DETAILED ACTION
Applicant’s amendment and remarks filed May 27, 2026 are acknowledged and entered. Claims 1-8 remain pending and under examination. Any rejection that is not repeated or addressed below is either withdrawn or moot in view of Applicant’s amendment.
Claims Summary
Claim 1 is directed to a method of providing information for active immune diagnosis by determining a presence of neutralizing antibodies to SARS-CoV-2 and a production of IFNγ. The specification discloses that active immune diagnosis is the determination of whether neutralizing antibodies to SARS-CoV-2, and IFNγ are produced (see paragraphs [0001], [0007], [0014], [0015] and [0033], for example, of the published application US 20240295551). The method comprises:
Preparing a plurality of biological samples; please note that paragraph [0025] of the published application defines “biological sample” as material taken from a person who has been vaccinated against SARS-CoV-2; the sample is whole blood, blood cells, or lymph fluid (claims 4 and 7);
Preparing:
A first reagent containing a vaccine antigen against SARS-CoV-2 or a protein antigen expressed by the vaccine, wherein the antigen is a protein derived from SARS-CoV-2; and,
A second reagent containing a protein derived from SARS-CoV-2 other than the antigen in the first reagent;
Additionally, a third reagent containing Nil and a fourth reagent containing mitogen are prepared (claim 2);
Preparing a plurality of mixed samples by mixing the biological samples with the reagents;
Preparing a plurality of detection reagents including:
A conjugate containing a signal generating means (see paragraph [0026] of the published application US 20240295551, or HRP or EuNP (claims 5 and 8)) and an anti-IFNγ antibody (which is defined as a monoclonal antibody specifically induced against IFNγ (see paragraph [0027] of the published application)); and
A complex comprising:
An RBD derived from the spike S1 protein of SARS-CoV-2, and
A signal generating means bound to the RBD; and
A biotinylated hACE2
Preparing a plurality of analyte samples by adding the detection reagent to the mixed sample;
Loading the analyte samples into a plurality of lateral flow cartridges and measuring signals using a signal detector; the cartridges comprise a strip including a sample inlet for injecting an analyte sample, a first test line with an immobilized anti-IFNγ antibody; a second test line with immobilized streptavidin, and a control line with immobilized capture agent (claims 3 and 6); and
Determining, based on the measured signals, the presence of level of neutralizing antibodies to SARS-CoV-2 and the production of IFNγ.
Claim Objections
(New Objection) Claims 1-8 are objected to because of the following informalities:
Claim 1, part e) should refer to the detection reagents [emphasis added] to be commensurate in scope with part d) which refers to a plurality of detection reagents. Claims 2-8 are included in this objection because they depend from claim 1. Appropriate correction is required.
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.
Claims 1-8 remain 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 claims encompass methods that employ a first reagent that encompasses a large genus of vaccine antigens against SARS-CoV-2 or a protein antigen expressed by the vaccine, wherein the antigens are proteins derived from SARS-CoV-2. A vaccine antigen is understood to be an antigen that induces protective immunity in a recipient such that upon subsequent exposure to SARS-CoV-2, disease is prevented.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, the claims identify the source of the vaccine antigen against SARS-CoV-2 as a protein derived from SARS-CoV-2, and a function (vaccinal). However, no proteins are identified from SARS-CoV-2 that are considered vaccinal. The specification discloses proteins to be used as the second reagents, such as S, E, M or N (see paragraph [0034] of the published application) however, no vaccine antigens derived from SARS-CoV-2 are identified. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Applicant’s remarks filed May 27, 2026 have been considered. Applicant states that the art recognizes that SARS-CoV-2 vaccines often employ the S1 protein or its RBD as a vaccine antigen. In response, what it known in the art (evidenced by references in the IDS filed 7/28/2025, for example) is not disclosed in the specification. Applicant is claiming a method that, broadly, uses any antigen derived from SARS-CoV-2 that serves as a vaccine against SARS-CoV-2, or a protein expressed by the antigen that serves as a vaccine against SARS-CoV-2. While the art recognizes that the S protein is source for vaccine antigens, Applicant has not named that antigen. The genus encompasses any protein from SARS-CoV-2 that functions as a vaccine, however, none have been identified in the specification. Even if the specification had identified the S protein as a vaccine antigen, that one species is not sufficient to represent the large genus of any vaccine antigen against SARS-CoV-2.
Suggested language to overcome this rejection:
In claim 1, part (b): preparing a first reagent containing a protein antigen from SARS-CoV-2 selected from the group consisting of spike protein, envelope protein, membrane protein and nucleocapsid protein, and a second reagent containing a protein from SARS-CoV-2 other than the protein antigen contained in the first reagent, wherein the second reagent is selected from the group consisting of spike protein, envelope protein, membrane protein and nucleocapsid protein.
This suggested language would remove the term “vaccine”, yet include relevant antigens for accomplishing the purpose of the method (i.e., active immune diagnosis), as disclosed in paragraph [0034] of the published application. This suggested language would also remove the term “derived”, thus further clarifying the structure of the relevant antigens.
Conclusion
No claim is 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
Prosecution Insights