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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The instant specification lacks antecedent basis for the claimed centrifuge plate as recited in independent claims 1, 11, and 15 as the specification does not define or describe a structure that makes up the claimed centrifuge plate. The Examiner notes that the specification does recite a multi-well plate, but points out that the phrases “multi-well plate” and “centrifuge plate” are not interchangeable as there are multi-well plates that are not compatible with centrifuges. The Examiner also notes that the phrase “centrifuge plate” is only recited in the claims, thus the instant specification lacks antecedent basis for the claimed centrifuge plate.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claim 5, the Examiner notes that the claim language is odd as claim 5 recites sonicating the centrifuge plate or tube to lyse microbial cells. The microbial cells are located in the soil suspension; thus, the Examiner contends that the claim should be amended to recite sonicating the soil suspension as sonicating the plate itself will not result in lysing microbial cells.
For claims 6, 7, 9, 16, 19, and 20, the Examiner contends that the term “excludes” does not provide a clear further limitation of the claimed method. The Examiner notes amendments reciting “consisting of,” or “consisting essentially of” will exclude components from the claimed method and/or kit.
For claim 18, the Examiner requests Applicant include the full names for NaCl, TE, and cTAB, along with the abbreviations
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 1-20 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.
For claims 1, 5, 10-15, and 17 the Examiner notes that the claimed “centrifuge plate” is unclear as the instant specification lacks antecedent basis for the claimed centrifuge plate (see the above objection to the specification). The Examiner notes that the specification does recite a multi-well plate, but points out that the phrases “multi-well plate” and “centrifuge plate” are not interchangeable as there are multi-well plates that are not compatible with centrifuges. The Examiner also notes that the phrase “centrifuge plate” is only recited in the claims, thus the instant specification does not define a structure that makes up the claimed centrifuge plate.
For claim 2, the phrase “about 250 µg to about 750 µg” is unclear as the Examiner is unable to determine the metes and bounds of the term about. As such, the Examiner is unable to determine a deviation from 250 µg to 750 µg that is covered by the term about.
For claim 3, the phrase “about 2 mL” is unclear as the Examiner is unable to determine the metes and bounds of the term about. As such, the Examiner is unable to determine a deviation from 2 mL that is covered by the term about.
For claim 4, the phrase “about 6M guanidine thiocyanate” is unclear as the Examiner is unable to determine the metes and bounds of the term about. As such, the Examiner is unable to determine a deviation from 6M that is covered by the term about.
For claim 6, the phrase “excludes proteinase K” is unclear as the Examiner is unable to determine if proteinase K is not a component of the buffer, or if the buffer is being claimed as preventing the actions of proteinase K. For the purposes of examination, any buffer meeting the limitations of claim 1 will be read as excluding proteinase K.
For claim 7, the phrase “excludes at least one reagent selected from the group consisting of sodium dodecyl sulfate, one or more lysozymes, and glusulase” is unclear as the Examiner is unable to determine if sodium dodecyl sulfate, one or more lysozymes, and glusulase are not components of the buffer, or if the buffer is preventing the actions of sodium dodecyl sulfate, one or more lysozymes, and glusulase. For the purposes of examination, any buffer meeting the limitations of claim 1 will be read as excluding one of sodium dodecyl sulfate, one or more lysozymes, and glusulase.
For claim 9, the phrase “excludes potassium iodide” is unclear as the Examiner is unable to determine if potassium iodide is not a component of the buffer, or if the buffer is being claimed as preventing the actions of potassium iodide. For the purposes of examination, any buffer meeting the limitations of claim 1 will be read as excluding potassium iodide.
For claim 12, the phrase “about 8 mL or about 10 mL” is unclear as the Examiner is unable to determine the metes and bounds of the term about. As such, the Examiner is unable to determine a deviation from 8 mL to 10 mL that is covered by the term about.
For claim 13, the phrase “about 2 mL” is unclear as the Examiner is unable to determine the metes and bounds of the term about. As such, the Examiner is unable to determine a deviation from 2 mL that is covered by the term about.
For claim 16, the phrase “excludes potassium iodide” is unclear as the Examiner is unable to determine if potassium iodide is not a component of the buffer, or if the buffer is being claimed as preventing the actions of potassium iodide. For the purposes of examination, any buffer meeting the limitations of claim 15 will be read as excluding potassium iodide.
For claim 17, the phrase “about 8 mL or about 10 mL” is unclear as the Examiner is unable to determine the metes and bounds of the term about. As such, the Examiner is unable to determine a deviation from 8 mL to 10 mL that is covered by the term about.
For claim 19, the phrase “excludes proteinase K and sodium dodecyl sulfate” is unclear as the Examiner is unable to determine if proteinase K and sodium dodecyl sulfate are not a components of the buffer, or if the buffer is being claimed as preventing the actions of proteinase K and sodium dodecyl sulfate. For the purposes of examination, any buffer meeting the limitations of claim 15 will be read as excluding proteinase K and sodium dodecyl sulfate.
For claim 20, the phrase “excludes metal beads” is unclear as the Examiner is unable to determine if metal beads are not a component of the buffer, or if the buffer is being claimed as preventing the actions of metal beads. For the purposes of examination, any buffer meeting the limitations of claim 15 will be read as excluding metal beads.
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, 3, and 6-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by wang et al., (CN 1990863).
For claims 1 and 10, Wang et al., teach a process for extracting DNA from soil comprising lysing cells in a buffer comprising centrimonium bromide (page 2 paragraph 4, page 3 paragraph 2), washing and re-suspending quartz sand and silica powder in water (page 3 paragraph 1), binding the released DNA to a silica substrate (page 2 paragraph 4, page 3 paragraphs 5 and 6), washing non-DNA from the substrate (page 4 paragraph 2), and eluting DNA in an elution buffer (page 4 paragraph 4). With respect to the first and second centrifuge plates or tubes, the Examiner notes that claim 1 is drafted with open-ended language (comprising) that does not preclude utilizing any number of centrifuge plates or tubes. As such, the Examiner contends that the number of centrifuge tubes taught by Wang et al., is within the scope of the claim. Independent claim 1 recites a process that does not comprise disposable bead tubes, membranes, or spin columns; however, the Examiner notes that any component can be considered as not disposable provided that a user wants to keep and reuse the component. As such, the Examiner contends that reference to Wang et al., reads on the “do not comprise disposable bead tubes, membranes, or spin columns.
For claim 3, Wang et al., teach mixing the soil sample and lysis buffer in a 2 ml centrifuge tube (page 3 paragraphs 1 and 2), thus the volume of the sample mixed with lysis buffer meets the limitation of about 2 ml as the 2 ml is the maximum volume of the vessel holding the sample and lysis buffer.
For claim 6, Wang et al., do not teach a buffer comprising proteinase K, thus the Examiner contends that the prior art buffer does not comprise proteinase K.
For claim 7, Wang et al., do not teach a buffer comprising sodium dodecyl sulfate, lysozymes, and glusulase, thus the Examiner contends that the prior art buffer does not comprise the components of claim 7.
For claim 8, Wang et al., teach a solution comprising diatomaceous earth and water (paragraph 0015). The Examiner notes that quartz sand and silica powder
For claim 9, Wang et al., do not teach the silica solution potassium iodide, thus the Examiner contends that the prior art buffer does not comprise potassium iodide.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., (CN 1990863).
For claim 2, Wang et al., teach extraction from 0.5g of soil (page 3 paragraph 2), but do not explicitly teach the sample ranging from 250 to 750 µg. The Examiner is reading this limitation as optimization through routine experimentation which would have been obvious to one of ordinary skill in the art (MPEP 2144.05 II A). The MPEP states that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art would have been motivated to discover the smallest sample size that yields a suitable amount of DNA in order to reduce the amount of reagents required for the extraction process. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wang et al., wherein the sample size is reduced from 0.5g to a range of 250 µg to 750 µg as optimization requires only routine skill in the art.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., (CN 1990863) in view of Reed et al., (US 2009/0215125).
Regarding claim 4, Wang et al., do not teach a silica solution comprising 6M guanidine thiocyanate.
Reed et al., teach that it is advantageous to provide 6M guanidine thiocyanate as a means of facilitating release and binding of nucleic acids to glass surfaces (paragraph 0086).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wang et al., to include 6M guanidine thiocyanate in a silica solution in order to facilitate the release and binding of nucleic acids as taught by Reed et al.
Regarding claim 5, Wang et al., do not teach utilizing sonication to lyse cells.
Reed et al, teach a process of nucleic acid extraction wherein cells are lysed by sonication (paragraph 0087). Reed et al., teach that lysing cells by sonication is well known and routinely utilized in the art (paragraph 0087). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results (see MPEP 2141 II A) which would have been obvious to one of ordinary skill in the art. The Examiner contends that based on the teachings of Reed et al., one of ordinary skill in the art would have found it obvious to utilize sonication to lyse cells as sonication is recognized as a routine technique for lysing cells. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wang et al., to utilize a sonication buffer as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Claim(s) 11, 13, and 14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., (CN 1990863) in view of MoBio PowerSoil Extraction Method (March 2012).
Regarding claims 11 and 14, Wang et al., teach a process for extracting DNA from soil comprising lysing cells in a buffer comprising centrimonium bromide (page 2 paragraph 4, page 3 paragraph 2), washing and re-suspending quartz sand and silica powder in water (page 3 paragraph 1), binding the released DNA to a silica substrate (page 2 paragraph 4, page 3 paragraphs 5 and 6), washing non-DNA from the substrate (page 4 paragraph 2), and eluting DNA in an elution buffer (page 4 paragraph 4). Independent claim 1 recites a process that does not comprise disposable bead tubes, membranes, or spin columns; however, the Examiner notes that any component can be considered as not disposable provided that a user wants to keep and reuse the component. As such, the Examiner contends that reference to Wang et al., reads on the “do not comprise disposable bead tubes, membranes, or spin columns. Wang et al., do not teach utilizing first and second centrifuge plates.
MoBio teaches a process for extracting DNA from soil wherein centrifuge plates are utilized lyse, wash, and elute DNA from soil samples (page 2 steps 2 and 5, pages 3-4 steps 11-30, page 4 step 31). With respect to claim 14, the Examiner contends that any centrifuge plate can be reusable provided that it is cleaned prior to any additional uses. As such, the centrifuge plates of MoBio are considered as reusable. The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art (MPEP 2141 III). Reference to MoBio clearly teaches utilizing centrifuge plates for extracting DNA from soil samples, thus one of ordinary skill in the art would have found it obvious to utilize the process of Wang et al., with a centrifuge plate as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 13, Wang et al., teach mixing the soil sample and lysis buffer in a 2 ml centrifuge tube (page 3 paragraphs 1 and 2), thus the volume of the sample mixed with lysis buffer meets the limitation of about 2 ml as the 2 ml is the maximum volume of the vessel holding the sample and lysis buffer.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., (CN 1990863) in view of MoBio PowerSoil Extraction Method (March 2012), and further in view of Kappel et al., (US 2004/0259162).
Regarding claim 12, Wang et al., in view of MoBio do not teach a centrifuge plate having a capacity of about 8 mL or about 10 mL.
Kappel et al., teach a solid phase cell lysis and capture platform wherein a 7.5ml container (paragraph 0135) is utilized for cell lysis and nucleic acid capture (paragraph 0007). Kappel et al., teach that the containers may hold a volume of about 100ml (paragraph 0026). Kappel et al., also teach that the containers can be in the format of a multi-well plate (paragraph 0028). Kappel et al., teach that utilizing the container or multi-well plate provides the advantage of eliminating the need to centrifuge the solution to remove insoluble material (paragraph 0007).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wang et al., in view of MoBio, to utilize a container or multi well plate as taught by Kappel et al., in order to eliminate the need to centrifuge a solution to remove insoluble material as taught by Kappel et al.
Claim(s) 15, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., (CN 1990863) in view of Reed et al., (US 2009/0215125).
Regarding claims 15 and 20, Wang et al., teach a process for extracting DNA from soil comprising lysing cells in a buffer comprising centrimonium bromide (page 2 paragraph 4, page 3 paragraph 2), washing and re-suspending quartz sand and silica powder in water (page 3 paragraph 1), binding the released DNA to a silica substrate (page 2 paragraph 4, page 3 paragraphs 5 and 6), washing non-DNA from the substrate (page 4 paragraph 2), and eluting DNA in an elution buffer (page 4 paragraph 4). With respect to the first and second centrifuge plates or tubes, the Examiner notes that claim 1 is drafted with open-ended language (comprising) that does not preclude utilizing any number of centrifuge plates or tubes. As such, the Examiner contends that the number of centrifuge tubes taught by Wang et al., is within the scope of the claim. Wang et al., also teach the components of the extraction process can be formed into a kit (paragraph 0006). Independent claim 15 recites a kit that does not comprise disposable bead tubes, membranes, or spin columns; however, the Examiner notes that any component can be considered as not disposable provided that a user wants to keep and reuse the component. As such, the Examiner contends that reference to Wang et al., reads on the “do not comprise disposable bead tubes, membranes, or spin columns. Wang et al., do not teach a sonication buffer.
Reed et al, teach a process of nucleic acid extraction wherein cells are lysed by sonication in a buffer comprising cTAB (paragraph 0087). Reed et al., also teach soil as a suitable sample from which nucleic acids may be extracted (paragraphs 0097, 0098). Reed et al., teach that lysing cells by sonication is well known and routinely utilized to lyse cells in a sample (paragraph 0087). Reed et al., also teach forming the components of the extraction process in a kit that includes various solutions and buffers (paragraph 0010). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results (see MPEP 2141 II A) which would have been obvious to one of ordinary skill in the art. The Examiner contends that based on the teachings of Reed et al., one of ordinary skill in the art would have found it obvious to utilize sonication to lyse cells in a buffer comprising cTAB as both are routine techniques utilized in the art. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wang et al., to utilize a sonication buffer comprising cTAB as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 16, Wang et al., do not teach the silica solution comprising potassium iodide, thus the Examiner contends that the prior art buffer does not comprise potassium iodide.
Regarding claim 19, Wang et al., in view of Reed et al., do not teach a buffer excluding proteinase K and sodium dodecyl sulfate, thus the Examiner contends that the prior art buffer does not comprise proteinase K and sodium dodecyl sulfate.
Regarding claim 20, Wang et al., do not teach a kit comprising metal beads, thus the Examiner contends that the prior art kit does not comprise metal beads.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., (CN 1990863) in view of Reed et al., (US 2009/0215125), as applied to claim 15 above, and further in view of Kappel et al., (US 2004/0259162).
Regarding claim 17, Wang et al., in view of Reed et al., do not teach a centrifuge plate comprising wells having a capacity of about 8 mL or about 10 mL.
Kappel et al., teach a solid phase cell lysis and capture platform wherein a 7.5ml container (paragraph 0135) is utilized for cell lysis and nucleic acid capture (paragraph 0007). Kappel et al., teach that the containers may hold a volume of about 100ml (paragraph 0026). Kappel et al., also teach that the containers can be in the format of a multi-well plate (paragraph 0028). Kappel et al., teach that utilizing the container or multi-well plate provides the advantage of eliminating the need to centrifuge the solution to remove insoluble material (paragraph 0007).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wang et al., in view of Reed et al., to utilize a container or multi well plate as taught by Kappel et al., in order to eliminate the need to centrifuge a solution to remove insoluble material as taught by Kappel et al.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., (CN 1990863) in view of Reed et al., (US 2009/0215125) as applied to claim 15 above, and further in view of Taguchi et al., (US 2009/0222941).
Regarding claims 18 and 19, Wang et al., in view of Reed et al., do not teach a buffer comprising NaCl, polyvinylpyrrolidone, TE, RNaseA, and cTAB.
Taguchi et al., teach a DNA extraction process (paragraph 0097) wherein a buffer comprising NaCl, polyvinylpyrrolidone, TE, RNaseA, and cTAB (paragraph 0099). Taguchi et al., also teach forming kits for DNA extraction (paragraph 0057). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Taguchi et al., clearly teach that a buffer comprising NaCl, polyvinylpyrrolidone, TE, RNaseA, and cTAB can be utilized in a DNA extraction process, thus one of ordinary skill in the art would have found it obvious to utilize the taught buffer in a DNA extraction process. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wang et al., in view of Reed et al., wherein a buffer comprising NaCl, polyvinylpyrrolidone, TE, RNaseA, and cTAB is utilized as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Conclusion
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797