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 .
Status of Claims
The claim listing filed 24 April 2024 is pending. Claim 10 has been canceled. Claims 1-9 and 11-14 are being examined on the merits of this office action.
Priority
The present application claims status as a 371 (National Stage) of PCT/EP2022/061825 filed 03 May, 2022, and claims priority under 119(a)-(d) to European Patent Application Nos. EP21171841.6 (filed 03 May 2021) and EP21176473.3 (filed 28 May 2021).
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 31 August 2023 and 6 August 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim recites the abbreviation “SEQ ID NO.” instead of “SEQ ID NO:.”, and as set forth in 37 CFR 1.821(d), the colon must be placed in front of the period in the instant claim. For improved clarity, please amend the claim to say “A peptide, wherein the peptide comprises the amino acid sequence of SEQ ID NO: 1, or a sequence variant thereof differing by one or two amino acid residues from said SEQ ID NO: 1.”. Appropriate correction is required. Claims 2-9 and 11 are objected to because they depend from an objected to claim 1. If claim 1 is amended to overcome the above objection, this objection will become moot.
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.
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to a peptide comprising an amino acid sequence of SEQ ID NO: 1, or a sequence variant differing by one or two amino acid residues from the SEQ ID NO:, capable of binding to the SARS-CoV-2 Spike S1 protein. Applicant shows that using the peptide CovA (instant SEQ ID NO: 1) results in a statistically significant reduction in relative binding activity between Spike S1 of SARS-CoV-2 and ACE2. The specification fails to disclose what structure of SEQ ID NO:1 is capable of binding to the SARS-CoV-2 Spike S1 protein. There is no teaching of which amino acids can or cannot be substituted of SEQ ID NO: 1 while allowing SEQ ID NO: 1 to retain its ability to reduce binding as described by the instant claim. The level of skill in the art is such that the ordinary skilled artisan would not be able to differentiate, without extensive further testing, which properties of the instant peptide having “one of two amino acid” variance can reduce binding and which peptides having “one of two amino acid” variance cannot be used to reduce binding. Unless all peptides that comprise a sequence having at least ~ 89% sequence identity to SEQ ID NO: 1 can reduce relative binding activity between Spike S1 of SARS-CoV-2 and ACE2, the disclosure of SEQ ID NO: 1, regarding claim 4, is not representative of the claimed sequence.
Therefore, the specification fails to satisfy the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C.112, first paragraph, with respect to claim 4.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to a peptide comprising an amino acid sequence of SEQ ID NO: 1, or a sequence variant differing by one or two amino acid residues from the SEQ ID NO:, inhibiting the binding of the spike S1 protein of SARS- CoV-2 to the human ACE2 receptor. Applicant shows that using the peptide CovA (instant SEQ ID NO: 1) results in a statistically significant reduction in relative binding activity between Spike S1 of SARS-CoV-2 and ACE2. The specification fails to disclose what structure of SEQ ID NO:1 is capable of inhibiting the binding of the Spike S1 protein of SARS- CoV-2 to the human ACE2 receptor. There is no teaching of which amino acids can or cannot be substituted of SEQ ID NO: 1 while allowing SEQ ID NO: 1 to retain its ability to inhibit binding as described by the instant claim. The level of skill in the art is such that the ordinary skilled artisan would not be able to differentiate, without extensive further testing, which properties of the instant peptide having “one of two amino acid” variance can inhibit binding and which peptides having “one of two amino acid” variance cannot be used to inhibit binding. Unless all peptides that comprise a sequence having at least ~ 89% sequence identity to SEQ ID NO: 1 can inhibit the binding of the spike S1 protein of SARS- CoV-2 to the human ACE2 receptor, the disclosure of SEQ ID NO: 1, regarding claim 5, is not representative of the claimed sequence.
Therefore, the specification fails to satisfy the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C.112, first paragraph, with respect to claim 5.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the phrase "such as", which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 12 recites " wherein the disease is COVID-19" immediately after stating “The method according to claim 10”. The claim is indefinite because claim 12 depends from claim 10, a canceled claim, therefore it is unclear what method the limitation is referencing. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites " wherein the administration route is systemic, local, enteral, or parenteral" immediately after stating “The method according to claim 10”. The claim is indefinite because claim 13 depends from claim 10, a canceled claim, therefore it is unclear what method the limitation is referencing. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites " wherein the administration is intravenous, oral, mucosal or sublingual" immediately after stating “The method according to claim 10”. The claim is indefinite because claim 14 depends from claim 10, a canceled claim, therefore it is unclear what method the limitation is referencing. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112
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.
Claims 12-14 are 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. Claims 12-14 depend from claim 10, a canceled claim. A claim that refers to a non-existent base claim violates the rules of dependency. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: SEQ ID NO: 1, as recited in claim 1, is not taught in the prior art in a 100% embodiment. The closest sequence match is a segment of the nucleotide sequence described in Downing et al. (“Whole genome sequencing of multiple Leishmania donovani clinical isolates provides insights into population structure and mechanisms of drug resistance.” Genome Res. 2011 Dec;21(12):2143-56. doi: 10.1101/gr.123430.111. Epub 2011 Oct 28. PMID: 22038251; PMCID: PMC3227103) with 50.8% sequence similarity to the instant SEQ ID NO: 1, as seen below.
PNG
media_image1.png
206
983
media_image1.png
Greyscale
Claim 1 (and 2, 6, 7, 9 and 11, due to their dependency on claim 1 would be allowable if rewritten to overcome the objection given above.
Summary
Claim 1-9 and 11 are objected to. Claims 4-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Claims 3 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claims 12-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daliyah M. Brown whose telephone number is (571)272-0136. The examiner can normally be reached Monday-Thursday 9:00 am - 4:30 pm.
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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654