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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/29/2024 and 4/18/2025 has been considered by the examiner.
Election/Restrictions
Applicant's election of Group I, Claims 1-9, without traverse in the reply filed on 06/30/2026 is acknowledged.
Applicant amended the unelected method claim 10 to depend from the elected claim 1 and requests examination of all pending claims. Although the amended method claim 10 depends on the elected apparatus claim 1, as outlined in the restriction mailed on 4/30/2026, the apparatus as claimed can be used to practice another and materially different process. Thus, the restriction is still valid and claims 10-16 of the unelected group II are withdrawn.
Claim Objection
Claim 9 is objected to because of the following informalities:
Claim 9: please amend “a solution” to – [[a]] the sample solution--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Regarding claim 1, claim 1 recites “a first inflow path at which a solution flows into the first liquid reservoir, a first outflow path at which the solution flows out from the first liquid reservoir”, and “a second inflow path at which the solution flows into the second liquid reservoir, a second outflow path at which the solution flows out from the second liquid reservoir”. Thus, claim 1 recites the same solution flowing into both the first and second liquid reservoirs and flowing out both the first and second liquid reservoirs. The instant specification discloses “a migration solution RS” is supplied into the first liquid reservoir via a first inflow path 34 [para. 0052 ] in PG-Pub, and “a sample solution SS” is supplied into the second liquid reservoir via a second inflow path 64 [para. 0053]. Thus, the solution (migration solution RS) flowing in/out of the first liquid reservoir is different from the sample solution SS flowing in/out of the second liquid reservoir. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In reHammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970) [see MPEP 2173.03]. Thus, the scope of claim 1 is indefinite. Claims 2-9 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
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 1-5 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drevinskas et al. (A gravity-independent single-phase electrode reservoir for capillary electrophoresis applications, Electrophoresis, 2023, 44, 1047-1056).
Regarding claim 1, Drevinskas teaches an electrophoresis unit (an electrophoresis unit as shown in Fig.S2 comprising two reservoirs connected by a separation capillary, and Fig.2 shows one of the reservoirs; annotation 1 in Fig.2 shows the separation capillary connecting one of the two reservoirs), comprising:
a first flow path including a first liquid reservoir (a first flow path including the right reservoir as shown in Fig.S2; a flow path including a reservoir is shown in Fig.2), a first inflow path (fluidic inlet line 3 in Fig.2) at which a solution flows into the first liquid reservoir (see Fig.2B), a first outflow path (fluidic outlet line 5 in Fig.2) at which the solution flows out from the first liquid reservoir (see Fig.2D), and a first liquid level adjustment section that is open to an exterior (Figs. 2B and 2D shows a first liquid level adjustment section that is open to an exterior through the fluidic outline line 5, and Figs. 2B and 2D show the liquid level in a reservoir);
a second flow path including a second liquid reservoir, a second inflow path at which the solution flows into the second liquid reservoir, a second outflow path at which the solution flows out from the second liquid reservoir, and a second liquid level adjustment section that is open to the exterior (Fig.S2 shows the two identical reservoirs are connected to the separation capillary, the flow path including the left reservoir located at the left side of the capillary in Fig.S2 is deemed as a second flow path including a second liquid reservoir, a second inflow path [fluidic inlet line 3 of the left reservoir] at which the solution flows into the second liquid reservoir [the left reservoir], a second outflow path [fluidic outline line 5 of the left reservoir] at which the solution flows out from the second liquid reservoir, and a second liquid level adjustment section that is open to the exterior [see the fluidic outlet line 5 in Figs. 2B and 2D for the left reservoir]),
a capillary (a separation capillary in Fig.S2) that leads from the first liquid reservoir to the second liquid reservoir (see Fig.S2); and
an electrode arranged in each of an interior of the first flow path and an interior of the second flow path (Figs. 2 and S2 show a stainless steel wire 11 arranged in each of an interior of the first flow path and an interior of the second flow path),
wherein vertical direction positions of the first liquid level adjustment section and the second liquid level adjustment section are equal to each other (the electrophoresis unit works under different physical orientations [Table 1 and Fig.S2], and Fig.5B shows electropherogram [curve a] when the two reservoirs were positioned at the same height [see caption of Fig.5B]; Fig.S2_D shows the vertical direction positions of the first liquid level adjustment section and the second liquid level adjustment section are equal to each other).
Regarding claim 2, Drevinskas teaches the electrophoresis unit of claim 1, wherein the first outflow path configures the first liquid level adjustment section extending laterally within a vertical direction range of the first liquid reservoir (Fig.2 shows the first outflow path [the fluidic outlet line 5 of the right reservoir in Fig.S2] configures the first liquid level adjustment section extending laterally within a vertical direction range of the first liquid reservoir) .
Regarding claim 3, Drevinskas teaches the electrophoresis unit of claim 2, wherein a valve for stopping a flow of the solution into the first liquid reservoir from above is provided at the first inflow path (Fig.2B shows a flow of the solution into the reservoir from the fluidic inlet line 3 and Fig.2D shows closed line for stopping a flow of the solution into the first liquid reservoir from the fluidic inlet line 3; an injection valve C4M-4354.008D-NAS2 is used to control the injection [section 2.4 and see Injector valve, Solenoid valve and Selector valve in Fig.S1]; Fig.S2_D shows the reservoir is rotated 180o; thus Drevinskas teaches a valve for stopping a flow of the solution into the first liquid reservoir from above is provided at the first inflow path for the configuration of Fig.S2_D).
Regarding claim 4, Drevinskas teaches the electrophoresis unit of claim 1, “wherein the first inflow path supplies the solution into the first liquid reservoir from above and configures the first liquid level adjustment section that is open to the exterior” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Drevinskas teaches the first inflow path supplies the solution into the first liquid reservoir from above (see Fig.S2_D wherein the reservoir of Fig.2 is rotated 180o; when the reservoir is rotated 180o, the fluidic inlet line 3 supplies the solution into the first liquid reservoir from above) and configures the first liquid level adjustment section that is open to the exterior (Figs. 2 and S2_D show the fluidic outline line 5 is open to the exterior).
Regarding claim 5, Drevinskas teaches the electrophoresis unit of claim 1, wherein a first opening path (exit port of the fluidic outlet line 5 in Fig.2) that branches from the first outflow path (the fluidic outlet line 5) configures the first liquid level adjustment section that is open to the exterior (Fig.2 shows that the fluidic outlet line 5 is open to the exterior).
Regarding claim 8, Drevinskas teaches a component analysis device (capillary electrophoresis system as shown in Fig.S1 [section 2.2]), comprising:
the electrophoresis unit of claim 1 (Drevinskas teaches the electrophoresis unit of claim 1);
a supply unit (piston pump B in Fig.S1 [section 2.4]) that supplies a sample solution into the electrophoresis unit (Fig.S1 shows the piston pump B connects the sample tank via a valve, and the standard mixture was injected with a sample injection valve [CE separation test in the 2nd paragraph in Col. 1 on pg.1051]; the CE system performed the function of supplying selected solutions to the HV reservoir [section 2.2], thus the disclosed supply unit is configured to supply a sample solution into the electrophoresis unit); and
a control unit that controls the supply unit (the CE system performed the functions needed for testing and validation of the HV reservoir, namely: (i) supplying selected solutions to the HV reservoir, (ii) collecting waste liquid and routing it to the waste reservoir, and (iii) supplying selected lines with gas as an insulator. These operational sequences were automated [section 2.2]. Thus, it must have a control unit that controls the supply unit for supplying selected solutions to the HV reservoir).
Regarding claim 9, Drevinskas teaches the component analysis device of claim 8, further comprising a detector (contactless conductivity detector [section 2.2]) that detects a component of a solution flowing inside the capillary (Figs.4-5 show the measured electropherograms wherein various peaks correspond to different components of the sample solution flowing inside the capillary [see caption of Fig.5], thus the disclosed detector is configured to perform the claimed functions).
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 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Drevinskas, as applied to claim 5 above.
Regarding claim 6, Drevinskas teaches the electrophoresis unit of claim 5, and Fig.2B shows a flow of the solution out from above the first liquid reservoir is provided at the first opening path, and Fig.2C shows the first opening path (fluidic outline line 5) is closed (see Closed Line X in Fig.2C). Drevinskas further teaches multiple solenoid valves are arranged in the electrophoresis system as shown in Fig.S1.
Although Drevinskas does not explicitly teach a valve for stopping a flow of the solution out from above the first liquid reservoir is provided at the first opening path, given the teachings that the first opening path (fluidic outline line 5) is open (see Fig.2B) and closed (see Fig.2C), and multiple valves are arranged to supply selected solutions to the reservoir, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a valve at the first opening path for stopping a flow of the solution out from above the first liquid reservoir, since it would allow to close the fluidic outlet line 5 as shown in Fig.2C.
Regarding claim 7, Drevinskas teaches the electrophoresis unit of claim 6, wherein a valve for stopping a flow of the solution into the first liquid reservoir from above is provided at the first inflow path (Fig.2B shows a flow of the solution into the reservoir from the fluidic inlet line 3 and Fig.2D shows closed line for stopping a flow of the solution into the first liquid reservoir from the fluidic inlet line 3; an injection valve C4M-4354.008D-NAS2 is used to control the injection [section 2.4 and see Injector valve, Solenoid valve and Selector valve in Fig.S1]; Fig.S2_D shows the reservoir is rotated 180o; thus Drevinskas teaches a valve for stopping a flow of the solution into the first liquid reservoir from above is provided at the first inflow path for the configuration of Fig.S2_D).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Drevinskas, and further in view of Hinojosa et al. (US20170121658A1).
The limitations of the control unit that controls the supply unit in claim 8 must be present in the CE system of Drevinska, as outlined in the rejection for claim 8 above. The limitations are further rejected in view of Hinojosa as outlined below.
Regarding claim 8, Drevinskas teaches a component analysis device (capillary electrophoresis system as shown in Fig.S1 [section 2.2]), comprising:
the electrophoresis unit of claim 1 (Drevinskas teaches the electrophoresis unit of claim 1);
a supply unit (piston pump B in Fig.S1 [section 2.4]) that supplies a sample solution into the electrophoresis unit (Fig.S1 shows the piston pump B connects to the sample tank via a valve, and the standard mixture was injected with a sample injection valve [CE separation test in the 2nd paragraph in Col. 1 on pg.1051]; the CE system performed the function of supplying selected solutions to the HV reservoir [section 2.2], thus the disclosed supply unit is configured to supply a sample solution into the electrophoresis unit); and
a control unit that controls the supply unit (the CE system performed the functions needed for testing and validation of the HV reservoir, namely: (i) supplying selected solutions to the HV reservoir, (ii) collecting waste liquid and routing it to the waste reservoir, and (iii) supplying selected lines with gas as an insulator. These operational sequences were automated [section 2.2]. Thus, it must have a control unit that controls the supply unit for supplying selected solutions to the HV reservoir. The limitation is further rejected in view of Hinojosa in the following).
Hinojosa teaches a system 1600 including an input reservoir 106a, a pressure source 1602, an OOC device 10, and an output reservoir 106b. In the illustrated embodiment, the pressure source 1602 is coupled to the fluid line between the input reservoir 106a and the OOC device 10. The pressure source 1602 is coupled to a controller that controls operation of the pressure source 1602. In some embodiments, the pressure source 1602 is a pump such as a volumetric pump. The pressure source 1602 applies a force to move the fluid from the upstream input reservoir 106a toward the OOC device 10 [para. 0095]. Thus, Hinojosa teaches a controller that controls operation of a fluid pump.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a controller that controls the supply unit (pump), as taught by Hinojosa, since it would allow to automate the operation (section 2.2 in Drevinskas) and control the flow rate [para. 0095 in Hinojosa].
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Hatfield et al. (US20160375694A1) teaches a liquid management system comprising a closed reservoir having an inlet 11, outlet 12 and a liquid level adjust section 13 as shown in Fig.2. Liu et al. (US20090090630A1) teaches a CE system comprising a reservoir connecting a capillary wherein the reservoir comprises an inlets with valves and drain outlet with a valve (see Fig.4a).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/Primary Examiner, Art Unit 1795
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