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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 in the reply filed on 2/24/2026 is acknowledged. Accordingly, the claims 12-16 are withdrawn from consideration as being drawn to a non-elected invention.
Priority
This application claims benefit of 63/306,639 filed 02/04/2022.
Drawings
The drawings were received on 2/3/2023. These drawings are found acceptable by the examiner.
Specification
The disclosure is objected to because of the following informalities:
(a) The use of the term “Triton-X 100” at paragraphs, [0013], [0014], [0029], [0030], [0033], [0061], [0086], [0091], [00106], and [0019], and “PEG 8000” at paragraphs [0016] and [0049], which are trade name(s) or a mark(s) 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. Appropriate correction is required.
(b) The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (https:// at paragraphs [00181], [00183], [00187] – [00191], [00193] – [00198], [00200], [00203] – [00205], [00210], [00217] and [00225]. 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.
List of Reference in Specification
The Examiner notes that an information disclosure statement filed under the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 have not been submitted with this application. It appears that Applicant has cited a list of references in the specification at pages 24-28, 30, 36-39, 41-42 and 44. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, applications, or other information submitted for consideration by the Office, and MPEP 609.04(a), subsection I, states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 6-7 are objected to because of the following grammatical informalities:
(a) Claims 6-7 lack a period (.) at the end of the sentence.
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.
Claims 1-11 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.
(a) Claims 1-11 are indefinite in the claim 1 because the claims do not recite a final process step which clearly relates back to the preamble. The claims are drawn to a method of detecting SARS -CoV-2, or a variant thereof, in a sample whereas the final step recites “conducting a RT-PCR” using primers to amplify SARS-CoV-2”. No specific primers or specific RT-PCR steps associated with SARS-CoV-2 or variants thereof are recited and therefore it cannot be determined if the goal of the preample, i.e., “detecting SARS-CoV-2” is achieved given the non-specificity of the claimed RT-PCR steps.
(b) Claims 2, 3 and 5 contains the trademark/trade names “Triton X-100” and “PEG 8000”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a surfactant or a water-soluble polyether compound, respectively. Accordingly, the identification/description is indefinite.
Closest Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
(a) Thom et al {Thom, used herein} (Frontiers in Cellular and Infection Microbiology, 11 (71643):1-7, September 2021) teaches an evaluation of the SARS-CoV2 teach a method of detecting SARS-CoV2, or variants thereof, in a sample, comprising: i) combining a sample with a buffer to obtain a mixture, the buffer comprising: a chaotropic agent (guanidinium isothiocyanate (GITC)), a surfactant (Triton X-100) and a serine protease (Proteinase K) (abstract, Table 1, (see also section “Viral Inactivation”), ii) heating said mixture to obtain a heated mixture (page 3, col. 2), iii) subjecting the heated mixture to a centrifugation steps to obtain a supernatant comprising RNA (page 2, col. bottom of col. 2 which teaches centrifugation 6000 x g for 5 minutes. Thom teaches discarding the supernatant which teaches away from the instant invention. Thom does not teach the concentration or combination of chaotropic, agent, reducing agent, surfactant or serine protease or the use of the supernatant in a magnetic bead suspension.
(b) Klein et al {Klein 1, used herein} (Viruses. August 7, 2020; 12(8):863, 1-17) teaches a method of detecting SARS-CoV-2, in a sample, comprising: i) combining a sample with a buffer to obtain a mixture, the buffer comprising: a chaotropic agent (guanidinium isothiocyanate), a reducing agent (dithiothreitol), a surfactant (Triton X-100), ii) vortexing the sample using an orbital shaker iii) combining the supernatant with a magnetic bead solution, shaking the sample and discarding the clear supernatant, washing the beads 3 times, eluting the nucleic acids from the surface of the magnetic beads using RNase -free water and performing RT-qPCR (see section 2, pages 3-6). Klein 1 does not teach heating the mixture and subjecting the mixture to a centrifugation step as instantly claimed. Klein 1 also does not teach the concentration or combination of chaotropic, agent, reducing agent, surfactant or serine protease as instantly claimed.
c) Klein et al {Klein 2, used herein} (WO 2011144304, November 2011) teaches universally applicable lysis buffer four use in detecting pathogens associated with a respiratory disease, wherein the method comprises applying a lysis buffer containing a chaotropic agent, reducing agent and a protease to the sample, wherein the sample is sputum, contacting the components of the mixture to a heating step, bead milling the mixture (see pages 3 and 4) followed by centrifugation at 4000 rpm instead of 8000 rpm and then performing PCR steps (see pages 3-9). Klein 2 does not teach wherein after the heating and centrifugation step; the supernatant is combined with a magnetic bead suspension and amplifying SARS-CoV2 by RT-PCR. Klein 2 also does not teach the concentration or combination of chaotropic, agent, reducing agent, surfactant or serine protease for detecting SAR-CoV2.
Conclusion
12. Claims 1-11 are rejected. Claims 6 and 7 are objected. However, the claims have not been rejected under prior art because while the art teaches various aspects of the instant invention as noted above and identified in the specification at Table 2, the art does not teach individually or in a combination teach a method of detecting SARS-CoV-2, or variants thereof, in a sample, comprising: i) combining a sample with a buffer to obtain a mixture, the buffer comprising: a chaotropic agent, a reducing agent, a surfactant, and a serine protease, ii)- heating said mixture to obtain a heated mixture; iii)- subjecting the heated mixture to a centrifugation step to obtain a supernatant comprising RNA; iv) combining the supernatant with a magnetic bead suspension, such that at least a portion of the RNA within the supernatant binds to the magnetic beads, the magnetic bead suspension obtained by suspension of magnetic beads in a bead-binding buffer to obtain RNA-bound magnetic beads, (v) washing said RNA-bound magnetic beads to obtained washed beads; and (vi) conducting a reverse-transcription polymerase chain reaction (RT-PCR) assay on the washed beads using primers to amplify SARS-CoV-2 or variants thereof and wherein said buffer comprises about 6 M guanidinium isothiocyanate, about 3% 2-mercaptoethanol, about 2.5% Triton X-100 and about 170 ng/mL proteinase K. Additionally, no prior art was found teaching or suggesting the specific concentrations and combinations of buffer components recited therein.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/ Primary Examiner, Art Unit 1681