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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 8/18/25 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 1-11 are pending.
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/18/25.
Claims 1-9 and 11 are currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The information disclosure statements filed on 9/20/22 and 9/29/25 have been considered. Signed copies are enclosed.
The references lined through were not considered because the references were not properly cited including date, journal, patent application number and/or author (i.e. “First search of priority application”, Abdo-Cuza, and “International Search Report” references) (see 37 CFR 1.98(b)), a copy of the reference was not provided (see 37 CFR 1.98(a) ) (i.e. CN202010378594, and “A Field Trial” reference) and/or a concise English statement of relevance was not provided (See 37 CFR 1.98(a) and MPEP 609.04(a)) (i.e. CN1777438).
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities: the terms “SARS-CoV-2”, “COVID-19”, and “IFN” contain acronyms and/or abbreviations that should be spelled out upon first occurrence. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “The method according to claim 1, SARS-CoV-2”, which should be amended to read “The method according to claim 1, wherein the SARS-CoV-2”
Specification
Abstract
The abstract of the disclosure is objected to because the terms “SARS-CoV-2” and “COVID-19” contain acronyms and/or abbreviations that should be spelled out upon first occurrence. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 and 11 are 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 preventing a disease caused by coronavirus infection, does not reasonably provide enablement for preventing coronavirus infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
It is noted that MPEP 2164.03 teaches that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability of the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The amount of guidance or direction refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as how to make and use the invention in order to be enabling.”
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)):
1) nature of the invention;
2) the breadth of the claims;
3) the state of the prior art;
4) the level of one of ordinary skill;
5) the level of predictability in the art;
6) the amount of direction or guidance provided by the inventor;
7) the existence of working examples; and
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention/Breadth of the claims. The claims are drawn to a method for preventing coronavirus infection or preventing a disease caused by coronavirus infection in a patient comprising administering interferon to a “subject in need thereof.” The term “subject in need thereof” is notably not defined by the specification, and therefore will be interpreted to include any individual that does not currently have coronavirus infection or suffering from a disease caused by a coronavirus infection. The recitation of “preventing” a coronavirus infection in a subject is interpreted to encompass the complete blockade of any individual cell within the subject from a herpesvirus infection.
State of the prior art/Predictability of the art. The art has not yet recognized the ability of any systemically administered agent to provide a complete blockade of a virus from entering any cell of a host. In fact, the principle of vaccination with an antigen, which prevents disease from infection, depends upon a host becoming minimally infected with a virus, with said vaccination having “primed” the host to mount a faster, more effective immune response against wild-type viral challenge and inhibiting viral dissemination and/or spread, thus inhibiting symptomatic infection, viremia, and/or disease. Therefore, while infection from a virus cannot necessarily be prevented through the use of administered systemic therapies, symptoms of infection or disease resulting from infection can be potentially be prevented.
The art supports this conclusion for interferon specifically. For example, Calabrese et al (Cleve Clin J Med. 2020 Dec 3) teaches that interferons are cytokines made and released by host cells in response to the presence of viral pathogens. There are three families of interferons: type I, type II, and type III (see e.g. page 2, left column). Interferon I has been used extensively to treat other viral infections such as viral hepatitis (se e.g. page 4, right column). Collectively studies testing treatment of COVID-19 with interferon demonstrated promise for interferon therapy as an adjunct in the treatment
of COVID-19 particularly when given early in the course of the infection (see e.g. page 6, left column). Further, Sengupta (Viruses. 2024 Mar 14;16(3):451) teaches that the role of interferons is to inhibit viral replication in host cells by triggering innate immune responses, which is a first line of defense triggered after the virus is already inside the body (see e.g. page 1, first paragraph). The prevention of infection is therefore dictated by the physical barriers that prevent the virus particles from entering the body. Administering interferon would prevent disease from infection, but not prevent the physical infection itself.
Working examples. No working example is disclosed in the specification that show prevention of all cells from infection. The working examples only describe the failure of subjects to develop coronavirus disease after infection and after administration of nasal interferon, which has been indicated as enabled. There is no demonstration that the interferon is capable of providing a physical barrier to prevent the virus from entering the body.
Guidance in the specification. The specification provides guidance towards methods of preventing development of COVID-19 disease by nasally administering interferon to individuals with an infection or high risk of infection, but does NOT provide guidance towards prevention of infection.
Amount of experimentation necessary. Undue experimentation would be required to identify mechanisms and compositions that could physically prevent infection by a virus upon administration.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to make and/or use the claimed methods.
In conclusion, the claimed invention does not provide enablement for preventing coronavirus infection. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
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 1-9 and 11 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 recites “a subject in need thereof”. The specification does not define which subjects are “in need thereof”, and which criteria could be used to identify such subjects. The recitation of a patient or a human "in need" gives life and meaning to the preamble’s statement of purpose, but does not define the subjects that “need” the treatment.
Regarding claims 1-4 and 7-9, the phrases "preferably", “more preferably” and “further preferably” all render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “coronavirus infection”, and the claim also recites “SARS-CoV-2” and “COVID-19” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “mainly” in claim 2 is a relative term which renders the claim indefinite. The term “mainly” is 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.
Claim 2 recites “droplet-nose-respiratory tract”. It is unclear if this term comprises steps of transmission, or a specific tract in the body, particularly due to the inclusion of the “droplet” term, which does not generally refer to a tract of the body.
Claim 2 recites “the interferon is one or more of IFN-α, IFN-β, and IFN-γ families.” It is unclear if the selection is a single interferon from within the named families, or if the selection is an entire interferon family of proteins.
In claim 3, the term “wherein the interferon is one or a combination of a plurality of IFN- α subtypes”. It is unclear whether the selection is a single interferon or a combination of interferons, or if the selection is a plurality of interferons and a combination of different pluralities of interferons. Further, the term “plurality” appears to contradict the recitation of single interferons as species within the same claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “IFN-α subtypes”, and the claim also recites specific interferons within the subtypes which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In claim 4, it is unclear what is encompassed by the term “natural interferon”. The term “natural” is not defined, and it is unclear whether this term is referencing a naturally occurring structure, or if the claim is referencing an interferon isolated from natural sources.
The term “common” in claim 5 is a relative term which renders the claim indefinite. The term “common” is 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.
The term “long-acting” in claim 5 is a relative term which renders the claim indefinite. The term “long-acting” is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “dosage form”, and the claim also recites “nasal formulation”, “nasal drop” and “nasal spray” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “normal” in claim 8 is a relative term which renders the claim indefinite. The term “normal” is 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.
Claims 8 contain terms or phrases that are referenced parenthetically. It is unclear, due to the presence of the parentheses, if the terms/phrases are intended as limitations of the claims, or are merely exemplary.
The term “final” in claim 8 is a relative term which renders the claim indefinite. The term “final” is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “buffer”, and the claim also recites specific species of buffers which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation 1000 U/ml to 3000000 U/ml, and the claim also recites 2000-10000 U/ml, or 5000-12000 U/ml, or 3000, 4000, 5000, 6000, 7000, or 8000 U/ml which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In claim 9, the term “peptides and proteolytic enzyme inhibitors” renders the claims indefinite. It is unclear if the peptides are enzyme inhibitors, or if peptides are alternative to proteolytic enzyme inhibitors. It is recommended that clearer punctuation be provided throughout the claims to clearly separate alternative species.
The term “interferon like active substance” in claim 9 renders the claim indefinite. This term is not standard in the art, and is not defined by the instant specification. It is unclear what criteria must be met to be included in this genus of substances.
The term “nerve growth-related protein” in claim 9 renders the claim indefinite. This term is not standard in the art, and is not defined by the instant specification. It is unclear what criteria must be met to be included in this genus of substances.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation of a “pharmaceutically acceptable carrier or excipient”, and the claim also recites specific sub-genera and specific species of carriers and excipients which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation 4-28% of mucosal absorption enhancer, and the claim also recites 6-14%, 4-15%, 10% or 5% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation 0.3-2.5%, and the claim also recites 0.8-1.6%, 0.3-1.0%, 1.2%, 0.5%, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation 0.2-0.6%, and the claim also recites 0.25%-0.4%, 0.45-0.6%, 0.3%, 0.5% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In claim 11, the term “wild-type strain” renders the claim indefinite. It is unclear which “wild type strain” is being referenced, and what criteria must be met to be considered “wild type strain”.
The term “11 currently known variant strains” in claim 11 is a relative term which renders the claim indefinite. The term “currently known variant strains” is 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.
Claim 11 is indefinite due to the lack of clarity regarding which strains are actually required. It is unclear if only one of the strains must be present, or if all strains must be present simultaneously.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “variant strains”, and the claim also recites specific variant strains, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Interpretation
The claims are directed to methods for “preventing coronavirus infection” and “preventing a disease caused by a coronavirus infection”. The term “preventing” is defined in the instant specification as including “the prevention of novel coronavirus from infecting healthy people, and refers to preventive measures taken to protect or prevent individuals who have not yet been infected with the virus from infection” (see e.g. page 8 of the instant specification). The claims therefore read on administering interferon to any individual that has not been infected with a coronavirus, including healthy individuals, and the claims do not require that any infection is present in the subject.
The claims include several limitations using the terms “preferably”, “more preferably” and “further preferably”. The term “preferably” is given its general meaning in the art of being by choice or preference, or what is wanted or preferred. The term is therefore interpreted to merely indicate a preference for a choice that would be ideal, if the limitation is available. Therefore, the claims are interpreted to not require any of the limitations that appear in the “preferably” phrases, because those limitations are optional preferences.
For limitations that are recited both as a broad range or limitation, and a narrow range or limitation, the claims are given the broadest reasonable interpretation, which is to require only the broader range or limitation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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) 1-9 and 11 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Pestka et al (WO 2005/023290 A2; filed 5/21/04; published 3/17/05).
Instant claim 1 is drawn to a method of preventing coronavirus infection or preventing a disease caused by coronavirus infection, the method comprising administering interferon to a subject in need thereof, wherein the coronavirus is SARS-CoV-2, and preferably the disease caused by coronavirus infection is COVID-19.
Instant claim 2 is drawn to the method according to claim 1, wherein the coronavirus is mainly SARS-CoV-2 infected through droplet-nose-respiratory tract; and preferably, the interferon is one or more of IFN-α, IFN-β, and IFN-γ families.
Instant claim 3 is drawn to the method according to claim 1, wherein the interferon is one or a combination of a plurality of IFN-α subtypes, preferably, the interferon is one or more of IFN-α1b, IFN-α2a, IFN-α2b, and IFN-ω, more preferably, IFN-α1b or IFN-α2b, and further preferably, IFN-α2b.
Instant claim 4 is drawn to the method according to claim 1, wherein the interferon is a natural interferon or a recombinant human interferon, and preferably a recombinant human interferon.
Instant claim 5 is drawn to the method according to claim 1, wherein the interferon is a common interferon or a long-acting interferon.
Instant claim 6 is drawn to the method according to claim 1, wherein the interferon is administered nasally.
Instant claim 7 is drawn to the method according to claim 1, wherein the interferon is present in a dosage form that is prepared with the interferon as a pharmaceutically active ingredient, preferably, the dosage form is a nasal formulation, and more preferably, the nasal formulation is a nasal drop or a nasal spray.
Instant claim 8 is drawn to the method according to claim 1, wherein the formulation comprises a buffer; and preferably, the buffer is normal saline, phosphate buffer, citrate buffer, glucose saline (5% glucose injection), sodium bicarbonate buffer, acetate buffer or Tris-hydrochloric acid buffer, and more preferably, citrate buffer; and preferably, a final concentration of the interferon is 1000 U/ml to 3000000 U/ml, still preferably 2000 U/ml to 10000 U/ml or 5000 U/ml to 12000 U/ml, more preferably 3000 U/ml, 4000 U/ml, 5000 U/ml, 6000 U/ml, 7000 U/ml, or 8000 U/ml.
Instant claim 9 is drawn to the method according to claim 1, wherein the drug further comprises another pharmaceutically acceptable carrier or excipient, preferably, the pharmaceutically acceptable carrier or excipient is one or more selected from the group consisting of a mucosal absorption enhancer, a protectant and a bacteriostatic agent; more preferably, the mucosal absorption enhancer is one or more selected from the group consisting of surfactants, cyclodextrins and derivatives thereof, mannitol, phospholipids, peptides and proteolytic enzyme inhibitors, glycyrrhetic acid and its derivatives and metal ion chelating agents, and is more preferably mannitol; the protectant is one or more selected from the group consisting of human albumin, artificial plasma, erythropoietin, brain-derived neurotrophic factor, nerve growth factor, epidermal growth factor, fibroblast growth factor, basic fibroblast growth factor, insulin-like growth factor 1, hyaluronidase, neuregulin, leukemia inhibitory factor, interleukin, interferon-like active substance, tumor necrosis factor, glial growth factor, growth differentiation factor, and nerve growth-related protein, and is more preferably human albumin; the bacteriostatic agent is one or more selected from the group consisting of sorbic acid, potassium sorbate, benzoic acid, parabens, and combined use of benzoic acid and potassium sorbate, and is more preferably sodium benzoate; preferably, a concentration of the mucosal absorption enhancer is 4-28% (v/v), preferably 6-14% (v/v) or 4-15% (v/v), and more preferably 10% (v/v) or 5% (v/v); preferably, a concentration of the protectant is 0.3-2.5% (w/v), preferably 0.8-1.6% (w/v) or 0.3-1.0% (w/v), and more preferably 1.2% (w/v) or 0.5% (w/v); and preferably, a concentration of the bacteriostatic agent is 0.2-0.6% (w/v), preferably 0.25-0.4% (w/v) or 0.45-0.6% (w/v), and more preferably 0.3% (w/v) or 0.5% (w/v).
Instant claim 11 is drawn to the method according to claim 1, SARS-CoV-2 comprises wild-type strain and 11 currently known variant strains, wherein the variant strains comprise α, β, δ, γ and Omicron, and Omicron comprises BA.1, BA.2, BA.3, BA.4 and BA.5.
Regarding the limitations of instant claim 1, Pestka teaches a method of treating or preventing an individual with coronavirus comprising administering interferon (see e.g. page 12, lines 5-11, 15-20).
Regarding the limitation of instant claim 2, Pestka teaches preventing a subject from becoming afflicted or infected with a virus (see e.g. page 15, lines 19-26 and page 16, lines 1-12). The prevention can be accomplished by administering an IFN-α (see e.g. page 16, lines 27-28). As indicated above, the claims do not require that an individual suffers from an infection to be administered the interferon, therefore administering to any individual that is not already infected meets the limitations of the claims.
Regarding the limitations of instant claim 3, Pestka teaches the administered interferon can be an IFN-α (see e.g. page 16, lines 25-end of page).
Regarding the limitations of instant claim 4, Pestka teaches the interferon proteins can be produced by recombinant techniques (see e.g. page 8, lines 23-26). The sequences of the interferons that may be administered are human interferon sequences (see e.g. page 3, lines 20-25).
Regarding the limitations of instant claim 5, Pestka teaches the terms “common” and “long-acting” are not defined by the instant specification. The term “common” will be interpreted to include any wild-type interferon, because these interferons will be the most “common”. Therefore, the reference reads on the claims because the administered interferon can be an IFN-α (see e.g. page 16, lines 25-end of page).
Regarding the limitations of instant claim 6 and 7, Pestka teaches the interferons can be administered nasally (see e.g. page 32, lines 1-10). This would inherently require a formulation prepared for nasal formation. Further, the administration can occur by nasal spray (see e.g. page 32, lines 1-10).
Regarding the limitations of instant claim 8, Pestka teaches the interferon can be formulated in a pharmaceutically acceptable carrier such as buffered saline (see e.g. page 30, lines 10-16). And the interferon can be formulated at 8000 U/ml (see e.g. page 85, lines 25-30).
Regarding the limitations of instant claim 9, Pestka teaches the reference interferon formulation can comprise mannitol or a number of other excipients and agents (see e.g. page 35, lines 14-25).
Regarding the limitation of instant claim 11, Pestka teaches the reference teaches preventing a subject from becoming afflicted or infected with a virus (see e.g. page 15, lines 19-26 and page 16, lines 1-12). The prevention can be accomplished by administering an IFN-α (see e.g. page 16, lines 27-28). As indicated above, the claims do not require that an individual suffers from an infection to be administered the interferon, therefore administering to any individual that is not already infected meets the limitations of the claims.
Conclusion
No claim is allowed.
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/ANDREA K MCCOLLUM/Examiner, Art Unit 1674