DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments of claims 1-3, 6, and 8-17 are acknowledged by the Examiner.
Applicant’s amendments of claim 1, 11, and 16 have overcome the previous claim objections. Therefore, the claim objections are withdrawn.
Applicant’s amendments of claims 6, 14, and 17 has overcome the previous claim rejections under 35 U.S.C. 112(b). Therefore, the claim rejections under 35 U.S.C. 112(b) are withdrawn.
Claims 1-18 are pending in the current application.
Response to Arguments
In response to Applicant’s arguments regarding the provisional non-statutory double patenting rejection, the terminal disclaimer has overcome the provisional non-statutory double patenting rejection. Therefore, the rejection is withdrawn.
Applicant’s arguments, see remarks, filed 11/26/2025, with respect to the rejection(s) of claim(s) 1 and 11 under 35 U.S.C. 103 over Ward (US 2010/0106065 A1) in view of Klopf (US 5,830,166 A) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, with respect to claim 1, a new ground(s) of rejection is made in view of Ward in view of newly found reference Ceriani (US 2006/0155232 A1), and with respect to claim 11, a new ground(s) of rejection is made in view of Ward in view of newly found reference Ceriani and previously relied upon reference Grim (US 2016/0151187 A1).
Terminal Disclaimer
The terminal disclaimer filed on 11/26/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of co-pending U.S. Application No. 18/136,534 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the plurality of upper/lower wraps…configured so as to… be sole load bearing contact surfaces on the upper leg portion, and sole load bearing contact surfaces on the lower leg portion, without contact on anterior or posterior faces of the upper/lower leg portion” as recited in claims 1 and 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not provide support for the limitations of “the plurality of upper/lower wraps…configured so as to… be sole load bearing contact surfaces on the upper leg portion, and sole load bearing contact surfaces on the lower leg portion, without contact on anterior or posterior faces of the upper/lower leg portion” as recited in claims 1 and 11. These limitations were amended into the claims after the initial filing of the application and are considered new matter. Thus, the specification should not be amended to provide antecedent support for these limitations as the specification would then contain new matter.
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.
Claims 1-18 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 1 recites the limitation “a plurality of upper wraps engaging with the upper medial member and the upper lateral member, and configured so as to…be sole load-bearing contact surfaces on the upper leg portion, without contact on anterior or posterior faces of the upper leg portion”. The specification does not provide support for any structure being “a sole load-bearing contact surface”, or for the plurality of upper wraps being “without contact on anterior or posterior faces of the upper leg portion”. Furthermore, it can clearly be seen in figure 6 that the upper wraps contact the anterior and posterior surfaces of the upper leg portion of the leg. Thus, this limitation is considered new matter.
Claim 1 recites the limitation “a plurality of lower wraps engaging with the lower medial member and the lower lateral member, and configured so as to…be sole load-bearing contact surfaces on the lower leg portion, without contact on anterior or posterior faces of the lower leg portion”. The specification does not provide support for any structure being “a sole load-bearing contact surface”, or for the plurality of lower wraps being “without contact on anterior or posterior faces of the lower leg portion”. Furthermore, it can clearly be seen in figure 6 that the lower wraps contact the anterior and posterior surfaces of the lower leg portion of the leg. Thus, this limitation is considered new matter.
Claim 11 recites the limitation “a plurality of upper wraps engaging with the upper medial member and the upper lateral member, and configured so as to…be sole load-bearing contact surfaces on the upper leg portion, without contact on anterior or posterior faces of the upper leg portion”. The specification does not provide support for any structure being “a sole load-bearing contact surface”, or for the plurality of upper wraps being “without contact on anterior or posterior faces of the upper leg portion”. Furthermore, it can clearly be seen in figure 6 that the upper wraps contact the anterior and posterior surfaces of the upper leg portion of the leg. Thus, this limitation is considered new matter.
Claim 11 recites the limitation “a plurality of lower wraps engaging with the lower medial member and the lower lateral member, and configured so as to…be sole load-bearing contact surfaces on the lower leg portion, without contact on anterior or posterior faces of the lower leg portion”. The specification does not provide support for any structure being “a sole load-bearing contact surface”, or for the plurality of lower wraps being “without contact on anterior or posterior faces of the lower leg portion”. Furthermore, it can clearly be seen in figure 6 that the lower wraps contact the anterior and posterior surfaces of the lower leg portion of the leg. Thus, this limitation is considered new matter.
Claims 2-10, and 12-18 are rejected under 35 U.S.C. 112(a) as being dependent on a rejected claim and therefore, containing the same offending limitations.
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 1-18 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 term “a substantial length of an upper leg portion” in claim 1 is a relative term which renders the claim indefinite. The term “substantial” is 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. For the purpose of examination, Examiner will interpret this limitation as “a length of an upper leg portion”.
The term “a substantial length of a lower leg portion” in claim 1 is a relative term which renders the claim indefinite. The term “substantial” is 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. For the purpose of examination, Examiner will interpret this limitation as “a length of a lower leg portion”.
Claim 1 recites the limitation “a plurality of upper wraps engaging with the upper medial member and upper lateral member, and configured so as to removably hold the upper medial member and the upper lateral member securely against a medial face and lateral face of the upper leg portion of the user and be sold load-bearing contact surfaces on the upper leg portion without contact on anterior or posterior faces of the upper leg portion”. This limitation renders the claim indefinite because it is unclear as to if applicant is claiming the plurality of upper wraps, or the upper medial member and upper lateral member (when held by the upper wraps) are the sole load-bearing surfaces without contact on anterior and posterior faces of the upper leg portion. For the purpose of examination, Examiner will interpret this limitation as “and the upper medial member and upper lateral member being sole load-bearing contact surfaces on the upper leg portion, without contact on anterior or posterior faces of the upper leg portion”.
Claim 1 recites the limitation “a plurality of lower wraps engaging with the lower medial member and upper lateral member, and configured so as to removably hold the lower medial member and the lower lateral member securely against a medial face and lateral face of the lower leg portion of the user and be sold load-bearing contact surfaces on the lower leg portion without contact on anterior or posterior faces of the lower leg portion”. This limitation renders the claim indefinite because it is unclear as to if applicant is claiming the plurality of lower wraps, or the lower medial member and lower lateral member (when held by the lower wraps) are the sole load-bearing surfaces without contact on anterior and posterior faces of the lower leg portion. For the purpose of examination, Examiner will interpret this limitation as “and the lower medial member and lower lateral member being sole load-bearing contact surfaces on the lower leg portion, without contact on anterior or posterior faces of the lower leg portion”.
The term “substantially at a right angle” in claim 6 is a relative term which renders the claim indefinite. The term “substantially” is 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. For the purpose of examination, Examiner will interpret this limitation as “at a right angle”.
The term “a substantial length of an upper leg portion” in claim 11 is a relative term which renders the claim indefinite. The term “substantial” is 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. For the purpose of examination, Examiner will interpret this limitation as “a length of an upper leg portion”.
The term “a substantial length of a lower leg portion” in claim 11 is a relative term which renders the claim indefinite. The term “substantial” is 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. For the purpose of examination, Examiner will interpret this limitation as “a length of a lower leg portion”.
Claim 11 recites the limitation “a plurality of upper wraps engaging with the upper medial member and upper lateral member, and configured so as to removably hold the upper medial member and the upper lateral member securely against a medial face and lateral face of the upper leg portion of the user and be sold load-bearing contact surfaces on the upper leg portion without contact on anterior or posterior faces of the upper leg portion”. This limitation renders the claim indefinite because it is unclear as to if applicant is claiming the plurality of upper wraps, or the upper medial member and upper lateral member (when held by the upper wraps) are the sole load-bearing surfaces without contact on anterior and posterior faces of the upper leg portion. For the purpose of examination, Examiner will interpret this limitation as “and the upper medial member and upper lateral member being sole load-bearing contact surfaces on the upper leg portion, without contact on anterior or posterior faces of the upper leg portion”.
Claim 11 recites the limitation “a plurality of lower wraps engaging with the lower medial member and upper lateral member, and configured so as to removably hold the lower medial member and the lower lateral member securely against a medial face and lateral face of the lower leg portion of the user and be sold load-bearing contact surfaces on the lower leg portion without contact on anterior or posterior faces of the lower leg portion”. This limitation renders the claim indefinite because it is unclear as to if applicant is claiming the plurality of lower wraps, or the lower medial member and lower lateral member (when held by the lower wraps) are the sole load-bearing surfaces without contact on anterior and posterior faces of the lower leg portion. For the purpose of examination, Examiner will interpret this limitation as “and the lower medial member and lower lateral member being sole load-bearing contact surfaces on the lower leg portion, without contact on anterior or posterior faces of the lower leg portion”.
The term “substantially at a right angle” in claim 17 is a relative term which renders the claim indefinite. The term “substantially” is 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. For the purpose of examination, Examiner will interpret this limitation as “at a right angle”.
Claims 2-5, 7-10, 12-16, and 18 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim, and therefore containing the same offending limitations.
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.
Claim(s) 1-2, and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward (US 2010/0106065 A1) in view of Ceriani (US 2006/0155232 A1).
In regards to claim 1, Ward discloses an unweighting leg orthotic system (system as seen in figures 15 and 16; see [0079] in reference to the device offloading a knee, thereby unweighting a leg), comprising
a leg brace (foot and leg brace system; see [0079-0080]; see figure 15 and 16) comprising a set of upper supports (medial and lateral 1609; see [0079-0080]; see figures 15 and 16) hingedly coupled to a set of lower supports (1209a-b; see [0079-0080]; see figures 15 and 16) at a set of joints (medial and lateral 1611; see [0079-0080]; see figures 15 and 16), said leg brace (foot and leg brace system) configured for removable attachment to a leg of a user (attachment of brace to user’s leg; see [0079-0080]; see figures 15 and 16);
an upper medial member (medial portion of 1661 disposed below medial instance of 1609; see [0079-0080]; see figures 15 and 16) and an upper lateral member (lateral portion of 1661 disposed below lateral instance of 1609; see [0079-0080]; see figures 15 and 16) associated with said set of upper supports (medial and lateral 1609; see figures 15 and 16), and a lower medial member (medial portion of 1205 disposed below 1209a; see [0079-0080]; see figures 15 and 16) and a lower lateral member (lateral portion of 1205 disposed below 1209b; see [0079-0080]; see figures 15 and 16) associated with said set of lower supports (1209 a and b), wherein the upper medial member and upper lateral member (medial and lateral portions of 1661) are configured to span a substantial length of an upper leg portion of the user (See figures 15-16), and the lower medial member and lower lateral member (medial and lateral portions of 1205) are configured to span a substantial length of a lower leg portion of the user (See figures 15-16);
a plurality of upper horizontal members (1633; see [0080]; see figure 16) engaging with the upper medial member and upper lateral member (medial and lateral portions of 1609; see [0080]; see figure 16), and configured so as to removably hold the upper medial member and upper lateral member (medial and lateral portions of 1609) securely against a corresponding medial face and lateral face of the upper leg portion of the user (see [0080] in reference to 1633 bracing 1661 and 1609 against a user's leg);
a plurality of lower horizontal members (1233; see [0073]; see figure 16) engaging with the lower medial member and lower lateral member (medial and lateral portions of 1205), and configured so as to removably hold the lower medial member and lower lateral member (medial and lateral portions of 1205) securely against a corresponding medial face and lateral face of the lower leg portion of the user (see [0073] in reference to 1233 bracing 1205 and 1209 a and b against a user’s leg); and
a pedal protector (111 and 115; see [0079-0080] and [0047]; see figure 15 and 16) having an insole (insole of 115) connected to said set of lower supports (1209a-b; see figures 5 and 16), having an upper portion (103b; see [0050]; see figure 16 that the embodiment of figure 16 comprises a structure 103b which does not have a reference numeral) corresponding to an ankle of the user (see figure 16) and a lower portion (115) corresponding to a foot of the user (see figure 16), wherein the upper portion (103b) is connected to the lower portion (115) by an ankle hinge (hinge which allows rotation of 111; see [0065]) configured to pivot the lower portion (115) in a dorsiflexion direction relative to the upper portion (103b; rotation of 111 is capable of pivoting 111 in a dorsiflexion direction as claimed).
Ward does not disclose the plurality of upper horizontal members are a plurality of upper wraps, and the upper medial member and upper lateral member (see 112b interpretation above) being sole load-bearing contact surfaces on the upper leg portion without contact on anterior or posterior faces of the upper leg portion; and
the plurality of lower horizontal members are a plurality of lower wraps, and the lower medial member and lower lateral member (see 112b interpretation above) being sole load-bearing contact surfaces on the lower leg portion without contact on anterior or posterior faces of the lower leg portion.
However, Ceriani teaches an analogous leg brace (10; see [0035]; see figure 1) comprising a set of upper supports (14a-b; see [0038] and [0042]; see figure 1), a set of lower supports (16a-b; see [0038] and [0042]; see figure 1), an upper medial member and lateral member (medial and lateral upper 72; see [0049]; see figure 1) associated with the set of upper supports (14a-b; see figure 1), a lower medial member and lateral member (medial and lateral lower 72; see [0049]; see figure 1) associated with the set of lower supports (16a-b; see figure 1), a plurality of upper horizontal members (82a and 84a; see [0051]; see figure 1), and a plurality of lower horizontal members (82b and 84b; see [0051]; see figure 1); the plurality of upper horizontal members are a plurality of upper wraps (82a and 84a wrap around a user’s upper leg and the brace, and thus are considered “upper wraps”; see figure 2), and the upper medial member and upper lateral member (medial and lateral upper 72) being without contact on anterior or posterior faces of the upper leg portion (see figures 2, 3, and 5); and
the plurality of lower horizontal members are a plurality of lower wraps (82b and 84b wrap around a user’s lower leg and the brace, and thus are considered “lower wraps”; see figure 2), and the lower medial member and lower lateral member (medial and lateral lower 72) being without contact on anterior or posterior faces of the lower leg portion (see figures 2, 3, and 5) for the purpose of securely fitting and retaining the brace on the user’s leg while the device is in use without the need for substantial readjustment (See [abstract]) and allowing the medial and lateral aspects of the brace to approximate the width of the leg due to their separation (see [0062]).
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 plurality of upper and lower horizontal members as disclosed by Ward by forming the plurality of upper horizontal members, and the plurality of lower horizontal members as a plurality of upper straps and a plurality of lower straps as taught by Ceriani, and to have modified the upper and lower, medial and lateral members as disclosed by Ward by forming the upper and lower, medial and lateral members without contact on anterior or posterior faces of the upper and lower leg portion respectively as taught by Ceriani in order to have provided an improved unweighting leg orthotic system that would add the benefit of securely fitting and retaining the brace on the user’s leg while the device is in use without the need for substantial readjustment (See [abstract]) and allowing the medial and lateral aspects of the brace to approximate the width of the leg due to their separation (see [0062]).
Thus, as now combined, the upper medial and lateral members, and the lower medial and lateral members of Ward as now modified by Ceriani are the only portions of the unweighting leg orthotic system which contact the upper and lower portions leg portions of the user, and thus are the sole load-bearing contact surfaces on the upper and lower leg portions respectively as claimed.
In regards to claim 2, Ward as now modified by Ceriani discloses the invention as discussed above.
Ward further discloses wherein said pedal protector is configured so as to maintain a gap (spaced relation; see [0078]; see figures 15 and 16) between the insole of the pedal protector and a sole of the foot of the user (see [0078]) as the unweighting leg orthotic system transfers all weight from the leg of the user to the set of upper supports (medial and lateral 1609) and set of lower supports (1209a-b; see [0046], and [0079-0080]).
In regards to claim 4, Ward as now modified by Ceriani discloses the invention as discussed above.
Ward further discloses further comprising a quick release interface (screws of 103a and b which facilitates connection of 117 and 119 to 1209a-b; see [0051]; see figure 16; screws are capable of being quickly screwed into or out of the device and thus, are considered “quick release” interfaces), between said set of lower supports (1209a-b) and a pair of fixed uprights (117 and 119; see [0050]; see figures 15 and 16).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Ceriani as applied to claim 2 above, and further in view of Franke et al. (US 2010/0130898 A1) (hereinafter Franke).
In regards to claim 3, Ward as now modified by Ceriani discloses the invention as discussed above.
Ward as now modified by Ceriani does not disclose said pedal protector further comprising a toe bolster on the insole of the pedal protector configured so as to support toes of the foot of the user.
However, Franke teaches an analogous unweighting leg orthotic system (702; see [0088]; see figure 7b) comprising an analogous pedal protector (704; see [0088]; see figure 7b) said pedal protector (704) further comprising a toe bolster (705; see [0088]; see figure 7e that 705 supports a user’s toes) on the insole of the pedal protector (704; see figure 7e that 705 is positioned on an insole of 704) configured so as to support toes of the foot of the user (see figure 7e) for the purpose of applying just enough pressure to the bottom of a subject's foot (e.g., the toes and/or the ball of the foot) to hold it generally perpendicular to the long axis of the lower leg (see [0095]).
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 pedal protector as disclosed by Ward as now modified by Ceriani and to have included the toe bolster as taught by Franke in order to have provided an improved pedal protector that would add the benefit of applying just enough pressure to the bottom of a subject's foot (e.g., the toes and/or the ball of the foot) to hold it generally perpendicular to the long axis of the lower leg (see [0095]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Ceriani as applied to claim 4 above, and further in view of Phillips (US 2012/0209163 A1).
In regards to claim 5, Ward as now modified by Ceriani discloses the invention as discussed above.
Ward as now modified by Ceriani does not disclose wherein the quick release interface between said set of lower supports and said pair of fixed uprights is adjustable in length so as to make a dimension of the gap adjustable.
However, Phillips teaches an analogous quick release interface (81 and 82; see [0028]; see figure 1) between a lower support (76; see [0028]; see figure 1) and fixed upright (78; see [0027]; see figure 1) of an analogous ankle foot orthosis device (10; see [0016]; see figure 1), wherein the quick release interface (81 and 82) is adjustable in length (the quick release interface is adjustable along 82; see figure 2) so as to make a dimension of the gap adjustable (see [0028]) for the purpose of locking the lower support in a selected inferior-superior position (see [0028]).
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 quick release interface as disclosed by Ward as now modified by Ceriani and to have made the quick release interface adjustable in length as taught by Phillips in order to have provided an improved quick release interface that would add the benefit of locking the lower support in a selected inferior-superior position (see [0028]) thereby allowing the device to be customized according to the needs of the user.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Ceriani as applied to claim 1 above, and further in view of Klopf (US 5,830,166 A).
In regards to claim 6, Ward as now modified by Ceriani discloses the invention as discussed above.
Ward as now modified by Ceriani does not disclose wherein said ankle hinge comprises a tension spring hinge configured to default to a neutral position with the lower portion of the pedal protector substantially at a right angle relative to the upper portion of the pedal protector.
However, Klopf teaches an analogous leg orthotic system for a user’s foot (device as seen in figure 1) comprising an analogous pedal protector (1 and 8; see [Col 3 ln 3-21]; see figure 1), wherein the pedal protector comprises an upper portion (1) corresponding to a user’s ankle and a lower portion (8) corresponding to a user’s foot connected via an analogous ankle hinge (3; see [col 3 ln 3-21]; see figure 1) configured to pivot the lower portion (8) in a dorsiflexion direction relative to the upper portion (1; see [Col 1 ln 60-col 2 ln 7]); wherein said ankle hinge (3) comprises a tension spring (5; see [Col 3 ln 5-22]; see figure 1) hinge (the presence of 5 makes 3 a tension spring hinge) configured to default to a neutral position with the lower portion (8) of the pedal protector substantially at a right angle relative to the upper portion (1) of the pedal protector (see [Col 2 ln 1-7] in reference to the spring returning the foot to a resting position; see figure 1 that the resting position of 1 and 8 is at a neutral position, which places the foot and pedal protector at a right angle) for the purpose of creating an upward rotation (dorsiflexion)) for the purpose of supporting and protecting the user’s foot to prevent damage from walking upon an unsupported foot (see [col 1 ln 10-22]).
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 ankle hinge as disclosed by Ward as now modified by Ceriani and to have included the tension spring of the ankle hinge thereby forming a tension spring hinge as taught by Klopf in order to have provided an improved pedal protector that would add the benefit of supporting and protecting the user’s foot to prevent damage from walking upon an unsupported foot (see [col 1 ln 10-22]).
In regards to claim 7, Ward as now modified by Ceriani and Klopf discloses the invention as discussed above.
Ward as now modified by Ceriani and Klopf does not disclose wherein said tension spring hinge comprises a stop that prevents the lower portion of the pedal protector from pivoting in a plantarflexion direction relative to the upper portion of the pedal protector.
However, Klopf further teaches wherein said tension spring hinge (3 and 5) comprises a stop (11; see [col 3 ln 15-22] that prevents the lower portion (8) of the pedal protector (1 and 8) from pivoting in a plantarflexion direction (see figure 1 that the anterior 11 prevents 8 from plantar flexion rotation) relative to the upper portion (1) of the pedal protector (1 and 8) for the purpose of supporting and protecting the user’s foot to prevent damage from walking upon an unsupported foot (see [col 1 ln 10-22]).
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 ankle hinge as disclosed by Ward as now modified by Ceriani and Klopf and to have included stop for preventing a plantar flexion rotation of the lower portion relative to the upper portion of the pedal protector as further taught by Klopf in order to have provided an improved pedal protector that would add the benefit of supporting and protecting the user’s foot to prevent damage from walking upon an unsupported foot (see [col 1 ln 10-22]).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Ceriani as applied to claim 1 above, and further in view of Grim (US 2016/0151187 A1).
In regards to claim 8, Ward as now modified by Ceriani discloses the invention as discussed above.
Ward as now modified by Ceriani does not disclose further comprising a pedal bladder within the pedal protector, wherein the pedal bladder is configured to enclose the ankle of the user in part so as to maintain position and comfort.
However, Grim teaches an analogous leg orthotic system (11; see [0020]; see figure 1) comprising an analogous pedal protector (30; see [0022]; see figure 1) further comprising a pedal bladder (152; see [0029]; see figure 1) within the pedal protector (30; see figure 1 that 152 is intended to be placed within 30), wherein the pedal bladder (152) is configured to enclose the ankle of the user in part so as to maintain position and comfort (see [0031]) for the purpose of providing additional support to the user’s ankle and leg (see [0019]).
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 pedal protector as disclosed by Ward as now modified by Ceriani and to have included the pedal bladder as taught by Grim in order to have provided an improved pedal protector that would add the benefit of providing additional support to the user’s ankle and leg (see [0019]).
In regards to claim 9, Ward as now modified by Ceriani and Grim discloses the invention as discussed above.
Ward as now modified by Grim further discloses wherein the pedal bladder (152 of Grim) comprises a variable cushion (155 of Grim; see Grim [0033] and figure 1b) with a pump (165 of Grim; see Grim [0033] and figure 1b) and a valve (167 of Grim; see Grim [0033] and figure 1b) configured to as to inflate or deflate the pedal bladder (152 of Grim) relative to the ankle of the user (see Grim [0033]).
In regards to claim 10, Ward as now modified by Ceriani and Grim discloses the invention as discussed above.
Ward as now modified by Grim further discloses wherein the pedal bladder (152 of Grim) has a general U-shape (see figure 1 of Grim) configured to receive the ankle of the user when applying the pedal protector (111 and 115 of Ward) thereto (see figure 1 of Grim that 152 is in a general U-shape to receive the user’s ankle).
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Ceriani and Grim.
In regards to claim 1, Ward discloses an unweighting leg orthotic system (system as seen in figures 15 and 16; see [0079] in reference to the device offloading a knee, thereby unweighting a leg), comprising
a leg brace (foot and leg brace system; see [0079-0080]; see figure 15 and 16) comprising a set of upper supports (medial and lateral 1609; see [0079-0080]; see figures 15 and 16) hingedly coupled to a set of lower supports (1209a-b; see [0079-0080]; see figures 15 and 16) at a set of joints (medial and lateral 1611; see [0079-0080]; see figures 15 and 16), said leg brace (foot and leg brace system) configured for removable attachment to a leg of a user (attachment of brace to user’s leg; see [0079-0080]; see figures 15 and 16);
an upper medial member (medial portion of 1661 disposed below medial instance of 1609; see [0079-0080]; see figures 15 and 16) and an upper lateral member (lateral portion of 1661 disposed below lateral instance of 1609; see [0079-0080]; see figures 15 and 16) associated with said set of upper supports (medial and lateral 1609; see figures 15 and 16), and a lower medial member (medial portion of 1205 disposed below 1209a; see [0079-0080]; see figures 15 and 16) and a lower lateral member (lateral portion of 1205 disposed below 1209b; see [0079-0080]; see figures 15 and 16) associated with said set of lower supports (1209 a and b), wherein the upper medial member and upper lateral member (medial and lateral portions of 1661) are configured to span a substantial length of an upper leg portion of the user (See figures 15-16), and the lower medial member and lower lateral member (medial and lateral portions of 1205) are configured to span a substantial length of a lower leg portion of the user (See figures 15-16);
a plurality of upper horizontal members (1633; see [0080]; see figure 16) engaging with the upper medial member and upper lateral member (medial and lateral portions of 1609; see [0080]; see figure 16), and configured so as to removably hold the upper medial member and upper lateral member (medial and lateral portions of 1609) securely against a corresponding medial face and lateral face of the upper leg portion of the user (see [0080] in reference to 1633 bracing 1661 and 1609 against a user's leg);
a plurality of lower horizontal members (1233; see [0073]; see figure 16) engaging with the lower medial member and lower lateral member (medial and lateral portions of 1205), and configured so as to removably hold the lower medial member and lower lateral member (medial and lateral portions of 1205) securely against a corresponding medial face and lateral face of the lower leg portion of the user (see [0073] in reference to 1233 bracing 1205 and 1209 a and b against a user’s leg); and
a pedal protector (111 and 115; see [0079-0080] and [0047]; see figure 15 and 16) having an insole (insole of 115) connected to said set of lower supports (1209a-b; see figures 5 and 16).
Ward does not disclose the plurality of upper horizontal members are a plurality of upper wraps, and the upper medial member and upper lateral member (see 112b interpretation above) being sole load-bearing contact surfaces on the upper leg portion without contact on anterior or posterior faces of the upper leg portion;
the plurality of lower horizontal members are a plurality of lower wraps, and the lower medial member and lower lateral member (see 112b interpretation above) being sole load-bearing contact surfaces on the lower leg portion without contact on anterior or posterior faces of the lower leg portion; and
the pedal protector comprising a pedal bladder configured to enclose an ankle of the user in part so as to maintain position and comfort when in use.
However, Ceriani teaches an analogous leg brace (10; see [0035]; see figure 1) comprising a set of upper supports (14a-b; see [0038] and [0042]; see figure 1), a set of lower supports (16a-b; see [0038] and [0042]; see figure 1), an upper medial member and lateral member (medial and lateral upper 72; see [0049]; see figure 1) associated with the set of upper supports (14a-b; see figure 1), a lower medial member and lateral member (medial and lateral lower 72; see [0049]; see figure 1) associated with the set of lower supports (16a-b; see figure 1), a plurality of upper horizontal members (82a and 84a; see [0051]; see figure 1), and a plurality of lower horizontal members (82b and 84b; see [0051]; see figure 1); the plurality of upper horizontal members are a plurality of upper wraps (82a and 84a wrap around a user’s upper leg and the brace, and thus are considered “upper wraps”; see figure 2), and the upper medial member and upper lateral member (medial and lateral upper 72) being without contact on anterior or posterior faces of the upper leg portion (see figures 2, 3, and 5); and
the plurality of lower horizontal members are a plurality of lower wraps (82b and 84b wrap around a user’s lower leg and the brace, and thus are considered “lower wraps”; see figure 2), and the lower medial member and lower lateral member (medial and lateral lower 72) being without contact on anterior or posterior faces of the lower leg portion (see figures 2, 3, and 5) for the purpose of securely fitting and retaining the brace on the user’s leg while the device is in use without the need for substantial readjustment (See [abstract]) and allowing the medial and lateral aspects of the brace to approximate the width of the leg due to their separation (see [0062]).
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 plurality of upper and lower horizontal members as disclosed by Ward by forming the plurality of upper horizontal members, and the plurality of lower horizontal members as a plurality of upper straps and a plurality of lower straps as taught by Ceriani, and to have modified the upper and lower, medial and lateral members as disclosed by Ward by forming the upper and lower, medial and lateral members without contact on anterior or posterior faces of the upper and lower leg portion respectively as taught by Ceriani in order to have provided an improved unweighting leg orthotic system that would add the benefit of securely fitting and retaining the brace on the user’s leg while the device is in use without the need for substantial readjustment (See [abstract]) and allowing the medial and lateral aspects of the brace to approximate the width of the leg due to their separation (see [0062]).
Thus, as now combined, the upper medial and lateral members, and the lower medial and lateral members of Ward as now modified by Ceriani are the only portions of the unweighting leg orthotic system which contact the upper and lower portions leg portions of the user, and thus are the sole load-bearing contact surfaces on the upper and lower leg portions respectively as claimed.
Ward as now modified by Ceriani does not disclose a pedal bladder within the pedal protector, wherein the pedal bladder is configured to enclose the ankle of the user in part so as to maintain position and comfort.
However, Grim teaches an analogous leg orthotic system (11; see [0020]; see figure 1) comprising an analogous pedal protector (30; see [0022]; see figure 1) further comprising a pedal bladder (152; see [0029]; see figure 1) within the pedal protector (30; see figure 1 that 152 is intended to be placed within 30), wherein the pedal bladder (152) is configured to enclose the ankle of the user in part so as to maintain position and comfort (see [0031]) for the purpose of providing additional support to the user’s ankle and leg (see [0019]).
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 pedal protector as disclosed by Ward and to have included the pedal bladder as taught by Grim in order to have provided an improved pedal protector that would add the benefit of providing additional support to the user’s ankle and leg (see [0019]).
In regards to claim 12, Ward as now modified by Ceriani and Grim discloses the invention as discussed above.
Ward as now modified by Grim further discloses wherein the pedal bladder (152 of Grim) comprises a variable cushion (155 of Grim; see Grim [0033] and figure 1b) with a pump (165 of Grim; see Grim [0033] and figure 1b) and a valve (167 of Grim; see Grim [0033] and figure 1b) configured to as to inflate or deflate the pedal bladder (152 of Grim) relative to the ankle of the user (see Grim [0033]).
In regards to claim 13, Ward as now modified by Ceriani and Grim discloses the invention as discussed above.
Ward as now modified by Grim further discloses wherein the pedal bladder (152 of Grim) has a general U-shape (see figure 1 of Grim) configured to receive the ankle of the user when applying the pedal protector (111 and 115 of Ward) thereto (see figure 1 of Grim that 152 is in a general U-shape to receive the user’s ankle).
In regards to claim 14, Ward as now modified by Ceriani discloses the invention as discussed above.
Ward further discloses wherein said pedal protector is configured so as to maintain a gap (spaced relation; see [0078]; see figures 15 and 16) between the insole of the pedal protector and a sole of the foot of the user (see [0078]) as the unweighting leg orthotic system transfers all weight from the leg of the user to the set of upper supports (medial and lateral 1609) and set of lower supports (1209a-b; see [0046], and [0079-0080]).
In regards to claim 16, Ward as now modified by Ceriani and Grim discloses the invention as discussed above.
Ward further discloses the pedal protector (111 and 115) comprising an upper portion (103b; see [0050]; see figure 13 and 16 that the embodiment seen in figure 16 has a similar structure to 103b) corresponding to the ankle of the user (see figure 16) and a lower portion (115) corresponding to a foot of the user (see figure 16) wherein the upper portion (103b) is connected to the lower portion (115) by an ankle hinge (hinge which allows rotation of 111; see [0065]) configured to pivot the lower portion (115) in a dorsiflexion direction relative to the upper portion (103b; rotation of 111 is capable of pivoting 111 in a dorsiflexion direction as claimed).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Ceriani and Grim as applied to claim 14 above, and further in view of Franke.
In regards to claim 15, Ward as now modified by Ceriani and Grim discloses the invention as discussed above.
Ward as now modified by Ceriani and Grim does not disclose said pedal protector further comprising a toe bolster on the insole of the pedal protector configured so as to support toes of the foot of the user.
However, Franke teaches an analogous unweighting leg orthotic system (702; see [0088]; see figure 7b) comprising an analogous pedal protector (704; see [0088]; see figure 7b) said pedal protector (704) further comprising a toe bolster (705; see [0088]; see figure 7e that 705 supports a user’s toes) on the insole of the pedal protector (704; see figure 7e that 705 is positioned on an insole of 704) configured so as to support toes of the foot of the user (see figure 7e) for the purpose of applying just enough pressure to the bottom of a subject's foot (e.g., the toes and/or the ball of the foot) to hold it generally perpendicular to the long axis of the lower leg (see [0095]).
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 pedal protector as disclosed by Ward as now modified by Ceriani and Grim and to have included the toe bolster as taught by Franke in order to have provided an improved pedal protector that would add the benefit of applying just enough pressure to the bottom of a subject's foot (e.g., the toes and/or the ball of the foot) to hold it generally perpendicular to the long axis of the lower leg (see [0095]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward in view of Ceriani and Grim as applied to claim 11 above, and further in view of Klopf.
In regards to claim 17, Ward as now modified by Ceriani and Grim discloses the invention as discussed above.
Ward as now modified by Ceriani and Grim does not disclose wherein said ankle hinge comprises a tension spring hinge configured to default to a neutral position with the lower portion of the pedal protector substantially at a right angle relative to the upper portion of the pedal protector.
However, Klopf teaches an analogous leg orthotic system for a user’s foot (device as seen in figure 1) comprising an analogous pedal protector (1 and 8; see [Col 3 ln 3-21]; see figure 1), wherein the pedal protector comprises an upper portion (1) corresponding to a user’s ankle and a lower portion (8) corresponding to a user’s foot connected via an analogous ankle hinge (3; see [col 3 ln 3-21]; see figure 1) configured to pivot the lower portion (8) in a dorsiflexion direction relative to the upper portion (1; see [Col 1 ln 60-col 2 ln 7]); wherein said ankle hinge (3) comprises a tension spring (5; see [Col 3 ln 5-22]; see figure 1) hinge (the presence of 5 makes 3 a tension spring hinge) configured to default to a neutral position with the lower portion (8) of the pedal protector substantially at a right angle relative to the upper portion (1) of the pedal protector (see [Col 2 ln 1-7] in reference to the spring returning the foot to a resting position; see figure 1 that the resting position of 1 and 8 is at a neutral position, which places the foot and pedal protector at a right angle) for the purpose of creating an upward rotation (dorsiflexion)) for the purpose of supporting and protecting the user’s foot to prevent damage from walking upon an unsupported foot (see [col 1 ln 10-22]).
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 ankle hinge as disclosed by Ward as now modified by Ceriani and Grim and to have included the tension spring of the ankle hinge thereby forming a tension spring hinge as taught by Klopf in order to have provided an improved pedal protector that would add the benefit of supporting and protecting the user’s foot to prevent damage from walking upon an unsupported foot (see [col 1 ln 10-22]).
In regards to claim 7, Ward as now modified by Ceriani, Grim, and Klopf discloses the invention as discussed above.
Ward as now modified by Ceriani, Grim, and Klopf does not disclose wherein said tension spring hinge comprises a stop that prevents the lower portion of the pedal protector from pivoting in a plantarflexion direction relative to the upper portion of the pedal protector.
However, Klopf further teaches wherein said tension spring hinge (3 and 5) comprises a stop (11; see [col 3 ln 15-22] that prevents the lower portion (8) of the pedal protector (1 and 8) from pivoting in a plantarflexion direction (see figure 1 that the anterior 11 prevents 8 from plantar flexion rotation) relative to the upper portion (1) of the pedal protector (1 and 8) for the purpose of supporting and protecting the user’s foot to prevent damage from walking upon an unsupported foot (see [col 1 ln 10-22]).
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 ankle hinge as disclosed by Ward as now modified by Ceriani, Grim, and Klopf and to have included stop for preventing a plantar flexion rotation of the lower portion relative to the upper portion of the pedal protector as further taught by Klopf in order to have provided an improved pedal protector that would add the benefit of supporting and protecting the user’s foot to prevent damage from walking upon an unsupported foot (see [col 1 ln 10-22]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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, Alireza Nia can be reached at 571-270-3076. 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.
/DANIEL A MILLER/Primary Examiner, Art Unit 3786