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
The amendment filed 5/13/2026 has been received and made of record. Claims 1-20 are currently pending and are being examined.
Response to Arguments
Applicant’s amendments overcome the previous rejections set forth under 35 USC 112 and 101. Therefore, those rejections have been withdrawn.
Applicant's arguments filed 5/13/2026 with respect to McCoy, Robran, and Roban have been fully considered but they are not persuasive. Applicant argues that Claims 1 and 11 as amended recite: an apex height, h; wherein the apex height, h, is configured to be positioned below a knee of the patient, and wherein the support is configured such that a calf, ankle, and foot of the patient extend outward from the support. Applicant further argues that the apex of the device of McCoy, Robran and Roban is not positioned below a knee of the user, and because the calf, ankle, and foot of the user do not extend outward from the support. In response to applicant's argument, 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. As noted in the updated rejections below (necessitated by Applicant’s amendments), the apex of the device of McCoy, Robran, and Roban is capable of placement below a knee of the user. Furthermore, the calf, ankle, and foot do extend outward from at least a proximal portion of the device of McCoy, Robran and Roban and would furthermore be capable of placement of extending outward. See the updated rejections below. Therefore, the rejections under 35 USC 102 have been maintained.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 8, 11, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0165138 A1 to McCoy.
Regarding claim 1, McCoy teaches a device (10, Fig 1; “support device 10” para [0013]) comprising: a support configured to raise a leg of a patient off of a procedure table (lift 12 under leg of patient, Fig 1, 5); wherein the support comprises an apex height h (top height of 22 at end 16; Figure 1); wherein the apex height h of the support is configured to be positioned below a knee of the patient (intended use; the top height of 22 at end 16 is capable of being placed under the knee); wherein the support is configured to raise a leg off of the procedure table by a predetermined amount (lifting leg off table a predetermined and desired amount, Fig 1 and 5; [0021]); wherein the support is configured such that a calf, ankle and foot of the patient extend outward from the support (intended use; the device is capable of being placed further up under the thigh/buttocks/back such that the calf, ankle, and foot would extend outward from the support, Figures 1 and 5; furthermore the calf, ankle, and foot extend outward from at least a portion 18 of the support, Figures 1 and 5).
Regarding claim 2, McCoy teaches the device of claim 1 and further teaches comprising a strap to secure the leg of the patient to the support (straps 38 of fasteners 36, Fig 1, 4-5; “the plurality of fasteners 36 comprises a plurality of straps 38...Each second coupler 46 is positioned to reversibly couple with a respective first coupler 42 to secure a respective strap 38 around a leg positioned on the top 22 of the lift 12” para [0017]).
Regarding claim 3, McCoy teaches the device of claim 2 and further teaches wherein the strap is secured using one selected from a group consisting of hook and loop material, belt fastener, and adhesive (“the first couplers 42 and the second couplers 46 are selected from the group of couplers consisting of hook-type and loop-type fasteners.” para [0017]).
Regarding claim 8, McCoy teaches the device of claim 1 and further teaches wherein the device parameters can be adjusted based on subject/patient anatomy and the surgical procedure being performed (adjustable by adding or removing wedges 14, Fig 1,5; para [0021]).
Regarding claim 11, McCoy teaches a device (10, Fig 1; “support device 10” para [0013]) comprising: a wedge-shaped block configured for placement under a leg of a patient (wedge-shaped lift 12 under leg of patient, Fig 1, 5), wherein the wedge-shaped block defines an incline (incline of wedge 12, Fig 1, 5), and wherein the incline is at an angle theta (incline having an angle, Fig 1, 5; [0021]), wherein the angle theta is configured to raise the leg of the patient to a predetermined height (lifting leg off table a predetermined and desired amount, Fig 5; [0021]); and wherein the wedge-shaped block comprises an apex height, h, (top height of 22 at end 16; Figure 1) wherein the apex height, h, of the wedge-shaped block is configured to be positioned below a knee of the patient (intended use; the top height of 22 at end 16 is capable of being placed under the knee), and wherein the wedge-shaped block is configured such that a calf, ankle, and foot of the patient extend outward from the support (intended use; the device is capable of being placed further up under the thigh/buttocks/back such that the calf, ankle, and foot would extend outward from the support; furthermore the calf, ankle, and foot extend outward from at least a portion 18 of the support, Figures 1 and 5).
Regarding claim 13, McCoy teaches the device of claim 11 and further teaches comprising a strap to secure the leg of the patient to the support (straps 38 of fasteners 36, Fig 1, 4-5; “the plurality of fasteners 36 comprises a plurality of straps 38...Each second coupler 46 is positioned to reversibly couple with a respective first coupler 42 to secure a respective strap 38 around a leg positioned on the top 22 of the lift 12” para [0017]).
Regarding claim 14, McCoy teaches the device of claim 13 and further teaches wherein the strap is secured using one selected from a group consisting of hook and loop material, belt fastener, and adhesive (“the first couplers 42 and the second couplers 46 are selected from the group of couplers consisting of hook-type and loop-type fasteners.” para [0017]).
Claims 1, 4-5, 11, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0186738 A1 to Robran.
Regarding claim 1, Robran teaches a device (limb elevation device 100, Fig 1; “limb elevation device 100” para [0024]) comprising: a support configured to raise a leg of a patient off of a procedure table (base 11 lifting leg 10 off surface 9, Fig 1); wherein the support comprises an apex height h (top height of 16 at upper surface 15; Figure 1); wherein the apex height h of the support is configured to be positioned below a knee of the patient (Figure 1; upper surface is under the knee); wherein the support is configured to raise a leg off of the procedure table by a predetermined amount (lifting leg 10 off surface 9 a predetermined amount, Fig 1); and wherein the support is configured such that a calf, ankle, and foot of the patient extend outward from the support (intended use; the device is capable of being placed further up under the thigh/buttocks/back such that the calf, ankle, and foot would extend outward from the support; Furthermore, the calf, ankle, and foot extend outward from at least a portion 13 of the support; Figures 1 and 5A).
Regarding claim 4, Robran teaches the device of claim 1 and further teaches comprising a strap to secure the support to the procedure table (straps 14, Fig 1, 4B; “...securement straps 14 to be fastened securely to a surface 9” para [0030]).
Regarding claim 5, Robran teaches the device of claim 4 and further teaches wherein the strap is secured to the procedure table using one selected from a group consisting of hook and loop material, belt fastener, and adhesive (“A strap 14A, 14B may be attached to an anchor point 19 as shown in FIG. 4B. A securing end 7A, 7B of the strap 14A, 14B may be attached to an anchor point 19 using hook and loop fasteners, clips, snaps, buttons, buckles or the like” para [0032]; see Fig 1, 4B).
Regarding claim 11, Robran teaches a device (limb elevation device 100, Fig 1; “limb elevation device 100” para [0024]) comprising: a wedge-shaped block configured for placement under a leg of a patient (base 11 lifting leg 10 off surface 9 with wedge-shaped front end 8, Fig 1), wherein the wedge-shaped block defines an incline (inclined surface 8, Fig 1), and wherein the incline is at an angle theta, wherein the angle theta raises the leg of the patient to a predetermined height (lifting leg 10 off surface 9 a predetermined amount, Fig 1); and wherein the wedge-shaped block comprises an apex height, h, (top height of 16 at upper surface 15; Figure 1) wherein the apex height, h, of the wedge-shaped block is configured to be positioned below a knee of the patient (Figure 1), and wherein the wedge-shaped block is configured such that a calf, ankle, and foot of the patient extend outward from the support (intended use; the device is capable of being placed further up under the thigh/buttocks/back such that the calf, ankle, and foot would extend outward from the support; Furthermore, the calf, ankle, and foot extend outward from at least a portion 13 of the support; Figures 1 and 5A).
Regarding claim 15, Robran teaches the device of claim 11 and further teaches comprising a strap to secure the support to the procedure table (straps 14, Fig 1, 4B; “...securement straps 14 to be fastened securely to a surface 9” para [0030]).
Regarding claim 16, Robran teaches the device of claim 14 and further teaches wherein the strap is secured to the procedure table using one selected from a group consisting of hook and loop material, belt fastener, and adhesive (“A strap 14A, 14B may be attached to an anchor point 19 as shown in FIG. 4B. A securing end 7A, 7B of the strap 14A, 14B may be attached to an anchor point 19 using hook and loop fasteners, clips, snaps, buttons, buckles or the like” para [0032]; see Fig 1, 4B).
Claims 1, 6-12, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0397608 A1 to Roban.
Regarding claim 1, Roban teaches a device (knee extension device 100, Fig 1) comprising: a support configured to raise a leg of a patient off of a procedure table (support 102, 104 for leg 10, Fig 1; “The knee extension device 100 includes a proximal section 102 and a distal section 104” para [0015]); wherein the support comprises an apex height, h (at 116; Figure 1); wherein the apex height, h, of the support is configured to be positioned below a knee of the patient (intended use, portion 116 is capable of being placed below a knee); wherein the support is configured to raise a leg off of the procedure table by a predetermined amount (see Fig 1 and 3 wherein leg 10 is raised from a surface); and, wherein the support is configured such that a calf, ankle, and foot of the patient extend outward from the support (intended use; the device is capable of being placed further up under the thigh/buttocks/back such that the calf, ankle, and foot would extend outward from the support; Furthermore the calf, ankle, and foot extend outward from at least a portion 1118 of the support, Figure 1).
Regarding claim 6, Roban teaches the device of claim 1 and further teaches wherein the support is formed from one selected from a group consisting of plastic, rubber, an inflatable membrane, and foam (“The proximal section 102 and distal section 104 may be formed of any material suitable for use in physical therapy environments. In preferred embodiments, the separate sections are formed of a foam polymer material” para [0030]).
Regarding claim 7, Roban teaches the device of claim 1 and further teaches comprising a sterile cover (“the device may include a removeable "skin" such as a fabric or sterile sheet material, and may optionally include one or more zippers, hook and loop fasteners, buttons, snaps, and/or other means of donning and doffing the removeable skin” para [0030]).
Regarding claim 8, Roban teaches the device of claim 1 and further teaches wherein the device parameters can be adjusted based on subject/patient anatomy and the surgical procedure being performed (adjustable by adding or removing distal section 104 to selectively raise the leg higher than with proximal section 102 alone, Fig 1, 3; “selectively attachable to one another via corresponding attachment features 112 and 114” para [0018]).
Regarding claim 9, Roban teaches the device of claim 1 and further teaches comprising a central recess for receiving the leg of the patient (recess 110, Fig 2A-2B; “The upper surface of the extension device 100 includes a leg depression 110 (underneath the leg 10 in this view) for receiving and conforming to the patient's leg 10.” para [0021]).
Regarding claim 10, Roban teaches the device of claim 9 and further teaches wherein the central recess is configured based on patient height, patient weight, and surgical procedure being performed (intended use; recess 110, Fig 2A-2B; “The upper surface of the extension device 100 includes a leg depression 110 (underneath the leg 10 in this view) for receiving and conforming to the patient's leg 10.” para [0021]).
Regarding claim 11, Roban teaches a device (knee extension device 100, Fig 1) comprising: a wedge-shaped block configured for placement under a leg of a patient (wedge shape 102, Fig 1, 2A-2B, 3; “The knee extension device 100 includes a proximal section 102” para [0015]), wherein the wedge-shaped block defines an incline (see Fig 1-3), and wherein the incline is at an angle theta (angle, Fig 1-3; para [0031]), wherein the angle theta raises the leg of the patient to a predetermined height (see Fig 1 and 3 wherein leg 10 is raised from a surface); wherein the wedge-shaped block comprises an apex height, h, (at 116; Figure 1) wherein the apex height, h, of the wedge-shaped block is configured to be positioned below a knee of the patient (intended use, portion 116 is capable of being placed below a knee), and wherein the wedge-shaped block is configured such that a calf, ankle, and foot of the patient extend outward from the support (intended use; the device is capable of being placed further up under the thigh/buttocks/back such that the calf, ankle, and foot would extend outward from the support; Furthermore the calf, ankle, and foot extend outward from at least a portion 1118 of the support, Figure 1).
Regarding claim 12, Roban teaches the device of claim 11 and further teaches comprising an end block (distal section 104, Fig 1-3), wherein the end block is configured to provide additional support for the leg of the patient (“The proximal section 102 and the distal section 104 are selectively attachable to one another via corresponding attachment features 112 and 114. In the illustrated embodiment, the proximal section 102 includes, at its distal end 120, a distal extension as an attachment feature 112, and the distal section 104 includes, at its proximal end 122, a cavity as a corresponding attachment feature 114” para [0018]).
Regarding claim 17, Roban teaches the device of claim 11 and further teaches wherein the support is formed from one selected from a group consisting of plastic, rubber, an inflatable membrane, and foam (“The proximal section 102 and distal section 104 may be formed of any material suitable for use in physical therapy environments. In preferred embodiments, the separate sections are formed of a foam polymer material” para [0030]).
Regarding claim 18, Roban teaches the device of claim 11 and further teaches comprising a sterile cover (“the device may include a removeable "skin" such as a fabric or sterile sheet material, and may optionally include one or more zippers, hook and loop fasteners, buttons, snaps, and/or other means of donning and doffing the removeable skin” para [0030]).
Regarding claim 19, Roban teaches the device of claim 11 and further teaches comprising a central recess for receiving the leg of the patient (recess 110, Fig 2A-2B; “The upper surface of the extension device 100 includes a leg depression 110 (underneath the leg 10 in this view) for receiving and conforming to the patient's leg 10.” para [0021]).
Regarding claim 20, Roban teaches the device of claim 19 and further teaches wherein the central recess is configured based on patient height, patient weight, and surgical procedure being performed (intended use; recess 110, Fig 2A-2B; “The upper surface of the extension device 100 includes a leg depression 110 (underneath the leg 10 in this view) for receiving and conforming to the patient's leg 10.” para [0021]).
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 Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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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.
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/KARI K RODRIQUEZ/ Primary Patent Examiner, Art Unit 3786
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