et al. (US 2015/0231172; hereafter D’Agostino).
As per claim 16, Pennnington fails to disclose wherein the one or more controllers control the administration of at least one of oxygen and hydrogen. D'Agostino discloses a cancer treatment system includes controlling the administration of at least one of oxygen and hydrogen (a method for treating cancer using a ketogenic diet while subjecting the patient to a hyperbaric oxygen enriched environment; figure 1; paragraphs [0012-0013]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controllers of Pennington to include controlling the oxygen level as in D'Agostino such that wherein the one or more controllers control the administration of at least one of oxygen and hydrogen. D'Agostino uses a method of lowering blood glucose levels similar to the Warburg method of Pennington, but also uses increased oxygen levels via a hyperbaric oxygen therapy as it helps contribute to cancer cell death via oxidative damage (D'Agostino; paragraphs [0012-0013]). As such using high levels of oxygen along with the Warburg method of Pennington would likely increase the effectiveness of cancer cell treatments in Pennington.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Pennington in view of Fleming et al. (US 5,871,769; hereafter Fleming).
In regard to claim 24, Pennington discloses the method further comprising the controller administers magnesium before or during administration of glucose.
In a similar art, Fleming teaches that administration of magnesium gluconate results in cellular resistance to oxygen free radical stress and free radical production, for example lipid peroxides and prostaglandins and glucose metabolism is altered by prostaglandins which participate with insulin in favoring the uptake of glucose into the skeletal muscle. Dietze G., et al., 1979, Adv. Exper. Med. Biol. 120A: 511-520. Thus diabetes mellitus is affected by the quantity and types of prostaglandins present. The insulin response to glucose in diabetes mellitus is improved by the administration of inhibitors of prostaglandin production. The preferred composition of the invention contains magnesium gluconate, desirably at a concentration of about 0.1 mM to about 1.5M.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Pennington with the administration of magnesium as taught by Fleming in order to improve the insulin response to glucose in patients.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
