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 . Applicant’s preliminary amendment filed 4/14/2023 have been amended. Claims 1, 3, 5-7, 14-18 have been amended. Claims 1-19 are pending.
Priority
This application is a 371 of PCT/EP2021/078603 filed 10/15/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/12//2023 The submission is 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 1-16 and 19 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.
(a) Claims 1-16 are indefinite in the claims 1 and 9 at the recitation of “at least about” because the limitation has not been defined in the claimed specification and thus the metes and bounds of the claimed limitation cannot be ascertained.
(b) Claims 4-9 are indefinite at the recitation of “preferably” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
(c) Claims 16 and 19 are indefinite because they merely recite a use without any active, positive steps delimiting how this use is actually practiced. MPEP 2173.05(q) states “attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph”.
Claim Rejections - 35 USC § 102
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.
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) 19 is/are rejected under 35 U.S.C. 102(a)(1) and/or alternatively 35 USC 102(a)(2) as being anticipated by Lambert, Karel (Agricultural and Biological Chemistry, 46(12), 3079-3080, 1982, citation made of record on IDS).
Regarding claim 19, Lambert teaches the use of at least 50% (v/v) dimethylsulfoxide (DMSO) (see pages 3079-3080). Thus, Lambert meets the limitations of the claim.
Claim(s) 19 is/are rejected under 35 U.S.C. 102(a)(1) and/or alternatively 35 USC 102(a)(2) as being anticipated by Latham et al (US 20130302810, November 2013, effective filing date March 2004).
Regarding claim 19, Latham teaches the use of 20% to 50% dimethylsulfoxide (DMSO) (see e.g., col. 94, at page 9 and [0097]). Thus, Latham meets the limitation of the claim.
Claim Rejections - 35 USC § 103
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.
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) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Latham (US 20130202810) in view of Adie et al (UA 20080187905).
Regarding claim 1, 17 and 18, Latham teaches a method and kit (see section D. Kits at pages 9 and 10) for purifying nucleic acids from a sample containing nucleic acids to be purified, wherein the method comprises the following steps conducted of: i) contacting the sample with a solid phase material having a coated surface in presence of a binding buffer containing a chaotropic salt to bind the nucleic acids to the glass surface and obtain a solid phase material having the nucleic acids bound to its coated surface, wherein the coated surface may comprise of glass fiber (see paragraphs [abstract, [0008] – [0009], [0019], [0024], [0029] – [0031] [0034], [0040], [0090], [0093] –[0094] and ; ii) washing the solid phase material having the nucleic acids bound to its glass surface with a first wash buffer containing a C2-C4 aliphatic alcohol ([0088] which teaches suitable solvents, [0090], [0092], [0097]; iii) washing the solid phase material having the nucleic acids bound to its glass surface with a final wash buffer comprising from about 20% to about 50% of (v/v/) of a solvent which may comprise of dimethyl sulfoxide (DMSO); see also paragraphs [0093] , [0094], [0097]; and after step iii) iv) eluting the nucleic acids from the glass surface with an elution buffer to provide purified nucleic acids [0094] and [0096]).
Latham does not expressly teach the method was conducted in the specific order, However, MPEP 2144.04 states that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930). Likewise, while Latham teaches a preference for dextran-coated magnetic particles, Latham also discusses the suitability of using glass coated with magnetically responsive particles for purification of RNA and DNA from silica magnetic beads (paragraphs [0007] – [0009]).
Nonetheless, in a similar embodiment for isolation and purification of nucleic acids, Adie teaches wherein the method comprises (para. 0065] – [0068]: a. incubating the biological sample in the presence of a chaotropic agent, a buffering substance, and 0.5 to 5% (V/V) polidocanol or a derivative thereof, and [0067] b. isolating the nucleic acid, thereby purifying the nucleic acid.
[0068] The incubation conditions of step a) of both methods according to the invention are preferably prepared by adding a composition according to the invention to the biological sample. In one embodiment of the invention, in step a) the biological sample is incubated in the presence of a chaotropic agent, a buffering substance, and 0.5 to 4.9% (V/V) polidocanol or a derivative thereof, 0.5 to 4.5% (V/V) polidocanol or a derivative thereof, 0.5 to 3% (V/V) polidocanol or a derivative thereof, preferably 0.75 to 1.75% (V/V) polidocanol or a derivative thereof. Preferably, the isolating step b) of the method comprises binding the nucleic acid to a material with an affinity to nucleic acids, preferably a material with a silica surface, optionally washing the nucleic acid bound to the material and eluting the nucleic acid from the material. Preferably, the material with a silica surface is a composition comprising magnetic glass particles. Adie teaches that magnetizable porous glass is proven to be very efficient and suitable for automation ([0070]).
Thus, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention that it would merely require routine optimization of known parameters to use glass coated particles in the purification of nucleic acids based on the practitioner’s desired results as discussed by Latham. The ordinary artisan would have been motivated to modify the method of Lathan to encompass magnetizable porous glass based on the advantages taught by Adie that magnetizable porous glass is proven to be very efficient and suitable for automation. The ordinary artisan could expect a reasonable expectation of success in purifying nucleic acids from a sample using the combination of the cited prior art.
Regarding claim 2, Latham teaches wherein the chaotropic salt is present in the binding buffer in a concentration of at least 0.5 M to about 2.0 M ([0088], [0090], [0094]).
Regarding claim 3, Adie teaches wherein the solid phase material having the glass surface comprises glass coated magnetic particles [0068] and [0070].
Regarding claim 4, Latham teaches suitable magnetic microparticles teaches magnetic saturation of >67 emu/g particles [0072].
Regarding claim 5, Adie et al teach wherein the glass coated magnetic particles are magnetic particles consisting of a shell and one or magnetic core wherein the core consists of ferrimagnetic and ferromagnetic or superparamagnetic pigments ([0070].
Regarding claim 6, Adie et al teach wherein the solid phase material having a glass surface is a porous glass fiber particle ([0068], [0070]). Latham teaches wherein glass fibers are used ([0113]).
Regarding claims 7 and 8, Latham teaches wherein the alcohol which may encompass ethanol or isopropanol may comprise an amount from at least 50% to 80% [0090].
Regarding claim 10 and 11, Latham teaches wherein the final wash buffer comprises of a complexation agent wherein the complexation agent comprises of ethylediaminetetraacetic acid (EDTA) [0096]. See also Adie at para. [0070].
Regarding claim 12 and 13, Latham teaches wherein the final wash buffer further comprises of an inorganic salt, wherein the salt is potassium iodide or sodium iodide ([0024]).
Regarding claim 14, Latham teaches wherein the elution buffer consists essentially of deionized water ([0012], [0096]).
Regarding 15, Latham teaches wherein the step ii) is conducted once ([0065] – [0068]).
Regarding claim 16, Latham teach wherein RT- PCR is used [0114] and [0123].
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681