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 .
Detailed Action
This application is a national stage application of PCT/US22/44601, filed September 23, 2922, which claims benefit of provisional application 63/247800, filed September 23, 2021. Claims 67-83 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted March 22, 2024 is acknowledged wherein claims 1-66 are canceled.
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.
Claim 69 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 69 specifies that the adsorbent is selected from a list including adsorbents having similar adsorbent properties of silica or sand. It is unclear from the claims and the specification what sort of similarities would count as similar adsorbent properties for the sake of interpreting this claim, rendering the claim indefinite.
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.
Claims 67-69, 72, 73, 75, 77-80, 82, and 83 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mason et al. (PCT international publication WO2018/195594, Reference included with PTO-1449)
Independent claim 67 claims a process comprising placing a biological sample in a first receptacle comprising a first surface and a first solution, suspending the sample, replacing the first surface with a second surface, adsorbing the DNA to the second surface, placing the second contact surface into a second receptacle containing a second solution, contacting it with a third solution, eluting the DNA into a third solution, transferring the third solution onto a reaction site, and detecting the cfDNA.
Mason et al. discloses a method for extraction of nucleic acids which can be conducted in less than about 2 minutes, comprising combining a fibrous or porous matric with a sample comprising a nucleic acid, and subsequently releasing the nucleic acid from the matrix. (p. 2 lines 8-19) In a specific embodiment this process can be used to isolate nucleic acids from an environmental sample that does not contain cells, which would reasonably be considered to be cell free DNA. (p. 21 lines 25-29) One specific embodiment of the invention is described, (figure 8, also p. 7 line 20 – p. 8 line d) wherein the sample is shaken in a tube with a first solution having a cap which is a first contact surface, the cap is removed and a dipstick (second contact surface) is dipped into the solution to bind nucleic acids, the dipstick is removed and transferred to a second tube containing a wash buffer, and then dipped into an amplification reaction solution wherein the nucleic acids are eluted. The subsequent amplification of the sample is reasonably considered to be a method of detection. Therefore claim 67 is anticipated by Mason.
Regarding claim 68, as discussed above the first solution as described by Mason is seen to promote adsorption of the nucleic acids to the adsorbent.
Regarding claim 69, Mason discloses using cellulose, nylon, polyester and/or polyvinyl as the adsorbent. (p. 3 lines 5-8) However, as discussed above, claim 69 contains the indefinite limitation “similar adsorbent properties of silica or sand,” which admits of no clear interpretation. Therefore the broadest reasonable interpretation of this claim includes any material having the ability to adsorb nucleic acids, which would render it similar to silica or sand.
Regarding claims 72 and 73, figure 8 of Mason describes the second solution as a washing solution. P. 13 lines 19-20 and p. 47 line 4 describe the wash solution as comprising an alcohol. Regarding claim 77, p. 35 lines 30-34 of Mason describe coating handling portions of the dipstick with wax, which is less polar than the aqueous amplification solution. Regarding claim 80, the third solution (amplification mix) is described as being performed in various aqueous buffers. (p. 36 line 26 – p. 37 line 14)
Regarding claims 82-83, Mason discloses amplification reactions including LAMP (p. 37 lines 9-14) which clearly anticipate the limitations of present claim 83 and additionally involve base pairing primers that would meet the limitations of present claim 82.
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.
Claims 70, 71, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al. (PCT international publication WO2018/195594, Reference included with PTO-1449)
The disclosure of Mason is discussed above. Mason does not specifically describe the steps recited in claims 70, 71, and 74 being carried out for a period of time between 30 seconds and 5 minutes. However, p. 33 lines 21-28 of Mason describes a wash step for cellulose-bound DNA that lasts one minute, falling within the scope of claim 74. P. 33 lines 30-32 describe a step of extracting DNA from plant tissue for 30 seconds before adding filter paper, similarly to claims 70 and 71. It would have been obvious to one of ordinary skill in the art at the time of the invention to carry out the aforementioned steps for the recited lengths of time, in view of the suggestion of the prior art reference.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
Claims 67-75, 77-80, 82, and 83 are rejected. Claims 76 and 81 are objected to for depending from a rejected base claim but would be allowable if rewritten in independent form incorporating all the limitations of the rejected base claim and any intervening claims.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 7/10/2026
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