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 .
Status of claims
No amendment to claims in the response filed in 11/21/2025. Currently, claims 1, 3-4, 6-7, 9-10, 12-13, and 15-18 are pending in the application.
Previous rejections are maintained since Applicant’s arguments are not persuasive to overcome the rejections. See responses to arguments below.
Claims 1, 3-4, 6-7, 9-10, 12-13, and 15-18 are rejected. See response to arguments below.
Response to Arguments
Applicant's arguments and declaration filed 6/18/2025 have been fully considered but they are not persuasive.
Applicant asserts that the Examiner is mistaken regarding to potentiometry and potentiometric methods. Applicant points to references to Stork, J. T. Anal.Chem. 1993, 65, 344A-351A, https ://chem.libretexts.org/Bookshelves/Analytical Chemistrv/Analvtical_ Chemistrv 2.1 (Harvey/11%3A_Electrochemical_Methods/11.02%3A_Potentiometric Methods, https:/www. sciencedirect.com/topics/engineering/potentiometry, etc… for the description that the potential of an electrochemical cell is measured under static condition of zero cell current. Applicant then points to figs. 4A and 4B showing potential responses. Applicant then concludes that Applicant has support for the limitations directed to a process of using or an intended use limitation of a pH sensing device such as “potential-measuring” and “the ion-selective electrode is adapted to operate by measuring a potential across the polymeric sensing membrane at zero current” (emphasis added) even though there is no process of potential-measuring by measuring a potential across the polymeric sensing membrane at zero current, or the intended use, being described in the originally filed disclosure.
The examiner replies “membrane potential-measuring ion-selective electrode” is nowhere being described in the originally filed disclosure, as well as the condition of “measuring a potential across the polymeric sensing membrane at zero current”. Potential responses are not inherently supporting for potential-measuring by measuring a potential across the polymeric sensing membrane at zero current. Potential responses do not tell or inherently reflects the potential responses are at zero cell current without further information being provided, e.g. zero current. Zero cell current, or the zero current of an entire cell with two electrodes, is not an inherency for measuring a potential across the polymeric sensing membrane at zero current where zero current is directed to the electrode current, and not cell current. Applicant also discloses the ion-selective electrodes are known in the art… which a membrane potential is measure between two references electrodes in page 1, lines 15- 17. That is, Applicant explicitly describes ion-selective electrodes are electrochemical devices, but not the conventional electrochemical devices with one working electrode and one reference electrode. Therefore, the zero cell current of a typical electrochemical cell of one working electrode and one reference electrode is not an inherency for supporting zero current that is not a zero cell current, but a zero electrode current.
Prior art rejection:
Applicant argues Kabagambe is not anticipatory to the claimed device, sensor and sensor array; because Kabagambe does not disclose subjecting the electrodes to volumetric measuring, or different intended use from the claimed the device/sensor/and sensor array, and does not disclose the characteristic of the polymeric sensing membrane without CO2 interference such as plasticized or unplasticized PVC, polyurethane, methacrylate, or silicon rubber films
The examiner replies that Kabagambe has all the structural limitations and material limitations as claimed. The reference is deemed to be anticipatory. Kabagambe also teaches using the same claimed material for the polymeric sensing membrane, e.g. plasticized PVC membrane, as claimed in claim 3. Applicant has not provided any factual supported objective evidence that an ion-selective electrode disclosed by Kabagambe having all structural limitations as claimed and using the same material as claimed cannot be used in potential-measuring by measuring a potential across the polymeric sensing membrane at zero current for pH sensing without CO2 interference, or the displayed properties/characteristic.
It is well settled that arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
Accordingly, Applicant’s arguments are not persuasive to overcome the rejection. Therefore, the rejections are maintained. See the copy of the previous rejection below.
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, 3-7, 9-13, and 15-18 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.
As amended, independent claims 1, 7, 13 recite “the ion-selective electrode is adapted to operate by measuring a potential across the polymeric sensing membrane at zero current” in lines 16-18 of claim 1, lines 11-13 of claim 7, and “membrane potential-measuring ion-selective electrode is adapted to operate by measuring a potential across the polymeric sensing membrane at zero current” in lines 15-17 of claim 13. Applicant has no support for the limitation in the originally filed disclosure. Applicant points to the Supplemental Declaration of Erno Lindner filed on 11/06/2023 and argues it is apparent and understandable to any person of ordinary skill in the art that the ISE being used to operate by measuring potential means static conditions where there is no current flowing, just potential. The examiner replies that Supplemental Declaration of Erno Lindner is not the originally filed disclosure, and the complex and elaborated method described in the Declaration is no where to be found in the originally filed disclosure. As explained in the office action 12/18/2023, in an electrical circuitry, a potential is a voltage difference between two points of the electrical circuitry; and in an electrical circuitry, there must be both voltage and current, and if there is a non-zero potential (or the voltage difference between two points of the circuit) there must be a current (or electron flow) between the two points in order to create such potential. To the examiner knowledge, there is such thing as zero current in a circuitry having non-zero potential, and such concept is not apparent and understandable from reading Applicant’s originally filed disclosure, which has no such description anywhere.
Claims 3-4, 6, 9-10, 12 and 15-18 are rejected on the same ground as claims 1, 7, and 13.
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, 3-4, 6-7, 9-10, 12-13, and 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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.
Claims 1, 3-4, 6-7, 9-10, 12-13, and 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. Claims 1, 3-4, 6-7, 9-10, 12-13, and 15-18 claim a device (in claim 1), a sensor (in claim 7) and a sensor array or platform (in claim 13), an intended use (pH sensing), a process of use ion-selective electrode (potential measuring by measuring potential across the polymeric sensing membrane at zero current), and an environment of use (without CO2 interference). This claim is an omnibus type claim.
Independent claims 1, 7, and 13 recite the ion-selective electrode is adapted to operate by measuring a potential across the polymeric sensing membrane at zero current” in lines 16-18 of claim 1, lines 11-13 of claim 7, and “membrane potential-measuring ion-selective electrode is adapted to operate by measuring a potential across the polymeric sensing membrane at zero current” in lines 15-17 of claim 13 (emphasis added). It is unclear what zero current being referred to. Applicant points to Supplemental Declaration of Erno Lindner and argues that zero current is the consequence of an ion-exchange equilibrium between the analyte solution and the sensing membrane of the sensor. The examiner replies that “ion-exchange equilibrium” is not current. An equilibrium of ion-exchange is understood as the forward exchange is closely matched with the backward exchange, or the exchanges in both directions are close to each other, and that does not mean each exchange is zero, and is not an inherent “zero current”. In addition, the Declaration is not the originally filed disclosure such that the “zero current” is defined as the consequence of ion exchange equilibrium in the originally filed disclosure.
For the purpose of this office action, recitations direct toward an intended use - pH sensing, hydrogen sensing, potassium sensing, sodium sensing, calcium sensing, magnesium sensing, process of use such as measuring a potential across the polymeric sensing membrane at zero current, and the environment of use such as without CO2 interference – are construed as the intended use of the device, the sensor, and the sensor array or platform.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 3-4, 7, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kabagambe (“Electrochemical ion-ionophore recognition at membrane/water interfaces for ultratrace ion sensing”).
Regarding claims 1, 3-4, 7 and 9-10, Kabagambe discloses a device of a sensor comprising an ion-selective electrode (see Figures 2-1 and 4-1, and also see sections “Electrode Modification”) comprising:
an electron-conducting substrate (see gold substrate in Figures 2-1 and 4-1, also see Au or glassy carbon disk in sections “Electrode Modification”);
a polymeric sensing membrane (see PVC membrane in Figures 2-1 and 4-1, or oNPOE-plasticized PVC membrane described in sections “Electrode Modification”); and
a hydrophobic sold contact of conducting polymer film of PEDOT-C14 disposed between the electron conducting substrate and the polymeric sensing membrane (see Figures 2-1 and 4-1, and sections “Electrode Modification”) in combination with hydrophobic counter ion such as tetrakis(pentafluorophenyl) borate (TFAB) (see sections “Chemicals” 1.2.1, 2.3.1, 3.2.1, 4.2.1);
wherein no aqueous film or ion-to-electron transducer layer with hydrophilic properties is located between the polymeric sensing membrane (oNPOE-plasticized PVC membrane) and the hydrophobic solid contact (PEDOT-C14) as Kabagambe describes there is no film and no layer between the polymeric sensing membrane (oNPOE plasticized PVC membrane) and the hydrophobic solid contact (PEDOT-C14).
Kabagambe discloses all the structural limitations of the claimed electrode. The reference is deemed to be anticipatory.
Kabagambe discloses using the same conductive polymer film layer as claimed, e.g. PEDOT-C14, the conductive polymer film of PEDOT-C14 of Kabagambe will display the same property/characteristic of having a water contact angle between approximately 134o to 152o as claimed. See MPEP 2112.
Recitations directed to an intended use of the device/sensor such as “improved pH sensing device”, “membrane potential-measuring”, “polymeric sensing membrane is a hydrogen ion-selective membrane such that the ion-selective electrode is pH sensitive and without CO2 interference” and the ion-selective electrode is adapted to operate by measuring a potential across the polymeric sensing membrane at zero current” recited in independent claims 1 and 7. Said recitations do not differentiate the device/sensor claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process limitations do not have patentable weight in an apparatus claim; so long as the disclosed apparatus is capable of performing the process limitations, the limitations are deemed to have been met. See Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969) that states “Expressions relating the apparatus to contents thereof and to an intended operation are of no significance in determining patentability of the apparatus claim.” The device/sensor of Kabagambe is fully capable of being used as claimed, because the device/sensor of Kabagambe includes an ion-selective electrode with all the structural and material limitations as claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kabagambe as applied to claims 1 and 7 above, in view of Vlasov et al. (US Patent 5,344,547).
Regarding claims 6 and 12, Kabagambe discloses a solid contact ion-selective electrode and a sensor as in claims 1 and 7 above.
Kabagambe does not disclose including a liquid junction free reference membrane layered over the hydrophobic conductive polymer film layer.
Vlasov et al. teaches including an intermediate or middle membrane (or layer 38, fig. 2) between the electrode (48, fig. 2) and the sensing membrane (34, fig. 2) and having gradient concentration of electrolyte to improve the ion selective electrode by providing the electrode having an extremely high level of stability of potential across the surface of membrane and which exhibits excellent precision and reliability of measurement during long term operation (see col. 3 lines 7-33).
It would have been obvious to one skilled in the art at the time the invention was made to modify the ion selective electrode of modified Kabagambe by incorporating an intermediate/middle layer (or membrane) taught by Vlasov et al. layered over the hydrophobic polymer film layer of PEDOT-C14 of Kabagambe, because Vlasov et al. teaches such intermediate/middle layer (or membrane) would improve the ion selective electrode by providing the electrode having an extremely high level of stability of potential across the surface of membrane and which exhibits excellent precision and reliability of measurement during long term operation (see col. 3 lines 7-33). The intermediate/middle layer (or membrane) of modified Kabagambe corresponds to instant liquid junction free (e.g. not in junction with liquid) reference membrane.
Claims 13, 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kabagambe (“Electrochemical ion-ionophore recognition at membrane/water interfaces for ultratrace ion sensing), in view of Han et al. (US 2013/0030510) or Heule et al. (US 2008/0149501)
Regarding claims 13 and 15, Kabagambe teaches a sensor platform comprising a solid contact ion-selective electrode as in claims 1 and 7 above.
Kabagambe does not teach using a plurality of solid contact ion-selective electrodes so as to form a sensor array.
Han et al. teaches using a plurality of ion-selective electrodes (see title, figs. 1A-1B, [0009]) to actively control the local ion concentration along a nerve fiber in a neural prosthetic device ([0007] and [0025]).
Heule et al. also discloses a sensor or a sensor array having a plurality of ion-selective electrodes (see figs. 2-6) for different ions in an analysis solution ([0019]) or for increasing the accuracy and reliability of the measurement and permits improved quality assurance ([0025])
It would have been obvious to one skilled in the art at the time of the invention was made to have used a plurality of ion-selective electrodes of Kabagambe above as taught by Han et al. or Huele et al., because Han et al. teaches using a plurality of ion-selective electrodes would control the local ion concentration along a nerve fiber in a neural prosthetic device, and Huele et al. teaches having a plurality of ion-selective electrodes would provide detection of different ions or would increase the accuracy and reliability of the measurement and permits improved quality assurance. Furthermore, such modification would involve nothing more than a mere duplication of parts. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 124 USPQ 378, 380 (CCPA 1960). Further, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 16, modified Kabagambe discloses a sensor platform as in claim 13 above, wherein Kabagambe discloses using tetrakis(pentafluorophenyl) borate (TFAB) (see sections “Chemicals” 1.2.1, 2.3.1, 3.2.1, 4.2.1).
Regarding claim 17, modified Kabagambe discloses a sensor platform as in claim 13 above, wherein Kabagambe discloses the sensing membrane is for ions such as potassium (K+), calcium (Ca2+, see pages iv-v, Figure 1-1, Introduction and Experimental Section).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over modified Kabagambe as applied to claim 13 above, and further in view of Vlasov et al. (US Patent 5,344,547).
Regarding claim 18, modified Kabagambe discloses a sensor array as in claim 13 above.
Modified Kabagambe does not disclose including a liquid junction free reference membrane layered over the hydrophobic conductive polymer film layer.
Vlasov et al. teaches including an intermediate or middle membrane (or layer 38, fig. 2) between the electrode (48, fig. 2) and the sensing membrane (34, fig. 2) and having gradient concentration of electrolyte to improve the ion selective electrode by providing the electrode having an extremely high level of stability of potential across the surface of membrane and which exhibits excellent precision and reliability of measurement during long term operation (see col. 3 lines 7-33).
It would have been obvious to one skilled in the art at the time the invention was made to modify the ion selective electrode of modified Kabagambe by incorporating an intermediate/middle layer (or membrane) taught by Vlasov et al. layered over the hydrophobic polymer film layer of PEDOT-C14, because Vlasov et al. teaches such intermediate/middle layer (or membrane) would improve the ion selective electrode by providing the electrode having an extremely high level of stability of potential across the surface of membrane and which exhibits excellent precision and reliability of measurement during long term operation (see col. 3 lines 7-33). The intermediate/middle layer (or membrane) of modified Kabagambe corresponds to instant liquid junction free (e.g. not in junction with liquid) reference membrane.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANH-TRUC TRINH whose telephone number is (571)272-6594. The examiner can normally be reached on 9:00am - 6:00pm.
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THANH-TRUC TRINH
Primary Examiner
Art Unit 1726
/THANH TRUC TRINH/ Primary Examiner, Art Unit 1726
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