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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/02/2026 has been entered.
Response to Amendment
Applicant’s amendment of claims 1, 3, 14, and 16 are acknowledged by the Examiner.
Claims 1-24 are pending in the current application with claims 2, 8-11, and 20-24 being withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 02/02/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that Miklaus does not disclose bracing members configured to grasp a portion of the lower leg above the ankle joint for load transfer. Examiner respectfully agrees. The bracing members (28 and 30) of Miklaus are configured to grasp a portion of the lower leg above the ankle joint through use of straps (70 and 72), similar to Applicant’s device. Thus, the bracing members (28 and 30) of Miklaus are configured to grasp a portion of the lower leg above the ankle joint for load transfer as claimed (i.e. capable of functioning as claimed).
In response to applicant's argument that Miklaus does not disclose the coating of the liner pads with a contact material having a static coefficient of friction sufficient to resist downward slippage during load bearing. Examiner agrees. As discussed in the non-final rejection mailed 08/05/2025, it is clearly stated that Miklaus does not disclose the coating of the liner pads. However, Wozniak teaches such a coating on an analogous device comprising an analogous deformable material, which is utilized for the purpose of allowing better adhesion of the device to the user (see [pg 2]). Thus, the combination of Miklaus and Wozniak discloses liner pads coated with a contact material provides an improved offloading device that would add the benefit of providing a coating to be placed against a user’s leg allowing better adhesion of the device to the user (see [pg 2]) thereby increasing the securement of the device to the user’s leg.
Additionally, because the silicone coating of Wozniak in the combination of Miklaus as modified by Wozniak is used for the purpose of better adhering the ankle device of Miklaus to the user’s leg when in use (see Wozniak [pg 2]), when coated onto the pads (48 and 50) of the bracing members (28 and 30) of Miklaus, the silicone coating of Wozniak in combination with the fastening straps (70 and 72) of Miklaus, accordingly allows for the transfer of reactionary forces applied by the ground through the brace to reduce load on the ankle joint during a user’s gait.
With regards to Applicant’s arguments that Wozniak does not specify any coefficient of friction for the silicone coating, and in regards to Applicant’s arguments that the inherency argument that the silicone coating of Wozniak is unsupported. Examiner agrees that Wozniak does not explicitly disclose a coefficient of friction. However, Wozniaks’s coating being made from silicone to provide the similar function of prevent slippage of the ankle device down the user’s leg when the ankle device is in use, is the same as Applicant’s coating and function (see Applicant’s specification [0080]) and therefore, is expected to exhibit the claimed material properties of a coefficient of friction sufficient to inhibit relative sliding between the liner pads and the skin of the user since it has been held that “(w)here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (see MPEP 2112.01)). Thus, due to the similarities in material and function of the silicone coating of Wozniak, the inherency argument under MPEP 2112.01 is supported, and Examiner has established a nexus that the material of Wozniak inherently has the friction properties and functional purpose.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as discussed above, the devices of Miklaus and Wozniak are analogous, and the padding of Miklaus and the deformable material of Wozniak are held to be analogous cushioning materials which both provide comfort to a user when using the respective devices. Wozniak teaches the use of an inner surface of the deformable material being coated with a silicone coating for the purpose of allowing better adhesion of the device to the user (see [pg 2]). Thus, Wozniak provides a teaching and motivation to modify the device of Miklaus which would add a benefit to the analogous padding of Miklaus to provide additional securement of the device of Miklaus to the user.
In response to Applicant’s assertion that the characterization of Miklaus and Wozniak have “fundamental differences” and that “Miklaus prevents lateral ankle injuries (inversion/eversion) through rigid support, while Wozniak corrects infant foot malpositions through elastic corrective forces”. Examiner respectfully disagrees. It’s clearly stated in Miklaus [col 2 ln 63-67] that “The frame assembly 22 by itself serves to provide sufficient support and stabilization for the ankle”. It’s also clearly stated in Wozniak [pg 1] that the device of Wozniak is a support orthosis to protect fragile joints from an exaggerated movement”, and on [pg 3] that such a malposition is “valgus of the hind foot” (i.e. inversion or eversion of the hindfoot). Thus, Miklaus and Wozniak do not actually have “fundamental differences” as suggested by Applicant and are analogous as asserted by the Examiner.
In response to applicant's argument that the claimed invention has a fundamentally different purpose from both Miklaus and Wozniak to be used for “offloading body weight to reduce ankle pain”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the claimed invention does not result in a structural difference from the device resulting from the combination of Miklaus as modified by Wozniak. Therefore, the device of Miklaus as modified by Wozniak is capable of performing the intended use, and as such it meets the claim.
In response to applicant's argument that the claimed invention achieves unexpected results of “offloading a percentage of the user’s body weight during normal walking gait”. As discussed above the offloading is a recitation of the intended use of the invention, and does not result in a structural difference from the device resulting from the combination of Miklaus as modified by Wozniak. Thus, the unexpected results are not persuasive.
Thus, Miklaus in view of Wozniak renders obvious the subject matter of claims 1 and 14, and the rejections under 35 U.S.C. 103 over Miklaus in view of Wozniak are maintained.
Applicant’s arguments with respect to the rejection(s) of claim(s) 3 and 16 under 35 U.S.C. 103 over Miklaus in view of Wozniak have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Miklaus in view of Wozniak and further in view of newly found reference Schwartz (US 2005/0274046 A1).
Claim Objections
Claims 1, 3, 7, and 14-16 are objected to because of the following informalities:
Claim 1 recites the limitation “an offloading device for offloading load from an ankle joint of the user”. This limitation should be amended to include “configured for”.
Claim 1 recites the limitation “offloading load” in line 1. This limitation, while not unclear, should be amended to recite “offloading a load” to properly present the limitation.
Claim 1 recites the limitation “made from rigid material” in line 5. This limitation, while not unclear, should be amended to recite “made from a rigid material” to properly present the limitation.
Claim 1 recites the limitation “inhibit relative sliding” in line 12. This limitation, while not unclear, should be amended to recite “inhibit a relative sliding” to properly present the limitation.
Claim 1 recites the limitation “the liner pads” in line 13. This limitation, while not unclear, should be amended to recite “the one or more liner pads” to maintain consistency in the claims.
Claim 1 recites the limitation “that ground reaction forces” in line 13. This limitation, while not unclear, should be amended to recite “that a plurality of ground reaction forces” to properly present the limitation.
Claim 1 recites the limitation “reduce the load on the ankle” in line 15. This limitation, while not unclear, should be amended to recite “reduce the load on the ankle joint” to maintain consistency in the claims.
Claim 3 recites the limitation “posteriror”. This limitation should be amended to recite “posterior”.
Claim 7 recites the limitation “the right-side member” in line 3. This limitation, while not unclear, should be amended to recite “the right-side arm member” to maintain consistency in the claims.
Claim 14 recites the limitation “an offloading device for offloading load from an ankle joint of the user”. This limitation should be amended to include “configured for”.
Claim 14 recites the limitation “offloading load” in line 1. This limitation, while not unclear, should be amended to recite “offloading a load” to properly present the limitation.
Claim 14 recites the limitation “inhibit relative sliding” in line 16. This limitation, while not unclear, should be amended to recite “inhibit a relative sliding” to properly present the limitation.
Claim 14 recites the limitation “the liner pads” in line 17. This limitation, while not unclear, should be amended to recite “the one or more liner pads” to maintain consistency in the claims.
Claim 14 recites the limitation “that ground reaction forces” in line 17. This limitation, while not unclear, should be amended to recite “that a plurality of ground reaction forces” to properly present the limitation.
Claim 14 recites the limitation “reduce the load on the ankle” in line 19 . This limitation, while not unclear, should be amended to recite “reduce the load on the ankle joint” to maintain consistency in the claims.
Claim 15 recites the limitation “the right-side member” in line 3. This limitation, while not unclear, should be amended to recite “the right-side arm member” to maintain consistency in the claims.
Claim 16 recites the limitation “posteriror”. This limitation should be amended to recite “posterior”.
Appropriate correction is required.
Claim Interpretation
The term “sufficient” in claims 1 and 14 is a relative term. However, the claims are not indefinite because the term “sufficient” with respect to the coefficient of friction is defined by the specification [0016] as “static coefficient of friction of the contact material ranging from 0.4 to 1.0, and kinetic coefficient of friction of the contact material ranging from 0.3 to 0.8”. Thus, the relative term “sufficient” is interpreted as such.
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 4 and 17 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.
Claim 4 recites the limitation “wherein the insole member is in contact with and bonded to the foot locating member, along an entire length of the foot locating member”. This limitation is unclear in view of claim 3 which recites “a predefined clearance is provided between the insole posterior portion and a posteriror portion of the foot locating member”. Thus, it is unclear as to how the insole member is in contact with and bonded to the foot locating member, along an entire length of the foot locating member, when claim 3 requires a clearance (i.e. a portion not in contact with and bonded) between the insole posterior portion and a posteriror portion of the foot locating member. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 17 recites the limitation “wherein the insole member is in contact with and bonded to the basal locating member, along an entire length of the basal locating member”. This limitation is unclear in view of claim 16 which recites “a predefined clearance is provided between the insole posterior portion and a posteriror portion of the foot locating member”. Thus, it is unclear as to how the insole member is in contact with and bonded to the basal locating member, along an entire length of the basal locating member, when claim 16 requires a clearance (i.e. a portion not in contact with and bonded) between the insole posterior portion and a posteriror portion of the foot locating member (which is formed by the basal locating member). For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 6-7, 12-15, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miklaus et al. (US 5,209,722) (hereinafter Miklaus) in view of Wozniak (FR 2840525 A1) (Examiner relies on a machine translation provided by PE2E search).
In regards to claim 1, Miklaus discloses an offloading device (20; see [col 2 ln 45-60]; see figure 1) for offloading load from an ankle joint of a user (20 being structurally similar to Applicant’s device (see figure 1 and Applicant’s figure 2a) is capable of being fastened to perform the intended use of offloading load from an ankle joint of a user), the offloading device (20) comprising:
a foot locating member (26; see [Col 3 ln 5-10]; see figure 1) configured to locate therewithin a foot of the user (see figure 5);
one or more bracing members (28 and 30; see [col 3 ln 5-15]; see figure 1-2) pivotably coupled to the foot locating member (26) on a left side and a right side of the foot locating member (26; see [col 4 ln 5-10]), the one or more bracing members (28 and 30) are made from rigid material (see [col 3 ln 7-13]) configured to grasp a portion of a lower leg that is located above the ankle joint (see [col 3 ln 43-60] and [col 4 ln 55-68]);
one or more liner pads (48 and 50; see [col 3 ln 45-55]; see figure 1) provided on inner surfaces of the one or more bracing members (28 and 30; see figure 1), wherein the one or more liner pads (48 and 50) are configured to make contact with skin of the user (see [col 3 ln 40-60]); and
a fastening arrangement (70, 72, 74, 76; see [col 4 ln 55-60]; see figure 1) configured to fasten the one or more bracing members (28 and 30) to the portion of the lower leg that is located above the ankle joint (see [col 4 ln 55-65]),
wherein the one or more liner pads (48 and 50) are made from a deformable material (see [col 4 ln 43-54]).
Miklaus does not disclose the deformable material is coated with a contact material, having a coefficient of friction sufficient to inhibit relative sliding between the liner pads and the skin of the user such that ground reaction forces are transferred from the foot locating member through the one or more bracing members to the portion of the lower leg located above the ankle joint, and thereby reduce the load on the ankle.
However, Wozniak teaches an analogous device (1; see [pg 1]; see figure 1) for the analogous purpose of supporting an ankle joint of a user (see [pg 1] in reference to the device protecting foot joints of infants) comprising an analogous deformable material (elastic fabric sleeve; see [pg 2]) the deformable material (elastic fabric sleeve) is coated with a contact material (silicone coating) having a coefficient of friction sufficient to inhibit relative sliding between the sleeve and the lower leg (see [pg 2] in reference to the silicone coating allowing for adhesion of the support to the lower limb; adhesion provided by the silicone coating is a coefficient of friction sufficient to inhibit relative sliding between the sleeve and the lower leg) for the purpose of providing better adhesion of the device to the user (see [pg 2]).
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 one or more liner pads as disclosed by Miklaus and to have coated the inner surface of the deformable material of the one or more liner pads with a silicone coating as taught by Wozniak in order to have provided an improved offloading device that would add the benefit of providing a coating to be placed against a user’s leg allowing better adhesion of the device to the user (see [pg 2]) thereby increasing the securement of the device to the user’s leg.
Miklaus as now modified by Wozniak’s contact material is coated on the deformable material of the one or more liner pads, and is made from silicone, which is positioned the same, and made from the same material as Applicant’s coating of contact material (see Applicant’s specification [0072]). Thus, the coating of contact material of Miklaus as now modified by Wozniak is expected to exhibit the claimed material properties of “a coefficient of friction sufficient to inhibit relative sliding between the liner pads and the skin of the user such that ground reaction forces are transferred from the foot locating member through the one or more bracing members to the portion of the lower leg located above the ankle joint, and thereby reduce the load on the ankle” since it has been held that “(w)here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (see MPEP 2112.01)). In the instant case, the claimed and prior art products are identical or substantially identical in structure and composition, and thus a prima facie case of obviousness has been established.
In regards to claim 6, Miklaus as now modified by Wozniak discloses the invention as discussed above.
Miklaus further discloses wherein the foot locating member (26) comprises a basal locating member (32, 34, 36; see [Col 3 ln 15-25]; see figure 1-2]) made from a rigid material (see [Col 3 ln 9-12] in reference to 26 being substantially rigid, therefore 32, 34, 36, being portions of 26, are rigid), a left-side arm member (38; see [Col 3 ln 20-25]; see figure 1), and a right-side arm member (40; see [Col 3 ln 20-25]; see figure 1), the left-side arm member (38) and the right-side arm member (40) coupled to the basal locating member (32, 34, 36), on a left and a right side of the basal locating member (32, 34, 36; see figure 1), respectively.
In regards to claim 7, Miklaus as now modified by Wozniak discloses the invention as discussed above.
Miklaus further discloses wherein the one or more bracing members (28 and 30) are pivotably coupled to the foot locating member (26) through first apertures (54; see [Col 4 ln 10-15]) provided in upper portions of the left-side arm member (38) and the right-side member (40; see [Col 4 ln 10-15]; see figure 2), respectively, the first apertures (54) aligning with second apertures (52; see [col 4 ln 3-10]; see figure 3) provided in lower portions of the one or more bracing members (28 and 30; see figure 3; see [col 4 ln 3-23] in reference to the pivotal connection of 28 and 30 to 38 and 40).
In regards to claim 12, Miklaus as now modified by Wozniak discloses the invention as discussed above.
Miklaus further discloses wherein the fastening arrangement (70, 72, 74, 76) comprises a plurality of belts and/or a plurality of straps (70, 72, 74, 76 are a plurality of straps; see [col 4 ln 55-60]; see figure 1).
In regards to claim 13, Miklaus as now modified by Wozniak discloses the invention as discussed above.
Miklaus further discloses wherein the plurality of belts and/or the plurality of straps (70, 72, 74, 76) are provided with one or more a loops and hooks fastening arrangement (see [Col 5 ln 35-40]), a buckle pin and holes fastening arrangement, and a spring-loaded friction buckle fastening arrangement.
In regards to claim 14, Miklaus discloses an offloading device (20; see [col 2 ln 45-60]; see figure 1) for offloading load from an ankle joint of a user (20 being structurally similar to Applicant’s device (see figure 1 and Applicant’s figure 2a) is capable of being fastened to perform the intended use of offloading load from an ankle joint of a user), the offloading device (20) comprising:
a foot locating member (26; see [Col 3 ln 5-10]; see figure 1) configured to locate therewithin a foot of the user (see figure 5);
one or more bracing members (28 and 30; see [col 3 ln 5-15]; see figure 1-2) pivotably coupled to the foot locating member (26) on a left side and a right side of the foot locating member (26; see [col 4 ln 5-10]), the one or more bracing members (28 and 30) configured to grasp a portion of a lower leg that is located above the ankle joint (see [col 3 ln 43-60]);
one or more liner pads (48 and 50; see [col 3 ln 45-55]; see figure 1) provided on inner surfaces of the one or more bracing members (28 and 30; see figure 1), wherein the one or more liner pads (48 and 50) are configured to make contact with skin of the user (see [col 3 ln 40-60]); and
a fastening arrangement (70, 72, 74, 76; see [col 4 ln 55-60]; see figure 1) configured to fasten the one or more bracing members (28 and 30) to the portion of the lower leg that is located above the ankle joint (see [col 4 ln 55-65]),
wherein the foot locating member (26) comprises a basal locating member (32, 34, 36; see [Col 3 ln 15-25]; see figure 1-2]) made from a rigid material (see [Col 3 ln 9-12] in reference to 26 being substantially rigid, therefore 32, 34, 36, being portions of 26, are rigid), a left-side arm member (38; see [Col 3 ln 20-25]; see figure 1), and a right-side arm member (40; see [Col 3 ln 20-25]; see figure 1), the left-side arm member (38) and the right-side arm member (40) coupled to the basal locating member (32, 34, 36), on a left and a right side of the basal locating member (32, 34, 36; see figure 1), respectively, and
wherein the one or more liner pads (48 and 50) are made from a deformable material (see [col 4 ln 43-54]).
Miklaus does not disclose the deformable material is coated with a contact material, having a coefficient of friction sufficient to inhibit relative sliding between the liner pads and the skin of the user such that ground reaction forces are transferred from the foot locating member through the one or more bracing members to the portion of the lower leg located above the ankle joint, and thereby reduce the load on the ankle.
However, Wozniak teaches an analogous device (1; see [pg 1]; see figure 1) for the analogous purpose of supporting an ankle joint of a user (see [pg 1] in reference to the device protecting foot joints of infants) comprising an analogous deformable material (elastic fabric sleeve; see [pg 2]) the deformable material (elastic fabric sleeve) is coated with a contact material (silicone coating) having a coefficient of friction sufficient to inhibit relative sliding between the sleeve and the lower leg (see [pg 2] in reference to the silicone coating allowing for adhesion of the support to the lower limb; adhesion provided by the silicone coating is a coefficient of friction sufficient to inhibit relative sliding between the sleeve and the lower leg) for the purpose of providing better adhesion of the device to the user (see [pg 2]).
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 one or more liner pads as disclosed by Miklaus and to have coated the inner surface of the deformable material of the one or more liner pads with a silicone coating as taught by Wozniak in order to have provided an improved offloading device that would add the benefit of providing a coating to be placed against a user’s leg allowing better adhesion of the device to the user (see [pg 2]) thereby increasing the securement of the device to the user’s leg.
Miklaus as now modified by Wozniak’s contact material is coated on the deformable material of the one or more liner pads, and is made from silicone, which is positioned the same, and made from the same material as Applicant’s coating of contact material (see Applicant’s specification [0072]). Thus, the coating of contact material of Miklaus as now modified by Wozniak is expected to exhibit the claimed material properties of “a coefficient of friction sufficient to inhibit relative sliding between the liner pads and the skin of the user such that ground reaction forces are transferred from the foot locating member through the one or more bracing members to the portion of the lower leg located above the ankle joint, and thereby reduce the load on the ankle” since it has been held that “(w)here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (see MPEP 2112.01)). In the instant case, the claimed and prior art products are identical or substantially identical in structure and composition, and thus a prima facie case of obviousness has been established.
In regards to claim 15, Miklaus as now modified by Wozniak discloses the invention as discussed above.
Miklaus further discloses wherein the one or more bracing members (28 and 30) are pivotably coupled to the foot locating member (26) through first apertures (54; see [Col 4 ln 10-15]) provided in upper portions of the left-side arm member (38) and the right-side member (40; see [Col 4 ln 10-15]; see figure 2), respectively, the first apertures (54) aligning with second apertures (52; see [col 4 ln 3-10]; see figure 3) provided in lower portions of the one or more bracing members (28 and 30; see figure 3; see [col 4 ln 3-23] in reference to the pivotal connection of 28 and 30 to 38 and 40).
In regards to claim 19, Miklaus as now modified by Wozniak discloses the invention as discussed above.
Miklaus further discloses wherein the fastening arrangement (70, 72, 74, 76) comprises a plurality of belts and/or a plurality of straps (70, 72, 74, 76 are a plurality of straps; see [col 4 ln 55-60]; see figure 1).
Claim(s) 3-5 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miklaus in view of Wozniak as applied to claims 1 and 14 above, and further in view of Schwartz (US 2005/0274046 A1).
In regards to claim 3, Miklaus as now modified by Wozniak discloses the invention as discussed above.
Miklaus further discloses further comprising an insole member (110; see [Col 6 ln 13-20]; see figure 1) fastened to the foot locating member (26; see [Col 6 ln 20-25]), the insole member (110) comprising an insole anterior portion (anterior portion of 110) and an insole posterior portion (posterior portion of 110), wherein at least the insole posterior portion (posterior portion of 110) is configured to undergo deformation within a predetermined range (110 is a pad, therefore the posterior portion of 110 is configured to undergo a predetermined deformation within a predetermined range (i.e. from the top of 110 to the surface of 26) caused by the user’s foot compressing the pad while using the device).
Miklaus as now modified by Wozniak does not disclose wherein a predefined clearance is provided between the insole posterior portion and a posteriror portion of the foot locating member.
However, Schwartz teaches an analogous ankle supporting device (10; see [0016]; see figure 1; see [0020] in reference to the device supporting an ankle) comprising an analogous foot locating member (12; see [0016]; see figure 1 and 3), and an analogous insole member (22; see [0016]; see figure 3); wherein a predefined clearance (56; see [0017]; see figures 2-4) is provided between the insole posterior portion and a posteriror portion of the foot locating member (see figures 3-4 that the clearance defined by 56 is provided between a posterior portion of 22 and a posterior portion of 12) for the purpose of allowing the insole posterior portion to flex downwardly to form a depression when a user applies weight onto the insole member to inhibit medial-lateral movement of the user’s heel, and correctly position the user’s heel during the weight bearing portion of walking (see [0020]).
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 engagement between the posterior portions of the insole member and foot member as disclosed by Miklaus as now modified by Wozniak and to have included the predefined clearance between the posterior portions of the insole member and foot member as taught by Schwartz in order to have provided an improved offloading device that would add the benefit of allowing the insole posterior portion to flex downwardly to form a depression when a user applies weight onto the insole member to inhibit medial-lateral movement of the user’s heel, and correctly position the user’s heel during the weight bearing portion of walking (see [0020]).
In regards to claim 4, Miklaus as now modified by Wozniak and Schwartz discloses the invention as discussed above.
Miklaus further discloses wherein the insole member (110) is in contact with and bonded to the foot locating member (26; see [Col 6 ln 20-25]), along an entire length of the foot locating member (26; see [Col 6 ln 13-20]), the insole member (110) being made from a deformable material (see [Col 6 ln 13-15]).
In regards to claim 5, Miklaus as now modified by Wozniak and Schwartz discloses the invention as discussed above.
Miklaus further discloses wherein at least the insole posterior portion (posterior portion of 110) is suspended from lateral surfaces (38 and 40; see [Col 3 ln 20-25]; see figure 1) of the foot locating member (26; see [Col 6 ln 20-25] in reference to 110 being mounted on 38 and 40, thus the entirety of the pad is suspended from lateral surfaces 38 and 40).
In regards to claim 16, Miklaus as now modified by Wozniak discloses the invention as discussed above.
Miklaus further discloses further comprising an insole member (110; see [Col 6 ln 13-20]; see figure 1) provided above an upper surface of the basal locating member (upper surface of 32, 34, 36; see figure 3), the insole member (110) comprising an insole anterior portion (anterior portion of 110) and an insole posterior portion (posterior portion of 110), wherein at least the insole posterior portion (posterior portion of 110) is configured to undergo deformation within a predetermined range (110 is a pad, therefore the posterior portion of 110 is configured to undergo a predetermined deformation within a predetermined range (i.e. from the top of 110 to the surface of 26) caused by the user’s foot compressing the pad while using the device).
Miklaus as now modified by Wozniak does not disclose wherein a predefined clearance is provided between the insole posterior portion and a posteriror portion of the foot locating member.
However, Schwartz teaches an analogous ankle supporting device (10; see [0016]; see figure 1; see [0020] in reference to the device supporting an ankle) comprising an analogous foot locating member (12; see [0016]; see figure 1 and 3), and an analogous insole member (22; see [0016]; see figure 3); wherein a predefined clearance (56; see [0017]; see figures 2-4) is provided between the insole posterior portion and a posteriror portion of the foot locating member (see figures 3-4 that the clearance defined by 56 is provided between a posterior portion of 22 and a posterior portion of 12) for the purpose of allowing the insole posterior portion to flex downwardly to form a depression when a user applies weight onto the insole member to inhibit medial-lateral movement of the user’s heel, and correctly position the user’s heel during the weight bearing portion of walking (see [0020]).
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 engagement between the posterior portions of the insole member and foot member as disclosed by Miklaus as now modified by Wozniak and to have included the predefined clearance between the posterior portions of the insole member and foot member as taught by Schwartz in order to have provided an improved offloading device that would add the benefit of allowing the insole posterior portion to flex downwardly to form a depression when a user applies weight onto the insole member to inhibit medial-lateral movement of the user’s heel, and correctly position the user’s heel during the weight bearing portion of walking (see [0020]).
In regards to claim 17, Miklaus as now modified by Wozniak and Schwartz discloses the invention as discussed above.
Miklaus further discloses wherein the insole member (110) is in contact with and bonded to the basal locating member (32, 34, 36; see [Col 6 ln 20-25]), along an entire length of the basal locating member (32, 34, 36; see [Col 6 ln 13-20]), the insole member (110) being made from a deformable material (see [Col 6 ln 13-15]).
In regards to claim 18, Miklaus as now modified by Wozniak discloses the invention as discussed above.
Miklaus further discloses wherein at least the insole posterior portion (posterior portion of 110) is suspended from the left-side arm member and the right-side arm member (38 and 40; see [Col 3 ln 20-25] and [Col 6 ln 20-25]; see figure 1).
Conclusion
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786