DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/31/2026 has been entered.
Specification
The use of the term VELCRO, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. As for example, VELCRO ® (hook and loop fastener). Note: hook and loop fastener are the generic terminology.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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) 1-9, 14, 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fryer U.S. Patent No. (3,631,854) in view of Canie U.S. Patent No. (4,306,549) and further in view of Gan et al. (CN 113040998 A).
With respect to claim 1, Fryer substantially discloses a garment-based splint system (figs.1-4) and (abstract) comprising:
a garment shaped to partially surround a body part (shown in phantom in figs.1-2 and 4) to be stabilized leaving a slit or opening (21, figs.2 and 4), the garment comprising:
an inner layer (12, figs.2 and 4) having a skin-facing surface layer (as shown in figs. 2 and 4), and an outer layer (14, figs.2 and 4) wherein the inner layer and the fabric layer define one or more pockets (space between layer 12 and 14, as shown in figs.2 and 4) and one or more channels via opening (21) configured to connecting to a filler source or container or tube (32, fig.4) and communicate filler or foamable polyurethane prepolymer composition (abstract) from the filler source (32) to the one or more pockets (as shown in fig.4).
Fryer substantially discloses the invention as claimed except the inner and outer layer comprise fabric and an interior surface layer.
Canie however, teaches a splint-cast (abstract) comprising an inner fabric layer (liner 3 of a wool/cotton composition, abstract and ([Col.5], lines 12-13) and an outer layer (2 of fiberglass mat) and an interior surface layer or insulation layer 1 and ([Col.4], lines 37-51 and 58-67).
In view of the teachings of Canie, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the garment-based splint system of Fryer by incorporating (1) inner and outer layer made of a fabric material that would be comfortable to the skin of the user and (2) an interior surface layer or insulation layer which functions to prevent heat conduction to the liner when a hardening agent in the envelope is curing.
The combination of Fryer/Canie substantially discloses the invention as claimed except wherein the garment is configurable to different orientations of the body part before the filler is introduced into the one or more pockets.
Gan et al. however, teaches in an analogous art, a garment-based splint system (as shown in figs.3-4) specifically for emergency fixing treatment of fracture part under the emergency condition ([Page 2], 1st paragraph) wherein the garment is configurable to different orientations of the body part (as shown in fig.3, the garment is configured and position at the forearm of the user and as shown in fig.4, the garment is configured and position at the thigh of the user) before the filler is introduced into the one or more pockets, discussed in ([Page 2], 5-8th paragraph).
In view of the teachings of Gan et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the garment of Fryer/Canie such that the garment is configurable to different orientations of the body part before the filler is introduced into the one or more pockets in order to promote bone healing speed and quality to fractured limbs.
With respect to claim 2, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Fryer further discloses a one way quick disconnect at an end of at least one of the one or more channels adapted for connection with the filler source to allow filler to flow through the one or more channels into the one or more pockets, and to allow disconnection and removal of the filler source (as shown in fig.4).
With respect to claim 3, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Fryer further discloses the garment is shaped and configured to stabilize the body part and the body part comprises one or more of, such as an upper limb (as shown in phantom, in figs.2 and 4).
With respect to claim 4, Fryer substantially discloses a kit for garment-based splint system (figs.1-4) and (abstract) the kit comprising:
a garment shaped to partially surround a body part (shown in phantom in figs.1-2 and 4) to be stabilized leaving a slit or opening (21, figs.2 and 4), the garment comprising:
an inner layer (12, figs.2 and 4) having a skin-facing surface layer (as shown in figs. 2 and 4), and an outer layer (14, figs.2 and 4) wherein the inner layer and the fabric layer define one or more pockets (space between layer 12 and 14, as shown in figs.2 and 4) and one or more channels via opening (21) configured to connecting to a filler source or container or tube (32, fig.4) and communicate filler or foamable polyurethane prepolymer composition (abstract) from the filler source (32) to the one or more pockets (as shown in fig.4).
Fryer substantially discloses the invention as claimed except the inner and outer layer comprise fabric and an interior surface layer.
Canie however, teaches a splint-cast (abstract) comprising an inner fabric layer (liner 3 of a wool/cotton composition, abstract) and an outer layer (2 of fiberglass mat) and an interior surface layer or insulation layer 1 and ([Col.4], lines 37-51 and 58-67).
In view of the teachings of Canie, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the garment-based splint system of Fryer by incorporating (1) inner and outer layer made of a fabric material that would be comfortable to the skin of the user and (2) an interior surface layer or insulation layer which functions to prevent heat conduction to the liner when a hardening agent in the envelope is curing.
Note: a kit relates to a combination of multiple components or elements sold together as a package to be assembled and used together to achieve the intended functionality and security features of the invention which is disclosed in the combination of Fryer/Canie as set forth in claim 1 above.
The combination of Fryer/Canie substantially discloses the invention as claimed except wherein the garment is configurable to different orientations of the body part before the filler is introduced into the one or more pockets.
Gan et al. however, teaches in an analogous art, a garment-based splint system (as shown in figs.3-4) specifically for emergency fixing treatment of fracture part under the emergency condition ([Page 2], 1st paragraph) wherein the garment is configurable to different orientations of the body part (as shown in fig.3, the garment is configured and position at the forearm of the user and as shown in fig.4, the garment is configured and position at the thigh of the user) before the filler is introduced into the one or more pockets, discussed in ([Page 2], 5-8th paragraph).
In view of the teachings of Gan et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the garment of Fryer/Canie such that the garment is configurable to different orientations of the body part before the filler is introduced into the one or more pockets in order to promote bone healing speed and quality to fractured limbs.
With respect to claim 5, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Fryer further discloses the filler source comprises a pressurized dispenser of a curable expanding foam or foamable polyurethane prepolymer composition (abstract) and ([Col.4], lines 36-70). Note: ([Col.3], lines 59-69, discloses the tubular neck 34 of the primary container 32 is provided with an external annular lip 35 which serves to provide a generally fluidtight engagement with the nipple 28. Once the introduction of the liquid composition 30 into the sleeve 11 has proceeded to the desired extent, the liquid material is cured within the sleeve to a solid state to provide the required rigidification of the cast 10. The primary tube 32 is then removed from the sleeve 11 and the protruding nipple 28 which is plugged with solidified material is then severed to provide a level outer surface for the cast 10] as such, the “fluidtight engagement with the nipple” implies that the filler source is pressurized.
With respect to claim 6, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Canie further teaches the skin-facing surface layer of the inner fabric layer of the garment comprises a bandage (Abstract, the splint-cast is applied to an injured limb as a bandage but with consecutive wrappings about the limb in spaced relationship to each other).
With respect to claim 7, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Canie further teaches the interior surface layer of the inner fabric layer of the garment comprises a breathable moisture wicking fabric ([Col.4], lines 37-51 and 58-67).
With respect to claim 8, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Canie further teaches one or both of the skin- facing surface layer of the garment comprises flannel cotton (abstract and ([Col.5], lines 12-13).
With respect to claim 9, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Canie further teaches the filler comprises curable expanding foam and the outer fabric layer of the garment comprises a breathable fabric configured to facilitate curing of the curable expanding foam (abstract, the fibreglass reinforcing mat absorbing the hardening agent along the length of the splint-cast blank).
With respect to claim 14, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Canie further teaches the garment further comprises a waterproof layer (5, fig.2) disposed outside of the outer fabric layer (as shown in fig.2) and configured to repel water ([Col.2], lines 53-59) and ([Col.3], lines 8-20) and ([Col.4], lines 52-57).
With respect to claim 16, regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will inherently perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of anticipation has been established. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) and In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); (under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device) see MPEP 2112.01(1), as such, the combination of Fryer/Canie/Gan et al. discloses a method of stabilizing a body part using a garment-based splint system, the method comprising: partially surrounding a body part to be stabilized with a garment leaving a slit, the garment comprising: an inner fabric layer having a skin-facing surface and an interior surface, and an outer fabric layer, wherein the inner fabric layer and the outer fabric layer define one or more pockets and one or more channels connecting to the one or more pockets; wherein the garment is configurable to different orientations of the body part before the filler is introduced into the one or more pockets, fluidically connecting a filler source to the one or more channels, wherein the filler source comprises a pressurized dispenser of a curable expanding foam; flowing a quantity of the curable expanding foam into the one or more pockets, using the one or more channels; and expanding and curing the curable expandable foam in the one or more pockets.
With respect to claim 17, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Canie further teaches the interior surface layer of the inner fabric layer of the garment comprises a breathable moisture wicking fabric and the method further comprises wicking moisture from the body part using the breathable moisture wicking fabric ([Col.4], lines 37-51 and 58-67).
With respect to claim 20, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Canie further teaches the garment further comprises a waterproof layer disposed outside of the outer fabric layer and the method further comprises repelling water, using the waterproof layer ([Col.2], lines 53-59) and ([Col.3], lines 8-20) and ([Col.4], lines 52-57).
Claim(s) 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fryer/Canie/Gan et al. as applied to claims 1 and 17 above, and further in view of Root et al. U.S. Publication No. (2022/0387658 A1).
With respect to claim 10, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Fryer discloses the filler comprises curable expanding foam (abstract, foamable polyurethane prepolymer composition) except the outer fabric layer of the garment comprises flannel cotton.
Root et al. however, teaches (abstract, a kit includes a sleeve including an outer lining and an inner lining; a pouch arranged within the sleeve and including one or more polymer sheets, a plurality of channels, and a plurality of vents; and a foam precursor capable of forming a foam within the pouch. In one aspect, a method of stabilizing a body part includes providing a sleeve including an outer lining and an inner lining around a body part; providing a pouch arranged within the sleeve and including one or more polymer sheets, a plurality of channels, and a plurality of vents; providing a foam precursor in the pouch; and forming a foam within the pouch) wherein the outer lining comprise cotton [0007].
In view of the teachings of Root et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the outer layer of Fryer/Canie/Gan et al. by incorporating a flannel cotton that is comfortable to the touch [0140] of Root et al.
With respect to claim 18, the combination of Fryer/Canie/Gan et al./Root et al. substantially discloses the invention as claimed. Root et al. further teaches the outer fabric layer of the garment comprises a breathable fabric or cotton [0007] and [0140] and the method further comprises facilitating, using the breathable fabric of the outer fabric layer or cotton [0007] and [0140], the curing of the curable expanding foam.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fryer/Canie/Gan et al. as applied to claim 1, and further in view of Grim U.S. Patent No. (4,852,557).
With respect to claim 11, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed. Fryer further discloses the filler comprises curable expanding foam (abstract) except the garment further comprises adjustable straps across the slit configured to permit removal of the body part from a garment-based split system after the one or more pockets are filled with a cured expanded foam.
Grim however, teaches a splint comprises adjustable straps via hook and loop fasteners ([Col.4], lines 21-34) and (figs.1-2) capable of permitting removal of the body part from a garment-based split system after the one or more pockets are filled with a cured expanded foam.
In view of the teachings of Grim, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the garment-based splint of Fryer/Canie/Gan et al. by incorporating adjustable straps across the slit configured to permit removal of the body part from a garment-based split system after the one or more pockets are filled with a cured expanded foam to accommodate different sized users.
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Fryer/Canie/Gan et al. as applied to claim 1 above, and further in view of Ericson U.S. Patent No. (3,332,415).
With respect to claim 12, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed except the one or more channels comprise at least a tube.
Ericson however, teaches a splint comprising at least one tube via valve 144 in one or more channels formed from sheets (141 and 142, as shown in fig.18) and ([Col.5], lines 8-20).
In view of the teachings of Ericson, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the garment-based splint of Fryer/Canie/Gan et al. by incorporating at least one tube for regulating the amount of filler from the filler source.
With respect to claim 13, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed except the one or more channels comprise at least a fold flat tube.
Ericson however, teaches a splint comprising a splint is a tubular double-walled structure with an opening 32 extending through the tube. Heat sealed ends 24 and 25 and a fin type heat seal 26, joining the walls longitudinally, seal the structure. A removable tube 23 of metal, paper, glass, plastic or other material is used for inflating and deflating; [Note: the removable tube is made of paper and plastic which are capable of bending or folding]. The valve 22 is heat-sealed as is shown in FIGURES 2 and 3 between the outer wall 29 and the inner wall 31 with heat seals 27 and 28 which merge with heat seal end 25. In practice, the valve may be made separately in which case a thin layer of high melt material such as polytetrafluoroethylene is inserted in the tube during the period when the valve is being beat sealed into position so that the opening will not be heat sealed closed. The flaps 33 and 34 of the valve 22 are seen in FIGURE 3 to be in a position with the structure slightly inflated ([Col.3], lines 31-46).
In view of the teachings of Ericson, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the one or more channels of Fryer/Canie/Gan et al. by incorporating at least a fold tube for filling and dispensing fluid within the splint.
The combination of Fryer/Canie/Gan et al./Ericson substantially discloses the invention as claimed except the tube is a flat tube, however, it would have been an obvious matter of design choice to make the tube of whatever form or shape was desired or expedient in order to allow the tube to bend or fold easily. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fryer/Canie/Gan et al. as applied to claim 1 above, and further in view of Young et al. U.S. Patent No. (3,643,656).
With respect to claim 15, the combination of Fryer/Canie/Gan et al. substantially discloses the invention as claimed except the body part comprises a lower limb and the garment further comprises one or more of a sock, a socklette, and a sole.
Young et al. however, teaches a surgical cast having a rigid tubular outer wall or shell and a flexible tubular inner wall which form a substantially cylindrical chamber about a body portion, such as a leg, arm, torso and the like, to be immobilized by the cast and a foamed-in-place rigid plastic filling the chamber and causing the inner surfaces of the flexible wall to contact the body portion and assume the configuration of the body portion to hold immobile the body portion (abstract) comprising a woven stocking (65) and ([Col.4], lines 14-21).
In view of the teachings of Young et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the garment-based splint system of Fryer/Canie/Gan et al. in like manner to be utilized on the lower limb and the garment comprises a sock or a stocking as taught by Young et al. for providing some degree of compression to the anatomy of the user.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Fryer/Canie/Gan et al./Root et al. as applied to claim 18 above, and further in view of Grim U.S. Patent No. (4,852,557).
With respect to claim 19, the combination of Fryer/Canie/Gan et al./Root et al. substantially discloses the invention as claimed except the garment further comprises adjustable straps across the slit and the method further comprises removing, using the adjustable straps and the slit, the body part from the garment-based split system after the one or more pockets are filled with the cured expanded foam.
Grim however, teaches a splint comprises adjustable straps via hook and loop fasteners ([Col.4], lines 21-34) and (figs.1-2) capable of being removed after the one or more pockets are filled with the cured expanded foam.
In view of the teachings of Grim, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the garment-based splint of Fryer/Canie/Gan et al./Root et al. by incorporating adjustable straps across after the one or more pockets are filled with the cured expanded foam to accommodate different sized users.
Response to Arguments
Applicant’s arguments as to the newly submitted amendments as to independent claims 1, 4 and 16, see pages 1-7, filed 03/31/2026, with respect to the rejection(s) of claim(s) 1-12 and 14-20 under 35 U.S.C. 103 have been fully considered and are persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Fryer/Canie in view of Gan et al. which cure the deficiencies of Fryer/Canie. The Office maintains the teaching of the secondary reference drawn to cure the deficiencies of Fryer/Canie.
The objection to the drawing has been withdrawn in view of Applicant’s remarks.
The objection to claim 13 has been withdrawn in view of the prior art drawn to Ericson.
The objection to the Specification is maintained by the Office has the amendment to the specification is not proper. While the Specification acknowledge and include the proper symbol as regard the trademark, it is not followed by the generic terminology, as for example, VELCRO ® (hook and loop fastener).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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