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 amendment filed 5/15/2026 is acknowledged. Claims 1, 4, 7, 8, 12, 16 have been amended. Claim 19 has been canceled. Claims 1-18 are pending and under examination.
All of the amendment and arguments have been thoroughly reviewed and considered. Any rejection not reiterated in this action has been withdrawn as being obviated by the amendment of the claims.
This action is made Final.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Previous rejection
Status of previous rejections:
(a) The 35 USC 112(b) rejections directed to the claims 1-4 and 7-16 are withdrawn in view of Applicant’s amendment, but are maintained for the claims 5 and 6 as discussed below.
(b) The prior art rejection under 35 USC 102 directed to the claim 19 is withdrawn is withdrawn in view of Applicant’s cancellation of the claim.
(c) The prior art rejection under 35 USC 103 directed to the claims 1-15 is withdrawn in view of Applicant’s arguments of unexpected results of the method steps based on the specific ordered steps as supported by the instant specification. The examiner agrees with Applicant’s assertion that the combination of the cited prior art do not teach the specific order steps of an alcohol-based first wash (step ii) followed by a DMSO final wash at >50 wt-% (step iii) followed by elution (step iv). This step ordering relates to the unexpected benefit provided by the claimed method (the elimination of the drying step) (see arguments at pages 7-11).
(d) The prior art rejected under 35 USC directed to the claims 17-18 are maintained and discussed below.
Claim Rejections - 35 USC § 103
Note: The rejection below has been modified to remove withdrawn claims deemed to contain allowable subject matter.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Regarding claim 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.
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]).
Latham teaches suitable magnetic microparticles teaches magnetic saturation of >67 emu/g particles [0072].
Latham teaches wherein the alcohol which may encompass ethanol or isopropanol may comprise an amount from at least 50% to 80% [0090].
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].
Latham teaches wherein the final wash buffer further comprises of an inorganic salt, wherein the salt is potassium iodide or sodium iodide ([0024]).
Latham teaches wherein the elution buffer consists essentially of deionized water ([0012], [0096]).
Latham teaches wherein the step ii) is conducted once ([0065] – [0068]). Latham teach wherein RT- PCR is used [0114] and [0123].
Adie teaches wherein the solid phase material having the glass surface comprises glass coated magnetic particles [0068] and [0070].
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].
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]).
Response to Arguments
Applicant’s Traversal
Applicant traverse the rejection on the following grounds: Applicant summarizes the claimed invention and the cited prior art. Applicant notes that the claimed invention addresses the problem of drying steps consuming more than 50% of total purification process time that represents a significant operational bottleneck. Applicant states that Latham does not merely distinguish glass-surface methods neutrally and cites passages from the specification that Applicant asserts that rather Latham teaches away from the use of glass surface solid phase materials.
Applicant asserts that the neither the references alone or in combination suggest the specific reference teaches, nor does the combination suggest, the specific step ordering recited in claim 1: an alcohol-based first wash (step ii) followed by a DMSO final wash at ≥50wt-% (step iii) followed by elution (step iv). This step ordering relates to a practical advantage provided by the claimed method (the elimination of the drying step) and it is not found in either reference.
Applicant states that that Lathem does not teach any two-step wash sequence in which an alcohol wash is followed by a DMSO wash and recites DMSO wash as an alternative to ethanol or isopropanol wash.
Applicant states that Edie does not teach a DMSO wash and focuses on ethanol base washes.
Applicant concludes that the proposed combination of Latham in view of Adie do not meet the limitations of the claims.
Examiner’s Response
All of the arguments have been thoroughly reviewed and considered but are not found persuasive for the reasons that follow:
In the instant case, the claims are directed to a product, which includes a list of components for an intended purpose. The limitations recited therein “for purifying nucleic acids from a sample, for “preparing the first wash buffer” are intended use limitations of the claimed kit. MPEP states that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The components of the buffers and reagents used in the method of claim 1 are all commonly-known reagents used in purifications methods of nucleic acids as evidence by the cited prior art. The allowability of the method claim as recited in the claim 1 is not based on the reagents or buffers used but rather is based on the specific order and combination of the method step recited in the claim. These order method steps are considered instructions for the use of the kit. MPEP 2112.01 states “[W]here the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, **>367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)< (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed.). See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983) ("Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability”. Applicant’s arguments are not found persuasive to obviate the rejections directed to the claims 17 and 18. Accordingly , the rejections are maintained.
Conclusion
Claims 1-4 and 7-16 contain allowable subject matter. The claims 5, 6 17 and 18 are rejected. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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