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 .
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 02/03/2026 and 05/01/2026 have been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The claim set and Applicant’s remarks filed February 20, 2026 have been entered. Claims 4, 7 and 15 are canceled.
Thus, claims 1-3, 5-6, 8-14 and 16-17 as amended are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on November 20, 2025:
(I) The objection to the specification is withdrawn in view of the amendment to the specification filed on February 20, 2026.
(II) The objection to claims 1-12 and 17 is withdrawn in view of the amendment to claims 1-3, 5-6, 8-12 and 17 and the cancelation of claims 4 and 7 as discussed above.
(III) The rejection of claims 1-17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of the amendments to claims 1-2, 6, 10 and 14; and the cancelation of claims 4 and 15 as discussed above.
(IV) The rejection of claims 1-2, 4-5, 7-8 and 10-12 under 35 U.S.C. 102(a)(1) is withdrawn in view of the amendments to claim 1.
Response to Arguments
The rejection of claims 3, 6, 9 and 13-17 under 35 U.S.C. 103 is maintained.
Applicant argues:
(A) The cited art does not teach or suggest the combination of elements recited by the amended claims, especially the C12 linker, see Applicant’s remarks, pg. 7, VI. Rejections Under 35 U.S.C. § 103, paragraph 3.
(B) The C12 linker recited in amended claim 1 and claim 14 is not disclosed or suggested by the cited art, Applicant’s remarks, pg. 7, VI. Rejections Under 35 U.S.C. § 103, paragraph 4.
(C) Satterfield would not have provided any reason or motivation to modify the C6 linker disclosed therein in any manner, such as by shortening it, extending it, adding substituents, etc., see Applicant’s remarks, pg. 8, paragraph 1.
(D) Even if the Examiner maintains that the C12 linker recited by Applicant’s amended claims would have been derived from the cited art, the alleged case of prima facie obviousness should be overcome by the surprising results of record, particular those shown at FIG. 4 of the application as filed, see Applicant’s remarks, pg. 8, last paragraph of the page.
(E) FIG. 4 shows that the claimed C12 linker as compared to a C6 linker significantly increased and nearly doubled the dynamic binding capacity, which is a surprising and unexpected result that overcomes any alleged case of prima facie obviousness improperly maintained by the Examiner after entry and consideration of the foregoing amendments, See Applicant’s remarks, pg. 9, last paragraph of the page.
With respect to Applicant’s arguments (A)-(E), the Examiner respectfully notes the Davis reference is included within the 103 rejections below to address the new limitations within independent claim 1, specifically, the C12 linker.
New Claim Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on February 20, 2026, where the limitations in pending claims 1-3, 5-6, 8-14 and 16-17 as amended now have been changed.
Therefore, rejections from the previous Office Action, dated November 20, 2025, have been modified and are listed below.
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.
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.
(I) Claims 1-2, 5-6, 8, 10-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Satterfield et al. (Published 11 July 2007, Analytical Chemistry, Vol. 79, Issue 16, pp. 6230-6235, IDS filed 07/06/2023) in view of Davis et al. (Published 07 July 2019, US-20190203199-A1, PTO-892).
Regarding claims 1-2, 5-6, 8, 10-14 and 16, Satterfield teaches microfluidic purification and preconcentration (e.g. a process for recovering, required in claim 1, line 1) of mRNA (e.g. the product, required in claim 2, line 1) by flow-through polymeric monolith (e.g. the chromatography material comprising a convection-based chromatography material, required in claim 1, line 2-3; and the membrane, claim 1, line 6), see pg. 6230, title. The Examiner reasonably interprets the monolith of Satterfield is the convection-based chromatography material in the form of a membrane as evidenced by the Specification which discloses the adsorptive membrane could alternatively be a monolith material (see pg. 7, lines 10-20).
Satterfield teaches the development of UV-initiated methacrylate-based porous polymer monoliths (PPM) for microfluidic trapping and concentration of eukaryotic mRNA, where PPM are cast-to-shape and are tunable for functionalization using a variety of amine-terminated molecules. Efficient isolation of eukaryotic mRNA from total RNA was first mathematically modeled and then achieved using PPM in capillaries. See pg. 6230, abstract.
Satterfield teaches purification protocols using oligo dT’s, locked nucleic acid substituted dT’s, and tetramethylammonium chloride salts were characterized, see abstract. Satterfield teaches after PPM were formed in the capillary, the material was flushed with 100 µL of DEPC water and then the PPM were functionalized with the oligonucleotide complete with a 5′NH3-C6 linked oligo dT (30-mer) (e.g. the oligo(dT)-ligand, required in claim 1, lines 4-5 and claim 5), see pg. 6231, left column, functionalizing PPM, paragraph 1.
Satterfield teaches the purity of the extracted mRNA was also examined with dt functionalized monoliths and compared with commercial kits and control mRNA (summarized in Table 1), see pg. 6234, right column, table 1.
Satterfield teaches for each method performed an optimization of the wash buffer by washing with progressively lower salt concentrations until the bound mRNA eluted (e.g. the method, required in claim 11), see pg. 6235, left column, second full paragraph.
Satterfield teaches the 1-315 µg of rat liver total RNA (0.2-1.0 µg/µL) with 10 mM Tris-HCl buffer with 180 mM NaCl and 0.1% SDS (e.g. the solution, required in claim 12, line 1) was loaded onto each capillary (e.g. the column, required in claim 8), see pg. 6232, left column, mRNA purification, paragraph 1.
Satterfield teaches optimization was required before comparing mRNA extraction methods to optimize the contact time with the monolith by controlling the flow rates. Satterfield discovered that a contact time of 5 s was sufficient to achieve maximal binding (Figure 3) (e.g. the contact time, required in claim 10). See pg. 6233, right column, last full paragraph.
Satterfield teaches the use of functionalized cellulose to selectively extract polynucleotides was developed early in the 1960s. The integration of oligo dT’s, specifically for the purpose of mRNA purification, with cellulose columns was an innovation that followed (e.g. the chromatography material comprises polymer nanofibers and is in the form of one or more membrane(s), required in claim 1, lines 5-6; the non-woven polymer nanofibers, required in claim 6; and the polymer nanofibers and claim 14, line 3). See pg. 6230, right column, paragraph 1.
Satterfield teaches the poly-A purist mRNA kit used as a commercial source contains a dried pellet of oligo dT cellulose, see pg. 6234, right column, paragraph 2.
Satterfield teaches within Table 1, the use of a monolith dT-LNA mRNA to isolate mRNA, see pg. 6234, Table 1; wherein said monolith comprises a 20-mer oligo dT (e.g. the oligo (dT) ligand, required in claim 16, lines 2-3) substituted with 50% locked nucleic acid (LNA) analogues, see pg. 6231, left column, experimental section, reagents and supplies, paragraph 1.
Although, Satterfield does not teach (a) the chromatography material is coupled via a C12 linker, required in claim 1, last line of the claim and claim 14, last line of the claim; and (b) repeating the process at least 10 times without cleaning in place (CIP), required in claim 13;.
However, in the same field of endeavor of isolating RNA, with respect to limitation (a), Davis teaches polynucleotide purification with monolith columns, see title.
Davis teaches purifying polynucleotides and formulated polynucleotides, exemplifying mRNA using monolithic chromatography columns which allow for improved purification of polynucleotides, exemplifying polynucleotides comprising poly-A, see paragraph [0026].
Davis teaches these methods are applicable to immobilizing a ligand via an active moiety to an activated monolith matrix, wherein the ligand specifically binds to the polynucleotide to be purified, see paragraph [0026].
Davis exemplifies a ligand comprising an oligo-dT probe, see paragraph [0028].
Davis exemplifies the ligand probe is an oligomer between 5 and 30 nucleotides and further exemplifies specific embodiments include the oligo-DT probe is dT20, see paragraph [0034].
Davis teaches the oligo-dT is aminated and comprising a carbon linker, see paragraph [0037]. Davis teaches the carbon linker is a whole number between 5 and 50 and further exemplifies specific embodiments of C6 and C12 (e.g. the C12 linker, required in claim 1, last line of the claim), see paragraph [0035].
Davis teaches Example 6 which evaluated the effect of the ligand linker on purification efficiency of RNA containing a poly-A tail with a shorter linker when comparing the carbon linkers C6 and C12 where the binding and resulting yield of said RNA was compared, see paragraph [0061].
Davis teaches Fig. 11 shows an overlay of chromatograms of the same RNA run with the two different linkers and found for the C6-linker column the yield was 65% (peak labeled ** in FIG. 11); while the C12-linker column yield was about 100% (peak labeled * in FIG. 11), see paragraph [0062].
Davis teaches the difference may be due to the shorter linker arm and proximity of the dT being closer to the monolith hindering fully complementary binding of the poly-A tail to the dT stretch of nucleotides, see paragraph [0062].
With respect to limitation (b), the Examiner reasonably interprets the limitation of “the process is repeated at least 10 times without cleaning in place (CIP)” as required in claim 13 is a physical limitation that is well within the scope of the artisan, as the teachings of Satterfield teach all structural limitations required in instant claim 1 and all process steps required in instant claim 11, from which claim 13 either relies on with respect to claim 1 or depends from with respect to claim 11.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated limitations (a)-(b) as taught by Davis above into the method of Satterfield as discussed above as combining prior art elements according to known methods to yield predictable results as limitation (a) is a simple addition as taught by Davis above and limitation (b) is a physical limitation well within the scope of the artisan to isolate biological molecules, specifically the mRNAs of either Satterfield or Davis as discussed above. One of ordinary skill would have been motivated to purify and preconcentrate the mRNA as taught by Satterfield above.
One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated limitations (a)-(b) into the method of Satterfield above, as both Satterfield and Davis are drawn to isolating RNA; Satterfield teach functionalized cellulose; Satterfield specifically teaches functionalized cellulose with oligo dT’s specifically for the purpose of mRNA purification; and Davis teaches the C12 linker within the oligo dT as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
(II) Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Satterfield et al. (Published 11 July 2007, Analytical Chemistry, Vol. 79, Issue 16, pp. 6230-6235, IDS filed 07/06/2023) and Davis et al. (Published 07 July 2019, US-20190203199-A1, PTO-892) as applied to claims 1-2, 5-6, 8, 10-14 and 16 above, and further in view of Hummersone et al. (Published 10 October 2019, US-20190308169-A1, PTO-892 mailed 11/20/2025).Satterfield and Davis address claims 1-2, 5-6, 8, 10-14 and 16 as written above.
Although, Satterfield and Davis do not teach (a) a heatable metal structure is placed between the membrane or sheets, required in claim 9; and (b) the at least two membranes or sheets and the at least one heatable metal surface, required in claim 17.
However, in the same field of endeavor of isolating RNA, with respect to limitations (a)-(b), Hummersone teaches a functionalized chromatography medium, see paragraph [0025]; a chromatography cartridge which comprises one or more functionalized chromatography media, see paragraph [0027]; use of a functionalized chromatography medium or a chromatography cartridge in chromatography, see paragraph [0028]; and a process for isolating one or more biological material from a mobile phase comprising contacting one or more biological molecules in a mobile phase with a functionalized chromatography medium or a chromatography cartridge, see paragraph [0029].
Hummersone teaches the one or more biological materials are chosen from and including RNA, see paragraph [0326].
Hummersone teaches the chromatography cartridge comprises one or more functionalized chromatography media stacked inside a cylindrical holder, see paragraph [0305].
Hummersone teaches the chromatography cartridge also comprises one or more frits within the typically cylindrical holders, wherein frits are well known to the person skilled in the art and refer to porous structures, typically including rigid metal, preferably rigid metal porous surfaces (e.g. the heatable metal structure, required in claim 9, line 1 and the at least one heatable metal structure, required in claim 17), see paragraph [0307]; and wherein the cartilage may comprise alternative spacer materials in addition to frits, where typical alternative spacer materials include non-woven materials (e.g. the holder, required in claim 8), see paragraph [0310].
Hummersone teaches the functionalized chromatography medium comprises polymer nanofibers, see title; wherein the polymer used to produce the nanofibers is not particularly limited, where suitable polymers include cellulose and polymethacrylic acid, see paragraph [0052]. Hummersone teaches a substrate formed of one or more non-woven sheets, and exemplifies cellulose acetate nanofibers, see paragraph [0054].
Hummersone teaches preparing a functionalized cellulose chromatography medium, see paragraph [0054].
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated limitations (a)-(b) as taught by Hummersone into the compositions, apparatuses, and methods as taught by Satterfield above as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to purify and preconcentrate the mRNA as taught by Satterfield above. One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated limitations (a)-(b) as discussed above into the compositions, apparatuses, and methods as taught by Satterfield above; because Satterfield and Hummersone are both drawn to isolating RNA using functionalized cellulose; Hummersone teaches preparing a functionalized cellulose chromatography medium; and Satterfield specifically teaches the integration of oligo dT’s, specifically for the purpose of mRNA purification, within cellulose columns as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
(III) Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Satterfield et al. (Published 11 July 2007, Analytical Chemistry, Vol. 79, Issue 16, pp. 6230-6235, IDS filed 07/06/2023)and Davis et al. (Published 07 July 2019, US-20190203199-A1, PTO-892) as applied to claims 1-2, 5-6, 8, 10-14 and 16 above, and further in view of Clerici et al. (Published 01 January 1979, Nucleic Acids Research, Vol. 6, Issue 1, pp. 247-258, PTO-892 mailed 11/20/2025).
Satterfield and Davis address claims 1-2, 5-6, 8, 10-14 and 16 as written above.
Although, the combination of Satterfield and Davis do not teach the oligo(dT)-ligand density on the chromatography material is 10-20 µmol/g as required in claim 3.
However, in the same field of endeavor of functionalized cellulose, Clerici teaches naturally occurring DNA as well as synthetic polydeoxynucleotides covalently linked to solid particles, such as cellulose, serve as immobilized ligands to isolate nucleic acid fractions by complementary pairing, see pg. 247, introduction, paragraph 1.
Clerici teaches synthetically-prepared 5'-NH2-dT(pdT)n oligomers were immobilized on cyano bromide activated cellulose where the influence of temperature on the rate of the coupling process was studied, see pg. 247, abstract.
Clerici teaches the effect of temperature on the coupling reaction of CNBr-cellulose with different NH2-dT(pdT)n substrates, where Clerici exemplifies a NH2-dT(pdT)8 where at 42°C, a coupling time of 24 hours, 20 mg of CNBr-cellulose and 500 nmoles of NH2-dT(pdT)8 generated 265 nmoles of NH2-dT(pdT)8 linked cellulose, which corresponds to 13.25 nmoles per mg, see pg. 253, Table II. The Examiner notes 13.25 nmoles per mg is equivalent to 13.25 µmoles per gram as required in claim 3.
Clerici teaches the oligomer 5'-NH2-dT(pdT)8 could be elongated enzymatically to the polymer 5'-NH2-dT(pdT)n wherein n=20, which could be immobilized on cellulose, see pg. 247, abstract.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated the oligo(dT)-ligand density on the chromatography material as taught by Clerici above into the functionalized cellulose chromatography medium as taught by the combination of Satterfield and Davis above as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to produce the functionalized cellulose column of Satterfield for isolating biological molecules, for example the mRNA taught by Satterfield as discussed above.
One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated the limitation as discussed above into the functionalized cellulose column of Satterfield above, as Satterfield, Davis and Clerici are all drawn to functionalized polymers for isolation of nucleic acids; Satterfield and Clerici teach cellulose functionalized with oligo dT’s; Clerici teaches a process of creating oligo dT-functionalized cellulose at the recited density; and Satterfield teaches the integration of oligo dT’s into cellulose columns for the specific purpose of mRNA purification as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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