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 .
Drawings
The drawings are objected to because the shading of the TSCE log scale in Figures 8, 10, and 12 does not aid in understanding the invention but rather makes drawings difficult to decipher and reduces legibility (37 CFR 1.84 (m)), particularly due to the highest and lowest values on the scale having the same levels of shading. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10, 14, and 30-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The terms “gradually” and “graduated” in claims 1, 4, 30, and 32-33 are relative terms which render the claims indefinite. The terms “gradually” and “graduated” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. By virtue of dependency, claims 2-3, 5-10, 14, and 31 are also rejected.
Claim 10 recites the limitation "a plurality of said sections.” There is insufficient antecedent basis for this limitation in the claim. Examiner recognizes “a plurality of sections” to be recited in claim 8.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-7, 14, 20, and 28-33 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Milgrom (US 20200297522 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.”), and
wherein said region has at least one mechanical property value that gradually varies along at least one dimension of said region and wherein said mechanical property's graduated variation is determined based on said internal tissue loading state ([0077] “an insole adaptive layer (IAL) that is based on the patient's peak dynamic pressure map. In some embodiments, 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;” [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.” [0047] “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.” [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.”).
Regarding claim 3, Milgrom teaches the foot support structure of claim 1, wherein said at least one mechanical property is one of: resiliency, flexibility, elasticity, density, stiffness, and compressibility ([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, Milgrom teaches 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 gradually varies by associating each of said sub-zones with a specified value of said at least one mechanical property ([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, Milgrom teaches the foot support structure of claim 4, wherein said optimizing comprises determining, with respect to the tissue loading alleviation zone ([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;” [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 6, Milgrom teaches the foot support structure of claim 4, wherein said sub-zones are arranged in a sequence representing a graduated change in said at least one mechanical property along said at least one dimension of said region ([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.”).
Regarding claim 7, Milgrom teaches the foot support structure of claim 6, wherein said graduated 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 ([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.”).
Regarding claim 14, Milgrom teaches 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 ([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.”).
Regarding claim 20, Milgrom teaches a method ([Abstract] “patient specific device for reducing plantar pressure, a system and a method for manufacturing the same”) 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, based on the scan ([0023] “plantar data for manufacturing an IAL is obtained using one or more of pedobarography and non-pressure related scans. In some embodiments, the non-pressure related scans include one or more of thermal imaging, ultrasound, x-ray, CT-scans, Mill, and spectroscopy. In some embodiments, the plantar data obtained by the non-pressure related scans is converted to pedobarographic data. In some embodiments, the data obtained from the non-pressure related scans is converted by a computer algorithm to mechanical properties values or data that indicate contour lines of the surface zones of the IAL;” [0083] “obtained pedobarographic data 500 is in the form of a plantar pressure distribution map.”);
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”);
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 ([0087] “the processor 604 comprises a computer program product configured to allot values corresponding to mechanical properties of production materials with the pedobarographic data.” [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. In some embodiments, the IAL is added to a specific area of interest only on the insole where there is clinical interest to relieve plantar peak dynamic pressures.”).
Regarding claim 28, Milgrom teaches the method of claim 20, wherein said tissue loading alleviation zone represents a downward concavity in said pressure support surface ([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 ([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 ([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 ([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 ([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 (Fig. 5B, zone 402).
Regarding claim 29, Milgrom teaches the method of claim 28, wherein said outline is circular, and said set of parameters comprises a diameter of said outline (Fig. 5B, zone 402).
Regarding claim 30, Milgrom teaches the method of claim 20, wherein said set of parameters gradually varies at least one mechanical property value along at least one dimension of a region defined by said tissue loading alleviation zone ([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, Milgrom teaches the method of claim 30, wherein said at least one mechanical property is one of: resiliency, flexibility, elasticity, density, stiffness, and compressibility ([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, Milgrom teaches the method of claim 30, wherein said region comprises a plurality of sub-zones, and wherein said at least one mechanical property value gradually varies by associating each of said sub-zones with a specified value of said at least one mechanical property ([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, Milgrom teaches the method of claim 32, wherein said sub-zones are arranged in a sequence representing a graduated change in said at least one mechanical property along said at least one dimension of said region ([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.”).
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) 2 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milgrom (US 20200297522 A1) in view of Gefen (US 20050165284 A1).
Regarding claim 2, Milgrom teaches the foot support structure of claim 1. However, Milgrom fails to disclose determining internal tissue loading state particularly based on tissue stress, strain, or hydrostatic pressure.
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.”).
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 Milgrom to include determining internal tissue loading state particularly based on tissue compressive stress 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]).
Regarding claim 26, Milgrom teaches the method of claim 20. However, Milgrom fails to disclose taking into account mechanical properties of bone, cartilage, tendons, soft tissue, or skin.
Gefen discloses 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 ([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.”).
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 Milgrom to include taking into account mechanical properties of bone, cartilage, tendons, soft tissue, or skin 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]).
Regarding claim 27, Milgrom teaches the method of claim 20, wherein, with respect to each of said high-risk sub-VOI and 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”). However, Milgrom fails to disclose tissue loading specifically representing tissue stress, strain, or hydrostatic pressure.
Gefen discloses 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 ([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.”).
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 Milgrom to include tissue loading specifically representing tissue compressive stress 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) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milgrom (US 20200297522 A1) in view of Gallegos (US 20060277796 A1).
Regarding claim 8, Milgrom teaches the foot support structure of claim 4, comprising a plurality of sections (zones 402). However, Milgrom fails to disclose removably secured sections.
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 wherein each of said sections may be removably secured to said foot support structure, and wherein all of said sections together form said foot support surface for engagement by said foot of said subject ([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 (Gallegos [0027]). Additionally, the surface type can also be varied based upon type and location of the sections, allowing for control over the co-efficient of friction, to, for example, enable the toes to move and slide while prevent sliding of the heel (Gallegos [0027]).
Regarding claim 9, the combination of Milgrom/Gallegos discloses the foot support structure of claim 8, wherein each of said sections is associated with a specified value of said at least one mechanical property ([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. For example certain surfaces can be slick or smooth have a low co-efficient of friction, such as those that would enable the toes to move and slide, to surface types that are gripping to prevent sliding of portions of the foot, such as the heel. The ability to slide and move the toes of the foot may also enhance circulation in the foot.”).
Regarding claim 10, Milgrom teaches the foot support structure of claim 4, wherein said plurality of sub-zones (zones 402-1 and 402-2, Fig. 4; zones 402, Fig. 10C). However, Milgrom fails to disclose removably secured sections.
The combination of Milgrom/Gallegos discloses 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. For example certain surfaces can be slick or smooth have a low co-efficient of friction, such as those that would enable the toes to move and slide, to surface types that are gripping to prevent sliding of portions of the foot, such as the heel. The ability to slide and move the toes of the foot may also enhance circulation in the foot.” 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).
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 (Gallegos [0027]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLY HALPRIN whose telephone number is (703)756-1520. The examiner can normally be reached 12PM-8PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
Prosecution Insights