DETAILED ACTION
A non-final Office action was mailed 22 September 2025 (“Office Action”).
Applicant’s reply to the Office Action was received 17 December 2025 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1–3 and 31–36 are pending. Claims 4–30 are canceled.
Claims 1–3 and 31 are amended. Claims 32–36 are new.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Objections
Claims 3 and 32 are objected to for minor informalities.
Claim 3 is objected to for containing grammatical error. The term “organ failure cause by COVID-19” should be replaced with “organ failure caused by COVID-19.”
Claim 32 is objected to because it recites “the patient.” Claim 32 references claim 1. There is insufficient antecedent basis for using definite article “the patient” in claim 32 because there is no preceding recitation of indefinite article “a patient” in claim 1.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
Claims 1–3, 31, and 32 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites, “a coronavirus disease COVID-19 or a symptom arising therefrom . . . to a subject in need thereof.” Claim 1 is indefinite because it is ambiguous: there are contrasting interpretations as to whether the “coronavirus disease COVID-19” and “symptom arising therefrom” clauses refer to alternative patient populations. Claim 1 does not define the subject as having COVID-19; it merely states “a subject in need thereof.” One interpretation: the term a symptom arising therefrom means the symptom is caused by COVID-19; therefore, the subject has COVID-19 and the method is directed to a single patient population. Another interpretation: the term a symptom arising therefrom is shorthand for symptoms shared by subjects having COVID-19 and subjects having another disorder—the patient population is not required to have COVID-19. In the context of the claimed method of administering a known therapeutic, in which the patentability depends on treating a disease and/or patient population that is distinct from what the therapeutic is known in the art to treat, resolving any ambiguities in the claim is required.
Claim 3 is indefinite because it depends from claim 1 without curing the ambiguity.
Claim 3 is also indefinite because it recites a list of diseases followed by the term “cause[d] by COVID-19.” It is unclear whether is the term used to modify each member of the list (“pneumonia, respiratory disease, pulmonary edema, inflammatory response, inflammatory factor storm, or organ failure”) or only the member preceding the term (“organ failure”).
Claim 2 recites, “the coronavirus disease COVID-19 is a hypoxia-related disease caused by COVID-10.” The term hypoxia-related disease is explicitly undefined in the specification:
According to the present disclosure, the hypoxia-related disease is not specifically defined. It comprises symptoms that result in hypoxia or insufficient oxygen intake in a subject's body, or a lesion or injury caused by insufficient oxygen supply to cells, tissues or organs of the subject. According to the present disclosure, the hypoxia-related disease is at least one selected from respiratory distress syndrome, pneumonia, pulmonary edema, acute lung injury, ventilator-induced lung injury, smoking-induced lung injury, lung cancer, pathological apnea, ischemic heart disease, acute myocardial infarction (AMI), ischemic encephalopathy, ischemic stroke, ocular ischemic disease, ischemic optic neuropathy, inflammation, septicemia, renal failure, tissue fibrosis, bronchial dysplasia, fetal distress, postsurgical hypoxia, anemia, hypovolemia, rheumatoid arthritis, poisoning (e.g., carbon monoxide poisoning, heavy metal poisoning), ischemia reperfusion injury (e.g., limb, bowel and kidney ischemia), asphyxia and vascular embolism. For example, the hypoxia-related disease is a pulmonary disease caused by hypoxia, including but not limited to, respiratory distress syndrome, pneumonia, pulmonary edema and acute lung injury. For another example, the hypoxia-related disease is respiratory distress syndrome or a complication thereof caused by respiratory tract infection, acute lung injury, trauma or poisoning, and the complication comprises at least one selected from pulmonary edema, inflammatory response or inflammatory factor storm, sepsis and organ failure.
(Spec., 2:15–31) (emphasis added).
Claim 2 is indefinite because the scope of the term hypoxia-related disease is unknown. The specification merely characterizes the term with symptoms and examples. Thus, a third-party would not be informed of the boundaries of what constitutes infringement of the claim.
Claim 2 is also indefinite because it states COVID-19 is caused by COVID-19. The disease is recited as being caused by itself. Thus, the term COVID-19 is used inconsistently as both a pathogen and a disease, and that inconsistent use renders the claim indefinite because it is not sufficiently clear what subject matter the inventor regards as the invention.
Claim 31 recites, “the coronavirus disease COVID-19 or a symptom arising therefrom” and refers to claim 1. Claim 31 is indefinite because claim 1 also recites “a symptom,” and it is unclear if claim 31 is referring to the same or a different “symptom” recited in claim 1.
Claim 32 recites, “a severe or critical COVID-19.” The terms severe and critical are relative terms that render the claim indefinite. Claim 32 is indefinite because relative terms are 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.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 102
(i) Claims 1–3, 31, and 33–36 are rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by US 6,884,879 (“Baca”) [IDS].
Applicant acknowledges that Baca discloses bevacizumab. (Spec., 8:28–9:2).
Baca discloses a composition comprising the VEGF inhibitor. (Id., 4:15–18).
Baca discloses administering the VEGF inhibitor composition via intravenous injection, intramuscular injection, subcutaneous injection, oral, or inhalation. (Id., 31:29–37).
Baca discloses treating lung cancer, chronic inflammation, and lung inflammation, among other diseases with a VEGF inhibitor. (Id., 31:51–32:13).
Baca discloses using a dose of the VEGF inhibitor ranging from about 1 mg/kg to about 50 mg/kg. (Id., 32:22–34).
Response to Arguments
Applicant’s arguments submitted with the Reply have been considered but are not persuasive. Applicant states Baca does not disclose COVID-19. (Remarks, p.5). But, as noted above, there is a reasonable interpretation of claim 1 in which the method is recited as treating a symptom that is shared by COVID-19 and other diseases. If the symptom is inflammation and the term “symptom arising therefrom” is considered shorthand for a list of symptoms such as inflammation, then Baca discloses each element recited in the claim.
Examiner recommends amending the claim to a method of treating “a subject having COVID-19,” which would define the patient population and clarify that the “symptom” was caused by COVID-19.
(ii) Claims 1–3 and 32–36 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Assistance Publique, Hospital of Paris, ID NCT04344782, posted 17 April 2020 at https://clinicaltrials.gov/study/NCT04344782?term=NCT04344782&rank=1 (accessed 10 September 2025) (“Paris”).
Paris discloses administering a pharmaceutical composition comprising bevacizumab (25 mg/ml of Zerbiv) to a patient with COVID-19. (Paris, p.1). In one protocol, 7.5 mg/kg of bevacizumab is administered by infusion. (Id., p.5).
Response to Arguments
Applicant’s arguments submitted with the Reply have been considered but are not persuasive. Among other things, Applicant states the subject matter disclosed in Paris was obtained from an inventor of the instant application. But Applicant does not allege facts in a declaration signed by someone with firsthand knowledge. See MPEP § 2155.03. Attorney argument is not evidence. Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d 1371, 1380 (Fed. Cir. 2009). Accordingly, the statements in the Reply are insufficient to disqualify Paris as prior art. Applicant’s further arguments regarding the disclosure of Paris have been considered but fail to distinguish the claimed invention from what is disclosed in Paris.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Communication
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/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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