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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/15/2026 has been entered.
Response to amendments
The amendments made to the claims 09/15/2026 have been entered.
Status of claims
Claims currently pending are claims 1, 4, 7, 12, 18, 23-24, 30, 37, 45, 50, 63, 65, 79, 96, 124-125, 127-130.
Claims 63, 65, and 96, are currently withdrawn.
Withdrawn Rejection
In view of the amendments, arguments made, and the affidavits presented in the reply received 09/15/2026, the 103, 102, and Non-statutory double patenting rejections made in the final office action of 06/15/2026 have been withdrawn.
Upon further consideration, a new rejection under different grounds is made. See rejections below.
Rejoinder
Claims 63, 65 and 96 are hereby rejoined.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 63, 65, and 96 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for specific doses of caffeine, sodium benzoate, and any of lactic acid, acetic acid, aspartic acid, and glutamic acid, does not reasonably provide enablement for all doses and concentrations of caffeine, sodium benzoate and any of lactic acid, acetic acid, aspartic acid, and glutamic acid. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The following Wands factors have been considered if not explicitly considered if not explicitly stated: (A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth of the claims
Claim 63 is drawn to “a method of accelerating emergence from anesthesia or countering the effect of anesthesia comprising parenterally administering to a patient undergoing a medical procedure with an anesthesia agent a pharmaceutically effective amount of a pharmaceutical composition of claim 1.”
Claim 65, dependent form claim 63, specifies that the administration of the compound is any of intravenous, intramuscular, or subcutaneous.
Claim 96 is drawn to a “method of treating a patient suffering from opioid intoxication or overdose comprising parenterally administering to the patient a pharmaceutically effective amount of a pharmaceutical composition of claim 1.”
The composition of claim 1 is the following:
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State of the prior art
Compositions comprising caffeine, sodium benzoate, and water are known within the art. However, compositions comprising caffeine, sodium benzoate, water, and any of lactic acid, acetic acid, aspartic acid, or glutamic acid are not known within the art.
Additionally, the claimed composition of claim 1 is not obvious for the reason that, at concentrations discussed below, lactic acid acts to dissolve the caffeine and sodium benzoate in aqueous solution.
Direction provided and working examples
The instant specification discloses working examples in Tables 4-7, p. 28-30, shown below.
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Additionally, as discussed in the affidavit received 09/15/2026, an experiment that saw 2500.3 mg of caffeine and 2500.8 mg of sodium benzoate dissolved in 10 mL distilled water showed particulates present. The presence of particulate indicates incomplete dissolution.
Upon addition of lactic acid, the particulates disappeared indicating complete dissolution into solution.
While the specification does not disclose “emergence from anesthesia or countering the effects of anesthesia” or “treating…opioid intoxication or overdose”, the specification in para. [0003]-[0005] does discuss that solution containing caffeine and/or caffeine and sodium benzoate are used “in recovery from anesthesia” and that “caffeine is effective in treating opioid intoxication or overdose”.
Therefore, the instant claims are enabled for the specific compositions exemplified in tables 4-8 above.
However, the instant specification in para. [0004] also states that “With a caffeine and sodium benzoate composition, a median dose given to patients was 150mg of caffeine sodium benzoate with a maximum dose of 250 mg of caffeine sodium benzoate.” This discussion indicates that there is at least a minimum dose of caffeine and sodium benzoate required to elicit the effects of claims 63 and 96.
Level of predictability
Considering the scope of claim 1, which is drawn broadly to any combination of caffeine, sodium benzoate, water, and any of lactic acid, acetic acid, aspartic acid, or glutamic acid, considering the teachings within the specification, and considering the effective amounts taught within the instant disclosure, one of ordinary skill could not predictably practice the full scope of the methods of claims 63, 65, and 96.
Examiner suggests amending claim 1 to include specific amounts as enabled by the working examples.
Allowable Subject Matter
The affidavits received 09/15/2026 indicate the following:
The solubility of caffeine in water is only amplified to a certain extent when combined with sodium benzoate. An almost 1:1 mixture of results in a mixture containing the caffeine and sodium benzoate but where the caffeine and sodium benzoate are not completely dissolved. Additionally, the pH of the solution at 1:1 is outside of the claimed pH range. The affidavit shows that lactic acid, or alternative as shown in the instant specification, is required to further increase the solubility of the caffeine. Additionally, the specific ratio of caffeine, sodium benzoate, lactic acid (or alternatives) in water results in the claimed pH range.
Therefore, the combination of caffeine, sodium benzoate, water and any of lactic acid, acetic acid, aspartic acid, and glutamic acid is not obvious.
Claims 1, 4, 7, 12, 18, 23-24, 30, 37, 45, 50, 79, 124-125, and 127-130 are considered allowable over the art.
Conclusion
Claims 63, 65 and 96 are rejected.
Allowable subject matter indicated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
