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 .
Status of Claims
The claim set submitted on 13 AUGUST 2026 is acknowledged and considered. In the claim set, Claims 1, 6, 13 are 19 ‘Current Amended’; Claims 2-5, 7-12, 14-18 and 20-23 are ‘Original’.
Current pending claims are Claims 1-23 and are considered on the merits below.
Response to Amendment/Arguments
In the REMARKS filed on 13 AUGUST 2026, Applicant asserts the combination of reference do not teach the limitations of claims 1 and 6 “relating to: the outer surface of the surface-attached structures and the inside surface of the chamber of the flow cell comprise nucleic acid adsorbant material (claim 1), the inside surface of the chamber facing the surface-attached structures comprises a nucleic acid adsorbant material (claim 6).”
Examiner respectfully disagrees. TONER teaches the channel wall, one or more channel walls may be chemically modified to be non-adherent or repulsive. Which is interpreted by the Examiner that it is not required that the channel wall, one or more channel walls are chemically modified to be non-adherent or repulsive. It is a design choice to make the channel walls, or one or more channel walls make them to reduce the adsorption. TONER also teaches the walls may also be coated to capture materials in the sample, i.e. be adsorbent, Column 9 line 41-62. TONER also teaches the array of obstacles are coated with a binding moiety, which can be selective, Claim 8, 9, 15, 16, 29, 31, 32.
The Examiner has reconsidered the applied art and has withdrawn the rejection of Claims 13-23, including the double patenting rejection because the cited reference do not teach or suggest beads as required by Claims 13 and 19.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, both references are directed to same flow cell, which include obstacles in which a sample fluid is placed in contact with. The EVANS teach the desired motion obstacles not taught in TONER.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 6 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7, 13, 15, 16, 18 and 19 of U.S. Patent No. 10,900,896 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant invention, direct to a flow cell, and the ‘896, also directed to a flow cell comprise the same structural limitation of the flow cell and the system including the flow cell for nucleic acid extraction. The instant invention more simply claimed in the independent claims, its dependent claims claim elements like the driver and binding agents.
The ‘896 patent is more specifically claimed while the instant invention is more broadly claimed. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the ‘896 to more simply claim the inventions to streamline the flow cell and system.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over TONER, US Patent 8,304,230 B2, submitted on the Information Disclosure Statement on 23 MAY 2024; US Patents Cite No. 1, in view of EVANS, Magnetically Actuated Nanorod Arrays as Biomimetic Cilia, Nano Letters, 2007, Vol. 7, No. 5, page 1428-1434.
Applicant’s invention is directed towards a flow cell.
Regarding Claim 1, the reference TONER discloses a flow cell for nucleic acid extraction, abstract, Figure 7, 19, 20 and 24A, microfluidic apparatus, Column 11 line 7-18, Column 18 line 23-35, comprising:
a chamber enclosing an interior and comprising a fluid inlet, a fluid outlet, and an inside surface facing the interior , Figure 7, 8, 19, 20, 24A, in particular Figure 8, Column 11 line 7-38; and
a plurality of surface-attached structures attached to the inside surface at a plurality of respective attachment sites and extending into the interior therefrom, Figure 7, 8, 19, 20, 24A, microposts, Column 11 line 7-38;
wherein the flow cell does not include any binding agents disposed on or integrated with the outer surface of the surface-attached structures, or disposed on or integrated with the inside surface of the chamber of the flow cell, Claim 1, and
wherein the outer surface of the surface-attached structures and the inside surface of the chamber of the flow cell each comprise nucleic acid adsorbent material, Column 9 line 41-62.
The TONER reference discloses the claimed invention, but is silent in regards to wherein each surface-attached structure comprising a flexible body and a metallic component disposed on or in the body, wherein application of an actuation force actuates the surface-attached structure into movement relative to the corresponding attachment site.
EVANS discloses a flow cell, Figure 1 and 3, the space between the PDMS spacers, comprising:
a chamber enclosing an interior and an inside surface facing the interior, Figure 1 and 3, space between the PDMS spacers, white space; a plurality of surface-attached structures attached to the inside surface at a plurality of respective attachment sites and extending into the interior therefrom, Figure 1-3, rod array, page 1430; each surface-attached structure comprising a flexible body and a metallic component disposed on or in the body, Figure 2, 4-6, page 1430-1431, flexible magnetic rod, wherein application of an actuation force actuates the surface-attached structure into movement relative to the corresponding attachment site, Figure 2, 4-6, page 1430-1431, flexible magnetic rod bend/rotates upon actuation of magnetic field.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the TONER reference with the surface-attached structures / rod array as taught by EVANS to generate a variety of spatial and temporal beat patterns, page 1430.
Applicant’s invention is directed towards a system.
Regarding Claim 2, the TONER reference discloses a system for nucleic acid extraction, Figure 7 and 8, comprising: the flow cell of claim 1, See Rejection to Claim 1 above; and a driver configured for applying an actuation force to the interior of the flow cell to actuate movement of the surface-attached structures, Column 16 line 13-19, EVANS Figure 3.
Additional Disclosures Included is: Claim 3: wherein the system of claim 2, wherein the nucleic acid extraction system further comprises a housing configured for removably receiving the flow cell, TONER, Figure 8, top layer.
Applicant’s invention is directed towards a method.
Regarding Claim 4, the reference TONER discloses a method for extracting a nucleic acid from a sample, Column 15 line 12-Column 17 line 26, comprising the steps of:
a) flowing a nucleic acid-containing sample in the presence of one or more chaotropic agents through the flow cell of claim 1, Column 9 line 63-Column 10 line 20 and See Rejection to Claim 1 above, and into contact with the outer surface of the surface-attached structures and/or the inside surface of the chamber of the flow cell, Column 9 line 63-Column 10 line 20;
b) allowing the nucleic acids in the sample to adsorb to the outer surface of the surface-attached structures and/or the inside surface of the chamber of the flow cell, Column 9 line 63-Column 10 line 20;
c) flowing a solution comprising a rinsing/washing agent through the flow cell so as to purge the flow cell of residual components from step (b), Column 10 line 11-20;
d) flowing a solution comprising an elution buffer through the flow cell so as to deadsorb the nucleic acids from the outer surface of the surface-attached structures and/or the inside surface of the chamber of the flow cell, Column 10 line 11-20; and
e) while flowing the solution comprising an elution buffer through the flow cell, applying an actuation force to actuate movement of the surface-attached structures to redistribute the nucleic acids in the chamber of the flow cell, Column 10 line 21-31, 50-54, Column 16 line 13-19.
Additional Disclosure Included is: Claim 5: wherein the method of claim 4, wherein prior to step (a) the flow cell includes binding agents disposed on or integrated with the outer surface of the surface-attached structures, and/or disposed on or integrated with the inside surface of the chamber of the flow cell, and further wherein prior to step (a) the flow cell is washed with a solution capable of removing the binding agents disposed on or integrated with the outer surface of the surface-attached structures, and/or disposed on or integrated with the inside surface of the chamber of the flow cell, Column 14 line 10-42.
Applicant’s invention is directed towards a flow cell.
Regarding Claim 6, the TONER reference discloses a flow cell for nucleic acid extraction, abstract, Figure 7, 19, 20 and 24A, microfluidic apparatus, Column 11 line 7-18, Column 18 line 23-35, comprising:
a chamber enclosing an interior and comprising a fluid inlet, a fluid outlet, and an inside surface facing the interior, Figure 7, 8, 19, 20, 24A, in particular Figure 8, Column 11 line 7-38; and
a plurality of surface-attached structures attached to the inside surface at a plurality of respective attachment sites and extending into the interior therefrom, Figure 7, 8, 19, 20, 24A, microposts, Column 11 line 7-38,
wherein the flow cell does not include any binding agents disposed on or integrated with the outer surface of the surface-attached structures, or disposed on or integrated with the inside surface of the chamber of the flow cell, Claim 1; and wherein the inside surface of the chamber facing the surface-attached structures comprises a nucleic acid adsorbant material Column 10 line 41-62.
The TONER reference discloses the claimed invention, but is silent in regards to wherein each surface-attached structure comprising a flexible body and a metallic component disposed on or in the body, wherein application of an actuation force actuates the surface-attached structure into movement relative to the corresponding attachment site.
EVANS discloses a flow cell, Figure 1 and 3, the space between the PDMS spacers, comprising:
a chamber enclosing an interior and an inside surface facing the interior, Figure 1 and 3, space between the PDMS spacers, white space; a plurality of surface-attached structures attached to the inside surface at a plurality of respective attachment sites and extending into the interior therefrom, Figure 1-3, rod array, page 1430; each surface-attached structure comprising a flexible body and a metallic component disposed on or in the body, Figure 2, 4-6, page 1430-1431, flexible magnetic rod, wherein application of an actuation force actuates the surface-attached structure into movement relative to the corresponding attachment site, Figure 2, 4-6, page 1430-1431, flexible magnetic rod bend/rotates upon actuation of magnetic field.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the TONER reference with the surface-attached structures / rod array as taught by EVANS to generate a variety of spatial and temporal beat patterns, page 1430.
Additional Disclosures Included are: Claim 7: wherein the flow cell of claim 6, wherein the inside surface of the chamber facing the surface-attached structures comprises a patterned surface, Column 15 line 12-36.; and Claim 8: wherein the flow cell of claim 7, wherein the patterned surface comprises high aspect ratio structures, Column 15 line 12-36.
Applicant’s invention is directed towards a system.
Regarding Claim 9, the combination above suggests the claimed invention, including a system for nucleic acid extraction, TONER Figure 7 and 8, comprising: the flow cell of claim 6, see Rejection to Claim 6 above; and
a driver configured for applying an actuation force to the interior of the flow cell to actuate movement of the surface-attached structures, Column 16 line 13-19, EVANS Figure 3.
Additional Disclosures Included is: Claim 10: wherein the system of claim 9, wherein the nucleic acid extraction system further comprises a housing configured for removably receiving the flow cell, TONER, Figure 8, top layer.
Applicant’s invention is directed towards a method.
Regarding Claim 11, the combination above suggests the claimed invention, including a method for extracting a nucleic acid from a sample, TONER, Column 15 line 12-Column 17 line 26, comprising the steps of:
a) flowing a nucleic acid-containing sample in the presence of one or more chaotropic agents through the flow cell of claim 6, Column 9 line 63-Column 10 line 20 and See Rejection to Claim 6 above, and into contact with the inside surface of the chamber facing the surface-attached structures, Column 9 line 63-Column 10 line 20;
b) allowing the nucleic acids in the sample to adsorb to the inside surface of the chamber facing the surface-attached structures, Column 9 line 63-Column 10 line 20;
c) flowing a solution comprising a rinsing/washing agent through the flow cell so as to purge the flow cell of residual components from step (b), Column 10 line 11-20;
d) flowing a solution comprising an elution buffer through the flow cell so as to deadsorb the nucleic acids from the inside surface of the chamber facing the surface-attached structures comprises a nucleic acid adsorbant material, Column 10 line 21-31, 50-54, Column 16 line 13-19.; and
e) while flowing the solution comprising an elution buffer through the flow cell, applying an actuation force to actuate movement of the surface-attached structures to redistribute the nucleic acids in the chamber of the flow cell, Column 10 line 21-31, 50-54, Column 16 line 13-19.
Additional Disclosures Included is: Claim 12: wherein the method of claim 11, wherein prior to step (a) the flow cell includes binding agents disposed on or integrated with the outer surface of the surface-attached structures, and/or disposed on or integrated with the inside surface of the chamber of the flow cell, and further wherein prior to step (a) the flow cell is washed with a solution capable of removing the binding agents disposed on or integrated with the outer surface of the surface-attached structures, and/or disposed on or integrated with the inside surface of the chamber of the flow cell, Column 14 line 10-43.
Allowable Subject Matter
Claims 13-23 are allowed.
The claim limitation directed to “beads comprising nucleic acid adsorbant material are attached to the outer surface of the surface-attached structures” is not found or suggested in the prior art to TONER or EVANS. While at least TONER teaches and suggest modification of the outer surface of the obstacles, which include a chemical derivation or even a binding moiety, the reference does not teach or suggest a physical bead integrated into the outer surface of the surface attached structure. While EVANS suggest chemical modifications of the surfaces of PDMS and in Figure 2, there is the appearance of a particle on the outer surface of the nanorod, these are not bead comprising nucleic acid adsorbant material.
Claims 14-18 and 20-23 are dependent upon Claims 13 and 19 and are also found allowable over the prior art.
Conclusion
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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