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
Election/Restrictions
1. Applicant's election of Group I, claims 1-15, without traverse, filed July 21, 2026 is acknowledged and has been entered. Claims 16-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as claims drawn to a non-elected invention. Accordingly, claims 1-19 are pending. Claims 1-15 are under examination.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Based on the Filing Receipt, the present application claims the benefit of priority of Provisional Application Number 63/436,198 filed on 12/30/2022. Accordingly, the effective filing date of the instant application is December 30, 2022, which is the filing date of Provisional Application Number 63/436,198 from which the benefit of domestic priority is claimed.
Claim Objections
3. Claim 11 is objected to in reciting “The immunoassay device … comprising a housing supporting the membrane and comprising a container comprising a wash reagent.” It should recite “The immunoassay device … comprising a housing supporting the membrane and a container comprising a wash reagent.” Appropriate correction is required.
4. Claim 12 is objected to in reciting “The immunoassay device … comprising a housing supporting the membrane and comprising a container comprising a wash reagent and a container comprising the substrate.” It should recite “The immunoassay device … comprising a housing supporting the membrane, a container comprising a wash reagent and a container comprising the substrate.” Appropriate correction is required.
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.
5. Claim 12 is 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 12 has improper antecedent basis in reciting “a container comprising a wash reagent.” Perhaps, Applicant intends “the container comprising the wash reagent.”
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.
6. Claim 5 is 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. In this case, claim 5 recites exactly the same limitations recited in claim 4.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 1-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mohanty et al. (US 2023/0104815 A1).
Mohanty et al. disclose an immunoassay device for determining one (i.e. first) or more (i.e. first, second) different target analytes (infectious pathogens) in a liquid biological sample (Abstract; [0044, 0058, 0065, 0172-0178]). The device comprises a) a membrane (membrane strip) including a vitrified matrix that supports lateral flow of a liquid (biological sample), and b) a dried detection reagent comprising at least one anti-analyte antibody (i.e. first, second: binding partners, reporter molecules) that is dried (vitrified) on the membrane matrix and solubilizable (hydrated, reconstituted) by a liquid biological sample (Abstract; [0006, 0007, 0044, 0051, 0065, 0087]). The a) membrane comprises a sample application zone (sample pad = conjugate pad) and a detection zone, and the dried first detection reagent is dried in the sample application zone; or may comprise a reagent zone (conjugate pad) between the sample application zone and the detection zone, wherein the dried detection reagent is dried in the reagent zone ([0132, 0133]; Figure 14). The detection zone has test sites in distinct regions having a first immobilized capture reagent which is non-diffusively (covalently) bound to the membrane and a second immobilized capture reagent which is non-diffusively bound to the membrane; wherein the first and second immobilized capture reagents are first and second anti-analyte antibodies in distinct regions that bind to the first and second labeled analytes [0006, 0007, 0044, 0068, 0069, 0084, 0087, 0133, 0172-0178].
Mohanty et al. teach that the b) dried detection reagent (reporter molecules) that is dried (vitrified) on the membrane matrix and solubilizable by a liquid biological sample specifically comprises a gold nanoparticle (AuNPs: Gold-Ab-HRP) having bound thereto (i) a first anti-analyte antibody (i.e. first binding partner) for the first analyte, and (ii) a first label (HRP). In use, the first anti-analyte antibody binds to the first target analyte present in the liquid biological sample, when added, and the solubilized detection reagent is released and the labeled analyte is captured by the first capture agent (Abstract; [0006, 0007, 0106-0109, 0165]). The b) dried detection reagent may further comprise a gold nanoparticles (Gold-Ab-HRP) having bound thereto (iii) a second anti-analyte antibody (i.e. second binding partner) for the second analyte, and (ii) a second label. In use, the second anti-analyte antibody also binds to the second target analyte present in the liquid biological sample and the solubilized detection reagent is released and the labeled second analyte is captured by the second capture agent (Abstract; [0006, 0007, 0044, 0047, 0106-0109, 0133, 0165]; Figure 14). Mohanty et al. teach that the first and second labels may be the same or different labels and the capture agents may be the same or different capture agents ([0133]; Figure 14). The reagent zone may be coated with a screen layer to prevent or inhibit chemical interaction between the dried first detection reagent and the membrane (i.e. contaminant filter) [0048]. The first label may be an enzyme which is horseradish peroxidase (HRP) and wherein the device further comprises a substrate for the enzyme [0006, 0092, 0093, 0099, 0100]. The first label may also be fluorescent or chemiluminescent [0092, 0099]. The immunoassay device further comprises a housing cassette [500] supporting the membrane, a container comprising a wash reagent, and a container comprising the substrate ([0050, 0105, 0129, 0132, 0133, 0172-0178]; Figure 12, Figure 15).
Although Mohanty et al. is silent in teaching that the immunoassay device has a shelf life of over 18 months at room temperature; paragraphs [0044, 0060] of the specification provides that the immunoassay device is storable or storage-stable having the capability to preserve and maintain viability of the immunoassay reagent materials. The immunoassay device as taught by Mohanty et al. also appears to be consonant to the claimed immunoassay device. Absent evidence to the contrary, therefore, the immunoassay device as taught by Mohanty et al. should have a shelf life of over 18 months at room temperature. It is deemed that products of identical structure or chemical composition, or produced by identical or substantially identical processes, cannot have mutually exclusive properties. A chemical composition or device structure and its properties are inseparable. Therefore, if the prior art teaches the structure of the device as claimed, the properties applicant discloses and/or claims are necessarily present. When the USPTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not. In re Best, 195 USPQ 430 (CCPA 1977), and In re Spada, 15 USPQ2d 1655 (Fed. Cir. 1990). See MPEP § 2112.01. Accordingly, Mohanty et al. appears to read on Applicant’s claimed invention.
8. No claims are allowed.
Remarks
9. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Parolo et al. (Enhanced lateral flow immunoassay using gold nanoparticles loaded with enzymes. Biosensors and Bioelectronics. 40: 412-416 (2013) IDS) disclose a LFIA test strip comprising AuNP modified with anti-human IgG gamma chain specific HRP (detection reagent). The detection reagent is absorbed into the conjugate pad and dried, and then solubilized by the addition of liquid biological sample (p. 413).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
September 4, 2026
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