DETAILED ACTION
Response to Arguments
The Examiner indicated claims 2, 3, 15 and 16 as allowable “if rewritten in independent form, including all limitations of the base claim and intervening claims” in the Non-Final rejection mailed 4/14/2026. Instead, the application rewrote and broadened all base claims, so the independent claims as now presented are broader in scope that what was indicated as allowable. Upon further search and consideration, the claims are no longer allowable, and once again rejected, as set forth below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 5-7 and 9-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170156658 A1 to Maharbiz et al. (hereinafter, Maharbiz).
Regarding Claims 1 and 11, Maharbiz discloses a system and method comprising inter alia:
applying, via first electrodes ([0067] “FIG. 8B shows a 4-point sensor configuration 12a, in which drive signals are sent via two electrodes (14a and 14d)”), one or more electrical inputs to a periwound tissue outside a wound bed ([0055] a microcontroller 30 that dictates … which electrodes are used as the sense pair (S+ and S−) and the corresponding drive pair (D+ and D−)”) ([0066] “the electrode array boards are configured to make contact with the wound bed”) ([0074] “one pair 110 was selected to measure the healthy tissue”);
receiving one or more outputs from second electrodes based on applying the or more electrical inputs ([0067] “ sense signals are sent/received via two electrodes (14b and 14c)”) ([0053] “ The electrode array 12 is connected through the control board 20 to an impedance analyzer 40 (e.g. LCZ meter, or the like) which provides the drive signal and calculates the complex impedance of the tissue.”);
generating one or more impedance maps of the wound bed based on the one or more outputs ([0069] “a map 100 resembling the electrode array is created and shown in FIG. 9B. FIG. 9A”); ([0071] “plotted using a color gradient to create a “wound map” for magnitude 102 and phase 104”) ([0055] “cycle through all possible nearest-neighbor pairs to generate a map of the measured impedance”); and
converting the one or more impedance maps to one or more tissue characteristics maps representing a spatial distribution of clinical metrics of the wound bed ([0083] “the damage threshold that is determined from the magnitude and phase data at each pair, and mapped across the array”) ([0085] “Spatial impedance data can thus be translated into a map of the tissue damage parameter that differentiates healthy tissue from a wound”) ([0096] “ differentiate between a moist wound (exposed wound bed, potentially pus and so on) and a healing, scab-covered wound”);
wherein converting the one or more impedance maps to the one or more tissue characteristics maps comprises using a calibration model that correlates the one or more outputs to physically measured wound data related to the clinical metrics of the wound bed ([0085] “a contrast optimization process that identified 15 kHz as the frequency at which the maximum difference was observed in impedance between damaged and non-damaged tissue” e.g., the calibration) ([0085] “|Z|=6 kΩ and a phase window of −30°≦φ≦−10° measured at 15 kHz was an effective threshold for identifying damaged tissue while avoiding false positive readings”, e.g., the model correlating outputs (impedance) to tissue condition) ([0094] “[0094] Histological cross-sections performed at various time points throughout the study (FIG. 23A through FIG. 23C and FIG. 24A through FIG. 24B) support the hypothesis that the alteration of cell membranes and tissue structure causes the observed impedance changes” e.g., physically measured wound data) ([0085] “Spatial impedance data can thus be translated into a map of the tissue damage parameter…” e.g., using the model to convert the map) (Maharbiz calibrates impedance against histology-confirmed tissue damage, then uses that threshold to map the metric, reading on “calibration model” under broadest reasonable interpretation); and
a processor (microcontroller 30/ computer 50) to perform the steps as set forth above [0052]-[0055].
Regarding Claim 5, Maharbiz discloses the method of claim 1, wherein the one or more impedance maps comprise a spatial map ([0069] “…a map 100 resembling the electrode array is created…”) at one or more sampling frequencies of a measurement selected from the group consisting of conductivity, resistivity, conductance, resistance, reactance, capacitance, inductance, impedance magnitude, impedance phase angle, complex impedance, and a combination thereof ([0071] “…then plotted using a color gradient to create a “wound map” for magnitude 102 and phase 104.”).
Regarding Claims 6 and 12, Maharbiz discloses the method of claims 1 and 11, wherein the one or more tissue characteristics maps comprise healing stage of the wound bed ([0096] “The above measurements confirm that it is possible to identify not only the size and shape of an excision by determining the border of the wound, but also differentiate between a moist wound (exposed wound bed, potentially pus and so on) and a healing, scab-covered wound.”).
Regarding Claim 7, Maharbiz discloses the method of claim 1, further comprising displaying, via a graphic user interface (GUI), the one or more tissue characteristics maps ([0054] “…application software 56 is stored in memory 54 and executable on processor 52.”) ([0069] “To visualize the impedance magnitude and phase data collected, a map 100 resembling the electrode array is created and shown in FIG. 9B. FIG. 9A illustrates an electrode array 12 according to an embodiment of the technology disclosed herein overlaid on a photo of the wound area 86 and example impedance map 100.”) ([0083] “The fourth row illustrates the damage threshold that is determined from the magnitude and phase data at each pair, and mapped across the array., and receiving, via the GUI, system configuration parameters from a user.”) and system status ([0014] “…configured to sound an alarm when tissue health reaches a threshold level beyond which a pressure ulcer is likely to form.”) ([0083] “ The markers indicate the measured data values, whereas the lines and the shaded regions indicate the estimated transfer function and the 95% fit confidence interval, respectively.”), and receiving, via the GUI, system configuration parameters from the user ([0055] “Control board 20 comprises a microcontroller 30 that dictates the measurement configuration (e.g. 2-point or 4-point impedance, as described in further detail below), as well as which electrodes are used as the sense pair (S+ and S−) and the corresponding drive pair (D+ and D−).”).
Regarding Claim 9, Maharbiz discloses the method of claim 1, further comprising determining at least one tissue characteristic, based on the one or more tissue characteristics maps, wherein the at least one tissue characteristic is selected from the group consisting of a wound cross-sectional area, a wound length, and a wound width ([0096] “The above measurements confirm that it is possible to identify not only the size and shape of an excision by determining the border of the wound.”).
Regarding Claim 10, Maharbiz discloses the method of claim 1, further comprising outputting information indicative of one or more tissue characteristics based on the one or more tissue characteristics maps ([0085] “Spatial impedance data can thus be translated into a map of the tissue damage parameter that differentiates healthy tissue from a wound.”).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maharbiz in view of Determination of upper arm muscle and fat areas using electrical impedance measurements to Brown et al. (hereinafter, Brown).
Maharbiz discloses measures wound conductance [0049] but does not expressly disclose where the calibration model comprises a calibration curve correlating measured relative conductance values to wound depth values. However, Brown teaches using impedance to allows fat and muscle to be recorded (Abstract) and specifically plots conductance/resistance plotted as a curve (Fig. 4 and see pg. 53, lines 1-8). Maharbiz already measuring wound conductance and Brown establishes impedance and tissue geometry calibration to obtain wound geometry objectively. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Maharbiz to include the calibration curve correlating measurement relative conductance values to depth values of Brown, as Brown teaches in the Abstract and Discussion that these results are more accurate than measurements made using traditional techniques and in the last paragraph of the Introduction (page 48) that the measurements give a better estimate of fat and muscle cross-sections.
Claim(s) 8 and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maharbiz and/or Maharbiz in view of Seo in view and/or and further in view of WO 2004049937 A1 to McAdams et al. (hereinafter, McAdams).
Maharbiz and/or Maharbiz in view of Seo disclose disclose the claimed invention except for expressly disclosing determining a volume of the wound bed from the one or more tissue characteristics maps, wherein the wound bed includes one or more subdermal features. However, McAdams teaches a system and method for mapping tissue of a skin wound (page 1, lines 3-4) using an array of test electrodes (page 6, lines 21-26). McAdams states that their array of test electrodes is used to monitor the wounds size, shape, depth and composition (page 6, lines 15-17). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the electrode array system of
Claim(s) 15-17, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maharbiz in view of Recent Progress on Frequency Difference Electrical Impedance Tomography to Seo et al. (hereinafter, Seo).
Regarding Claims 15 and 20, Maharbiz discloses a system and method comprising inter alia:
applying, via first electrodes ([0067] “FIG. 8B shows a 4-point sensor configuration 12a, in which drive signals are sent via two electrodes (14a and 14d)”), one or more electrical inputs to a periwound tissue outside a wound bed ([0055] a microcontroller 30 that dictates … which electrodes are used as the sense pair (S+ and S−) and the corresponding drive pair (D+ and D−)”) ([0066] “the electrode array boards are configured to make contact with the wound bed”) ([0074] “one pair 110 was selected to measure the healthy tissue”);
receiving one or more outputs from second electrodes based on applying the or more electrical inputs ([0067] “ sense signals are sent/received via two electrodes (14b and 14c)”) ([0053] “ The electrode array 12 is connected through the control board 20 to an impedance analyzer 40 (e.g. LCZ meter, or the like) which provides the drive signal and calculates the complex impedance of the tissue.”);
generating one or more impedance maps of the wound bed based on the one or more outputs ([0069] “a map 100 resembling the electrode array is created and shown in FIG. 9B. FIG. 9A”); ([0071] “plotted using a color gradient to create a “wound map” for magnitude 102 and phase 104”) ([0055] “cycle through all possible nearest-neighbor pairs to generate a map of the measured impedance”); and
converting the one or more impedance maps to one or more tissue characteristics maps representing a spatial distribution of clinical metrics of the wound bed ([0083] “the damage threshold that is determined from the magnitude and phase data at each pair, and mapped across the array”) ([0085] “Spatial impedance data can thus be translated into a map of the tissue damage parameter that differentiates healthy tissue from a wound”) ([0096] “ differentiate between a moist wound (exposed wound bed, potentially pus and so on) and a healing, scab-covered wound”);
wherein converting the one or more impedance maps to the one or more tissue characteristics maps comprises using a calibration model that correlates the one or more outputs to physically measured wound data related to the clinical metrics of the wound bed ([0085] “a contrast optimization process that identified 15 kHz as the frequency at which the maximum difference was observed in impedance between damaged and non-damaged tissue” e.g., the calibration) ([0085] “|Z|=6 kΩ and a phase window of −30°≦φ≦−10° measured at 15 kHz was an effective threshold for identifying damaged tissue while avoiding false positive readings”, e.g., the model correlating outputs (impedance) to tissue condition) ([0094] “[0094] Histological cross-sections performed at various time points throughout the study (FIG. 23A through FIG. 23C and FIG. 24A through FIG. 24B) support the hypothesis that the alteration of cell membranes and tissue structure causes the observed impedance changes” e.g., physically measured wound data) ([0085] “Spatial impedance data can thus be translated into a map of the tissue damage parameter…” e.g., using the model to convert the map) (Maharbiz calibrates impedance against histology-confirmed tissue damage, then uses that threshold to map the metric, reading on “calibration model” under broadest reasonable interpretation);
where the one or more impedance maps of the wound bed are algorithmically estimated using measurement-scale features (averaging the impedance measurements, as set forth in [0084] and [0086], is using an arithmetic mean, which is a measurement-scale feature); and
a processor (microcontroller 30/ computer 50) to perform the steps as set forth above [0052]-[0055];
(Claims 16 and 21) Maharbiz discloses where the one or more impedance maps of the wound bed are algorithmically estimated using measurement-scale features comprising an arithmetic mean (averaging the impedance measurements, as set forth in [0084] and [0086], is using an arithmetic mean, which is a measurement-scale feature);
(Claim 17) quantifying one or more electrode or connectivity performances ([0082] “The asymmetry in the surface map on day 3 is due to the rejection of one broken electrode”);
Maharbiz discloses where the one or more impedance maps of the wound bed are algorithmically estimated, but Maharbiz does require a baseline measurement of unwounded tissue ([0071], [0073], [0085]). Therefore, Maharbiz does not expressly disclose where the impedance maps do not require a baseline measurement of unwounded tissue.
However, Seo teaches a device using electrical conductivity to provide wound mapping (Introduction, pg. 150 “The electrical conductivity and permittivity values of biological tissues and organs change with their physiological and pathological conditions and thus provide useful diagnostic information.”). Seo teaches algorithmically estimated maps of a wound that do not require a baseline (Introduction, pg. 151 “In fdEIT, it is essential to use the weighted difference of boundary voltage data to produce an image of frequency-dependent changes of the internal complex conductivity distribution. Compared with tdEIT, fdEIT does not require a reference data set from the past.”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the algorithmically estimated maps of Maharbiz to not require a baseline measurement of unwounded tissue, because Seo teaches that a skilled artisan would have adopted fdEIT to eliminate Maharbiz’s baseline requirement, because unwounded-tissue baseline is often unavailable and/or unreliable.
Claim(s) 17, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maharbiz in view of “Real-time management of faulty electrodes in electrical impedance tomography” to Hartinger et al. (hereinafter, Hartinger).
Maharbiz discloses the claimed invention as set forth and cited above except for expressly disclosing (Claim 17) quantifying one or more electrode or connectivity performances wherein the processor algorithmically compensates for degradation of the one or more electrode or connectivity performances, (Claim 18) wherein the one or more electrode or connectivity performances are detected by performing a test based on voltage-current reciprocity and (Claim 19) wherein algorithmically compensating for the degradation of the one or more electrode or connectivity performances comprises applying a weight parameter to electrical measurements corresponding to the one or more electrode or connectivity performances.
However, Hartinger teaches the management of faulty electrodes in electrical impedance tomography (Abstract). Hartinger teaches (Claim 17) quantifying one or more electrode or connectivity performances (Abstract “The second part of the approach allows automatic real time detection of at least one faulty electrode with 100% sensitivity and two faulty electrodes with 80% sensitivity enabling the clinical staff to fix the problem as soon as possible to minimize data loss”) wherein the processor algorithmically compensates for degradation of the one or more electrode or connectivity performances (Abstract “Results show that the algorithm is able to automatically determine the valid portion of the data and use it to calculate high quality images”), (Claim 18) wherein the one or more electrode or connectivity performances are detected by performing a test based on voltage-current reciprocity (Abstract “This paper presents a two-part approach for real-time management of faulty electrodes based on the principle of voltage-current reciprocity. The first part allows accounting for faulty electrodes in EIT image reconstruction without a priori knowledge of which electrodes are at fault. The method properly weights each measurement according to its compliance with the principle of voltage-current reciprocity.”) and (Claim 19) wherein algorithmically compensating for the degradation of the one or more electrode or connectivity performances comprises applying a weight parameter to electrical measurements corresponding to the one or more electrode or connectivity performances (Abstract “The method properly weights each measurement according to its compliance with the principle of voltage-current reciprocity.).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the electrode array of Maharbiz to apply the detection of faulty electrode logic of Hartinger and Hartinger teaches in this Abstract this would have prevented data loss.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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