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
Claims 1-16 and 18-20 are pending. Claims 3-4, 7-8, 10, 15, or 18-20 are withdrawn. Claims 1-2, 5-6, 9, 11-14, and 16 are presently considered.
Election/Restrictions
Applicant's election with traverse of the species represented by Example 3, using SEQ ID NO: 1 (i.e., “Peptide 346-001”) to treat SARS-CoV-2 infection in the reply filed on 11/21/2025 is acknowledged. The traversal is on the grounds that (i) the claimed embodiments share a special technical feature (see, e.g., Reply filed 11/21/2025 at 2), (ii) define a contribution over the prior art (see, e.g., Reply filed 11/21/2025 at 2), and (iii) that the request for a single, disclosed species is “unduly limiting” (see, e.g., Reply filed 11/21/2025 at 3). The prior art set forth in the Requirement identified the prior art taught the same peptide (i.e., “Peptide 346-001”) could be utilized to treat any viral infections (see, e.g., Requirement at 5), and therefore the claims do not recite a “special technical feature” within the meaning of PCT Rules 13.1 and 13.2. Regarding (ii), allegations of unexpected results, reliance upon unclaimed limitations, and arguments that the prior art teachings should be dismissed as speculative in the absence of a reduction to practice are not persuasive because they fail to establish unity of invention or otherwise a special technical feature within the meaning of PCT Rules 13.1 and 13.2. Regarding (iii), a requirement to elect a single, disclosed species is consistent with the MPEP and species election practice (see, e.g., Requirement at 3 at footnote). Regarding arguments regarding the fact that the disclosed example is to a model system, Applicant is advised that the model system is understood to be an obvious variant for human treatment of SARS-CoV-2, consistent with the pending claims. In addition, Examiner notes that no unity of invention exists in view of the rejections placed on record, below.
The requirement is still deemed proper and is therefore made FINAL.
The originally elected species is understood to be a treatment of a subject for SARS-CoV-2, wherein the treatment comprises the administration of SEQ ID NO: 1 (i.e., “Peptide 346-001”; “SWLRDIWDWICEVLSDFK”; CAS No. 811418-15-2) via intranasal or pulmonary routes, consistent with instant claim 1. The originally elected species is understood to read upon instant claims 1-2, 5-6. 9, 11-14, and 16. However, the originally elected species does not read upon claims requiring a peptide other than SEQ ID NO: 1 (i.e., claims 3-4, 19-20), claims requiring additional components (i.e., claims 10, 18), or claims requiring the treatment of a virus other than SARS-CoV-2 (i.e., claims 7-8, 15). Accordingly, the originally elected species reads upon instant claims 1-2, 5-6, 9, 11-14, and 16; but does not read upon instant claims 3-4, 7-8, 10, 15, or 18-20.
Following extensive search and examination, the originally elected species has been deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
Accordingly, claims 1-2, 5-6, 9, 11-14, and 16 are rejected in view of the originally elected species and claims that do not read upon the originally elected species are withdrawn.
Claims 3-4, 7-8, 10, 15, or 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/21/2025.
Accordingly, claims 1-2, 5-6, 9, 11-14, and 16 are presently considered.
Priority
The priority claim to US Provisional Application 63/056,301 (filed 7/24/2020) is acknowledged.
Examiner notes that the disclosure and claims of Pro’301 differ substantially from the instant application and claims. Notably, the specifics of Example 3, Table 1, and limitations pertaining to variability of SEQ ID NO: 1 commensurate in scope with the instant claims are absent.
Information Disclosure Statement
The IDS filed 11/17/2023; 07/09/2024; and 12/03/2025 are each acknowledged and presently considered.
Applicant should note that one or more documents disclosed on the IDS form submitted on 11/17/2023 and 12/03/2025 were not considered since they did not conform to 37 CFR 1.98(b) by providing a proper date, as 37 CFR 1.98(b) requires that each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue. See MPEP 609.04(a). Here, the earliest priority claim is to US Provisional Application 63/056,301, filed 7/24/2020; therefore, all documents published in 2019 or later must be accompanied by both month and date of publication.
References that were not considered have been indicated by strike-though on the attached IDS forms. Although not considered, these documents have been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of 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 statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claims 1 and 11 are representative of the pending claim scope. Applicable claim interpretation is discussed below.
“Preventing” is explicitly defined on record and given a special definition to mean “in the context of the disclosure” something other than “100% inhibition of appearance of the disease”; specifically, the term is understood to include “Any degree of reduction in the initial appearance of symptoms, inhibition of viral infection, prolonging relapse” and “inhibiting an initial surge of viral load” (see, e.g., Spec. filed 1/23/2023 at ¶[0033]). In view of the specialized definition, “preventing” does not mean “100%” prevention of infection (i.e., a virus or viral particle entering the body).
“Treating” is explicitly defined on record to mean “Any degree of ‘treatment’”, including “lessening of one or more symptoms of the disease, reduction in viral load” and “improvement in quality of life”, wherein “treating” of a disease “does not require 100% abolition of the disease or disorder” (see, e.g., Spec. filed 1/23/2023 at ¶[0033]).
“Respiratory virus” is exemplified, but not exhaustively defined (see, e.g., Spec. filed 1/23/2023 at ¶[0032]). Accordingly, for purposes of examination, the term is understood to fully encompass all viruses “which affect the upper respiratory tract”, and have “similar traits” (e.g., causing fever, headache, body aches, dry cough, hypoxia, and/or pneumonia) consistent with the description in the originally filed disclosure (see, e.g., Spec. filed 1/23/2023 at ¶[0032]).
Additional claim interpretations are set forth below.
Claim Objections
Claims 1-2, 11, and 12 are objected to because of the following informalities:
At claims 1-2 and 11, the name “Peptide 346-001” is not a term of art, IUPAC name, gene name, or protein name. The term is understood to refer to SEQ ID NO: 1. The claim should be amended to refer to the SEQ ID NO (e.g., “Peptide 346-001 (SEQ ID NO: 1)” or “SEQ ID NO: 1”).
Claim 11 refers to “Formula I”, which is identified as SEQ ID NO: 72 at ¶[0037], but claim 11 does not recite “SEQ ID NO: 72”. Per MPEP 37 CFR 1.831,
(c) Where the description or claims of a patent application discuss a sequence that is set forth in the "Sequence Listing XML" in accordance with paragraph (a) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:" or the like in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.
Accordingly, claim 11 should be amended to include the reference to SEQ ID NO: 72.
Claim 12 is objected because the claim attempts to incorporate one or more Tables by reference (e.g., Table 1), which is improper per MPEP § 2173.05(s). MPEP § 2173.05(s) states that
[w]here possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.
Here, if Applicant meant to incorporate the Tables by reference, the incorporation is improper because no necessity has been asserted or established. Furthermore, simply reciting sequence identifiers is common in the art and does not evidence or suggest the existence of any “exceptional circumstances where there is no practical way to define the invention”.
Appropriate correction is required.
Sequence Listing
The instant disclosure is objected to for not complying with 37 C.F.R. 1.821 as detailed in MPEP §§ 2421–2424. Specifically, the instant application does not comply with 37 C.F.R. 1.821(b)-(e). The instant claims and/or disclosure contain references or disclosures of amino acid sequences that should be accompanied by a sequence listing and identified using "SEQ ID NOs” as prescribed (see, MPEP §§ 2421–2424). Specifically, the instant application discloses a sequences at Figure 1, but does not identify a SEQ ID NO either in the Figure or in the Specification (see, e.g., Spec. at ¶[0008]).
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.
Claim 12 is 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 12 recites the limitation "Table 1" at line 2. There is insufficient antecedent basis for this limitation in the claim. If Applicant attempt means to incorporate Table 1 from the Specification by reference, that is improper per MPEP § 2173.05(s), and creates additional issues of indefiniteness because claim 12 recites “comprising”. The term “comprising” is open-ended suggesting that additional N- or C-terminal extensions may exist, but Table 1 shows multiple sequences (e.g., SEQ ID NOs: 17-30, 36-39, 60-71), that are defined in a manner that appears to exclude additional N- or C- terminal extensions, or other modifications, without materially and substantially altering the structure recited at Table 1. Accordingly, even assuming arguendo that the incorporation by reference of Table 1 was proper, claim 12 would still be rejected as indefinite because it is unclear how a larger peptide may “comprise” the sequences set forth at Table 1. For purposes of applying prior art, claim 12 is understood to read upon at least a polypeptide consisting of instant SEQ ID NO: 1. This rejection could be overcome by explicitly reciting the species of Table 1 at claim 12, and by using “consisting of” rather than “comprising” language.
Accordingly, claim 12 is rejected as indefinite.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-2 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over US2007/0073039A1 in view of Vielle et al.1
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejection and also in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below
Regarding instant claims 1-2 and 11-12, US’039 pertains to the treatment and prevention of viral infections by members of the Flaviviridae family by administering an effective amount of SEQ ID NO: 43 to humans (see, e.g., US’039 at claims 22, 40, 44-45, ¶¶[0044], [0068]-[0069], [0132]-[0133], [0135]-[0137], [0222]). Regarding instant claims 1-2, 11-12, and the structure of instant SEQ ID NO: 1, US’039 discloses SEQ ID NO: 43 (compare US’039 at SEQ ID NO: 43 with instant SEQ ID NO: 1, showing 100% identity and noting that both sequences are SWLRDIWDWICEVLSDFK). Accordingly, the peptide is a prior art element. Regarding instant claims 1-2, 11-12, and intranasal or pulmonary administration, US’039 identifies that the disclosed peptides, including SEQ ID NO: 43, may be administered to the “upper (nasal) or lower respiratory tract by inhalation” (see, e.g., US’039 at ¶[0166]), and generally discloses that such compounds can be administered to the respiratory tract “to treat or prevent the clinical symptoms of the viral infection” (see, e.g., US’039 at ¶¶[0163]-[0164]; see also id. at ¶¶[0139]-[0140]-[0145], [0148], [0153]). Regarding instant claims 1-2, 11-12, and the amount administered, US’039 provides guidance regarding what constitutes an “effective amount” for inhalation treatments, including dosages of 0.01 mg/kg to 100 mg/kg, and total daily doses of 0.1g/day over 4 g/day (see, e.g., US’039 at ¶¶[0139]-[0140], [0142]-[0145], [0153], [0163]-[0164], [0166]). Regarding instant claims 1-2, 11-12, and the formulation administered, US’039 provides guidance regarding formulations for inhalation (see, e.g., US’039 at ¶¶[0139]-[0140]-[0145], [0148], [0153], [0163]-[0164]; see esp. id. at ¶¶[0145], [0149], [0153], [0166]).
The prior art of US’039 differs from instant claims 1-2 and 11-12 as follows: The primary reference does not explicitly teach that members of Flaviviridae include a “respiratory virus” as instantly claimed, and US’039 does not use the term “respiratory virus”.
The term “respiratory virus” as recited at instant claim 1 is not defined on record to exclude any virus from the Flaviviridae family (see, e.g., Spec. filed 1/23/2023 at ¶[0032]). Rather, the term “respiratory virus” as used at instant claim 1 is reasonably understood to fully encompass all viruses “which affect the upper respiratory tract”, and have “similar traits” (e.g., causing fever, headache, body aches, dry cough, hypoxia, and/or pneumonia) consistent with the description in the originally filed disclosure (see, e.g., Spec. filed 1/23/2023 at ¶[0032]). Therefore, the relevant issue is whether or not a virus of the Flaviviridae would be considered a “respiratory virus” within the scope of the instant claims.
Vielle discloses that, circa 2019, it was known in the art that Flaviviruses affect the upper respiratory tract in humans (see, e.g., Vielle at title, abs, 2 at col I at 1st partial ¶, 2 at 1st full ¶, 5 at col I-II at bridging ¶), and that Flaviviruses have been detected “in the human upper respiratory tract within the first days of fever” (see, e.g., id. at 2 at col I at 1st partial ¶). Accordingly, circa 2019, an artisan would readily appreciated that a Flavivirus would “affect the upper respiratory tract”, and therefore would fall within the meaning of a “respiratory virus” as recited at instant claim 1 (compare Vielle at title, abs, 2 at col I at 1st partial ¶, 2 at 1st full ¶, 5 at col I-II at bridging ¶ with instant claim 1 and Spec. filed 1/23/2023 at ¶[0032], identifying that a “respiratory virus” included all viruses “which affect the upper respiratory tract”).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The claimed invention is the combination of prior art elements (i.e., known peptide, known administration route, known dosage ranges, known pharmaceutical formulations for inhalation) according to known methods of treating Flaviviruses as taught by the primary reference, wherein the family of Flaviviruses are understood to include viruses affecting the upper respiratory tract in humans as disclosed by the secondary reference, and wherein performing such treatment would predictably yield the exact results taught and disclosed by US’039, namely the successful treatment of viruses of the Flaviviridae family (see, e.g., MPEP §§ 2143(I)(A), 2143(I)(C), 2144.07). Furthermore, each prior art compound merely performs its art-recognized function.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the art to treat a known family of viruses using a known compound via a known administration route and within a known dosage range to predictably obtain the exact results taught and disclosed by the prior art.
Accordingly, claims 1-2 and 11-12 are rejected.
Claims 1-2, 5-6, 9, 11-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US2007/0073039A1 in view of Martinez2, Park et al.3, Lin et al.4, and WO2009/014615A2.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejection and also in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below
Regarding instant claims 1-2 and 11-12, US’039 pertains to the treatment and prevention of viral infections by members of the Flaviviridae family by administering an effective amount of SEQ ID NO: 43 to humans (see, e.g., US’039 at claims 22, 40, 44-45, ¶¶[0044], [0068]-[0069], [0132]-[0133], [0135]-[0137], [0222]). Regarding instant claims 1-2, 11-12, and the structure of instant SEQ ID NO: 1, US’039 discloses SEQ ID NO: 43 (compare US’039 at SEQ ID NO: 43 with instant SEQ ID NO: 1, showing 100% identity and noting that both sequences are SWLRDIWDWICEVLSDFK). Accordingly, the peptide is a prior art element. Regarding instant claims 1-2, 11-12, and intranasal or pulmonary administration, US’039 identifies that the disclosed peptides, including SEQ ID NO: 43, may be administered to the “upper (nasal) or lower respiratory tract by inhalation” (see, e.g., US’039 at ¶[0166]), and generally discloses that such compounds can be administered to the respiratory tract “to treat or prevent the clinical symptoms of the viral infection” (see, e.g., US’039 at ¶¶[0163]-[0164]; see also id. at ¶¶[0139]-[0140]-[0145], [0148], [0153]). Regarding instant claims 1-2, 11-12, and the amount administered, US’039 provides guidance regarding what constitutes an “effective amount” for inhalation treatments, including dosages of 0.01 mg/kg to 100 mg/kg, and total daily doses of 0.1g/day over 4 g/day (see, e.g., US’039 at ¶¶[0139]-[0140], [0142]-[0145], [0153], [0163]-[0164], [0166]). Regarding instant claims 1-2, 11-12, and the formulation administered, US’039 provides guidance regarding formulations for inhalation (see, e.g., US’039 at ¶¶[0139]-[0140]-[0145], [0148], [0153], [0163]-[0164]; see esp. id. at ¶¶[0145], [0149], [0153], [0166]).
The prior art of US’039 differs from instant claims 1-2 and 11-12 as follows: The primary reference does not explicitly teach the application of the prior art methods to the treatment of a coronavirus infection, such as SARS-CoV-2. Therefore, the issue is whether or not it would have been obvious to treat SARS-CoV-2 with a known antiviral agent in view of the prior art.
Regarding claims 1-2, 5-6, 9, 11-14, and 16 and the treatment of SARS-CoV-2, Martinez explains that, circa 2020, there was an ongoing epidemic referred to as “COVID-19” or SARS-CoV-2, and there was a “need for therapeutic alternatives to alleviate and stop this new epidemic” (see, e.g., Martinez at title, abs), because the world was “in the thick of a SARS-CoV-2 pandemic” (see, e.g., Martinez at 5 at final ¶). Martinez identifies an art-recognized problem circa mid 2020, namely that “we urgently need to develop effective vaccine and antiviral therapeutics to stop the SARS-CoV-2 epidemic” (see, e.g., Martinez at 2-3 at bridging ¶). Martinez identifies an art-recognized solution, namely “repurposing preexisting compounds that might provide new opportunities for treating people infected with SARS-CoV-2” (see, e.g., Martinez at 2-3 at bridging ¶).
Upon review of the prior art, an artisan would readily appreciate that the primary reference disclosed methods of administering to humans the antiviral peptide of SEQ ID NO: 43 (SWLRDIWDWICEVLSDFK) (see, e.g., US’039 at claims 22, 40, 44-45, ¶¶[0044], [0068]-[0069], [0132]-[0133], [0135]-[0137], [0222]). Therefore, the issue is whether or not it would have been obvious to treat SARS-CoV-2 with SWLRDIWDWICEVLSDFK with a reasonable expectation of success.
Park, Lin, and WO’615 are cited herein to establish the predicted and expected results of administering SWLRDIWDWICEVLSDFK to patients, circa mid 2020.
First, Lin and Park establish that SWLRDIWDWICEVLSDFK was a prior art element, and art-recognized art-recognized amphipathic α-helical peptide referred to as “C5A” (see, e.g., Lin at title, abs, 2088 at § “Materials and Methods; see, e.g., Park at title, abs, Fig. 1 on 9935, Fig. 2 on 9936).
Second, Lin identifies that “C5A” was an art-recognized antiviral agent already known in the art to at least “inhibit infection by selected flaviviruses, paramyxoviruses, and HIV” as well as HCV (see, e.g., Lin at 2087-2088 at bridging ¶).
Third, Lin discloses that C5A acts as an antiviral agent through multiple pathways, and promotes host immune responses required for the destruction and clearance of infectious agents (see, e.g., Lin at 2093-2094 at bridging ¶; see also Lin at 2089 at col II at § Results, 2092 at col I-II at bridging ¶, 2092 at col II at 1st full ¶).
Fourth, Park identifies that “the C5A peptide has potent antiviral activity against numerous enveloped viruses” (see, e.g., Park at 9935 at col II at 1st full ¶). Park identifies that C5A can be utilized to effect “LEAD” (“Lipid envelope antiviral disruption”) to achieve “an antiviral peptide-induced reduction in the extracellular concentration of infectious virus particles” that would “lead to medically beneficial outcomes” (see, e.g., Park at abs, 9934-9935 at § Introduction, Fig. 1 on 9935, reproduced in part below):
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Fifth, WO’615 identifies that it was generally known in the prior art that amphipathic alpha-helical peptides were art-recognized antiviral agents (see, e.g., WO’615 at title, abs, claims; compare id. with Park at abs, 9934-9935 at § Introduction, Fig. 1 on 9935). Like Park, WO’615 discloses that amphipathic alpha-helical (AH) peptides could be utilized to cause disruption of lipid-containing vesicles, such as enveloped viruses (see, e.g., WO’615 at ¶[0006]). In view of US’039, Lin, and Park, an artisan would readily appreciate that the WO’615 disclosure pertained to C5A, because C5A comprises SEQ ID NO: 1 and 11 as disclosed by WO’615 (compare US’039 at SEQ ID NO: 43 with WO’615 at ¶¶[0064]-[0065], SEQ ID NOs: 1 and 11, noting that C5A comprises SEQ ID NO: 11 and satisfies the formula of SEQ ID NO: 1). This is relevant because WO’615 discloses that such “AH” peptides could be utilized to inactivate enveloped viruses and treat subjects having (or susceptible to) infection by an “enveloped virus” (see, e.g., WO’615 at claims 1, 37), wherein “administration” could be by inhalation (i.e., via the mouth and nose using a nebulizer) (see, e.g., WO’615 at ¶[00127]), and wherein “enveloped virus” explicitly included all “coronaviruses” (see, e.g., WO’615 at ¶¶[0099], [00101]).
In summary, SWLRDIWDWICEVLSDFK (a.ka., C5A) was already an art-recognized antiviral peptide, which was identified as amphipathic α-helical peptide, and would have been predicted and expected to (a) promote host immune responses required for the destruction and clearance of infectious agents as taught by Lin, (b) and to reduce the concentration of enveloped viruses, such as coronaviruses, by disputing the lipid containing vesicles of the virus, as taught by Park and WO’615.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
The claimed invention is the combination of prior art elements (i.e., known peptide of C5A, known administration route, known dosage ranges, known pharmaceutical formulations for inhalation, known “enveloped virus” of coronavirus like SARS-CoV-2 as taught by Martinez) according to known methods of treating enveloped viruses (e.g., coronaviruses including SARS-CoV-2) as taught and suggested by Lin, Park, and WO’615, wherein the expected and predicted result would be the treatment of the coronavirus infection (e.g., SARS-CoV-2) by (i) disrupting the viral envelope and (ii) promoting host immune responses required for the destruction and clearance of infectious actions, wherein such activity would reduce the concentration of the enveloped virus resulting in treatment of the infection (see, e.g., MPEP §§ 2143(I)(A), 2143(I)(C), 2144.07). Furthermore, each prior art compound merely performs its art-recognized function.
In addition or alternatively, the invention is the simple substitution of one enveloped virus (i.e., Flaviviruses) for another enveloped virus (i.e., coronaviruses, such as SARS-CoV-2) into the prior art methods of treating viral infections as taught by the primary reference, wherein such substitution would predictably and expectedly lead to the treatment of the viral infection in view of Lin, Park, and WO’615, because the expected and predicted result of such treatment with C5A would be the treatment of the coronavirus infection (e.g., SARS-CoV-2) by (i) disrupting the viral envelope and (ii) promoting host immune responses required for the destruction and clearance of infectious actions, wherein such activity would reduce the concentration of the enveloped virus resulting in treatment of the infection (see, e.g., MPEP §§ 2143(I)(B), 2143(I)(C), 2144.07).
In addition or alternatively, Martinez provides a direct teaching, suggestion, and motivation to repurpose and test known antiviral compounds against SARs-CoV-2, and therefore an artisan would be motivated to apply the known methodologies of treating viral infections by administering the amphipathic α-helical peptide of C5A as taught and suggested by US’039, Park, Lin, and WO’615, to patients having a SARs-CoV-2 infection, wherein the application of the prior art methodology would yield predictable results, namely the treatment of the coronavirus infection (e.g., SARS-CoV-2) by (i) disrupting the viral envelope and (ii) promoting host immune responses required for the destruction and clearance of infectious actions, wherein such activity would reduce the concentration of the enveloped virus resulting in treatment of the infection (see, e.g., MPEP §§ 2143(I)(C),(D),(F), (G) and 2144.07).
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the art to treat a known family of viruses using a known compound via a known administration route and within a known dosage range to predictably obtain the exact results taught and disclosed by the prior art.
No evidence of unexpected results commensurate in scope with the requirements of MPEP § 716.02 have been placed on record at this time.
Accordingly, 1-2, 5-6, 9, 11-14, and 16 are rejected.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li et al.5 discloses peptides derived from C5A (see, e.g., Li at title, abs, passim).
Sengupta6 explains that, circa mid 2020, there was an ongoing epidemic referred to as “COVID-19”, and that drug repurposing (i.e., testing known antivirals) was being performed specifically for SARS-CoV-2 (see, e.g., Sengupta, passim).
Conclusion
No claims are allowed.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
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