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 .
Information Disclosure Statement
The submitted information disclosure statement (IDS) were filed on 02/06/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Restriction
Applicants' election without traverse of Group I (Claims 1-15) in the reply filed on 06/01/2026 is acknowledged. The restriction is therefore made FINAL. Claims 1-15 of Group I are examined in this office action.
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.
Claim 9 is 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 9 is indefinite because it recites: “Table 1”, wherein Table 1 is only recited in the specification. A claim must be complete in itself and clear regarding its boundaries. For examining purposes, examiner will assume that claim 9 includes Human Medications, Human food, Household toxicants, insecticides or rodenticides . 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.
(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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stang (US 20140154334Al).
Claim 1,
Stang teaches a method of treating or preventing a gastrointestinal disorder comprising administering to a subject in need thereof an edible toxin-decontaminant product comprising a
plurality of ingredients said plurality comprising an effective amount of activated charcoal. (Claim 1, pg. 12).
With regard to claims 2-3,
Stang teaches Activated charcoal or AST-120, which is highly adsorptive, spherical carbon microspheres or combinations thereof. In certain embodiments, the sorbent of the invention is activated charcoal. (0045). (AST-120, commonly known by the brand name Kremezin, is an oral spherical activated carbon adsorbent used in medicine, which can be understood as 100% spherical activated charcoal. (Su et al., Efficacy of AST-120 for Patients With Chronic Kidney Disease: A Network Meta-Analysis of Randomized Controlled Trials. Front Pharmacol. 2021 Jul 26).
With regard to claims 4-5,
Stang teaches the term "pharmaceutically acceptable" means approved by a regulatory agency of the Federal or a state government or listed in the U.S. Pharmacopeia or other generally recognized pharmacopeia for use in animals, and more particularly in humans. (0041).
With regard to claim 6,
Stang teaches the invention encompasses an edible, toxin-decontaminant product that contains a therapeutically or prophylactically effective amount of activated charcoal and one or more second active agents, which is useful in mitigating, substantially reducing, or causing the cessation of at least one adverse effect in a subject associated with the ingestion of a toxic or poisonous substance or the ingestion of a substance causing illness. (0027).
With regard to claims 7-9,
Stang teaches the symptoms of poison or toxin ingestion. (0159) including diarrhea (0137), intestinal gas (0138), abdominal/enteric sepsis (0139), peptic ulcer (0140), gastritis (0141), reflux esophagitis (0142), gingivitis (0145); evidential information of poisonous substances including bleach, detergent, floor cleaner, furniture polish; cosmetics (e.g., nail polish, nail polish remover, make-up), perfumes, plants, pesticides (e.g., bug killers, weed killers, lawn products), prescription or non-prescription drugs (0042); or behavioral information including bad breath (0144), gastric upset or dizziness (0041), emesis or increased heart rate (0044).
With regard to claim 10,
Stang teaches the activated charcoal is administered at the site at which the poisoning incident occurs, which in most cases is the victim's home, immediately following the discovery of the accidental or purposeful ingestion, before the ingested toxins have had the opportunity to be
extensively absorbed into the bloodstream. (0122). The term "prophylactically effective" refers to an amount of activated charcoal capable of mitigating or substantially reducing adverse effects associated with the ingestion of a toxin or poison. The edible product of the invention is administered as a preventative measure to a subject, preferably a human, who potentially ingested a toxin or poison. (0044).
With regard to claims 11-12,
Stang teaches "edible product" refers to an edible composition of the invention containing a therapeutically or prophylactically effective amount of activated charcoal. Examples of illustrative embodiments of the edible product include, but are not limited to, breads, cakes, muffins, pastries, or cookies containing a therapeutically or prophylactically effective amount
of activated charcoal. (0033).
With regard to claim 13,
Stang teaches it is desirable to administer the edible product of the invention locally to the gastrointestinal tract of the subject. This may be achieved, for example, and not by way of limitation, by oral administration, (0152), which can include gavage or tubing gavage (tube feeding or stomach tubing) because it is a method of delivering a substance directly into the gastrointestinal tract through the mouth.
With regard to claims 14-15,
Stang teaches an amount of activated charcoal able to ameliorate or substantially reduce of at least one adverse effect associated with the ingestion of a toxin or poison, or at least one discernible symptom thereof. "Therapeutically effective" also refers to an amount of activated charcoal to result in an amelioration of at least one measurable physical parameter, not necessarily discernible by the patient. In yet another embodiment, the term "therapeutically effective" refers to an amount of an activated charcoal to inhibit the progression of at least one
adverse effect, either physically (e.g., stabilization of a discernible symptom), physiologically (e.g., stabilization of a physical parameter), or both. In yet another embodiment, the term "therapeutically effective" refers to an amount of activated charcoal resulting in a delayed onset of a disease or disorder. The amount of activated charcoal, which constitutes a "therapeutically effective amount" will vary depending on the toxin or poison ingested, the severity of the condition, and the age and body weight of the subject to be treated. (0050).
The present compositions will contain a therapeutically effective amount of activated charcoal, optionally with an additional therapeutic, preferably in purified form, wherein the additional therapeutic is in a suitable amount of a pharmaceutically acceptable vehicle so as to provide the form for proper administration to the patient. (0153).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGOC-ANH THI NGUYEN whose telephone number is (571)270-0867. The examiner can normally be reached Monday - Friday 8:00 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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