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 to the claims of Group I (Claims 1, 3, 6-7, 9, 12-15, 18, 20, 24, 26 and 28) in the reply filed on 08/11/2025 is acknowledged. 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)).
Claim Status
Claims 1, 3, 6-7, 9, 12-15, 18, 20, 24, 26 and 28 are the only claims pending and currently under consideration.
Specification
The disclosure is objected to because of the following informalities:
Page 11, line 27 refers to “Ref. 17: incorporated by reference in its entirety”.
Page 11, last line refers to “Ref. 18”.
However, the specification on the last page only lists references 1-15 and thus it’s unclear what reference 17 and 18 denote.
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)(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, 3, 6-7, 9, 12-15, 18, 20, 24, 26, and 28 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bao et al., WO 2021/194860, priority to March 23, 2020.
As to claims 1, and 12-15, Bao et al. teach a method of treating a subject infected with SARS-CoV-2 comprising administering an effective dose of 200mg or less of tocilizumab to the subject. See page 6. SARS-CoV-2 is the virus that causes Covid-19. According to one embodiment, tocilizumab subcutaneous (sc) formulation delivers “162 mg” tocilizumab (page 23, line 25). As to claims 12-15, the above encompasses treating an upper respiratory infection arising from a virus as the virus SARS-CoV-2 infects lung cells.
As to claim 3, Bao et al. teach (page 24, lines 9+) that the subject to be treated can have “severe”, or “critical”, or “moderate” or “moderate-severe” Covid-19. While the claimed term “mild” is not specifically taught, these are relative terms and one could reasonably equate mild with moderate and “moderate-severe” with some degree of moderate disease.
As to claims 6-7, and 9, Bao et al teach that the subject can exhibit symptoms and/or biomarkers of respiratory inflammation. This can include “cytokine release syndrome” (CRS) such as elevated IL-6 levels. The patient can have “severe pneumonia” (page 8) which can morph to “acute respiratory distress syndrome”. Typically, these patients can have severe dyspnea, respiratory distress, and tachypnea. Patients experiencing these conditions are exhibiting symptoms of respiratory inflammation or undergoing a “systemic inflammatory response”, “systemic hyperinflammation” and CRS. A patient suffering from severe pneumonia caused by SARS-CoV-2 would encompass those that can suffer systemic hyperinflammation which manifests as respiratory and or pulmonary inflammation. See Bao et al. page 8, line 21. In one embodiment, the patient has respiratory distress (RR≥30 breaths/minute). In one embodiment, the patient has >50% lesions in pulmonary imaging.
As to claim 18, 20, and 24, Bao et al. teach that tocilizumab can be administered subcutaneously or intravenously (see page 23, lines 9-25). As to claim 18, the reference refers to weight-based dosing of tocilizumab which is 8mg/kg. Assuming the treated subject might be a toddler or preschooler weighing a max of approximately 12kg (26.5 lbs.) then the maximum dose of tocilizumab would be 96mg. Bao et al. also teach that the subject can be administered “multiple doses” (page 24, line 24). Thus, if the same toddler or preschooler was given a second dose of 96 mg, this would be a total dose of less than 400 mg of tocilizumab.
As to claims 26 and 28, Bao et al. teach that the tocilizumab can be co-administered with anti-viral agents including remdesivir (see page 11, line 4, page 26, lines 21-35, also see page 37) or corticosteroids (page 11, line 9, page 27, lines 1-10) such as prednisone or hydrocortisone. Corticosteroids can act as immunosuppressants or anti-inflammatory agents.
No claim is allowed.
Conclusion
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/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645
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