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
Change of Examiner
The examiner has changed. Please direct all future correspondences to Primary Examiner Katherine Salmon.
This action is in response to papers filed 5/26/2026.
Claims 1, 3-5, 7-8, 10, 12, 14, 15, 17, 19-21, 24-25, 71-74 are pending. CLiams 2, 6, 9, 11, 13, 16, 18, 22-23, and 26-70 have been cancelled.
The following rejections are newly applied.
This action is nonfinal.
Withdrawn Rejections and Objections
The drawing objection made in the previous office action is withdrawn based upon the submission of the amended drawings of 5/26/2026.
The 35 USC 112b and 35 USC 112a rejections made in the previous office action are withdrawn based upon reconsideration of the claims or amendments to the claims. It is noted that the 35 USC 112b made below is newly applied.
The 35 USC 102 and 35 USC 103 made in the previous office action are withdrawn based upon amendments to the claims.
Claim Rejections - 35 USC § 112 (b) / Second Paragraph
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, 3-5, 7-8, 10, 12, 14, 15, 17, 19-21, 24-25, 71-74 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 1, 3-5, 7-8, 10, 12, 14, 15, 17, 19-21, 24 are indefinite over the preamble of “removing RNA” and the step of the claim. In particular the step requires “contacting” the sample to the solution. This step merely requires the sample to be in contact with the aqueous solution. There is no active step of removing RNA and therefore the claim appears to be missing essential steps.
Claims 25 and 71-74 are indefinite over the preamble of “preparing a biological sample” and the step of the claim. In particular the step requires “contacting” the sample to the solution. This step merely requires the sample to be in contact with the aqueous solution. There is no active step of preparing and therefore the claim appears to be missing essential steps.
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) 1,3-4,8,10,12,14,15,17,19,20,21,24,25,72,73,74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Biol Trace Elem Res 2013 Vol 156 p. 329-337) in view of Griffiths et al. (US Patent Application 20130273637 October 17, 2013).
With regard to claims 1 and 10, Kim et al. teaches a method of contacting cell culture with sodium metasilicate (p. 330 2nd column 2nd para). As such Kim et al. teaches a method of contacting with an aqueous solution and as such would have the intended result of removing RNA. Kim et al. teaches concentrations between 50 mM to 200 mM (figure 2). However, Kim does not teach pH of sodium metasilicate.
With regard to claim 3, Kim et al. teaches cultured cells (p. 330 2nd column 2nd para).
With regard to claims 4 and 8, Kim et al. teaches murine macrophage RAW 264.7 which would be derived from tumor tissue and considered a cytological sample (p 330 1st column).
With regard to claims 14-15 and 17, Kim et al. teaches taking the cells after treating with sodium metasilicate in a RT-PCR and therefore heats for the time recited (p. 331 2nd column).
With regard to claim 19, Kim et al. teaches a step after contacting of using TRIzol reagent (p. 331 2nd column) which would be considered a washing step.
With regard to claims 20-21., Kim et al. teaches a method wherein in reverse transcribed of cDNA from the isolated RNA for hybridization assays (p. 331 2nd column).
With regard to claim 24, Kim et al. teaches mRNA (p. 331 2nd column).
With regard to claim 25, Kim et al. teaches a method of contacting cell culture with sodium metasilicate (p. 330 2nd column 2nd para). As such Kim et al. teaches a method of contacting with an aqueous solution and as such would have the intended result of removing RNA. Kim et al. teaches concentrations between 50 mM to 200 mM (figure 2). Kim et al. teaches reverse transcribing the RNA to cDNA and as such detects target DNA. However, Kim does not teach pH of sodium metasilicate.
With regard to claims 73-74, Kim et al. teaches taking the cells after treating with sodium metasilicate in a RT-PCR and therefore heats for the time recited (p. 331 2nd column).
However, Kim does not teach pH of sodium metasilicate.
With regard to claims 1, 12, and 72, Griffiths et al. teaches a method of providing silicate to culture media (abstract). Griffiths teaches that culture media grows microorganisms at a pH lower than 9 and therefore silicate solubility would be low (para 112). Griffiths et al. teaches that sodium metasilicate solution of pH of around 12.5 is provides during harvesting (para 170).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Kim et al. to use the pH of 12 for sodium metasilicate as taught by Griffiths et al. in order to have a pH of silicate at a range that would solubilize. Griffiths et al. teaches that sodium metasilicate solution of pH of around 12.5 is provides during harvesting (para 170).
Claim(s) 5,7,71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Biol Trace Elem Res 2013 Vol 156 p. 329-337) and Griffiths et al. (US Patent Application 20130273637 October 17, 2013) as applied to claims 1,3-4,8,10,12,14,15,17,19,20,21,24,25,72,73,74 and in view of Domenyuk et al. (US Patent Application 20190078093 March 14, 2019).
Kim et al. teaches a method of contacting cell culture with sodium metasilicate (p. 330 2nd column 2nd para). As such Kim et al. teaches a method of contacting with an aqueous solution and as such would have the intended result of removing RNA. Kim et al. teaches concentrations between 50 mM to 200 mM (figure 2). Griffiths et al. teaches that sodium metasilicate solution of pH of around 12.5 is provides during harvesting (para 170).
However, Kim and Griffiths et al. do not teach that the sample is blood or FFPE.
With regard to claims 5, 7, and 71, Domenyuk et al. samples that can be used for RNA extraction include FFPE and blood (para 107-109).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Kim and Griffiths et al. to use known samples from a finite list of samples including the blood or FFPE of Domenyuk et al. which can have RNA extracted from the sample.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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