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 .
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.
Response to Arguments
Applicant’s arguments filed 11 May 2026 with respect to claim(s) 1, 16 and newly added claim 21 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.
Applicant's arguments filed 11 May 2026 have been fully considered but they are not persuasive. Applicant argues that Noyes does not teach “an electrical heating element disposed with the interior sleeve portion, wherein a user can independently adjust the temperature of the first heating element separately from the temperature of the second heating element.” Applicant argues that Noyes explains that different heating panels may receive different duty cycles “simultaneously” while functioning together in the same operating mode. Paragraph [0046] teaches that to balance the heating circuit, different “On” mode outputs are provided by the controller to the individual heating panels for a given set. The duty cycle output for a heating panel positioned in a hand section of the waring sleeve is less active than the duty cycle outputs for larger heated panels positioned in a forearm section of the sleeve. The microcontroller and relays function to provide multiple “On” modes with distinct duty cycles for different panels simultaneously.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the second circumference" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7, 9 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2007/041207 A1 to Hewes et al. (Hewes) in view of US 2007/0100264 A1 to Hanson (Hanson).
Regarding claim 1, Hewes teaches a thermal intravenous sleeve (title “Heater and Disposable Sleeve for Assisting in Venous Catheterization” and 400, Figures 9-12), comprising a thermally insulative material (pg. 11, lines 8-17; It is noted that all materials have a degree of thermal insulative properties, and therefore as broadly as claimed the disclosed materials of Hewes read on the claim language.), wherein the thermally insulative material includes a proximal end (54), a distal end (55), a first lateral end (52), and a second lateral end (53), wherein a portion of the first lateral end and the second lateral end are joined (pg. 11, lines 16-21), thereby defining an interior sleeve portion (pg. 10, line 31-pg. 11, line 4 and Figures 9-12) and an exterior sleeve portion (Figures 9-12), a thermal element disposed within the interior sleeve portion (pg. 10, lines 27-30), and a tourniquet (60) disposed at a proximal end of the thermal intravenous sleeve (Figures 10-12).
However, Hewes does not teach a first and second thru-hole defined at a proximal end of the thermal intravenous sleeve, wherein the fist and second thru-holes are circumferentially spaced apart from one another about a central axis defined by the sleeve when the first lateral end and the second lateral end are joined and wherein the tourniquet passes through the first and second thru-holes.
Hanson teaches an analogous device (title “Cold/Heat Treatment Boot for Ankles and Lower Legs”) including a first and second thru-hole (Fig. 2) defined at a proximal end of the device (Fig. 2), wherein the first and second thru-holes are circumferentially spaced apart from one another about a central axis (Fig. 2) defined by the device when a first lateral end and a second lateral end are joined ([0028] and Fig. 2) wherein a tightening strap (36a) passes through the first and second thru-holes. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hewes to include the thru-hole construction of Hanson as an obvious matter of engineering design choice, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art.
Regarding claim 2, Hanson further teaches a pocket (40/42) disposed on the interior sleeve portion into which the thermal element ([0026] which states in part “It is expected that the heat or cold-producing devices used in connection with the cold/heat treatment boot 10 of the present invention will likely be in the form of ice packs 70, bags of ice 72, or, for heat, in the form of hot water bottles, chemical heat packs or other such cold or heat-producing device, any of which may be used with the cold/heat treatment boot 10 of the present invention so long as they fit within the left and right side wall pockets 40 and 42.”) is disposed. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hewes to include the pocket and thermal element of Hanson as an obvious matter of engineering design choice. This is especially true as Hewes teaches that the sleeve can be used with any heater known in the art (pg. 10, lines 25-26).
Regarding claim 3, Hanson further teaches where ither thermal element includes a chemical heating element disposed within the pocket ([0026] which states in part “It is expected that the heat or cold-producing devices used in connection with the cold/heat treatment boot 10 of the present invention will likely be in the form of ice packs 70, bags of ice 72, or, for heat, in the form of hot water bottles, chemical heat packs or other such cold or heat-producing device, any of which may be used with the cold/heat treatment boot 10 of the present invention so long as they fit within the left and right side wall pockets 40 and 42.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hewes to include the thermal element of Hanson as an obvious matter of engineering design choice. This is especially true as Hewes teaches that the sleeve can be used with any heater known in the art (pg. 10, lines 25-26).
Regarding claim 4, Hewes further teaches wherein the thermal element includes an electrical heating element (heating element 10 and pg. 10, lines 25-30 which state in part “…the sleeve is used with a heater according to any of the embodiments described herein.”).
Regarding claim 7, Hewes further teaches wherein the first lateral end and the second lateral end are releasably joined to one another (pg. 11, lines 22-28).
Regarding claim 9, Hewes further teaches wherein the tourniquet is an integrated tourniquet attached to the proximal end of the intravenous sleeve (Figures 10-12 which show the tourniquet attached to the sleeve and thus an integrated torniquet attached to the sleeve).
Regarding claim 13, Hanson further teaches wherein the tightening strap is exposed to the interior sleeve portion between a first circumference extending between the first and second thru-hole (Fig. 2 as the tightening straps are exposed at the ends).
Regarding claim 14, Hanson further teaches wherein the tightening strap is exposed to the exterior sleeve portion between a second circumference extending between the first and second thru-holes (Fig. 2 as the straps are in contact with the exterior surface).
Regarding claim 15, Hanson further teaches wherein the first circumference and the second circumference together define an opening to the proximal end of the intravenous sleeve (Fig. 2).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewes and Hanson as applied to claim 1 above, and further in view of US 2019/0321217 A1 to Taylor er al. (Taylor).
Regarding claim 5, Hewes in view of Hanson teaches the sleeve of claim 1, but not wherein the thermally insulative material includes a heat reflective foil. Taylor teaches an analogous device (abstract which states “A reinforcing clinical wrap is provided with integral thermal management.”) including at least one thermally insulating layer (70) of known insulating materials such as a medical grade foil or heat reflective thin plastic sheeting including biaxially-oriented polyethylene terephthalate, as sold under the trade name Mylar ([0029]). The thermally insulating layer is preferably adjacent to the outermost layer of the warp ([0029]). It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hewes to include the insulating layer of Taylor to increase the thermal conduction/convection efficiency, and to insulate the wrap from an external environment as taught by Taylor ([0029]).
Regarding claim 6, the combination teaches the sleeve of claim 5 as well as Hewes teaching a cloth material disposed on the interior sleeve portion (pg. 11, lines 9-17).
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewes in view of US 2023/0008747 A1 to Noyes (Noyes).
Regarding claims 16 and 17, Hewes teaches a thermal intravenous sleeve (title “Heater and Disposable Sleeve for Assisting in Venous Catheterization” and 400, Figures 9-12), comprising a thermally insulative material (pg. 11, lines 8-17; It is noted that all materials have a degree of thermal insulative properties, and therefore as broadly as claimed the disclosed materials of Hewes read on the claim language.), wherein the thermally insulative material includes a proximal end (54), a distal end (55), a first lateral end (52), and a second lateral end (53), wherein a portion of the first lateral end and the second lateral end are joined (pg. 11, lines 16-21), thereby defining an interior sleeve portion (pg. 10, line 31-pg. 11, line 4 and Figures 9-12) and an exterior sleeve portion (Figures 9-12), an electrical heating element disposed within the interior sleeve portion (pg. 10, lines 27-30), and an integrated tourniquet cuff (60 and Figures 10-12 which show the tourniquet attached to the sleeve and thus an integrated torniquet attached to the sleeve) disposed at a proximal end of the thermal intravenous sleeve (Figures 10-12).
However, Hewes does not teach wherein the electrical heating element includes a first heating element disposed on the interior sleeve portion in an area that corresponds to a patient’s wrist, a second heating element disposed on the interior sleeve portion in an area that corresponds to the patient’s cubital fossa and wherein a user’s can independently adjust the temperature of the first heating element separately from the temperature of the second heating element.
Noyes teaches an analogous device (title “Warming Sleeve”) to that of Hewes that is sized to cover a portion between a hand and elbow of a wearer ([0018]) and including a first (50) and second (60) heating element, wherein the first heating element is located in an area that corresponds to the patient’s wrist (Fig. 3), and the second heating element is located in an area that corresponds to the patient’s cubital fossa (Fig. 4). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hewes to locate the heating elements as in Noyes in order to provide thermal therapy to desired areas of the arm as taught by Noyes.
Noyes additionally teaches wherein a temperature of the first heating element and the second heating element are independently controllable ([0046] which teaches “To balance the heating circuit….different “On” mode outputs are provided by the PWM controller to the individual heating panels for a given set….The microcontroller and relays function to provide multiple “On” modes with distinct duty cycles for different panels simultaneously.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the distinct duty cycles to the different panels to allow for a balanced heating circuit as taught by Noyes.
Claim(s) 1, 4, 7-9, 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewes in view of US 10,272,211 B1 to Cooke et al. (Cooke) and Hanson.
Regarding claims 1 and 9, Hewes teaches a thermal intravenous sleeve (title “Heater and Disposable Sleeve for Assisting in Venous Catheterization” and 200, Figures 3-5), comprising a thermally insulative material (pg. 5, lines 19-21; It is noted that all materials have a degree of thermal insulative properties, and therefore as broadly as claimed the disclosed materials of Hewes read on the claim language.), wherein the thermally insulative material includes a proximal end (end opposite 29 in Fig. 3), a distal end (29), a first lateral end, and a second lateral end (pg. 8, lines 15-21 which states in part “the side edges 21 are sewn together to form cuff prior to fitting the cuff onto the extremity. Alternatively, side edges 21 are connected together using reversible fasteners….”), thereby defining an interior sleeve portion (tubular cavity of the cuff as seen in Figures 3 and 4) and an external sleeve portion (outside of the cuff as seen in Figures 3 and 4), a thermal element (heating element 10) enclosed within the interior sleeve portion (Figures 4 and 5). However, Hewes does not teach an integrated tourniquet cuff disposed at a proximal end of the thermal intravenous sleeve.
Cooke teaches an analogous device (title “Disposable Tourniquet/Sleeve Warmer”) that includes a warming apparatus with an attached tourniquet that allow for warming to induce vasodilation resulting in vessel engorgement and a tourniquet to slow venous blood flow from the intended site to preferably cause vessel engorgement, raise local blood volume and pressure of the distal extremity to preferably identify an injection or insertion site (abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hewes to include the attached tourniquet of Cooke to allow for slowing of venous blood flow from the intended site to preferably cause vessel engorgement, raise local blood volume and pressure of the distal extremity to preferably identify an injection or insertion site as taught by Cooke (abstract).
Neither Hewes nor Cooke teaches a first and second thru-hold defined at a proximal end of the thermal intravenous sleeve, wherein the first and second thru-holes are circumferentially spaced apart from one another about a central axis defined by the sleeve when the first lateral end and the second lateral end are joined or wherein the tourniquet passes through the first and second thru-holes.
Hanson teaches an analogous device (title “Cold/Heat Treatment Boot for Ankles and Lower Legs”) including a first and second thru-hole (Fig. 2) defined at a proximal end of the device (Fig. 2), wherein the first and second thru-holes are circumferentially spaced apart from one another about a central axis (Fig. 2) defined by the device when a first lateral end and a second lateral end are joined ([0028] and Fig. 2) wherein a tightening strap (36a) passes through the first and second thru-holes. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hewes in view of Cooke to include the thru-hole construction of Hanson as an obvious matter of engineering design choice.
Regarding claim 4, the combination teaches the sleeve of claim 1 as well as Hewes teaches wherein the thermal element includes an electrical heating element (heating element 10 and pg. 10, lines 25-30 which state in part “…the sleeve is used with a heater according to any of the embodiments described herein.”).
Regarding claim 7, the combination teaches the sleeve of claim 1 as well as Hewes teaching wherein the first lateral end and the second lateral end are releasably joined to one another (pg. 8, lines 15-21 which states in part “…side edges 21 are connected together using reversible fasteners….”).
Regarding claim 8, the combination teaches the sleeve of claim 7 as well as Hewes teaching wherein the first lateral end and the second lateral end are releasably joined to one another with a hook and loop fastener (pg. 8, lines 18-21 which recite “side edges 21 are connected together using reversible fasteners, for example hook-and-loop…”).
Regarding claim 21, Hewes teaches a thermal intravenous sleeve (title “Heater and Disposable Sleeve for Assisting in Venous Catheterization” and 200, Figures 3-5), comprising a thermally insulative material (pg. 5, lines 19-21; It is noted that all materials have a degree of thermal insulative properties, and therefore as broadly as claimed the disclosed materials of Hewes read on the claim language.), wherein the thermally insulative material includes a proximal end (end opposite 29 in Fig. 3), a distal end (29), a first lateral end, and a second lateral end (pg. 8, lines 15-21 which states in part “the side edges 21 are sewn together to form cuff prior to fitting the cuff onto the extremity. Alternatively, side edges 21 are connected together using reversible fasteners….”), thereby defining an interior sleeve portion (tubular cavity of the cuff as seen in Figures 3 and 4) and an external sleeve portion (outside of the cuff as seen in Figures 3 and 4), a thermal element (heating element 10) enclosed within the interior sleeve portion (Figures 4 and 5). However, Hewes does not teach a tourniquet disposed at a proximal end of the thermal intravenous sleeve, wherein the tourniquet includes an integrated tourniquet cuff attached to the proximal end of the intravenous sleeve via a first and second thru-hole, the first and second thru-holes being spaced apart circumferentially.
Cooke teaches an analogous device (title “Disposable Tourniquet/Sleeve Warmer”) that includes a warming apparatus with an attached tourniquet cuff that allows for warming to induce vasodilation resulting in vessel engorgement and a tourniquet to slow venous blood flow from the intended site to preferably cause vessel engorgement, raise local blood volume and pressure of the distal extremity to preferably identify an injection or insertion site (abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hewes to include the attached tourniquet of Cooke to allow for slowing of venous blood flow from the intended site to preferably cause vessel engorgement, raise local blood volume and pressure of the distal extremity to preferably identify an injection or insertion site as taught by Cooke (abstract).
Neither Hewes nor Cooke teaches the tourniquet cuff attached to the proximal end of the intravenous sleeve via a first and second thru-hole, the first and second thru-holes being spaced apart circumferentially.
Hanson teaches an analogous device (title “Cold/Heat Treatment Boot for Ankles and Lower Legs”) including a first and second thru-hole (Fig. 2) defined at a proximal end of the device (Fig. 2), wherein the first and second thru-holes are circumferentially spaced apart from one another about a central axis (Fig. 2) defined by the device when a first lateral end and a second lateral end are joined ([0028] and Fig. 2) wherein a tightening strap (36a) passes through the first and second thru-holes. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hewes in view of Cooke to include the thru-hole construction of Hanson as an obvious matter of engineering design choice.
Regarding claim 22, Hanson further teaches wherein the thermal intravenous sleeve defines first and second thru-holes at the proximal end of the intravenous sleeve (Fig. 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
