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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/18/2025 has been entered.
Status of the Claims
The amendment filed 11/18/2025 has been entered. Claims 1, 4-5, 8, and 14 have been amended. Claims 1-19 are currently pending and examined herein.
Status of the Rejection
Applicant’s amendments to the claims have overcome various rejections previously set forth in the Final Rejection mailed 9/4/2025.
The specification, drawing, and claim objections have been overcome by the applicant's amendments.
All 35 U.S.C. § 112(b) rejections from the previous office action are withdrawn in view of the Applicant’s amendments.
New grounds of rejection under 35 U.S.C. § 112(a) are necessitated by the amendments as outlined below.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “11” has been used to designate both the flow path in Figs. 2-4 (see paras. [044, 047, 058] in the instant specification) and the clamping nut in Fig. 5 (see para. [066] in the instant specification), and reference character “14” has been used to designate both the polymeric tubing in Fig. 2 (see para. [051] in the instant specification) and the reference electrode cavity in Fig. 5 (see para. [065] in the instant specification). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a flexible dual-lumen polymeric tubing” in line 11. While the instant specification details that the dual-lumen tubing is a polymeric tubing (see para. [058]), there is no teaching regarding the flexibility of the tubing. Thus, a flexible dual-lumen polymeric tubing is considered new matter. Claims 2-13 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of claim 1.
Claim 14 recites “a flexible dual-lumen polymeric tubing” in line 12. While the instant specification details that the dual-lumen tubing is a polymeric tubing (see para. [058]), there is no teaching regarding the flexibility of the tubing. Thus, a flexible dual-lumen polymeric tubing is considered new matter. Claims 15-19 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of claim 14.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 20130091936 A1) in view of Kasem et al. (“Platinum as a Reference Electrode in Electrochemical Measurements,” 2008, Platinum Metals Rev., vol. 52, pgs. 100-106) and Polastri et al. (“PTFE Nanocomposites in Tubes and W&C,” 2007, International Wire & Cable Symposium - Proceedings of the 56th IWCS, pgs. 186-189).
Regarding claim 1, Cheng teaches a detection cell for a chromatography system (chromatographic detection cell 30a in Fig. 2, noting that detection cell 30a is similar to detection cell 30 in Fig. 1 except for the arrangement of the reference electrode system in Fig. 2 [0054]), the detection cell comprising:
a cell body (conductive cell body 35a in Fig. 2 [0057]) including a counter electrode in a form of the cell body (cell body 35a serves as the counter electrode [0060]);
a working electrode block including a working electrode (working electrode block 37 includes working electrode 39 in Fig. 1 [0040, 0054]);
a gasket separating the working electrode block from the cell body (gasket 40 is disposed between the counter and working electrodes [0040, 0054]), the gasket defining a sample flow pathway (gasket 40 includes a cutout forming a thin-layer channel 44 [0040, 0054]) extending between an inlet and an outlet of the detection cell (channel 44 connects to inlet 47 and outlet 49 to form fluid sample line 51 in Fig. 1, such that inlet 47a and outlet 49a are connected in Fig. 2 [0041, 0054, 0057]) and in fluid contact with the cell body, the counter electrode, and the working electrode (channel 44 contacts counter electrode/cell body 35 and working electrode 39 in Fig. 1); and
a reference electrode system (the reference electrode system including reference electrode 53a and auxiliary electrode 58a in Fig. 2 [0055]) in fluidic contact with the outlet (electrodes 53a and 58a must contact the sample flow pathway, such that the electrodes fluidically contact outlet 49a in Fig. 2 [0059-0060]) and including a platinum auxiliary electrode (auxiliary electrode 58a may be platinum [0055]) operably connected to a positive pole of a power supply (auxiliary electrode 58a is connected to positive pole 60a of a power supply in Fig. 2 [0045]) and a reference electrode operably connected to a negative pole of the power supply (reference electrode 53a is connected to negative pole 56a of a power supply in Fig. 2 [0044]), wherein the platinum auxiliary electrode and the platinum reference electrode are disposed within a dual-lumen tubing having two isolated lumens (electrodes 58a and 53a are inserted into reference electrode housing 63 in Fig. 2 [0058-0059]. Housing 63 has two separate lumens to accommodate the electrodes, as demonstrated by the need for a separate channel to connect electrodes 58a and 53a [0060]), the dual-lumen tubing being secured to the outlet of the detection cell via a compression or threaded fitting (reference electrode housing 63 is secured in threaded electrode cavity 61 by clamping nut 65 to bring the electrodes in contact with the fluid sample line [0057-0058]).
Cheng further teaches that the reference electrode 53 is a palladium-hydrogen electrode [0021, 0044].
Cheng is silent to the following limitations: (1) the reference electrode is a platinum reference electrode and (2) the dual-lumen tubing is a flexible polymeric tubing.
Kasem teaches solid-state platinum reference electrodes for electrochemical measurements [pg. 100, Title], and further teaches that platinum as a solid-state reference electrode has near-Nernstian behavior, low hysteresis, and rapid response [pg. 100, col. 2, para. 1].
Cheng and Kasem are both considered analogous to the claimed invention because they are in the same field of electrochemical sensors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the palladium-hydrogen reference electrode in Cheng with a solid-state platinum reference electrode, as taught in Kasem, because the substitution would provide near-Nernstian behavior, low hysteresis, and rapid response [pg. 100, col. 2, para. 1 in Kasem]. Furthermore, the claimed device differs from Cheng by the substitution of some components (the palladium-hydrogen reference electrode in Cheng) with other components (the solid-state platinum reference electrode in Kasem) whose functions were known in the prior art. One of ordinary skill in the art could substitute one known element for another to yield predictable results (MPEP 2143(I)(B)).
Polastri teaches that the flexible polymer polytetrafluoroethylene (PTFE) is a suitable material for wire tubing due to its outstanding electrical properties, chemical inertness, and high temperature resistance [pg. 186, col. 1, paras. 1-2].
Modified Cheng and Polastri are both considered analogous to the claimed invention because they are in the same field of electrical wire tubing. 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 dual-lumen tubing in modified Cheng by using PTFE as the material, as taught in Polastri, such that the dual-lumen tubing is a flexible polymeric tubing, since this would provide outstanding electrical properties, chemical inertness, and high temperature resistance [pg. 186, col. 1, paras. 1-2 in Polastri]. Furthermore, Polastri teaches the claimed improvement as a known technique that is applicable to the base device in modified Cheng. One skilled in the art could have applied the PTFE tubing material in Polastri in the same way to the base device in modified Cheng, yielding predictable results (MPEP 2143(I)(D)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
Regarding claim 2, modified Cheng teaches the detection cell according to claim 1, and Cheng further teaches wherein the detection cell is a three-electrode detection system (the detection cell is a three-electrode cell [0039]).
Regarding claim 3, modified Cheng teaches the detection cell according to claim 1, and Cheng further teaches wherein the cell body is formed of a conductive material (cell body 35a is conductive [0060]).
Regarding claim 6, modified Cheng teaches the detection cell according to claim 1, and further teaches wherein the reference electrode system includes a solid-state reference electrode (as stated in the rejection of claim 1 above, the reference electrode in modified Cheng is a solid-state platinum reference electrode [pg. 100, col. 2, para. 1 in Kasem]).
Regarding claim 7, modified Cheng teaches the detection cell according to claim 1, and further teaches wherein the platinum reference electrode and the platinum auxiliary electrode are in electrical contact with the flow pathway (auxiliary electrode 58a and reference electrode 53a fluidically contact the flow pathway through gasket 68 in Fig. 2 [0041 in Cheng]).
Regarding claim 8, modified Cheng teaches the detection cell according to claim 7, and further teaches wherein the platinum reference electrode includes a wire extending into a reference electrode bore of the cell body (the reference electrode 53a may include a wire extending into a reference electrode bore of the cell body [0028 in Cheng], the substituted solid-state platinum reference electrode includes a Pt wire extending into a reference electrode bore of the cell body).
Regarding claim 9, modified Cheng teaches the detection cell according to claim 1, and Cheng further teaches wherein the cell body includes an electrode cavity fluidly connected to the inlet and the outlet thereby forming a portion of the flow pathway (cell body may include an inlet and an electrode cavity fluidly connected to the inlet and the outlet thereby forming a portion of the flow pathway [0030]).
Regarding claim 10, modified Cheng teaches the detection cell according to claim 9, and further teaches wherein at least one of the platinum reference electrode and the platinum auxiliary electrode is a wire (at least one of the reference electrode and the auxiliary electrode may be a wire [0030 in Cheng]).
Regarding claim 11, modified Cheng teaches a chromatography system comprising the detection cell according to claim 1 (as stated in the rejection of claim 1 above, modified Cheng teaches the detection cell according to claim 1. Cheng further teaches a chromatography system including a plurality of detection cells, wherein the detection cells may be arranged in series [0031]).
Regarding claim 12, modified Cheng teaches a chromatography system comprising the detection cell according to claim 9 (as stated in the rejection of claim 9 above, modified Cheng teaches the detection cell according to claim 9. Cheng further teaches a chromatography system including a plurality of detection cells, wherein the detection cells may be arranged in series [0031]).
Regarding claim 13, modified Cheng teaches a chromatography system comprising a plurality of detection cells according to claim 1, wherein the detection cells are arranged in series (as stated in the rejection of claim 1 above, modified Cheng teaches the detection cell according to claim 1. Cheng further teaches a chromatography system including a plurality of detection cells, wherein the detection cells may be arranged in series [0031]).
Claim 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Kasem, as applied to claim 1 above, and further in view of Halle et al. (US 20200072803 A1).
Regarding claim 4, modified Cheng teaches the detection cell according to claim 1, and Cheng further teaches wherein the cell body is formed of a first portion comprising a corrosion-resistant metal or a conductive polymer (cell body may be formed of a corrosion resistant metal or a conductive polymer [0027]).
Modified Cheng is silent to the limitation wherein the cell body further comprises a second portion comprising a nonconductive polymer.
Halle teaches a detection cell for a liquid chromatography system [Abstract], the detection cell comprising a cell body (flow cell body 3 in Fig. 1 [0219]) including electrodes in the form of wires (electrodes 9 and 10 in Fig. 1 may be rods or pins [0109, 0221]) that contact a sample flow pathway (detection channel 13 contacts electrodes 9 and 10 in Fig. 1 [0219, 0221]). The cell body is formed of a metal (the electrodes are metal [0105]) and a nonconductive polymer (the flow cell body is made of an electrically insulating material such as PEEK, PTFE, or polychlorotrifluoroethylene [0108]). Halle further teaches that using a nonconductive polymer as the cell body material that is not the electrodes prevents material interference with the analyte and detection, and are particularly suited for forming a sample flow pathway [0108].
Modified Cheng and Halle are both considered analogous to the claimed invention because they are in the same field of liquid chromatography. 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 cell body in modified Cheng by forming the counter electrode as a wire rather than the entire cell body and using a nonconductive polymer (e.g., PEEK, PTFE, or polychlorotrifluoroethylene) as the cell body material that is not the electrode, as taught in Halle, since this would prevent material interference with the analyte and detection, and the nonconductive polymers are particularly suited for forming a sample flow pathway [0108 in Halle]. Furthermore, Halle teaches the claimed improvement as a known technique that is applicable to the base device in modified Cheng. One skilled in the art could have applied the nonconductive polymer cell body material aside from the electrodes in Halle in the same way to the base device in modified Cheng, yielding predictable results (MPEP 2143(I)(D)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
Regarding claim 5, modified Cheng teaches the detection cell according to claim 1, and Cheng further teaches wherein the cell body is formed of a conductive material selected from the group consisting of titanium, corrosion resistant alloy, stainless steel, carbon-loaded polyetherether ketone (PEEK), polythiophene, polyindole, and polynaphthalene (the counter electrode may be formed of titanium, corrosion resistant alloy, stainless steel, carbon-loaded PEEK, polythiophene, polyindole, or polynaphthalene [0027 in Cheng])
Cheng is silent to the limitation wherein the cell body is further formed of a nonconductive material selected from the group consisting of polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polychlorotrifluoroethylene (Kel-F), and polycarbonate.
Halle teaches a detection cell for a liquid chromatography system [Abstract], the detection cell comprising a cell body (flow cell body 3 in Fig. 1 [0219]) including electrodes in the form of wires (electrodes 9 and 10 in Fig. 1 may be rods or pins [0109, 0221]) that contact a sample flow pathway (detection channel 13 contacts electrodes 9 and 10 in Fig. 1 [0219, 0221]). The cell body is formed of a metal (the electrodes are metal [0105]) and a nonconductive polymer (the flow cell body is made of an electrically insulating material such as PEEK, PTFE, or polychlorotrifluoroethylene [0108]). Halle further teaches that using a nonconductive polymer as the cell body material that is not the electrodes prevents material interference with the analyte and detection, and are particularly suited for forming a sample flow pathway [0108].
Modified Cheng and Halle are both considered analogous to the claimed invention because they are in the same field of liquid chromatography. 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 cell body in modified Cheng by forming the counter electrode as a wire rather than the entire cell body and using a nonconductive polymer (e.g., PEEK, PTFE, or polychlorotrifluoroethylene) as the cell body material that is not the electrode, as taught in Halle, since this would prevent material interference with the analyte and detection, and the nonconductive polymers are particularly suited for forming a sample flow pathway [0108 in Halle]. Furthermore, Halle teaches the claimed improvement as a known technique that is applicable to the base device in modified Cheng. One skilled in the art could have applied the nonconductive polymer cell body material aside from the electrodes in Halle in the same way to the base device in modified Cheng, yielding predictable results (MPEP 2143(I)(D)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
Claims 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Ives et al. (Reference Electrodes Theory and Practice, 1961, Academic Press, pg. 111) and Polastri.
Regarding claim 14, Cheng teaches a detection cell for a chromatography system (chromatographic detection cell 30a in Fig. 2, noting that detection cell 30a is similar to detection cell 30 in Fig. 1 except for the arrangement of the reference electrode system in Fig. 2 [0054]), the detection cell comprising:
a cell body (conductive cell body 35a in Fig. 2 [0057]);
a working electrode block including a working electrode (working electrode block 37 includes working electrode 39 in Fig. 1 [0040, 0054]);
a sample channel (gasket 40 includes a cutout forming a thin-layer channel 44 [0040, 0054]) extending between an inlet and an outlet of the detection cell (channel 44 connects to inlet 47 and outlet 49 to form fluid sample line 51 in Fig. 1, such that inlet 47a and outlet 49a are connected in Fig. 2 [0041, 0054, 0057]) and in fluid contact with the cell body and the working electrode (channel 44 contacts cell body 35 and working electrode 39 in Fig. 1);
a counter electrode in fluid contact with the sample channel (cell body 35 serves as the counter electrode [0040]); and
a reference electrode system (the reference electrode system including reference electrode 53a and auxiliary electrode 58a in Fig. 2 [0055]) in fluidic contact with the outlet (electrodes 53a and 58a must contact the sample flow pathway, such that the electrodes fluidically contact outlet 49a in Fig. 2 [0059-0060]) and including an auxiliary electrode (auxiliary electrode 58a [0055]) operably connected to a positive pole of a power supply (auxiliary electrode 58a is connected to positive pole 60a of a power supply in Fig. 2 [0045]) and a reference electrode operably connected to a negative pole of the power supply (reference electrode 53a is connected to negative pole 56a of a power supply in Fig. 2 [0044]), wherein the auxiliary electrode and the Pt/H2 reference electrode are disposed within a dual-lumen tubing having two isolated lumens (electrodes 58a and 53a are inserted into reference electrode housing 63 in Fig. 2 [0058-0059]. Housing 63 has two separate lumens to accommodate the electrodes, as demonstrated by the need for a separate channel to connect electrodes 58a and 53a [0060]), the dual-lumen tubing being secured to the outlet of the detection cell via a compression or threaded fitting (reference electrode housing 63 is secured in threaded electrode cavity 61 by clamping nut 65 to bring the electrodes in contact with the fluid sample line [0057-0058]).
Cheng further teaches that the reference electrode 53 is a palladium-hydrogen electrode [0021, 0044].
Cheng is silent to the following limitations: (1) the reference electrode is a Pt/H2 reference electrode and (2) the dual-lumen tubing is a flexible polymeric tubing.
Ives teaches both palladium-hydrogen and platinum-hydrogen reference electrodes, and further teaches that platinum as an electrode material has a higher activity, slower decay, and requires less surface area compared to palladium in a hydrogen reference hydrogen electrode (book and chapter title indicate hydrogen electrodes for use as reference electrodes [pg. 111, para. 3]) .
Cheng and Ives are both considered analogous to the claimed invention because they are in the same field of electrochemical sensors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the palladium-hydrogen reference electrode in Cheng with a platinum-hydrogen reference electrode, as taught in Ives, because the substitution would provide higher activity, slower decay, and lower required surface area [pg. 111, para. 3 in Ives]. Furthermore, the claimed device differs from Cheng by the substitution of some components (the palladium-hydrogen reference electrode in Cheng) with other components (the platinum-hydrogen reference electrode in Ives) whose functions were known in the prior art. One of ordinary skill in the art could substitute one known element for another to yield predictable results (MPEP 2143(I)(B)).
Polastri teaches that the flexible polymer polytetrafluoroethylene (PTFE) is a suitable material for wire tubing due to its outstanding electrical properties, chemical inertness, and high temperature resistance [pg. 186, col. 1, paras. 1-2].
Modified Cheng and Polastri are both considered analogous to the claimed invention because they are in the same field of electrical wire tubing. 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 dual-lumen tubing in modified Cheng by using PTFE as the material, as taught in Polastri, such that the dual-lumen tubing is a flexible polymeric tubing, since this would provide outstanding electrical properties, chemical inertness, and high temperature resistance [pg. 186, col. 1, paras. 1-2 in Polastri]. Furthermore, Polastri teaches the claimed improvement as a known technique that is applicable to the base device in modified Cheng. One skilled in the art could have applied the PTFE tubing material in Polastri in the same way to the base device in modified Cheng, yielding predictable results (MPEP 2143(I)(D)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
Regarding claim 15, modified Cheng teaches the detection cell according to claim 14, and Cheng further teaches wherein the cell body is formed of a conductive material (cell body 35a is conductive [0039]).
Regarding claim 16, modified Cheng teaches the detection cell according to claim 14, and further teaches wherein the Pt/H2 reference electrode and the auxiliary electrode are in electrical contact with the sample channel, and in which the auxiliary electrode includes a platinum electrode (auxiliary electrode 58 and reference electrode 53 fluidically contact thin-layer channel 44 through fluid sample line 51 in Fig. 1, and auxiliary electrode 58 may be platinum [0041, 0045 in Cheng]).
Regarding claim 17, modified Cheng teaches the detection cell according to claim 14, and further teaches wherein the Pt/H2 reference electrode includes a wire extending into a reference electrode bore of the cell body (the reference electrode may include a wire extending into a reference electrode bore of the cell body [0028 in Cheng], thus the substituted Pt/H2 reference electrode includes a wire extending into a reference electrode bore of the cell body).
Regarding claim 18, modified Cheng teaches the detection cell according to claim 14.
The limitation “wherein the reference electrode system operates at a potential less than approximately 10V subject to variations in voltage of less than approximately 10 mV” 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, modified Cheng teaches a reference electrode system that is configured to perform the functional limitations above (the potential applied to the reference electrode system is less than 3 V, and variations in voltage are less than approximately 10 mV [0047]).
Regarding claim 19, modified Cheng teaches the detection cell according to claim 14, and Cheng further teaches wherein the channel has a volume of approximately 1 pL to 100 µL (volume of the thin-layer channel is in the range of 1 pL to 1 µL [0042]).
Response to Arguments
Applicant’s arguments, see Remarks Pg. 5-7, filed 11/18/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered. All 35 U.S.C. § 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment. However, applicant’s arguments are moot in view of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE Y TSENG whose telephone number is (703)756-5542. The examiner can normally be reached Mon - Fri 9-6 PT.
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/K.T./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795
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