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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 30, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Claim Status
Claims 1-9, 11-18, and new claims 19-26 are under consideration in this office action.
Withdrawn Rejections
Any rejection of record pertaining to canceled claim 10 is rendered moot by applicant' s cancellation of said claim.
The rejection of claims 1-9 and 11-18 under 35 U.S.C. 112(b) in view of applicant’s amendment.
The rejection of claims 1-4, 7-9, and 13 under 35 U.S.C. 102(a)(2) as being anticipated by US 2021/0299226 is withdrawn in view of applicant’s amendment of claim 1 to include the limitation wherein the patient is assessed as having a score of at least 3 or 4 on the WHO OSCI upon first inhale administration of IFN-b.
The rejection of claims 1-4, 6-7, 9, 13, and 17-18 under 35 U.S.C. 102(a)(2) as being anticipated by US 2020/0237689 is withdrawn in view of applicant’s amendment of claim 1 to include the limitation wherein the patient is assessed as having a score of at least 3 or 4 on the WHO OSCI upon first inhale administration of IFN-b.
The rejection of claims 1-7 and 9-18 under 35 U.S.C. 103 are withdrawn in view of applicant’s amendment of claim 1 to include the limitation wherein the patient is assessed as having a score of at least 3 or 4 on the WHO OSCI upon first inhale administration of IFN-b.
New Objections/Rejections Necessitated by Amendment
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 recites, “wherein the patient does not increase score on the same scale”. Because the patient does not “not” increase score, rather it is the score that does not increase, the claim should read, “wherein the score of the patient does not increase”. Also, the phrase “same scale” is unnecessary; the claim should read “the scale” or “the WHO OSCI”.
Appropriate correction is required.
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, 5-9, 11-18 and new claims 19-26 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 is directed to a method for preventing or reducing the severity of lower respiratory tract illness in a patient infected with a coronavirus “or other virus capable of causing acute respiratory distress syndrome (ARDS)”. The quoted phrase is indefinite because it is unclear what other viruses cause ARDS and the specification provides no guidance regarding the treatment of other viruses with the claimed method.
Claim 1 is directed to a method for preventing lower respiratory tract illness in a patient infected with a coronavirus who is assessed as having a score of at least 3 on the WHO OSCI (i.e. a patient who is hospitalized). Preventing lower respiratory tract illness is not possible in a patient who is already presenting with lower respiratory tract illness. Since the prevention method of the preamble cannot be applied to the claimed patient population, the scope of the method is indefinite.
Claim 8 recites, “administration is by use of a nebuliser.” “[U]se of a nebuliser” is indefinite because the term “use” fails to specify the steps of the use, and the scope of the claim is unclear. Amending the claim to instead recite, “said administration is via a nebulizer”, would be sufficient to overcome this rejection.
Claim 11 is dependent on canceled claim 10. As such, it is unclear how to interpret the metes of bounds of what is claimed. In the interest of compact prosecution, claim 11 will be interpreted to be dependent on claim 1.
Claim 12 recites the limitation "the time period". There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites “the start”. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “the following scale”. There is insufficient antecedent basis for this limitation in the claim.
Claims 15 and 16 recite “the determiner”. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites “the home environment”. There is insufficient antecedent basis for this limitation in the claim.
Claims 5-9, 17-18 and new claims 19-26 are included in this rejection for being dependent on a rejected base claim and failing to cure the indefiniteness.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16, which dependent on claim 1, includes the limitation wherein the patient has an OSCI score of no more than 2, which is broader than the limitation of claim 1 directed to a patient with an OSCI score of 3 or more. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 11-18, and new claims 19-26 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of reducing the severity of respiratory tract illness or improving one or more symptoms or outcomes in a patient infected with a coronavirus, does not reasonably provide enablement for a method for reducing the severity of lower respiratory tract illness in a patient infected with any virus capable of causing ARDS. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Case law holds that applicant’s specification must be “commensurately enabling [regarding the scope of the claims].” See Ex Parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. Appl. Inter. 1989). Otherwise undue experimentation would be involved in determining how to practice and use applicant’s invention. Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described in In re Colianni, 195 USPQ 150 (CCPA 1977) and have been adopted by the Board of Patent Appeals and Interferences in Ex Parte Forman, 230 USPQ 546 (BPAI 1986). Among these factors are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the breath of the claims,
5. the amount of direction or guidance present, and
6. the presence or absence of working examples.
The following is an analysis of these factors in relationship to this application.
Nature of the invention/breadth of claims
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. The claims are directed to a broad method for both the treatment and prevention of the severity of lower respiratory tract illness in a patient infected with a coronavirus or other virus capable of causing ARDS.
State of the art/predictability
US 20210299226, filed March 31, 2020 (“Levetan”; see PTO-892 from 9/30/2025) teaches methods for delivering interferon-beta via inhalation for the prevention and treatment of coronaviruses infections, including SARS-CoV-2 -- the virus that causes COVID-19 (abstract, [0001], [0010], [0011]). US 20200237689, filed March 24, 2020 (“Peralta”; see PTO-892 from 9/30/2025) teaches nanoemulsion compositions for intranasal delivery of agents for the prevention and treatment of coronavirus in a patient (abstract, [0006], [0227]); the agent comprises interferon-beta ([0012], [0157]). Thus, treating coronavirus with inhaled IFN-b was a known therapy at the time the application was filed.
Guidance/working examples
Applicant has surprisingly found that only a subset of patients infected with a coronavirus improve following inhaled administration of IFN-b. These patients have a score of at least 3 on the WHO OSCI prior to inhaled IFN-b; patients with a score of 2 or less do not exhibit any benefit. As the findings are drawn to unexpected results, the applicant cannot use the art at the time the application was filed to support the entire genus claimed, and thus, the showing of unexpected results must be reviewed to see if the conclusion drawn from the results can be extended to the entire genus as shown by the prior art. Applicant has described the method in only patients infected with coronavirus, and the enabling disclosure does not extend to patients infected with all viruses capable of causing ARDS.
The instant specification is not enabling for claims 1-9, 11-18, and new claims 19-26 because one cannot follow the guidance presented therein, or within the art at the time of filing, to reduce severity of lower respiratory tract illness in a patient infected with a virus that causes ARDS without engaging in extensive and undue experimentation. Given that the nature of the invention is a method of treating respiratory tract illness, a person having ordinary skill in the art would have to perform multiple further in vivo experiments in order to demonstrate whether the treatment exhibits unexpected results across different viruses associated with ARDS. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine’ within the art, and constitutes undue further experimentation for the fusion protein.
Therefore, in light of the above factors, it is seen that undue experimentation would be necessary to use the invention of claim 1 in the method claims 1-9, 11-18, and new claims 19-26 are rejected under 35 U.S.C. 112, first paragraph, for failing to meet the enablement requirement.
Response to Arguments
Applicant's arguments filed December 30, 2025 have been fully considered. Amendments to claims are sufficient to overcome the rejections detailed in the office action mailed September 30, 2025. However, claim amendments have introduced new issues under 35 U.S.C. 112, and the claims are not in condition for allowance.
Conclusion
No claim is allowed.
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 CFR 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 CFR 1.17(a)) pursuant to 37 CFR 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675