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 statement (IDS) submitted on 1/17/2025, has been considered by the examiner.
Election/Restrictions
Applicant's election of Group II, Claims 14-20, with traverse in the reply filed on 05/20/2026 is acknowledged.
The traversal is on the ground(s) that “Although applicant does not necessarily agree with the bases of the restriction requirement, in order to expedite prosecution, Applicant elects for prosecution on the merits the claims of Group II, claims 14-20”. Since Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the requirement is still deemed proper and is therefore made FINAL.
Claim Objection
Claims 15-16 and 19 are objected to because of the following informalities:
Claim 15: please amend “the electrophoresis capillary” to -- the at least one electrophoresis capillary --; “pumping electrophoresis buffer” to -- pumping the electrophoresis buffer--.
Claim 16: please amend “establish establishing more than one of the optical communication, electrical communication, fluidic communication, thermal communication, electromagnetic communication, and magnetic communication” to -- establish the electrical communication, the fluidic communication, the thermal communication, the electromagnetic communication, and the magnetic communication--.
Claim 19: please amend “the electrophoresis interface” to -- the electrophoresis cartridge interface--
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14, 16-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Amirkhanian et al. (US20100170799A1).
Regarding claim 14, Amirkhanian teaches a system (a capillary separation system 200 as shown in Figs.1-2 [para. 0046, 0051]), comprising:
an electrophoresis cartridge interface ( interface mechanism 300 in Fig.2 [para. 0051]) that is releasably engageable with an electrophoresis cartridge ( the cartridge 100 includes a twelve-channel fused silica capillary array that is used for separation and detection of the samples as part of a disposable and/or portable, interchangeable cartridge assembly 100 [para. 0054]; the front and rear support blocks 360 and 363 of the interface mechanism 300 are provided with holes to receive the various barrels and/or actuators. The positions of the holes match the associated components on the cartridge 100 [para. 0086]; After the cartridge has been securely received by the interface mechanism 300, a connection or interfacing sequence is initiated by the BioCalculator [user interface] software from computer 918 [para. 0090]; cartridge assembly 100 is deemed as the electrophoresis cartridge) comprising (1) an anode sub-assembly comprising an anode (anode 134 [see Figs. 7-8] for all 12-capillaries, which is automatically connected by the interface mechanism 300 to a high voltage power supply 76 [Fig. 2] for electrophoresis when installed inside the system 200 [para. 0054]), (2) a cathode sub-assembly comprising a cathode (at the lower end of the lower-section body 110 are cathode electrodes 114 that are also bonded to the lower section 110 [or insert molded as part of the lower section 110] [para. 0055]; the cartridge 100 has a single common anode 134 at the top opening of the mid-section body 120 and multiple cathodes 114 at the lower-section body 110 as part of the cartridge assembly [Other means of having two separate electrodes may be used as well] [para. 0059]), and (3) at least one electrophoresis capillary (the cartridge 100 shown in Figs. 2 and 7 holds up to 12 capillaries 140 [para. 0054]) having a first end and a second end (Fig.7 shows each capillary 140 having a first end and a second end), wherein said cathode and said anode are configured to provide a voltage gradient between said first end and said second end of said at least one electrophoresis capillary (The cartridge gel reservoir 140 is equipped with a built-in anode 134 common for all twelve capillaries, which is automatically connected to the high voltage power supply 76 via anode contact pins 304 provided on the interface mechanism in the interface module 300, for electrophoresis when installed inside the CE system 200. A commercially available high voltage power supply is used to deliver 0 to 20 KV of electrical field to gel-filled capillaries 140 for the electrokinetic injection and separations of DNA fragments [para. 0059]. Cathode contacts 340 and barrels 342—Similar to the high voltage anode contacts 304, 12 axially compliant contacts 340 provide connections to the twelve cathodes 114 in the cartridge 100 through the cathode contact ports 343 [para. 0081]; By applying high voltage across the total length of the capillary 140, separation of the DNA sample into DNA fragments is achieved [para. 0099]; thus said cathode and said anode are configured to provide a voltage gradient between said first end and said second end of said at least one electrophoresis capillary to perform electrophoresis),
wherein said system is configured such that, in response to engagement of said electrophoresis cartridge at the electrophoresis cartridge interface, communication of one or more of the following is automatically established:
(i) optical communication between said system and a portion of said at least one electrophoresis capillary (Fig. 14 shows a sectional view of the cartridge 100 along with the excitation and emission optical systems. The cartridge when installed inside the instrument through this support frame 164 in the interface mechanism 300 gets mechanically aligned with LED module/barrel assemblies. The structure of the lower body of cartridge 110 provides the optical alignment means or coupling of lens barrel assembly 188 to the excitation fibers inside the cartridge. The excitation system includes the coupling micro-ball lenses 182 with respective LEDs 184. The excitation light from the LEDs 184 is directed through the excitation fibers 116 to the detection zone 155 of the capillaries. The emission system includes the emission collection fiber array 170, which is connected at the rear side 122 of the cartridge 100 [para. 0064]; the interface provides separate electrical and optical connections to each separation channel [para. 0071]; (c) the emission detection probe piston barrels 320 actuates the detection probes 170 to make engagements with the conical seat at each capillary [para. 0095]. The emission detection probes 170 is deemed as the optical detection assembly, and the detection zone 155 of the capillaries is deemed as a portion of said at least one electrophoresis capillary),
(ii) electrical communication between said system and said anode and said cathode (The cartridge gel-reservoir 130 is equipped with a built in common electrode anode 134 [see Figs. 7-8] for all 12-capillaries, which is automatically connected by the interface mechanism 300 to a high voltage power supply 76 [FIG. 2] for electrophoresis when installed inside the system 200 [para. 0054, 0059]; the interface provides separate electrical and optical connections to each separation channel [para. 0071]; (b) High voltage anode contact barrels 305 actuate the anode contacts 304 to make engagement with the cartridge anode 134 through the anode contact ports 306. (d) The cathode contact piston barrels 342 actuates the cathode contacts 340 to make engagement with the cathodes 114 in the cartridge through the cathode contact ports 343 [para. 0094, 0096]),
(iii) fluidic communication between said system and said at least one electrophoresis capillary (The fully automated DNA analysis system 200 has a base 74, supporting a modular X-Z sample handling tray mechanism 80, which moves one 96-well micro-titer plates 70 and a buffer plate 72 in relation to the multi-capillary cartridge 100 supported by the interface mechanism 300 [para. 0051]; the interface provides precise and repeatable mechanical positioning of the cartridge, to accurately position the components of the cartridge in relation to the support elements in the CE system 200, including positioning the capillary tips in relation to external sample or buffer reservoirs, found on 96-well titer plate [para. 0071]; (a) The purge-air piston barrel 303 gets actuated to engage the cartridge reservoir 130 [para. 0093]), and
(iv) thermal communication between said system and said at electrophoresis cartridge or said at least one electrophoresis capillary (A fan or Peltier cooler on the adjacent structure to the cartridge 100 provides temperature control of the cartridge. The cartridge will have vent holes [input and output] for air circulation [temperature controlled air to be introduced to the cartridge from the instrument side] [para. 0054]).
Regarding claim 16, Amirkhanian teaches the system of claim 14, wherein said electrophoresis cartridge interface is engageable with said electrophoresis cartridge to automatically establish more than one of the optical communication, the electrical communication, the fluidic communication, and the thermal communication (as outlined in the rejection of claim 14 above, the electrophoresis cartridge interface is engageable with said electrophoresis cartridge to automatically establish the optical communication, the electrical communication, the fluidic communication, and the thermal communication).
Regarding claim 17, Amirkhanian teaches the system of claim 14, further comprising: a fluid handling system configured to move analyte from a sample outlet port to said at least one electrophoresis capillary in a state of engagement of the electrophoresis cartridge with said electrophoresis cartridge interface (The fully automated DNA analysis system 200 has a base 74, supporting a modular X-Z sample handling tray mechanism 80, which moves one 96-well micro-titer plates 70 and a buffer plate 72 in relation to the multi-capillary cartridge 100 supported by the interface mechanism 300 [para. 0051]; the interface provides precise and repeatable mechanical positioning of the cartridge, to accurately position the components of the cartridge in relation to the support elements in the CE system 200, including positioning the capillary tips in relation to external sample or buffer reservoirs, found on 96-well titer plate [para. 0071]; (a) The purge-air piston barrel 303 gets actuated to engage the cartridge reservoir 130 [para. 0093]).
Regarding claim 19, Amirkhanian teaches the system of claim 14, further comprising a reaction chamber (96-well micro-titer plates 70 and a buffer plate 72 [para. 0051]), wherein in a state of engagement of the electrophoresis cartridge with the electrophoresis interface, the reaction chamber is configured to be placed in flow communication with the electrophoresis cartridge (The fully automated DNA analysis system 200 has a base 74, supporting a modular X-Z sample handling tray mechanism 80, which moves one 96-well micro-titer plates 70 and a buffer plate 72 in relation to the multi-capillary cartridge 100 supported by the interface mechanism 300 [para. 0051]; the interface provides precise and repeatable mechanical positioning of the cartridge, to accurately position the components of the cartridge in relation to the support elements in the CE system 200, including positioning the capillary tips in relation to external sample or buffer reservoirs, found on 96-well titer plate [para. 0071]; (a) The purge-air piston barrel 303 gets actuated to engage the cartridge reservoir 130 [para. 0093]).
Regarding claim 20, Amirkhanian teaches the system of claim 19, further comprising a thermal control assembly configured to control a temperature of the reaction chamber (A fan or Peltier cooler on the adjacent structure to the cartridge 100 provides temperature control of the cartridge. The cartridge will have vent holes [input and output] for air circulation [temperature controlled air to be introduced to the cartridge from the instrument side] [para. 0054]. The fan or Peltier cooler is deemed as the thermal control assembly, which is configured to perform the claimed function of controlling a temperature of the reaction chamber).
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 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 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Amirkhanian, as applied to claim 14 above, and in view of Jovanovich et al. (US20130224846A1).
Regarding claim 15, Amirkhanian teaches the system of claim 14, wherein the electrophoresis cartridge further comprises:
a reagent container comprising electrophoresis buffer (The fully automated DNA analysis system 200 has a base 74, supporting a modular X-Z sample handling tray mechanism 80, which moves one 96-well micro-titer plates 70 and a buffer plate 72 in relation to the multi-capillary cartridge 100 supported by the interface mechanism 300 [para. 0051]; the interface provides precise and repeatable mechanical positioning of the cartridge, to accurately position the components of the cartridge in relation to the support elements in the CE system 200, including positioning the capillary tips in relation to external sample or buffer reservoirs, found on 96-well titer plate [para. 0071]; the sample handling tray transport mechanism 80, with a 96-well plate (8×12) 70 and 72, is used to introduce the amplified DNA samples [or analytes] to each capillary 140. The X-Z transport mechanism 80 indexes a row of sample carrying wells under the row of capillary tips and dip the tips into the well [para. 0099]) ;
a pump (a syringe pump [para. 0048]); and
a sample inlet port (the sample handling tray transport mechanism 80, with a 96-well plate (8×12) 70 and 72, is used to introduce the amplified DNA samples (or analytes) to each capillary 140. The X-Z transport mechanism 80 indexes a row of sample carrying wells under the row of capillary tips and dip the tips into the well [para. 0099]).
Amirkhanian does not explicitly teach: (1) wherein the reagent container in fluidic communication with the cathode sub-assembly via a fluid conduit that connects the cathode sub-assembly to the reagent container and is disposed between the electrophoresis capillary and the reagent container; (2) wherein the pump is for pumping electrophoresis buffer from the reagent container to the cathode sub-assembly through the fluid conduit; and (3) wherein the sample inlet port is fluidically connected to the cathode sub-assembly.
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Jovanovich teaches an electrophoresis system as shown in Fig. 73 [para. 0311] including: (1) an anode sub-assembly comprising an anode (see anode in Fig. 73); (2) a cathode sub-assembly comprising a cathode (see cathode in Fig. 73); and (3) at least one electrophoresis capillary (electrophoresis channels in Fig.73) having a first end in fluid communication with the cathode sub-assembly and a second end in fluid communication with the anode sub-assembly (see Fig. 73). Jovanovich further teaches: (1) a reagent container comprising electrophoresis buffer (reagent chambers in dashed lines of Fig.73 [para. 0312] comprising Buffer) in fluidic communication with the cathode sub-assembly (see cathode in Fig.73) via a fluid conduit (fluid connectors in Fig.73) that connects the cathode sub-assembly (cathode in Fig.73) to the reagent container and is disposed between the electrophoresis capillary and the reagent container (see Fig.73); (2) wherein the pump is for pumping electrophoresis buffer from the reagent container to the cathode sub-assembly through the fluid conduit (the cartridge element consists of several integrated parts. These include a piece that contains reaction chambers and that functions as a fluidic manifold. The chambers, on one side of the piece, communicate with the opposite side of the piece through ports. The opposite, or fluidic side, is engaged with fluidic chips comprising channels and diaphragm valves and pumps that move liquids between reaction chambers and reaction tubing [para. 0313]; Fig.73 shows the buffer chamber is connected to the cathode through the fluidic connectors); and (3) wherein the sample inlet port is fluidically connected to the cathode sub-assembly (“sample inlet port” in annotated Fig.73 in Jovanovich is fluidically connected to the cathode).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Amirkhanian to have the reagent container in fluidic communication with the cathode sub-assembly via a fluid conduit that connects the cathode sub-assembly to the reagent container and is disposed between the electrophoresis capillary and the reagent container; use the pump for pumping electrophoresis buffer from the reagent container to the cathode sub-assembly through the fluid conduit; and have the sample inlet port being fluidically connected to the cathode sub-assembly, as taught by Jovanovich, since it would allow to introduce the sample(s)/buffer(s) into each capillary for performing electrophoresis analysis of the sample ([para. 0099 in Amirkhanian]; Fig.73 and [para. 0312] in Jovanovich).
Regarding claim 18, Amirkhanian teaches the system of claim 14, further comprising:
a sample cartridge interface (a modular X-Z sample handling tray mechanism 80 [para. 0051]) engageable with a sample cartridge (The fully automated DNA analysis system 200 has a base 74, supporting a modular X-Z sample handling tray mechanism 80, which moves one 96-well micro-titer plates 70 and a buffer plate 72 in relation to the multi-capillary cartridge 100 supported by the interface mechanism 300 [para. 0051]; the 96-well micro-titer plates 70 is deemed as a sample cartridge).
Amirkhanian further teaches in operation, a prepared biological sample (e.g., a DNA sample), direct from Polymerase Chain Reaction (PCR) machine is introduced into the far end of the capillary column away from the detection zone by any of a number of ways that is not part of the present invention (e.g., electrokinetic injection from a sample reservoir or physical pressure injection using a syringe pump) [para. 0048 ]. Fig.18 shows 96-well PCR plate 70/72.
Amirkhanian is silent to: a sample preparation module configured to (1) perform sample analysis on a sample from said sample cartridge to produce an analyte in response to engagement of said sample cartridge with said sample cartridge interface and (2) direct the analyte to a sample outlet port configured to be placed in fluidic communication with an inlet port of the electrophoresis cartridge.
Jovanovich teaches a reaction module comprising a reaction chamber in fluidic communication with the microfluidic channel adapted to immobilized the captured analyte and perform a biochemical reaction on the analyte in a non-microfluidic volume to produce a reaction product; and (c) and an analysis module in fluidic communication with the reaction chamber adapted to perform an analysis on the reaction product. The reaction module is adapted to perform thermal cycling [para. 0021]. This invention provides a system comprising: (a) a disposable cartridge comprising at least one set of fluidic chambers including a sample chamber, a mixing chamber and a thermal cycling chamber in fluid communication with each other, and a reagent card comprising reagents for performing a chemical reaction involving thermal cycling, wherein the reagent card is configured to be carried on the cartridge in a closed configuration and to be moved into fluid communication with the at least one set of fluidic chambers; (b) an actuator assembly configured to move fluids between chambers when the cartridge is engaged with the actuator assembly; (c) a thermal cycler configured to cycle temperature in the thermal cycling chamber when the cartridge is engaged with the actuator assembly; (d) a capillary electrophoresis assembly configured to accept a sample from cartridge when the cartridge is engaged with the actuator assembly and to perform capillary electrophoresis on the sample; and (e) a computerized control system configured to control the actuator assembly, the thermal cycler and the capillary electrophoresis assembly [para. 0023]. Thus, Jovanovich teaches: a sample preparation module (a reaction module adapted to perform thermal cycling) configured to (1) perform sample analysis on a sample from said sample cartridge to produce an analyte in response to engagement of said sample cartridge with said sample cartridge interface (perform a biochemical reaction such as a thermal cycling reaction on the sample to produce a reaction product [PCR product] when the cartridge is engaged with the actuator assembly); and (2) direct the analyte to a sample outlet port configured to be placed in fluidic communication with an inlet port of the electrophoresis cartridge (an analysis module in fluidic communication with the reaction chamber adapted to perform an analysis on the reaction product; a capillary electrophoresis assembly configured to accept a sample from cartridge when the cartridge is engaged with the actuator assembly and to perform capillary electrophoresis on the sample).
Given the teachings of Amirkhanian regarding injecting reaction product from a PCR machine into the capillaries for CE analysis of the PCR product; and the teachings of Jovanovich regarding performing a thermal cycling reaction in a sample preparation module and then direct the PCR product to a capillary electrophoresis assembly to perform capillary electrophoresis analysis on one or more products of the thermal cycling reaction, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Amirkhanian by adding a sample preparation module configured to (1) perform sample analysis on a sample from said sample cartridge to produce an analyte in response to engagement of said sample cartridge with said sample cartridge interface and (2) direct the analyte to a sample outlet port configured to be placed in fluidic communication with an inlet port of the electrophoresis cartridge, as taught by combined Amirkhanian and Jovanovich, since it would integrate the thermal cycling reaction module and the CE analysis into an integrated system and would allow to perform PCR followed by electrophoresis analysis of the PCR product ([para. 0048 in Amirkhanian] and [para. 0021 in Jovanovich]).
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Amirkhanian et al. (US20050106612A1) teaches an integrated CE system comprising an electrophoresis cartridge 100, an electrophoresis cartridge interface 300, and a peltier unit in the sample preparation device provides thermal cycling of samples. Amirkhanian et al. (WO2005064325A2) teaches an integrated CE system comprising an electrophoresis cartridge 100, an electrophoresis cartridge interface 300, thermal cycling controller module 68, and a tracking mechanism including a non-volatile rewritable memory 'smart key' that is associated with the cartridge to provide automatic tracking dedicated to the cartridge. Nielsen et al. (WO2013059750A1) teaches an integrated and automated sample-to-answer system that can perform several operations, including (a) extraction and isolation of nucleic acid; (b) amplification of nucleotide sequences at selected loci (e.g., genetic loci); and (c) detection and analysis of amplification product. These operations can be carried out in a system that comprises several integrated modules, including an analyte preparation module; a detection and analysis module and a control module.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V. Van can be reached on (571) 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Examiner, Art Unit 1795
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