DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In response to amendments, filed January 22, 2026, claims 1, 4, 20, 30, and 32-33 have been amended. Claims 6-9 have been cancelled. No claims have been added. Claims 1-5, 10, 14, 20, and 26-33 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed January 22, 2026, with respect to the drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive in view of the amendments -- although claims were not updated to include “varies in a stepwise manner” or “stepwise” as stated in the Remarks. Claim 10 still depends from claim 4, rather than claim 8 as stated in the Remarks, but the claim 1 was amendment resolves the previous antecedent basis issue. The 35 USC 112(b) rejections have been withdrawn.
Applicant’s arguments with respect to the prior art rejections have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Milgrom (US 20200297522 A1), Gallegos (US 20060277796 A1), Chatzistergos (US 20180116523 A1), and Gefen (US 20050165284 A1).
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(s) 1, 3-5, 10, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milgrom (US 20200297522 A1) in view of Gallegos (US 20060277796 A1) and Chatzistergos (US 20180116523 A1).
Regarding claim 1, Milgrom teaches a foot support structure (insole adaptive layer (IAL) 400, insole 900) comprising:
a foot support surface for engagement by a foot of a subject ([0090] “In some embodiments, the IAL 400, base 802 and/or the cover 804 are placed in a shoe. In some embodiments, the IAL 400 replaces a shoe insole. In some embodiments, and as shown in the exemplary embodiment depicted in FIGS. 9A-9C, which are plan view simplified illustrations of an insole adaptive layer in accordance with some embodiments of the invention, the IAL 400 covers at least a portion of an insole 900.”);
and a tissue loading alleviation zone within said foot support surface, wherein said tissue loading alleviation zone defines a region of said foot support surface configured for optimizing an internal tissue loading state in a volume-of-interest (VOI) in said foot of said subject ([0094] “In some embodiments, the IAL comprises various areas having different mechanical properties for engaging at least one of plantar region of a patient. In one example, an IAL can be manufactured for subjects who suffers plantar ulcers (e.g., diabetics), wherein the IAL of the patient includes zones 402 made to engage with the plantar areas containing the ulcers. In this example, the zones engaging with the plantar areas containing the ulcers have a lower Shore hardness and higher elasticity than the surrounding zones 402 of the IAL which engage with the healthy portions of the subject's foot. In this example, the IAL relieves some of the pressure applied by an insole to ulcers within weight-bearing plantar areas.”). However, Milgrom fails to disclose removable sections of the foot support structure.
Gallegos teaches an insole for use in footwear, and is comprised of a plurality of sections that are removably or securably attachable to a bottom layer. Gallegos discloses and wherein said region comprises a plurality of removable sections ([0032] “The insole 2 is formed of a plurality of sections that are integral with the insole or that are removably attachable or securably attachable to at least a portion of the top side 6 of the bottom layer of the insole.” Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the foot support structure of Milgrom to include removably secured sections as disclosed in Gallegos because of increased versatility and speed of construction versus conventional custom or special-fit insoles, as depending upon needs and changes in a wearer's foot, certain sections can be switched with other counterpart sections that can be made from a spectrum of different materials having different hardnesses and/or different surfaces that reduce the risk of many foot complications, such as the formation of calluses, foot ulcers, poor circulation, decreased resistance to infection, foot deformities, and neuropathy, that are especially problematic for diabetics (Gallegos [0004, 0027]).
The combination of Milgrom/Gallegos discloses sections arranged in a sequence representing a change in at least one mechanical property along at least one dimension of said region, and wherein said change represents one of: an increase or a decrease in said value of said at least one mechanical property along said at least one dimension of said region (Milgrom: [0091] “Reference is made to FIG. 10A-C, which are cross section view simplified illustrations of an insole adaptive layer in accordance with some embodiments of the invention…. In some embodiments, such as depicted by FIG. 10C, the boundary lines 404 of each zone 402 are virtual lines 1000 separating at least two regions of the IAL which comprise different mechanical properties. In some embodiments, such as depicted by FIG. 10C, the IAL comprises segments 1002 of materials.” [0093] “the IAL comprises a plurality of zones 402 configured to succumb to pressure applied by a corresponding plantar pressure zone on a subject's sole placed on said insole. In some embodiments, the Shore hardness of the surface of a zone 402 corresponding to a high-pressure region of the pedobarographic data is lower than the Shore hardness of the surface of a zone 402 corresponding to a low pressure region of the pedobarographic data. In some embodiments, the Shore hardness of a zone 402 is inversely related to the pressure measurement of the corresponding region of the pedobarographic data.” [0047] “regions of the device corresponding to areas having an extra high and/or high pressure may have lower thickness than regions of the device corresponding to areas having medium pressure. ... to prevent injuries, a borderline between regions of different thicknesses is smooth and continuous. In a non-limiting example, a thickness may vary gradually from a region of a first thickness to a region of a second thickness.”).
However, the combination of Milgrom/Gallegos fails to disclose internal tissue stress analysis. Chatzistergos teaches prescribing an optimised insole to decrease plantar soft tissue internal stress.
Chatzistergos discloses and wherein said change is determined by minimizing a combined tissue loading index calculated from internal tissue stress analysis of said VOI and wherein said mechanical property's variation is determined based on said internal tissue loading state ([0043] “Tissue properties may be determined based on ultrasound and/or pressure measurements. … The properties may be calculated based on the tissue being under different loads. Any one of or any combination of the following properties may be measured based on the ultrasound and/or pressure measurements: tissue thickness, structural integrity, structural details, configuration of fatty cells, alignment of macro and micro chambers, internal deformation, energy absorption capacity, stiffness during loading, perfusion.” [0047] “The mechanical properties of an insole may be prescribed to decrease plantar soft tissue internal stress. The mechanical properties of an insole may be prescribed to decrease peak or average plantar pressure, plantar pressure-time integral, the rate plantar pressure is applied and/or plantar shear stress/load at a region of interest.” [0048] “The diagnostic device may comprise means to calculate materials for an optimised insole. The diagnostic device may comprise means to calculate an optimised shape for an insole. A material may be selected from a database, where the selected material may have the closest mechanical properties to the mechanical properties identified, relative to other materials in the database.” [0050] “A variable contoured insole may be printed from a 3D printer to match the required mechanical properties. 3D printing of bespoke insoles is advantageous as this method of manufacture has the ability to create a variety of different materials with different characteristics. These characteristics may include shore hardness, density, elasticity, viscosity, stress-strain relationship, etc.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Milgrom/Gallegos to include internal tissue stress analysis as disclosed in Chatzistergos to prescribe an optimized insole with mechanical properties that effectively reduce internal pressure in required regions of the sole of the foot to relieve or prevent certain symptoms (Chatzistergos [0047, 0052]).
Regarding claim 3, the combination of Milgrom/Gallegos/Chatzistergos discloses the foot support structure of claim 1, wherein said at least one mechanical property is one of: resiliency, flexibility, elasticity, density, stiffness, and compressibility (Milgrom: [0070] “the mechanical properties include at least one or combination of Shore hardness, young's modulus, shear modulus, yield stress, compression, thickness, elasticity, and ductility.”).
Regarding claim 4, the combination of Milgrom/Gallegos/Chatzistergos discloses the foot support structure of claim 1, wherein said region comprises a plurality of sub-zones, and wherein said at least one mechanical property value varies by associating each of said sub-zones with a specified value of said at least one mechanical property (Milgrom: [0079] “FIG. 4, zone 402-1 surrounds zone 402-2;” [0091] “such as depicted by FIG. 10C, the boundary lines 404 of each zone 402 are virtual lines 1000 separating at least two regions of the IAL which comprise different mechanical properties. In some embodiments, such as depicted by FIG. 10C, the IAL comprises segments 1002 of materials.” [0093] “the IAL comprises a plurality of zones 402 configured to succumb to pressure applied by a corresponding plantar pressure zone on a subject's sole placed on said insole. In some embodiments, the Shore hardness of the surface of a zone 402 corresponding to a high-pressure region of the pedobarographic data is lower than the Shore hardness of the surface of a zone 402 corresponding to a low pressure region of the pedobarographic data. In some embodiments, the Shore hardness of a zone 402 is inversely related to the pressure measurement of the corresponding region of the pedobarographic data.” [0047] “In a non-limiting example, a thickness may vary gradually from a region of a first thickness to a region of a second thickness.”).
Regarding claim 5, the combination of Milgrom/Gallegos/Chatzistergos discloses the foot support structure of claim 4, wherein said optimizing comprises determining, with respect to the tissue loading alleviation zone (Milgrom: [0094] “In some embodiments, the IAL comprises various areas having different mechanical properties for engaging at least one of plantar region of a patient. In one example, an IAL can be manufactured for subjects who suffers plantar ulcers (e.g., diabetics), wherein the IAL of the patient includes zones 402 made to engage with the plantar areas containing the ulcers. In this example, the zones engaging with the plantar areas containing the ulcers have a lower Shore hardness and higher elasticity than the surrounding zones 402 of the IAL which engage with the healthy portions of the subject's foot. In this example, the IAL relieves some of the pressure applied by an insole to ulcers within weight-bearing plantar areas.”), one or more of: dimensions of the tissue loading alleviation zone, an outline of the tissue loading alleviation zone, arrangement of said sub-zones within the tissue loading alleviation zone, a number of said sub-zones, dimensions of each of said sub-zones, and at least one mechanical property value associated with each of said sub-zones ([0084] “the zone boundary lines 404 of the IAL 400 correspond to the contour lines 502 indicated by the pedobarographic data 500 [and internal stress measurements per Chatzistergos];” [0079] “a boundary line 404 circumscribes a group of zones 402. In some embodiments, the zone boundary lines 404 are visually indistinguishable. In some embodiments, the zone boundary lines 404 are marked onto at least one surface of the IAL 400. In some embodiments, some of the zones 402 are surrounded by other zones 402. For example, in the embodiment depicted by FIG. 4, zone 402-1 surrounds zone 402-2;” [0084] “In some embodiments, each contour line 502 of the pedobarographic data 500 encloses an area 504. In some embodiments, each of the zones 402 in the IAL 400 correspond to an area 504 of the pedobarographic data 500. In some embodiments, each zone 402 corresponding to a specific area 504 is identical in shape and size to the corresponding area 504 in the pedobarographic data 500;” [0047] “Optionally, the device may vary in thickness… regions of the device corresponding to areas having an extra low and/or low pressure may have higher thickness than regions of the device corresponding to areas having medium pressure… Optionally, regions of the device corresponding to areas having an extra high and/or high pressure may have lower thickness than regions of the device corresponding to areas having medium pressure. ... Optionally, to prevent injuries, a borderline between regions of different thicknesses is smooth and continuous. In a non-limiting example, a thickness may vary gradually from a region of a first thickness to a region of a second thickness.”).
Regarding claim 10, the combination of Milgrom/Gallegos/Chatzistergos discloses the foot support structure of claim 4, wherein said plurality of sub-zones (Milgrom: zones 402-1 and 402-2, Fig. 4; zones 402, Fig. 10C) comprises a plurality of said sections arranged to create said tissue loading alleviation zone based, at least in part, on said associated at least one mechanical property of each of said sections (Gallegos: [0027] “depending upon needs and changes in a wearer's foot, certain sections can be switched with other counterpart sections that can be made from a spectrum of different materials having different hardnesses and/or different surfaces. For example, the insole sections can be comprised of cushioning materials or rigid materials to lend support, rigid materials, and those in between. The surface type can also vary based upon type and location of the sections.” Milgrom: [0079] “a boundary line 404 circumscribes a group of zones 402;” [0093] “the Shore hardness of the surface of a zone 402 corresponding to a high-pressure region of the pedobarographic data is lower than the Shore hardness of the surface of a zone 402 corresponding to a low pressure region of the pedobarographic data.” zones 402-1 and 402-2, Fig. 4; zones 402, Fig. 10C).
Regarding claim 14, the combination of Milgrom/Gallegos/Chatzistergos discloses the foot support structure of claim 1, wherein said VOI encompasses at least one of: an ulcerated region of said foot, a region of said foot representing ulceration risk, and a peripheral region surrounding an ulcerated region of said foot (Milgrom: [0042] “As a non-limiting example, thresholds values may be predefined by measuring and analyzing plantar pressure of normal subjects and sick subjects (e.g., subjects suffering from plantar pain and/or plantar ulcers). As a non-limiting example, the percent of deviation of a pressure from a threshold pressure in a specific region is used to compute the durometer of the material suitable for a region of the device corresponding to the plantar region.” [0094] “the IAL comprises various areas having different mechanical properties for engaging at least one of plantar region of a patient. In one example, an IAL can be manufactured for subjects who suffers plantar ulcers (e.g., diabetics), wherein the IAL of the patient includes zones 402 made to engage with the plantar areas containing the ulcers. In this example, the zones engaging with the plantar areas containing the ulcers have a lower Shore hardness and higher elasticity than the surrounding zones 402 of the IAL which engage with the healthy portions of the subject's foot. In this example, the IAL relieves some of the pressure applied by an insole to ulcers within weight-bearing plantar areas.”).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milgrom (US 20200297522 A1) in view of Gallegos (US 20060277796 A1) and Chatzistergos (US 20180116523 A1), and in further view of Gefen (US 20050165284 A1).
Regarding claim 2, the combination of Milgrom/Gallegos/Chatzistergos discloses the foot support structure of claim 1. While the combination of Milgrom/Gallegos/Chatzistergos discloses determining internal tissue loading state via ultrasound and/or pressure measurements of tissue thickness, structural integrity, structural details, configuration of fatty cells, alignment of macro and micro chambers, internal deformation, energy absorption capacity, stiffness during loading, and perfusion for determination of internal stress (Chatzistergos [0043, 0047]), the combination fails to explicitly disclose tissue compressive/tensile stress/strain or energy density.
Gefen teaches a system for determining a risk of pressure ulcer onset on a subject being in contact with a supporting-surface. Gefen discloses wherein said internal tissue loading state is determined based on one or more of: tissue strain, tissue compressive strain, tissue tensile strain, tissue shear strain, tissue strain energy density, tissue compressive stress, tissue tensile stress, tissue shear stress, and tissue hydrostatic pressure ([0217] “With reference to FIG. 17a, FIG. 17b and FIG. 18, in a first experiment two random pressure pulses were applied to the pressure sensors by a direct contact. The contact compressive stress, from 0 KPa to about 4.5 KPa, was converted to internal stress, ranging from 0 KPa to about 600 KPa. As discussed in Example 1, pressure under 0.4 KPa was filtered out, i.e., considered as internal stress of 0 KPa. FIG. 17a shows the applied random contact compressive stress in units of KPa and FIG. 17b shows the calculated internal stress in units of KPa. FIG. 18 shows the pressure and the pressure dose in units of KPa as a function of time for the calculated internal stresses of FIG. 17b. It is shown that the pressure dose trace follows the applied pressure signal over the duration of the two random pulses.” [0248] “For each strain percentage, two mechanical observables were calculated: (i) a tangent tensile modulus, E.sub.t, defined as the slope of the stress-strain curve; and (ii) strain energy density, SED, defined as the area under the stress-strain curve. Thus, a total amount of six mechanical properties was used for comparison between the sub-groups.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Milgrom/Gallegos/Chatzistergos to include determining internal tissue loading state based on tissue compressive/tensile stress/strain or energy density as disclosed in Gefen because focal internal stresses in muscle tissue enveloping bony prominences is considerably higher than surface contact stresses and accounting for those stresses, rather than determining risk of pressure ulcers solely based on interfacial pressures, successfully addresses the problem of calculating stresses in deep tissues so as to determine the pressure ulcers onset once initiated therein (Gefen [0162]).
Claim(s) 20 and 26-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chatzistergos (US 20180116523 A1) in view of Milgrom (US 20200297522 A1) and Gefen (US 20050165284 A1).
Regarding claim 20, Chatzistergos teaches a method ([0047] “method may comprise prescribing an optimised insole”) comprising:
receiving, as input, a volumetric scan of an anatomy of a foot of a subject; generating data representing an internal tissue loading state of a volume of interest (VOI) in said foot, ([0043] “Tissue properties may be determined based on ultrasound and/or pressure measurements. The properties may be calculated based on static and/or dynamic measurements. The properties may be calculated based on the tissue being under different loads. Any one of or any combination of the following properties may be measured based on the ultrasound and/or pressure measurements: tissue thickness, structural integrity, structural details, configuration of fatty cells, alignment of macro and micro chambers, internal deformation, energy absorption capacity, stiffness during loading, perfusion.”), based on the scan wherein said data representing an internal tissue loading state uses finite element analysis to evaluate internal tissue loads in said VOI ([0044] “The tissue properties may be calculated using mathematical and reverse finite element modelling.”).
However, Chatzistergos fails to disclose high-risk and peripheral sub-VOIs. Milgrom teaches a patient specific device for reducing plantar pressure and plantar ulcers.
Milgrom discloses defining, in said VOI, a high-risk sub-VOI and a peripheral sub-VOI ([0079] “FIG. 4, zone 402-1 [peripheral sub-VOI] surrounds zone 402-2 [high-risk sub-VOI];” [0084] “the zone boundary lines 404 of the IAL 400 correspond to the contour lines 502 indicated by the pedobarographic data 500”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Chatzistergos to include defining high-risk and peripheral sub-VOIs as disclosed in Milgrom in order to customize the mechanical properties of different zones of an insole adaptive layer to optimally interface with a subject’s foot for therapeutic benefit (Milgrom [0002, 0071]).
The combination of Chatzistergos/Milgrom discloses and calculating, based on said data, a set of parameters for a tissue loading alleviation zone within a foot support surface of a foot support structure for engagement by said foot of said subject, wherein said calculation minimizes a combined tissue loading index in said high-risk and peripheral sub-VOIs (Chatzistergos: [0047] “The method may comprise prescribing an optimised insole. Mechanical properties of the insole may be prescribed using the measured tissue properties. The mechanical properties of an insole may be prescribed to decrease plantar soft tissue internal stress. The mechanical properties of an insole may be prescribed to decrease peak or average plantar pressure, plantar pressure-time integral, the rate plantar pressure is applied and/or plantar shear stress/load at a region of interest.” Milgrom: [0087] “the processor 604 comprises a computer program product configured to allot values corresponding to mechanical properties of production materials with the pedobarographic data [and measured tissue properties of Chatzistergos to decrease plantar soft tissue internal stress].” [0070] “the mechanical properties include at least one or combination of Shore hardness, young's modulus, shear modulus, yield stress, compression, thickness, elasticity, and ductility.” [0093] “the Shore hardness of a zone 402 is inversely related to the pressure measurement of the corresponding region of the pedobarographic data;” [0094] “the IAL comprises various areas having different mechanical properties for engaging at least one of plantar region of a patient. In one example, an IAL can be manufactured for subjects who suffers plantar ulcers (e.g., diabetics), wherein the IAL of the patient includes zones 402 made to engage with the plantar areas containing the ulcers. In this example, the zones engaging with the plantar areas containing the ulcers have a lower Shore hardness and higher elasticity than the surrounding zones 402 of the IAL which engage with the healthy portions of the subject's foot. In this example, the IAL relieves some of the pressure applied by an insole to ulcers within weight-bearing plantar areas;” [0077] “the IAL is fixed to the upper portion of the insole and then covered with a top cover which when added relieves pressure from high peak dynamic plantar pressure areas.”).
While the combination of Chatzistergos/Milgrom discloses decreasing plantar soft tissue internal stress (Chatzistergos [0047]), the combination fails to explicitly disclose a total stress-concentration exposure.
Gefen discloses and wherein said combined tissue loading index comprises a total stress-concentration exposure (TSCE) value computed based on volumetric exposures of said high-risk sub-VOI and said peripheral sub-VOI to internal tissue stress ([0071] “the method further comprising converting an interfacial stress into an internal stress, using at least one conversion function.” [0225] “Predictions of internal stress distributions were validated experimentally by comparing simulated to measured contact compressive stresses.” [0226] “For each solid volume, the distribution of von Mises stresses were calculated. The von Mises equivalent stresses (.sigma..sub.v.M.) weight the effect of all principal stresses (.sigma..sub.1, .sigma..sub.2, .sigma..sub.3) according to the equation: 1 v . M . = { 1 2 [ ( 1 - 2 ) 2 + ( 2 - 3 ) 2 + ( 3 - 1 ) 2 ] } 1 2 ( EQ . 9 ).”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Chatzistergos/Milgrom to include a total stress-concentration exposure being the distribution of von Mises stresses based on volumetric exposures as disclosed in Gefen to provide a method of evaluating internal tissue stresses based on skin surface loading, as internal stresses in muscle tissue enveloping bony prominences is considerably higher than surface contact stresses and accounting for those stresses, rather than determining risk of pressure ulcers solely based on interfacial pressures, successfully addresses the problem of calculating stresses in deep tissues so as to determine the pressure ulcers onset once initiated therein (Gefen [0107, 0162]).
Regarding claim 26, the combination of Chatzistergos/Milgrom/Gefen discloses the method of claim 20, wherein said data representing an internal tissue loading state takes into account mechanical properties of at least some of: foot bone tissue, foot cartilage, foot tendons, foot soft tissue, and foot skin within said VOI (Gefen: [0163] “risk parameter calculator 30 comprises an interfacial stress converter 32, for converting interfacial stresses, as transmitted from sensors 14, into internal stresses;” [0164] “the geometry of a particular part of the body (e.g., the pelvis, the head, the scapula, the sacrum, the buttocks, the pelvis, the heels etc.), may be constructed, based on real images (e.g., Ultrasound, MRI and/or CT or anthropometrical data measured or retrieved from the literature) and using a suitable computer software. Then, the constructed geometry may be used for solving an appropriate set of equations which correspond to skeletal, muscular, and other forces or internal pressures (e.g., abdominal) acting within the particular part of the body to obtain an internal stress distribution within tissues and organs.”).
Regarding claim 27, the combination of Chatzistergos/Milgrom/Gefen discloses the method of claim 20, wherein, with respect to each of said high-risk sub-VOI and peripheral sub-VOI (Milgrom: [0079] “FIG. 4, zone 402-1 [peripheral sub-VOI] surrounds zone 402-2 [high-risk sub-VOI];” [0084] “the zone boundary lines 404 of the IAL 400 correspond to the contour lines 502 indicated by the pedobarographic data 500”), said tissue loading represents one or more of: tissue strain, tissue compressive strain, tissue tensile strain, tissue shear strain, tissue strain energy density, tissue compressive stress, tissue tensile stress, tissue shear stress, and tissue hydrostatic pressure (Gefen: [0217] “With reference to FIG. 17a, FIG. 17b and FIG. 18, in a first experiment two random pressure pulses were applied to the pressure sensors by a direct contact. The contact compressive stress, from 0 KPa to about 4.5 KPa, was converted to internal stress, ranging from 0 KPa to about 600 KPa. As discussed in Example 1, pressure under 0.4 KPa was filtered out, i.e., considered as internal stress of 0 KPa. FIG. 17a shows the applied random contact compressive stress in units of KPa and FIG. 17b shows the calculated internal stress in units of KPa. FIG. 18 shows the pressure and the pressure dose in units of KPa as a function of time for the calculated internal stresses of FIG. 17b. It is shown that the pressure dose trace follows the applied pressure signal over the duration of the two random pulses.”).
Regarding claim 28, the combination of Chatzistergos/Milgrom/Gefen discloses the method of claim 20, wherein said tissue loading alleviation zone represents a downward concavity in said pressure support surface (Milgrom: [0047] “Optionally, regions of the device corresponding to areas having an extra high and/or high pressure may have lower thickness than regions of the device corresponding to areas having medium pressure. As used herein, lower thickness is at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, or at least 90% decrease in thickness. Optionally, to prevent injuries, a borderline between regions of different thicknesses is smooth and continuous. In a non-limiting example, a thickness may vary gradually from a region of a first thickness to a region of a second thickness.”), and wherein said set of parameters comprises one or more of:
(i) dimensions of said tissue loading alleviation zone (Milgrom: [0084] “In some embodiments, the zone boundary lines 404 of the IAL 400 correspond to the contour lines 502 indicated by the pedobarographic data 500. In some embodiments, the shapes of the zone boundary lines 404 in the IAL 400 are identical to the shapes of the contour lines 502 of the pedobarographic data 500 … In some embodiments, each contour line 502 of the pedobarographic data 500 has a corresponding boundary line 404 of one or more zones 402 in the IAL 400…. In some embodiments, each zone 402 corresponding to a specific area 504 is larger than its corresponding area 504 in the pedobarographic data 500. In some embodiments, each zone 402 corresponding to a specific area 504 is at least 2-15% larger than its corresponding area 504 in the pedobarographic data 500. In some embodiments, each zone 402 corresponding to a specific area 504 is at least 15-50% larger than its corresponding area 504 in the pedobarographic data 500. In some embodiments, the perimeter of each zone boundary 404 corresponding to a contour line 502 is larger than the perimeter of its corresponding area 504 in the pedobarographic data 500. In some embodiments, the perimeter of each zone boundary 404 corresponding to a contour line 502 is similar to the perimeter of its corresponding area 504 in the pedobarographic data 500.”);
(ii) an outline of a peripheral edge of said tissue loading alleviation zone (Milgrom: [0079] “a boundary line 404 circumscribes a group of zones 402. In some embodiments, the zone boundary lines 404 are visually indistinguishable. In some embodiments, the zone boundary lines 404 are marked onto at least one surface of the IAL 400. In some embodiments, some of the zones 402 are surrounded by other zones 402. For example, in the embodiment depicted by FIG. 4, zone 402-1 surrounds zone 402-2”);
(iii) a total surface area defined by said peripheral edge (Milgrom: [0084] “In some embodiments, each contour line 502 of the pedobarographic data 500 encloses an area 504. In some embodiments, each of the zones 402 in the IAL 400 correspond to an area 504 of the pedobarographic data 500. In some embodiments, each zone 402 corresponding to a specific area 504 is identical in shape and size to the corresponding area 504 in the pedobarographic data 500”);
(iv) a depth of said tissue loading alleviation zone (Milgrom: [0047] “Optionally, the device may vary in thickness… regions of the device corresponding to areas having an extra low and/or low pressure may have higher thickness than regions of the device corresponding to areas having medium pressure… Optionally, regions of the device corresponding to areas having an extra high and/or high pressure may have lower thickness than regions of the device corresponding to areas having medium pressure. ... Optionally, to prevent injuries, a borderline between regions of different thicknesses is smooth and continuous. In a non-limiting example, a thickness may vary gradually from a region of a first thickness to a region of a second thickness.”); and
(v) a radius of curvature of said peripheral edge (Milgrom: Fig. 5B, zone 402).
Regarding claim 29, the combination of Chatzistergos/Milgrom/Gefen discloses the method of claim 28, wherein said outline is circular, and said set of parameters comprises a diameter of said outline (Milgrom: Fig. 5B, zone 402).
Regarding claim 30, the combination of Chatzistergos/Milgrom/Gefen discloses the method of claim 20, wherein said set of parameters varies at least one mechanical property value along at least one dimension of a region defined by said tissue loading alleviation zone (Milgrom: [0091] “Reference is made to FIG. 10A-C, which are cross section view simplified illustrations of an insole adaptive layer in accordance with some embodiments of the invention…. In some embodiments, such as depicted by FIG. 10C, the boundary lines 404 of each zone 402 are virtual lines 1000 separating at least two regions of the IAL which comprise different mechanical properties. In some embodiments, such as depicted by FIG. 10C, the IAL comprises segments 1002 of materials.” [0093] “the IAL comprises a plurality of zones 402 configured to succumb to pressure applied by a corresponding plantar pressure zone on a subject's sole placed on said insole. In some embodiments, the Shore hardness of the surface of a zone 402 corresponding to a high-pressure region of the pedobarographic data is lower than the Shore hardness of the surface of a zone 402 corresponding to a low pressure region of the pedobarographic data. In some embodiments, the Shore hardness of a zone 402 is inversely related to the pressure measurement of the corresponding region of the pedobarographic data.”).
Regarding claim 31, the combination of Chatzistergos/Milgrom/Gefen discloses the method of claim 30, wherein said at least one mechanical property is one of: resiliency, flexibility, elasticity, density, stiffness, and compressibility (Milgrom: [0070] “the mechanical properties include at least one or combination of Shore hardness, young's modulus, shear modulus, yield stress, compression, thickness, elasticity, and ductility.”).
Regarding claim 32, the combination of Chatzistergos/Milgrom/Gefen discloses the method of claim 30, wherein said region comprises a plurality of sub-zones, and wherein said at least one mechanical property value varies by associating each of said sub-zones with a specified value of said at least one mechanical property (Milgrom: [0091] “such as depicted by FIG. 10C, the boundary lines 404 of each zone 402 are virtual lines 1000 separating at least two regions of the IAL which comprise different mechanical properties. In some embodiments, such as depicted by FIG. 10C, the IAL comprises segments 1002 of materials.” [0093] “the IAL comprises a plurality of zones 402 configured to succumb to pressure applied by a corresponding plantar pressure zone on a subject's sole placed on said insole. In some embodiments, the Shore hardness of the surface of a zone 402 corresponding to a high-pressure region of the pedobarographic data is lower than the Shore hardness of the surface of a zone 402 corresponding to a low pressure region of the pedobarographic data. In some embodiments, the Shore hardness of a zone 402 is inversely related to the pressure measurement of the corresponding region of the pedobarographic data.” [0047] “In a non-limiting example, a thickness may vary gradually from a region of a first thickness to a region of a second thickness.”).
Regarding claim 33, the combination of Chatzistergos/Milgrom/Gefen discloses the method of claim 32, wherein said sub-zones are arranged in a sequence representing a change in said at least one mechanical property along said at least one dimension of said region (Milgrom: [0091] “such as depicted by FIG. 10C, the boundary lines 404 of each zone 402 are virtual lines 1000 separating at least two regions of the IAL which comprise different mechanical properties. In some embodiments, such as depicted by FIG. 10C, the IAL comprises segments 1002 of materials.” [0093] “the IAL comprises a plurality of zones 402 configured to succumb to pressure applied by a corresponding plantar pressure zone on a subject's sole placed on said insole. In some embodiments, the Shore hardness of the surface of a zone 402 corresponding to a high-pressure region of the pedobarographic data is lower than the Shore hardness of the surface of a zone 402 corresponding to a low pressure region of the pedobarographic data. In some embodiments, the Shore hardness of a zone 402 is inversely related to the pressure measurement of the corresponding region of the pedobarographic data.” [0047] “In a non-limiting example, a thickness may vary gradually from a region of a first thickness to a region of a second thickness.”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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