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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “adjustment mechanism” in claim 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (see [0131] of the instant specification and fig. 45).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1, 2, 5, 6, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frydman US 2016/0296030 A1.
Regarding claim 1, Frydman discloses an extremity offloading system 10 (figs. 4-5 and [0027], leg support device 10 comprises two components, pillow 12 and extension 13, which is capable of being used to offload the weight of the extremity, as shown in fig. 7) comprising:
a body 12 comprising an outer surface 20, an inner surface 22 (fig. 1 and [0028], arcuate outer surface 20 and inner surface 22), and a thickness extending between the outer surface 20 and the inner surface 22 (fig. 1, the pillow 12 having a thickness forming the body of the pillow between the inner and outer surfaces), the outer surface 20 being at least partially round (fig. 1 and [0028], arcuate outer surface 20), the inner surface 22 defining an aperture 32, the aperture 32 configured to accept insertion of a leg or an ankle of a patient (fig. 2 and [0028], thigh channel 32); and
a contraction adjustment support 13/27 comprising a convex bottom surface 17 and a concave top surface 19 (figs. 3-5 and [0030], top portion 19 and bottom portion 17 being arcuate in shape, which can particularly be seen in the figures as convex on bottom and concave on top; [0033], support 13 further has a sling 27 by which it can be attached to pillow 12), the concave top surface 19 configured to receive at least a portion of the body 12 (figs. 5 and 6 and [0032], the bottom surface of the pillow 12 lies on the top portion 19 of extension 13; depending on how the device is placed, it would be capable of adjustably supporting the extremity under a joint to prevent it from contracting).
Regarding claim 2, Frydman discloses the contraction adjustment support 13/27 being removably attached to the body 12 (fig. 5 and [0032], the pillow 12 is attached to the extension 13 via sling 27, and it would thus be removable by removing it from the sling 27).
Regarding claim 5, Frydman discloses the contraction adjustment support 13/27 being configured to be positioned between the body 12 and a surface on which the contraction adjustment support 13 rests (fig. 7, the support 13 is between the pillow 12 and the bottom thigh, on which the support 13 rests).
Regarding claim 6, Frydman discloses the convex bottom surface 17 being positioned on the surface on which the contraction adjustment support 13 rests (fig. 7).
Regarding claim 8, Frydman discloses the contraction adjustment support 13 comprising foam ([0027], pillow 12 and extension 13 may comprise polyurethane foam).
Claim(s) 9, 14, and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klein US 5,957,874.
Regarding claim 9, Klein discloses an extremity offloading system 10 (fig. 3 and col. 1, line 5, heel elevating device, which would provide offloading to the foot) comprising:
a body 20 comprising an outer surface, an inner surface, and a thickness extending between the outer surface and the inner surface (fig. 1 and col. 7, lines 6-9, shearling comfort liner 20 being interpreted as the claimed body; the outer surface being the convex bottom surface facing support 12, the inner surface being the concave upper surface that receives the leg (as in figs. 3 and 4), and the thickness being the body of the liner 20 between the outer and inner surfaces), the outer surface being at least partially round (fig. 1 shows the outer bottom surface of liner 20 being convex and rounded to form a u-shape), the inner surface defining an aperture, the aperture configured to accept insertion of a leg or an ankle of a patient (figs. 3-5 and col. 7, lines 6-9, the u-shaped channel formed by the liner 20 forming an aperture that receives and interfaces with the leg, particularly when the top strap 34 is in place); and
a foot-ankle positioner 44 attached to the body 20 by at least one strap 36 (col. 7, lines 37-42 and 47-49, foot-drop strap 36 comprises shearling pad 44, which positions the foot and ankle in the proper position to prevent the foot from dropping forward, as shown in fig. 3; the shearling pad 44 is attached to the rest of the device 10, including body 20, via the strap 36, which is attached to one side of support 12 and threads through a catch 46 on the other side, as described in col. 7, lines 47-53), the foot-ankle positioner 44 configured to at least partially support a foot of the patient, the ankle of the patient, or the foot and the ankle of the patient (fig. 3, the strap 36 and shearling pad 44 hold the ankle and foot in place to prevent it from dropping forward).
Regarding claim 14, Klein discloses a first end of the at least one strap 36 being attached to a first side 14 of the body 12 (fig. 2 shows the left end of strap 36 being attached to extension 14 of body 12) and a second end 36A of the at least one strap 36 being attached on a second side 16 of the body 12 (fig. 2 and col. 7, lines 47-53, the right free end 36A of strap 36 attaches to the right extension 16 of body 12 by threading through catch 46).
Regarding claim 16, Klein discloses the at least one strap 36 comprising an adjustment mechanism H/L (fig. 2 and col. 7, lines 47-53, strap 36 comprising hook and loop members H/L that would provide adjustability).
Regarding claim 17, Klein discloses the foot-ankle positioner 44 comprising a convex bottom surface and a concave top surface (fig. 5, the shearling pad 44 having a convex bottom/outer surface and a concave top/inner surface facing the foot).
Regarding claim 18, Klein discloses a top surface of the foot-ankle positioner 44 comprising a plurality of grooves (fig. 5 shows the top surface of shearling pad 44 facing the foot being bumpy and thus comprising grooves).
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frydman US 2016/0296030 A1 in view of Klein US 5,957,874.
Regarding claims 3 and 4, Frydman discloses the claimed invention as discussed above.
Frydman is silent on the concave top surface comprising an adhesive that is configured to attach the concave top surface to the outer surface of the body, wherein the adhesive comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners.
However, Klein teaches an extremity offloading system 10 (fig. 3 and col. 1, line 5, heel elevating device, which would provide offloading to the foot) comprising an analogous body 20 (fig. 1 and col. 7, lines 6-9, shearling comfort liner 20 being interpreted as the claimed body) which sits atop an analogous support 12 (fig. 1 and col. 7, lines 6-9), wherein the concave top surface (fig. 2, the upper concave surface of support 12) comprises an adhesive 28/30/32 that is configure to attach the concave top surface to the outer surface of the body 44, wherein the adhesive 28/30/32 comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners (figs. 1 and 2 and col. 7, lines 22-26, the interior walls/upper surface of support 12 comprises loop strips 28/30/32 that mate with hook strips 23/24/25 on bottom surface of liner 20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the concave top surface of the contraction adjustment support 13/27 of Frydman with an adhesive that is configured to attach the concave top surface to the outer surface of the body, wherein the adhesive comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners, as taught by Klein, to provide additional securement between the support and the body, as the sling would still allow the body to slide within it without an additional form of fixation.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frydman US 2016/0296030 A1 in view of Ravikumar US 2007/0095353 A1.
Regarding claim 7, Frydman discloses the claimed invention as discussed above.
Frydman is silent on the contraction adjustment support being configured to elevate the body between 3 mm to 4 mm from the surface on which the contraction adjustment support rests.
However, Ravikumar teaches an analogous extremity offloading system (fig. 3 and [0003]) comprising an analogous support 20/23 for a body (fig. 3 and [0043], bladders 20 and 23 may support the heel elevation device) that is configured to elevate the body between 3 mm to 4 mm from the surface on which the support 20/23 rests (fig. 3 and [0043], bladders 20 and 23 may each provide up to 2 inches of cushioning when fully inflated, indicating that they may be less inflated and would provide less than 2 inches each of cushioning; [0037], elevation height is adjustable based on the volume of air pumped into the bladder; thus, the bladders 20/23 combined provide up to 4 inches of total cushioning, which includes an elevation of between 3-4 mm when less inflated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the contraction adjustment support of Frydman to be configured to elevate the body between 3 mm to 4 mm from the surface on which the contraction adjustment support rests, as taught by Ravikumar, as this height may be preferred by the specific patient depending on comfort and/or anatomy.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein US 5,957,874 in view of Scher US 6,607,245 B1.
Regarding claims 10-12, Klein discloses the claimed invention as discussed above.
Klein is silent on the at least one strap comprising a first end attached to the body and a second end attached to the foot-ankle positioner, wherein each of the first end is attached to the body and the second end is attached to the foot-ankle positioner with an adhesive, wherein the adhesive comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners.
However, Scher teaches an analogous strap 19/20 (fig. 2 and col. 2, lines 42-55, securement straps 19 and 20 attach a central piece 15 to opposite sides of a separate body 11, similarly to Klein’s strap) comprising a first end 23 attached to the body 11 and a second end 21 attached to the analogous central piece 15 (fig. 2 shows the attachment of ends 23 and 21 of strap 19 to the body 11 and piece 15, respectively, in the phantom lines, further described in col. 2, lines 42-55), wherein each of the first end 23 is attached to the body 11 and the second end 21 is attached to the analogous central piece 15 with an adhesive 27/27’, wherein the adhesive 27/27’ comprises tape, glue, hook and loop fasteners (fig. 2 and col. 2, lines 42-55, hook and eye portions 27 and 27’), magnetic fasteners, or snap fasteners.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the at least one strap of Klein to comprise a first end attached to the body and a second end attached to the foot-ankle positioner, wherein each of the first end is attached to the body and the second end is attached to the foot-ankle positioner with an adhesive, wherein the adhesive comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners, as taught by Scher, to allow for adjustment on both ends of the strap, as Klein’s strap only provides adjustment on one side.
Regarding claim 13, Klein discloses the claimed invention as discussed above.
Klein is silent on the at least one strap comprising two straps, a first strap on a first side of an opening of the body and a second strap on a second side of the opening of the body.
However, Scher teaches an analogous strap 19/20 (fig. 2 and col. 2, lines 42-55, securement straps 19 and 20 attach a central piece 15 to opposite sides of a separate body 11, similarly to Klein’s strap) comprising two straps 19 and 20, a first strap 19 on a first side of an opening of the body 11 and a second strap 20 on a second side of the opening of the body 11 (fig. 2 and col. 2, lines 42-55, securement straps 19 and 20 are on each side the central piece 15 to attach it to opposite sides of analogous body 11, which has a central opening).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the at least one strap of Klein to comprise two straps, a first strap on a first side of an opening of the body and a second strap on a second side of the opening of the body, as taught by Scher, to allow for adjustment on both ends of the strap, as Klein’s strap only provides adjustment on one side.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein US 5,957,874 in view of Huber US 4,616,639.
Regarding claim 15, Klein discloses the claimed invention as discussed above.
Klein is silent on the foot-ankle positioner comprising a channel extending through a width of the foot-ankle positioner, the channel configured to receive the at least one strap.
However, Huber teaches an analogous pad 22/38/40 (figs. 2 and 4 and col. 4, lines 9-10) comprising a channel 38/40 extending through a width of the pad 22, the channel 38/40 configured to receive the at least one strap 16 (figs. 2 and 4 and col. 4, lines 19-23, pad 22 has loops 38/40 through which belt 16 extends; thus, the channel is the passageway formed through the loops 38/40, which are interpreted to be part of the pad assembly 22/38/40; fig. 2 particularly shows the loops 38/40 (and thus the channel) spanning the up-down width of the pad 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the pad/foot-ankle positioner of Klein with a channel extending through a width of the foot-ankle positioner, the channel configured to receive the at least one strap, as taught by Huber, to allow relative movement between the foot-ankle positioner and the strap to allow more precise and adjustable positioning relative to the user.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein US 5,957,874 in view of Spann US 4,573,456.
Regarding claim 19, Klein discloses the claimed invention as discussed above.
Klein is silent on a length of each of the plurality of grooves extending along a length of the top surface of the foot-ankle positioner.
However, Spann teaches a foot-ankle positioner 10 (figs. 1 and 2, block 10 is also for interfacing with and positioning the foot and ankle), wherein a length of each of a plurality of grooves B/C extending along a length of the top surface of the foot-ankle positioner 10 (figs. 1 and 2 and col. 2, lines 43-50, the supporting/top surface A of the foam block comprises slits B with air channels C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the foot-ankle positioner of Klein with a length of each of the plurality of grooves extending along a length of the top surface of the foot-ankle positioner, as taught by Spann, to allow body heat to be dissipated (col. 2, lines 52-54).
Regarding claim 20, Klein discloses the claimed invention as discussed above.
Klein is silent on the foot-ankle positioner comprising foam.
However, Spann teaches a foot-ankle positioner 10 (figs. 1 and 2, block 10 is also for interfacing with and positioning the foot and ankle) comprising foam (col. 2, lines 42-43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the foot-ankle positioner of Klein to comprise foam, as taught by Spann, as foam may provide an enhanced cushioning and protecting effect compared to a shearling layer.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 5, 6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,877,960 B2 in view of Frydman US 2016/0296030 A1.
Regarding claim 1, the patent claims an extremity offloading system comprising: a body comprising an outer surface, an inner surface, and a thickness extending between the outer surface and the inner surface, the outer surface being at least partially round, the inner surface defining an aperture, the aperture configured to accept insertion of a leg or an ankle of a patient (claim 1).
The patent is silent on a contraction adjustment support comprising a convex bottom surface and a concave top surface, the concave top surface configured to receive at least a portion of the body.
However, Frydman teaches an extremity offloading system 10 (figs. 4-5 and [0027], leg support device 10 comprises two components, pillow 12 and extension 13, which is capable of being used to offload the weight of the extremity, as shown in fig. 7) comprising: a contraction adjustment support 13/27 comprising a convex bottom surface 17 and a concave top surface 19 (figs. 3-5 and [0030], top portion 19 and bottom portion 17 being arcuate in shape, which can particularly be seen in the figures as convex on bottom and concave on top; [0033], support 13 further has a sling 27 by which it can be attached to pillow 12), the concave top surface 19 configured to receive at least a portion of the body 12 (figs. 5 and 6 and [0032], the bottom surface of the pillow 12 lies on the top portion 19 of extension 13; depending on how the device is placed, it would be capable of adjustably supporting the extremity under a joint to prevent it from contracting).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the extremity offloading system of the patent with a contraction adjustment support comprising a convex bottom surface and a concave top surface, the concave top surface configured to receive at least a portion of the body, as taught by Frydman, to further support the body on a surface and elevate it to the height necessary for offloading.
Regarding claim 2, the patent in view of Frydman discloses the claimed invention as discussed above.
Frydman further teaches the contraction adjustment support 13/27 being removably attached to the body 12 (fig. 5 and [0032], the pillow 12 is attached to the extension 13 via sling 27, and it would thus be removable by removing it from the sling 27), to allow replacement and cleaning of each component.
Regarding claim 5, the patent in view of Frydman discloses the claimed invention as discussed above.
Frydman further teaches the contraction adjustment support 13/27 being configured to be positioned between the body 12 and a surface on which the contraction adjustment support 13 rests (fig. 7, the support 13 is between the pillow 12 and the bottom thigh, on which the support 13 rests), to further support the body on a surface and elevate it to the height necessary for offloading.
Regarding claim 6, the patent in view of Frydman discloses the claimed invention as discussed above.
Frydman further teaches the convex bottom surface 17 being positioned on the surface on which the contraction adjustment support 13 rests (fig. 7), to further support the body on a surface and elevate it to the height necessary for offloading.
Regarding claim 8, the patent in view of Frydman discloses the claimed invention as discussed above.
Frydman further teaches the contraction adjustment support 13 comprising foam ([0027], pillow 12 and extension 13 may comprise polyurethane foam), to be comfortable and provide cushioning.
Claims 3 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,877,960 B2 in view of Frydman US 2016/0296030 A1 further in view of Klein US 5,957,874.
Regarding claims 3 and 4, the patent in view of Frydman discloses the claimed invention as discussed above.
The patent in view of Frydman is silent on the concave top surface comprising an adhesive that is configured to attach the concave top surface to the outer surface of the body, wherein the adhesive comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners.
However, Klein teaches an extremity offloading system 10 (fig. 3 and col. 1, line 5, heel elevating device, which would provide offloading to the foot) comprising an analogous body 20 (fig. 1 and col. 7, lines 6-9, shearling comfort liner 20 being interpreted as the claimed body) which sits atop an analogous support 12 (fig. 1 and col. 7, lines 6-9), wherein the concave top surface (fig. 2, the upper concave surface of support 12) comprises an adhesive 28/30/32 that is configure to attach the concave top surface to the outer surface of the body 44, wherein the adhesive 28/30/32 comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners (figs. 1 and 2 and col. 7, lines 22-26, the interior walls/upper surface of support 12 comprises loop strips 28/30/32 that mate with hook strips 23/24/25 on bottom surface of liner 20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the concave top surface of the contraction adjustment support 13/27 of the patent in view of Frydman with an adhesive that is configured to attach the concave top surface to the outer surface of the body, wherein the adhesive comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners, as taught by Klein, to provide additional securement between the support and the body, as the sling would still allow the body to slide within it without an additional form of fixation.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,877,960 B2 in view of Frydman US 2016/0296030 A1 further in view of Ravikumar US 2007/0095353 A1.
Regarding claim 7, the patent in view of Frydman discloses the claimed invention as discussed above.
The patent in view of Frydman is silent on the contraction adjustment support being configured to elevate the body between 3 mm to 4 mm from the surface on which the contraction adjustment support rests.
However, Ravikumar teaches an analogous extremity offloading system (fig. 3 and [0003]) comprising an analogous support 20/23 for a body (fig. 3 and [0043], bladders 20 and 23 may support the heel elevation device) that is configured to elevate the body between 3 mm to 4 mm from the surface on which the support 20/23 rests (fig. 3 and [0043], bladders 20 and 23 may each provide up to 2 inches of cushioning when fully inflated, indicating that they may be less inflated and would provide less than 2 inches each of cushioning; [0037], elevation height is adjustable based on the volume of air pumped into the bladder; thus, the bladders 20/23 combined provide up to 4 inches of total cushioning, which includes an elevation of between 3-4 mm when less inflated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the contraction adjustment support of the patent in view of Frydman to be configured to elevate the body between 3 mm to 4 mm from the surface on which the contraction adjustment support rests, as taught by Ravikumar, as this height may be preferred by the specific patient depending on comfort and/or anatomy.
Claims 9, 14, and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,877,960 B2 in view of Klein US 5,957,874.
Regarding claim 9, the patent claims an extremity offloading system comprising: a body comprising an outer surface, an inner surface, and a thickness extending between the outer surface and the inner surface, the outer surface being at least partially round, the inner surface defining an aperture, the aperture configured to accept insertion of a leg or an ankle of a patient (claim 1).
The patent is silent on a foot-ankle positioner attached to the body by at least one strap, the foot-ankle positioner configured to at least partially support a foot of the patient, the ankle of the patient, or the foot and the ankle of the patient.
However, Klein teaches an extremity offloading system 10 (fig. 3 and col. 1, line 5, heel elevating device, which would provide offloading to the foot) comprising a foot-ankle positioner 44 attached to the body 20 by at least one strap 36 (col. 7, lines 37-42 and 47-49, foot-drop strap 36 comprises shearling pad 44, which positions the foot and ankle in the proper position to prevent the foot from dropping forward, as shown in fig. 3; the shearling pad 44 is attached to the rest of the device 10, including body 20, via the strap 36, which is attached to one side of support 12 and threads through a catch 46 on the other side, as described in col. 7, lines 47-53), the foot-ankle positioner 44 configured to at least partially support a foot of the patient, the ankle of the patient, or the foot and the ankle of the patient (fig. 3, the strap 36 and shearling pad 44 hold the ankle and foot in place to prevent it from dropping forward).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the extremity offloading system of the patent with a foot-ankle positioner attached to the body by at least one strap, the foot-ankle positioner configured to at least partially support a foot of the patient, the ankle of the patient, or the foot and the ankle of the patient, as taught by Klein, to support the foot and prevent it from dropping forward.
Regarding claim 14, the patent in view of Klein discloses the claimed invention as discussed above.
Klein further teaches a first end of the at least one strap 36 being attached to a first side 14 of the body 12 (fig. 2 shows the left end of strap 36 being attached to extension 14 of body 12) and a second end 36A of the at least one strap 36 being attached on a second side 16 of the body 12 (fig. 2 and col. 7, lines 47-53, the right free end 36A of strap 36 attaches to the right extension 16 of body 12 by threading through catch 46), to provide support across the width of the foot.
Regarding claim 16, the patent in view of Klein discloses the claimed invention as discussed above.
Klein further teaches the at least one strap 36 comprising an adjustment mechanism H/L (fig. 2 and col. 7, lines 47-53, strap 36 comprising hook and loop members H/L that would provide adjustability), to allow customization for each patient.
Regarding claim 17, the patent in view of Klein discloses the claimed invention as discussed above.
Klein further teaches the foot-ankle positioner 44 comprising a convex bottom surface and a concave top surface (fig. 5, the shearling pad 44 having a convex bottom/outer surface and a concave top/inner surface facing the foot), to cradle the foot and increase comfort.
Regarding claim 18, the patent in view of Klein discloses the claimed invention as discussed above.
Klein further teaches a top surface of the foot-ankle positioner 44 comprising a plurality of grooves (fig. 5 shows the top surface of shearling pad 44 facing the foot being bumpy and thus comprising grooves), to provide air circulation.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,877,960 B2 in view of Klein US 5,957,874 further in view of Scher US 6,607,245 B1.
Regarding claims 10-12, the patent in view of Klein discloses the claimed invention as discussed above.
The patent in view of Klein is silent on the at least one strap comprising a first end attached to the body and a second end attached to the foot-ankle positioner, wherein each of the first end is attached to the body and the second end is attached to the foot-ankle positioner with an adhesive, wherein the adhesive comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners.
However, Scher teaches an analogous strap 19/20 (fig. 2 and col. 2, lines 42-55, securement straps 19 and 20 attach a central piece 15 to opposite sides of a separate body 11, similarly to Klein’s strap) comprising a first end 23 attached to the body 11 and a second end 21 attached to the analogous central piece 15 (fig. 2 shows the attachment of ends 23 and 21 of strap 19 to the body 11 and piece 15, respectively, in the phantom lines, further described in col. 2, lines 42-55), wherein each of the first end 23 is attached to the body 11 and the second end 21 is attached to the analogous central piece 15 with an adhesive 27/27’, wherein the adhesive 27/27’ comprises tape, glue, hook and loop fasteners (fig. 2 and col. 2, lines 42-55, hook and eye portions 27 and 27’), magnetic fasteners, or snap fasteners.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the at least one strap of the patent in view of Klein to comprise a first end attached to the body and a second end attached to the foot-ankle positioner, wherein each of the first end is attached to the body and the second end is attached to the foot-ankle positioner with an adhesive, wherein the adhesive comprises tape, glue, hook and loop fasteners, magnetic fasteners, or snap fasteners, as taught by Scher, to allow for adjustment on both ends of the strap, as Klein’s strap only provides adjustment on one side.
Regarding claim 13, the patent in view of Klein discloses the claimed invention as discussed above.
The patent in view of Klein is silent on the at least one strap comprising two straps, a first strap on a first side of an opening of the body and a second strap on a second side of the opening of the body.
However, Scher teaches an analogous strap 19/20 (fig. 2 and col. 2, lines 42-55, securement straps 19 and 20 attach a central piece 15 to opposite sides of a separate body 11, similarly to Klein’s strap) comprising two straps 19 and 20, a first strap 19 on a first side of an opening of the body 11 and a second strap 20 on a second side of the opening of the body 11 (fig. 2 and col. 2, lines 42-55, securement straps 19 and 20 are on each side the central piece 15 to attach it to opposite sides of analogous body 11, which has a central opening).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the at least one strap of the patent in view of Klein to comprise two straps, a first strap on a first side of an opening of the body and a second strap on a second side of the opening of the body, as taught by Scher, to allow for adjustment on both ends of the strap, as Klein’s strap only provides adjustment on one side.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,877,960 B2 in view of Klein US 5,957,874 further in view of Huber US 4,616,639.
Regarding claim 15, the patent in view of Klein discloses the claimed invention as discussed above.
The patent in view of Klein is silent on the foot-ankle positioner comprising a channel extending through a width of the foot-ankle positioner, the channel configured to receive the at least one strap.
However, Huber teaches an analogous pad 22/38/40 (figs. 2 and 4 and col. 4, lines 9-10) comprising a channel 38/40 extending through a width of the pad 22, the channel 38/40 configured to receive the at least one strap 16 (figs. 2 and 4 and col. 4, lines 19-23, pad 22 has loops 38/40 through which belt 16 extends; thus, the channel is the passageway formed through the loops 38/40, which are interpreted to be part of the pad assembly 22/38/40; fig. 2 particularly shows the loops 38/40 (and thus the channel) spanning the up-down width of the pad 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the pad/foot-ankle positioner of Klein with a channel extending through a width of the foot-ankle positioner, the channel configured to receive the at least one strap, as taught by Huber, to allow relative movement between the foot-ankle positioner and the strap to allow more precise and adjustable positioning relative to the user.
Claims 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,877,960 B2 in view of Klein US 5,957,874 further in view of Spann US 4,573,456.
Regarding claim 19, the patent in view of Klein discloses the claimed invention as discussed above.
The patent in view of Klein is silent on a length of each of the plurality of grooves extending along a length of the top surface of the foot-ankle positioner.
However, Spann teaches a foot-ankle positioner 10 (figs. 1 and 2, block 10 is also for interfacing with and positioning the foot and ankle), wherein a length of each of a plurality of grooves B/C extending along a length of the top surface of the foot-ankle positioner 10 (figs. 1 and 2 and col. 2, lines 43-50, the supporting/top surface A of the foam block comprises slits B with air channels C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the foot-ankle positioner of the patent in view of Klein with a length of each of the plurality of grooves extending along a length of the top surface of the foot-ankle positioner, as taught by Spann, to allow body heat to be dissipated (col. 2, lines 52-54).
Regarding claim 20, the patent in view of Klein discloses the claimed invention as discussed above.
The patent in view of Klein is silent on the foot-ankle positioner comprising foam.
However, Spann teaches a foot-ankle positioner 10 (figs. 1 and 2, block 10 is also for interfacing with and positioning the foot and ankle) comprising foam (col. 2, lines 42-43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the foot-ankle positioner of the patent in view of Klein to comprise foam, as taught by Spann, as foam may provide an enhanced cushioning and protecting effect compared to a shearling layer.
Conclusion
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786