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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 27-30 and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 27 follows.
STEP 1
Regarding Claim 27, the claim recites a series of steps or acts, including mounting an electrode harness; providing electrical signals from an interrogator to electrodes; measuring electrical response; carrying out EIT reconstruction; determining whether a contact impedance between a tested electrode and a surface of a body part meets predetermined criteria; providing contact quality test result information; receiving contact quality test result information at a computing device; providing information to a user based on EIT reconstruction; and displaying on a user interface a representation of contact quality. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining whether a contact impedance between a tested electrode and a surface of a body part meets predetermined criteria sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 27 recites providing contact quality test result information and providing information to a user based on EIT reconstruction, which is merely adding insignificant post-solution activity to the judicial exception (MPEP 2106.05(g)). The providing of information does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the generated output, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 27 recites additional steps of mounting an electrode harness comprising a plurality of electrodes to a subject, selectively providing electrical signals to multiple groups of the electrodes, measuring electrical signals, and receiving electrical properties. The mounting, providing, measuring, and receiving steps are recited at a high level of generality such that they amount to insignificant pre-solution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. Additionally, the displaying contact quality test information pertaining to each electrode step is recited at a high level of generality such that it amounts to extra post-solution activity. When recited at this high level of generality, there is no meaningful limitation such as a particular or unconventional step that distinguishes it from activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the providing, measuring, and receiving steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Dependent Claims 28-30 and 32 fail to add something more to the abstract independent claims as they generally recite structural components which do not equate to a “particular machine” as well as recite components pertaining to pre-solution data gathering and processing.
The mounting, providing, measuring, determining, receiving, and displaying steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 1-2, 5, 8-9, 11, 13-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stroem'580 (EP Patent Application 1000580 – previously cited) in view of Rood et. al.'330 (U.S. Patent 8201330 – previously cited), further in view of Avery et. al.'126 (WO Patent Publication 2013177126 – as cited by applicant), and further in view of Chetham et. al.’015 (WO Patent Publication 2015003015 – previously cited).
Regarding Claim 1, Stroem’580 discloses an electrode harness for use in carrying out Electrical Impedance Tomography (EIT) on a subject comprising a human or animal subject (Paragraph [0014] - This EIT system comprises an array of electrodes 4a..n, typically 16 electrodes, mounted on a belt 5 so as to form a ring about the patient 1 when in use. When the belt 5 is located about the chest of the patient), the electrode harness comprising:
an electrode support (Paragraph [0014] - electrodes, mounted on a belt 5 so as to form a ring about the patient 1 when in use);
a plurality of electrodes disposed on the electrode support for contacting a surface of an external body part of the subject (Paragraph [0004] - comprises typically sixteen or more surface electrodes positionable at known intervals on the surface of patient to define a plane through the body of the patient); and
a plurality of connectors, each connector coupled to a respective electrode of the plurality of electrodes (Paragraph [0015] - The EIT data acquisition system 10 comprises electrical signal generation and measurement electronics which are operably connected to the electrodes 4a..n on the belt 5); and
a control unit comprising (Paragraph [0015] - acquisition system 10):
an interrogator for coupling to the plurality of electrodes via the plurality of connectors, the interrogator being configured to selectively provide electrical signals to multiple groups of electrodes of the plurality of electrodes and for measuring, in response to the provided electrical signals, electrical response signals of at least some electrodes of the plurality of electrodes (Paragraph [0015] - The acquisition system 10 is configured to operate in a known manner to successively apply a low amplitude, alternating current across pairs of electrodes and to measure the voltage differences produced between each of the remaining pair combinations formed by the remaining electrodes in the array 4a..n.); and
communication circuitry for transmitting information associated with the electrical response signals to an external computing device (Paragraph [0014] - within the EIT system is a microprocessor unit 6, having integral therewith a digital data store 7; a display unit 8; a conventional X-ray imaging system 9 and an EIT data acquisition system 10. Typically the unit 6 and store 7 can be realised within a conventional personal computer in which its hard disk or its random access memory may be used as the data store 7 dependant largely on whether permanent or temporary storage is required; Paragraph [0016] - These physical images are digitised and transmitted to the digital data store 7 of the microprocessor unit 6), wherein
determining impedance values against predetermined criteria and providing a display to a user (Paragraph [0021] – Preferably the combined image of Figure 2b, generated using the microprocessor 6 and displayed on the unit 8 is colour coded wherein the different shadings of Figure 2b are replaced by specific colours denoting different ranges of impedance values. Indeed, as an alternative, the microprocessor 6 may be programmed to show only those regions of the EIT image where measured electrical impedances lie outside predetermined limits).
Stroem’580 fails to disclose each electrode comprising an electrode mount extending from a surface of the electrode support to provide an electrode mounting interface at an end furthest from the surface of the electrode support, wherein at least a portion of the electrode mounting interface is serrated for abrading the surface of the external body part of the subject.
Rood et. al.’330 teaches an electrode on a support system with an electrode surface that is able to penetrate the skin of a user and anchor – mount – the electrode to the surface of the skin (Paragraph [0064] - the size and shape of the penetrator 16 is such that the penetrator(s) 16 will not break or bend during normal use, will limit the depth the penetrator enters the skin under typical application conditions, and/or will anchor the electrode 10 to prevent motion artifacts or any substantial movement). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem’580 to include electrodes with anchors – mounting surfaces – in order to prevent motion artifacts if the electrode moves due to movement of the user as seen in Rood et. al.’330.
Avery et. al.’126 teaches pyramidal extrusion – serrated – electrodes (Paragraph [0057] - the electrode 4a is constructed out of brass, and has a grid of pyramidal extrusions 80) that are coated with conductive materials (Paragraph [0057] - The electrode tip thus provides for skin abrasion by rotation and may, if needed, be coated in a conductive paste gel or hydrogel). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem’580 in view of Rood et. al.'330 to include an electrode with a serrated tip in order to abrade the skin to obtain electrical signals from the skin or tissue of the user as seen in Avery et. al.’126.
Avery et. al.’126 further teaches electrodes with an abrasive surface to assist in abrading a user’s skin at a point of contact (Paragraph [0057] - the electrode 4a is constructed out of brass, and has a grid of pyramidal extrusions 80. This creates an abrasive surface, which more readily removes the top layer of skin of the subject 5. The electrode tip thus provides for skin abrasion by rotation and may, if needed, be coated in a conductive paste gel or hydrogel). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem’580 in view of Rood et. al.’330 to include electrodes with a self-abrading surface in order to remove a top layer of skin for readings within the user’s skin or tissue without the use of another tool or machine as seen in Avery et. al.’126.
Stroem’580 also fails to disclose wherein the control unit is configured to carry out an electrode contact quality test for each electrode of the plurality of electrodes when the electrode support is mounted on the subject to determine, for each tested electrode, whether a contact impedance between the tested electrode and the surface of the external body part of the subject meets a predetermined criteria and to provide, for each tested electrode, contact quality test result information for transmission by the communication circuitry to the external computing device for display to a user.
Chetham et. al.’015 teaches determining contact quality values for electrodes based on impedance and selected criteria (Paragraph [0072] - positioning the electrodes on a subject; scoring a plurality of electrical resistivity arrays, wherein each electrical resistivity array 10 comprises a pair of current-injecting electrodes and a pair of voltage detection electrodes, wherein the score comprises an estimation of signal error for the electrodes in the electrical resistivity array and an estimation of a depth of investigation for the electrical resistivity array; applying current and recording voltages from a subject using only those electrical resistivity arrays meeting a selection criterion based upon their scores; and determining a relative spatial 15 change in subsurface resistivities across frequencies using applied currents and resulting voltages only from those electrical resistivity arrays meeting the selection criterion). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem’580 in view of Rood et. al.’330 and further in view of Avery et. al.’126 to include measuring quality of contact of electrodes against a known criteria in order to better ensure that the readings are accurate as seen in Chetham et. al.’015.
Regarding Claim 2, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 1 above. Stroem’580 further discloses wherein the control unit is integrated with the electrode support (Paragraph [0015] - The EIT data acquisition system 10 comprises electrical signal generation and measurement electronics which are operably connected to the electrodes 4a..n on the belt 5).
Regarding Claim 5, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 1 above. Stroem’580 further discloses wherein the external body part is a chest of a subject and the electrode support is configured for mounting on the chest of the subject (Paragraph [0014] - This EIT system comprises an array of electrodes 4a..n, typically 16 electrodes, mounted on a belt 5 so as to form a ring about the patient 1 when in use. When the belt 5 is located about the chest of the patient), wherein the electrode support comprises a front portion and a back portion, the control unit is on one of the front portion or the back portion and each connector of the plurality of connectors extend from a respective electrode to the interrogator over the front portion and/or the back portion (Figure 1; Paragraph [0015] - The EIT data acquisition system 10 comprises electrical signal generation and measurement electronics which are operably connected to the electrodes 4a..n on the belt 5 – anything two dimensional contains a front and back portion). Stroem’580 fails to disclose wherein the plurality of electrodes are on the front portion and the back portion. Chetham et. al.’015 teaches an electrode support with a front portion and a back portion (Paragraph [0127] - For apparent resistivity measurements taken on the torso, with a an array of electrodes (the sensor) with spacing chosen to provide sensitivity to underlying tissue, the finite boundary conditions of the torso should be considered; Paragraph [0033] - the sensor may include placing the sensor on the subject's back so that a long axis of the sensor is a proximal to distal axis that extends cranially to caudally along the subject's back, and the electrodes on the sensor may be positioned lateral to the subject's spine). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, and further in view of Avery et. al.'126 to include an electrode support with a front and back portion that can gather readings from both sides of the user as seen in Chetham et. al.’015.
Regarding Claim 8, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 1 above. Stroem’580 further discloses a plurality of electrodes on a support (Paragraph [0014] - 16 electrodes, mounted on a belt 5), but fails to disclose a conductive pad formed on at least a portion of the electrode mounting interface, the conductive pad being electrically coupled to a respective connector. Chetham et. al.’015 teaches an electrode with conductive material connected to an electrical system in the form of a sensor (Paragraph [0064] - Any appropriate conductive material may be used to form the electrodes, including silver/silver chloride. In some variations the sensor includes a conductive gel on the electrodes 20 (or is compatible with a conductive gel). In some variations the conductive gel may include an adhesive. For example, some variations, the sensor is non-adhesive and the gel adheres it to the subject). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, and further in view of Avery et. al.'126 to include an electrode with conductive material in order to provide a surface for electrical properties to be sensed across the electrode as seen in Chetham et. al.’015.
Regarding Claim 9, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the electrode harness outlined in Claim 8 above, but fails to disclose wherein the conductive pad is formed on at least the portion of the electrode mounting interface that is serrated. Avery et. al.’126 teaches pyramidal extrusion – serrated – electrodes (Paragraph [0057] - the electrode 4a is constructed out of brass, and has a grid of pyramidal extrusions 80) that are coated with conductive materials (Paragraph [0057] - The electrode tip thus provides for skin abrasion by rotation and may, if needed, be coated in a conductive paste gel or hydrogel). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include an electrode with a serrated tip in order to abrade the skin to obtain electrical signals from the skin or tissue of the user as seen in Avery et. al.’126.
Regarding Claim 11, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the electrode harness outlined in Claim 8 above, but fails to disclose wherein at least a portion of the conductive pad is covered with a conductive adhesive material. Chetham et. al.’015 teaches a conductive gel as an adhesive on an electrode (Paragraph [0064] - Any appropriate conductive material may be used to form the electrodes, including silver/silver chloride. In some variations the sensor includes a conductive gel on the electrodes 20 (or is compatible with a conductive gel). In some variations the conductive gel may include an adhesive. For example, some variations, the sensor is non-adhesive and the gel adheres it to the subject). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, and further in view of Avery et. al.'126 to include an electrode with conductive adhesive material in order to adhere the electrode to the user as seen in Chetham et. al.’015.
Regarding Claim 13, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the electrode harness outlined in Claim 1 above, but fails to disclose wherein the electrode support is formed from an elasticated or stretchable material. Chetham et. al.’015 teaches an electrode support in the form of a vest made out of stretchable material (Paragraph [0270] - The vest can be made of various materials both stretchy (like spandex or lycra) or taut like polyester). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, and further in view of Avery et. al.'126 to include a stretchable material in order to fit and conform to the wearer as seen in Chetham et. al.’015.
Regarding Claim 14, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the electrode harness outlined in Claim 1 above, but fails to disclose an insulator layer formed over at least the connectors. Chetham et. al.’015 teaches an insulated layer of connections between electrodes and a processor (Paragraph [0061] - The leads are typically insulated connections between the surface of the electrodes applying current and/or sensing voltage and the rest of the system, including the processors and the like). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, and further in view of Avery et. al.'126 to include an insulated layer between connectors in order to keep signals from interfering with each other as seen in Chetham et. al.’015.
Regarding Claim 15, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the electrode harness outlined in Claim 1 above. Stroem’580 further discloses wherein the interrogator comprises: a signal source for selectively providing electrical signals to the multiple groups of electrodes (Paragraph [0015] - The acquisition system 10 is configured to operate in a known manner to successively apply a low amplitude, alternating current across pairs of electrodes); and
a detector for measuring, in response to the provided electrical signals, electrical response signals of at least some electrodes of the plurality of electrodes (Paragraph [0015] - and to measure the voltage differences produced between each of the remaining pair combinations formed by the remaining electrodes in the array 4a..n).
Regarding Claim 16, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the electrode harness outlined in Claim 1 above, but fails to disclose the control unit is further configured to determine a position of the electrodes with respect to the external body part of the subject when the electrode support is mounted on the subject by performing operations comprising: providing electrical signals and measuring electrical signal responses using different combinations of the plurality of electrodes and determining impedance responses based on the provided electrical signals and the measured electrical signal responses; or by determining distances between electrodes of the plurality of electrodes by measuring resistance of the connectors of the electrodes. Chetham et. al.’015 teaches determining positions of electrodes with respect to an external body part of a user (Paragraph [0026] - The data recording unit may record the voltage(s) sensed as well as the identity and/or positions of the driving electrodes (e.g., current source/current sink) and sensing electrodes corresponding to the sensed voltages, as 35 well as the frequency of the current being applied…This information; the matrix of sensed voltages as well as the relative positions of the electrodes doing the driving and sensing, may be used to solve for the electrical properties within the sub-regions beneath the sensor, as described in detail below) as well as determining impedance responses based on responses from a plurality of electrodes (Paragraph [0150] - the system may use the sensor to measure one or more electrical properties 103 (e.g., voltages, complex impedances, complex conductivities, etc.) from the subject. The system or device then typically determines the spatial relationship of resistivities (or a derived value) using the known arrangement of the electrodes in the array as well as the known applied currents and the sensed electrical properties at a plurality of the electrodes in the sensor and solving inverse problems. In general, the subsurface spatial resistivities are solved for using this information). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, and further in view of Avery et. al.'126 to include determining positions of electrodes in order to better understand the relationship of the impedance readings received as seen in Chetham et. al.’015.
Regarding Claim 17, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the electrode harness outlined in Claim 16 above. Stroem’580 further discloses wherein the control unit is further configured to determine impedance responses of part of the subject within the external body part based on the provided electrical signals and the electrical response signals that were measured and wherein the information transmitted to the external computing device includes the impedance responses for EIT processing at the external computing device (Paragraph [0021] - Preferably the combined image of Figure 2b, generated using the microprocessor 6 and displayed on the unit 8 is colour coded wherein the different shadings of Figure 2b are replaced by specific colours denoting different ranges of impedance values. Indeed, as an alternative, the microprocessor 6 may be programmed to show only those regions of the EIT image where measured electrical impedances lie outside predetermined limits).
Regarding Claim 20, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the electrode harness outlined in Claim 1 above. Stroem’580 fails to disclose wherein the control unit is configured to carry out the electrode contact quality test when the electrode support is mounted on the subject by, for each tested electrode by performing operations comprising: measuring the contact impedance of the tested electrode; comparing the measured contact impedance with a threshold impedance; and when the measured contact impedance is greater than the threshold impedance, identifying the tested electrode as having a poor contact quality wherein when at least one tested electrode of the plurality of electrodes is identified as having a poor contact quality, the control unit is configured to provide contact quality test result information identifying the at least one tested electrode having poor contact quality for transmission by the communication circuitry to the external computing device. Chetham et. al.’015 teaches a system that determines contact quality of electrodes (Paragraph [0334] - In some variations, the apparatus may also determine bad (or inaccurate) measurements by comparing across neighboring electrodes in the array and flagging outliers) by measuring impedance values of electrodes and comparing the values to threshold values (Paragraph [0329] - The system 25 may be configured to determine "reasonable" impedance bounds based on either predetermined values or set by experimental data, including based on skin contact) in order to identify electrodes with poor contact (Paragraph [0329] - This technique may be used to determine if one or more driving electrodes are bad; Paragraph [0330] - For example, the apparatus may flag measurements if the std/mean > 5%. In any of these variations flagged measurements may be rejected or may be modified (e.g., filtered, weighted, etc.) in some way… indicate that there is not good contact) and notify the user of the contact quality of the electrodes (Paragraph [0330] - If enough electrodes are flagged, the system may alert the user or patient that there is not 5 adequate contact and to re-apply the patch). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, and further in view of Avery et. al.'126 to include measuring quality of contact of electrodes in order to identify electrode with poor contact quality and therefore ensure that the readings are accurate and will provide accurate notifications to the user as seen in Chetham et. al.’015.
Claims 3-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Stroem'580 (EP Patent Application 1000580 – previously cited) in view of Rood et. al.'330 (U.S. Patent 8201330 – previously cited), further in view of Chetham et. al.’015 (WO Patent Publication 2015003015 – previously cited), further in view of Avery et. al.'126 (WO Patent Publication 2013177126 – as cited by applicant), as applied to Claim 1 above, and further in view of Philip Church'285 (CA Patent Application 2191285 – previously cited).
Regarding Claim 3, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 1 above. Stroem’580 further discloses the plurality of electrodes are on the electrode support in the form of a ring around the electrode support (Paragraph [0014] - This EIT system comprises an array of electrodes 4a..n, typically 16 electrodes, mounted on a belt 5 so as to form a ring about the patient 1 when in use), but fails to disclose the plurality of electrodes are arranged to form a plurality of rings around the electrode support and each ring comprises more than one electrode. Philip Church'285 teaches a plurality of electrodes arranged on a plurality of rings on a support structure (Page 11 Lines 18-19 - A minimum of 32 electrodes were considered, arranged in two concentric rings). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include a plurality of rings with electrodes in order to arrange the electrodes at different positions around the user that can be used to gather different electrical properties that relate to those positions as seen in Philip Church’285 (Page 2 Lines 19-25 - positioning adjacent a surface of the body an array of electrodes with a first group of the electrodes closer to the surface than a second group of the electrodes, applying a stimulation current to selected pairs of electrodes in turn and measuring, for each pair stimulated, corresponding electrical potential differences produced between pairs of the remaining electrodes, and processing the measured potential differences to determine electrical conductivity variations within the body).
Regarding Claim 4, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Philip Church’285 discloses the system outlined in Claim 3 above. Stroem’580 further discloses wherein the interrogator is configured to measure, in response to electrical signals being provided to electrodes of a particular ring, electrical response signals at electrodes of the particular ring (Paragraph [0015] - The acquisition system 10 is configured to operate in a known manner to successively apply a low amplitude, alternating current across pairs of electrodes and to measure the voltage differences produced between each of the remaining pair combinations formed by the remaining electrodes in the array 4a..n).
Regarding Claim 6, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 5 above. Stroem’580 also discloses the plurality of electrodes are on the electrode support in the form of a ring around the electrode support (Paragraph [0014] - This EIT system comprises an array of electrodes 4a..n, typically 16 electrodes, mounted on a belt 5 so as to form a ring about the patient 1 when in use), but Stroem’580 in view of Rood et. al.'330, further in view of Chetham et. al.’015, and further in view of Avery et. al.'126 fails to disclose the plurality of electrodes are arranged to form a plurality of rings around the electrode support and each ring comprises at least 8 electrodes. Philip Church'285 teaches a plurality of electrodes arranged on a plurality of rings on a support structure wherein at least 16 electrodes are arranged on one of the plurality of rings (Page 11 Lines 18-19 - A minimum of 32 electrodes were considered, arranged in two concentric rings). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include a plurality of rings with electrodes in order to arrange the electrodes at different positions around the user that can be used to gather different electrical properties that relate to those positions as seen in Philip Church’285 (Page 2 Lines 19-25 - positioning adjacent a surface of the body an array of electrodes with a first group of the electrodes closer to the surface than a second group of the electrodes, applying a stimulation current to selected pairs of electrodes in turn and measuring, for each pair stimulated, corresponding electrical potential differences produced between pairs of the remaining electrodes, and processing the measured potential differences to determine electrical conductivity variations within the body). It is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to each ring comprising at least eight electrodes. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimal numbers of electrodes position on each ring of the electrode harness. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Stroem'580 (EP Patent Application 1000580 – previously cited) in view of Rood et. al.'330 (U.S. Patent 8201330 – previously cited), further in view of Chetham et. al.’015 (WO Patent Publication 2015003015 – previously cited), further in view of Avery et. al.'126 (WO Patent Publication 2013177126 – as cited by applicant), as applied to Claim 8 above, and further in view of Ambrose Alan'947 (GB Patent Application 2541947 – previously cited).
Regarding Claim 10, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 8 above, but fails to disclose wherein the electrode mount has a flat conical shape, and wherein the electrode mounting interface is at least part of a flat surface of the electrode mount that has the flat conical shape. Ambrose Alan’947 teaches electrodes with mounting surfaces in a frusto-conical shape (Page 64 Paragraph 2 - the axial members are conical or frusto-conical, the annular electrodes are typically offset back from the electrolyte ducts. Typically the annular electrodes are mounted to sections of the conical or frusto-conical axial members). It is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to the shape of the electrodes being “flat conical”. As such, it is noted that according to section 2144.04 IV. B. of the MPEP, the changing of shape of an electrode to match that of Ambrose Alan’947 would merely be a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. Therefore, the electrode of Stroem’580 could be considered to take shape of flat conical. In light of MPEP 2144.04 IV. B., it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the shape of Stroem’580 to be the shape of a flat conical.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Stroem'580 (EP Patent Application 1000580 – previously cited) in view of Rood et. al.'330 (U.S. Patent 8201330 – previously cited), further in view of Chetham et. al.’015 (WO Patent Publication 2015003015 – previously cited), further in view of Avery et. al.'126 (WO Patent Publication 2013177126 – as cited by applicant), as applied to Claim 8 above, and further in view of Bohorquez et. al.'471 (WO Patent Publication 2012149471 – previously cited).
Regarding Claim 12, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 8 above, but fails to disclose wherein the electrode mount comprises a same material as the surface of the electrode support. Bohorquez et. al.’471 teaches using a printing method to form electrodes on a support structure (Paragraph [0220] - In one embodiment, a conformable, rubber-like base with hollow middle was designed such that the electrode array easily conforms to curved surfaces. The electrode arrays were then printed on thin PET (2 mils) and wrapped around the rubber base, adhering them using double- sided, pressure-sensitive adhesive (PSA). The electrodes were "printed" onto the PET material using a carbon-based conductive ink overlaid on silver-based conductive ink. This allows significantly less expensive manufacturing and greater flexibility with respect to electrode array design). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include electrodes that are made out of the same material as the support they are on in order to reduce cost of manufacturing and provide flexibility between the electrode and the user as seen in Bohorquez et. al.’471.
Claim 18, 21-25, 27-30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Stroem'580 (EP Patent Application 1000580 – previously cited) in view of Rood et. al.'330 (U.S. Patent 8201330 – previously cited), further in view of Chetham et. al.’015 (WO Patent Publication 2015003015 – previously cited), further in view of Avery et. al.'126 (WO Patent Publication 2013177126 – as cited by applicant), as applied to Claim 1 above, and further in view of Yoo et. al.'131 (CN Patent Application 105899131 – previously cited).
Regarding Claim 18, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 16 above. Stroem’580 further discloses wherein the control unit further comprises an EIT processing module for carrying out an EIT reconstruction of impedance responses based on the provided electrical signals and the electrical response signals that were measured (Paragraph [0024] - Furthermore, if the size, shape or position of the body structure which is to be imaged does not alter with time, or if impedance measurements are made (and therefore impedance images generated) at the same point in a relevant physiological cycle, such as the breathing cycle or cardiac cycle, then it will be obvious to those skilled in the art that only one physical image needs to be stored in the digital data store 7), but fails to disclose wherein the information provided to the external computing device is based on the EIT reconstruction. Yoo et. al.’131 teaches an external computing device that receives electrical properties from a reconstructed EIT (Page 3 Paragraph 3 - then transmitted to the external device for restoration to a three dimensional tomographic image and to display; Page 11 Paragraph 4 - calculating the impedance matrix by the measured impedance values, the external equipment 900 by impedance matrix reverse-pushing inner skin structure to calculate the impedance distribution of the skin, so as to not only display the image, but also display a different distance in the depth direction of the image and the distribution of the relative impedance value of each image, and so on). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include an external device that receives electrical properties from an EIT restoration in order to display electrical properties and allow user analysis as seen in Yoo et. al.’131.
Regarding Claim 21, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 1 above. Stroem’580 further discloses an electrode harness (Paragraph [0014] - This EIT system comprises an array of electrodes 4a..n, typically 16 electrodes, mounted on a belt 5 so as to form a ring about the patient 1 when in use. When the belt 5 is located about the chest of the patient); and an external computing device for receiving information associated with the electrical response signals transmitted by the communication circuitry of the electrode harness, wherein the external computing device (Paragraph [0007] - The physical image may be obtained, for example, by computer generation or by using a conventional physical imaging system, such as an x-ray system; a computer aided tomography system; a magnetic resonance imaging system; or an ultrasonic imaging system and may even be a "template image" representative of a typical image of the region of interest). Stroem’580 fails to disclose an EIT processing module for carrying out an EIT reconstruction of impedance responses based on the information associated with the electrical response signals received from the communication; and a user interface for providing information to a user relating to the EIT reconstruction.
Yoo et. al.'131 teaches transferring electrical readings from electrodes to an external device in order to perform EIT restoration (Page 3 Paragraph 3 - then transmitted to the external device for restoration to a three dimensional tomographic image and to display; Page 10 Paragraph 10 - Next, the connection of the shooting patch 100 on the communication cable C and intelligent mobile phone, tablet computer or notebook computer external equipment 900 is connected, then operation installed on the application program independently of the external device 900; Page 10 Paragraph 11 - application program can be measurement all the electrodes 235 and the contact impedance of the breast surface to confirm whether to photograph) and a user interface to display electrode results from electrical readings (Page 10 Paragraph 11 - displaying it on a display screen of the external device 900, thereby confirming whether all of the electrodes 235 are in contact with the skin of the user, then performing impedance tomography of the breast). It would have been obvious to one of ordinary skill in the art to have modified the system of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include an external device with a user interface capable of receiving electrical signals from another device and perform an EIT restoration in order to allow users to receive and respond to displayed information as seen in Yoo et. al.’131.
Regarding Claims 22 and 23, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 1 above, but fails to disclose wherein the EIT processing module is configured reconstruct the impedance responses into a tomographic image of the electrical properties in order to determine one or more parameters based on the derived electrical properties, and wherein the user interface is a display and the external computing device is configured to display the tomographic image or at least one of the one or more parameters on the display of the external computer computing device. Yoo et. al.'131 teaches deriving electrical properties and a tomographic image from EIT measurements, and displaying the tomographic image and parameters related to the derived electrical properties (Page 10 Paragraph 11 - the application program can be measurement all the electrodes 235 and the contact impedance of the breast surface to confirm whether to photograph, and displaying it on a display screen of the external device 900, thereby confirming whether all of the electrodes 235 are in contact with the skin of the user, then performing impedance tomography of the breast; Page 11 Paragraph 4 - when calculating the impedance matrix by the measured impedance values, the external equipment 900 by impedance matrix reverse-pushing inner skin structure to calculate the impedance distribution of the skin so as to not only display the image, but also display a different distance in the depth direction of the image and the distribution of the relative impedance value of each image; Page 11 Paragraph 5 - by using the method, the reduced to the three dimensional tomographic image tomography image based on impedance of the skin depth, and display). It would have been obvious to one of ordinary skill in the art to have modified the system of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include deriving electrical properties and displaying tomographic images including parameters so that a user can see the image and derived parameters and analyze them as seen in Yoo et. al.’131.
Regarding Claim 24, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 discloses the system outlined in Claim 1 above, but fails to disclose wherein the control unit is configured to carry out an electrode contact quality test for each electrode of the plurality of electrodes when the electrode support is mounted on the subject to determine, for each tested electrode, whether a contact impedance between the tested electrode and the surface of the external body part of the subject meets a predetermined criteria and to provide contact quality test result information for transmission by the communication circuitry to the external computing device; and wherein the user interface of the external computing device is a display and the external computing device is configured to display a representation of contact quality of each of the plurality of electrodes based on the contact quality test result information. Yoo et. al.’131 teaches measuring impedance from electrodes in contact with a user in order to determine quality of contact of the electrodes via an image display (Page 10 Paragraph 10 - Next, the connection of the shooting patch 100 on the communication cable C and intelligent mobile phone, tablet computer or notebook computer external equipment 900 is connected, then operation installed on the application program independently of the external device 900; Page 10 Paragraph 11 - the application program can be measurement all the electrodes 235 and the contact impedance of the breast surface to confirm whether to photograph, and displaying it on a display screen of the external device 900, thereby confirming whether all of the electrodes 235 are in contact with the skin of the user, then performing impedance tomography of the breast). It would have been obvious to one of ordinary skill in the art to have modified the system of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include measuring quality of contact of electrodes in order to ensure that the readings are accurate and will provide accurate images as seen in Yoo et. al.’131.
Regarding Claim 25, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Yoo et. al.’131 discloses the system outlined in Claim 21 above, but fails to disclose wherein the external computing device is configured to determine positions of the electrodes with respect to the external body part of the subject when the electrode support is mounted on the subject based on information provided by the communication circuitry of the electrode harness. Chetham et. al.’015 teaches determining electrode position (Paragraph [0026] - The data recording unit may record the voltage(s) sensed as well as the identity and/or positions of the driving electrodes (e.g., current source/current sink) and sensing electrodes corresponding to the sensed voltages, as 35 well as the frequency of the current being applied…the matrix of sensed voltages as well as the relative positions of the electrodes doing the driving and sensing, may be used to solve for the electrical properties within the sub-regions beneath the sensor, as described in detail below). It would have been obvious to one of ordinary skill in the art to have modified the system of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Yoo et. al.’131 to include determining positions of electrodes in order to gather accurate readings of electrical properties as seen in Chetham et. al.’015.
Regarding Claim 27, Stroem’580 discloses a method for determining electrical properties relating to part of a subject comprising a human or animal subject using Electrical Impedance Tomography (EIT) (Paragraph [0014] - This EIT system comprises an array of electrodes 4a..n, typically 16 electrodes, mounted on a belt 5 so as to form a ring about the patient 1 when in use. When the belt 5 is located about the chest of the patient), the method comprising:
mounting an electrode harness comprising a plurality of electrodes disposed on an electrode support and a control unit on the subject such that at least some of the plurality of electrodes contact a surface of an external body part of the subject (Paragraph [0004] - comprises typically sixteen or more surface electrodes positionable at known intervals on the surface of patient to define a plane through the body of the patient);
selectively providing electrical signals, from an interrogator of the control unit coupled to the plurality of electrodes via a plurality of connectors, to multiple groups of electrodes of the plurality of electrodes (Paragraph [0015] - The acquisition system 10 is configured to operate in a known manner to successively apply a low amplitude, alternating current across pairs of electrodes);
measuring, by the interrogator of the control unit, in response to the provided electrical signals, electrical response signals of at least some electrodes of the plurality of electrodes (Paragraph [0015] - and to measure the voltage differences produced between each of the remaining pair combinations formed by the remaining electrodes in the array 4a..n);
carrying out an EIT reconstruction of impedance responses based on the provided electrical signals and the measured electrical response signals to derive electrical properties relating to part of the subject within the external body part (Paragraph [0024] - Furthermore, if the size, shape or position of the body structure which is to be imaged does not alter with time, or if impedance measurements are made (and therefore impedance images generated) at the same point in a relevant physiological cycle, such as the breathing cycle or cardiac cycle, then it will be obvious to those skilled in the art that only one physical image needs to be stored in the digital data store 7);
determining impedance values against predetermined criteria and providing a display to a user (Paragraph [0021] – Preferably the combined image of Figure 2b, generated using the microprocessor 6 and displayed on the unit 8 is colour coded wherein the different shadings of Figure 2b are replaced by specific colours denoting different ranges of impedance values. Indeed, as an alternative, the microprocessor 6 may be programmed to show only those regions of the EIT image where measured electrical impedances lie outside predetermined limits);
receiving, at the external computing device, the contact quality test result information (Paragraph [0007] - The physical image may be obtained, for example, by computer generation or by using a conventional physical imaging system, such as an x-ray system; a computer aided tomography system; a magnetic resonance imaging system; or an ultrasonic imaging system and may even be a "template image" representative of a typical image of the region of interest);
providing by a user interface of the external computing device, information to a user based on EIT reconstruction (Paragraph [0007] - The physical image may be obtained, for example, by computer generation or by using a conventional physical imaging system, such as an x-ray system; a computer aided tomography system; a magnetic resonance imaging system; or an ultrasonic imaging system and may even be a "template image" representative of a typical image of the region of interest); and
displaying on the user interface a representation of impedance values (Paragraph [0021] – Preferably the combined image of Figure 2b, generated using the microprocessor 6 and displayed on the unit 8 is colour coded wherein the different shadings of Figure 2b are replaced by specific colours denoting different ranges of impedance values. Indeed, as an alternative, the microprocessor 6 may be programmed to show only those regions of the EIT image where measured electrical impedances lie outside predetermined limits).
Stroem’580 fails to disclose each electrode comprising an electrode mount extending from a surface of the electrode support to provide an electrode mounting interface at an end furthest from the surface of the electrode support, wherein at least a portion of the electrode mounting interface is serrated for abrading the surface of the external body part of the subject.
Rood et. al.’330 teaches an electrode on a support system with an electrode surface that is able to penetrate the skin of a user and anchor – mount – the electrode to the surface of the skin (Paragraph [0064] - the size and shape of the penetrator 16 is such that the penetrator(s) 16 will not break or bend during normal use, will limit the depth the penetrator enters the skin under typical application conditions, and/or will anchor the electrode 10 to prevent motion artifacts or any substantial movement). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem’580 to include electrodes with anchors – mounting surfaces – in order to prevent motion artifacts if the electrode moves due to movement of the user as seen in Rood et. al.’330.
Avery et. al.’126 teaches pyramidal extrusion – serrated – electrodes (Paragraph [0057] - the electrode 4a is constructed out of brass, and has a grid of pyramidal extrusions 80) that are coated with conductive materials (Paragraph [0057] - The electrode tip thus provides for skin abrasion by rotation and may, if needed, be coated in a conductive paste gel or hydrogel). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem’580 in view of Rood et. al.'330 to include an electrode with a serrated tip in order to abrade the skin to obtain electrical signals from the skin or tissue of the user as seen in Avery et. al.’126.
Avery et. al.’126 further teaches electrodes with an abrasive surface to assist in abrading a user’s skin at a point of contact (Paragraph [0057] - the electrode 4a is constructed out of brass, and has a grid of pyramidal extrusions 80. This creates an abrasive surface, which more readily removes the top layer of skin of the subject 5. The electrode tip thus provides for skin abrasion by rotation and may, if needed, be coated in a conductive paste gel or hydrogel). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem’580 in view of Rood et. al.’330 to include electrodes with a self-abrading surface in order to remove a top layer of skin for readings within the user’s skin or tissue without the use of another tool or machine as seen in Avery et. al.’126.
Stroem’580 also fails to disclose determining, for each of a tested plurality of the electrodes when the electrode support is mounted on the subject, whether a contact impedance between each tested electrode and the surface of the external body part of the subject meets a predetermined criteria providing, by the control unit to an external computing device, contact quality test result information based on determining whether the contact impedance between each tested electrode and the surface of the external body part of the subject meets the predetermined criteria, and displaying on the user interface a representation of contact quality of each of the plurality of electrodes based on the contact quality test result information.
Chetham et. al.’015 teaches determining contact quality values for electrodes based on impedance and selected criteria (Paragraph [0072] - positioning the electrodes on a subject; scoring a plurality of electrical resistivity arrays, wherein each electrical resistivity array 10 comprises a pair of current-injecting electrodes and a pair of voltage detection electrodes, wherein the score comprises an estimation of signal error for the electrodes in the electrical resistivity array and an estimation of a depth of investigation for the electrical resistivity array; applying current and recording voltages from a subject using only those electrical resistivity arrays meeting a selection criterion based upon their scores; and determining a relative spatial 15 change in subsurface resistivities across frequencies using applied currents and resulting voltages only from those electrical resistivity arrays meeting the selection criterion). It would have been obvious to one of ordinary skill in the art to have modified the electrode harness of Stroem’580 in view of Rood et. al.’330 and further in view of Avery et. al.’126 to include measuring quality of contact of electrodes against a known criteria in order to better ensure that the readings are accurate as seen in Chetham et. al.’015.
Stroem’580 further fails to disclose providing, by a user interface of the external computing device, information to a user based on the EIT reconstruction. Yoo et. al.’131 teaches providing information regarding electrical signals from electrodes via an external device with user interface (Page 10 Paragraph 10 - intelligent mobile phone, tablet computer or notebook computer external equipment 900 is connected; Page 5 Paragraph 10 - the detection can be transmitted to the external device for display, and can be received from the external device control signal; Page 5 Paragraph 8 - calculating the impedance matrix by the measured impedance values, the external equipment 900 by impedance matrix reverse-pushing inner skin structure to calculate the impedance distribution of the skin). It would have been obvious to one of ordinary skill in the art to have modified the method of Stroem’580 in view of Rood et. al.'330, further in view of Chetham et. al.’015, and further in view of Avery et. al.'126 to include providing, by a user interface of the external device, information to a user based on the derived electrical properties in order for a user to receive and respond to the displayed information as seen in Yoo et. al.’131.
Regarding Claim 28, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Yoo et. al.’131 discloses the method outlined in Claim 27 above. Stroem’580 also discloses wherein carrying out an EIT reconstruction of impedance responses is performed by the control unit (Paragraph [0024] - Furthermore, if the size, shape or position of the body structure which is to be imaged does not alter with time, or if impedance measurements are made (and therefore impedance images generated) at the same point in a relevant physiological cycle, such as the breathing cycle or cardiac cycle, then it will be obvious to those skilled in the art that only one physical image needs to be stored in the digital data store 7) and the method further comprises: transmitting, by communication circuitry of the control unit, information based on the EIT reconstruction to the external computing device (Paragraph [0007] - The physical image may be obtained, for example, by computer generation or by using a conventional physical imaging system, such as an x-ray system; a computer aided tomography system; a magnetic resonance imaging system; or an ultrasonic imaging system and may even be a "template image" representative of a typical image of the region of interest).
Regarding Claim 29, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Yoo et. al.’131 discloses the method outlined in Claim 27 above, but fails to disclose wherein carrying out an EIT reconstruction of impedance responses is performed by the external computing device and the method further comprises: transmitting, by communication circuitry of the control unit, information associated with the electrical response signals to the external computing device. Yoo et. al.’131 teaches an external device that performs EIT reconstruction of impedance signals (Page 3 Paragraph 3 - a plurality of electrodes in contact with the skin and the applied electrical signal set on the flexible substrate as the impedance of the electrical signal and measuring the measuring object skin between the plurality of the electrodes, then transmitted to the external device for restoration to a three dimensional tomographic image and to display) and transmits information via communication circuitry (Page 4 Last Paragraph - the circuit layer may include a communication connection part of connection with the communication cable). It would have been obvious to one of ordinary skill in the art to have modified the method of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include an external device capable of EIT restoration to create images and displays of the information from the electrodes in order for the user to receive and understand the readings as seen in Yoo et. al.’131.
Regarding Claim 30, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Yoo et. al.’131 discloses the method outlined in Claim 27 above, but fails to disclose wherein the user interface of the external computing device is a display, the method further comprising: determining one or more parameters relating to functioning of the part of the subject within the external body part; and displaying at least one of the one or more parameters on the display of the external computing device. Yoo et. al.’131 teaches an external computing device with a user interface and display system (Page 10 Paragraph 10 - intelligent mobile phone, tablet computer or notebook computer external equipment 900 is connected; Page 5 Paragraph 10 - the detection can be transmitted to the external device for display, and can be received from the external device control signal; Page 11 and Paragraph 4 - so as to not only display the image, but also display a different distance in the depth direction of the image and the distribution of the relative impedance value of each image, and so on) used to determine and communicate impedance values (Page 5 Paragraph 8 - when calculating the impedance matrix by the measured impedance values, the external equipment 900 by impedance matrix reverse-pushing inner skin structure to calculate the impedance distribution of the skin). It would have been obvious to one of ordinary skill in the art to have modified the method of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, and further in view of Chetham et. al.’015 to include using an external computing device with user interface to display readings of electrodes in order for the user to receive and visualize readings obtained from the device as seen in Yoo et. al.’131.
Regarding Claim 32, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Yoo et. al.’131 discloses the method outlined in Claim 27 above, but fails to disclose determining a position of the electrodes with respect to the external body part of the subject when the electrode support is mounted on the subject. Chetham et. al.’015 teaches determining positions of electrodes (Paragraph [0026] - The data recording unit may record the voltage(s) sensed as well as the identity and/or positions of the driving electrodes (e.g., current source/current sink) and sensing electrodes corresponding to the sensed voltages, as 35 well as the frequency of the current being applied…the matrix of sensed voltages as well as the relative positions of the electrodes doing the driving and sensing, may be used to solve for the electrical properties within the sub-regions beneath the sensor, as described in detail below). It would have been obvious to one of ordinary skill in the art to have modified the method of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Yoo et. al.’131 to include determining positions of electrodes in order to gather accurate readings of electrical properties as seen in Chetham et. al.’015.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Stroem'580 (EP Patent Application 1000580 – previously cited) in view of Rood et. al.'330 (U.S. Patent 8201330 – previously cited), further in view of Chetham et. al.’015 (WO Patent Publication 2015003015 – previously cited), further in view of Avery et. al.'126 (WO Patent Publication 2013177126 – as cited by applicant), further in view of Yoo et. al.'131 (CN Patent Application 105899131) as applied to Claim 21 above, and further in view of Song et. al.'637 (WO Patent Publication 2009042637).
Regarding Claim 26, Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Yoo et. al.’131 discloses the system outlined in Claim 21 above, but fails to disclose wherein the external computing device is configured to determine positions of the electrodes with respect to the external body part of the subject when the electrode support is mounted on the subject based on photogrammetry using one or more images obtained of the electrode harness when mounted on the subject, or laser based time-of-flight measurements. Song et. al.’637 teaches using images to determine positions of electrodes (Paragraph [0019] - multicamera photogrammetry to track surface electrode position; Paragraph [0054] - Electrode and fiducial location measurement from photogrammetry: In order to follow surface changes, surface marker movement may be recorded using four cameras). It would have been obvious to one of ordinary skill in the art to have modified the system of Stroem'580 in view of Rood et. al.'330, further in view of Avery et. al.'126, further in view of Chetham et. al.’015, and further in view of Yoo et. al.’131 to include images that track positions of electrodes in order to ensure there is appropriate contact between the electrode for the electrode to gather readings as seen in Song et. al.’637.
Response to Arguments
Applicant's arguments filed 22 December 2025 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior claim objections.
Applicant’s amendments have overcome the prior 35 U.S.C. 112b rejections.
Application’s amendments and reasons regarding overcoming the prior 35 U.S.C. 101 rejections were considered, but were found not to be persuasive. The applicant had amended the claims to remove the limitation "step of deriving electrical properties from an EIT reconstruction of impedance responses" as an attempt remove the recited “judicial exception”, but as addressed in the Paragraphs above, the examiner notes that additional limitations have been added that set forth judicial exceptions. The analysis of the 101 rejection is in Paragraph 3 above.
Claims 1-6, 8-18, 20-30, and 32 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 4-9 above. It is noted that Claims 1-2, 15, and 17 that were once rejected under 35 U.S.C. 102 are now rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraph 4 above.
The examiner has considered the applicant's arguments regarding Chetham et. al.’015 teaching away from Stroem’580, but these arguments were found to not be persuasive. The applicant is arguing that Chetham et. al.’015 “teaches away” from determining tissue wetness. However, Chetham et al.'015 is not being relied upon to teach using EIT for tissue wetness/hydration monitoring. Additionally, it is noted by the examiner that the instant application’s claims are not directed towards tissue wetness/hydration that would require Stroem'580 to require this type of element or reliance. Chetham et. al.'015 was relied upon to teach electrode contact quality control, positioning electrodes on a front and back portion of a subject, electrodes with conductive material, and an elastic material containing electrodes. These relied upon elements of Chetham et. al.’015 solve the issues of Stroem'580 that would enable the invention of Stroem'580 to be able to ensure electrodes are positioned appropriately in order to receive accurate readings, obtain measurements across a subject's body, sense electrical properties across said electrodes, and include a material that enables electrodes to conform to a subject's body in order to obtain accurate readings while withstanding a subject’s movements. All of which the examiner believes would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed as addressed in Paragraphs 4-8 above.
Additionally, the examiner notes the following recitation of MPEP 2145 Section X.D.1.: "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.") (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)). The examiner further notes the following recitation of MPEP 2141.01(a) Section I: “A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212”. Based on these two sections of the MPEP as well as the rationales stated above by the examiner within this “Response to Argument” section, Chetham et. al.’015 is not believed to “teach away” from Stroem’580 as argued by the applicant.
The examiner has also considered the applicant's arguments regarding the electrodes of Avery and Chetham et. al.’015 teaching alternative approaches, but these reasonings were found to not be persuasive. The examiner notes that Chetham et. al.’015 teaches a conductive material to provide a surface for electrical properties to be sensed across electrodes whereas Avery teaches abrasive electrodes in order to obtain electrical signal from beyond surface level access skin/tissue. Therefore, these elements provide advantageous modifications to the device of Stroem'580 for different reasons. Furthermore, Avery teaches that the electrode tips could be coated in a conductive gel and therefore, the addition of quality testing, as seen in Chetham et. al.’015, would ensure the coating of Avery is not affected during actions such as rotating the electrode into a surface of a user's skin/tissue.
Furthermore, it is noted by the examiner that the examiner has considered the applicant's arguments regarding Stroem’580 failing to indicate a need to improve electrodes, but they are found to not be persuasive. Although Stroem'580 does not indicate a need to improve their device as stated by the applicant, this does not mean that improvement cannot or does not need to be made. The modifications, as addressed in Paragraphs 4-8, indicate how and why such modifications would be advantageous.
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 SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791