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 1-18 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/17/24 and 5/5/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-18 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 contains the trademark/trade name “Triton X-100” and (Tween-20). 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 surfactants and, accordingly, the identification/description is indefinite.
Claims 2-18 are also rejected since they depend from claim 1, but do not remedy this deficiency.
Claim 7 recites the limitation "The purification method" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites, “wherein the virus is selected from SARS-CoV-2.”, however, it is unclear if additional viruses are intended to recited since the claim recites, “selected from”.
Claims 8 and 15-18 recite, “A method of use of the biological extraction buffer according to claim…, added into a certain volume of a virus extraction buffer…”. However, claims 8 and 15-18 while indicating that the method is for use of a biological extraction buffer, the active steps of the claims do not require using “a biological extraction buffer”. While “a virus extraction buffer” is recited, this is a different buffer compared to the biological extraction buffer. Therefore, it is unclear if the biological extraction buffer of claims 1, 2, 3, 4, of 5 is required by the claimed methods or if the only buffer employed is a virus extraction buffer.
Claims 9-10 are also rejected since they depend from claim 8, but do not remedy this deficiency.
Claims 8 and 15-18 recite, “a certain volume of a virus extraction buffer”, however, the claims nor the specification provide a metes and bounds of what “a certain volume” is relative to this buffer. What are the units of the certain volume, is the certain volume in a range.
Claims 9-10 are also rejected since they depend from claim 8, but do not remedy this deficiency.
Claims 8 and 15-18 recite, “virus extraction buffer, incubation and extraction”, however, it is unclear what is extracted in this method that is to be added to a test device and which result is to be interpreted as a result of the extraction.
Claims 9-10 are also rejected since they depend from claim 8, but do not remedy this deficiency.
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)(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.
Claim(s) 1, 2, 4-8, 13-15 and 17-18 are rejected under 35 U.S.C. 102a1 as being anticipated by YI et al. (CN 111983217, published 11/24/2020-machine translation provided by Examiner).
Claim 1: The claimed invention is drawn to a biological sample extraction buffer, comprising a surfactant and a salt ion, the surfactant being selected from Triton X-100 or Tween-20.
Claims 2, 4: Wherein a concentration of the surfactant is 0.5% to 2% (w/v);; wherein the salt ion is selected from NaCl or KCl.
Claim 5: Wherein pH of the biological sample extraction buffer is 8.0-9.0.
The claimed invention also requires an application of the biological sample extraction buffer according to claims 1, 2, 4 or 5 in extraction of a protein sample of a SARS-CoV-2.
The claimed invention also requires a method of use of the biological sample extraction buffer according to claim 1, wherein a swab sample or a liquid sample is directly added into a certain volume of a virus extraction buffer, incubation and extraction, and the extracted sample is dropwise added to a test device to interpret a result.
The claimed invention also requires a method of use of the biological sample extraction buffer according to claim 2, 4, or 5, wherein a swab sample or a liquid sample is directly added into a certain volume of a virus extraction buffer, incubation and extraction, and the extracted sample is dropwise added to a test device to interpret a result.
Yi et al. teach the formulation of a sample processing fluid for immunoassays. The sample processing fluid contains salt, such as magnesium chloride and sodium chloride and a surfactant, such as Triton X-100 or Tween-20. The amount of magnesium chloride can be 10 or 400 mM and the sodium chloride can be 50 to 200 mM. The amount of surfactant can be 0.5% w/v and the pH of the solution can be 8.0. Yi et al. also teach “In some embodiments, the test kit or test strip of the present invention includes the sample processing solution of any one of the foregoing embodiments. The detection kit of the present invention should be understood in a broad sense, and it mainly refers to tools carrying immunoassay-related reagents. In some embodiments, the detection kit may also include some supporting reagents. The detection test strip of the present invention includes absorbent paper, a marker binding pad, a coating film, a sample pad and a bottom plate.” With regard to the specific use of the taught sample processing fluid, Yi et al. teach “in some embodiments, the sample is a sample containing the component to be tested; in some embodiments, the component to be tested is an RNA virus; in some embodiments, the RNA virus is an RNA enveloped virus; In an embodiment, the RNA enveloped virus is at least any one of a coronavirus or an influenza virus; in some embodiments, the RNA enveloped virus is, for example, 2019-nCoV.” The 2019-nCoV is interpreted to meet the requirements of SARS-CoV-2.
Therefore, Yi et al. teach generating a biological sample extraction buffer that comprises a surfactant (Triton X-100 or Tween-20) at a w/v % of 0.5 and a salt ion that is Sodium Chloride and the pH of the buffer is 8.0. The intent of the buffer/solution of Yi et al. is to collect SARS-CoV-2 from a sample, thereby forming a collection sample that can be used to detect the presence of the virus. Since Yi et al. teach the addition of the sample processing solution to an immunoassay tool at the “sample pad”, the addition of the sample would be achieved through droplets. [see entire document]
Therefore, Yi et al. anticipate the instant invention.
Claim(s) 1-6, 8 and 10-18 are rejected under 35 U.S.C. 102a1 as being anticipated by Bandla et al. (US PGPub 2004/0142398)).
Claim 1: The claimed invention is drawn to a biological sample extraction buffer, comprising a surfactant and a salt ion, the surfactant being selected from Triton X-100 or Tween-20.
Claims 2-4: Wherein a concentration of the surfactant is 0.5% to 2% (w/v); wherein a concentration of the salt ion is 0.9%-5% (w/v); wherein the salt ion is selected from NaCl or KCl.
Claim 5: Wherein pH of the biological sample extraction buffer is 8.0-9.0.
The claimed invention also requires an application of the biological sample extraction buffer according to claims 1, 2, 4 or 5 in extraction of a protein sample of a virus.
The claimed invention also requires a method of use of the biological sample extraction buffer according to claim 1, wherein a swab sample or a liquid sample is directly added into a certain volume of a virus extraction buffer, incubation and extraction, and the extracted sample is dropwise added to a test device to interpret a result.
Wherein the test device comprises an upper cover and a lower plate, and a test strip is assembled between the upper cover and the lower plate.
The claimed invention also requires a method of use of the biological sample extraction buffer according to claim 2, 4, or 5, wherein a swab sample or a liquid sample is directly added into a certain volume of a virus extraction buffer, incubation and extraction, and the extracted sample is dropwise added to a test device to interpret a result.
Bandla et al. teach a method for determining whether a material contains an analyte, which comprises: (a) providing a detection apparatus which includes mounted on a support member an elongated membrane having a first end and a second end wherein in lateral contact with the first end of the membrane is a sample pad for receiving a liquid sample and in lateral contact with the second end of the membrane is a wicking pad which allows the liquid sample to flow through the membrane from the sample pad to the wicking pad and wherein the membrane further comprises at least one detection zone laterally spaced from the sample pad in which is immobilized a binding member specific for the analyte;
(b) mixing the material with an extraction solution to produce a mixture including the analyte; (c) mixing an aliquot of the mixture in step (b) with colored particles at room temperature for a time sufficient for the particles to bind a sufficient quantity of the analyte to enable detection of the colored particles in the detection zone;
(d) mixing a particle blocking solution including a blocking agent with the mixture in step (c) at room temperature for a time sufficient to block sites on the particles not bound to the analyte; and
(e) applying the mixture with the particles bound to the analyte and the blocking agent to the sample pad in the detection apparatus at room temperature wherein binding of the analyte bound to the particles bound by the binding member specific for the analyte immobilized in the detection zone indicates the presence of the analyte in the material.
The analyte is selected from the group consisting of protein selected from the group consisting of viral protein, bacterial protein, immunoglobulin, parasite protein, plant protein, mammalian protein, hormone, and insect protein.
The membrane further includes a reference zone laterally spaced between the detection zone and the wicking pad in which is immobilized therein a control antibody and the particle blocking solution further includes particles which have bound thereon an antigen which binds the control antibody.
The particle blocking solution includes bovine serum albumin and polysorbate 20 in a buffer.
The membrane is a nitrocellulose membrane that has a pore size from about 10 to 20 um.
The extraction solution includes a salt in a buffer that contains about 2% NaCl in the buffer. [see claims 77-97]
Bandla et al. also teach the use of a lateral flow device as presented in Figure 1a:
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Number 30 is a film, which meets the claim limitation of an upper cover and number 18 is a support member, which meets the claim limitation of a lower plate and numbers 20, 14, 27, 28, 12, 16 and 24 represent zones that make up what would function as a test strip that are between the film and the support member. By carrying out steps b-d of the taught method, bandle et al. achieved a buffer that contains the claimed surfactant and salt ion.
Bandle et al. also teach that particle blocking solution can contain 2% tween-20. [see paragraph 154] and that the extraction buffer can have a pH of about 9.6, which would include a pH of 9.0.
Therefore, Bandle et al. anticipate the instant invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bandle et al. as applied to claims 1-6, 8 and 10-18 above, and further in view of MPEP § 2144.05 (II) (A).
The claimed invention further requires: wherein the swab sample or the liquid sample is incubated in the virus extraction buffer for 30s to 1min.
Bandle et al. further teach that buffers containing viruses, can be mixed and incubated with particle blocking solutions for one minute at room temperatures prior to applying to the immunostrip. [see paragraphs 180-183]
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Bandle et al. in order to incubate their liquid sample (buffer) for 1 min. One would have been motivated to do so, given the suggestion by Bandle et al. that methods for extracting virus from a sample can include incubating for one minute prior to applying to an immunostrip. There would have been a reasonable expectation of success, given the knowledge that MPEP § 2144.05 (II) (A) states, “…Optimization Within Prior Art Conditions or Through Routine Experimentation…“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation…”. Therefore, one of ordinary skill in the art would adapt the teachings of Bandle et al. through routine optimization to incubate for one minute at room temperature the extraction buffer containing 2% of salt with the particle blocking solution that contains Tween-20.
Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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