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
1. Applicant’s election without traverse of Group I (1, 4-5 and 27-32) in the reply filed on June 11, 2026 is acknowledged.
Status of the Application
2. Claims 1, 4-5 and 27-32 are considered for examination. Claims 14-20 have been withdrawn from further consideration as being drawn to nonelected group.
Priority
3. This application filed on April 01, 2024 is a 371 of PCT/US2022/045036 filed on September, 28, 2022 which claims priority benefit to US 63/304,970 filed on January 31, 2022 and US 63/250,412 filed on September, 30, 2021.
Informalities
4. The following informalities are noted:
(i) The claims 1, 4-5, 32 recite the term ‘PCR’, ‘dNTPs’, ‘SARS-Cov-2’. Expanding the terms at least for the first time that it appears in the claims is suggested.
(ii) claim 1 and 27 recite ‘the presence or absence of one or more nucleic acid target’. Amending it to ‘the presence or absence of one or more nucleic acid targets’ is suggested.
Objection to the Specification
5. The disclosure is objected to because of the following informalities:
(i) The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (para 0069). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
(ii) The use of the term (FAM, HEX, JA270, CAL635, SYBR and other dyes disclosed in para 0024)., which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The terms are not followed by generic names.
(iii) Nucleotide and/or amino acid sequences appearing in the specification (para 0063, 0065, 0067, 0070) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Further, it is noted that this application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure and a CRF of the “Sequence Listing.”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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 28-32 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. Regarding claims 28-29, the phrase "such as" 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 Rejections -35 USC § 102
7. 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
A. Claims 1, 4-5 and 27-32 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sabeti et al. (US 2021/0102197).
Note claims 28-29 recite ‘optionally’. The limitations followed by the term optionally are not considered as required limitations of the claim because said limitations are optional.
Sabeti et al. teach a method of claim 1, for amplifying and detecting one or more nucleic acid targets in a sample comprising:
collecting a sample, applying the sample to a filter paper, heat inactivating the sample on the filter paper, applying a PCR cocktail on the filter paper, inserting the filter paper into a handheld real-time PCR device, performing one or more amplification cycles using said device using the handheld real-time PCR device and detecting the presence or absence of one or more nucleic acid targets, wherein the sample comprises blood, serum, wherein the filter paper comprises quantitative filter paper (para 0056-0062).
With reference to claim 4, Sabeti et al. teach that heat inactivating comprises incubating the sample on the filter paper at 950 C for at least 5 minutes (para 0056-0062, 0481-0492, 0577-0579).
With reference to claim 5, Sabeti et al. teach that the PCR cocktail comprises at least one primer pair for priming amplification of a nucleic acid target, an enzyme for amplifying the nucleic acid targets, dNTPs, and a reaction buffer (para 0585).
With reference to claim 27, Sabeti et al. teach a method for amplifying and detecting one or more nucleic acid targets in a sample comprising:
collecting a sample on a filter paper comprising one or more capture molecules immobilized thereon, heat inactivating the sample on the filter paper, applying a PCR cocktail on the filter paper, inserting the filter paper into a handheld real-time PCR device, performing one or more amplification cycles using said device using the handheld real-time PCR device and detecting the presence or absence of one or more nucleic acid targets (para 0577-0579, 0481-0492).
With reference to claim 28-31, Sabeti et al. teach that the capture molecule is an antibody or aptamer (nucleic acid aptamer) that binds to an antigen, wherein the antigen is a virus pathogen, wherein the virus comprises a surface protein and the antibody or aptamer that binds to the surface protein (para 0481-0492).
With reference to claim 32, Sabeti et al. teach that the surface protein is spike protein of SARS-Cov-2 (para 0056). For all the above, the claims are limited.
B. Claims 1, 4-5 and 27-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cary (US 2016/0083716).
Cary teaches a method of claim 1, for amplifying and detecting one or more nucleic acid targets in a sample comprising:
collecting a sample, applying the sample to a filter paper, heat inactivating the sample on the filter paper, applying a PCR cocktail on the filter paper, inserting the filter paper into a handheld real-time PCR device, performing one or more amplification cycles using said device using the handheld real-time PCR device and detecting the presence or absence of one or more nucleic acid targets, wherein the sample comprises blood, serum, wherein the filter paper comprises quantitative filter paper (para 0011-0014, 0023, 0032-0034, 0045-0050, 0055, 0085, 0022-0024, 0077-0078).
With reference to claim 4, Cary teaches that heat inactivating comprises incubating the sample on the filter paper at 950 C for at least 5 minutes (para 0048, 0055).
With reference to claim 5, Cary teaches that the PCR cocktail comprises at least one primer pair for priming amplification of a nucleic acid target, an enzyme for amplifying the nucleic acid targets, dNTPs, and a reaction buffer (para 0070, 0084-0085).
With reference to claim 27, Cary teaches a method for amplifying and detecting one or more nucleic acid targets in a sample comprising:
collecting a sample on a filter paper comprising one or more capture molecules immobilized thereon, heat inactivating the sample on the filter paper, applying a PCR cocktail on the filter paper, inserting the filter paper into a handheld real-time PCR device, performing one or more amplification cycles using said device using the handheld real-time PCR device and detecting the presence or absence of one or more nucleic acid targets (para 0013-0014, 0045-0050, 0055-0057).
With reference to claim 28, Cary teaches that the capture molecule is an antibody or aptamer (nucleic acid aptamer), that binds to an antigen (para 0013-0014, 0045-0050).
With reference to claims 29-31, Cary teaches that the antigen is a virus pathogen, wherein the virus comprises a surface protein and the antibody or aptamer that binds to the surface protein (para 0045-0050). For all the above the claims are anticipated.
Conclusion
No claims are allowable.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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