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 .
The preliminary amendment filed January 10, 2025, canceling claims 8-11, 13-14, 17, 19-20, 24, 26-28, 30-31, 34-42, 45-81 and amending claims 5-7, 12, 15, 18, 21-23, 25, 29, 32-33, 43-44 is acknowledged. Claims 1-7, 12, 15-16, 18, 21-23, 25, 29, 32-33 and 43-44 are pending and will be examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 11, 2026, July 12, 2024 and March 6, 2026 was filed 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 32-33 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.
Claims 1 and 4 establish “wherein the lysis buffer does not comprise sodium dodecyl sulfate (SDS), cetyl trimethylammonium bromide (CTAB), or both”. Then Claim 32 and 33, recite wherein the “one or more surfactants comprises one or more of cetyl trimethylammonium bromide (CTAB), cetyl trimethylammonium chloride (CTAC), SDS, sodium decyl sulfate (SDeS), cetyl trimethylammonium chloride (CTAC), and sodium octyl sulfate (S Octyl S)”. The buffer of claim 1 excludes either SDS, CTAB or both, while the buffer of claim 32, as currently recited, encompasses a buffer that includes both SDS and CTAB.
These claims are in direct conflict. It is unclear if the lysis buffer includes or excludes SDS and or CTAB or both. Clarification of the expected composition of the lysis buffer is requested.
Claim 33 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 33 recites the limitation " the lysis buffer comprises: about 0.2% (w/v) CTAB and the (NH4)2SO4 is present at a concentration of about 5 mM;
about 0.4% (w/v) SDS and the (NH4)2SO4 is present at a concentration of about 10 mM;" in the body of the claim. There is insufficient antecedent basis for this limitation in the claim because it does not present these concentrations in the alternative or optional format as would be required by the exclusion of one or both of these components within the lysis buffer of claim 1.
Claim Interpretation
Claims 1, 3 and 12 recite that precipitate is “substantially inhibited” for a certain period of time. While this language is recited within the claims and the specification, the mechanism and manner by which the precipitate is inhibited is not described in any way. Therefore, the lysis buffer and storage lengths which includes each of the components of the buffer within the claims will be interpreted as reading on the inhibition of precipitation, as claimed.
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.
(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.
Claim(s) 1-7, 12, 18, 21-22, 25, 29, 32-33 and 44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nyan et al. (US Patent 10072309; September 2018 as evidenced by Miyoshi et al. (US Patent 8435741; May 2013)).
With regard to claim 1, Nyan teaches a lysis buffer, comprising:
one or more surfactants;
ammonium sulfate ((NH4)2SO4); and
magnesium sulfate (MgSO4), wherein the lysis buffer does not comprise sodium dodecyl sulfate (SDS), cetyl trimethylammonium bromide (CTAB), or both, and
wherein formation of a precipitate in the lysis buffer is substantially inhibited for a period of time under a storage condition (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0; where Triton and Trehalose are surfactants, as evidenced by Miyoshi col. 8, line 50 to col. 10, line 12, where the surfactants include TWEEN and TRITON).
With regard to claim 2, Nyan teaches a lysis buffer of claim 1, wherein the appearance of the precipitate in the lysis buffer does not occur for at least about twenty days during the storage condition (Fig 11 legend, col. 5, lines 28-34, where the buffer is stored; see also col. 21, line 8-23, where the buffer can be stored for 7 days to up to about 12 months).
With regard to claim 3, Nyan teaches a lysis buffer, comprising:
one or more surfactants;
ammonium sulfate ((NH4)2SO4); and
magnesium sulfate (MgSO4),
wherein formation of a precipitate in the lysis buffer is substantially inhibited for a period of time under a storage condition, thereby no detectable precipitate is formed in the lysis buffer for at least about twenty days during the storage condition (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0; where Triton and Trehalose are surfactants, as evidenced by Miyoshi col. 8, line 50 to col. 10, line 12, where the surfactants include TWEEN and TRITON).
With regard to claim 4, Nyan teaches a lysis buffer of claim 3, wherein the lysis buffer does not comprise one or more of sodium dodecyl sulfate (SDS) and cetyl trimethylammonium bromide (CTAB) (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0; where Triton and Trehalose are surfactants, as evidenced by Miyoshi col. 8, line 50 to col. 10, line 12, where the surfactants include TWEEN and TRITON).
With regard to claim 5, Nyan teaches a lysis buffer of claim 1, wherein the precipitation of complexes consisting of Mg+2 and the surfactant is suppressed, optionally wherein the concentration of soluble Mg+2 is not reduced more than about 1.1-fold relative to the start of the period of time (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0; where Triton and Trehalose are surfactants, as evidenced by Miyoshi col. 8, line 50 to col. 10, line 12, where the surfactants include TWEEN and TRITON).
With regard to claim 6, Nyan teaches a lysis buffer of claim 1, wherein the appearance of the precipitate in the lysis buffer does not occur for at least about thirty days, about sixty days, about ninety days, about six months, about a year, or about 18 months, during the storage condition (Fig 11 legend, col. 5, lines 28-34, where the buffer is stored; see also col. 21, line 8-23, where the buffer can be stored for 7 days to up to about 12 months).
With regard to claim 7, Nyan teaches a lysis buffer of claim 1, wherein the storage condition comprises:
transport of the lysis buffer;
thermal stress, one or more freeze-thaw cycles, agitation, pressure changes, light irradiation, or any combination thereof;
ambient conditions;
a temperature of about 20°C to about 25°C;
refrigeration conditions;
a temperature of about 4°C; and/or a temperature of 14°C (Fig 11 legend, col. 5, lines 28-34, where the buffer is stored; see also col. 21, line 8-23, where the buffer can be stored for 7 days to up to about 12 months and where the storage can be varied across temperatures, including heat stress, oxidation, and a range from 25 to 65 degrees).
With regard to claim 12, Nyan teaches a lysis buffer of claim 1, wherein:
the period of time is at least about thirty days, about sixty days, about ninety days, about six months, about a year, or about 18 months;
the substantial inhibition of formation of the precipitate comprises the lysis buffer having no visible particulates as assessed by visual inspection; and/or the absence of the precipitate in the lysis buffer comprises the lysis buffer as assessed by visual inspection (Fig 11 legend, col. 5, lines 28-34, where the buffer is stored; see also col. 21, line 8-23, where the buffer can be stored for 7 days to up to about 12 months).
With regard to claim 18, Nyan teaches a lysis buffer of claim 1, wherein:
the MgSO4 is present at a concentration of about 0.1 mM to about 10 mM;
optionally 4 mM;
the (NH4)2SO4 is present at a concentration of about 0.1 mM to about 20 mM;the (NH4)2SO4 is present at a concentration of about 5 mM;
and/or the (NH4)2SO4 is present at a concentration of about 10 mM, and wherein the appearance of the precipitate in the lysis buffer is delayed by at least about ten days as compared a comparable lysis buffer wherein the (NH4)2SO4 is present at a concentration of about 5mM (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0; where Triton and Trehalose are surfactants, as evidenced by Miyoshi col. 8, line 50 to col. 10, line 12, where the surfactants include TWEEN and TRITON).
With regard to claim 21, Nyan teaches a lysis buffer of claim 1, further comprising an acid at a concentration of about 0.1mM to about 20 mM, optionally wherein the acid comprises an organic acid, an inorganic acid, or a mixture thereof, further optionally the inorganic acid is hydrogen chloride (HCl), optionally the acid is present at a concentration of about 8.8 mM (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0; where Triton and Trehalose are surfactants, as evidenced by Miyoshi col. 8, line 50 to col. 10, line 12, where the surfactants include TWEEN and TRITON).
With regard to claim 22, Nyan teaches a lysis buffer of claim 1, further comprising a pH buffer (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0).
With regard to claim 25, Nyan teaches a lysis buffer of claim 1, wherein the one or more surfactants are capable of lysing biological entities to release sample nucleic acids comprised therein, and wherein:
the sample nucleic acids comprise sample ribonucleic acids and/or sample deoxyribonucleic acids;
the biological entities comprise a virus, a bacteria, a fungi, a protozoa, portions thereof, or any combination thereof;
and/or the biological entities comprise one or more of prokaryotic cells, eukaryotic cells, viral particles, exosomes, protoplasts, and microvesicles (col. 14, lines 41-45, where the samples can include cells, tissues, organs and many other sample types).
With regard to claim 29, Nyan teaches a lysis buffer of claim 1, wherein:
the one or more surfactants comprise about 0.001% (w/v) to about 2.0% (w/v) of the lysis buffer;
the one or more surfactants comprise a cationic surfactant, an anionic surfactant, a non-ionic surfactant, or an amphoteric surfactant; and/or the lysis buffer further comprises anon-ionic surfactant (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0; where Triton and Trehalose are surfactants, as evidenced by Miyoshi col. 8, line 50 to col. 10, line 12, where the surfactants include TWEEN and TRITON).
With regard to claim 32, Nyan teaches a lysis buffer of claim 1, wherein the one or more surfactants comprises one or more of cetyl trimethylammonium bromide (CTAB), cetyl trimethylammonium chloride (CTAC), SDS, sodium decyl sulfate (SDeS), cetyl trimethylammonium chloride (CTAC), and sodium octyl sulfate (S Octyl S) optionally the lysis buffer comprises about 0.2% (w/v) CTAB and the (NH4bSO4) is present at a concentration of about 5 mM (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0; where Triton and Trehalose are surfactants, as evidenced by Miyoshi col. 8, line 50 to col. 10, line 12, where the surfactants include TWEEN and TRITON).
With regard to claim 33, Miyoshi teaches a lysis buffer of claim 1, wherein the one or more surfactants comprises cetyl trimethylammonium chloride (CTAC), optionally the lysis buffer comprises:
about 0.2% (w/v) CTAC and the (NH4)2SO4 is present at a concentration of about 5 mM;
about 0.2% (w/v) CTAB and the (NH4)2SO4 is present at a concentration of about 5 mM;
about 0.4% (w/v) SDS and the (NH4)2SO4 is present at a concentration of about 10 mM;
about 0.2% (w/v) SDeS and the (NH4)2SO4 is present at a concentration of about 5 mM;
about 0.2% (w/v) SDeS and the (NH4)2SO4 is present at a concentration of about 10 mM;
about 0.4% (w/v) SDeS and the (NH4)2SO4 is present at a concentration of about 10 mM;
about 0.8% (w/v) SDeS and the (NH4)2SO4 is present at a concentration of about 10 mM;
about 0.4% (w/v) SDeS and the (NH4)2SO4 is present at a concentration of about 10 mM;
about 0.2% (w/v) CTAB and the (NH4)2SO4 is present at a concentration of about 5 mM;
about 0.2% (w/v) CTAC and the (NH4)2SO4 is present at a concentration of about 5 mM;
or about 0.2% (w/v) S Octyl S and the (NH4)2SO4 is present at a concentration of about 5 mM (col. 20, “IV. Lysis Buffer” heading, where the lysis buffer includes Tris-HCl, EDTA, Sucrose, Triton X-100 and Tween 20, where the pH is 7.8; see also col. 20-21, “V. Assay Lysis-Reaction Buffer” (LRB) heading, where the buffer includes Triton-X 100, Sucrose, Trehalose, Tris-HCl, KCl, (NH4)2SO4, MgSO4, dNTPs, Tris Acetate and Potassium Acetate, where the pH is 7.6 to 8.0; where Triton and Trehalose are surfactants, as evidenced by Miyoshi col. 8, line 50 to col. 10, line 12, where the surfactants include TWEEN and TRITON).
With regard to claim 44, Nyan teaches a method of processing a sample, comprising:
(a) contacting a sample comprising biological entities with a lysis buffer of claim 1 to generate a treated sample, thereby lysing the biological entities to release sample nucleic acids comprised therein (col. 14, lines 41-45, where the samples can include cells, tissues, organs and many other sample types; Abstract; Fig 11).
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(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nyan et al. (US Patent 10072309; September 2018 as evidenced by Miyoshi et al. (US Patent 8435741; May 2013) as applied over claims 1-7, 12, 18, 21-22, 25, 29, 32-33 and 44 above and further in view of Miyoshi et al. (US Patent 8435741; May 2013).
With regard to claim 15, Myoshi teaches a lysis buffer of claim 1, wherein the lysis buffer further comprises one or more alcohols (col. 8, lines 50-67).
With regard to claim 16, Myoshi teaches a lysis buffer of claim 15, wherein:
the one or more alcohols have a carbon chain length in the range of 1 to 6;
optionally the one or more alcohols are selected from the group consisting of ethanol, isopropanol, isobutyl alcohol, pentanol, and hexanol;
and/or the lysis buffer comprises the one or more alcohols at about 0.001% (v/v) to about 5.0% (v/v) (col. 8, lines 50-67).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the teachings of Nyan to include a variety of additional components as guided by Myoshi, for example, to arrive at the lysis buffer, as claimed, with a reasonable expectation for success. Myoshi teaches “In the present invention, a surfactant is added to a reaction Solution. An advantageous effect of the present invention; that is, prevention of nonspecific nucleic acid amplification, is achieved via the use of a Surfactant. Types of Such surfactant that can be used in the present invention are not particularly limited, and may include the following: anionic Surfactants such as alkylbenzene Sulfonate, lauryl Sulfate (SDS), octyl Sulfo Succinate, and Stearic acid soap: nonionic surfactants such as sorbitan fatty acid ester, POE sorbitan fatty acid ester (e.g., TWEENR), POE alkyl ether (e.g., BRIJ(R), POE alkyl phenyl ether (e.g., TRITONR), nonylphenol, lauryl alcohol, polyethylene glycol, polyoxyethylene-polyoxypropylene block polymer, POE alkylamine, and POE fatty acid bisphenyl ether; cationic Surfactants such as cetylpyridium chloride, lauryl dimethylbenzyl ammonium chloride, and Stearyltrimethylammonium chloride; and ampholytic Surfactants such as alkyldimethylamine oxide and alkylcarboxybetaine” (col. 8, lines 50-67). Therefore, one of ordinary skill in the art at the time the invention was made would have adjusted the teachings of Nyan to include a variety of additional components as guided by Myoshi, for example, to arrive at the claimed invention with a reasonable expectation for success.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nyan et al. (US Patent 10072309; September 2018 as evidenced by Miyoshi et al. (US Patent 8435741; May 2013)) as applied over claims 1-7, 12, 18, 21-22, 25, 29, 32-33 and 44 above and further in view of Lim et al. (J Microbiol Biotechnol, 2014, 24(6):803-811).
With regard to claim 23, Lim teaches a lysis buffer of claim 22, wherein:
the pH buffer comprises glycine and an acid, optionally 10.0 mM glycine and HCl, optionally 8.8 mM; and/or the pH of the lysis buffer is about 1.0 to about 4.0 (p 32, col 1, where glycine is included).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the teachings of Nyan to include a variety of additional components as guided by Lim to arrive at the lysis buffer, as claimed, with a reasonable expectation for success. Lim teaches “To verify the optimum pH for bacterial lysis activity, the enzymatic reaction was performed at different pH values using the JBScreen pH-2D broad-range pH buffer (Jena Bioscience, Germany). The relative lysis activity was calculated by combining
the results obtained with six different buffers ranging from pH 4 to 10 (SSG buffer, succinic acid: sodium dihydrogen phosphate:glycine = 2:7:7; CHC buffer, citric acid:HEPES:CHES = 2:3:4; MI buffer, malonic acid:imidazole:boric acid = 2:3:3) or with three different types of buffers ranging in pH from 4 to 9 (SAB buffer, sodium acetate:ADA:bicine = 1:1:1; MMT buffer, L-malic acid:MES:tris = 1:2:2; SBG buffer, sodium tartrate dehydrate:bistris: glycylglycine = 3:2:2). To determine the optimum temperature for the SPN9CC endolysin, the antimicrobial activity assay was performed at different temperatures (24°C, 30°C, 37°C, 45°C, 50°C, 55°C, 60°C, or 65°C) for 3 min”. Lin also teaches “showed maximal activity at 50°C, and its optimum pH range was from pH 7.5 to 8.5. The SPN9CC endolysin showed antimicrobial activity against only gram-negative bacteria and functioned by cutting the glycosidic bond of peptidoglycan” (Abstract). Therefore, one of ordinary skill in the art at the time the invention was made would have adjusted the teachings of Nyan to include a variety of additional components as guided by Lim to arrive at the lysis buffer, as claimed, with a reasonable expectation for success.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nyan et al. (US Patent 10072309; September 2018 as evidenced by Miyoshi et al. (US Patent 8435741; May 2013)) as applied over claims 1-7, 12, 18, 21-22, 25, 29, 32-33 and 44 above and further in view of Bienvenue et al. (J Forensic Sci, 2006, 51(2):266-273).
With regard to claim 43, Bienvenue teaches a lysis buffer of claim 1, wherein the lysis buffer further comprises a reducing agent, further optionally wherein the reducing agent is present at a concentration of about 0.1 mM to about 100 mM, further optionally the reducing agent is or comprises cysteine (Table 1, p 268, col. 1, where DTT concentrations in lysis were tested; see also, Fig 3 legend).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the teachings of Nyan to include a variety of additional components as guided by Bienvenue to arrive at the lysis buffer, as claimed, with a reasonable expectation for success. Bienvenue teaches “In order to tailor the previously published protocol to the extraction of DNA from semen or purified sperm cells, a cell lysis buffer was developed and demonstrated for both macro- and micro-scale cell rupture. A 6M GuHCl solution containing 40mM DTT was demonstrated to work effectively as a dual lysis and loading buffer for sperm cells both on- and off-chip. DNA purified using the methods developed was suitable for subsequent STR analysis, producing results that while preliminary in nature, compare favorably with DNA extracted by a commonly utilized commercially available method” (p. 273, col. 1). Therefore, one of ordinary skill in the art at the time the invention was made would have adjusted the teachings of Nyan to include a variety of additional components as guided by Bienvenue to arrive at the lysis buffer, as claimed, with a reasonable expectation for success.
Conclusion
No claims are allowed. All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681
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