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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/25/2026 has been entered.
Response to Amendment
The amendment filed 06/25/2026 has been entered. Claims 1-2, 4, 6-9, 11-20 & 22-23 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed 03/25/2026.
Response to Arguments
Applicant's arguments with respect to claims 1-2, 4, 6-9, 11-20 & 22-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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 is rejected under 35 U.S.C 103 as being unpatentable over Zhu (US 20030120170) herein referred to as Zhu and Zhu et al. (US 10362968) herein referred to as Zhu2 in further view of Bohorquez et al. (US 20130338473) herein referred to as Bohorquez.
Regarding Claim 1, Zhu discloses An appliance for monitoring compression therapy of a compression means (Figure 2) comprising: a measuring device (Figure 2, 1 & 3) including: a compressive member comprising a textile material configured to be applied to a body portion of a wearer (Paragraph [0053]; wherein the compressive wrapping is composed of a fabric or other flexible material that preferably is capable of being easily cleaned and/or decontaminated and is wrapped around a body segment), the measuring device having two end sections (See annotated Figure 10 below), which enclose a middle section between the end sections (See annotated Figure 10 below), the middle section being configured to compress the body portion when applied to the body portion of the wearer (Paragraph [0033]; wherein wrap compresses the body segment when applied), 4 electrodes arranged in a end section (Figure 10, 9 & 10), a first electrode in the end section forming a first electrode pair (Figure 10, 9), a second electrode in each end section forming a second electrode pair (Figure 10, 10), wherein an electric current is determined via the first electrode pair (Paragraph [0060]; wherein current flow through electrodes 9 is at a constant current) and an electric voltage is determined via the second electrode pair (Paragraph [0081]; wherein electrodes 10 measure voltage), wherein the electrodes are designed so that the electric current, when the measuring device is applied to a wearer, flows between the electrodes of the second electrode pair through the body of the wearer below the skin (Paragraph [0081]; wherein a current source which generates different frequencies injected at constant current to the electrodes 9; a synchronized control circuit used to synchronize the phase between the current and voltage measured; a measuring circuit which includes amplifier and filter circuits for measuring voltage from the measurement electrodes 10; Paragraph [0013]; wherein the electrical input means being adapted to receive the current transmitted through the body segment therefore is seen as being through the skin since it is being transmitted through a body segment); and an evaluation device coupled to the electrodes for monitoring a variation of a bioimpedance of the body portion of the wearer responsive to a change in liquid content in the body portion by compression thereof by at least the middle section of the compressive wrapping during the compression therapy (Figure 2, 1; Paragraph [0064]; wherein the measuring hydration before and after treatment is the same as monitoring a change in liquid content in the body portion since its measuring the amount of water in that portion; Paragraph [0081]; wherein assessing change in the extracellular volume using bioimpedance techniques during hemodialysis treatments is described in detail), wherein the evaluation device is able to determin the variation in bioimpedance being ascertained via measurement of phase shift between the electric voltage and the electric current (Paragraph [0081]; wherein synchronized control circuit used to synchronize the phase between the current and voltage measured which is used assessing change in the extracellular volume using bioimpedance techniques) wherein the phase shift is induced by the change in the liquid content (Paragraph [0081]; wherein synchronized control circuit used to synchronize the phase between the current and voltage measured which is used assessing change in the extracellular volume using bioimpedance techniques therefore, the phase shift is induced by the change in the liquid content). However, Zhu does not explicitly disclose two electrodes arranged in each longitudinal end section, a first electrode in each longitudinal end section forming a first electrode pair, a second electrode in each longitudinal end section forming a second electrode pair; wherein the evaluation device is able to determine the variation in bioimpedance being ascertained via measurement of a phase shift between a sine curve of the electric voltage and a sine curve of the electric current.
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Zhu2 discloses a measuring device (Figure 4) wherein two electrodes arranged in each longitudinal end section (See annotated figure 4 below), a first electrode in each longitudinal end section forming a first electrode pair (Figure 4, “current injecting electrodes”), a second electrode in each longitudinal end section forming a second electrode pair (Figure 4, “measuring electrodes”). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the design of the measuring device taught by Zhu to be designed as taught by Zhu2. The motivation being a simple substitution of one measuring device design, Zhu having 4 electrodes in one end section for another, Zhu2 having two electrodes in each end section to obtain predictable results of measuring voltage and current passing through the electrode pairs (MPEP 2143 (B)).
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Bohorquez discloses an appliance (Figure 1) wherein the evaluation device is able to determine the variation in bioimpedance being ascertained via measurement of a phase shift between a sine curve of the electric voltage and a sine curve of the electric current (Figure 62A). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the evaluation device taught by Zhu in view of Zhu2 to determine the variation in bioimpedance as measured by Bohorquez. The motivation being the shifting of the voltage sine curve relative to the current sine curve allows for detection of disease progression (Bohorquez, Paragraph [0013]).
Regarding claim 12, Zhu and Zhu2 in further view of Bohorquez discloses the appliance according to claim 1. Zhu also discloses wherein the compressive member is a compression wrapping (Paragraph [0053]; wherein the pressure cuff 3 is a blood-pressure cuff type device that comprises a substantially rectangular form suitable for wrapping around a body segment, such that the body segment is encircled by the device)
Regarding claim 16, Zhu and Zhu2 in further view of Bohorquez discloses the appliance according to claim 1. Zhu also discloses wherein the change in the liquid content includes a loss of liquid in the body portion (Paragraph [0074]; wherein the loss of liquid is the loss of blood in a limb)
Regarding claim 23, Zhu and Zhu2 in further view of Bohorquez discloses the appliance according to claim 1. Zhu also discloses wherein: the compressive member is a compressive wrapping defining a longitudinal axis along which the wrapping extends (Figure 2, 3; Paragraph [0033]; wherein compressive wrapping 3 is meant to compress a body segment); the two end sections are longitudinal end sections (See annotated Figure 10 below); the middle section has a greater elasticity in at least a longitudinal direction relative to the longitudinal end sections (Paragraph [0053]; wherein wrapping 3 is flexible, and end portions contain Velcro 26 & conductive plates 28 which are both not flexible in a longitudinal direction therefore the middle section containing all flexible components is seen to have a great elasticity); and the middle section defines a longitudinal length greater than a corresponding longitudinal length of each of the two longitudinal end sections (See annotated Figure 10 below).
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Claim 2 is rejected under 35 U.S.C 103 as being unpatentable over Zhu, Zhu2 and Bohorquez in further view of UCHIMAYA (Translated JP 2013132325 provided) herein referred to as UCHIMAYA.
Regarding claim 2, Zhu and Zhu2 in further view of Bohorquez discloses the appliance of claim 1. However, Zhu and Zhu2 in further view of Bohorquez does not explicitly disclose wherein a direct current source is used as a current source, wherein an oscillator is arranged between the direct current source and the first electrode pair
UCHIYAMA discloses an appliance for monitoring the compression therapy of a compression means (Figure 1, 1) wherein a direct current source is used as the current source (Paragraph [0054]; wherein direct current can be used as the current source), and wherein an oscillator is arranged between the direct current source and the first electrode pair (Figure 11, 204; Paragraph [0040]; wherein current generation unit 204 acts as oscillator generating periodic signals). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the appliance taught by Zhu and Zhu2 in further view of Bohorquez to include a direct current source and an oscillator as taught by UCHIYAMA. The motivation to generate periodic signals (UCHIYAMA, Paragraph [0040])
Claims 4, 6, 8, 13-14 are rejected under 35 U.S.C 103 as being unpatentable over Zhu, Zhu2 and Bohorquez in further view of BOZKURT et al. (WO 2016073655) herein referred to as BOZKURT.
Regarding Claim 4, Zhu and Zhu2 in further view of Bohorquez discloses the appliance as claimed in claim 1. However, Zhu and Zhu2 in further view of Bohorquez does not explicitly wherein the textile material of the measuring device is a woven material and the electrodes are woven electrodes.
BOZKURT discloses a smart patch comprising of sensory elements (Figure 2) for monitoring tactile forces (Abstract) wherein the textile material of the measuring device is a woven material and the electrodes are woven electrodes (Figure 4a-d; wherein the electrode from 4a can be seen being weaved in with other sensors and materials to create the final material shown in figure 4d). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the textile material taught by Zhu and Zhu2 in further view of Bohorquez to substitute it for the textile material taught by BOZKURT. The motivation being it allows for a more careful impedance analysis to differentiate tactile-forces based on capacitive changes from the moisture-based conductivity changes when bodily fluids are present (BOZKURT, Paragraph [0090]).
Regarding Claim 6, Zhu and Zhu2 in further view of Bohorquez discloses the appliance as claimed in claim 1. However, Zhu and Zhu2 in further view of Bohorquez does not explicitly disclose wherein the electrodes can be contacted via electrically conductive threads.
BOZKURT discloses a smart patch comprising of sensory elements (Figure 2) wherein the electrodes can be contacted via electrically conductive threads (Figure 4; wherein electrode is contacted by CoMFi threads; Paragraph [0098]; wherein CoMFi is designed to be conductive). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the textile material taught by Zhu and Zhu2 in further view of Bohorquez to substitute it for the textile material taught by BOZKURT. The motivation being using electrically conductive threads can provide better contact with the surface for biopotential detection. (BOZKURT, Paragraph [00116]).
Regarding Claim 8, Zhu and Zhu2 in further view of Bohorquez discloses the appliance as claimed in claim 1. However, Zhu and Zhu2 in further view of Bohorquez does not explicitly disclose wherein an electrically conductive coating is applied in the region of the electrodes.
BOZKURT discloses a smart patch comprising of sensory elements (Figure 2) wherein an electrically conductive coating is applied in the region of the electrodes (Figure 20; wherein a conductive paste coating is applied to region of the electrodes). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the textile material taught by Zhu and Zhu2 in further view of Bohorquez to include an electrically conductive coating taught by BOZKURT. The motivation being applying a known technique, applying a conductive coating, to a known device, the electrodes of the measurement device taught by Zhu in view of Zhu2, for improvement to yield predictable results of establishing a better conductive connection between the electrodes and the skin of the user (MPEP 2143 (D)).
Regarding Claim 13, Zhu, Zhu2 and Bohorquez in further view of BOZKURT discloses the appliance as claimed in claim 6. BOZKURT also discloses wherein the electrically conductive threads are guided in the textile material (Figure 9; wherein electrically conductive threads are woven in with nonconductive threads in the textile material). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the textile material taught by Zhu to substitute it for the textile material taught by BOZKURT. The motivation being a simple substitution of the textile material taught by Zhu in view of Zhu2 for the textile material taught by BOZKURT to obtain predictable results of monitoring the compression therapy of a compression means (MPEP 2143 (B)).
Regarding Claim 14, Zhu, Zhu2 and Bohorquez in view of BOZKURT discloses the appliance as claimed in claim 13. BOZKURT also discloses wherein the electrically conductive threads are guided in the textile material and are connected via this guiding to a current source and/or an evaluation device (Figure 9; Paragraph [00108]; wherein the patch 10, is constructed of electrically conductive threads and non-conductive threads which are connected to an array of sensors for concurrent tactile, biopotential and wetness detection which are connected to a PCB which is further discussed in Paragraph [00117]). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the textile material taught by Zhu and Zhu2 in further view of BOZKURT to include the current source connections taught BOZKURT. The motivation being a simple substitution of the textile material taught by Zhu and Zhu2 in further view of BOZKURT for the textile material taught by BOZKURT to obtain predictable results of monitoring the compression therapy of a compression means (MPEP 2143 (B)).
Claim 7 is rejected under 35 U.S.C 103 as being unpatentable over Zhu, Zhu2 and Bohorquez in further view of GU et al. (US 20170367594) herein referred to as GU.
Regarding Claim 7, Zhu and Zhu2 in further view of Bohorquez discloses the appliance of claim 1. However, Zhu and Zhu2 in further view of Bohorquez does not explicitly disclose wherein the end sections are inelastic and the middle section is elastic.
GU discloses a multi sensor wrapping (Figure 2) wherein the end sections are inelastic (Paragraph [0061]; wherein the strip can include rigid therefore inelastic terminal ends) and the middle section is elastic (Paragraph [0031]; wherein the backing of the strip is flexible therefore elastic being able to wrap and conform to the surface of a subject). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the appliance taught by Zhu and Zhu2 in further view of Bohorquez to include elastic and inelastic portions as taught by GU. The motivation being by having a portion of the device being flexible or therefore elastic, it can allow for motion of the limb (GU, Paragraph [0045]).
Claim 9,11, 15, 17-18 & 20,22 are rejected under 35 U.S.C 103 as being unpatentable over Zhu, Zhu2 and Bohorquez in further view of Pan et al (US 20180000651) herein referred to as Pan
Regarding claim 9, Zhu discloses a method for compression therapy (Paragraph [0033]), comprising: applying compression to a body portion of a wearer with a compression member (Paragraph [0013]), the compression member comprising a textile material and having two end sections to accommodate the region of the body portion (Figure 10; Paragraph [0053]; wherein the compressive wrapping is composed of a fabric or other flexible material that preferably is capable of being easily cleaned and/or decontaminated and is wrapped around a body segment), wherein a end section has four electrodes (Figure 10, 9 & 10), which each interact with the electrodes of the longitudinal end section in pairs (Figure 10; electrodes 9 are a pair and electrodes 10 are a pair); applying an electrical current between the electrodes of a first pair of the electrodes and through the region of the body portion (Paragraph [0081]; wherein a current source which generates different frequencies injected at constant current to the electrodes 9; a synchronized control circuit used to synchronize the phase between the current and voltage measured; a measuring circuit which includes amplifier and filter circuits for measuring voltage from the measurement electrodes 10; Paragraph [0013]; wherein the electrical input means being adapted to receive the current transmitted through the body segment therefore is seen as being through the skin since it is being transmitted through a body segment); detecting an electrical voltage between the electrodes of a second pair of the electrodes through the region of the body portion (Paragraph [0081]; wherein a current source which generates different frequencies injected at constant current to the electrodes 9; a synchronized control circuit used to synchronize the phase between the current and voltage measured; a measuring circuit which includes amplifier and filter circuits for measuring voltage from the measurement electrodes 10; Paragraph [0013]; wherein the electrical input means being adapted to receive the current transmitted through the body segment therefore is seen as being through the skin since it is being transmitted through a body segment); determining bioimpedance of the region of the body portion of the wearer wherein determining bioimpedance comprises measuring a phase shift between the electrical voltage and electrical current (Paragraph [0081]; wherein synchronized control circuit used to synchronize the phase between the current and voltage measured which is used assessing change in the extracellular volume using bioimpedance techniques); and monitoring the bioimpedance of the region of the body portion during the compression therapy to determine a variation in the bioimpedance (Figure 7), the variation in bioimpedance representative of a change in a liquid content in the region of the body portion by compression of the compression member (Paragraph [0064]; wherein the measuring hydration before and after treatment is the same as monitoring a change in liquid content in the body portion since its measuring the amount of water in that portion). However, Zhu does not explicitly disclose wherein a compression member to stimulate liquid flow in a region of the body portion to treat edema; and each end section has two electrodes which each interact with the electrodes of the other longitudinal end section in pairs;
Zhu2 discloses a measuring device (Figure 4) wherein two electrodes arranged in each longitudinal end section (See annotated figure 4 below), a first electrode in each longitudinal end section forming a first electrode pair (Figure 4, “current injecting electrodes”), a second electrode in each longitudinal end section forming a second electrode pair (Figure 4, “measuring electrodes”). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the design of the measuring device taught by Zhu to be designed as taught by Zhu2. The motivation being a simple substitution of one measuring device design, Zhu having 4 electrodes in one end section for another, Zhu2 having two electrodes in each end section to obtain predictable results of measuring voltage and current passing through the electrode pairs (MPEP 2143 (B)).
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Pan discloses a method for compression therapy (Paragraph [0015]), comprising: applying compression to a body portion of a wearer with a compression member to stimulate liquid flow in a region of the body portion to treat edema (Paragraph [0013]). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the compression member taught by Zhu in view of Zhu2 to allow to stimulate liquid flow in a region of the body portion to treat edema as taught by Pan. The motivation being to improve the velocity and flow of venous blood and lymph return and to decrease edema and reduce venous hypertension and its long-term complications (Pan, Paragraph [0013].
Bohorquez discloses an appliance (Figure 1) wherein the evaluation device is able to determine the variation in bioimpedance being ascertained via measurement of a phase shift between a sine curve of the electric voltage and a sine curve of the electric current (Figure 62A). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the evaluation device taught by Zhu in view of Zhu2 to determine the variation in bioimpedance as measured by Bohorquez. The motivation being the shifting of the voltage sine curve relative to the current sine curve allows for detection of disease progression (Bohorquez, Paragraph [0013]).
Regarding claim 11, Zhu and Zhu2 in further view of Pan discloses the method of claim 9. Zhu also discloses wherein the compression member is a compression wrapping (Paragraph [0053]; wherein the pressure cuff 3 is a blood-pressure cuff type device that comprises a substantially rectangular form suitable for wrapping around a body segment, such that the body segment is encircled by the device), and wherein applying compression includes winding compression member onto the body portion as a bandage (Paragraph [0053]; wherein the pressure cuff 3 is a blood-pressure cuff type device that comprises a substantially rectangular form suitable for wrapping around a body segment, such that the body segment is encircled by the device).
Regarding claim 15, Zhu and Zhu2 in further view of Pan discloses the method of claim 9. Zhu also discloses wherein the body to which the compression member is applied is a limb of a wearer (Paragraph [0062]; wherein the body segment may be any portion of the body or the entire body, but is preferably a limb segment, more preferably a leg or arm segment, most preferably a thigh segment)
Regarding claim 17, Zhu and Zhu2 in further view of Pan discloses the method of claim 9. Zhu also discloses wherein the compression member comprises a middle section disposed between the two longitudinal end sections (See annotated Figure 10 below), and wherein applying compression includes positioning the middle section on the region of the body portion to compress the region (Paragraph [0053]; wherein contained within the pressure cuff 3 is a flexible air-bladder 25 or similar means of compressing the body segment, and applying substantially circumferential pressure of at least about systolic blood pressure to the body segment).
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Regarding claim 18, Zhu, Zhu2 and Bohorquez in further view of Pan discloses the method of claim 9. Zhu also discloses wherein the middle section of the compression member has a greater elasticity than the longitudinal end sections (Paragraph [0053]; wherein wrapping 3 is flexible, and end portions contain Velcro 26 & conductive plates 28 which are both not flexible in a longitudinal direction therefore the middle section containing all flexible components is seen to have a great elasticity) and wherein applying compression includes compressing the region of the body portion with the middle section (Paragraph [0053]; wherein contained within the pressure cuff 3 is a flexible air-bladder 25 or similar means of compressing the body segment, and applying substantially circumferential pressure of at least about systolic blood pressure to the body segment).
Regarding claim 20, Zhu, Zhu2 and Bohorquez in further view of Pan discloses the method of claim 9. Zhu also discloses including coupling an evaluation device to the electrodes and wherein monitoring the bioimpedance of the region of the body portion is performed with the evaluation device (Figure 2, 1).
Regarding claim 22, Zhu, Zhu2 and Bohorquez in further view of Pan discloses the method of claim 9. Zhu also discloses wherein the change in the liquid content includes a loss of liquid in the region of the body portion (Paragraph [0074]; wherein the loss of liquid is the loss of blood in a limb).
Claim 19 is rejected under 35 U.S.C 103 as being unpatentable over Zhu, Zhu2, Bohorquez, Pan, and GU.
Regarding Claim 19, Zhu, Zhu2 and Bohorquez in view of Pan discloses the method of claim 18. However, Zhu, Zhu2 and Bohorquez in view of Pan does not explicitly disclose wherein the end sections are inelastic and the middle section is elastic.
GU discloses a multi sensor wrapping (Figure 2) wherein the end sections are inelastic (Paragraph [0061]; wherein the strip can include rigid therefore inelastic terminal ends) and the middle section is elastic (Paragraph [0031]; wherein the backing of the strip is flexible therefore elastic being able to wrap and conform to the surface of a subject). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the appliance taught by Zhu, Zhu2 and Bohorquez in view of Pan to include elastic and inelastic portions as taught by GU. The motivation being by having a portion of the device being flexible or therefore elastic, it can allow for motion of the limb (GU, Paragraph [0045]).
Conclusion
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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