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 1-4, 9-12, 16, and 18-221 are pending. Claims 5-8 and 13-15 were canceled; claim 22 was newly added; and claims 1-3, 9-12, 16, and 21 were amended in the Reply filed 4/06/2026. Claims 3-4, 10, and 18-22 are withdrawn. Claims 1-2, 9, 11-12, 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 was previously considered and not found persuasive for reasons of record (see, e.g., Action mailed 1/05/2026 at 2-3), and the requirement was 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 claim 1 as filed 7/10/2023.
Following amendments filed 4/06/2026, the originally elected species is understood to read upon instant claims 1-2, 9, 11-12, and 16; however, the originally elected species does not read upon instant claims 3-4, 10, and 18-22 (see, e.g., discussion in Action mailed 1/05/2026 at 2-3). Note that claims 21-22 require a D-amino acid to be present, but instant SEQ ID NO: 1 lacks a D-amino acid.
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claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.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, 9, 11-12, 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, 10, and 18-22 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, 9, 11-12, 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 4/06/2026 is acknowledged and presently considered.
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]).
“Coronavirus infection” is understood to encompass all variants of SARS-CoV2, SARS-CoV, and MERS-CoV, alphacoronaviruses, betacoronaviruses, and common cold viruses (e.g., HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1)
Additional claim interpretations are set forth below.
Withdrawn Claim Rejections
The rejection of claim 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn in view of the amendments filed 4/06/2026.
The rejection of claims 1-2 and 11-12 under 35 U.S.C. 103 as being unpatentable over US2007/0073039A1 in view of Vielle et al.2 are withdrawn in view of the amendments filed to claim 1 and 11, limiting the scope of the claims to coronavirus infections. A revised rejection has been placed on record below.
New or Revised Claim Rejections as Necessitated by Applicant Amendments
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Amended claim 12 depends from amended claim 11, wherein claim 11 now recites and requires a peptide comprising SEQ ID NO: 72, which is a variable sequence defining a genus of 677,503,346,688,000 species of peptides (see, e.g., instant claim 11). All species comprise only L-amino acids per the sequence listing of SEQ ID NO: 72, and lack P at X1. However, amended claim 12 attempts to claim SEQ ID NOs: 1-71, but at least SEQ ID NOs: 2, 5, 9, 11, 18, 21, 26, 34, and 38 (this list is not exhaustive), are excluded from the amended scope of claim 11 because such sequences either comprise D-amino acids or otherwise have a P at X1. Accordingly, claim 12 is rejected for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 9, 11-12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US2007/0073039A1 in view of Martinez3, Park et al.4, Lin et al.5, 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, 9, 11-12, 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 16, 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]7, [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, 9, 11-12, and 16 are rejected.
Response to Arguments
Applicant's arguments filed 4/06/2026 have been fully considered but they are not persuasive. Arguments pertaining to withdrawn rejections and withdrawn objections have been rendered moot. Applicant addresses the maintained rejection under 35 USC § 103 at pages 12-15 of the Reply (see, e.g., Reply filed 4/06/2026 at 12 at 1st ¶ to page 15 at 1st full ¶), and these remaining applicable arguments are addressed below.
Explicit rationales supporting a determination of obviousness have been set forth in the rejection: It is the Examiner’s understanding that Applicant is alleging that “the Office has provided no reasoning as to why one of ordinary skill would have modified the cited references to arrive at the instantly-claimed methods with a reasonable expectation of success” (see, e.g., Reply filed 4/06/2026 at 12 at 2nd full ¶; see also id. at 12 at penultimate ¶). In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner has explicitly identified numerous alternative rationales supporting a determination of obviousness, including rationales supported by MPEP §§ 2143(I)(A), 2143(I)(B), 2143(I)(C), 2143(I)(D), 2143(I)(F), 2143(I)(G), and 2144.07, which Applicant fails to acknowledge, address, or otherwise rebut with specificity in the response.
Allegations suggesting “lack of predictability” or “lack of reasonable expectation of success”: It is the Examiner’s understanding that Applicant is alleging a lack of predictability or otherwise a lack of reasonable expectation of success” (see, e.g., Reply filed 4/06/2026 at 12 at 2nd full ¶). This is not persuasive because the Applicant’s assertions do not reflect the proper legal standards for evaluating predictability. MPEP § 2143.02(II) explains that “[o]bviousness does not require absolute predictability”, but instead clarifies that only “at least some degree of predictability is required” (see, e.g., MPEP § 2143.02(II)). Here, the rejection explicitly addresses predictability and reasonable expectation of success, but Applicant fails to address the explicitly identified predicted and expected results set forth in the rejection. Here, the Examiner’s basis for “predictability” is merely based upon the presumption that the prior art is fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), which is permissible. As explained at MPEP § 2143.02, predictability and reasonable expectation of success are satisfied when “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art”. Here zero evidence of unexpected results commensurate in scope with the requirements of MPEP 716.02 have been set forth on record, all elements of the claimed invention were known in the prior art, one of ordinary skill was fully enabled to combine each prior art element using routine methods in the biochemical arts per the guidance of the primary reference, and the elements would have merely performed their art-recognized, respective functions (see Rejection, above, noting that C5A and similar peptides were art-recognized anti-viral peptides predicted and expected 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 the genus of an “enveloped virus” explicitly included all “coronaviruses” (see, e.g., WO’615 at ¶¶[0099], [00101]). Accordingly, a reasonable expectation of successfully using a known peptide according to known methods to achieve known and art-recognized results existed in view of the prior art.
Applicant addresses the references piecemeal without consideration of the teachings of the prior art of record as a whole: It is the Examiner’s understanding that Applicant addresses the teachings of US’039 alone, and alleges that it alone does not indicate usage for treatment of coronaviruses (see, e.g., Reply filed 4/06/2026 at 12-13 at bridging ¶). Similarly, it is the Examiner’s understanding that Applicant addresses Maritnez, Lin, and WO’615 either alone, or otherwise in view of less than the combined teachings of all references of record (see, e.g., Reply filed 4/06/2026 at 13 at 1st full ¶ to 3rd full ¶). Similarly, it is the Examiner’s understanding that Applicant addresses Park alone without considering the combined teachings of the prior art (see, e.g., Reply filed 4/06/2026 at 14-15 at bridging ¶). Such arguments are not persuasive because one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Accordingly, arguments addressing references considered alone, or less than the combination of all references relied upon in the rejection have been fully considered but not found persuasive or relevant, because no rejections of record alleges that the references alone (or less than the combination set forth in the rejection), renders the claim scope obvious.
Applicant draws an incorrect conclusion regarding WO’615 because Applicant suggests Figure 11 of WO’615 illustrates lack of enablement, a teaching away from the claimed invention, or otherwise a “significant degree of unpredictability”: Figure 11 of WO’615 is referenced by the Applicant (see, e.g., Reply filed 4/06/2026 at 13 at final ¶ to 15 at 1st full ¶), wherein Applicant alleges that Figure 11 shows that “vaccina virus, which is an enveloped virus, was not inactivated by amphipathic α-helical peptides” (see id), and therefore weighs against the “sweeping assertions made in WO’615” and “teaches away from the Office’s position that any amphipathic alpha-helical peptide would have been reasonably expected to be effective against any enveloped virus, let alone a coronavirus as claimed” (see id.). Examiner is not persuaded because Figure 11, taken alone, is clearly taken out of context of the WO’615 disclosure. In context, WO’615 discusses the results and implications of Figure 11 (see, e.g., WO’615 at ¶¶[0028], [00206]-[00210], [00215], [00220], Fig. 13). Specifically, Figures 11 and 13 shows results confirming that AH Peptide-mediated disruption occurs for “small” (HCV, average diameter of 50 nm) but not “large” (Vaccinia, average diameter of 360 nm) viral particles (see id), wherein it was determined that AH peptides result in a complete rupture of vesicles with an average size range from 54 nm to 72 nm, but reduced potency for vesicles with an average size distribution greater than 90 nm, and wherein “the ability of the AH peptide to induce the lysis of vesicles further lessened when the average vesicle size distribution became greater than 150 nm” (see, e.g., WO’615 at ¶¶[0215], Fig. 13), wherein AH peptide induced lysis did not occur with vesicles having an effective diameter over 250 nm (see, e.g., WO’615 at ¶¶[0098], [0215], Fig. 13). Therefore, in context, Figure 11 does not “teach away” from all enveloped viruses other than HCV, but instead characterizes what specific size-range of enveloped viruses can be treated using such peptides based upon virus particle size, wherein viruses having an average viral particles size of less than 250 could be treated, but wherein an artisan would readily appreciate that treatment of viruses having a smaller average particle sizes (e.g., ~50-150 nm as shown at Fig. 13 of WO’615), would be more efficiently treated. This raises a basic question, “what is the average diameter of a coronavirus particle?”; which is answered by WO’615, which discloses that coronaviruses have an average particle diameter of “about 80-160 nm” (see, e.g., WO’615 at ¶[0099]). This guidance is consistent with the diameter limitations disclosed by WO’615 (see, e.g., WO’615 at ¶¶[0098], [0099], noting that the upper limit is for “enveloped viruses having an average particle diameter . . . .less than about 250 nm”). Accordingly, WO’615 at Figure 11, when taken in context of the disclosure of WO’615 as a whole, clearly does not “teach away” from the claimed invention or otherwise suggest that WO’615 is not enabled for treatment of enveloped viruses within the scope of the invention (see, e.g., WO’615 at ¶¶[0098], [0099]). Furthermore, Figure 11, taken in context, does not reduce predictability, but instead provides more predictability because WO’615 identifies a mechanistic detail applicable to AH peptides, namely a size-dependent limitation, and such knowledge permits an artisan to more predictably identify which viruses and viral strains are or are not susceptible to treatment by AH peptides. Therefore, arguments premised upon Figure 11 suggesting lack of predictability or enablement, or otherwise that it “teaches away” from the full scope of WO’615 have been fully considered, but not found persuasive, because Figures 11, 13, and the disclosures at paragraphs [0028], [0098]-[0099], [00206]-[00210], [00215], [00220], establish and support the conclusion that AH peptides could be utilized predictably and successfully to treat viral infections mediated by enveloped viruses, including coronavirus. Accordingly, the teachings relied upon by the Examiner in view of WO’615 to support a determination of obviousness remain applicable.
Arguments alleging that WO’615 has a broad disclosure: It is the Examiner’s understanding that Applicant is alleging that WO’615, relied upon by the Examiner to establish general knowledge and expected functionality of C5A and similar compounds, is “very broad” and therefore does not support a determination of obviousness (see, e.g., Reply filed 4/06/2026 at 13 at 2nd full ¶ to 3rd full ¶, alleging that WO’615 teaches a “massive genus” of amphiphathic α-helical peptides and only tests one peptide). The legal basis of this argument is unknown, and therefore presumably the Applicant is either alleging (i) that the disclosure of WO’615 is inoperable or not enabled; (ii) that the disclosure of WO’615 would be faced with skepticism of experts; (iii) that the broad disclosure of WO’615 amounts to a “teaching away” from the claimed invention, or (iv) that WO’615 is only applicable for explicitly tested and disclosed embodiments (see, e.g., Reply filed 4/06/2026 at 13 at 2nd full ¶ to 3rd full ¶, alleging that WO’615 teaches a “massive genus” of amphiphathic α-helical peptides and only tests one peptide).
First, 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)), and the burden is on the Applicant to rebut the presumption of operability (see, e.g., MPEP § 2121(I); MPEP § 716.07). No evidence of inoperability of lack of enablement commensurate in scope with the requirements of MPEP § 716.07 have been placed on record to date, and therefore, in view of the current record, WO’615 is fully enabled. Accordingly, all disclosed peptides in WO’615 are presumed enabled8.
Second, no evidence that skepticism of experts “expressed before these inventors proved him wrong” has been identified on record commensurate in scope with the requirements of MPEP § 716.05. As noted above, the prior art is presumed fully enabled, for all that is disclosed, including nonpreferred and alternative embodiments (see, e.g., MPEP §§ 2121(I)-(II), 2123(I)-(II)). To the contrary, WO’615 is set forth on record to establish the basic understanding 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), and that 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]), wherein 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); and wherein an “AH” peptide 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]). Accordingly, no showing or evidence of skepticism of experts commensurate in scope with the requirements of MPEP § 716.05 has been placed on record at this time.
Third, regarding a “teaching away” rationale, although WO’615 provides additional guidance regarding additional amphipathic alpha-helical peptides, this does not provide the basis for a “teaching away” from the claimed invention because “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments” (see, e.g., MPEP § 2123(II)). Furthermore, no evidence that WO’615 criticizes, discredits, or otherwise discourages the solution claimed has been identified by the Applicant. According, no “teaching away” has been identified on record.
Fourth, prior art is not limited to exemplified embodiments only, but rather prior art is presumed fully enabled, for all that is disclosed, including nonpreferred and alternative embodiments (see, e.g., MPEP §§ 2121(I)-(II), 2123(I)-(II)). Accordingly, the lack of testing coronaviruses directly does not diminish or erase the fact that WO’615 expressly identifies that such AH peptides could be predictably utilized to treat “coronaviruses” (see, e.g., WO’615 at ¶¶[0099], [00101]).
Accordingly, arguments regarding the breadth of the teachings of WO’615 have been fully considered, and not found persuasive. The fact that WO’615 provides guidance to unclaimed inventions and embodiments does not justify ignoring or dismissing pertinent disclosures within the art.
No evidence of unexpected results or criticality of range has been placed on record: To date, zero evidence of unexpected results sufficient to rebut prima facie obviousness and commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 has been placed on record. Zero species within the scope of the instant invention (i.e., an in vivo method) were reduced to practice on record. Zero evidence showing criticality of range has been placed on record. Rather the instant claims achieve the predicted and expected result taught and suggested by the prior art (i.e., that coronaviruses could be successfully treated by administering an AH peptide, including the prior art AH peptide of C5A or SWLRDIWDWICEVLSDFK). Arguments and evidence simply confirming the expected and predicted utility of a prior art element and art-recognized structure, wherein the compound is simply used to perform a prior art method of treating a viruses it was taught to treat, weighs in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)). The closest data related to the claimed invention appears to be directed to unclaimed, in vitro SARS-CoV-2 Prevention Models tested using only Peptides 346-001 (SEQ ID NO: 1), 346-002 (SEQ ID NO: 2), 346-003 (SEQ ID NO: 3), 346-004 (SEQ ID NO: 4), 346-005 (SEQ ID NO: 5), 346-007 (SEQ ID NO: 7), 346-008 (SEQ ID NO: 8), and 346-009 (SEQ ID NO: 9) (see, e.g., Spec. filed 1/23/2023 at ¶¶[0024]-[0027], [0084], [0097]-[0102]). No evidence of in vivo potency was provided.
The weight of evidence currently of record, weighs in favor of a determination of obviousness: The courts have stated that
"[W]hen a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious."
KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 , 417 , 127 S. Ct. 1727 , 167 L. Ed. 2d 705 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273 , 282 , 96 S. Ct. 1532 , 47 L. Ed. 2d 784 (1976)).
Likewise, the Supreme Court has rejected rigid tests for obviousness and has emphasized that
[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 416.
And has also emphasized that
“If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 417.
Here, as explained in the rejection above, all elements of the invention are prior art elements, and the prior art literally and explicitly teaches mechanistic details of AH peptides work, what viruses they would be predicted to treat, how to administer such peptides, the dose ranges to administer, etc., etc. It is not surprising nor unexpected that a prior art compound, namely an antiviral AH peptide, would work exactly as taught and predicted in view of the prior art. Although the prior art may teach additional, unclaimed embodiments, the courts have stated that
“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle."
Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945), at 335.
Likewise, faced with a problem like “how can we treat SARS-CoV2?”, and guidance to “repurpose” known antiviral compounds, it is obvious to visit an online database and cross-reference known antiviral agents disclosed as capable of treating coronaviruses, and then to review ones associated with the treatment of coronaviruses and other respiratory diseases known in the art. Using such prior art compounds for the exact purpose for which they are taught in the prior art, is obvious. Here, Applicant provides no objective evidence that the method and compound claimed does anything more than what the prior art already discloses, teaches, and informs artisans, namely that an AH peptide would be expected and predicted to treat infections of enveloped viruses having an average particle diameter of less than 250 nm, including coronaviruses.
Examination has not proceeded beyond the originally elected species: Applicant is advised that examination has not proceeded beyond the originally elected species of utilizing instant SEQ ID NO: 1. Examiner notes that the current rejection could be overcome by limiting the scope of the invention to exclude SEQ ID NO: 1, and then examination would proceed to other non-elected species. Examination could be further advanced by limiting the claims to sequences actually tested in an in vitro SARS-CoV2 system and shown to be effective, and sharing a common consensus structure. No allowable subject matter has been identified on record at this time.
In sum, all applicable arguments have been fully considered, but not found persuasive for the reasons discussed above. Accordingly, the rejection is maintained as revised above, wherein all revisions were necessitated by Applicant’s amendments.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li et al.9 discloses peptides derived from C5A (see, e.g., Li at title, abs, passim).
Sengupta10 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).
Vielle et al.11 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”).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 The prior action contained a typographical error, wherein claim 21 was inadvertently not included. However, claim 21 is directed to a non-elected species because instant SEQ ID NO: 1 lacks any D-amino acids, and claim 21 was treated as withdrawn. Therefore, the typographical and inadvertent error did not impact prosecution of the examined claims. The typographical error has been corrected, and newly added claim 22 is withdrawn for reasons applicable to claim 21.
2 Vielle et al., The Human Upper Respiratory Tract Epithelium Is Susceptible to Flaviviruses. Front Microbiol. 2019 Apr 16;10:811. doi: 10.3389/fmicb.2019.00811. PMID: 31057517; PMCID: PMC6477545; hereafter “Vielle”.
3 Martinez, Compounds with Therapeutic Potential against Novel Respiratory 2019 Coronavirus. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e00399-20. doi: 10.1128/AAC.00399-20. PMID: 32152082; PMCID: PMC7179632.
4 Park et al., Comparing the Membrane-Interaction Profiles of Two Antiviral Peptides: Insights into Structure-Function Relationship. Langmuir. 2019 Jul 30;35(30):9934-9943. doi: 10.1021/acs.langmuir.9b01052. Epub 2019 Jul 19. PMID: 31291111; hereafter “Park”.
5 Lin et al., HCV peptide (C5A), an amphipathic α-helical peptide of hepatitis virus C, is an activator of N-formyl peptide receptor in human phagocytes. J Immunol. 2011 Feb 15;186(4):2087-94. doi: 10.4049/jimmunol.1002340. Epub 2011 Jan 12. PMID: 21228351; PMCID: PMC7385933; hereafter “Lin”.
6 WO’615 at claim 1 identifies that the method is applicable to “an enveloped virus having an average particle diameter of less than 250 nm”
7 WO’615 at paragraph [0099] identifies that the average particle diameter for coronaviruses ranges from “about 80-160 nm”.
8 Note that the courts have stated that “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945), at 335.
9 Li et al. Rational design of peptides with anti-HCV/HIV activities and enhanced specificity. Chem Biol Drug Des. 2011 Nov;78(5):835-43. doi: 10.1111/j.1747-0285.2011.01201.x. Epub 2011 Sep 26. PMID: 21801309; cited in previous action.
10 Sengupta, Combing through old drugs to find new ones for Covid-10, Broad Institute (May 12, 2020), 4 pages, attached as a pdf, also available at https://www.broadinstitute.org/blog/combing-through-old-drugs-find-new-ones-covid-19 (last visited 12/18/2025); cited in previous action.
11 Vielle et al., The Human Upper Respiratory Tract Epithelium Is Susceptible to Flaviviruses. Front Microbiol. 2019 Apr 16;10:811. doi: 10.3389/fmicb.2019.00811. PMID: 31057517; PMCID: PMC6477545; hereafter “Vielle”; cited in previous action.
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