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 amendment filed October 17, 2025 has been entered. Claims 2 and 14 have been cancelled, and claims 1, 9, and 13 have been amended. Claims 15-20 are new. Claims 1, 3-13, and 15-20 are pending in this application.
Response to Arguments
Applicant’s arguments, see pgs. 13-14, filed October 17, 2025, with respect to the rejection(s) of claim(s) 1, 9, and 13 under 35 USC 103 over Hafezi in view of Yoo have been fully considered and are persuasive. Claims 1, 9, and 13 have been amended to include claim limitations from cancelled claims 2 and 14. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ward (US 2008/0319336, previously cited).
As elaborated in the rejection below, Hafezi in view of Yoo, and Ward teaches or suggests using a Cole-Cole plot to find an optimal electrode combination involving a maximal change in a value of capacitance.
Regarding dependent claims, Applicant relies on the same arguments, and the dependent claims are also rejected under the new grounds of rejection.
Claim Interpretation
Claims 1, 9, and 13 recite “a capacitive component in a predetermined resistive component in at least one of the created Cole-Cole plots is included in a range of a predetermined threshold value.”
Applicant’s specification indicates “the impedance of the living body has predetermined values in the capacitive component and the resistive component,” (par. 60) and “when a current having an intermediate frequency…is applied, the capacitive component and the resistive component each have a predetermined value” (par. 61). Additionally, the specification indicates “using a value of a capacitive component in a predetermined resistance value component as an index. For example, the control unit 11 may determine one combination using a value of a capacitive component at a center of the Cole-Cole plot as the index…the control unit 11 may determine, for example, a combination having the highest value of the capacitive component at the center of the Cole-Cole plot,” (par. 64).
From the disclosure, it seems that an ideal combination of electrodes is indicated by the value of maximum capacitance in the Cole-Cole plot. “A capacitive component in a predetermined resistive component” seems to refer to that the maximum capacitance is generally found in the middle of the Cole-Cole plot, which falls into a range of resistance values. The specification further recites “the predetermined threshold value is a threshold value indicating an allowable range for measuring the impedance of the living body,” (par. 71). So the phrasing “a capacitive component…included in a range of a predetermined threshold value” is interpreted as a capacitive component of a Cole-Cole plot, which falls within a range of resistance values, satisfying a threshold, which further indicates the accuracy of the combination of electrodes.
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.
Claim 1, 3-5, 8-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hafezi (WO 2018/053045, cited previously) in view of Yoo (US 2016/0296135, cited previously) and Ward (US 2008/031936, cited previously).
Regarding claims 1 and 13, Hafezi teaches a measurement device (breast sense patch 34, Fig. 1) capable of executing measurement processing of impedance of a living body by applying alternating current to the living body (“An applied sinusoidal or square wave current (typically < 1 mA) will produce a voltage detected by electrode on the breast. The voltage will provide a direct measure of the impedance,” par. 35), the measurement device comprising:
three or more electrodes (electrodes 58 and/or electrodes 56, Fig. 4B); and
a control unit (impedance sensor circuit 8 and microprocessor 12) configured to control application of an alternating current (“the impedance circuit applies a voltage suitable for driving the desired current through the body, measures the resulting current flow and the voltage at the sense electrodes simultaneously, then processes the data to derive the desired output and transmit this information to the microprocessor 12,” par. 83), wherein the control unit is further configured to: measure the impedance of the living body when a current is applied to the living body for a predetermined plurality of combinations of electrodes constituted by a plurality of electrodes selected from the three or more electrodes (“the drive current is still driven through electrodes 56. However, in this case it is possible to sense between different pairs of electrodes among the sense electrodes 58,” par. 118), and determine one combination to be used for the measurement processing of impedance of the living body among the predetermined plurality of combinations based on the measured impedance (“with multiple electrodes, there is the option of sensing different combination of electrodes and picking the one that gives the most signal,” par. 120); and perform the measurement processing using only the determined one combination (“picking the one that gives the most signal,” par. 120; “one pair of electrodes is more sensitive during the first few days of feeding after birth,” par. 122; “optimization of sensing,” par. 126),
wherein the control unit applies a plurality of alternating currents having different frequencies to the living body (“the impedance sensor typically operates at one or more frequencies in the range of about 0.1 to 1 MHz, such as about 1 to 100 kHz,” par. 161) and measures a resistive component and a capacitive component of the impedance of the living body (“it is understood by those skilled in the art that biological impedance data can usually be fit to multiple theoretical models or equivalent circuits to obtain resistor and capacitor values,” par. 160).
Hafezi explicitly teaches or suggests all limitations of claim 1 and 13 except for the predetermined plurality of combinations of electrodes including different combinations of electrodes that apply alternating current, plotting the resistive and capacitive components in a Cole-Cole plot for each of the combinations, and determines one combination to be used for the measurement processing of impedance of the living body among the predetermined plurality of combinations using a value of a capacitive component in a predetermined resistive component in at least one of the created Cole-Cole plots is included in a range of a predetermined threshold value.
Regarding the plurality of combinations of electrodes, Hafezi further teaches that the number of electrodes can be modified to achieve a desired sensitivity (“It is always possible add more electrodes to the Breast Sense Feeding Monitor system…an increased number of electrodes, while increasing sensitivity…the ordinary skilled artisan will consider design parameters for the end use to optimize effects and balance these considerations,” para. 139).
Yoo teaches an analogous electrode array that can measure the impedance of the breast tissue (Fig. 1; “measures impedance, i.e., an electrical signal, of the skin of a measurement target placed between the plurality of electrodes,” para. 13). Yoo further teaches applying alternating current to a pair of electrodes (“current generation unit 530 generates alternating current,” para. 71; “a certain current generated through the current generation unit 530 is applied to any one pair of electrodes 235,” para. 111) and measuring an impedance for a predetermined plurality of combinations of electrodes including different combinations of electrodes that apply the current to create a map of the tissue impedance (“the voltage sensor unit 540 measures voltage between the electrodes 235 of the pairs other than the pair of electrodes 235 to which the current is applied,” para. 112; “an impedance matrix of all impedance values can be obtained by repeatedly performing this process on the electrodes 235 of the other pairs,” para. 115).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi to include more electrodes, output current from different pairs of electrodes and measure impedances from combinations including the different pairs of electrodes outputting current to select an optimal sensing combination. One would be motivated to do so because Hafezi already suggests such an arrangement (“Another advantage to having multiple electrodes in the Breast Sense Feeding Monitor system 2 is that the system can *sense* through different pairs of electrodes in the 58 group, and generally map the location of optimal sensitivity by interpolating the signal,” par. 125; “this optional mapping function allows the potential for optimization of sensing,” par. 126). Since Hafezi doesn’t explicitly show a multiple electrode arrangement, one may further be motivated to look at known arrangements in the art, such as Yoo’s disclosure of multiple electrodes for measuring impedance (Fig. 3; “the present invention as described above may stably measure impedance of any curved part of a body,” para. 119). Since Hafezi already teaches that more electrodes can be used to gain higher resolution (“an increased number of electrodes, while increasing sensitivity…the ordinary skilled artisan will consider design parameters for the end use to optimize effects and balance these considerations,” para. 139; “to facilitate this mapping capability, more than four electrodes can be provided under 58,” para. 125), this modification should yield successful results.
Regarding the Cole-Cole plots, Hafezi also teaches that is advantageous to select the electrode that gives the largest change for capacitance (“It is advantageous to select the electrode that gives largest change for capacitance. The system interpolate electrode readings to get highest change data, providing breast volume and mapping the breast,” par. 38).
Ward teaches an analogous method of using impedance to detect fluid in the body, specifically tissue edema (Abstract). Ward teaches a Cole-Cole plot, which plots resistance and reactance, can be used to determine a peak and further used to quantify fluid in the body (“Another important value is the impedance Zc at the peak of the locus in FIG, 2,” par. 137; “take impedance measurements at multiple frequencies and to construct a section of a Cole-Cole plot. The plot can be extrapolated to determine Zc,” par. 138; “Once the values of R0, R∞, and Zc are determined they can be used…to detect and quantify oedema,” par. 142). The reactance is indicative of capacitance, as evidenced by Hayn (US 2014/0296662, cited previously – “a resistance value and a reactance value being determined from the impedance measurement…The reactance describes the capacitive proportion of the measurement,” par. 6).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi in view of Yoo to plot the measured resistance and reactance components of impedance measurements from different combinations of electrodes at different frequencies in Cole-Cole plots to determine peaks of the Cole-Cole plots, as taught by Ward par. 138. One would be motivated to do so because Hafezi paragraph 38 indicates that it is desirable to select electrodes based on the measurement that “gives the largest change for capacitance” and that the system may “interpolate electrode readings to get the highest change data” but does not explicitly teach or suggest how the change data is determined from the electrode readings. Thus, one would be motivated to look at known methods in the art for determining an impedance measurement which provides the largest change in capacitance, such as the method of determining the impedance at the peak of Cole-Cole plot as taught by Ward paragraph 138. This additional analysis could be carried out with a reasonable expectation of success because Hafezi already teaches interpolating electrode data and analyzing the imaginary part or capacitance portion of the impedance measurement (paras. 38, 160).
Regarding claim 3, Hafezi teaches the electrodes are disposed on a mounting tool configured to be mounted on a user of the measurement device (Fig. 2A; “The sensing patch length can be designed to balance comfort with functionality. Typically, the sensing patch has a form factor similar to a bandage,” par. 22).
Regarding claim 4, Hafezi teaches the combination of the electrodes includes two electrodes selected from the three or more electrodes (“driving through electrode first electrode 20 and fourth electrode 26, and actually sensing with those same electrodes,” para. 117).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi in view of Yoo and Ward to use bipolar measurements to drive current and measure impedance between various electrodes. One would be motivated to do so because Hafezi explicitly suggests such measurements in a different embodiment and further suggests that bipolar measurements may be alternated with tetrapolar measurements (“driving through electrode first electrode 20 and fourth electrode 26, and actually sensing with those same electrodes…the system can move fluidly between any of these modes,” para. 117). Since this is explicitly disclosed as an alternative embodiment, modification of Hafezi and Yoo to use different electrode pairs for a bipolar impedance measurement should yield a successful impedance measurement.
Regarding claim 5, Hafezi and Yoo teach five or more of the electrodes are provided (both drive electrodes 56 and sense electrodes 58 can be interpreted as the plurality of electrodes, Hafezi Fig. 4B; Yoo Fig. 3-4 teaches an array of electrodes), and the combination of the electrodes includes four electrodes selected from the five or more electrodes (Hafezi teaches selecting drive electrodes 56 and some pair of sense electrodes 58: “it is possible to sense between different pairs of electrodes among the sense electrodes 58,” par. 118; “the voltage sensor unit 540 measures voltage between the electrodes 235 of the pairs other than the pair of electrodes 235 to which the current is applied,” Yoo para. 112).
Regarding claim 8, Hafezi teaches the predetermined plurality of combinations are include several combinations that the three or more electrodes are capable of taking (“the drive electrodes could be used to do sensing as well,” par. 116; “it is possible to sense between different pairs of electrodes among the sense electrodes 58,” par. 118). Yoo teaches sensing between all pairs of electrodes in an array, thus using every combination of four electrodes among the electrodes 235 (“the voltage sensor unit 540 measures voltage between the electrodes 235 of the pairs other than the pair of electrodes 235 to which the current is applied,” para. 112; “an impedance matrix of all impedance values can be obtained by repeatedly performing this process on the electrodes 235 of the other pairs,” para. 115).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi in view of Yoo and Ward to measure using every combination that the three or more electrodes are capable of taking. One would be motivated to do so because Hafezi and Yoo teaches this arrangement maps the impedances in the array and optimizes sensing (“after calculating an impedance matrix, the external device may calculate distribution of impedance inside the skin…display an impedance tomographic image according to depth of the skin using the distribution of impedance,” Yoo para. 40; “this optional mapping function allows the potential for optimization of sensing,” Hafezi par. 126). One would further be motivated to do so because Hafezi explicitly teaches measurement modes may be switched (“driving through electrode first electrode 20 and fourth electrode 26, and actually sensing with those same electrodes…driving with first electrode 20 and fourth electrode 26, and sensing with second electrode 22 and third electrode 24. The system can move fluidly between any of these modes,” para. 117). Thus, modification of Hafezi and Yoo to use every possible combination of electrodes to measure impedance would find the most sensitive electrodes and optimize sensing (“to facilitate mapping capability, more than four electrodes can be provided under 58,” Hafezi para. 125).
Regarding claim 9, Hafezi teaches a measurement system (Fig. 1) including a measurement device (breast sense patch 34) and an information processing device (mobile phone 38),
wherein the measurement device includes three or more electrodes (electrodes 58 and/or electrodes 56, Fig. 4B), and a communication unit (Bluetooth chip 18) configured to transmit, to the information processing device (“the functions provided by the circuitry in first layer 4 is provided in said cell phone 38. In other embodiments…the raw or partially processed data from the sensors in second layer 6 is transmitted to the cloud, processed, and then returned to the cell phone to be displayed to the user,” par. 90), a result of measurement of impedance of a living body when an alternating current is applied to the living body (“An applied sinusoidal or square wave current (typically < 1 mA) will produce a voltage detected by electrode on the breast. The voltage will provide a direct measure of the impedance,” para. 35) for a predetermined plurality of combinations of electrodes constituted by a plurality of electrodes selected from the three or more electrodes (“the drive current is still driven through electrodes 56. However, in this case it is possible to sense between different pairs of electrodes among the sense electrodes 58,” par. 118; “the impedance circuit…then processes the data to derive the desired output and transmit this information to the microprocessor 12,” par. 83), and
the information processing device includes a control unit (a mobile phone 38 comprises microprocessor 12: “functions provided by the circuitry in first layer 4 is provided in said cell phone 38,” par. 90) configured to determine one combination to be used for measurement processing of the impedance of the living body among the predetermined plurality of combinations based on the result of measurement of the impedance of the living body (“with multiple electrodes, there is the option of sensing different combination of electrodes and picking the one that gives the most signal,” par. 120), and to perform the measurement processing using only the determined one combination (“picking the one that gives the most signal,” par. 120; “one pair of electrodes is more sensitive during the first few days of feeding after birth,” par. 122; “optimization of sensing,” par. 126).
Hafezi explicitly teaches or suggests all limitations of claim 1 and 13 except for the predetermined plurality of combinations of electrodes including different combinations of electrodes that apply alternating current, plotting the resistive and capacitive components in a Cole-Cole plot for each of the combinations, and determines one combination to be used for the measurement processing of impedance of the living body among the predetermined plurality of combinations using a value of a capacitive component in a predetermined resistive component in at least one of the created Cole-Cole plots is included in a range of a predetermined threshold value.
Regarding the plurality of combinations of electrodes, Hafezi teaches that the number of electrodes can be modified to achieve a desired sensitivity (“It is always possible add more electrodes to the Breast Sense Feeding Monitor system…an increased number of electrodes, while increasing sensitivity…the ordinary skilled artisan will consider design parameters for the end use to optimize effects and balance these considerations,” para. 139).
Yoo teaches an analogous electrode array that can measure the impedance of the breast tissue (Fig. 1; “measures impedance, i.e., an electrical signal, of the skin of a measurement target placed between the plurality of electrodes,” para. 13). Yoo further teaches applying alternating current to a pair of electrodes (“current generation unit 530 generates alternating current,” para. 71; “a certain current generated through the current generation unit 530 is applied to any one pair of electrodes 235,” para. 111) and measuring an impedance for a predetermined plurality of combinations of electrodes including different combinations of electrodes that apply the current to create a map of the tissue impedance (“the voltage sensor unit 540 measures voltage between the electrodes 235 of the pairs other than the pair of electrodes 235 to which the current is applied,” para. 112; “an impedance matrix of all impedance values can be obtained by repeatedly performing this process on the electrodes 235 of the other pairs,” para. 115).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi to include more electrodes, output current from different pairs of electrodes and measure impedances from combinations including the different electrodes outputting current to select an optimal sensing combination. One would be motivated to do so because Hafezi already suggests such an arrangement (“Another advantage to having multiple electrodes in the Breast Sense Feeding Monitor system 2 is that the system can *sense* through different pairs of electrodes in the 58 group, and generally map the location of optimal sensitivity by interpolating the signal,” par. 125; “this optional mapping function allows the potential for optimization of sensing,” par. 126). Since Hafezi doesn’t explicitly show a multiple electrode arrangement, one may further be motivated to look at known arrangements in the art, such as Yoo’s disclosure of multiple electrodes for measuring impedance (Fig. 3; “the present invention as described above may stably measure impedance of any curved part of a body,” para. 119). Since Hafezi already teaches that more electrodes can be used to gain higher resolution (“an increased number of electrodes, while increasing sensitivity…the ordinary skilled artisan will consider design parameters for the end use to optimize effects and balance these considerations,” para. 139; “to facilitate this mapping capability, more than four electrodes can be provided under 58,” para. 125), this modification should yield successful results.
Regarding the Cole-Cole plots, Hafezi also teaches that is advantageous to select the electrode that gives the largest change for capacitance (“It is advantageous to select the electrode that gives largest change for capacitance. The system interpolate electrode readings to get highest change data, providing breast volume and mapping the breast,” par. 38).
Ward teaches an analogous method of using impedance to detect fluid in the body, specifically tissue edema (Abstract). Ward teaches a Cole-Cole plot, which plots resistance and reactance, can be used to determine a peak and further used to quantify fluid in the body (“Another important value is the impedance Zc at the peak of the locus in FIG, 2,” par. 137; “take impedance measurements at multiple frequencies and to construct a section of a Cole-Cole plot. The plot can be extrapolated to determine Zc,” par. 138; “Once the values of R0, R∞, and Zc are determined they can be used…to detect and quantify oedema,” par. 142). The reactance is indicative of capacitance, as evidenced by Hayn (US 2014/0296662, cited previously – “a resistance value and a reactance value being determined from the impedance measurement…The reactance describes the capacitive proportion of the measurement,” par. 6).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi in view of Yoo to plot the measured resistance and reactance components of impedance measurements from different combinations of electrodes at different frequencies in Cole-Cole plots to determine peaks of the Cole-Cole plots, as taught by Ward par. 138. One would be motivated to do so because Hafezi paragraph 38 indicates that it is desirable to select electrodes based on the measurement that “gives the largest change for capacitance” and that the system may “interpolate electrode readings to get the highest change data” but does not explicitly teach or suggest how the change data is determined from the electrode readings. Thus, one would be motivated to look at known methods in the art for determining an impedance measurement which provides the largest change in capacitance, such as the method of determining the impedance at the peak of Cole-Cole plot as taught by Ward paragraph 138. This additional analysis could be carried out with a reasonable expectation of success because Hafezi already teaches interpolating electrode data and analyzing the imaginary part or capacitance portion of the impedance measurement (paras. 38, 160).
Regarding claim 10, Hafezi teaches the electrodes are disposed on a mounting tool configured to be mounted on a user of the measurement device (Fig. 2A; “The sensing patch length can be designed to balance comfort with functionality. Typically, the sensing patch has a form factor similar to a bandage,” par. 22).
Regarding claim 11, Hafezi teaches the combination of the electrodes includes two electrodes selected from the three or more electrodes (“driving through first electrode 20 and fourth electrode 26, and actually sensing with those same electrodes,” par. 117; “it is possible to sense between different pairs of electrodes among the sense electrodes 58,” par. 118).
Regarding claim 12, Hafezi teaches five or more of the electrodes are provided (both drive electrodes 56 and sense electrodes 58 can be interpreted as the plurality of electrodes, Fig. 4B), and the combination of the electrodes includes four electrodes selected from the five or more electrodes (Hafezi teaches selecting drive electrodes 56 and some pair of sense electrodes 58: “it is possible to sense between different pairs of electrodes among the sense electrodes 58,” par. 118).
Regarding claims 15-20, Hafezi teaches the control unit repeats the processing until it is determined that there is a combination suitable for measuring the impedance of the living body and when it is determined that there is no combination suitable for measuring the impedance of the living body for all the combinations of electrodes that can be taken, the control unit determines one combination most suitable for measuring the impedance of the living body from all the combinations that can be taken as the one combination to be used for the measurement processing of the impedance of the living body (“Another advantage to having multiple electrodes in the Breast Sense Feeding Monitor system 2 is that the system can *sense* through different pairs of electrodes…With sensing from different pairs of electrodes map, the less sensitive spots could be identified, narrowing down to the most sensitive spot…To facilitate this mapping capability, more than four electrodes can be provided under 58,” par. 125; “This optional mapping function allows the potential for optimization of sensing,” par. 126). “Narrowing down” to the most sensitive spot suggests that the most suitable combination out of all combinations is selected among the electrodes.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hafezi in view of Yoo and Ward as applied to claim 5 above, and further in view of US 2010/0076328, hereinafter Matsumura.
Regarding claim 6, Hafezi teaches that there may be different arrangements of electrodes, there may be more than the disclosed number of electrodes, and that two-terminal impedance measurements may be used alternatively to four-terminal measurements (“it is always possible [to] add more electrodes to the Breast Sense Feeding Monitor system…the ordinary skilled artisan will consider design parameters for the end use to optimize effects and balance these considerations,” par. 139; “alternate between driving through first electrode 20 and fourth electrode 26, and sensing with second electrode 22 and third electrode 24. This mode of operation is in contrast to driving through electrode first electrode 20 and fourth electrode 26, and actually sensing with those same electrodes,” par. 117). Yoo further teaches additional electrode arrangements (Figs. 3-4). Hafezi, Yoo, and Ward do not explicitly teach or suggest the predetermined plurality of combinations are all combinations of electrodes arranged on a straight line among the five or more electrodes.
Matsumura teaches an analogous impedance sensing arrangement comprising 16 electrodes (Fig. 17). Matsumura also teaches testing difference electrode combinations for choosing an optimum set for measuring impedance (“measurement of the fluctuation of the biological impedance for each combinations of the various electrode portion pairs and determines the combination of the optimum electrode portion pair (step S202),” par. 126).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi, Yoo, and Ward to use a 16 electrode array for sensing, as taught by Matsumura. One would be motivated to do in order to increase the sensitivity of measurements as suggested by Hafezi (“an increased number of electrodes, while increasing sensitivity…the ordinary skilled artisan will consider design parameters for the end use to optimize effects and balance these considerations,” par. 139). Furthermore, this arrangement was known in the art as shown by Matsumura Fig. 17. This modification could be carried out with a reasonable expectation of success because Hafezi explicitly suggests different electrode arrangements to optimize measurements (par. 139; “another advantage to having multiple electrodes in the Breast Sense Feeding Monitor system 2 is that the system can * sense* through different pairs of electrodes…and generally map the location of optimal sensitivity,” par. 125).
It would further be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi in view of Yoo, Ward, and Matsumura such that the predetermined plurality of combinations are all combinations of electrodes arranged in a straight line. One of ordinary skill in the art would recognize that different combinations between 16 electrodes would require several measurements and be motivated to reduce the number of combinations needed to be measured in order to shorten the processing time to select optimum electrodes. Furthermore, since Hafezi teaches that the most basic version of the device comprises electrodes in a line (Fig. 4A; “In the basic version of the breast sense feeding monitor, the electrodes are provided linearly in pairs, par. 20), this would further motivate one to select an optimal line of four electrodes out of the array of 16 to perform impedance measurements. In this way, mapping an optical sensitivity can be balanced with processing time (Hafezi par. 139).
Regarding claim 7, Hafezi teaches that there may be different arrangements of electrodes, there may be more than the disclosed number of electrodes, and that two-terminal impedance measurements may be used alternatively to four-terminal measurements (“it is always possible [to] add more electrodes to the Breast Sense Feeding Monitor system…the ordinary skilled artisan will consider design parameters for the end use to optimize effects and balance these considerations,” par. 139; “alternate between driving through first electrode 20 and fourth electrode 26, and sensing with second electrode 22 and third electrode 24. This mode of operation is in contrast to driving through electrode first electrode 20 and fourth electrode 26, and actually sensing with those same electrodes,” par. 117). Hafezi, Yoo, and Ward do not explicitly teach or suggest the predetermined plurality of combinations are all combinations of electrodes arranged in a rectangular shape among the five or more electrodes.
Matsumura teaches an analogous impedance sensing arrangement comprising 16 electrodes (Fig. 17). Matsumura also teaches testing difference electrode combinations for choosing an optimum set for measuring impedance (“measurement of the fluctuation of the biological impedance for each combinations of the various electrode portion pairs and determines the combination of the optimum electrode portion pair (step S202),” par. 126).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi in view of Yoo and Ward to use a multi-electrode array arranged in a grid for sensing, as taught by Matsumura. One would be motivated to do in order to increase the sensitivity of measurements as suggested by Hafezi (“an increased number of electrodes, while increasing sensitivity…the ordinary skilled artisan will consider design parameters for the end use to optimize effects and balance these considerations,” par. 139). Furthermore, this arrangement was known in the art as shown by Matsumura Fig. 17. This modification could be carried out with a reasonable expectation of success because Hafezi explicitly suggests different electrode arrangements to optimize measurements (par. 139; “another advantage to having multiple electrodes in the Breast Sense Feeding Monitor system 2 is that the system can * sense* through different pairs of electrodes…and generally map the location of optimal sensitivity,” par. 125).
Matsumura further teaches that sets of electrodes in a rectangular shape may have higher precision in determining a source of fluid (i.e., a radial artery 510) in the body (Figs. 20, 22 and associated description). Hafezi teaches that electrodes that give the greatest signal strength are closest to a source of fluid (i.e., milk reservoir).
It would further be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hafezi in view of Yoo, Ward and Matsumura such that the predetermined plurality of combinations are all combinations of electrodes arranged in a rectangle. One of ordinary skill in the art would recognize that different combinations between an array of electrodes would require several measurements and be motivated to reduce the number of combinations needed to be measured in order to shorten the processing time to select optimum electrodes. Furthermore, Hafezi suggests “more complexed and nuanced configurations” of electrodes have advantages over linear pairs in certain applications (par. 20), and Matsumura shows that it is possible for a rectangular arrangement to better identify a volume of fluid in the body (Figs. 20, 22). Thus, selecting a rectangle of electrodes may be obvious to try to identify an optimal sensitivity for detecting a milk volume (“The greatest signal strength is if the sense electrodes are closest to where most of the milk reservoir are located. With multiple electrodes, there is the option of sensing different combination of electrodes and picking the one that gives the most signal,” par. 120). In this way, mapping an optical sensitivity can be balanced with processing time (Hafezi paras. 125, 139).
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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/ALICE LING ZOU/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791