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 .
Claims Summary
Claim 1 is directed to a method of providing information for active immune diagnosis. 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, 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); please note that claim 1 (and dependent claims 2-8) does not identify any particular vaccine antigen against SARS-CoV-2, nor the protein antigen expressed by the vaccine;
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 composed of:
An RBD derived from the spike S1 protein of SARS-CoV-2, and
A signal generating means for generating a detectable signal by binding to the RBD; and
A biotinylated hACE2
Preparing a plurality of analyte samples by adding the detection reagent to the mixed sample; and
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).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitations recite sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitations are “signal generating means” in claims 5 and 8, where the means are identified as HRP or EuNP.
Because these claim limitations are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-8 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 1 recites, “A method of providing information for active immune diagnosis”. Although the methods steps are clearly outlined resulting in signals being read, the claim does not circle back to how the signals relate to the information that is provided for active immune diagnosis. As set forth in the specification, active immune diagnosis is the determination of whether neutralizing antibodies to SARS-CoV-2, and IFNγ are produced. It is suggested that the claim language indicate how the signals relate to the determination of whether neutralizing antibodies to SARS-CoV-2, and IFNγ produced (i.e., the information for active immune diagnosis) using language that is supported in the specification. Claims 2-8 are included in this rejection because they are dependent on claim 1.
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 are 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. 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 do not identify the source of the vaccine antigen against SARS-CoV-2, nor a protein antigen expressed by the vaccine. Thus, while the antigen has a function (vaccinal), no structure is provided for the vaccine antigen. The specification does not appear to provide one example of a vaccine antigen against SARS-CoV-2. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lapointe et al. (US 2021/0389308 A1, “Lapointe”) discloses a method for detecting a neutralizing antibody against S protein of SARS-CoV-2 from a biological sample of a human that has been vaccinated against SARS-CoV-2 (see paragraphs [0016]-[0017]). According to paragraph [0017], the method comprises:
Obtaining a biological sample from a human that has been vaccinated against SARS-CoV-2
Detecting a level of neutralizing antibody against the S protein, wherein the neutralizing antibody blocks binding between the S protein and ACE2, according to the following:
Contacting the biological sample with ACE2, or a fragment thereof, and S protein, or a fragment thereof, wherein either or both of ACE2 and S protein are labeled with a detection reagent
Detecting a signal corresponding to the level of ACE2-S complex that is inversely correlated with the level of neutralizing antibody in the sample
Lapointe discloses a plurality of samples (see paragraph [0814]). Lapointe discloses a lateral flow immunoassay device comprising a housing/cartridge (see paragraphs [0021], [0123], [0311] and [0317]). Lapointe discloses a competitive assay and the detection of more than one analyte, such as other proteins of SARS-CoV-2, and the use of other biomarkers as analytes, such as IFNγ (see paragraphs [0121], [0128], and [0085]-[0087]). Paragraphs [0451] and [0505] discloses mixtures of biological sample with ACE2 and S protein. Solid surfaces for capture molecules are coated with streptavidin, for example (see paragraph [0090]). While Lapointe discloses some aspects of the instantly claimed invention with regard to the detection reagents and lateral flow format/method, there is no teaching or fair suggestion to mix the biological sample with a first reagent containing a vaccine antigen against SARS-CoV-2 or a protein antigen expressed by the vaccine, nor mix the sample with a second reagent containing a protein derived from SARS-CoV-2 other than the antigen contained in the first reagent (claim 1, (b)) prior to the lateral flow detection method.
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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