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 Status
Applicant’s amendments in the response filed on 5/30/2025 has been considered by the Examiner. Currently, claims 1-6, 8-9, 11-13, and 16-22 are pending, claims 1, 9, 16, and 22 have been amended, claims 7, 10, and14-15 are canceled. Examiner withdraws the previously filed rejection of the claims under 35 U.S.C 112(a). A complete action on the merits of claims 1-6, 8-9, 11-13, and 16-22 follows below.
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.
Claim(s) 1, 4- 6, 8, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rose (3,745,998) in view of Sconce (3,901,225).
Regarding claim 1, Rose teaches a [[cryo]] splint (vacuum splint immobilizer) comprising:
a vacuum splint that includes an envelope that defines an enclosed volume (closed envelope 36), the vacuum splint configured to be wrapped around an injured body part of a patient and then have air evacuated from the enclosed volume to stabilize the injured body part (Fig. 1 opening a source of negative pressure to an evacuation tubing 42 ), the vacuum splint further comprising rigid stabilizing portions that extend along at least one side of the injured body part, extending beyond the injured body part of the patient (styrofoam filler particles 37), the rigid stabilizing portions configured to restrict movement of the injured body part while the patient moves (the splint configured to immobilize the injured extremity and patient can freely move other extremities) .
Rose does not teach a cold pack configured to be attached to the vacuum splint to provide application of cold to the injured body part simultaneous to the vacuum splint stabilizing the injured body part wherein the cold pack includes multiple sealed chambers when applying cold to the injured body part to prevent liquid coolant within the cold pack from flowing entirely to one end of the cold pack.
However, Sconce teaches a device within the same field of invention (a splint including comprising a bladder/envelope and configured to immobilize the injured extremity [Abstract]), further comprising a cold pack including multiple sealed chambers and configured to be attached to the vacuum splint (layer that includes multiple partially sealed pockets and receive fully sealed cold packs; chemical cold packs 63, 64 can be removably placed in the pockets on opposite sides of the splint to counteract swelling and/or restrict blood flow from the injured area; Col. 4 lines 1-5) to provide application of cold to the injured body part simultaneous to the splint stabilizing the injured body part (a splint for immobilizing an injured extremity and concurrently applying thermal pressure to an injured area of the immobilized extremity; Col. 1 lines 5-7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the splint in Rose such that it receives a cold pack since Sconce teaches thermal therapy can counteract swelling and/or restrict blood flow from the injured area (Col. 4 lines 4-5).
Regarding claim 4, Rose in view of Sconce teaches the limitations of claim 1 as previously rejected above. Rose teaches wherein the cold pack is a single-use cold pack (cold packs can be used one time).
Regarding claim 5, Rose in view of Sconce teaches the limitations of claim 4 as previously rejected and wherein the single-sue cold pack is configured to activate to become colder without refrigeration (chemical cold packs [Abstract]).
Regarding claim 6, Rose in view of Sconce teaches the limitations of claim 4 as previously rejected above and wherein the vacuum splint in reusable vacuum splint configured to be used repeatedly (the device can be used repeatedly).
Regarding claim 8, Rose in view of Sconce teaches the limitations of claim 1 as previously rejected above. The combination does not teach a second cold pack configured to be attach to an interior surface of the vacuum splint an including multiple sealed chambers. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include an additional multiple sealed chamber cold pack in order to provide cooling to other areas on an appendage, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis C o . , 193. USPQ 8 MPEP 2144.04 (VI-B). (See further evidence by Potter (2014/0039584; [0022]).
Regarding claim 22, Rose in view of Sconce teaches the limitations of claim 1 as previously rejected. Rose teaches a hose through which the air is evacuated, the enclosed volume accessible through the hose (the evacuation conduit 42); and
a clamp to close the hose such that the air remains evacuated from the enclosed volume while the patient is able to move (A detachable vacuum coupling 54 forming a termination of a short evacuation tubing 42 is then connected to a course of vacuum, and the envelope 36 is quickly evacuated to rigidi0fy it in the desired supporting position; Col. 7 lines 45-50)
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rose (3,745,998) in view of Sconce (3,901,225) and in further view of Crews (4,886,063).
Regarding claim 2, Rose in view of Scone teaches the limitations of claim 1 as previously rejected above. While Scone provides for cold packs or compresses that are removable form the splint it does not teach the cold pack is temporarily attached to the vacuum splint using hook and loop fasteners that are attached to the vacuum splint.
However, Crews teaches a cold pack with multiple sealed chambers that is removably attached to a flexible sheet 34 with hook and loop fasteners 28/26; Fig. 4.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cold pack layer in Rose in view of Sconce such that the entire cold pack section is removable from the splint via hook and loop fastener since Crews teaches this will allow a user to solely temperature condition the cold pack prior to use and not the entire device (Col. 6 lines 30-35 both components need not to be subjected to predetermined temperature conditions or to be stored in a thermally insulated container when not in use, only the heating and cooling component of device 10).
Claim(s) 3, 9, and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rose (3,745,998) in view of Sconce (3,901,225), Crews (4,886,063), and in further view of and Rich (2001/0051820).
Regarding claim 3, Rose in view of Sconce and Crews teaches the limitations of claim 2 as previously rejected above. Rose does not teach wherein the cold pack is transparent such that the hook and loop fasteners that are attached to the vacuum splint are visible even when facing away from a user.
However, Rich teaches a thermal therapy device comprising transparent cold packs which are selectively attachable through hook and loop fasteners.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided for a transparent cold attached to hook and loop fasteners to be able to properly secure the cold pack to cryosplint and view the content of the cold pack.
Regarding claim 9, Rose teaches a [[cryo]] splint (vacuum splint immobilizer) comprising:
a vacuum splint that includes an envelope that defines an enclosed volume (closed envelope 36), the vacuum splint configured to be wrapped around an injured body part of a patient and then have air evacuated from the enclosed volume to stabilize the injured body part (Fig. 1 opening a source of negative pressure to an evacuation tubing 42 ), the vacuum splint further comprising rigid stabilizing portions that extend along at least one side of the injured body part, extending beyond the injured body part of the patient (styrofoam filler particles 37), the rigid stabilizing portions configured to restrict movement of the injured body part while the patient moves (the splint configured to immobilize the injured extremity and patient can freely move other extremities) .
Rose does not teach a cold pack configured to be attached to the vacuum splint to provide application of cold to the injured body part simultaneous to the vacuum splint stabilizing the injured body part wherein the cold pack includes multiple sealed chambers when applying cold to the injured body part to prevent liquid coolant within the cold pack from flowing entirely to one end of the cold pack.
However, Sconce teaches a device within the same field of invention (a splint including comprising a bladder/envelope and configured to immobilize the injured extremity [Abstract]), further comprising a cold pack including multiple sealed chambers and configured to be attached to the vacuum splint (layer that includes multiple partially sealed pockets and receive fully sealed cold packs; chemical cold packs 63, 64 can be removably placed in the pockets on opposite sides of the splint to counteract swelling and/or restrict blood flow from the injured area; Col. 4 lines 1-5) to provide application of cold to the injured body part simultaneous to the splint stabilizing the injured body part (a splint for immobilizing an injured extremity and concurrently applying thermal pressure to an injured area of the immobilized extremity; Col. 1 lines 5-7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the splint in Rose such that it receives a cold pack since Sconce teaches thermal therapy can counteract swelling and/or restrict blood flow from the injured area (Col. 4 lines 4-5).
While Scone provides for cold packs or compresses that are removable form the splint it does not teach the cold pack is temporarily attached to the vacuum splint using hook and loop fasteners that are attached to the vacuum splint.
However, Crews teaches a cold pack with multiple sealed chambers that is removably attached to a flexible sheet 34 with hook and loop fasteners 28/26; Fig. 4.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cold pack layer in Rose in view of Sconce such that the entire cold pack section is removable from the splint via hook and loop fastener since Crews teaches this will allow a user to solely temperature condition the cold pack prior to use and not the entire device (Col. 6 lines 30-35 both components need not to be subjected to predetermined temperature conditions or to be stored in a thermally insulated container when not in use, only the heating and cooling component of device 10).
Rose does teach wherein the cold pack is transparent such that the hook and loop fasteners that are attached to the vacuum splint are visible even when facing away from a user.
However, Rich teaches a thermal therapy device comprising transparent cold packs which are selectively attachable through hook and loop fasteners.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided for a transparent cold attached to hook and loop fasteners to be able to properly secure the cold pack to cryosplint and view the content of the cold pack.
Regarding claim 11, Rose in view of Sconce, Crews and Rich teaches the limitations of claim 9 as previously rejected above. Claim 11 teaches the same limitations of claim 4 as previously rejected above.
Regarding claim 12, Rose in view of Sconce, Crews and Rich teaches the limitations of claim 11 as previously rejected above. Claim 12 recites the same limitation as claim 5 as previously rejected above.
Regarding claim 13, Rose in view of Sconce, Crews and Rich teaches the limitations of claim 11 as previously rejected above. Claim 13 recites the same limitation as claim 6 as previously rejected above.
Claim(s) 16, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rose (3,745,998) in view of Sconce (3,901,225), and in further view of and Rich (2001/0051820).
Regarding claim 16, Rose teaches a [[cryo]] splint (vacuum splint immobilizer) comprising:
a vacuum splint that includes an envelope that defines an enclosed volume (closed envelope 36), the vacuum splint configured to be wrapped around an injured body part of a patient and then have air evacuated from the enclosed volume to stabilize the injured body part (Fig. 1 opening a source of negative pressure to an evacuation tubing 42 ), the vacuum splint further comprising rigid stabilizing portions that extend along at least one side of the injured body part, extending beyond the injured body part of the patient (styrofoam filler particles 37), the rigid stabilizing portions configured to restrict movement of the injured body part while the patient moves (the splint configured to immobilize the injured extremity and patient can freely move other extremities) .
Rose does not teach a cold pack including multiple sealed chambers configured to be attached to the vacuum splint to provide application of cold to the injured body part simultaneous to the vacuum splint stabilizing the injured body part wherein the multiple sealed chambers of the cold pack exist during application of cold to the injured part to prevent liquid coolant within the cold pack from flowing entirely to one end of the cold pack.
However, Sconce teaches a device within the same field of invention (a splint including comprising a bladder/envelope and configured to immobilize the injured extremity [Abstract]), further comprising a cold pack including multiple sealed chambers and configured to be attached to the vacuum splint (layer that includes multiple partially sealed pockets and receive fully sealed cold packs; chemical cold packs 63, 64 can be removably placed in the pockets on opposite sides of the splint to counteract swelling and/or restrict blood flow from the injured area; Col. 4 lines 1-5) to provide application of cold to the injured body part simultaneous to the splint stabilizing the injured body part (a splint for immobilizing an injured extremity and concurrently applying thermal pressure to an injured area of the immobilized extremity; Col. 1 lines 5-7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the splint in Rose such that it receives a cold pack since Sconce teaches thermal therapy can counteract swelling and/or restrict blood flow from the injured area (Col. 4 lines 4-5). Furthermore, having plurality of partially sealed thermal pockets across the device whereby the pockets receive cold packets would allow for more uniform thermal therapy.
Rose does teach wherein the cold pack is transparent such that the hook and loop fasteners that are attached to the vacuum splint are visible even when facing away from a user.
However, Rich teaches a thermal therapy device comprising transparent cold packs which are selectively attachable through hook and loop fasteners.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided for a transparent cold attached to hook and loop fasteners to be able to properly secure the cold pack to cryosplint and view the content of the cold pack.
Claim 18 recites the same limitations of claims 4 and 5 as previously rejected above.
Claim 19 recites the same limitations of claim 6 as previously rejected above.
Claim(s) 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rose (3,745,998) in view of Sconce (3,901,225), Rich (2001/0051820), and Crews (4,886,063).
Regarding claim 17, Rose in view of Sconce and Rich teaches the limitations of claim 16 as previously rejected. Rich teaches a thermal therapy device comprising transparent cold packs which are selectively attachable through hook and loop fasteners.
While Scone provides for cold packs or compresses that are removable from the splint it does not teach the cold pack is temporarily attached to the vacuum splint using hook and loop fasteners that are attached to the vacuum splint and to the cold back.
However, Crews teaches a cold pack with multiple sealed chambers that is removably attached to a flexible sheet 34 with hook and loop fasteners 28/26 attached to the cold pack and the flexible sheet; Fig. 4.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cold pack layer in Rose in view of Sconce such that the entire cold pack section is removable from the splint via hook and loop fastener since Crews teaches this will allow a user to solely temperature condition the cold pack prior to use and not the entire device (Col. 6 lines 30-35 both components need not to be subjected to predetermined temperature conditions or to be stored in a thermally insulated container when not in use, only the heating and cooling component of device 10).
Claim 20 recites the same limitations in claim 8 as previously rejected above. Sconce does not teach each of the multiple sealed chambers having a liquid coolant contained.
However, Crews teaches each of the sealed chambers include water (Col 5 lines 45 -50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the cold packet in the combination since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rose (3,745,998) in view of Sconce (3,901,225) and in further view of Borschneck (2009/0043232).
Regarding claim 21, Rose in view of Sconce teaches the limitations of claim 1 as previously rejected above. The combination does not teach wherein the cryosplint is radiolucent such that the cryosplint may be retained in place and continue to stabilize the injured body part while an x-ray or MRI scan is taken of the injured body part.
However, Borschneck teaches a device within the same field of invention (lockable alignment arm to model the size and shape of the fractured limb). Borschneck provides there is a need for a splint which is radiolucent particularly in the region of the patient's injury. This feature affords the option of leaving the device intact on the patient during X-ray, CAT scan and MRI studies[0013].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the properties of the fracture alignment device in Rose in view of Sconce since Borschneck provides splints with radiolucent properties around and along the region of the injury to allow X-ray, Cat Scan and MRI imaging of the injury without the need for removing the splint [0014].
Response to Arguments
Applicant’s arguments, filed 5/30/2025 has been considered by the Examiner. Applicant’s amendments necessitate a new grounds of rejection over Rose (3,745,998) in view of Sconce (3,901,225) for claim 1; Rose (3,745,998) in view of Sconce (3,901,225), Crews (4,886,063), and in further view of and Rich (2001/0051820) for claim 9; and Rose (3,745,998) in view of Sconce (3,901,225), and in further view of and Rich (2001/0051820) for claim 16.
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.
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/Y.E/Examiner, Art Unit 3794
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794