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 .
Priority
This patent application claims priority from Provisional Application No. 63/590,768 filed October 16, 2023.
Status of the claims
Claims 1-10 are pending in the instant application, and are the subject of the office action below.
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 7-10 are directed to non-statutory subject matter
Claims 7-10 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because they are directed to “use of acetaminophen…” The claims are not directed towards a “process, machine, manufacture, or composition,” but merely the “use of” acetaminophen. The “use of” acetaminophen implies a method, but no methodological steps are recited. See MPEP 2173.05(q)
Accordingly, at the time the invention was filed, claims 7-10 fail to comply with 35 U.S.C 101 and are not patentable subject matter.
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.
Claims 3, 6, and 7-10 are indefinite:
Claims 3, 6, and 7-10 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 3 recites "coronavirus" in reference to claim 1, which recites “a virus-associated infection.” There is insufficient antecedent basis for this limitation in the claim. For examination purposes claim 3 will be read as if dependent on claim 2, which recites “coronavirus.”
Claim 6 recites “wherein the non-human mammal subject is a pig” in lines 1-2 as a further limitation of claim 1, which recites a patient population of “subject” with a virus-associated infection. There is insufficient antecedent basis for this limitation in the claim. Specifically, it is unclear whether the patient population of claim 6 is limited to “non-human mammal subjects that are pigs, whether the “non-human mammal subject” is referring to the “subject” of claim 1 (which in itself is not limited to non-human mammals), or if some other meaning is intended. As such, it is unclear how claim 6 further limits the patient population of claim 1. For examination purposes claim 6 will read as if dependent on claim 5, which recites “the subject is a human or non-human mammal.”
Claims 7-10 are indefinite for reciting “use of acetaminophen” because “use of” acetaminophen merely recites a use without any active, positive steps delineating how this use is actually practiced. Specifically, the “use of” acetaminophen is not patently distinct from acetaminophen itself and does not purport to claim any of the four patentable statutory categories: “a process, machine, manufacture, or composition of matter.” See MPEP 2173.05(q)
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.
Claims 1, 2, 5, 7 and 8 are anticipated by Lomaga
Claims 1, 2, 5, 7, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lomaga, PCT Publication Number 2009/012590 A1, published on January 29, 2009.
Claim 1 is directed towards a method of treating virus-associated infection in a subject by the administration of a therapeutically effective amount of a pharmaceutical composition comprising an acetaminophen compound.
Applicant’s Specification defines the claim terms “treating,” “effective amount,” and “an acetaminophen compound” as follows:
“[0018] As used herein, the term “treating” refers to the therapeutic measures to a disease or the symptoms or conditions of a disease, which include but are not limited to applying or administering one or more active agents to a subject suffering from the disease or the symptoms or conditions of the disease or exacerbation of the disease. The purpose of the therapeutic measures is to treat, cure, mitigate, relieve, alter, remedy, ameliorate, improve, or affect the disease, the symptoms or conditions of the disease, disability caused by the disease, or exacerbation of the disease. Specifically, the present invention provides an acetaminophen compound for for treating virus infection.”
“[0020] As used herein, the term “effective amount” refers to the amount of an active ingredient achieving desired biological efficacy or therapeutic effects in a subject being treated, for example, pain relief.”
“[0017] According to the present invention, an acetaminophen compound is acetaminophen, its derivatives, or its prodrug.”
Specification, paragraphs 0018, 0020, and 0017 (emphasis added).
As required by the claimed invention, Lomaga teaches treating virus-associated infections through the use of active agents, such as acetaminophen, or acetaminophen in combination with ibuprofen. Lomaga teaches symptomatic management of medical symptoms caused by viruses, such as fever and rhinitis:
“Situations associated with fever and rhinitis include (but not limited to): the common cold, influenza, sinusitis and measles.
The cold is the most commonly occurring illness in the entire world, with more than 1 billion colds per year reported in the United States alone. The common cold is a self-limiting illness caused by any 1 of more than 200 viruses.
The common cold produces mild symptoms usually lasting 5-10 days. In contrast, the "flu" (influenza), which is caused by a different class of virus, can have severe symptoms. Of the viruses that cause a cold, the most commonly occurring subtype is a group that lives in the nasal passages known as the "rhinovirus." Other less common cold viruses include coronavirus, adenovirus, and respiratory syncytial virus (RSV).”
Lomaga, page 1 (emphasis added).
Lomaga also describes a number of advantages of the preferred compound acetaminophen, which is a well-studied and safe cyclooxygenase inhibitor for the treatment of pain and fever, while being a non-opiate or inducing Reye’s syndrome (unlike aspirin), and common means of providing oral formulation. See, specification, pages 2 and 3.
Lomaga exemplifies a preferred pharmaceutical formulation comprising 325 mg acetaminophen and 200 mg ibuprofen in Example 1 for the treatment of the symptoms caused by these viruses:
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Example 1, pages 23 and 23.
Accordingly, at the time the invention was filed, the claimed invention was not novel.
Claim 2 further limits claim 1 to treating virus-associated infection in a subject experiencing coronavirus infection. Lomaga teaches the invention as discussed above in claim 1. Further, Lomaga teaches symptomatic treatment of medical symptoms caused by viruses including coronavirus:
“The common cold produces mild symptoms usually lasting 5-10 days. In contrast, the "flu" (influenza), which is caused by a different class of virus, can have severe symptoms. Of the viruses that cause a cold, the most commonly occurring subtype is a group that lives in the nasal passages known as the "rhinovirus." Other less common cold viruses include coronavirus, adenovirus, and respiratory syncytial virus (RSV).”
Lomaga, page 1 (emphasis added).
Lomaga is therefore anticipatory of claim 2.
Claim 5 further limits claim 1 to treating virus-associated infection in human and non-human mammals. Lomaga teaches the invention as described above in claims 3, 2, or 1, and further teaches a method of treating virus-associated infection in mammals using the described composition:
“The present invention further comprises a method of treating one or more of the 20 following symptoms comprising pain, headache, fever, nasal congestion, sinus congestion, runny nose, or otic barotrauma, where the method involves administering to a mammalian subject any of the formulations listed above.
Lomaga, page 12 (emphasis added)
Lomaga is therefore anticipatory of claim 5.
Claim 7 is directed towards treating or preventing viral infections via use of acetaminophen. Claim 8 further limits claim 7 to coronavirus. As required by the claimed invention, and as discussed above in claims 1-2, Lomaga teaches treating virus-associated infections through the use of active agents, such as acetaminophen, or acetaminophen in combination with ibuprofen. Lomaga also teaches symptomatic treatment of medical symptoms caused by viruses including coronavirus.
Lomaga is therefore anticipatory of claims 7 and 8.
Claims 1-3, 5 and 7-9 are anticipated by Javid et al.
Claims 1-3, 5, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Javid et al., U.S. Patent Number 11090315 B1 published on August 17, 2021.
Claims 1-3 are directed towards the treatment of SARS-associated coronavirus in a subject via administration of a pharmaceutical composition comprising acetaminophen.
As required by the claimed invention, Javid et al. teaches a method of treating SARS COVID-19 infections, to patients in need thereof, through the use of pharmaceutical compositions comprising acetaminophen:
“A method for treating, providing symptomatic relief, reducing the severity of, or reducing complications of a SARS COVID-19 infection in a patient in need thereof, comprising administering to the patient a composition comprising a therapeutically effective amount of ibuprofen, spironolactone, chlorpheniramine, and acetaminophen.”
Javid et al., Claims, C8/L38-43 (emphasis added)
Javid et al. is therefore anticipatory of claims 1-3 and 5.
Claims 7-9 are directed to treatment or prevention of SARS-associated coronavirus via use of acetaminophen. Javid et al. teaches the invention as discussed above in claims 1-3 and 5. Javid et al. is therefore anticipatory of claims 1-3, 5, and 7-9.
Claims 1, 4-7, and 10 are anticipated by Ceva Animal Health Ltd.
Claims 1, 4-7, and 10 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention.
Claims 1 and 4-6 are directed towards the treatment of PRRS virus infection in a pig via administration of acetaminophen. As required by the claimed invention, Ceva Animal Health Ltd. received national (UK) authorization for the sale of PRACETAM®, published on March 22, 2005, product number A006454 in the Veterinary Medicines Directorate Product Information Database.1
A published brochure from Ceva Animal Health Ltd (last modified on October 8, 2015) identifies the active substance of PRACETAM®, acetaminophen, as a veterinary medicinal product for treating piglets, growing pigs, adult pigs and/or sows for “influenza-like syndrome, respiratory disease, PRRS out-break or non-specific fever.”
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Ceva Animal Health Ltd., PRACETAM® Brochure, page 4
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Ceva Animal Health Ltd., PRACETAM® Brochure, page 7
Ceva Animal Health Ltd. sells and markets PRACETAM® as a premixed acetaminophen composition (0.1 g acetaminophen, excipient qs 1.00 g) for daily oral administration to pigs, and suggests combination treatment with an appropriate anti-infective treatment. The recommended daily dose is 30 mg of acetaminophen per kg of live weight, during 5 consecutive days, administered in feed.
Ceva Animal Health Ltd., PRACETAM® brochure, pages 4 and 7 (emphasis added)
Accordingly, Ceva Animal Health Ltd. is anticipatory of claims 1 and 4-6.
Claims 7 and 10 are directed towards the use of acetaminophen to treat a PRRS viral infection in pigs. Claims 7 and 10 are anticipated by Ceva Animal Health Ltd. for the same reasons as claims 1 and 4-6.
Conclusion and Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jarrod Stanley whose telephone number is (571)272-3520. The examiner can normally be reached Mon-Th 9-5pm.
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, Jeff Lundgren can be reached at 5712725541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARROD STANLEY/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Directorate, V. M. (2026, August 21). Product Information Database. Retrieved from product A006454:
https://vmd.defra.gov.uk/productinformationdatabase/product/A006454
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