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 5/3/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election without traverse of Group I, Claims 1-8 and 21-32 in the reply filed on 01/6/2026 is acknowledged.
Claim Objection
Claim 4 is objected to because of the following informalities:
Claim 4: please amend “defined in between” to -- defined [[in]] between--.
Appropriate correction is required.
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 1, 7-8, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Otomo et al. (JP 2013127455 A, English translation) in view of Staunton (US 3,461,055A) and Knopfmacher et al. (US20170342459A1). Otomo, Staunton, and Knopfmacher are provided in IDS filed on 5/3/2024.
Regarding claim 1, Otomo teaches a method of measuring a solution characteristic of a liquid sample (a method of measuring redox potential of a liquid sample [pure water 4 with adsorbed chemical substances; paras. 0016, 0021; Figs.3-4]), comprising:
filling a sample chamber (internal space of both the porous substance 3 and the arranging portion 21 in Fig.3 [para. 0023]) of a sample container (both the porous substance 3 and the arranging portion 21 in Fig.3 [para. 0023]) with the liquid sample (the porous substance 3 is impregnated with pure water 4 that adsorbs chemical substances from air [paras. 0019, 0021-0022]; chemical substances such as sulfur compound, nitrogen compound, carbohydrate, halide, ozone, particulate substance, and harmful substance [para. 0016]);
attaching a container cap (liquid tank 16 in Fig. 3 [para. 0023]) to the sample container (see Fig.3),
wherein the container cap (liquid tank 16 in Fig.3) comprises a reference conduit (liquid tank 16) comprising a reference conduit cavity (the tank 16 for storing the potassium chloride solution 17 in Fig.3 [para. 0023]), a reference conduit first opening (groove 14 in Fig.3 [para. 0023]), and a reference conduit second opening (top opening wherein lead wire 11 is inserted into the liquid tank 16 as shown in Fig.3),
wherein the reference conduit cavity is filled in part by a wicking component extending through the reference conduit cavity having a wick distal end and a wick proximal end (the silver powder 19 surrounding the silver wire 15 is prevented from flowing into the liquid tank of the internal fluid. It is packed with cotton 20 [paras. 0023, 0025 ]. The cotton 20 corresponds to the wicking component extending through the reference conduit cavity having a wick distal end [the bottom end of the cotton 20 away from the silver powder 19 in Fig.3] and a wick proximal end [the top end of the cotton 20 contacting the silver powder 19 in Fig.3]),
wherein a reference electrode material (silver powder 19 surrounding a silver wire 15 in Fig.3 [para. 0023]) is disposed at the wick proximal end (see Fig.3);
electrically coupling the reference electrode material to a parameter analyzer (a potential difference meter 24 in Fig.3 [para. 0023]) and electrically coupling the parameter analyzer to an active sensor component comprising an active electrode material (indicator electrode 5 comprising a platinum rod 12 in Fig.3 [para. 0023]),
wherein at least part of the active electrode material extends into the sample chamber and is in fluid contact with the liquid sample (the platinum rod 12 is inserted into the holding portion 3 and contacts the liquid junction portion 13 [para. 0023]); and
determining the solution characteristic of the liquid sample based on a potential difference measured between the active electrode material and the reference electrode material (the potential of the indicator electrode 5 with respect to the reference electrode 2 is measured by the potential difference meter 24 as shown in Figs.3-4 [para. 0024]).
Otomo further teaches wherein the silver wire 15 is packed with cotton 20 and leads to the fine groove 14 [para. 0023], and Figs. 3-4 show that the sample chamber and the container cap are in fluid communication by the fine groove 14. Thus, Otomo is silent to the following limitations: (1) wherein at least part of the wicking component is in fluid contact with the liquid sample within the sample chamber and wherein at least some of the liquid sample is drawn by the wicking component in a direction of the wick proximal end; and (2) wherein the liquid sample comprising an infectious agent.
Staunton teaches a reference sensor component (a reference electrode as shown in Fig.1 [Col. 2, Lines 31-35]) comprising: a container cap (glass tube 11 in Fig.1 [Col. 2, Lines 51-54]), wherein the container cap comprises a reference conduit (glass tube 11 in Fig.1 [Col. 2, lines 51-54]) comprising a reference conduit cavity (the internal space of the glass tube 11 filled with potassium chloride solution 13 in Fig. 1 [Col. 2, lines 51-54]), a reference conduit first opening (the top opening of the tube 11 wherein a cap 2 is disposed in Fig.1 [Col. 2, lines 62-65]), and a reference conduit second opening (the bottom opening of the tube 11 wherein a wicking component 15 is disposed in Fig.1 [Col.2, lines 54-59]), wherein the reference conduit cavity is filled in part by a wicking component (wicking component 15 in Fig.1 [Col.2, lines 54-59]) extending through the reference conduit cavity having a wick distal end and a wick proximal end (see Fig.1), wherein at least part of the wicking component is in fluid contact with a liquid sample (surrounding sample solution into which the tube 11 is immersed [Col.2, lines 53-59]) and wherein at least some of the liquid sample is drawn by the wicking component in a direction of the wick proximal end (at least some of the surrounding sample solution is drawn by the wicking component 15 in a direction of the wick proximal end, as shown in Fig.1), wherein a reference electrode material (platinum wire 3 in tube 1 in Figs.1-2 [Col. 2, lines 36-39]) is disposed in the reference conduit cavity as a reference electrode [Col.2 line67 to Col.3 line 23]. Thus, Staunton teaches a reference electrode disposed in a container cap which is in fluid communication with the target liquid sample by a wicking component 15 disposed at the bottom opening of the container cap.
Given the teachings of Otomo regarding the reference electrode (silver wire 15) packed with cotton 20 and the groove 14 bridging the sample chamber and the reference electrode chamber (container cap), and the teachings of Staunton regarding a reference electrode disposed in a container cap which is in fluid communication with the target liquid sample by a wicking component 15 disposed at an opening (the bottom opening) of the container cap, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the container cap in Otomo by extending the cotton 20 through the bottom end of the liquid tank, and have the modified container cap in fluid communication with the liquid sample in the sample chamber through the wicking component (the modified cotton 20) disposed at the bottom end of the container cap, as taught by Staunton, since it would allow to establish a constant reference potential with respect to the test solution (Col.1, lines 39-41 in Staunton). The above modification essentially substitutes the groove 14 in Otomo with the wicking component disposed at the bottom opening of the container cap such that the fluid communication between the reference electrode chamber and the sample chamber is achieved by the modified wicking component instead of the groove. The simple substitution of one known element for another (i.e., a wicking component for a groove which fluidically connects the sample chamber and reference electrode chamber) is likely to be obvious when predictable results are achieved (i.e., providing a reference electrode for the measurement of pH/ORP of the test sample solution) [MPEP § 2143(I)(B)].
Modified Otomo is silent to the following limitations: (2) wherein the liquid sample comprising an infectious agent.
Knopfmacher teaches methods and devices for detecting infectious agents in a fluid sample (abstract), and Fig. 2A shows the sensing device which is an electrochemical cell comprising a parameter analyzer 114 coupled to a reference electrode 202 and an electrode (the conductive layer 210), wherein the electrodes 202 and 210 are in contact with the electrolyte 204 containing the fluid sample 124 [paras. 0063-0065]. The fluid sample 124 contains infectious agent 102 such as bacteria, fungus, virus, or prion [para. 0049]. The parameter analyzer 114 can detect a change in the electrical characteristic of the sensing device 116 exposed to the sample effluent 134. In one embodiment, the parameter analyzer 114 can be a voltage meter [para. 0057].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to take the sensor apparatus of modified Otomo to detect infectious agents such as bacteria, fungus, virus, or prion in the fluid sample, as taught by Knopfmacher, since it would allow to detect viable infectious agents in a fluid sample and determine the susceptibility of such infectious agents to anti-infectives [para. 0002 in Knopfmacher].
Regarding claim 7, modified Otomo teaches the method of claim 1, and Otomo teaches wherein determining the solution characteristic of the liquid sample comprises determining an oxidation reduction potential (ORP) of the liquid sample and wherein the active electrode material is made in part of a redox-sensitive material (the method for measuring ORP in redox electricity [para. 0038]; the redox potential (ORP) is not only the reaction potential of a single hydrogen… [para. 0039]. Since the device of Otomo is capable of measuring ORP, the active electrode material is made in part of a redox-sensitive material. Otomo further teaches wherein the active electrode material is platinum [a platinum rod as an indicator electrode was used, para. 0038], as evidenced by the specification of this instant application, platinum is a redox-sensitive material [0017 in PGPub and instant claim 8]).
Regarding claim 8, modified Otomo teaches the method of claim 7, and Otomo teaches wherein the redox-sensitive material comprises platinum (a platinum rod as an indicator electrode was used [para. 0038]).
Regarding claims 21-22, modified Otomo teaches the method of claim 1, and Otomo is silent to: wherein the container cap is made in part of a non-conducting material (of claim 21); and wherein the container cap is made in part of a transparent non-conducting material such that at least part of the wicking component is visible through the container cap (of claim 22).
Staunton does teach wherein the container cap is made in part of a non-conducting material (glass tube 11 [Col.2, line 52]). Glass is a transparent non-conducting material such that at least part of the wicking component is visible through the container cap).
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 material of the container cap in modified Otomo with glass such that the container cap is made of glass, as taught by Staunton, since Staunton teaches glass would be a suitable material for making the container cap (glass tube 11 [Col.2, line 52]). 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 23, modified Otomo teaches the method of claim 1, and Otomo further teaches wherein the wicking component is made of cotton (cotton 20 [paras. 0023, 0025 ]), thus is silent to wherein the wicking component is made in part of a porous polymeric material.
Staunton teaches wherein the wicking component is made in part of a porous polymeric material (the packing 7 may consist of a cellular plastic foam material [Col.3 , lines 28-29]. Plastic foam material is a porous polymeric material).
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 material of the wicking component in modified Otomo with a cellular plastic foam material, as taught by Staunton, since Staunton teaches cellular plastic foam material as a suitable alternative material for the wicking component [Col.3 , lines 28-29]. 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 24, modified Otomo teaches the method of claim 1, and Otomo further teaches wherein the wicking component is made of cotton (cotton 20 [paras. 0023, 0025 ]), thus is silent to wherein the wicking component is made in part of natural fibers.
Staunton teaches wherein the wicking component is made in part of natural fibers (cotton or natural fiber yarns are operable as the material of the packing 7 [Col. 3, Lines 41-42]).
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 material of the wicking component in modified Otomo with natural fiber yarns, as taught by Staunton, since Staunton teaches natural fiber yarns as a suitable alternative material to cotton for the wicking component [Col.3 , lines 41-42]. 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 2 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Otomo in view of Staunton and Knopfmacher, as applied to claim 1 above, and further in view of Martin et al. (WO 2009055092 A1). Martin was provided in the IDS filed on 5/3/2024.
Regarding claim 2, modified Otomo teaches the method of claim 1, and Otomo teaches silver powder 19 connecting the silver wire 15 and disposed on the wick proximal end of the cotton 20 [para. 0023], but is silent to wherein the reference electrode material is a cured electrically-conductive ink.
Martin teaches a compact inexpensive reference electrode design with very small residual junction potentials, very low electrolyte leakage, and very low silver leakage (title). Martin further teaches a reference electrode 30 shown in Fig.4. Reference electrode 30 also includes a salt pellet 20, a hydrophilic wick material 22, a silver coated electrode 18, and pads 24 and 26. As a non-limiting example, the wick 22 may be made of a cellulose fiber-based material. In preferred embodiment, a portion of the wick 22 can be positioned between the frit 1 and the compressed salt pellet 20. In other examples, the wick 22 also runs through the length of the salt pellet 20, to facilitate quicker water uptake into the body of the salt pellet 20. In yet other examples, the wick material 22 can also be in contact with the wire 18. In the example of Figure 4, pad 24 can be comprised of a microporous materials, such as cellulose, and can be positioned between the salt pellet 20 and the frit 1. In the example of Figure 4, pad 26 can be comprised of a porous material, such as cellulose, coated with a silver/silver chloride coating, and can be positioned between a portion of the wire 18 and the salt pellet 20. In this example, silver epoxy 28 can be positioned between the disk 14 and wire 18. The silver epoxy 28 may also come in contact with hydrophilic wick material 22. [the 3rd para. in page 10]. Fig.4 shows that pad 26 with a silver/silver chloride coating is positioned on the proximal end of the wick material 22. In order to achieve the reproducible absolute potential, it is necessary that the silver ion activity near the silver wire remain stable. This is accomplished herein by (i) using silver/silver chloride ink, which leaks silver ion at a slower rate than conventional electrode materials, and (ii) maintaining a saturated electrolyte solution, which governs the solubility and activity of the silver ion [the 1st para. in page 8].
Modified Otomo and Martin are considered analogous art to the claimed invention because they are in the same field of electrochemical sensor and both use wick material. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sensor apparatus of modified Otomo by applying a cured silver/silver chloride ink disposed on the proximal end of the wick material, as taught by Martin so that the electrode can be a silver/silver chloride reference electrode [the 2nd para. in page 10 of Martin] which would be capable of providing a reproducible absolute potential [the 1st para. in page 8 of Martin]. Furthermore, the claimed limitations of cured silver/silver chloride ink disposed on the wick proximal end are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (i.e., using silver/silver chloride as a reference electrode, which would be well-known by one skilled in the art, by known methods with no change in their respective functions would provide the obvious and predictable benefit of achieving the reproducible absolute potential, as taught by Martin) [MPEP 2143(I)(A)].
Regarding claim 27, modified Otomo teaches the method of claim 1, and is silent to wherein the wicking component is treated by a surfactant such that at least a surface of the wicking component is covered by the surfactant, wherein the surfactant is configured to increase a hydrophilicity of the wicking component.
Martin teaches a reference electrode 30 including a hydrophilic wick material 22 wherein a surfactant may be included to prevent the pores of the frit from becoming clogged (the 2nd para. on page 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the wicking component in modified Otomo by treating the wicking component by a surfactant, as taught by Martin, since it would prevent the pores of the wicking component from becoming clogged (the 2nd para. on page 5 of Martin). Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results [MPEP 2143(I)(A)].
Regarding the limitation “wherein the surfactant is configured to increase a hydrophilicity of the wicking component”, modified Otomo teaches wherein the wicking component is treated by a surfactant, which is configured to perform the function of increasing a hydrophilicity of the wicking component in order to prevent the pores of the wicking component from becoming clogged.
Regarding claim 28, modified Otomo teaches the method of claim 2, wherein the electrically-conductive ink is silver-silver chloride ink (As outlined in the rejection of claim 2 above, the electrically-conductive ink is silver-silver chloride ink [the 1st para. on page 8 in Martin]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Otomo in view of Staunton and Knopfmacher, as applied to claim 1 above, and further in view of Fey (US Pub. No. 20130295660 A1). Fey was provided in IDS filed on 5/3/2024.
Regarding claim 3, modified Otomo teaches the method of claim 1, and Otomo teaches further comprising pumping air into the sample chamber through an aeration port defined along at least one of a bottom side and a lateral side of the sample container (pumping air by the fan device 7 into the sample chamber through round hollow holes 22 defined along a lateral side of the porous substance 3 as shown in Figs.3-4 [paras. 0022-0023]), and the limitation “wherein the air pumped into the sample chamber aerates the liquid sample” is an intended result of a positively recited step. The court noted that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited." Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Otomo is silent to a hydrophobic air-permeable membrane covering the aeration port.
Fey teaches a bioreactor or culture vessel for incubation of one or more cell cultures, tissue biopsies, cell clusters, tissue-like structures, “prototissues” or similar samples (Abstract). Fey further teaches the bioreactor comprising an incubation chamber (1), conduction means (2), a reservoir (3), a first semipermeable membrane (M1) between 1 and 2, and a second semipermeable membrane (M2) between 2 and 3 ([para.0014]). The term “substantially impermeable to water” is used to describe characteristics of membranes of the present invention and refers to a membrane that exhibits a high degree of repulsion of water and water-like molecules in gas and/or liquid phase ([para. 0045]). Membranes comprised of a wide variety of materials can be used, that are “substantially impermeable to water” and “substantially permeable to oxygen and carbon dioxide,” including but not limited to membranes well known in the art comprised of polytetrafluoroethylene (PTFE), Polyvinylidene fluoride (PVDF), silicon rubber, foam plastics, radiation treated plastic or similar materials ([para. 0082]). Therefore, Fey teaches hydrophobic air-permeable membrane, for example, the PTFE membrane is substantially impermeable to water and substantially permeable to air.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add a hydrophobic air-permeable membrane such as a PTFE membrane, to cover the aeration port of modified Otomo, as taught by Fey, since it would provide ventilation means for enhancing gas exchange with the atmosphere surrounding the bioreactor ([para.0014] of Fey).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Otomo in view of Staunton and Knopfmacher, as applied to claim 1 above, and further in view of Bychkova et al. (US Pub. No. 20170261464 A1). Bychkova is provided in IDS filed on 5/3/2024.
Regarding claim 5, modified Otomo teaches the method of claim 1, wherein determining the solution characteristic of the liquid sample comprises determining the pH of the liquid sample (Otomo teaches wherein the reaction potential of a single hydrogen ion as a measurement target as in a pH meter [para. 0039]).
Otomo is silent to wherein the active electrode material is made in part of a pH-sensitive material.
Bychkova teaches microelectronic pH sensors (abstract). Bychkova further teaches a microelectronic pH-sensitive indicating electrode was made on a silicon substrate with silicon dioxide (SiO2) passivation layers surrounding a gold electrode. An iridium/iridium oxide (Ir/IrOx) reactive layer was deposited at the sensing window [para. 0068]. Thus, Bychkova teaches wherein pH-sensitive material comprises at least silicon dioxide and iridium dioxide.
Modified Otomo and Bychkova are considered analogous art to the claimed invention because they are in the same field of electrochemical sensor for measuring pH. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the active electrode material of modified Otomo with a pH-sensitive material comprising silicon dioxide and iridium dioxide, as taught by Bychkova, since it would allow to determine the pH of the sample solution. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 (I)(B)).
Regarding claim 6, modified Otomo teaches the method of claim 5, wherein the pH-sensitive material comprises at least one of silicon dioxide and iridium dioxide (as outlined in the rejection of claim 5 above, Bychkova teaches wherein pH-sensitive material comprises silicon dioxide and iridium dioxide).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Otomo in view of Staunton and Knopfmacher, as applied to claim 1 above, and further in view of Wolf et al. (US 20090026078 A1) and Ghannam et al. (US20180334021A1). Wolf is provided in IDS filed on 5/3/2024.
Regarding claim 25, modified Otomo teaches the method of claim 1, and is silent to wherein the wicking component is made in part of high-density polyethylene (HDPE).
Wolf teaches a controlled activation pH sensor (title). Wolf further teaches when the user removes the sensor from the package and the sensor tip is submerged in a hydration (ion conduction) media or solution, the hydrophilic coating along with the impregnated reference wick, absorb the fluid to create an electrolytic gel inside the reference wick, which activates the pH sensor (Abstract). The dry “non-activated” reference wick 19 can be fabricated from a variety of polymeric based materials. Examples of such materials are polysaccharides, (cotton, regenerated cellulose) polyester, polyethylene [para. 0026].
Ghannam teaches resin wicker may be formed of strands of PVC, nylon, polyethylene, or high-density polyethylene [para. 0046].
since Wolf teaches polyethylene as a suitable alternative material to cotton for the wicking component [para. 0026], and Ghannam teaches high-density polyethylene as a suitable alternative material to polyethylene for the wicking component [para. 0046], thus high-density polyethylene is a suitable alternative material to cotton for the wicking component. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the material of the wick component (i.e., cotton) in modified Otomo with a high-density polyethylene, as taught by combined Wolf and Ghannam, since high-density polyethylene is a suitable alternative material to cotton for the wicking component, as explained above. 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].
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Otomo in view of Staunton and Knopfmacher, as applied to claim 1 above, and further in view of Wolf et al. (US 20090026078 A1) and Strong et al. (US20180217140A1).
Regarding claim 26, modified Otomo teaches the method of claim 1, and is silent to wherein the wicking component comprises pores sized between about 15 µm to about 150 µm.
Wolf teaches a controlled activation pH sensor (title). Wolf further teaches when the user removes the sensor from the package and the sensor tip is submerged in a hydration (ion conduction) media or solution, the hydrophilic coating along with the impregnated reference wick, absorb the fluid to create an electrolytic gel inside the reference wick, which activates the pH sensor (Abstract). The dry “non-activated” reference wick 19 can be fabricated from a variety of polymeric based materials. Examples of such materials are polysaccharides, (cotton, regenerated cellulose) polyester, polyethylene [para. 0026].
Strong teaches the wicking pad 102 contains porous polyethylene, such as porous polyethylene having a pore size between 0.2 and 20 microns [para. 0057].
since Wolf teaches polyethylene as a suitable alternative material to cotton for the wicking component [para. 0026], and Strong teaches porous polyethylene having a pore size between 0.2 and 20 microns as a wicking component [para. 0057], it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the material of the wick component (i.e., cotton) in modified Otomo with a porous polyethylene having a pore size between 0.2 and 20 microns, as taught by combined Wolf and Strong, since a porous polyethylene having a pore size between 0.2 and 20 microns is a suitable alternative material to cotton for the wicking component, as explained above. 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]. The disclosed pore size overlaps with the claimed pore size.
Furthermore, it would have been obvious to have selected and utilized a porous polyethylene with a pore size within the disclosed range as the wicking component, as taught by modified Otomo above, including those amounts that overlap within the claimed range of the pore size, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Strong specifically teaches the range of the pore size to be suitable for the porous polyethylene as the wicking component. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 (I).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Otomo in view of Staunton, Knopfmacher and Martin, as applied to claim 2 above, and further in view of Nakamura et al. (US6468416B1).
Regarding claim 29, modified Otomo teaches the method of claim 2, and is silent to wherein the electrically-conductive ink has been cured for a period of time between about 60 minutes and about 180 minutes.
Nakamura teaches wherein an Ag/AgCl electrode is formed by the screen- printing method with a conductive silver/silver chloride ink and dried by heating (60 oC, 1 hour) (Col. 6, Lines 43-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the undisclosed curing condition for curing the Ag/AgCl ink in modified Otomo to cure the Ag/AgCl ink by heating at 60 oC for 1 hour, as taught by Nakamura, since it would form cured silver/silver chloride electrode (Col. 6, Lines 43-45 in Nakamura). The disclosed curing time of 1 hour falls within the claimed time range between about 60 minutes and about 180 minutes.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Otomo in view of Staunton, Knopfmacher and Martin, as applied to claim 2 above, and further in view of Nie et al. (Electrochemical sensing in paper-based microfluidic devices, Lab on a chip, 2010, 10, 477-483).
Regarding claim 30, modified Otomo teaches the method of claim 2, and is silent to wherein a volume of the electrically-conductive ink disposed at the wick proximal end is less than about 500 µL.
Nie teaches an Ag/AgCl reference electrode formed by a cured Ag/AgCl ink on a paper substrate (wicking component), wherein the thickness, length and width of the Ag/AgCl reference electrode are, respectively, d=100 µm, L=1.5 cm, and w=3 mm (section of Electrodes in Col.2 on page 478). The volume of reference electrode is V=d x L x w=0.1 mm (d) x 15 mm (L) x 3 mm (w)=4.5 mm3=4.5 µL, falling within the claimed volume range of the Ag/AgCl ink.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the undisclosed volume of the Ag/AgCl ink in modified Otomo to 4.5 µL, as taught by Nie, since it would form a cured inexpensive and robust silver/silver chloride electrode (section of Choice of materials in Col. 1 on page 478 in Nie). The disclosed volume falls within the claimed volume range.
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Otomo in view of Staunton, and Knopfmacher, as applied to claim 1 above, and further in view of Schultz (US 4,891,125A). Schultz is provided in IDS filed on 5/3/2024.
Regarding claims 31-32, modified Otomo teaches the method of claim 1, and Otomo is silent to: wherein the reference conduit is tapered (of claim 31); and wherein the wicking component is shaped such that the wicking component tapers from the wick proximal end to the wick distal end (of claim 32).
Staunton further teaches wherein the wicking component is shaped such that the wicking component essentially fills the remainder of the reference conduit cavity (i.e., tube 1) from the wick distal end to the wick proximal end, as shown in Fig.2 (Col. 2, lines 45-46).
Schultz teaches a miniaturized reference electrode includes a dielectric thermoplastic cup having a cavity to hold a reference liquid solution and having a sample contacting orifice at one end (abstract and Figs. 1-2). Figs. 1-2 shows that the cup means 12 having a generally tubular configuration including a main body portion 14, a narrower forwardly projecting portion 16, and a stepped shoulder 18 therebetween. The front end 20 of forward portion 16 includes a narrow sample contacting orifice or opening 22 having an outwardly flared lead in 24 as shown. The opposed upper or rearward end 26 of main body portion 14 also includes an enlarged opening 28. Cup means 12 further includes a cavity 30 extending between orifice 22 and opening 28 having an enlarged electrode-receiving portion 32, a central portion 34 of generally constant internal diameter and a tapered transition portion 36 (Col. 5, Lines 28-45). The tapered cavity 30 as shown in Figs. 1-2 corresponds to the claimed reference conduit. Thus, Schultz teaches a reference electrode component wherein the reference conduit is tapered.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to change the cylindrical tube shape of the reference conduit in modified Otomo to a reference conduit with a tapered shape, as taught by Schultz, since it would provide an improved miniaturized reference electrode [Col. 1, Lines 8-14 in Schultz]. Generally, differences in shape will not support the patentability of subject matter encompassed by the prior art absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). Therefore, it would have been a matter of choice to use a reference conduit with a cylindrical shape or a tapered shape which a person of ordinary skill in the art would have found obvious.
Modified Otomo teaches the reference conduit is tapered, as outlined in the rejection above. Given the teachings of Staunton regarding the wicking component is shaped such that the wicking component essentially fills the reference conduit from the wick proximal end to the wick distal end, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to fill the tapered reference conduit with the wicking component from the wick proximal end to the wick distal end, yielding the wicking component tapers from the wick proximal end to the wick distal end, since it would allow to physically retain the mixture in the half cell [Col.2, Lines 40-46 in Staunton]. Generally, differences in shape will not support the patentability of subject matter encompassed by the prior art absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). Therefore, it would have been a matter of choice to use a tapered wicking component which a person of ordinary skill in the art would have found obvious.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 4 would be allowable for disclosing the following limitations: wherein the air pumped into the sample chamber exits the sample chamber through an additional air-permeable membrane covering at least part of an underside of the container cap and through air gaps defined between the container cap and the sample container along an attachment connection.
Modified Otomo teaches the hydrophobic air-permeable membrane covering the hollow holes 22 of the sample chamber, as outlined in the rejection of claim 3 above. As outlined in the rejection of claim 1 above, Modified Otomo teaches wherein the container cap (the reference electrode chamber) is in fluid communication with the sample chamber through the wicking component disposed at the bottom opening of the container cap, which suggests that the container cap is disposed above the sample chamber. The prior art of the record does not teach and suggest that there are air gaps defined between the container cap and the sample container along an attachment connection, and especially one skill in the art would not be motivated to add an additional air-permeable membrane covering at least part of an underside of the container cap wherein the wicking component is disposed. Therefore, there does not appear to be any teaching, suggestion, or motivation to have the air pumped into the sample chamber exiting the sample chamber through an additional air-permeable membrane covering at least part of an underside of the container cap and through air gaps defined between the container cap and the sample container along an attachment connection, recited in claim 4, thus claim 4 is allowable.
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Haar et al. (US4838999A) teaches a sample chamber of a sample container (pipe 22 in Fig.2) and a container cap (housing 24) comprising a reference conduit comprising a reference conduit cavity, first and second openings, a reference electrode material 30 disposed in the reference conduit, and an active sensor component (measurement electrode 20) disposed in the sample chamber, and a parameter analyzer (voltage measurement device 34) electrically coupled to the reference electrode and the measurement electrode for measuring electrolytic components in a sample liquid. Bychkova et al. (US20150101938A1) teaches a pH sensing probe comprising a container cap (fluidic chamber 358) attaching to a sample container (fluidic channel 359), wherein the container cap comprises a reference electrode 360, and an indicating electrode 375 disposed in the sample chamber, and a parameter analyzer (electronic module 320 of reader 310) is electrically coupled to the reference electrode and the indicating electrode. Betts et al. ( US5338435A) teaches a sample container (housing 10 in Fig.5) comprising a sample chamber (channels 12, 60, 62 in Fig.5), and one or more sensors 18 of sensor element 14 are positioned in channel 12 while other sensors or electrodes 18 are positioning in side channels 60 and 62 (Fig.18), and preferably reference electrodes 64 and 66, respectively, are in contact with channels 60 and 62.
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/SHIZHI QIAN/Examiner, Art Unit 1795