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 .
DETAILED ACTION
Claims 2 and 6 are canceled. Claims 1, 3, 4, 5, and 7 are amended.
Claims 1, 3-5, 7 are considered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/26/2023 and 07/23/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
(Previous objection to “ACE” maintained, other objections withdrawn).
The disclosure is objected to because of the following informalities:
The inventors use ACE2 in the specification [4]. While aspects of this paragraph were amended, an “ACE” still remains at the end of the paragraph in the disclosure submitted 03/16/2026.
Appropriate correction is required.
Claim Objections
(Previous objections, withdrawn) Claims 1, 3, 6, and 7 are objected to because of informalities.
See claims 1, 3, and 7 as submitted 03/16/2026. Claim 6 is canceled so objection is moot.
Applicant contends the claims have been amended.
In view of the applicant’s amendments, the objection is withdrawn as to claims 1, 3, and 7.
Claim Rejections - 35 USC § 112
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.
(Previous rejection, maintained as to Claims 1, 3-5, and 7) Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not reasonably provide enablement for a method of preventing SARS-CoV-2 infection in a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
See claims 1, 3-5, 7 as submitted 03/16/2026.
Applicant contends:
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as allegedly not being enabled by the specification.
As an initial matter, in order to establish a prima facie case for lack of enablement, the Examiner must demonstrate that one skilled in the art would not be able to make or use the claimed invention without undue experimentation. In order to make such a showing, the Examiner needs to account for the various factors outlined in MPEP 2164.01(a), which includes the "(A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure." Using these factors, the Examiner needs to provide a rational basis as to why one skilled in the art would be unable to make or use the claimed invention. This basis needs to be supported by evidence beyond conclusory statements.
The Office Action on pages 5-10 asserts that: i) the level of skill in the art is high and would include, e.g., Ph.D. level scientists and medical doctors (MDs); ii) the state of the art (in late 2020) does not provide solid evidence of or predictability for preventive therapies for SARS- CoV-2 success yet as encompassed by instant claims; iii) no working examples are provided that suggest or imply preventing SARS-CoV-2 by administering CSNP1, CSNP2, CSNP3, or CSNP4 to a subject as recited in instant claims; and iv) it would take undue trials and errors, not to mention intense scrutiny from health officials globally, to practice the claimed invention.
Applicant respectfully disagrees.
Applicant respectfully submits that claims 1, 3-5, and 7 are fully enabled by the specification such that one skilled in the art would be able to make or use the claimed invention without undue experimentation.
Notably, Applicant clarifies that the claimed invention is not directed to vaccine-based prevention or immune induction, and does not rely on immunogenicity or antibody generation. Rather, the claimed invention is directed to direct viral entry inhibition via spike-ACE2 blockade, as demonstrated by neutralization assays.
For clarification, Applicant respectfully submits that:
The claimed composition is not a vaccine;
The CSNP peptides are not immunogens;
The claimed method does not require induction of an immune response;
The specification contains no immunogenicity data because the claimed
invention does not rely on immune activation;
Rather, "prevention" as used in the claims refers to mechanistic prevention
of viral entry through receptor binding inhibition, not immune-mediated prophylaxis;
The claimed peptides function as direct-acting antiviral entry inhibitors, similar to receptor antagonists used in other viral infections; and
Accordingly, any interpretation of the claims as requiring vaccine-like immune
protection is inconsistent with the specification.
As of the effective filing date of the instant application, i.e., December 24, 2020, it was well-established in the art that:
SARS-CoV-2 infection requires binding of the viral spike receptor binding domain (RBD) to the angiotensin-converting enzyme 2 (ACE2) receptor;
ACE2 engagement is mandatory for viral entry;
Blocking spike-ACE2 interaction prevents viral entry.
Furthermore, this mechanism was structurally resolved early in 2020 (e.g., Yang et al., Nature 2020, submitted as IDS on June 26, 2023). The claimed invention directly targets this indispensable viral entry step.
In this regard, the instant specification demonstrates:
Structural interface mapping of RBD-ACE2 interaction;
Rational peptide design derived from the ACE2 a1 helix;
Nanomolar binding affinity via SPR;
Inhibition of S1-ACE2 interaction in HEK293 cells;
Pseudovirus neutralization, including Delta and Omicron variants
(e.g., Shah et al., Comput Struct Biotechnol J. 2022, submitted herewith as IDS); and
The neutralization assays directly measure inhibition of viral entry.
Thus, the claimed "prevention" is not immune-mediated prevention, but prevention of viral entry at the cellular level, which is mechanistically predictable and directly supported by the data.
Furthermore, in response to the Office's assertion that no working examples
suggest preventing SARS-CoV-2 infection in a subject, Applicant respectfully disagrees.
Specifically, the instant specification provides:
Design and synthesis of CSNP peptides (paras. [57]-[59]);
In vitro binding assays confirming RBD engagement (paras. [77]-[80]);
Pseudovirus neutralization assays demonstrating inhibition of viral entry (paras. [93]-[94]);
Molecular dynamics validation; and
Variant neutralization data.
Pseudovirus neutralization assays are a recognized surrogate for viral entry
inhibition and are widely used in antiviral development. The claimed invention does not claim immune protection or long-term immunity. Rather, the claimed invention is directed to direct inhibition of spike-ACE2 interaction through administration of defined peptide sequences.
The functional effect demonstrated-blocking viral entry-is the biological mechanism underlying infection. Therefore, Applicant respectfully submits that the instant specification provides sufficient working examples enough to practice the claimed entry-inhibition method.
Also, the specification provides guidance on:
Pharmaceutical compositions (paras. [27]-[34]);
Acceptable carriers and excipients;
Routes of administration (systemic and local); and
Formulation strategies.
The claimed invention is directed to direct antiviral inhibition. It does not require immune priming, antigen presentation, or adaptive immune response. Optimization of dosage and administration parameters for peptide therapeutics is routine for one skilled in the art and does not require undue experimentation. Importantly, the claimed invention does not require demonstration of immunogenicity, antibody titers, or vaccine efficacy, as those are not elements of the invention.
The Office Action cites uncertainty in vaccine and therapeutic development in 2020. Applicant respectfully submits that unpredictability in vaccine-induced immunity does not apply to direct receptor-binding inhibition.
Rather, by December 2020:
ACE2 was confirmed as the required entry receptor;
The spike-ACE2 interaction was structurally characterized; and
Entry inhibition was a recognized antiviral strategy.
Again, the claimed invention does not rely on immune modulation. Rather, it relies on receptor binding blockade. Therefore, Applicant respectfully submits that the art was sufficiently predictable for peptide-based viral entry inhibitors.
Applicant respectfully submits that, to avoid confusion with vaccine-based prevention, the claims should be interpreted as covering:
Inhibition of viral entry;
Reduction of viral infectivity; and
Neutralization of SARS-CoV-2.
Again, the invention does not require induction of immune memory or adaptive immunity.
Furthermore, no in vivo examples are required for enablement when in vitro data and mechanism are provided, especially for predictable arts like antiviral peptides. See e.g., In re Brana, 51 F.3d 1560 (Fed. Cir. 1995)).
Still furthermore, Applicant has amended claims 1 and 7 in the interest of expediting prosecution such that the breadths of claims 1 and 7 are commensurate in scope with the disclosure, focusing on specific peptides with demonstrated function. The cited references including Lochte and GAO highlight general challenges in vaccine/therapeutic development but do not undermine enablement for these targeted peptides.
Therefore, Applicant respectfully submits that claims 1, 3-5, and 7 are fully enabled by the specification such that one skilled in the art would be able to make or use the claimed invention without undue experimentation.
Accordingly, Applicant respectfully requests withdrawal of the 112(a) rejections of claims 1 and 7. Claims 3-5 depend from claim 1, and are allowable at least for this reason. Claims 2 and 6 have been canceled without prejudice or disclaimer.
Response to Arguments:
Applicant's arguments filed 03/16/2026 have been fully considered but they are not persuasive.
Although amendments were made to the claims and the specification, the amendments are insufficient to address enablement for preventing SARS-CoV-2 infection with administration of CSNP1, CSNP2, CSNP3, or CSNP4 as an active ingredient to a subject (as recited in claim 1) or administering a health functional food composition comprising CSNP1, CSNP2, CSNP3, or CSNP4 as an active ingredient to a subject (as recited in claim 7).
As stressed above by the applicant, “the claimed invention is directed to direct inhibition of spike-ACE2 interaction through administration of defined peptide sequences.
The functional effect demonstrated-blocking viral entry-is the biological mechanism underlying infection”. The mechanism of action is acknowledged and understood. Similarly, the in vitro working examples present in the specification were also acknowledged in the previous rejection and now. However, as also noted within the previous rejection, the disclosure only covers in vitro experimentation examples, not in vivo experimentation. Prevention of SARS-CoV-2 infection data is not provided for outcomes of administering a pharmaceutical composition or health functional food composition comprising CSNP1, 2, 3, 4 as an active ingredient to an actual subject suggesting that there could be unknown outcomes, whether positive or negative and whether supportive or unsupportive of the claims.
The previous rejection did cover vaccine entities but it also covered the unpredictability of use and effectiveness of non-vaccine, non-immunogen entities in vivo in 2020 such as chloroquine/hydroxychloroquine and remdesivir for the prevention and/or treatment of SARS-CoV-2 subjects. Additionally, in November 2020, Galanakis et al. (Galanakis) “reviewed [the] current best evidence and information underpinning the role of food ingredients and bioactive compounds in supporting immune functions in humans and animals, specifically in the prevention and treatment of COVID-19 disease”(p.1, Abstract). In Table 1 and the text of their article, Galanakis discussed several different types of bioactive compounds such as bioactive peptides, polysaccharides, vitamins, medicinal herbs, bioactive lipids, and natural polyphenols, their purported health benefits, and mode of action against SARS-CoV-2 such as disruption of the virus spike protein, restriction of angiotensin-converting enzyme 2 activity, and inhibition of angiotensin-converting enzyme and restriction of virus ability to enter the cells. In the end, Galanakis concluded there has not been adequate published evidence correlating the consumption of food bioactives with direct prevention or recovery from COVID-19 disease”(p. 10). The state of the art does not appear to provide solid evidence of or predictability for preventive therapies for SARS-CoV-2 success yet as encompassed by the instant claims. Therefore, the specification does not enable a person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. As stated above, claims 2 and 6 were canceled. And, the rejection is maintained for claims 1, 3-5, and 7.
However, in order to overcome this rejection, applicant should delete the word “preventing” in claim 1 so that it reads, “A method of treating SARS-CoV-2 infection…” and claim 7 so that it reads, “A method of alleviating SARS-CoV-2 infection…”.
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.
(Previous rejection, withdrawn as to claims 1-7) Claims 1-7 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.
See claims 1, 3, 4, 5,and 7 as submitted 03/16/2026. Claims 2 and 6 are canceled.
Applicant contends the claims have been amended.
In view of the applicant’s amendments, the rejection is withdrawn as to claims 1, 3, 4, 5, and 7.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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