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, filed 3/9/2026, to claims 1, 3-4, 7, 14, 21, 24 acknowledged by Examiner.
Claims 1-14 and 21-26 are now pending.
Previous claim objections withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new reference Marshall has been provided for the argued claimed matter of directly coupling wings to side panels of a wedge pad.
Examiner’s Notes
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 1-6, 9, 13-14, 23, 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gainey (US 20190314184 A1) in view of Marshall (US 20040093673 A1).
Regarding claim 1, Gainey discloses a wedge cushioning system for supporting a lower limb of a patient, the wedge cushioning system (Figures 1-9, wedge cushion 40 supporting lower limb) comprising:
a wedge assembly 1 (Fig. 1-9) comprising:
a wedge pad 40 (Fig. 1-9 and [0014-0015], the wedge pad 40 and all the structures in the bottom section 33 [0045]) configured to cushion the lower limb of the patient (see [0021]),
the wedge pad 40 (Fig. 8-9) comprising:
a top panel 42/49 (Fig. 8-9 [0064]),
a bottom panel 47 (Fig. 8-9 [0065]),
a first side panel (left side wall panel of wedge 40, Fig. 7 and 9) coupled between the top panel 42/49 and the bottom panel 47 on a first side of the wedge pad 40 (Fig. 7 and 9, left side wall panel on the left side therein), and
a second side panel (right side wall panel of wedge 40, Fig. 7 and 9) coupled between the top panel 42/49 and the bottom panel 47 on a second side of the wedge pad 40 (Fig. 7 and 9, right side wall panel on the left side therein), the second side opposite the first side (right and left sides being opposites),
wherein the top panel, the bottom panel, the first side panel, and the second side panel collectively define a cavity (Fig. 7-9 and [0060-0061], the wedge pad 40 is formed of foam material, wherein foam material is inherently cavernous having cavities formed within its confines established by the panel borders of the wedge pad 40, thus defining at least a cavity therein),
a first wedge wing 10 pivotably coupled to the first side panel of the wedge pad 40 (left side) (Fig. 4-5 and 7, first wedge wing 10 indirectly coupled to the first/left side of the wedge pad 40 via the stitching 8 and filler 2 intermediary materials therein [0052]) and selectively pivotable between a first lowered position and a first raised position (Fig. 3 for raised position of left wall 10, and Fig. 5-6 for lowered position of a first wedge wing 10, being a left wall 10, wherein the wedge section 40 is stitched to the first wedge wing 10 at a left side such that it is foldable between raised and lowered positions, thus being pivotably coupled),
a second wedge wing 20 pivotably coupled to the second side panel of the wedge pad 40 (right side) (Fig. 4-5 and 7, second wedge wing 20 indirectly coupled to the second/right side of the wedge pad 40 via the stitching 8 and filler 2 intermediary materials therein [0052]) and selectively pivotable between a second lowered position and a second raised position independent of the first wedge wing 10 (Fig. 2 for raised position of 20, and Fig. 5-6 for lowered position of a second wedge wing 20, being a right wall 20, wherein the wedge section 40 is stitched to the second wedge wing 20 at a right side such that it is foldable between raised and lowered positions, thus being pivotably coupled), and
a strap 30 configured to be releasably coupled between the first wedge wing 10 and the second wedge wing 20 (Fig. 6, [0049] hook and loop attachment enabling strap releasably coupled).
Gainey does not disclose the first wedge wing directly pivotably coupled to the first side panel of the wedge pad and the second wedge wing directly pivotably coupled to the second side panel of the wedge pad.
However, Marshal teaches analogous wedge pads 20a/20b (Fig. 5 and [0036] foam wedges for foot placement) having an analogous top panel, side panels, and bottom panel (Fig. 5 and 3D-3F) having an analogous cavity defined by the panels therein (Fig. 3E and [0036] may be hollow), wherein the wedge pads 20a/20b have analogous first and second wedge wings 51n (Fig. 5 and [0047], analogously wrap around the sides of a foot and secures to the wedge pad), wherein the first and second wings 51n are directly pivotably coupled to the first and second side panels 53a/53b of the wedge pad (Fig. 5 and [0047]) using hook and loop fastener ([0047]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the attachment between the wings 10/20 and the wedge pad 33/40 such that the first and second wings 10/20 are directly pivotably coupled to the respective first and second side panels as taught by Marshal in order to provide an improved foot cushion by enabling the wings to be removable to the sides of the foot cushion of the wedge pad 40 thus enabling the user easily clean the wings and alter the position the wings as desired (Marshall [0036, 0047]).
Regarding claim 2, Gainey in view of Marshall discloses the invention of claim 1 above.
Gainey further discloses wherein the first wedge wing 10, the second wedge wing 20, and the strap 30 are configured such that when the strap 30 is coupled between the first wedge wing 10 and the second wedge wing 20, the first wedge wing 10 is in the first raised position and the second wedge wing is in the second raised position (Fig. 1 and 6, wings 10 and 20 each in their first and second raised positions).
Regarding claim 3, Gainey in view of Marshall discloses the invention of claim 1 above.
Gainey further discloses the top panel 42/49 comprises a wedge top surface 42/62 (Fig 1 and 5, top surface of fabric 5 over wedge pad 40 and top surface 42 of wedge 40 are both wedge top surfaces);
the first wedge wing 10 comprises a first wing inside surface 60 (Fig. 1, 5);
the second wedge wing 20 comprises a second wing inside surface 61 (Fig. 1, 5); and
the wedge pad 40, the first wedge wing 10, and the second wedge wing 20 are configured such that the wedge top surface 62 is co-planar with the first wing inside surface 60 and the second wing inside surface 61 when the first wedge wing 10 is in the first lowered position and the second wedge wing 20 is in the second lowered position (Fig. 4-5, unfolded device has the surfaces 60, 61, and 62 being planar with each when laid flat).
Regarding claim 4, Gainey in view of Marshall discloses the invention of claim 3 above.
Gainey further discloses wherein the first side panel and the second side panel are oriented perpendicular to the wedge top surface 42/49 (Fig. 7-9, left and right flat sides of the wedge are flat and perpendicular to the wedge top surface 42/49 therein).
Regarding claim 5, Gainey in view of Marshall discloses the invention of claim 3 above.
Gainey further discloses the first wedge wing 10 comprises a first wing outside surface 4,10 opposing the first wing inside surface 60 (Fig. 1);
the second wedge wing 20 comprises a second wing outside surface 4,20 opposing the second wing inside surface 61 (Fig. 1); and
the strap 30 is configured to be releasably coupled between the first wing outside surface 4,10 and the second wing outside surface 4,20 (Fig. 1, 6 strap 30 attaches between the outside surfaces).
Regarding claim 6, Gainey in view of Marshall discloses the invention of claim 3 above.
Gainey further discloses wherein the wedge pad 40, the first wedge wing 10, and the second wedge wing 20 are configured such that the first wing inside surface 60 and the second wing inside surface 61 face each other when the first wedge wing 10 is in the first raised position and the second wedge wing 20 is in the second raised position (Fig. 1 and 6).
Regarding claim 9, Gainey in view of Marshall discloses the invention of claim 1 above.
Gainey further discloses the wedge assembly further comprises a wedge tip end 46 and a wedge base end 44 (Fig. 9);
a height of the wedge pad 40 increases in a direction from the wedge tip end 46 towards the wedge base end 44 (Fig. 9); and
a width of the strap 30 in the direction from the wedge tip end 46 towards the wedge base end 44 is less than a wing length of the first wedge wing 10 in the direction from the wedge tip end 46 towards the wedge base end 44 (Fig. 4-5, width of strap 30 is less than the length of the wing 10).
Regarding claim 13, Gainey in view of Marshall discloses the invention of claim 1 above.
Gainey further discloses the wedge assembly further comprises a wedge tip end 46 and a wedge base end 44 (Fig. 9);
a height of the wedge pad 40 increases in a direction from the wedge tip end 46 towards the wedge base end 44 (Fig. 9); and
the first wedge wing 10 comprises a first wing tip edge on an end of the first wedge wing 10 positioned closest to the wedge tip end, the first wing tip edge extending away from the wedge tip end as the first wing tip edge extends away from the wedge pad (See Annotated Fig. 4 of Gainey wherein the first wing tip edge positioned closest to the wedge tip end extends away from the wedge pad as it extends away from the wedge tip end as a continuous edge therein).
Regarding claim 14, Gainey in view of Marshall discloses the invention of claim 1 above.
Gainey further discloses the wedge assembly further comprises a wedge tip end 46 and a wedge base end 44 (Fig. 9);
a height of the wedge pad 40 increases in a direction from the wedge tip end 46 towards the wedge base end 44 (Fig. 9); and
the first wedge wing 10 comprises a first wing tip edge on an end of the first wedge wing 10 positioned closest to the wedge base end (See Annotated Figure 4),
the first wing tip edge extending towards the wedge base end as the first wing tip edge extends away from the wedge pad 40 (See Annotated Figure 4, wherein the indicated edge is a stitch formed edge of the portion 10 as it goes towards the wedge base end extends away from the wedge pad 40).
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Regarding claim 23, Gainey in view of Marshall discloses the invention of claim 1 above.
Gainey further discloses the wedge assembly further comprises a wedge tip end 46 and a wedge base end 44 (Fig. 9);
a height of the wedge pad 40 increases in a direction from the wedge tip end 46 towards the wedge base end 44 (Fig. 9); and
the wedge pad 40 has wedge tip corners at the wedge tip end 46 (Fig. 9);
the wedge pad 40 has wedge base corners at the wedge base end; and
at least one of: (i) the wedge tip corners are rounded or (ii) the wedge base corners are rounded (See Annotated Figure 9 below, wherein the wedge base corners are rounded at a curve 44, thus being rounded; see Merriam Webster [https://www.merriam-webster.com/dictionary/rounded] wherein “rounded” is defined as “having a curving rather than jagged or angular shape”, wherein the curve 44 present up to the corners at base 44 then means the corners are rounded therein).
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Regarding claim 25, Gainey in view of Marshall discloses the invention of claim 4 above.
Gainey further discloses the wedge assembly further comprises a wedge tip end 46 and a wedge base end 44 (Fig. 9);
a height of the wedge pad 40 increases in a direction from the wedge tip end 46 towards the wedge base end 44 (Fig. 9); and
and the wedge pad 40 comprises a wedge base surface 45 at the wedge base end 44 of the wedge assembly, the wedge base surface 45 oriented perpendicular to the first side panel, the second side panel, and the wedge top surface (Fig. 9).
Regarding claim 26, Gainey in view of Marshall discloses the invention of claim 3 above.
Gainey further discloses wherein the wedge pad 40, the first wedge wing 10, and the second wedge wing 20 are configured such that the wedge top surface 62 is perpendicular to the first wing inside surface 60 and the second wing inside surface 61 when the first wedge wing 10 is in the first raised position and the second wedge wing 20 is in the second raised position (Fig. 1 and 7).
Claim(s) 7, 8 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gainey (US 20190314184 A1) in view of Marshall (US 20040093673 A1) in view of Spahn (US 20160256329 A1).
Regarding claim 7, Gainey in view of Marshall discloses the invention of claim 1 above.
Gainey further discloses wherein the top panel 42/49 comprises a wedge top surface 62 (Fig. 5, 8, [0045] the wedge top panel is topped by the surface 62) having a first coefficient of friction ([0051] fabric 5 making up the top surface 62 has an implicit first coefficient of friction, [0046] fabric 5 being “brushed, micro-suede, or similar material that is treated to exhibit anti-bacterial properties”); and
the bottom panel 47 comprises a wedge bottom surface 63 (Fig. 4, 8 [0051] bottom surface 63 is on the bottom panel 47) opposing the wedge top surface 62 (Fig. 4-5, opposite sides [0037-0038]),
the wedge bottom surface 63 having a second coefficient of friction ([0051] fabric 4 making up the bottom surface 63 has an implicit second coefficient of friction, [0046] fabric 4 being “a woven, nylon-threaded material which is generally water resistant”).
Gainey does not explicitly disclose the wedge bottom surface second coefficient of friction being less than the first coefficient of friction.
Examiner firstly asserts that Gainey provides implicit disclosure as it is known in the art that a brushed micro suede material would have more friction than a moisture repellent nylon fabric [0046, 0018].
However, Spahn teaches an analogous therapeutic cushioning boot (title) and provides an analogous top inner layer 124 and an analogous bottom outer layer 126 (Fig. 4), wherein the inner layer 124 is analogous formed of a micro suede material and the outer layer 126 is analogous formed of a nylon material, wherein the outer layer has a lower coefficient of friction than the inner layer in order to ensure minimal movement of the invention for increased comfort (Spahn [0032]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have understood that Gainey implicitly discloses the wedge bottom surface second coefficient of friction being less than the first coefficient of friction as taught with evidence from Spahn in analogous boot with analogous materials such that the nylon outer bottom layer has a lower coefficient of friction than the microsuede inner top layer in order to provide resistance of movement thus increasing comfort for the user (Spahn [0032]).
Regarding claim 8, Gainey in view of Marshall and Spahn discloses the invention of claim 7 above.
Gainey in view of Spahn further discloses the first wedge wing 10 comprises a first wing inside surface 5,60 having the first coefficient of friction (Fig. 5, wing 10 inside surface also made of fabric 5 being the same material as the top wedge surface, thus also having the first coefficient of friction therein); and
the second wedge wing 20 comprises a second wing inside surface 5,61 having the first coefficient of friction (Fig. 5, wing 20 inside surface also made of fabric 5 being the same material as the top wedge surface, thus also having the first coefficient of friction therein).
Regarding claim 24, Gainey in view of Spahn discloses the invention of claim 7 above.
Gainey in view of Spahn further discloses wherein the first side comprises a first side surface having the second coefficient of friction; and the second side comprises a second side surface having have the second coefficient of friction (see [0051] and Fig. 7, wherein the fabrics 5 and 4 each respectively formed to the sides of the wedge 40 via stitching 8 form on sides of the wedge 40 therein forming side surfaces of the fabrics 4 and 5 therein on the sides of the wedge pad 40, thus the lower ends of the first and second sides would have the second coefficient of the material via stitching 8 coupling).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gainey (US 20190314184 A1) in view of Marshall (US 20040093673 A1) in view of Finley (US 20230270578 A1).
Regarding claim 10, Gainey in view of Marshall discloses the invention of claim 1 above.
Gainey does not disclose a heel wrap assembly configured to wrap around the lower limb of the patient, the heel wrap assembly comprising:
a wrap base portion,
a wrap heel portion extending from the wrap base portion, and a plurality of wrap arms extending from the wrap base portion, the wrap arms configured to be wrapped around the lower limb to couple the heel wrap assembly to the lower limb;
wherein the heel wrap assembly is configured to be positioned between the wedge pad and the lower limb of the patient.
However, in the same field of endeavor, Finley teaches an analogous wedge foot cushioning system comprising an analogous wedge pad 26 (Fig. 7/9, wedge 26 underlies the lower leg for positioning therein [0022]) with an analogous heel receiving wedge area 60 (analogous to Gainey functionality, Fig. 1) further comprising:
a heel wrap assembly 30 configured to wrap around the lower limb of the patient (Fig. 1 and 9, being located adjacent/near a heel of the user when worn), the heel wrap assembly 30 comprising:
a wrap base portion 80 (Fig. 3, [0041]),
a wrap heel portion 74 extending from the wrap base portion 80 (Fig. 3 and [0041], the wrap heel portion extending as a thickness away from the wrap base portion 80), and
a plurality of wrap arms 70/72 extending from the wrap base portion 80 (Fig. 3, [0041]), the wrap arms 70/72 configured to be wrapped around the lower limb to couple the heel wrap assembly to the lower limb (Fig. 1 and [0037], arms 70/72 wrap around the lower limb and couples the heel wrap assembly to the lower limb in conjunction with cover 90 extending between the wrap arms 70/72);
wherein the heel wrap assembly 30 is configured to be positioned between the wedge pad 26 and the lower limb of the patient (Fig. 8-9, the lower limb goes into the heel wrap 30, and then positioned onto the wedge pad 30 with attachment to hook and loop 40 on the wedge 26 [0026]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the heel assembly 30 as taught by Finley to the wedge cushioning system of Gainey to enable the limb of the user to be held at varying locations along the wedge length and locked into those positions therein for improved adjustability and stability (Finley [0027]).
Regarding claim 11, Gainey in view of Marshall and Finley discloses the invention of claim 10 above.
Gainey in view of Finley discloses the wedge pad, the first wedge wing, and the second wedge wing are configured as reusable elements; and
the heel wrap assembly and the strap are configured as disposable elements (the limitations herein in regards to both reusability and disposability are purely intended use/functional language with no apparent required structure, the wedge pad and wings of Gainey are fully capable of being reused as desired by a user/owner of the device, and the heel wrap assembly 30 of Finely and the strap 30 of Gainey are fully capable of being disposed of by a user as desired making them capable of being disposable).
Regarding claim 12, Gainey in view of Marshall and Finley discloses the invention of claim 10 above.
Finley further teaches wherein the heel wrap assembly 30 further comprises:
a grip element 40/42 (Fig. 9 and [0026], hook and loop fastener 40 on the wedge 26 and the hook and loop fastener 42 on the heel wrap assembly 30) configured to be positioned between the wrap heel portion 74 and the wedge pad 26 (Fig. 9, hook and loop elements 40/42 positioned between the wrap heel portion 74 and the wedge pad 26), the grip element 40/42 configured restrict movement between the wedge pad 26 and the heel wrap assembly 30 (Fig. 9 and [0026], grip elements 40/42 cause a coupling between wedge 26 and heel wrap assembly 30 thus restricting movement between them therein).
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gainey (US 20190314184 A1) in view of Marshall (US 20040093673 A1) in view of Lafleche (US 20140068869 A1).
Regarding claim 21, Gainey in view of Marshall discloses the invention of claim 1 above.
Gainey does not disclose wherein the wedge assembly further comprises a support gel matrix positioned within the cavity of the wedge pad, the support gel matrix configured to cushion the lower limb of the patient.
However, Lafleche teaches an analogous wedge assembly 10 (Fig. 2) being an analogous wedge pad cushion (see [0013]) to provide support to analogous body of a human (see [0086]), wherein the wedge assembly 10 further comprises a support gel matrix positioned within a cavity of the wedge pad, the support gel configured to cushion the lower limb of the patient (see [0021, 0087] wherein there is a support gel matrix within a cavity of the wedge pad to cushion a patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the support gel matrix within a cavity of the wedge pad 40 of Gainey as taught by Lafleche in order to reduce high pressure points against the user’s body (Lafleche [0032]).
Regarding claim 22, Gainey in view of Marshall discloses the invention of claim 21 above.
Lafleche further teaches wherein the support gel matrix defines a plurality of matrix openings 136 to facilitate a flow of air through the support gel matrix (see [0109], support gel matrix has openings/passage ways 136 to enable air flow therethrough).
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 KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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