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 Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 16 March 2026, have been entered in full. Claims 20 and 23 are withdrawn from consideration as being drawn to a non-elected invention. Claims 1-10, 13 and 22 are canceled. Claims 11, 12, 14-19 are amended. Claims 11, 12, 14-19 and 21 are under examination.
Foreign Priority
Acknowledgment is made of Applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The English translation of certified copies CHINA 202010244894.4, CHINA 202010287037.2, CHINA 202010344572.7, CHINA 202010286986.9, CHINA 202010344084.6 and CHINA 20201078365.3 have been placed of record in the file.
Withdrawn Objections And/Or Rejections
The objection to claims 11 and 12, as set forth at page 7 of the previous Office Action (16 December 2025), is withdrawn in view of the amendment (16 March 2026).
The rejection to claims 11-19 and 21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre- AIA ), second paragraph, as set forth at pages 8-9 of the previous Office Action (16 December 2025), is withdrawn in view of the amendment (16 March 2026).
The rejection to claim 12 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as set forth at pages 9-10 of the previous Office Action (16 December 2025), is withdrawn in view of the amendment (16 March 2026).
The rejection to claims 11-19 and 21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre- AIA ), first paragraph, written description, as set forth at pages 10-22 of the previous Office Action (16 December 2025), is withdrawn in view of the amendment (16 March 2026).
The rejection to claims 11, 12, 17, 18 and 21 under 35 U.S.C. 102(a2) as being anticipated by Babb et al. (US Patent 10,787,501, published Sept. 29, 2020, priority date April 2, 2020), as set forth at pages 22-24 of the previous Office Action (16 December 2025), is withdrawn in view of the amendment (16 March 2026).
Nucleotide and/or Amino Acid Sequence Disclosures
The specification is still objected to because of Nucleotide and/or Amino Acid Sequence issues.
The basis for the objection is set forth at pages 4-7 (specifically the top of page 7) of the previous Office Action. The Office Action stated that the incorporation by reference paragraph does not identify the size of the XML file in BYTES. Rather, the paragraph indicates that the file is 62.1 KB.
APPICANT’S ARGUMENTS: Applicant states that the instant application is a U.S. national stage application under 35 U.S.C. 371 of PCT/CN2021/084069 having an international filing date of March 30, 2021. Applicant states that this date is prior to July 1, 2022, is not subjected to 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2), which is only applicable to applications containing a nucleotide and/or amino acid sequence filed on or after July 1, 2022. Applicant maintains that the incorporation by reference paragraph is not required to identify the size of the XML file in bytes.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. The Examiner notes that the Nucleotide and/or Amino Acid Sequence issues should have been under ST.25 rules. Nonetheless, the same issue is present under ST.25.
The Examiner directs Applicant’s attention to MPEP 2422 for ST.25 info.
Specifically, 2422.03 and 2422.03(a)
MPEP 2422.03(a) "Sequence Listing" Submitted as ASCII Plain Text Files [R-01.2024] [Editor Note: This section is not applicable to applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b). See MPEP §§ 2412-2419 for guidance on WIPO ST.26 requirements for applications filed on or after July 1, 2022.]
The Legal Framework for Patent Electronic System (www.uspto.gov/PatentLegalFramework ) and MPEP § 502.05 provide detailed information pertaining to filing applications and other documents via the USPTO patent electronic filing system. The information below is specific to "Sequence Listing" submissions via the USPTO patent electronic filing system.
Pursuant to the Legal Framework for Patent Electronic System, applicants may submit a "Sequence Listing" under 37 CFR 1.821 as an ASCII plain text file via the USPTO patent electronic filing system or on read-only optical disc(s), provided the specification contains a statement in a separate paragraph (preferably on the first page) that incorporates by reference the material in the ASCII plain text file identifying the name of the ASCII plain text file, the date of creation, and the size of the ASCII plain text file in bytes. See 37 CFR 1.77(b)(5) and 1.823(b)(1). An exception is that an incorporation by reference statement is not required in an international application and is not required in an application file under 35 U.S.C. 371 where the "Sequence Listing" has been previously communicated to the International Bureau or originally filed in the USPTO and complies with Patent Cooperation Treaty Rule 5.2. See 37 CFR 1.821(c), 1.823(b)(2), and 1.825(c). The requirements of 37 CFR 1.52(e) for documents submitted on read-only optical disc(s) are not applicable to a "Sequence Listing" submitted as ASCII plain text files via the USPTO patent electronic filing system. However, each text file must be an ASCII plain text file and have a file name with a ".txt" extension. See 37 CFR 1.824.
However, in the instant case, Applicant has filed more than one sequence listing with the USPTO. Hence, Applicant needs the incorporation by reference paragraph with BYTES. This is the same whether in ST.25 or ST.26.
Furthermore, in the Response of 16 March 2026, Applicant submitted a substitute "Sequence Listing" part of the disclosure. However, Applicant did not provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of: a copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); and copy of the amended specification without markings (clean version).
The scientific reasoning and evidence as a whole indicates that the objection should be maintained.
MATTER OF RECORD
Claims 11, 12, 14-19 and 21 are allowable. Claims 20 and 23, previously withdrawn from consideration as a result of a restriction requirement, requires all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among Inventions IV and VI, as set forth in the Office action mailed on 28 August 2025 is hereby withdrawn and claims 20 and 23 are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
NEW REJECTIONS/OBJECTIONS
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Scope of Enablement
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 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification,
while being enabling for:
“A method for treating COVID-19 in a patient, comprising administering to the patient an effective dose of the fusion protein according to claim 11”.
does not reasonably provide enablement for:
“A method for treating SARS in a patient, comprising administering to the patient an effective dose of the fusion protein according to claim 11”.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The instant claim is not enabled for the full scope for the following reasons:
1. The specification teaches that SARS is caused by SARS-COV and that COVID-19 is caused by SARS-COV-2.
The instant specification teaches the use of SARS-COV-2 pseudovirus (Example 7). The specification teaches that the claimed fusion protein was able to inhibit SARS-COV-2 pseudovirus from infecting cells.
The claim is not enabled for a method for treating SARS in a patient because the specification only teaches the ability of the claimed fusion protein to inhibit
SARS-COV-2 pseudovirus from infecting cells expressing ACE2 in vitro.
The specification does not teach the use of a SARS-COV pseudovirus nor does the specification teach animal models infected with SARS-COV. SARS (SARS-COV) and COVID-19 (SARS-COV-2) may be related, but they are different coronaviruses. Various coronaviruses cause different diseases. It could not be predicted that the data representing the claimed fusion protein and COVID-19 (using SARS-COV-2 pseudovirus) would be correlative with therapeutic agents for in vivo treatment of SARS.
2. See wherein Tan et al. teach that pseudoviruses are safe, replication-deficient, chimeric viral particles used to study virus entry and neutralizing antibodies in low-level biosafety labs. Because they are non-replicating, they allow researchers to study viral mechanisms and evaluate vaccines/antivirals without requiring high-level biosafety facilities.
Tan et al. teach SARS-CoV-2 pseudoviruses can replace highly pathogenic wild-type viruses in laboratories, where they are widely used for drug screening and the development of vaccines. Tan et al. teach that the in vitro investigations using a pseudovirus have also yielded information about the virus’s entry method into host cells (bottom of page 2-3). Tan et al. teach the application of SARS-COV-2 pseudovirus in drug screening and development. Tan et al. teach that the infection of SARS-CoV-2 to host cells is related to the membranes fusion process. The process involves binding S protein to cell membrane receptor ACE2 and cleavage of S protein by protease on cell membrane. Tan et al. teach that according to this principle; therapeutic drugs are designed. Tan et al. teach that the SARS-CoV-2 entry inhibitor blocks the pseudovirus from entering the cell, lowering the reporter fluorescent protein production. Tan et al. teach that it is the most suitable tool for drug development and screening at the cellular level (page 9). Tan et al. teach some limitations to using the SARS-COV-2 pseudovirus, but maintains that SARS-CoV-2 pseudoviruses have been shown to correlate well with live viruses in some areas, and their application has lowered the threshold of experimental techniques and greatly facilitated the study of SARS-CoV-2 (Tan et al. The development and application of pseudoviruses: assessment of SARS-CoV-2 pseudoviruses. PeerJ, DOI 10.7717/peerj.16234, 17 pages, 2023).
3. See wherein Muñoz-Fontela et al. teach that the World Health Organization (WHO) has launched a global campaign to test therapeutic agents and vaccines on an unprecedented scale. Muñoz-Fontela et al. teach that to test these and other potential medical countermeasures, it is imperative to identify animal models for COVID-19 that provide measurable readouts for potential interventions and that use representative virus isolates. Muñoz-Fontela et al. teach a summary of the current literature on animal models for COVID-19 (page 509). Muñoz-Fontela et al. teach it is important to attempt to induce vaccine-associated enhanced respiratory disease in models of COVID-19 challenge using suboptimal doses of candidate vaccines or antigenic preparations with the goal of inducing the required detrimental immune profile and associated lung pathology (page 513)(Muñoz-Fontela et al. Animal models for COVID-19. Nature Vol 586:509-515; 2020).
The instant specification provides insufficient guidance with regard to these issues and provides no working examples which would provide guidance to one skilled in the art and no evidence has been provided which would allow one of skill in the art to predict the efficacy of the claimed methods with a reasonable expectation of success. It would have been unpredictable what affects the recited fusion protein would have when administered to a SARS patient. For the above reasons, undue experimentation would be required to practice the claimed inventions with a reasonable expectation.
Due to the inherent unpredictability regarding a correlation between the claimed fusion protein inhibiting SARS-COV-2 pseudovirus from infecting cells expressing ACE2 in vitro and the ability of administering the claimed fusion to effectively treat a SARS patient; the lack of direction/guidance presented in the specification regarding same; the absence of working examples directed to same; the complex nature of the invention; and the state of the art which establishes the application of SARS-COV-2 pseudovirus or COVID-19 animal models to screen for anti-COVID-19 drugs and in vivo treatment of COVID-19; undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Allowable Subject Matter
Claims 11, 12, 14-21 are allowed.
Conclusion
Claim 23 is rejected.
Claims 11, 12, 14-21 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 REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 5/11/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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