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 of TLR-7 Agonist in the reply filed on 11/12/2025 is acknowledged. Applicants did not elect a singular fully defined compound of a TLR-7 agonist as required on page 3 of the Restriction Requirement.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-17 are examined on the merits.
Priority
This Application is a national stage entry of PCT/US2021/048151 and also claims priority to US provisional application 63/071,905.
The instant claims find support from the provisional application. Therefore, the effective filing date is 08/28/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/12/2025, 04/07/2023, and 02/27/2023, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 10 and 17 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.
Claims 10 and 17 as drafted references any compound of “Table 1” through “Table 16”. This limitation renders the metes and bounds of claims 10 and 17 undefined (thus claims 10 and 17 are indefinite). As drafted, the reader has no idea to what compounds claims 10 and 17 are truly drawn. Referencing compounds by Table number or Figure number in the specification renders a claim indefinite, since Applicants are free to update the specification any time before issue fee payment is due, including after prosecution (of claims) has closed. Thus, if Examiner were to allow the claims in which the indefinite reference was made to Table 1-16, Applicants could then amend the specification to include compounds not previously examined, pay the issue fee, and thus have a patent drawn to compound(s) that was never previously examined. See MPEP 2173.05(s).
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 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by FDA (“Clinical Pharmacology Review”, FDA, Reference ID: 2846410, 2008).
FDA anticipates an Imiquimod cream (Aldara for topical use) (page 1). This anticipates claim 16.
This also seems to be a cream of claim 17 (however claim 17 is indefinite and it is unclear what compounds are included in the scope of claim 17).
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erlich (Erlich et al., “Intranasal and epicutaneous administration of Toll-like receptor 7 (TLR7) agonists provides protection against influenza A virus-induced morbidity in mice”, Scientific Reports, February 20, 2019) as evidenced by HEALTHLINE (Dr. Meredith Goodwin and Leilani Fraley, “COVID-19 and Shortness of Breath”, Healthline, June 5, 2020).
Erlich anticipates treating or alleviating a symptom of a coronavirus infection (airway and pulmonary inflammation) in a subject (mouse) by administering imiquimod (abstract).
Healthline is relied upon for the beneficial teaching that COVID-19 causes breathing difficulty because of inflammation (pages 2 and 4).
This anticipates claims 1-2.
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.
Claims 3, 7-9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over POULAS (Poulas et al., “Activation of TLR7 and Innate Immunity as an Efficient Method Against COVID-19 Pandemic: Imiquimod as a Potential Therapy”, Frontiers, June 10, 2020).
POULAS teaches Imiquimod as a potential therapy for COVID-19 (title).
POULAS teaches Coronaviruses are a large group of viruses that can cause illness, the symptoms of which are ranging from the common cold to more severe diseases, like Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). This helps teach claims 7 and 8.
POULAS teaches Imiquimod enhances innate and acquired cellular immunity (page 2).
POULAS teaches Imiquimod has antiviral properties (page 2). POULAS teaches that “We have clear evidence that IQ [Imiquimod] is able to offer satisfactory stimulation of innate and acquired immunity, helping the elimination of SARS-CoV-2, at least during the early phases of infection. We propose the trial of IQ as a potential anti-SARS-CoV-2 drug” (page 2). This helps teach the compound of claim 9.
POULAS proposes repurposing Imiquimod and the systematic administration, by compounding suppositories, containing 6.25 mg each (page 2). Examiner understands that by compounding suppositories that this would include a pharmaceutical acceptable excipient. This teaches claims 12-14.
POULAS does not anticipate treating a subject with Imiquimod.
However, it would have been obvious to treat a subject infected with a coronavirus by administering Imiquimod (POULAS title). The artisan would be motivated to use Imiquimod as a COVID-19 treatment (POULAS page 2). The artisan would have expected Imiquimod to be able offer satisfactory stimulation of innate and acquired immunity, helping the elimination of SARS-CoV-2, at least during the early phases of infection of COVID-19 (POULAS CITAITON). This teaches claims 3, 7-9, and 12-14.
It would have been obvious to treat a human subject.
Claims 3, 7-9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over POULAS (Poulas et al., “Activation of TLR7 and Innate Immunity as an Efficient Method Against COVID-19 Pandemic: Imiquimod as a Potential Therapy”, Frontiers, June 10, 2020) in view of (Erlich et al., “Intranasal and epicutaneous administration of Toll-like receptor 7 (TLR7) agonists provides protection against influenza A virus-induced morbidity in mice”, Scientific Reports, February 20, 2019) and in view of Angelopoulou (Angelopoulou et al., “Imiquimod – A toll like receptor 7 agonist -Is an ideal option for management of COVID 19”, Environ Res. June 23, 2020).
POULAS teaches claims 3, 7-9, and 12-14 above.
Erlich teaches treating or alleviating a symptom of a coronavirus infection (airway and pulmonary inflammation) in a subject (mouse) by administering imiquimod (abstract). Erlich also teaches that imiquimod reduced peak viral replication (abstract). Examiner understands that reducing peak viral replication would also be reducing or arresting viral load in a subject (at the peak time). Additionally, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical compound (imiquimod) and its properties, reducing or arresting viral load, are inseparable. See MPEP 2112.01 (II). This teaches claim 6.
Erlich teaches administering imiquimod once daily (Methods-Virus infection models and treatment regimens). This teaches claim 11.
Erlich does not teach anything related to the cytokine storm and a coronavirus.
Angelopoulou teaches that imiquimod is a TLR-7 agonist and may be appropriate for early-stage COVID-19 patients (Highlights). This teaches claim 15.
Angelopoulou teaches the cytokine storm accompanies coronavirus infection (section 2.2).
Angelopoulou teaches that patients with COVID-19 hospitalized in ICU presented with cytokine storm had elevated levels of pro-inflammatory cytokines and chemokines (Section 2.2).
Angelopoulou teaches that imiquimod should be used in the early stages of SAR-CoV-2, where activation of innate immunity by a TLR-7 agonist is of vital importance (section 3.1). Angelopoulou further teaches that in late stage infected patients by SARS-CoV-2 Imiquimod could provoke further up-regulation of the “cytokine storm” (Section 3.1). This helps teach claims 4-5.
It would have been obvious that Imiquimod would prevent an acute inflammatory condition (cytokine storm) in a subject infected with coronavirus. In a subject infected with an early-stage coronavirus imiquimod would be expected to reduce peak viral replication for COVID-19 (Erlich abstract). Additionally, the artisan would expect that imiquimod would be useful in treating early-stage COVID-19 patients as it activates the innate immune system (Angelopoulou Section 3.1). In treating an early stage COVID-19 patient, the cytokine storm would be prevented. This teaches claims 4-5.
Conclusion
No claims are allowed as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625