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 .
Claims 1-13 are pending in the application. Preliminary amendment filed 11/17/2023.
Priority
This application is a 371 of PCT/EP2022/057426 filed 03/22/2022. This application claims foreign priority to GERMANY DE 102021204952.4 filed 05/17/2021, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
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.
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) 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Battrell et al (WO 2007/106579 A2; cited in IDS filed 11/17/2023) in view of Zielenski et al (EP 1566437 A1; cited in IDS filed 11/17/2023).
Battrell teaches a method for purifying nucleic acids. The method uses a microfluidic device. The sample is drawn through a filter element to get the crude filtrate. This is then mixed with a lysis buffer and drawn through a glass fiber filter to trap nucleic acids, and is then rinsed with ethanol which is a wash solution. The lysis buffer contains guanidinium thiocyanate which is a chaotropic salt (Example 2 at pages 67-71; method as in claim1; step 1 and part of step 2 regarding binding nucleic acid to filter). The filter is washed with a wash buffer (page 68-wash reagent; page 69, lines 12-14; as in claim 2). The nucleic acids are eluted using an elution buffer (page 69, lines 16-17; part of the limitation of claim 3 regarding elution). This means that in Battrell’s method the lysis buffer can be mixed with a first portion of the wash buffer so that a washing can be done after the nucleic acids are released by the chaotropic salt containing lysis buffer. This need not be done as a separate step.
Battrell teaches amplification of a portion of the nucleic acid via PCR (page 69; lines 18-25; as in claims 7 and 13). Since polyethylene glycol (PEG) is used as a component in the amplification step after elution, it can be included with the transport medium as in claim 6 (page 67, line 26). The artisan would have a reasonable expectation that a highly crosslinked polyethylene glycol would also perform the same function in the PCR amplification step. The artisan can adjust the concentration of the chaotropic salt in the transport medium and that of polyethylene glycol as in claims 11 and 12 for the purpose of optimizing the purification and amplification.
Battrell does not expressly teach mixing of the transport medium with a first portion of a wash buffer as in claim 1, step 2, and does not teach the limitations of claims 4-5 and 8-10.
Zielenski teaches a method of purifying nucleic acids wherein no binding buffer is needed. Experiments 5 and 7 disclose a method wherein a lysis buffer (transport buffer as in Battrell) is mixed with blood and then transferred to a filter. After centrifugation, an inhibitor removal buffer, which is a wash buffer as in claim 1, is added and centrifuged one more time. This method is used to isolate a nucleic acid (pages 14 and 17). Since nucleic acid is also isolated by Zielenski even without the use of a binding buffer, the wash buffer (first portion) can be added to the lysis buffer (transport buffer) in the method of Battrell.
In the instant method, the transport medium is mixed with a first portion of a wash buffer to adjust the binding conditions. From the teachings of Zielenski it is seen that a binding condition is provided without the washing buffer. It is provided with just the lysis buffer which is the transport buffer as in claim 1. This is also the case in Battrell. Zielenski adds the wash buffer and removes it after centrifuging using a Falcon tube. The use of a Falcon tube does not permit trapping the nucleic acids in a glass fiber, washing and eluting as done in Battrell. However, a portion of the washing buffer can be added to the transport buffer as in Battrell. After the nucleic acid is released by the lysis buffer and wash buffer mixture it will be trapped in the glass fiber. The lysis/wash buffer mixture can be run down so that the wash buffer can remove unwanted material and the guanidinium salt, and then the elution can be performed to get the nucleic acid.
Therefore, it would be obvious to add a portion of the wash buffer to the transport medium to adjust the binding conditions as in step 2 in claim 1, thereby eliminating the need for adding a binding buffer. This would be obvious to the artisan from the teachings of Battrell and Zielenski. Addition of the first portion of the wash buffer will also lower the concentration of the chaotropic substance in the transport medium as in claim 4 and will create a mixture having a concentration of chaotropic substance as in claim 5, and would also adjust the binding conditions as in claim 1, step 2.
Battrell teaches a microfluidic device (Fig. 4, and page 43). Battrell teaches the use of a transport medium and chaotropic substance. It is obvious to add a wash buffer to the transport medium containing the chaotropic substance. Therefore, it would be obvious to set up a kit as in claims 8-10.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, a method of purifying nucleic acids using a microfluidic apparatus, the steps and reagents as claimed is known individually in the art. Thus, it is obvious to arrive at the claimed method in view of the combined teachings of the prior art.Therefore, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Method improvement is the motivation. In addition, adding a portion of the wash buffer to the transport medium in the binding step to adjust the binding conditions eliminates the need for a separate step of adding a binding buffer. This reduces a step and also lowers the cost of the method.
Conclusion
Pending claims 1-13 are rejected.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693