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 .
Claim Status
The amendments and arguments filed 4/21/26 are acknowledged. Claim 3 is cancelled. New claims 12-20 are added. Claims 1-2, 4-5, 7-9, and 11 are amended.
Claims 1-2 and 4-20 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Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-2, 4-9, and 11-20 are currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The information disclosure statement filed on 5/4/25 has been considered. A signed copy is enclosed.
The references lined through were not considered because the references were not properly cited including date, journal, patent application number and/or author.
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.
Withdrawn Objections
The objection to claim 11 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” is withdrawn in light of Applicant’s amendments thereto.
The objection to the abstract of the disclosure because the terms “SARS-CoV-2” and “COVID-19” contain acronyms and/or abbreviations that should be spelled out upon first occurrence is withdrawn in light of Applicant’s amendments thereto.
Objections Maintained
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. The phrase SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2)should be amended to read “(SARS-CoV-2)” Appropriate correction is required.
The objection is maintained. Applicant has amended the claims to spell out the acronyms, abbreviations and/or initialisms. However, the full name of the term should be presented before the acronym, abbreviation or initialism, as shown above. Appropriate correction is required.
Claim Rejections Withdrawn
The rejection of claim(s) 1-2, 4-9 and 11 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) is withdrawn in light of Applicant’s amendments thereto. The rejection of claim 3 is rendered moot by cancellation of the claim.
Claim Rejections Maintained
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.
The rejection of claims 1-2, 4-9, and 11-20 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 is maintained. The rejection of claim 3 is rendered moot by cancellation of the claim. 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.
Applicant’s Arguments
Applicant did not provide amendments or arguments to address the rejection, and therefore the rejection is maintained.
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.
The rejection of claims 1-2, 4-9, and 11-20 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.
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.
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.
Claims depending from the rejected claims do not remedy the deficiency and therefore are also rejected.
Applicant’s Arguments
Applicant argues:
1. The term “in need thereof” refers to “healthy individuals in need of prevention of prevention of novel coronavirus infection,” “healthy people who are negative for novel coronavirus nucleic acid detection or novel coronavirus immunoglobulin,” “SARS-CoV-2 infected people who have been infected with SARS-CoV-2 but have no obvious symptoms.” The scope of the term is therefore clear. Further, the term “subject in need thereof” is a standard term for defining a subject population and is widely accepted by USPTO.
2. A long-acting interfering refers to product modified to extend in vivo half-life and reducing dosing frequency. Paragraph [0078] is identified, which states that “the interferon may be modified by polyethylene glycol to obtain a long-acting interferon.” Applicant identifies conventional techniques for modifying interferons.
3. Applicant asserts that the final concentration “is the concentration of interferon in the formation finally prepared.”
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
Applicant is attempting to use circular logic to define “a subject in need thereof” as “a subject in need thereof”. The specification does not define “need” and it is unclear if any subject not infected would be “in need” of treatment, or if there are further characteristics that define the population. Further, while the term “subject in need thereof” does appear in various patents issued by the Office, each case is evaluated on a case-by-case basis, and in particular, to determine whether the metes and bounds of the claimed invention are definite. The language of the instant claims suggests that subject must meet particular criteria to be “in need thereof,” yet the disclosure fails to identify those criteria. One of skill in the art would not be able to determine which subjects are “in need” and which are not. Therefore, the claim scope is indefinite.
A single example of a possible long-acting interferon does not identify the metes and bounds of the genus of compounds identified as “long-acting.” For example, how “long” is “long”? The scope of the term “long” is relative to the practitioner. Identifying an interferon as “modified to extend in vivo half-life” raises a similar question. To what is the half-life compared when identifying whether the half-life is “extended?” In other words, the terms “long” and “extended” are relative in nature and dependent on the comparison chosen by each individual practitioner. Therefore the scope of the claims is indefinite.
The term “finally prepared” is also relative. Neither the claim nor the disclosure identifies criteria for distinguishing “finally prepared” compositions from non-finally prepared compositions. Further, the use of the term “final” suggests that additional method steps are required that would produce intermediate concentrations. The term “final” also creates ambiguity regarding whether the composition in previous claims are “final” or intermediate. The issue is further compounded by reciting “a final concentration” which suggests that there could be multiple final concentrations. Amending the claim to read “and the concentration of the interferon is 1000 U/ml to 3000000 U/ml” would overcome the rejection.
New Claim Rejections
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 8, 9, 14-15, and 19-20 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 8 has been amended to recite “0.9% sodium chloride injection” and “5% glucose injection.” The claim is reciting limitations related to a buffer. It is unclear whether the injection is considered the buffer, or is a step in the method. It is recommended that the claim is amended to remove the term “injection.”
Claim 9 recites the limitation "the drug". There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "another pharmaceutically acceptable carrier or excipient". There is insufficient antecedent basis for this limitation in the claim. Specifically, the base claim does not require a pharmaceutically acceptable carrier or excipient, and therefore the term “another” lacks antecedent basis.
Overlapping ranges of for limitations (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 14 sets forth two recited ranges that overlap. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by the overlapping language is a required feature of the claims.
The term “final” in claims 14-15 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 19 recites the broad recitation 4-15%, and the claim also recites 6-14% 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 20 recites the broad recitations (0.8-1.6% and 0.25%-0.4%, and the claim also recites 0.3-1.0% and 0.45-0.6%, 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 20, it is unclear if both the protectant and the bacteriostatic agent must be present, as evidenced by the term “and,” or if the concentrations represent alternative agents that can be present in the composition that is administered.
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.
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) 1-2, 4-5, 7-8, 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 Shen et al (US 2006/0029573 A1; filed 6/30/05; published 2/9/06).
Instant claim 1 is drawn to a method of preventing SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) infection or preventing a disease caused by SARS-CoV-2 infection, the method comprising administering interferon to a subject in need thereof, and the interferon is α1b.
Instant claim 2 is drawn to the method according to claim 1, wherein the SARS-CoV-2 is infected through droplet-nose-respiratory tract.
Instant claim 4 is drawn to the method according to claim 1, wherein the interferon is a natural interferon or a recombinant human interferon.
Instant claim 5 is drawn to the method according to claim 1, wherein the interferon is 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.
Instant claim 8 is drawn to the method according to claim 1, wherein the formulation comprises a buffer; and the buffer is 0.9% sodium chloride injection, phosphate buffer, citrate buffer, 5% glucose injection, sodium bicarbonate buffer, acetate buffer or Tris-hydrochloric acid buffer; and a final concentration of the interferon is 1000 U/ml to 3000000 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, wherein 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; a concentration of the mucosal absorption enhancer is 4-28% (v/v); a concentration of the protectant is 0.3-2.5% (w/v); and a concentration of the bacteriostatic agent is 0.2-0.6% (w/v).
Instant claim 11 is drawn to the method according to claim 1, wherein the SARS-CoV-2 comprises α, β, δ, γ or Omicron variant strain, and Omicron comprises BA.1, BA.2, BA.3, BA.4 and BA.5.
Instant claim 12 is drawn to the method according to claim 7, wherein the dosage form is a nasal formulation.
Instant claim 13 is drawn to the method according to claim 12, wherein the nasal formulation is a nasal drop or a nasal spray.
Instant claim 14 is drawn to the method according to claim 8, wherein the final concentration of the interferon is 2000 U/ml to 10000 U/ml or 5000 U/ml to 12000 U/ml.
Instant claim 15 is drawn to the method according to claim 14, wherein the final concentration of the interferon is 3000 U/ml, 4000 U/ml, 5000 U/ml, 6000 U/ml, 7000 U/ml, or 8000 U/ml.
Instant claim 16 is drawn to the method according to claim 9, wherein the mucosal absorption enhancer is one or more selected from the group consisting of surfactants, cyclodextrins and derivatives thereof, mannitol, phospholipids, glycyrrhetic acid and its derivatives and metal ion chelating agents.
Instant claim 17 is drawn to the method according to claim 9, wherein 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, tumor necrosis factor, glial growth factor, and growth
Instant claim 18 is drawn to the method according to claim 9, wherein 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.
Instant claim 19 is drawn to the method according to claim 9, wherein the concentration of the mucosal absorption enhancer is 6-14% (v/v) or 4-15% (v/v)
Instant claim 20 is drawn to the method according to claim 9, wherein the concentration of the protectant is 0.8- 1.6% (w/v) or 0.3-1.0% (w/v), and the concentration of the bacteriostatic agent is 0.25-0.4% (w/v) or 0.45-0.6% (w/v).
Regarding the limitations of instant claim 1-2, 11, Shen teaches the administration of human interferon alpha-1b to treat and prevent viral infections (see e.g. paragraph [0002], [0021]-[0023], and [0026]). As stated above, the instant claims read on administering interferon to any individual that has not been infected with a coronavirus, and the claims do not require that any infection is present in the subject. Therefore, the administration of Shen to prevent disease would inherently prevent disease caused by SARS-CoV-2.
Regarding the limitations of instant claim 4, Shen teaches that the interferon alpha-1b can be isolated from human cells or tissues, or can be recombinant protein expressed in a host cell (see e.g. paragraph [0021]).
Regarding the limitations of instant claim 5, Shen teaches that the interferon can be modified to increase serum half-life and pharmacokinetic profile (see e.g. paragraph [0002]).
Regarding the limitations of instant claim 7, Shen teaches that the pharmaceutical composition can be present with a pharmaceutically acceptable carrier, excipient, or auxiliary agent (see e.g. paragraph [0078]).
Regarding the limitations of instant claim 8, Shen teaches that the interferon can be eluted into a buffer that comprises sodium acetate and sodium chloride buffers (see e.g. paragraph [0096]).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-8, and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al (US 2006/0029573 A1; filed 6/30/05; published 2/9/06) in light of Wang et al (Trends in Immunology April 2012, Vol. 33, No. 4; p. 190-197).
Instant claim 1 is drawn to a method of preventing SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) infection or preventing a disease caused by SARS-CoV-2 infection, the method comprising administering interferon to a subject in need thereof, and the interferon is α1b.
Instant claim 2 is drawn to the method according to claim 1, wherein the SARS-CoV-2 is infected through droplet-nose-respiratory tract.
Instant claim 4 is drawn to the method according to claim 1, wherein the interferon is a natural interferon or a recombinant human interferon.
Instant claim 5 is drawn to the method according to claim 1, wherein the interferon is 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.
Instant claim 8 is drawn to the method according to claim 1, wherein the formulation comprises a buffer; and the buffer is 0.9% sodium chloride injection, phosphate buffer, citrate buffer, 5% glucose injection, sodium bicarbonate buffer, acetate buffer or Tris-hydrochloric acid buffer; and a final concentration of the interferon is 1000 U/ml to 3000000 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, wherein 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; a concentration of the mucosal absorption enhancer is 4-28% (v/v); a concentration of the protectant is 0.3-2.5% (w/v); and a concentration of the bacteriostatic agent is 0.2-0.6% (w/v).
Instant claim 11 is drawn to the method according to claim 1, wherein the SARS-CoV-2 comprises α, β, δ, γ or Omicron variant strain, and Omicron comprises BA.1, BA.2, BA.3, BA.4 and BA.5.
Instant claim 12 is drawn to the method according to claim 7, wherein the dosage form is a nasal formulation.
Instant claim 13 is drawn to the method according to claim 12, wherein the nasal formulation is a nasal drop or a nasal spray.
Instant claim 14 is drawn to the method according to claim 8, wherein the final concentration of the interferon is 2000 U/ml to 10000 U/ml or 5000 U/ml to 12000 U/ml.
Instant claim 15 is drawn to the method according to claim 14, wherein the final concentration of the interferon is 3000 U/ml, 4000 U/ml, 5000 U/ml, 6000 U/ml, 7000 U/ml, or 8000 U/ml.
Instant claim 16 is drawn to the method according to claim 9, wherein the mucosal absorption enhancer is one or more selected from the group consisting of surfactants, cyclodextrins and derivatives thereof, mannitol, phospholipids, glycyrrhetic acid and its derivatives and metal ion chelating agents.
Instant claim 17 is drawn to the method according to claim 9, wherein 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, tumor necrosis factor, glial growth factor, and growth
Instant claim 18 is drawn to the method according to claim 9, wherein 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.
Instant claim 19 is drawn to the method according to claim 9, wherein the concentration of the mucosal absorption enhancer is 6-14% (v/v) or 4-15% (v/v)
Instant claim 20 is drawn to the method according to claim 9, wherein the concentration of the protectant is 0.8- 1.6% (w/v) or 0.3-1.0% (w/v), and the concentration of the bacteriostatic agent is 0.25-0.4% (w/v) or 0.45-0.6% (w/v).
Regarding the limitations of instant claim 1-2, 11, Shen teaches the administration of human interferon alpha-1b to treat and prevent viral infections (see e.g. paragraph [0002], [0021]-[0023], and [0026]). As stated above, the instant claims read on administering interferon to any individual that has not been infected with a coronavirus, and the claims do not require that any infection is present in the subject. Therefore, the administration of Shen to prevent disease would inherently prevent disease caused by SARS-CoV-2.
Regarding the limitations of instant claim 4, Shen teaches that the interferon alpha-1b can be isolated from human cells or tissues, or can be recombinant protein expressed in a host cell (see e.g. paragraph [0021]).
Regarding the limitations of instant claim 5, Shen teaches that the interferon can be modified to increase serum half-life and pharmacokinetic profile (see e.g. paragraph [0002]).
Regarding the limitations of instant claim 7, Shen teaches that the pharmaceutical composition can be present with a pharmaceutically acceptable carrier, excipient, or auxiliary agent (see e.g. paragraph [0078]).
Regarding the limitations of instant claim 8, Shen teaches that the interferon can be eluted into a buffer that comprises sodium acetate and sodium chloride buffers (see e.g. paragraph [0096]).
Shen does not teach the administration of the interferon as a nasal spray or in a nasal formulation.
Wang teaches a completed randomized controlled trial to examine safety and efficacy of recombinant IFN-α administered in the form of a nasal spray (see e.g. page 194, right column). One conclusion from the trial was that for SARS-CoV, the implications are that IFN-α treatment can override inhibitory effects of NS1 on an IFN response (see e.g. page 194, right column). Further, Wang specific indicates that data support the idea that IFN treatment demonstrates antiviral activity in SARS-CoV (see e.g. page 193, right column).
It would have been obvious to one with ordinary skill in the art, at the time of the invention, to formulate and administer the IFN-alpha-1b of Shen as a nasal formulation because nasally-administered IFN-alpha treatment has been shown to be effective for treating viral infection and preventing viral disease in Wang. The Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. Wang establishes that IFN-alpha treatment can be administered nasally, and shows that nasal administration can successfully reduce infection symptoms. Formulating the interferon of Shen as a nasal formulation would encompass an analogous product with differences that were encompassed in known variation or principle known in the art that would have been predictable to one of skill in the art. Thus, the combination of prior art references as combined provided a prima facie case of obviousness, absent convincing evidence to the contrary.
Regarding the specific concentrations of interferon, buffers, and other excipients, one of ordinary skilled in the art would have been motivated to optimize the concentrations of the agents in the composition, since “it is the normal desire of scientists or artisans to improve upon what is already generally known”. The MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller. 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson. 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc, v. Biocraft Laboratories Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert, denied, 493 U.S. 975 (1989); In re Kulling. 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler. 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
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.
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/ANDREA K MCCOLLUM/Examiner, Art Unit 1674
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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