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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 7, 9-11 and 16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2007/041207 A1 to Hewes et al. (Hewes).
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).
Regarding claim 4, Hewes teaches the sleeve of claim 1 as well as 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 teaches the sleeve of claim 1 as well as 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 teaches the sleeve of claim 1 as well as 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 10, Hewes teaches the sleeve of claim 1 as well as wherein the thermal intravenous sleeve defines first (58a) and second (58b) thru-holes at the proximal end of the intravenous sleeve (Figure 9).
Regarding claim 11, Hewes teaches the sleeve of claim 10 as well as wherein the first and second thru-holes are circumferentially spaced apart from one another about a central axis defined by the sleeve (Figure 9).
Regarding claim 16, 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).
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) 2, 3, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewes in view of US 5,873,903 to Garcia (Garcia).
Regarding claim 2, Hewes teaches the sleeve of claim 1, but not a pocket disposed on the interior sleeve portion into which the thermal element is disposed. Garcia teaches an analogous device (title “Therapeutic Sleeve for Human Limb) to that of Hewes including a pocket (packet compartment 24) disposed on the interior sleeve portion (Fig. 1) into which a thermal element (hot or cold pack 22) 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 (24) and thermal element (22) of Garcia 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, the combination teaches the sleeve of claim 2, but not specifically wherein the thermal element includes a chemical heating element disposed within the pocket. 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 selected a chemical heating element as an obvious matter of engineering design choice. This is especially true as one having ordinary skill in the art would have been reasonably apprised of the hot and cold pack available for placement in pockets of thermal devices.
Regarding claims 19 and 20, 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), 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 pocket disposed on the interior sleeve portion or a chemical heating element disposed in the pocket, or the pocket in an area that corresponds to a patient’s cubital fossa.
Garcia teaches an analogous device (title “Therapeutic Sleeve for Human Limb) to that of Hewes including a pocket (packet compartment 24) disposed on the interior sleeve portion (Fig. 1) and extending between lateral edges of the device into which a thermal element (hot or cold pack 22) 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 (24) and thermal element (22) of Garcia 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).
With respect to wherein the thermal element includes a chemical heating element disposed within the pocket; 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 selected a chemical heating element as an obvious matter of engineering design choice. This is especially true as one having ordinary skill in the art would have been reasonably apprised of the hot and cold pack available for placement in pockets of thermal devices.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewes in view of US 2019/0321217 A1 to Taylor er al. (Taylor).
Regarding claim 5, Hewes 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) 17 and 18 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 claim 17, Hewes teaches the sleeve of claim 1, but not wherein the thermal intravenous sleeve includes a first and second heating element, wherein the first heating element is disposed on the interior sleeve portion in an area that corresponds to a patient’s wrist, and the second heating element is disposed on the interior sleeve portion in an area that corresponds to the patient’s cubital fossa. 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.
Regarding claim 18, the combination teaches the sleeve of claim 17 as well as Noyes teaches wherein a temperature of the first heating element and the second heating element are independently controllable ([0046] which teaches “To balance the hating 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 and 7-9 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).
Regarding claim 1, 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.
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).
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…”).
Allowable Subject Matter
Claims 12-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or fairly suggest a tourniquet passing through first and second thru-holes at a proximal end of an intravenous device wherein the tourniquet passes through the first and second thru-holes. The closes prior art to Hewes (WO 2007/041207 A2) teaches the tourniquet attached to an external surface of device. Cooke (US 10,272,211 B1) teaches a tourniquet (31) attached to an external proximal edge (12) using an attachment (34).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alsaifi (US 9,750,895 B1) teaches a venipuncture device (100) comprising an inflatable cuff (110) and a heat pad (110) that wrap around the limb and allow secure fasteners (112, 122) to secure the cuff and heating pad around the limb (see for example Fig. 3B).
Aarabi (US 2019/0076294 A1) teaches a cooling sleeve and tourniquet (title) including a cooling/tourniquet component (110) and a cover portion (111) separated from the cooling pad (120). The cover portion (111) includes an integrated tourniquet (112), for example, a flexible strap 117 and an adjustable securement mechanism (118). The tourniquet is configured to be tightened about the limb with sufficient pressure to occlude blood flow to the limb, and to maintain the pressure until loosened by the caregiver ([0037]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794