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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 28-42 in the reply filed on 07/14/2026 is acknowledged. Claims 43-47 have been cancelled.
Specification
The disclosure is objected to because of the following informalities:
Claims 41 and 42 (correspond to originally filed claims 19 and 20) contain the terms “membrane” and “inflatable membrane” which are not present within the instant specification. The specification should be amended to provide support for and incorporate this terminology.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 34 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 34 is now a duplicate of claim 33 from which it depends after Applicant’s amendment to omit the limitation “through a component having a high magnetic permeability”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 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.
Claims 28-37 are rejected under 35 U.S.C. 103 as being unpatentable over Ogg et al. (US 20160305972 A1), in view of Malik (US 20140057277 A1).
Regarding claim 28, Ogg teaches a sample processing apparatus (Cartridge 1701; [0040]; Fig. 17), comprising:
a housing (a combination of all turrets including turret 1717; [0040]; Fig. 17) having at least one chamber (comprising a plurality of turret chambers (e.g., 1719); [0040]; Fig. 17); and
a valve body (a base 1703; [0040]; Fig. 17) coupled to the housing (The base has a central barrel 1705…wherein positioning a turret chamber at the port station puts the turret chamber aperture in fluid communication with the barrel chamber; [0040]; Fig. 17),
the valve body having a fluid displacement chamber (pump chamber 1707; [0040]; Fig. 17), no more than one fluid port (a port 1713; [0040]; Fig. 17) and no more than one fluid channel (a channel 1715; [0040]; Fig. 17),
the no more than one fluid channel fluidically connecting the fluid displacement chamber and the no more than one fluid port (“a channel 1715 fluidically connecting the barrel chamber to the port in the floor,” wherein the barrel chamber is the space within the central barrel 1705 which includes the pump chamber 1707; [0040]; Fig. 17),
the fluid displacement chamber being coupled to a pressure adjustment member (movable syringe 1709; [0040]; Fig. 17) which is configured to change a pressure within the fluid displacement chamber (the syringe is positioned within the pump chamber and is capable of “pushing the liquid from one side as the syringe provides vacuum from another side,” and therefore is functionally capable of changing a pressure within the pump chamber; [0134]; See Fig. 17),
the no more than one fluid port of the valve body is selectively in fluidic communication with the at least one chamber of the housing (positioning a turret chamber at the port station puts the turret chamber aperture in fluid communication with the barrel chamber through the floor aperture; [0040]; Fig. 17).
Ogg fails to teach the valve body is adjustable with respect to the housing.
Ogg instead teaches the opposite arrangement in that the housing is adjustable with respect to the valve (the turret is configured to rotate around the syringe barrel; [0040]; Fig. 17).
Malik teaches a valve body (connecting disk (3005); [0147; Fig. 30) is adjustable with respect to a housing (Channel (3015) is part of disk (3005), and by moving disk (3005), apertures (3010) can be connected by channel (3015), thereby allowing the movement of fluids between containing structures of a device…Disk (3035) is then now translated horizontally relative to the apertures in the containing structures which are located, for example, in a circular pattern (3040); [0148]-[0149]; Figs. 30, 24-25).
Malik is considered to be analogous to the claimed invention because it is in the same field of endeavor for fluidic devices for biological sample processing by selectively transferring fluids among chambers. Ogg teaches rotating the turret (housing) around the base (valve body) in order to selectively couple one of the turret chambers with the port, whereas Malik teaches an alternative arrangement where the connecting disk (valve body) is moved relative to the containing structures (housing) to selectively align a fluid channel (no more than one port) with apertures associated with the containing structures. Ogg even contemplates a different movement configuration by stating “the cartridge can implement a rotary selector valve, either by rotating the cartridge body 1717 or an internal valve,” ([0111]) indicating that the relative movable component is not critical to achieving the desired selective fluid communication and provides a reasonable expectation of success should Ogg’s base rotate instead of the turret. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge taught by Ogg to incorporate the teachings of Malik by configuring the base to move relative to the turret rather than moving the turret relative to the base because the modification predictably maintains Ogg’s function of selectively establishing fluid communication between the fluid port and turret chamber, and this involves a known reversal or rearrangement of parts (See MPEP 2144.04(VI)(A/C).
Regarding claim 29, Modified Ogg teaches the sample processing apparatus of claim 28, wherein the at least one chamber comprises a sample chamber configured to receive therein a biological sample (“Turret cambers can include…(C)…swab vial,” wherein “a sample contained on for example a swab or a card punch, can be introduced into sample chamber 207”; Ogg, [0113], [0145]).
Regarding claim 30, Modified Ogg teaches the sample processing apparatus of claim 29, wherein the sample chamber is configured to contain therein at least one reagent for processing the biological sample (“Turret cambers can include…(C) lysis chamber…(D) lysis buffer,” wherein “Cell lysis buffer..can be feed…into the sample chamber 207; Ogg, [0113], [0145]).
Regarding claim 31, Modified Ogg teaches the sample processing apparatus of claim 29, wherein the at least one chamber further comprises at least one reagent chamber configured to contain therein at least one reagent for processing the biological sample (“Turret cambers can include…(C) lysis chamber…(D) lysis buffer; Ogg, [0113], [0145]).
Regarding claim 32, Modified Ogg teaches the sample processing apparatus of claim 31, wherein the at least one reagent chamber is configured to contain therein magnetic beads, (Turret cambers can include…(E) mix chamber/beads; Ogg, [0113]) the magnetic beads being configured to facilitate a nucleic acid extraction of the biological sample (magnetically attractable particles that bind DNA; Ogg, [0145]).
Regarding claim 33, Modified Ogg teaches the sample processing apparatus of claim 32, wherein the at least one reagent chamber configured to contain the magnetic beads is magnetically coupled to an external magnetic field (the DNA reaction chamber can include magnetically attractable particles that bind DNA and that can be immobilized in the reaction chamber by applying a magnetic force generated in the interface; Ogg, [0145]).
Regarding claim 34, Modified Ogg teaches the sample processing apparatus of claim 33, wherein the at least one reagent chamber configured to contain the magnetic beads is magnetically coupled to an external magnetic field (the DNA reaction chamber can include magnetically attractable particles that bind DNA and that can be immobilized in the reaction chamber by applying a magnetic force generated in the interface; Ogg, [0145])(See 112(d) rejection above as claim 34 is a duplicate of claim 33).
Regarding claim 35, Modified Ogg teaches the sample processing apparatus of claim 28, wherein the valve body is rotatable relative to the housing (a supporting element which can slide, rotate or move within a plane, thereby establishing a fluidics connection, through the at least one fluidics channel, between the bottom opening of at least one container of the first plurality of containers; Malik, [0003]).
Regarding claim 36, Modified Ogg teaches the sample processing apparatus of claim 28, wherein the pressure adjustment member comprises a plunger or a piston (“syringe pump,” wherein “The syringe 1709 can in turn be driven by for example, a linear stepper motor”; Ogg, [0109], [0111]; Fig. 17).
Regarding claim 37, Modified Ogg teaches the sample processing apparatus of claim 28, wherein a decrease in pressure within the fluid displacement chamber draws fluid into the fluid displacement chamber, and wherein an increase in pressure within the fluid displacement chamber expels fluid from the fluid displacement chamber (“Arrows indicate the flow of liquids which are moved by the syringe,” wherein “lysate is pulled back into the syringe…pushing the liquid from one side as the syringe provides vacuum from another side…the amplification product is moved to an output port”; Ogg, [0134]; Figs. 22-28).
Claims 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Ogg et al. (US 20160305972 A1), in view of Malik (US 20140057277 A1), as applied to claim 28 above, and in further view of Dority (US 6374684 B1).
Regarding claim 38, Modified Ogg teaches the sample processing apparatus of claim 28, further comprising a reaction vessel (Turret cambers can include…(L) reaction chamber; Ogg, [0113]).
Modified Ogg fails to teach the reaction vessel is configured to removably couple to the housing.
Dority teaches a reaction vessel is configured to removably couple to a housing (A reaction vessel 104 is detachably coupled to the housing 102; col. 7,ll. 55-57; Fig. 10).
Dority is considered to be analogous to the claimed invention because it is in the same field of endeavor of fluidic devices for biological sample processing by selectively transferring fluids among chambers. Ogg teaches that a biological sample is processed within a reaction chamber and the resulting products are analyzed ([0146]), while Dority teaches a reaction vessel that is detachably coupled to a housing for sample preparation that can conveniently be removed, replaced and disposed of (col. 10, ll. 47-49). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge taught by Ogg in view of Malik to incorporate the teachings of Dority by substituting the reaction chamber for a removable reaction vessel because it would facility disposing of the reaction vessel after analysis of reaction products, and this involves the simple substitution of one known element for another to obtain predictable results (See MPEP 2143(I)(B)).
Regarding claim 39, Modified Ogg teaches the sample processing apparatus of claim 38, wherein the no more than one fluid port of the valve body is selectively in fluidic communication with the reaction vessel (the valve 16 is rotated to place the first external port 42 in fluidic communication with a first branch 84 coupled to the reaction vessel 18; Dority, col. 6, ll. 57-59; FIGS. 9K, 9KK, and 9K'K').
Regarding claim 40, Modified Ogg teaches the sample processing apparatus of claim 38, wherein the reaction vessel comprises a first port, a second port and a reaction region in fluidic communication with the first port and the second port (“The two branches 84, 86 allow filling and evacuation of the reaction chamber of the reaction vessel 18,” wherein the reaction chamber is the reaction region; Dority, col. 7, ll. 35-37; Fig. 9L-LL).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Ogg et al. (US 20160305972 A1), in view of Malik (US 20140057277 A1) and Dority (US 6374684 B1), as applied to claim 40 above, and in further view of Petersen et al. (US 20160367991 A1).
Regarding claim 41, Modified Ogg teaches the sample processing apparatus of claim 40.
Modified Ogg fails to teach the reaction region comprises a first side and a second side, and wherein the first side and the second side comprise a membrane.
Modified Ogg instead teaches “a flexible sidewall 202 separates a reagent chamber 204 and a waste chamber 206,” in order to “reduce the overall size of the cartridge…allow fast change-overs of chamber volumes…eliminate venting, and can cut costs by reducing the number of platforms that would otherwise need to be built with hard tooling” (Dority, col. 11, ll. 6-15; Fig. 13).
Peterson teaches a reaction region comprises a first side and a second side, and wherein the first side and the second side comprise a membrane (As shown in FIG. 21, the vessel 40 also includes thin, flexible sheets attached to opposite sides of the rigid frame 46 to form opposing major walls 48 of the chamber; [0068]; Fig. 21).
Peterson is considered to be analogous to the claimed invention because it is in the same field of endeavor for fluidic devices used in biological sample processing. Ogg teaches “In FIG. 27, the reaction chamber is subjected to thermal cycling to amplify target sequences” ([0134]) and that heat can be applied to a foil or metalized film to improve thermal contact and transmission to the reaction chamber (See para. [0145]). Dority teaches that “the reaction vessel 18 may be inserted into a thermal reaction chamber for performing nucleic acid amplification and/or detection” (col. 7, ll. 33-35). Likewise, Peterson teaches “The walls 48 facilitate optimal thermal conductance to the reaction mixture contained in the chamber 42. Each of the walls 48 is sufficiently flexible to contact and conform to a respective thermal surface, thus providing for optimal thermal contact and heat transfer between the thermal surface and the reaction mixture contained in the chamber 42” ([0068]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge taught by Ogg in view of Malik and Dority to incorporate the teachings of Peterson by providing membranes on the sides of the reaction chamber to improve thermal contact and heat transfer between reaction vessel and thermal surfaces for better DNA extraction, and this involves combining prior art elements according to known methods to yield predictable results. (See MPEP 2143(I)(A)).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Ogg et al. (US 20160305972 A1), in view of Malik (US 20140057277 A1) and Dority (US 6374684 B1), as applied to claim 40 above, and in further view of Voronov et al. (US 20210115368 A1; EFD 2020-10-16).
Regarding claim 42, Modified Ogg teaches the sample processing apparatus of claim 40.
Modified Ogg fails to teach the second port is sealed with an inflatable membrane.
Voronov teaches a port is sealed with an inflatable membrane (a flexible membrane below the corresponding addressable valve is inflated to create a barrier, thereby preventing fluid exchange between the one or more fluid flow layers and the cell layer from occurring via the corresponding addressable microfluidic ports; claim 3; See Fig. 1B and para. [0053]).
Voronov is considered to be analogous to the claimed invention because it is in the same field of endeavor for fluidic devices used in biological sample processing. Dority teaches that first and second ports (branches 84 and 86) couple to reaction vessel 18 for filling and evacuating the reaction chamber col. 7, ll. 35-37; Fig. 9L-LL. Dority also teaches closing fluid paths to isolate the reaction vessel during subsequent processing (col. 2, ll. 29-33). Voronov teaches an inflatable membrane for blocking fluid exchange through a fluid port. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge taught by Ogg in view of Malik and Dority to incorporate the teachings of Voronov by providing the second port (branch 86) with the inflatable membrane to selectively seal the second port after filling the reaction chamber/vessel because it would isolate the reaction mixture during subsequent processing, and this involves combining prior art elements according to known methods to yield predictable results. (See MPEP 2143(I)(A)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Adey et al., 2005 (instant PTO-892) teaches a reaction chamber with an inlet and outlet port and adjacent inflatable mixing bladders.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE SIMMONS whose telephone number is (703)756-1361. The examiner can normally be reached M-F 7:30-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
