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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The instant application is a 371 of PCT/KR2022/001489 filed on 01/27/2022 and claims foreign priority to application no. KR10-2021-0185773 filed on 12/23/2021. The certified copy of the foreign priority application filed on 06/21/2024 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/21/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The preliminary claim amendments filed on 06/21/2024 is acknowledged. Claim 5 is amended.
Accordingly, claims 1-13 are pending and being examined on the merits herein.
Claim Rejections - 35 USC § 112(b)
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 3 and 8 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 3 and 8 recite “wherein the porous ion charge particles are one or more selected from group consisting of polyacrylate, sodium polyacrylate, polyacrylamide, polyvinyl alcohol, polyethylene, polyacrylonitrile, alginate, ethylene maleic anhydride, methyl cellulose, hydroxy ethyl cellulose, hydroxypropyl methyl cellulose, cellulose acetate, carboxy methyl cellulose, and polymethacrylate (PMA)”.
Claims 3 and 8 are indefinite because these recited polymer species by itself are not known to be ion charged and/or porous particles. For example, the recited species such as polyvinyl alcohol, polyethylene, polyacrylonitrile, methyl cellulose, hydroxy ethyl cellulose, hydroxypropyl methyl cellulose, and cellulose acetate are non-ionic polymers and do not possess an ion charge. Furthermore, there is no additional disclosure in the specification for how a recited polymer species can be “porous ion charge particles”.
It is noted that the specification discloses that these recited polymer species are a component of the recited “porous ion charge particles” (page 11 lines 13-18 in specification). Therefore, for purposes of the examination, claims 3 and 8 are being interpreted such that the recited polymer species is a component of the recited “porous ion charge particles”
Claim Interpretation
The term “porous ion charge particles” is being interpreted as any material that has a porous structure and holds a negative charge. Support for this interpretation is found on lines 7-9 page 11 in the specification.
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) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhong et al. (APETC, 2017 in PTO-892) and as evidenced by Ma et al. (Biological Macromolecules, 2018 in PTO-892).
Zhong discloses porous sodium polyacrylate resin, in which the pore was cylindrical and has size distribution of about 10 um (paragraph under “Conclusion” page 1072).
As evidenced in the specification, the term “porous ion charge particles” is a material that is porous and has a negative charge, and it may be a synthetic resin or natural resin (lines 7-9 page 11 in specification). Additionally, as evidenced by Ma, sodium polyacrylate is an anionic polyelectrolyte (first paragraph right column page 15 in Ma).
Furthermore, MPEP 2111.01 II states that “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”.
In this case, the recited “for nucleic acid isolation” merely states the intended use of the invention and does not add structural limitations to the recited porous ion charge particles. Therefore, since Zhong teaches all of the structural limitations as described above, instant claims 1-4 are anticipated.
Claim(s) 1, 5-6, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mason et al. (WO2018195594A1 in PTO-892).
Mason discloses a method of extracting nucleic acid from a sample by (i) combining a fibrous and/or porous matrix with a sample comprising a nucleic acid whereby the nucleic acid is captured by the matrix; and (ii) releasing the nucleic acid from the matrix, to thereby extract the nucleic acid from the sample (Abstract and claim 1 of Mason). Mason discloses that the matrix is one or more of microporous, absorbent, and hydrophilic (Abstract) as well as preferably has a negative surface charge (lines 1-2 page 3).
Mason demonstrates their extraction method in Fig. 2B, in which tissue sample was first extracted by adding the sample into a tube containing a lysis buffer. Then, a Whatman no. 1 cellulose disc was added into the lysed extract and further washed. The cellulose disc was then placed into a tube to elute out the nucleic acid from the disc and amply via PCR. Mason further demonstrates in FIG. 6A that the cellulose disc was allowed to react with the nucleic acids for a period of 7 seconds, 30 seconds, 1 minute, and 5 minutes.
Mason discloses that Whatman no. 1 has a microporous matrix and carries a negative charge, which meets the limitations of the recited “porous ion charge particles”. Furthermore, the tube shown in Fig. 2B meets the limitation of a nucleic acid extraction tube.
Therefore, instant claims 1 and 5-6 are anticipated.
In regards to instant claim 10, even though Mason does not explicitly teach that their cellulose disc will adsorb cationic by-products in the lysed sample, this limitation would have been necessarily present because Mason discloses that the Whatman no. 10 cellulose disc carries a negative surface charge, which means positive charged cationic materials present in the sample would have absorbed via electrostatic interaction. Therefore, instant claim 10 is also anticipated.
In regards to instant claim 12, Mason further demonstrates in FIG. 6B where no washing step was performed during the extraction process and gave the highest DNA band intensity after amplification (lines 1-6 page 41). Therefore, instant claim 12 is also anticipated.
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.
Claim(s) 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al. (WO2018195594A1 in PTO-892) in view of Zhong et al. (APETC, 2017 in PTO-892) and as evidenced by Ma et al. (Biological Macromolecules, 2018 in PTO-892).
The teachings of Mason are as described above and teach the method of instant claim 6 as discussed above.
Furthermore, Mason teaches that the porous matrix has substantial capacity to take in and hold liquid and is preferably absorbent of water and aqueous solutions (page 16 lines 1-3). Mason teaches that the exemplified Whatman No. 1 cellulose disc has a pore size of 11 um (page 16 lines 21-22). Mason also teaches that in general, membranes that were found to be suitable for nucleic acid extraction were hydrophilic and microporous, and possessed neutral or negative charge (page 16 lines 4-32).
Mason, however, does not teach the use of anionic polyelectrolytes such as sodium polyacrylate.
The teachings of Zhong are as described above, which teaches a porous sodium polyacrylate resin that has cylindrical pores and size distribution of about 10 um (paragraph under “Conclusion” page 1072). Furthermore, Zhong teaches that the porous sodium polyacrylate resin had significantly higher moisture absorption in comparison to silica gel due to increased surface area from the micropores (Figure 3 and last paragraph on page 1071), and as evidenced by Ma, sodium polyacrylate is an anionic polyelectrolyte (first paragraph right column page 15 in Ma).
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the porous matrices disclosed in Mason with the porous sodium polyacrylate resin disclosed in Zhong to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this substitution because Zhong teaches that porous sodium polyacrylate resin had significantly higher moisture absorption performance due to the increased surface area of the micropores.
One of ordinary skill in the art would have a reasonable expectation of success because Mason discloses that membranes that were found to be suitable for nucleic acid extraction were hydrophilic and microporous, and possessed neutral or negative charge.
Claim(s) 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al. (WO2018195594A1 in PTO-892) in view of Nargessi et al. (US20030092045A1 in PTO-892).
The teachings of Mason are as described above and teach the method of instant claim 6 as discussed above.
Mason, however, does not teach wherein the reaction is performed at room temperature.
Nargessi teaches a method for the isolation and purification of nucleic acids from various sources using cellulose particles or cellulose paper (Abstract). Nargessi teaches that their method produces nucleic acids ready for further characterization and downstream processing such as PCR, sequencing, or blotting procedures (paragraph 0014).
Nargessi teaches that the cellulose material can be a Whatman No. 3 cellulose filter paper (paragraph 0051).
Nargessi demonstrates their method in Example 3 (paragraphs 0074-0082), in which the Whatman filter paper was used as a matrix to capture DNA in a binding buffer. The cellulose filter paper was placed in a 2 mL microcentrifuge tube, and a binding buffer solution further containing a calf thymus DNA solution was added. The mixture was incubated at room temperature for 10 minutes. After incubation, the filter was washed, and the nucleic acids was eluted out using an elution buffer.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the method of Mason by performing the reaction between the cellulose disc and DNA solution at room temperature as disclosed in Nargessi to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both Mason and Nargessi teach a method of extracting nucleic acids from a sample by using a cellulose-based matrix to capture the nucleic acids.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mason et al. (WO2018195594A1 in PTO-892) in view of Mori et al. (US20090226892A1 in PTO-892).
The teachings of Mason are as described above. Furthermore, Mason teaches a kit comprising their porous matrix together with one or more reagents for amplifying, analyzing or detecting the nucleic acid (claim 36 in Mason). Mason teaches these reagents include DNA polymerase enzymes, restriction endonucleases, probes and/or primers which in some embodiments may be labelled to facilitate detection (lines 8-11 page 30).
All of the recited method steps are taught in Mason as discussed above except for the last recited step of the in-situ detection of a sample during the PCR or after completing the same.
Mori teaches total system for nucleic acid analysis whereby the steps of extracting, amplifying, and detecting a nucleic acid can all be performed on a single solid support (Abstract).
Mori teaches that the method involves 1) extracting a nucleic acid using a porous support layer containing a reagent for nucleic acid extraction; 2) performing a nucleic acid amplification reaction for a target nucleic acid using a porous support layer containing a reagent for nucleic acid amplification; and 3) hybridizing a nucleic acid probe with the product of the nucleic acid amplification reaction, allowing a nucleic acid precipitant to act on the hybrid that has been produced so as to form an aggregate, and detecting the target nucleic acid in a specimen with the use of the obtained aggregate (claim 4 in Mori).
Mori teaches that the porous support can be cellulose and other materials (claim 13 in Mori). Mori teaches that the nucleic acid amplification can be carried out using PCR, ICAN, SDA, NASBA, or LAMP amplification methods (paragraph 0054).
Mori demonstrates in Example 1 (paragraphs 0094-0096) their method in which a cellulose filter paper was used in a LAMP amplification solution. CK20 was used as a target nucleic acid, and calcein fluorescence was measured to confirm the presence or absence of amplification. FIG. 2 shows that the amplification reaction took place when adding the filter paper to the LAMP solution. The FIG. 2 data meets the limitation of in-situ detection of a sample (target nucleic acid) during amplification.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the method of Mason by including the in situ detection step during amplification as disclosed in Mori to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both Mason and Nargessi teach a method of extracting nucleic acids by using a cellulose-based matrix and further amplifying the nucleic acids using methods such as PCR.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
