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 .
Response to Amendment
The Amendments filed February 19, 2026 have been entered. Applicant’s amendments have overcome the abstract objection, the claim objections, and has partially overcome the 112(b) rejections previously set-forth in the Non-Final Office Action mailed on 11/19/2025. Currently, claims 1-3, 5-10, and 12-13 have been amended, claims 4 and 11 have been cancelled, and claims 1-3, 5-10, and 12-13 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5-10 and 12-13 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.
Claim 1 recites the limitation "the fetal tissue" in line 3 of page 3. There is insufficient antecedent basis for this limitation in the claim. Claims 2-3, 5-6 are also objected to because they are dependent on claim 1.
Claim 1 recites the limitation "a fetal monitoring device comprising five electrodes” in line 1, and “wherein the second electrode (BRE) is also the third electrode (EWE) to form a combined BRE/EWE electrode” in lines 26-27. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner the total number of electrodes required in the claim language given that it describes a device with five electrodes but then proceeds to claim that the second and third electrodes are a singular/combined electrode. Claims 2-3, 5-6 are also objected to because they are dependent on claim 1.
Claim 1 recites the limitation "the first electrode (BWE), second electrode (BRE), and third electrode (EWE) form one or more protrusions” in lines 1-2 of page 3. The recitation renders the scope of the claim as indefinite because as explained above, the claim language dictates that the second and third electrodes are a singular/combined electrode, but then later on describes how the second and the third electrodes form one or more protrusions. If the second electrode and the third electrode are truly a single combined electrode, then they would form an individual protrusion. Hence, it is unclear to Examiner the precise structural requirement of the 1st/2nd/3rd electrode forming one or more protrusions. Claims 2-3, 5-6 are also objected to because they are dependent on claim 1.
Claim 5 recites the limitation "wherein either the second electrode (BRE) or the third electrode (EWE) is also a biosensor counter electrode (BCE)” in lines 1-3. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner the total number of electrodes required in the claim language given that, as explained above, claim 1 describes a device with five electrodes but then proceeds to claim that the second and third electrodes are a singular/combined electrode. However, claim 5 then proceeds to describe how either the second or the third electrode forms a biosensor electrode; if claim 1 already noted that the second and the third electrode are one combined electrode, it is unclear to Examiner how dependent claim 5 can describe them as separate entities.
Claim 6 recites the limitation "wherein the combined BRE/EWE electrode is a biosensor counter electrode (BCE)” in lines 1-2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner the total number of electrodes required in the claim language given that, as explained above, claim 1 describes a device with five electrodes but then proceeds to claim that the second and third electrodes are a singular/combined electrode.
Claim 7 recites the limitation "the fetal tissue" in line 6 of page 6. There is insufficient antecedent basis for this limitation in the claim. Claims 9-10, 12-13 are also objected to because they are dependent on claim 7.
Claim 7 recites the limitation "a fetal monitoring device comprising five electrodes” in line 4, and “wherein the second electrode (BRE) is also the third electrode (EWE) to form a combined BRE/EWE electrode” in lines 1-2 of page 5. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner the total number of electrodes required in the claim language given that it describes a device with five electrodes but then proceeds to claim that the second and third electrodes are a singular/combined electrode. Claims 9-10, 12-13 are also objected to because they are dependent on claim 7.
Claim 7 recites the limitation "the first electrode (BWE), second electrode (BRE), and third electrode (EWE) form one or more protrusions” in lines 4-5 of page 5. The recitation renders the scope of the claim as indefinite because as explained above, the claim language dictates that the second and third electrodes are a singular/combined electrode, but then later on describes how the second and the third electrodes form one or more protrusions. If the second electrode and the third electrode are truly a single combined electrode, then they would form an individual protrusion. Hence, it is unclear to Examiner the precise structural requirement of the 1st/2nd/3rd electrode forming one or more protrusions. Claims 9-10, 12-13 are also objected to because they are dependent on claim 7.
Claim 8 recites the limitation "the fetal tissue" in lines 20-21 of page 6. There is insufficient antecedent basis for this limitation in the claim. Claims 9-10, 12-13 are also objected to because they are dependent on claim 8.
Claim 8 recites the limitation "the mother" in line 4 of page 6. There is insufficient antecedent basis for this limitation in the claim. Claims 9-10, and 12-13 are also rejected because they are dependent on claim 8.
Claim 8 recites the limitation "providing a device comprising five electrodes” in line 4, and “wherein the second electrode (BRE) is also the third electrode (EWE) to form a combined BRE/EWE electrode” in lines 16-17 of page 6. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner the total number of electrodes required in the claim language given that it describes a device with five electrodes but then proceeds to claim that the second and third electrodes are a singular/combined electrode. Claims 9-10, and 12-13 are also rejected because they are dependent on claim 8.
Claim 8 recites the limitation "the first electrode (BWE), second electrode (BRE), and third electrode (EWE) form one or more protrusions” in lines 19-20 of page 6. The recitation renders the scope of the claim as indefinite because as explained above, the claim language dictates that the second and third electrodes are a singular/combined electrode, but then later on describes how the second and the third electrodes form one or more protrusions. If the second electrode and the third electrode are truly a single combined electrode, then they would form an individual protrusion. Hence, it is unclear to Examiner the precise structural requirement of the 1st/2nd/3rd electrode forming one or more protrusions. Claims 9-10, and 12-13 are also rejected because they are dependent on claim 8.
Claim 12 recites the limitation "wherein either the second electrode (BRE) or the third electrode (EWE) is also a biosensor counter electrode (BCE)” in lines 1-3. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner the total number of electrodes required in the claim language given that, as explained above, claims 7-8 describes a device with five electrodes but then proceeds to claim that the second and third electrodes are a singular/combined electrode. However, claim 12 then proceeds to describe how either the second or the third electrode forms a biosensor electrode; if claims 7-8 already noted that the second and the third electrode are one combined electrode, it is unclear to Examiner how dependent claim 12 can describe them as separate entities.
Claim 13 recites the limitation "wherein the combined BRE/EWE electrode is a biosensor counter electrode (BCE)” in lines 1-2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner the total number of electrodes required in the claim language given that, as explained above, claims 7-8 describes a device with five electrodes but then proceeds to claim that the second and third electrodes are a singular/combined electrode.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “third electrodes” on lines 1 and 11 of page 3 should not be plural. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the phrase “third electrodes” on lines 4 and 14 of page 5 should not be plural. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the phrase “monitoring the a concentration” on line 2 of page 4 contains an unnecessary “a”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the phrase “third electrodes” on line 19 and the last line of page 6 should not be plural. Appropriate correction is required.
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.
Claims 1-3, 6-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Challenor (W.O. Application No. 2020069572 A1), in view of Farrar (U.S. Patent No. 4281659 A), in view of Hunter (U.S. Patent No. 3120227 A), and further in view of Marston (W.O. Application No. 1989011819 A1).
Regarding independent claim 1, as best understood, Challenor discloses a fetal monitoring device (102) (pa. 0056, 0064 & Fig. 1) comprising five electrodes (310, 311, 502, 504, 506) for simultaneously monitoring a concentration of an analyte in a fetus and a heart rate of the fetus (pa. 0073, 0079 & Figs. 3, 9), wherein:
a) two electrodes of the five electrodes forming a biosensor (306) for monitoring the concentration of the analyte in the fetus wherein:
(i) a first electrode is a biosensor working electrode (BWE) (502), comprising a reactive substance (i.e., an immobilized enzyme),
(ii) a second electrode is a biosensor reference electrode (BRE) (504) (pa. 0073 & Figs. 3-4), wherein the second electrode (BRE) may be a Ag/AgCI electrode which provides a stable and reproducible potential to which the first electrode (BWE) electrode potential is compared (pa. 0073);
b) three electrodes of the five electrodes form an electrocardiogram (ECG) for monitoring the heart rate of the fetus wherein:
(iii) a third electrode is an electrocardiogram working electrode (EWE) (310) (pa. 0076),
(v) a fifth electrode (311) is an electrocardiogram electrode (pa. 0077),
c) a device body (302) for supporting the five electrodes, the device body being configured to contact a surface area (i.e., foetal scalp) of the fetus (pa. 0070);
wherein the first electrode (BWE) is not in physical contact with, or is electrically isolated from, the second electrode (BRE) (pa. 0077);
wherein the third electrode (EWE) is not in physical contact with the first electrode (BWE) (pa. 0077);
wherein the fifth electrode (EGE) is not in physical contact with the first electrode (BEW), second electrode (BRE), or third electrode (EWE) (pa. 0077);
wherein the fetal monitoring device is configured such that:
the first electrode (BWE), second electrode (BRE), and third electrodes (EWE) form one or more protrusions (304) that can be at least partially inserted into the fetal tissue (pa. 0072) so that (i) the analyte in the fetal tissue electrochemically reacts with the reactive substance of the first electrode (BWE) and in response to the electrochemical reaction the first electrode (BWE) of the biosensor detects an electronic signal, wherein a parameter of the electronic signal is indicative of the concentration of the analyte or a rate of change of concentration of the analyte (pa. 0107 & Fig. 14, see step 708); (ii) the third electrode (EWE) of the ECG detects the electrical activity of the fetal heart (pa. 0076); and (iii) when the device body contacts the surface area of the fetal tissue, the device body can be anchored to the fetal tissue using the one or more protrusions formed by the first electrode (BWE), second electrode (BRE), and third electrodes (EWE) as an anchor to secure the device body against the contacted surface area of the fetal tissue (pa. 0077, 0107 & Fig. 14, see step 706).
However, Challenor does not disclose the fourth electrode being an electrocardiogram reference electrode (ERE), nor wherein the fourth electrode (ERE) is not in physical contact with the first electrode (BWE), second electrode (BRE), or third electrodes (EWE).
Farrar, in the same field of endeavor, teaches a probe device for monitoring fetal ECG measurements during undergoing labor comprising an active electrode (5) and an ECG reference electrode (8) (Col. 8, lines 7-15 & Fig. 2A), where as seen in Fig. 2A, the reference electrode is not in physical contact with any other electrode in the probe.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the ECG reference electrode of Farrar in order provide the user with a method of assessing improper probe placement in the skin of the fetus (Farrar, Col. 5, lines 31-44).
However, Challenor/Farrar combination do not teach the fifth electrode (EGE) being a ground electrode connected externally to a mother.
Hunter, in the same field of endeavor, teaches a probe electrode made to pierce the scalp of the fetus in order to obtain the fetal electrocardiogram complex (Col. 1, lines 32-36), wherein an indifferent/grounding electrode is usually attached to the maternal right leg, using a standard electrocardiograph electrode (Col. 2, lines 44-47).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fifth ECG electrode of Challenor in order to be a ground electrode in order to allow background electrical noise to be filtered.
However, Challenor/Farrar/Hunter combination do not disclose wherein the second electrode (BRE) is also the third electrode (EWE) to form a combined BRE/EWE electrode.
Marston, in the same field of endeavor, teaches a fetal biosensing electrode (17) comprising a stainless-steel wire (10) (analogous to the third electrode (EWE) of Challenor), for measuring complex fetal ECG (page 5, lines 15-18), having a first coating layer of silver chloride, and then further coated with bio-compatible plastics material, e.g., "Tecoflex" (page 1, lines 9- 18).
Examiner is relying in the process of manufacturing the wire containing the silver chloride coating with the plastic top coat to indicate how the wire is capable of having both the functionalities of the third electrode (EWE) (since it can sense ECG signals) and of the second electrode (BRE) (since its made from the same silver chloride material as the second electrode (BRE) disclosed in the Challenor reference) in order to yield the combined BRE/EWE electrode. Additionally, Examiner highlights the manufacturing process to make the second electrode (BRE) as disclosed in the Specification of the instant application [pa. 0029] which specifically include a metal (e.g. stainless steel) which is then converted into a BRE/EWE by coating the conductive metal with a reference layer of silver/silver chloride. The silver/silver chloride reference layer allows for the creation of a stable reference voltage for the biosensor. The silver/silver chloride reference layer may then be coated with an additional protective layer (analogous to the Tecoflex layer of Marston) to protect the silver from mechanical damage during insertion of the spiral into the foetal tissue.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second electrode and the third electrode of Challenor with the wire of Marston in order to form a combined electrode with dual functionality and for the purpose of reducing in the number of cables/solder joints within the fetal monitoring device of Challenor.
Regarding claim 2, Challenor/Farrar/Hunter combination disclose wherein the analyte is a lactate analyte or an oxygen analyte (Challenor, pa. 0056).
Regarding claim 3, Challenor/Farrar/Hunter combination disclose wherein if (i) the analyte is a lactate analyte, the reactive substance of the first electrode is an immobilized enzyme (Challenor, pa. 0073 & Figs. 3-4).
Regarding claims 6 and 13, Challenor/Farrar/Hunter combination disclose the invention substantially as claimed in claims 1, 7-8 and discussed above.
However, they do not disclose wherein the combined BRE/EWE electrode is a biosensor counter electrode (BCE).
Marston, in the same field of endeavor, teaches the stainless-steel wire (10), for measuring complex fetal ECG (page 5, lines 15-18), having a first coating layer of silver chloride, and then further coated with bio-compatible plastics material, e.g., "Tecoflex" (page 1, lines 9- 18), wherein the combined BRE/EWE electrode is a biosensor counter electrode (BCE).
Examiner is relying in the process of manufacturing the wire containing the silver chloride coating with the plastic top coat to indicate how the wire is capable of having both the functionalities of the third electrode (EWE) (since it can sense ECG signals) and of the second electrode (BRE) (since its made from the same silver chloride material as the second electrode (BRE) disclosed in the Challenor reference) in order to yield the combined BRE/EWE electrode. Additionally, Examiner highlights the manufacturing process to make the second electrode (BRE) as disclosed in the Specification of the instant application [pa. 0029] which specifically include a metal (e.g. stainless steel) which is then converted into a BRE/EWE by coating the conductive metal with a reference layer of silver/silver chloride. The silver/silver chloride reference layer allows for the creation of a stable reference voltage for the biosensor. The silver/silver chloride reference layer may then be coated with an additional protective layer (analogous to the Tecoflex layer of Marston) to protect the silver from mechanical damage during insertion of the spiral into the foetal tissue.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second electrode and the third electrode of Challenor with the wire of Marston in order to form a combined electrode with dual functionality and for the purpose of reducing in the number of cables/solder joints within the fetal monitoring device of Challenor.
Regarding independent claim 7, as best understood, Challenor discloses a system for simultaneously monitoring a concentration of an analyte in a fetus and a heart rate of the fetus (pa. 0056 & Fig. 1), the system comprising:
A. a fetal monitoring device (102) (pa. 0056) comprising five electrodes (310, 311, 502, 504, 506) (pa. 0073, 0079 & Figs. 3, 9), wherein:
a) two electrodes of the five electrodes form a biosensor (306) for monitoring the a concentration of an analyte in the fetus, wherein:
(i) a first electrode is a biosensor working electrode (BWE) (502), comprising a reactive substance (i.e., an immobilized enzyme),
(ii) a second electrode is a biosensor reference electrode (BRE) (504) (pa. 0073 & Figs. 3-4), wherein the second electrode (BRE) may be a Ag/AgCI electrode which provides a stable and reproducible potential to which the first electrode (BWE) electrode potential is compared (pa. 0073);
b) three electrodes of the five electrodes form an electrocardiogram (ECG) for monitoring heart rate of the fetus, wherein:
(iii) a third electrode is an electrocardiogram working electrode (EWE) (310) (pa. 0076),
(v) a fifth electrode (311) is an electrocardiogram electrode (pa. 0077),
c) a device body (302) for supporting the five electrodes, the device body being configured to contact a surface area (i.e., foetal scalp) of fetus (pa. 0070);
B. an analysis component (106) in electronic communication with the biosensor and/or the ECG, the analysis component being configured to determine the concentration of the analyte and/or the fetal heart rate using the detected electronic signal of the biosensor and/or ECG (pa. 0074 & Fig. 1)
wherein the first electrode (BWE) is not in physical contact with, or is electrically isolated from, the second electrode (BRE) (pa. 0077);
wherein the third electrode (EWE) is not in physical contact with the first electrode (BWE) (pa. 0077);
wherein the fifth electrode (EGE) is not in physical contact with the first electrode (BWE), second electrode (BRE), or third electrode (EWE) (pa. 0077);
wherein the fetal monitoring device is configured such that:
the first electrode (BWE), second electrode (BRE), or third electrodes (EWE) form one or more protrusions (304) that can be at least partially inserted into the fetal tissue (pa. 0072) so that (i) the analyte in the fetal tissue electrochemically reacts with the reactive substance of the first electrode (BWE) and in response to the electrochemical reaction the first electrode (BWE) of the biosensor detects an electronic signal, wherein a parameter of the electronic signal is indicative of the concentration of the analyte or a rate of change of concentration of the analyte (pa. 0107 & Fig. 14, see step 708); (ii) the third electrode (EWE) of the ECG detects the electrical activity of the fetal heart (pa. 0076); and (iii) when the device body contacts the surface area of the fetal tissue, the device body can be anchored to the fetal tissue using the one or more protrusions formed by the first electrode (BWE), second electrode (BRE), and third electrodes (EWE) as an anchor to secure the device body against the contacted surface area of the fetal tissue (pa. 0077, 0107 & Fig. 14, see step 706).
However, Challenor does not disclose the fourth electrode being an electrocardiogram reference electrode (ERE) for monitoring the heart rate of the fetus, nor wherein the fourth electrode is not in physical contact with the first electrode (BWE), second electrode (BRE), or third electrodes (EWE).
Farrar, in the same field of endeavor, teaches a probe device for monitoring fetal ECG measurements during undergoing labor comprising an active electrode (5) and an ECG reference electrode (8) (Col. 8, lines 7-15 & Fig. 2A), where as seen in Fig. 2A, the reference electrode is not in physical contact with any other electrode in the probe.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the ECG reference electrode of Farrar in order provide the user with a method of assessing improper probe placement in the skin of the fetus (Farrar, Col. 5, lines 31-44).
However, Challenor/Farrar combination do not teach the fifth electrode being a ground electrode (EGE) connected externally to a mother, for monitoring the heart rate of the fetus.
Hunter, in the same field of endeavor, teaches a probe electrode made to pierce the scalp of the fetus in order to obtain the fetal electrocardiogram complex (Col. 1, lines 32-36), wherein an indifferent/grounding electrode is usually attached to the maternal right leg, using a standard electrocardiograph electrode (Col. 2, lines 44-47) for monitoring the heart rate of the foetus (Col. 2, lines 66-71).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fifth ECG electrode of Challenor in order to be a ground electrode in order to allow background electrical noise to be filtered.
However, Challenor/Farrar/Hunter combination do not disclose wherein the second electrode (BRE) is also the third electrode (EWE) to form a combined BRE/EWE electrode.
Marston, in the same field of endeavor, teaches a fetal biosensing electrode (17) comprising a stainless-steel wire (10) (analogous to the third electrode (EWE) of Challenor), for measuring complex fetal ECG (page 5, lines 15-18), having a first coating layer of silver chloride, and then further coated with bio-compatible plastics material, e.g., "Tecoflex" (page 1, lines 9- 18).
Examiner is relying in the process of manufacturing the wire containing the silver chloride coating with the plastic top coat to indicate how the wire is capable of having both the functionalities of the third electrode (EWE) (since it can sense ECG signals) and of the second electrode (BRE) (since its made from the same silver chloride material as the second electrode (BRE) disclosed in the Challenor reference) in order to yield the combined BRE/EWE electrode. Additionally, Examiner highlights the manufacturing process to make the second electrode (BRE) as disclosed in the Specification of the instant application [pa. 0029] which specifically include a metal (e.g. stainless steel) which is then converted into a BRE/EWE by coating the conductive metal with a reference layer of silver/silver chloride. The silver/silver chloride reference layer allows for the creation of a stable reference voltage for the biosensor. The silver/silver chloride reference layer may then be coated with an additional protective layer (analogous to the Tecoflex layer of Marston) to protect the silver from mechanical damage during insertion of the spiral into the foetal tissue.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second electrode and the third electrode of Challenor with the wire of Marston in order to form a combined electrode with dual functionality and for the purpose of reducing in the number of cables/solder joints within the fetal monitoring device of Challenor.
Regarding independent claim 8, as best understood, Challenor discloses a method (700) for simultaneously monitoring a concentration of an analyte in a fetus and a heart rate of the fetus (pa. 0073, 0079, 0107 & Figs. 1 and 14), the method comprising the steps of:
I. providing a device (102) comprising five electrodes (310, 311, 502, 504, 506) (pa. 0073, 0079 & Figs. 3, 9), wherein:
a) two electrodes of the five electrodes form a biosensor (306) for monitoring the concentration of the analyte in the fetus wherein:
(i) a first electrode is a biosensor working electrode (BWE) (502), comprising a reactive substance (i.e., an immobilized enzyme),
(ii) a second electrode is a biosensor reference electrode (BRE) (504) (pa. 0073 & Figs. 3-4), wherein the second electrode (BRE) may be a Ag/AgCI electrode which provides a stable and reproducible potential to which the first electrode (BWE) electrode potential is compared (pa. 0073);
b) three electrodes of the five electrodes form an electrocardiogram (ECG) for monitoring the heart rate of the fetus wherein:
(iii) a third electrode is an electrocardiogram working electrode (EWE) (310) (pa. 0076),
(v) a fifth electrode (311) is an electrocardiogram electrode (pa. 0077),
c) a device body (302) for supporting the five electrodes, the device body being configured to contact a surface area (i.e., foetal scalp) of the fetus (pa. 0070);
wherein the first electrode (BWE) is not in physical contact with, or is electrically isolated from, the second electrode (BRE) (pa. 0077);
wherein the third electrode (EWE) is not in physical contact with the first electrode (BWE) (pa. 0077);
wherein the fifth electrode (EGE) is not in physical contact with the first electrode (BWE), second electrode (BRE), or third electrode (EWE) (pa. 0077);
wherein the fetal monitoring device is configured such that:
the first electrode (BWE), second electrode (BRE), and third electrodes (EWE) form one or more protrusions (304) that can be at least partially inserted into the fetal tissue (pa. 0072) so that (i) the analyte in the fetal tissue electrochemically reacts with the reactive substance of the first electrode (BWE) and in response to the electrochemical reaction the first electrode (BWE) of the biosensor detects an electronic signal, wherein a parameter of the electronic signal is indicative of the concentration of the analyte or a rate of change of concentration of the analyte (pa. 0107 & Fig. 14, see step 708); (ii) the third electrode (EWE) of the ECG detects the electrical activity of the fetal heart (pa. 0076); and (iii) when the device body contacts the surface area of the fetal tissue, the device body can be anchored to the fetal tissue using the one or more protrusions formed by the first electrode (BWE), second electrode (BRE), and third electrodes (EWE) as an anchor to secure the device body against the contacted surface area of the fetal tissue (pa. 0077, 0107 & Fig. 14, see step 706).
II. inserting the protrusion at least partially into fetal tissue wherein when the protrusion has been at least partially inserted into the fetal tissue it anchors the device to the fetal tissue (pa. 0107, see steps 704-706); and
III. detecting an electronic signal at the electrode of the biosensor, the electronic signal being in response to an electrochemical reaction between the reactive substance of the biosensor and the analyte to be monitored and/or the electronic signal being in response to the electrical activity of the fetal heart as measured by the ECG (pa. 0107, see step 708);
wherein the method is conducted such that the detected electronic signal is indicative of the concentration of the analyte in the fetus and/or the heart rate of the fetus (pa. 0107).
However, Challenor does not disclose the fourth electrode being an electrocardiogram reference electrode (ERE), nor wherein the fourth electrode is not in physical contact with the first electrode (BWE), second electrode (BRE), or third electrode (EWE).
Farrar, in the same field of endeavor, teaches a probe device for monitoring fetal ECG measurements during undergoing labor comprising an active electrode (5) and an ECG reference electrode (8) (Col. 8, lines 7-15 & Fig. 2A), where as seen in Fig. 2A, the reference electrode is not in physical contact with any other electrode in the probe.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the ECG reference electrode of Farrar in order provide the user with a method of assessing improper probe placement in the skin of the fetus (Farrar, Col. 5, lines 31-44).
However, Challenor/Farrar combination do not teach the fifth electrode being a ground electrode (EGE) connected externally to the mother.
Hunter, in the same field of endeavor, teaches a probe electrode made to pierce the scalp of the fetus in order to obtain the fetal electrocardiogram complex (Col. 1, lines 32-36), wherein an indifferent/grounding electrode is usually attached to the maternal right leg, using a standard electrocardiograph electrode (Col. 2, lines 44-47).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fifth ECG electrode of Challenor in order to be a ground electrode in order to allow background electrical noise to be filtered.
However, Challenor/Farrar/Hunter combination do not disclose wherein the second electrode (BRE) is also the third electrode (EWE) to form a combined BRE/EWE electrode.
Marston, in the same field of endeavor, teaches a fetal biosensing electrode (17) comprising a stainless-steel wire (10) (analogous to the third electrode (EWE) of Challenor), for measuring complex fetal ECG (page 5, lines 15-18), having a first coating layer of silver chloride, and then further coated with bio-compatible plastics material, e.g., "Tecoflex" (page 1, lines 9- 18).
Examiner is relying in the process of manufacturing the wire containing the silver chloride coating with the plastic top coat to indicate how the wire is capable of having both the functionalities of the third electrode (EWE) (since it can sense ECG signals) and of the second electrode (BRE) (since its made from the same silver chloride material as the second electrode (BRE) disclosed in the Challenor reference) in order to yield the combined BRE/EWE electrode. Additionally, Examiner highlights the manufacturing process to make the second electrode (BRE) as disclosed in the Specification of the instant application [pa. 0029] which specifically include a metal (e.g. stainless steel) which is then converted into a BRE/EWE by coating the conductive metal with a reference layer of silver/silver chloride. The silver/silver chloride reference layer allows for the creation of a stable reference voltage for the biosensor. The silver/silver chloride reference layer may then be coated with an additional protective layer (analogous to the Tecoflex layer of Marston) to protect the silver from mechanical damage during insertion of the spiral into the foetal tissue.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second electrode and the third electrode of Challenor with the wire of Marston in order to form a combined electrode with dual functionality and for the purpose of reducing in the number of cables/solder joints within the fetal monitoring device of Challenor.
Regarding claim 9, Challenor/Farrar/Hunter combination disclose wherein the analyte is a lactate analyte or an oxygen analyte (Challenor, pa. 0056).
Regarding claim 10, Challenor/Farrar/Hunter combination disclose wherein if (i) the analyte is a lactate analyte, the reactive substance of the first electrode is an immobilized enzyme (Challenor, pa. 0073 & Figs. 3-4).
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Challenor, Farrar, Hunter, and Marston as applied to claims 1, 7-8 above, and further in view of Shults (U.S. Application No. 20080086273 A1).
Regarding claims 5 and 12, Challenor/Farrar/Hunter/Marston combination disclose the invention substantially as claimed in claims 1, 7-8 and discussed above.
However, they do not disclose wherein either the second electrode (BRE) or the third electrode (EWE) is also a biosensor counter electrode (BCE).
Shults, in the same field of endeavor, teaches an analyte sensor comprising a reference electrode (346), which can function as a reference electrode alone, or as a dual reference and counter electrode (pa. 0276, 0283).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second electrode of Challenor in order to have dual functions of a reference and a counter electrode as taught by Shults for the purpose of reducing in the number of cables/solder joints within the monitoring device.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive.
With regards to independent claims 1, 7-8, Applicant argues that the newly amended language (including features from the now cancelled claims 4 and 11) are not taught by the Challenor, Farrar, Hunter, in view of Marston reference. Specifically, Applicant contends that the Marston reference does not teach a combined BRE/EWE electrode, as the single electrode functions of Marston acts as an ECG pickup, and there is no mention of electrochemical detection such that the electrode could have a BRE function. However, Examiner, respectfully, disagrees.
The Challenor reference discloses the second electrode (BRE) (504), which is a reference electrode that is part of biosensor (306) which monitors the concentration of the analyte in the fetus, wherein the second electrode (BRE) is a Ag/AgC electrode which provides a stable and reproducible potential to which the working electrode/the first electrode (BEW) potential is compared (pa. 0073). Furthermore, Challenor discloses the third electrode (EWE) (310) is a fetal electrode for detecting a heart rate of the fetus (pa. 0076). The Challenor reference did not disclose a combined BRE/EWE electrode. Examiner utilized the Marston reference to teach a fetal monitoring electrode (17) comprising a stainless-steel wire (10) for measuring complex fetal ECG (page 5, lines 15-18), wherein the wire contains a coating of silver chloride (15) (page 1, lines 9-18). Examiner was relying in the process of manufacturing the wire (analogous to the working electrode (EWE) of Challenor since it can aid in sensing ECG signals) with the silver chloride coating (i.e., the same material used to make the second electrode (BRE) in the Challenor reference), to yield the combined BRE/EWE electrode which can sense ECG signals and is coated with the silver chloride material that allows it to provide a stable and reproducible potential for the first electrode (BEW). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second and the third electrode of Challenor with the wire of Marston in order to form a combined BRE/EWE electrode for the purpose of reducing in the number of cables/solder joints within the fetal monitoring device of Challenor.
Furthermore, Examiner highlights the Specifications of the instant application where a similar manufacturing process is disclosed in [pa. 0029] which reads, “The EWE may be made from a conductive biologically compatible non-toxic material such as: a metal (e.g. stainless steel, silver, titanium) or a biological or synthetic non-metallic conductive material. The EWE is then converted into a BRE/EWE by coating the conductive metal spiral with a reference layer of silver/silver chloride. The silver/silver chloride reference layer allows for the creation of a stable reference voltage for the biosensor. The silver/silver chloride reference layer may then be coated with an additional protective layer to protect the silver from mechanical damage during insertion of the spiral into the foetal tissue” (Emphasis added by Examiner). It is clear from the instant disclosure that the method steps involved in creating the combined BRE/EWE electrode is similar to the method steps taught by Marston. Therefore, the rejection set-forth above using the combination of references disclosed is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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