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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 18th, 2025, has been entered.
Response to Amendment
In view of the amendment, filed on November 18th, 2025, the following are withdrawn from the previous office action, mailed on August 18th, 2025.
Rejections of claims 10 and 17 under 35 U.S.C. 112(a) are withdrawn in view of the amendments
Rejections of claims 10-15 and 17-23 under 35 U.S.C. 103 are withdrawn in view of the amendments
Response to Arguments
Claims 10 and 17 were rejected under 35 U.S.C. 112(a) for introducing limitations that were not included in the specification. These claims are amended to remove these limitations, and therefore these rejections are withdrawn.
Applicant’s arguments with respect to claims 10-15 and 17-23 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.
New Grounds of Rejection
Claim Objections
Claims 10 and 22 are objected to because of the following informalities:
Claim 10, line 6, “the orthotic base model” should say “the base orthotic model” for claim language consistency.
Claim 22, line 7, “the orthotic base model” should say “the base orthotic model” for claim language consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 24 recites “providing a torus-shaped insert having an inner width and an outer width based on the wound position data”, which is not included in the specification. "While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163 (1B). In specification [00068], “As the wounds begin to heal, the depression and holes which are located under the center areas of the ulcerous wounds are filled by torus shaped inserts which reduce the diameter of these” does not include “having an inner width and an outer width based on the wound position data”. For purpose of compact prosecution, the claim limitation is interpreted as “providing a torus-shaped insert having a size”.
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 10-15 and 17-23 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.
Claim 10 recites the limitation “the original scan” in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation “the original scan” in line 13. There is insufficient antecedent basis for this limitation in the claim.
The dependent claims necessarily inherit the indefiniteness of the claims on which they depend.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 10, 11, 14, 17, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20160110479 A1), in view of DesJardins et al. (US 20160235158 A1; hereafter DesJardins).
Regarding claim 10, Li discloses a process for creating customized orthotics ([0002], methods constructing custom foot orthotic models), the process comprising:
receiving a 3D file of a foot ([0005], receiving an initial 3D model), the 3D file comprising the metatarsal region, the arch region, and the heel region ([0067], orthotic parameters include arch shape, heel cup depth, and forefoot width);
detecting ([0061], identifies points on the scanned foot) and assigning position data in the 3D file for the metatarsal region, the arch region, and the heel region ([0060], transforms the received coordinates to a coordinate system based on anatomy of the foot);
generating a base orthotic model ([0116], constructs an orthotic model), where the orthotic base model represents a surface for mating to a corresponding mapped plantar surface ([0116], the returned model corresponds to the scanned foot; [0006], both the model and the scanned foot are surfaces scan), such that the base orthotic model conforms to the corresponding mapped plantar surface ([0118], The characteristics captured in the scan such as number of lines, curves and contours are used to provide an orthotic model);
providing a user interface configured to allow visualization of the foot being fitted to and supported by the base orthotic model ([0054], displays a representation of the solid model on interconnected display 121 using graphics adapter 120 and overlay a visual representation of point cloud 136; Fig. 4A, point cloud 136 is showing an original scan of the foot in an opaque or semitransparent manner to allow visualization of the foot), wherein the user interface is further configured to show a cross section view which cuts along one of a plurality of main axes through the base orthotic model and through the original scan (Fig. 11B, point cloud 136 is showing a cross section view of the base orthotic model and through the original scan) to display a two-dimensional shape of the foot proximate to a two-dimensional shape of the base orthotic model ([0116], custom orthotics for the foot according to the scanned model and the initial orthotic parameters and returns an orthotic model… evaluate the returned model by aligning and comparing it with the scanned foot; Fig. 13, the scanned foot 136 is a two-dimensional shape of the foot; [0109], The user interface allow orthotic model 182 and point cloud 136 to be rotated, panned or zoomed relative to one another to asses fit; Li teaches the orthotic model 182 can be panned relative to the point cloud 136, which may be a two-dimensional shape of the foot. Since one can compare a two dimensional shape with a two dimensional model, it would be obvious to one of ordinary skill in the art that the orthotic model 182 of Li can be panned into a two dimensional model in order to compare with point cloud 136 for fitness evaluation).
Li does not disclose optimizing the base orthotic model to include at least one load offset by: detecting using spectral information from the 3D file one or more wounds on the foot; assigning wound position data in the 3D file for one or more wounds on the foot; and modifying the base orthotic model to include at least one optimization based on the wound position data, wherein the at least one optimization includes providing at least one of a load offset from the one or more wounds or a drug delivery to the one or more wounds.
However, DesJardins teaches a process for creating customized orthotics ([0010], methods for forming customized orthotic), comprising optimizing the base orthotic model ([0076]&[0077], an orthotic outline design information is created and modified) to include at least one load offset ([0010], form a lay er of orthotic based on desired off-loading area) by: detecting using spectral information from the 3D file ([0075], 3D data is derived from image to form a CAD image of the orthotic) one or more wounds on the foot ([0010] determine a characteristic of a foot; [0033], the characteristic can be an ulcer); assigning wound position data in the 3D file for one or more wounds on the foot (Fig. 1, the position of ulcer 1 is labeled on the 3D map); and modifying the base orthotic model to include at least one optimization based on the wound position data ([0077], create geometrically-desired durometer-map based on the characteristic), wherein the at least one optimization includes providing at least one of a load offset from the one or more wounds ([0044], pressure offloading in target area of ulcer is achieved by decreasing void volume in that region of the orthotic layer).
Li and DesJardins are both considered to be analogous to the claimed invention because they are in the same field of creating customized orthotics. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date to modify the base orthotic model in Li to incorporate an optimization process of the base orthotic model as taught by DesJardins as described above. Use of known technique to improve similar devices (methods or products) in the same way supports a conclusion of obviousness. See MPEP 2143 I(C). Doing so would improve comfort to the patient who has ulcers in their feet (DesJardins, [0044]).
Regarding claim 11, modified Li discloses the process of claim 10, wherein Li further discloses providing a body position device ([0065], aligning guide) that is operable to facilitate a constant foot position during a 3D image data capture to obtain the original scan of the foot ([0065], During scanning of 3D image, the foot may be placed on a guide so that the X axis aligns approximately with the transverse direction of the foot, the Y axis aligns approximately with the longitudinal direction of the foot and the Z axis aligns approximately with the vertical direction).
Regarding claim 14, modified Li discloses the process of claim 10, wherein Li further discloses providing at least one label ([0061], identifies anatomical landmarks) and marking the metatarsal region, the arch region, and the heel region ([0005], the reference plane is defined by a bottom point in the heel section, a lateral bottom point in the forefoot section, and a medial bottom point in the forefoot section, and vertical coordinates of the selected points in the arch section is adjusted based on the arch shape parameter).
Regarding claim 17, modified Li discloses the process of claim 10.
Modified Li does not disclose modifying the base orthotic model includes specifying a plurality of materials of different hardness levels, wherein a first material of the plurality of materials is softer than a second material of the plurality of materials, and wherein the first material is positioned on the base orthotic model proximate to at least one wound location.
However, DesJardins further teaches modifying the base orthotic model ([0076]&[0077], an orthotic outline design information is created and modified) includes specifying a plurality of materials of different hardness levels for the base orthotic model ([0030], the orthotic design uses materials with various hardness), wherein a first material of the plurality of materials is softer than a second material of the plurality of materials ([0049], a layer with first material in some regions has lower hardness than the region second material), and wherein the first material is positioned on the base orthotic model proximate to at least one wound location ([0044], adjust the void volume helps with lowering hardness at the offload region; [0046], using material with lower hardness has the same effect as adjusting the void volume; it would be obvious to one of ordinary skill in the art to use material with lower hardness to lower hardness level at the offload region).
It would have been obvious to one with ordinary skill in the art before the effective filing date to modify the orthotic model in Li to incorporate specifying hardness level of different materials of the shoe as taught by DesJardins as described above, in order to improve user comfort (DesJardins, [0044]).
Regarding claim 20, modified Li discloses the process of claim 10, wherein Li further discloses presenting the user interface ([0116], user interface 146) for manipulation of the base orthotic model ([0116], modify prospective orthotic model using interface 146), wherein the user interface is adapted to enable one or more functionalities including a rotation operation ([0054], Model viewer 132 can rotate on the displayed representation, such that the solid model may be aligned with point cloud 136 to evaluate the fit of the foot orthotics).
Regarding claim 21, modified Li discloses the process of claim 10, wherein Li further discloses generating the orthotic model ([0102], construct orthotic model 182) and transforming into a model for a mold ([0113], fabricate a custom orthotic device in accordance with orthotic model 182; Fig. 23, the custom orthotic device is a mold). Li further teaches that it’s customary to produce a mold that is a negative impression of the orthotic model when producing a footwear ([0004], the orthotic lab generates foot positive molds from negative molds, then custom foot orthotics are manually fabricated by using the foot positive molds). Thus, it would be obvious to one of ordinary skill in the art to generate a negative impression of the orthotic model and transforming into a model for a mold, because a rationale to support a conclusion that a claim would have been obvious is that all the claimed elements (generate a negative impression of the orthotic model and transforming into a model for a mold) were in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results (producing a footwear from a mold) to one of ordinary skill in the art. See MPEP 2143.02. A person of ordinary skill has good reason to pursue the known option within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." See MPEP 2144.05 (II).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20160110479 A1), in view of DesJardins et al. (US 20160235158 A1; hereafter DesJardins) as applied to claim 10, and further in view of Rusu et al. (US 20180218437 A1).
Regarding claim 18, modified Li discloses the process of claim 10.
Modified Li does not teach detecting the one or more wound on the foot includes using one or more of hotspot detection and color differentiation.
However, Rusu teaches detecting the one or more wound on the foot ([0030], finite element analysis of the creep deformation and calcified and noncalcified tissue) includes using one or more of hotspot detection ([0030], finite element analysis models loading “hotspots”).
Li and Rusu are both considered to be analogous to the claimed invention because they are in the same field of creating customized orthotics. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date to modify the detection process in Li to incorporate hotspot detection as taught by Rusu, in order to assist in determining when shoes, liners, or orthotics have “worn out” based upon geometric changes in these structures which may be detected based upon foot imaging as well as foot-shoe assembly imaging (Rusu, [0035]). Use of known technique to improve similar devices (methods or products) in the same way supports a conclusion of obviousness. See MPEP 2143 I(C).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20160110479 A1), in view of DesJardins et al. (US 20160235158 A1; hereafter DesJardins) as applied to claim 10, and further in view of Jonsson et al. (US 20170056212 A1), as evidenced by Summit et al. (US 20150328016 A1).
Regarding claim 19, modified Li discloses the process of claim 10, wherein Li further discloses modifying the base orthotic model further comprises modifying at least a portion of the base orthotic model ([0126], modifying 3D orthotic models).
Modified Li does not disclose provide recesses corresponding to the wound position data, applying a healing agent as a substrate in the recesses, and providing an exit channel in fluid communication with the recess and a remote reservoir.
Jonsson teaches a prosthetic foot (Fig. 12, [0083], a prosthetic foot 131), comprising modifying a skin contacting liner to provide recesses corresponding to the wound position data ([0059], the textured region 23 has recess 103 can drain blood and/or other fluids associated with a wound site away from the wound site); applying a healing agent as a substrate in the recesses ([0057], apply dosing of silicone additives toward the skin surface, such as essential oils, aloe vera, petroleum products (e.g., Vaseline), or other products with benefits for the skin); and providing an exit channel ([0046] flow channels 26) in fluid communication with the recess and a remote reservoir ([0046], Fluid or sweat generated at the interface first collect in the spaces 25 and then move through the flow channels 26).
Jonsson and Li are both considered to be pertinent to the problem of creating skin contacting liner in a prosthetic device. Additionally, making prosthetics and making orthotics involve analogous process, as evidenced by Summit ([0012] prosthetists and orthotists use analogous brace manufacturing process). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date to modify the orthodontics model in modified Li to incorporate recesses, healing agent, and fluid draining channels at wound locations as taught by Jonsson, in order to promote benefits to the skin (Jonsson, [0057]). Use of known technique to improve similar devices (methods or products) in the same way supports a conclusion of obviousness. See MPEP 2143 I(C).
Claim 12, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20160110479 A1), in view of DesJardins et al. (US 20160235158 A1; hereafter DesJardins) as applied to claim 10, and further in view of Summit et al. (US 20150328016 A1).
Regarding claim 12, modified Li discloses the process of claim 10, wherein Li further discloses marking the metatarsal region, the arch region, and the heel region ([0061], identifies anatomical landmarks; [0005], the reference plane is defined by a bottom point in the heel section, a lateral bottom point in the forefoot section, and a medial bottom point in the forefoot section, and vertical coordinates of the selected points in the arch section is adjusted based on the arch shape parameter).
Modified Li does not teach providing a marker pen.
However, Summit teaches a process for creating customized orthotics ([0014], fabricating a custom module brace, cast or device based upon scan data from a patient; [0018], applications for this technology include ankle foot orthosis), comprising using a marker pen to mark locations of body parts ([0068], mark the body suit 103 with a pen 105).
Li and Summit are both considered to be analogous to the claimed invention because they are in the same field of creating customized orthotics. It would have been obvious to one with ordinary skill in the art before the effective filing date to modify the process to identify body parts in modified Li to incorporate a marker pen as taught by Summit as detailed above, because it is an easily accessible way to mark areas of customization (Summit, [0069]). A person of ordinary skill has good reason to pursue the known option within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." See MPEP 2144.05 (II).
Regarding claim 13, modified Li discloses the process of claim 10, wherein Li further discloses marking the metatarsal region, the arch region, and the heel region ([0061], identifies anatomical landmarks; [0005], the reference plane is defined by a bottom point in the heel section, a lateral bottom point in the forefoot section, and a medial bottom point in the forefoot section, and vertical coordinates of the selected points in the arch section is adjusted based on the arch shape parameter).
Modified Li does not teach providing paint.
However, Summit further teaches using paint to mark locations of body parts ([0068], The reference points can be black or colored ink marks).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date to modify the process to identify body parts in modified Li to incorporate a marking paint as taught by Summit as detailed above, because it is an easily accessible way to mark areas of customization (Summit, [0069]) and it is easily visible (Summit, [0068]). A person of ordinary skill has good reason to pursue the known option within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." See MPEP 2144.05 (II).
Regarding claim 15, modified Li discloses the process of claim 10, wherein Li further discloses providing a 3D scanner ([0044], scanning device 108 is a 3D laser scanner), wherein the original scan of the foot is obtained using the 3D scanner ([0048], scanning device 108 to scan a foot). Li also discloses to provide information regarding depth and color of the foot ([0067], user interface 146 allows for entry of characteristics such as thickness).
Modified Li does not teach the 3D scanner is a depth and color camera.
However, Summit further teaches using a depth and color camera to provide information regarding depth and color of the foot ([0079], cameras use the photographic image which identify the coded markings or topography, and can distinguish different color codings as well as different pad textures).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date to modify the 3D scanner in modified Li to incorporate a depth and color camera as taught by Summit as detailed above, in order to automatically fulfill the request to design the brace or cast (Summit, [0079]).
Claim 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20160110479 A1), in view of DesJardins et al. (US 20160235158 A1; hereafter DesJardins) and Vindriis (US 20080047164 A1).
Regarding claim 22, Li discloses a process for creating customized orthotics ([0002], methods constructing custom foot orthotic models), the process comprising:
receiving a 3D file of a foot ([0005], receiving an initial 3D model), the 3D file comprising the metatarsal region, the arch region, and the heel region ([0067], orthotic parameters include arch shape, heel cup depth, and forefoot width);
detecting ([0061] identifies points on the scanned foot) and assigning position data in the 3D file for the metatarsal region, the arch region, and the heel region ([0060], transforms the received coordinates to a coordinate system based on anatomy of the foot);
generating a base orthotic model ([0116], constructs an orthotic model), where the orthotic base model represents a surface for mating to a corresponding mapped plantar surface ([0116], the returned model corresponds to the scanned foot; [0006] both the model and the scanned foot are surfaces scan), such that the base orthotic model conforms to the corresponding mapped plantar surface ([0118], The characteristics captured in the scan such as number of lines, curves and contours are used to provide an orthotic model);
providing a user interface configured to allow visualization of the foot being fitted to and supported by the base orthotic model ([0054], displays a representation of the solid model on interconnected display 121 using graphics adapter 120 and overlay a visual representation of point cloud 136; Fig. 4A, point cloud 136 is showing an original scan of the foot in an opaque or semitransparent manner to allow visualization of the foot), wherein the user interface is further configured to show a cross section view which cuts along one of a plurality of main axes through the base orthotic model and through the original scan (Fig. 11B, point cloud 136 is showing a cross section view of the base orthotic model and through the original scan) to display a two-dimensional shape of the foot proximate to a two-dimensional shape of the base orthotic model ([0116], custom orthotics for the foot according to the scanned model and the initial orthotic parameters and returns an orthotic model… evaluate the returned model by aligning and comparing it with the scanned foot; Fig. 13, the scanned foot 136 is a two-dimensional shape of the foot; [0109], The user interface allow orthotic model 182 and point cloud 136 to be rotated, panned or zoomed relative to one another to asses fit; Li discloses the orthotic model 182 can be panned relative to the point cloud 136, which may be a two-dimensional shape of the foot.
Since one can only compare two dimensional shape with two dimensional model, Li also teaches the orthotic model 182 is panned into a two dimensional model in order to compare with point cloud 136 for fitness evaluation).
Li does not disclose optimizing the base orthotic model to include at least one load offset by: detecting using spectral information from the 3D file one or more wounds on the foot; assigning wound position data in the 3D file for one or more wounds on the foot; and modifying the base orthotic model to include at least one optimization based on the wound position data.
However, DesJardins teaches a process for creating customized orthotics ([0010], methods for forming customized orthotic), comprising optimizing the base orthotic model ([0076]&[0077], an orthotic outline design information is created and modified) to include at least one load offset ([0010], form a lay er of orthotic based on desired off-loading area) by: detecting using spectral information from the 3D file ([0075], 3D data is derived from image to form a CAD image of the orthotic) one or more wounds on the foot ([0010], determine a characteristic of a foot; [0033] the characteristic can be an ulcer); assigning wound position data in the 3D file for one or more wounds on the foot (Fig. 1, the position of ulcer 1 is labeled on the 3D map); and modifying the base orthotic model to include at least one optimization based on the wound position data ([0077], create geometrically-desired durometer-map based on the characteristic).
Li and DesJardins are both considered to be analogous to the claimed invention because they are in the same field of creating customized orthotics. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date to modify the base orthotic model in Li to incorporate an optimization process of the base orthotic model as taught by DesJardins as described above, in order to improve comfort to the patient who has ulcer in their feet (DesJardins, [0044]). Use of known technique to improve similar devices (methods or products) in the same way supports a conclusion of obviousness. See MPEP 2143 I(C).
Li, in view of DesJardins, does not teach modifying the base orthotic model includes providing at least one opening that corresponds to the wound position data, and wherein the opening includes one of a recess, a pression, or a hole; and providing an insert to fill at least a portion of the opening.
However, Vindriis teaches modifying the base orthotic model ([0009] insole adjustment kit to adjust the insole layer) includes providing at least one opening that corresponds to the wound position data ([0037] perforation 106 to relief pressure; [0005] pressure relief is required for wound areas), and wherein the opening includes a hole ([0037] perforation 106); and providing an insert to fill at least a portion of the opening (Fig. 2c, insert 202 & 203 are inserts to fill the perforation).
Li and Vindriis are both considered to be analogous to the claimed invention because they are in the same field of creating customized orthotics. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date to modify the orthotic model in Li, in view of DesJardins, to incorporate holes at the wound area as taught by Vindriis as described above, in order to reduce damage of the wound (Vindriis, [0005]). Use of known technique to improve similar devices (methods or products) in the same way supports a conclusion of obviousness. See MPEP 2143 I(C).
Regarding claim 23, modified Li discloses the process of claim 22.
Modified Li does not disclose optimizing the base orthotic model further comprises providing a series of successively sized plugs, each plug having an outer width sized to fit in a successively larger plug or a recess and an inner opening sized for receiving a successively smaller plug, wherein the series of successively sized plugs are configured to be inserted into each other and into the recess to accommodate a gradually shrinking wound during a healing process.
However, Vindriis further teaches wherein modifying the base orthotic model ([0009], insole adjustment kit) further comprises: providing a series of successively sized plugs (Fig. 2a-2d, different sizes of inserts), each plug having an outer width sized to fit in a successively larger plug or a recess and an inner opening sized for receiving a successively smaller plug ([0017], The inserts are dimensioned to fit into the pockets, but may have a thickness that is less than the pocket in order to combine different inserts into the same pocket), wherein the series of successively sized plugs are configured to be inserted into each other and into the recess ([0017], different inserts fit into the same pocket) to accommodate a gradually shrinking wound during a healing process ([0018], the adjustment of the inserts will adapt to specific skin conditions of the foot).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date to modify the orthotic model in modified Li to incorporate adjustment of inserts at the wound area as taught by Vindriis as described above, in order to reduce damage of the wound (Vindriis, [0005]).
Regarding claim 24, modified Li discloses the process of claim 22, wherein Li further teaches providing the insert includes providing a torus-shaped insert having an inner width and an outer width based on the wound position data (Under claim interpretation, “providing the insert includes providing a torus- shaped insert having an inner width and an outer width” is interpreted as “providing a torus-shaped insert having a size” due to lack of description in the specification; Vindriis, Fig. 2c, insert 202&203 are torus shaped insert having a size).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vipul Malik whose telephone number is (571)272-0976. The examiner can normally be reached M-F.
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/V.M./Examiner, Art Unit 1754
/SUSAN D LEONG/ Supervisory Patent Examiner, Art Unit 1754