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
Status of the Claims
Claims 1-6 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on March 25th 2025 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter (process, machine, manufacture, or composition of matter) because they are directed towards “The use of pyridostigmine,” which implies a treatment method in which a compound is used as part of a pharmaceutical composition, but the claim does not provide either a patient population or methodological steps, both of which would be required for a proper method claim. Claims 2-5 each suffer from the same deficiencies, being directed towards the “use of” a compound, implying a method, but without providing methodological steps.
Claim Rejections - 35 USC § 112(b)
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 1-6 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 1 recites the limitation "The use of…" There is insufficient antecedent basis for this limitation in the claim.
The term “severe” in claim 1 is a relative term which renders the claim indefinite. The term “severe” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “of legal age” in claim 3 is a relative term which renders the claim indefinite. The term “of legal age” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, the “legal age” both varies by area (i.e. between different states/countries) and by activity (for example, the legal age for driving differs from the legal age for drinking alcohol). As one of ordinary skill in the art would not reasonably know which “legal age” is being referenced in the claim, claim 3 is indefinite.
Claim 3 is generally narrative and indefinite, failing to conform with current U.S. practice. It appears to be a literal translation into English from a foreign document and is replete with grammatical and idiomatic errors.
Claims 1-5 are indefinite for the phrases “The use of pyridostigmine,” because the use of a compound is not patently distinct from the compound itself.
Claim 6 is indefinite for reciting a compound “for use,” as the use of a compound is not patently distinct from the compound itself.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osman (Osman AH. COVID-19: Targeting the cytokine storm via cholinergic anti-inflammatory (Pyridostigmine). Int J Clin Virol. 2020; 4: 041-046).
Claims 1-5 are directed towards “The use of pyridostigmine for the treatment of COVID-19.” Claim 6 is directed towards “pyridostigmine for use in the treatment of COVID-19.”
In both cases, the claimed subject matter is patently indistinct from the compound, pyridostigmine (see the above 112(b) rejections over claims 1-6).
Osman suggests the administration of pyridostigmine for the treatment of COVID-19:
“Pyridostigmine works by inhibiting the acetylcholinesterase (AChE) enzyme from breaking down the neurotransmitter acetylcholine (ACh), and thereby increases the bioavailability of (Ach) and enhances the transmission of nerve impulses at neuromuscular junctions.”
“The nervous system senses cytokines and other inflammatory signals and responds, through an anti-inflammatory reflex, via the vagus. Accordingly, electrical stimulation of the vagus, or administration of cholinergic agonists, inhibit the inflammatory response and lower the mortality of SARSCoV-2 infection patient as and other cytokine-mediated inflammation by inducing or facilitating the cholinergic antiinflammatory pathway (CAP). Likewise, activation of the CAP during systemic inflammation down-regulates the assembly and release of inflammatory cytokines.”
“I am suggesting that Pyridostigmine (PDG) may improve the number of circulating CD4+ T-cells and reduce the release of inflammatory cytokines. Therefore, lung tissue damage will decrease in COVID-19 infected patient even not need to breathing support, such as mechanical ventilation.”
[Osman, pg. 044]
As Osman teaches the compound, pyridostigmine, and each of the claims is patently indistinct from the compound, Osman anticipates claims 1-6.
Conclusion
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629