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 .
Response to Arguments
Applicant's arguments filed 17 November 2026 have been fully considered but they are not persuasive.
Applicant argues that channels 30 of Hadtke are not formed in the flexible wrap portion 12, the spacer layer 34, or any layer for that matter. This is not found to be persuasive. Hadtke (Col. 4, lines 1-3) teaches specifically that “the spacer layer 34 may include integrally formed projections which may extend from one or both sides of layer 34.” Therefore, it is clear that the projections 35 which form the channel 30 are formed in the spacer layer 34 as set forth below.
Applicant argues that there is nothing in Hadtke to suggest that the spacer layer/projections 34/35 are insulative as required by claim 1. This is not found to be persuasive. Col. 3, lines 58-60 of Hadtke states in part “The spacer layer 34 is preferably formed of a flexible material such as PP or PVC…” and PP and PVC are thermal insulators.
Applicant argues that layer 38 of Hadtke is not secured to a surface of the layer 38 and does not cover the channel as required by claim 1. This is not found to be persuasive. Hadtke in Fig. 3 shows that the 38 is secured to the surface of the pad at least at the periphery and covers the bottom of the channel.
Applicant’s arguments with respect to the outlet valve in amended claim 1 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 argues that the Examiner acknowledges that Hadtke does not disclose a pad that is an insulating material. However, the Examiner has made no such acknowledgment. Benyaminpour is relied upon to teach an additional layer of foam material. The material of Benyaminpour would be in addition to the layers already disclosed in Hadtke.
Applicant argues that as the outer portion of Hadtke is the inflation chamber 28 that is holding air it may already be considered an insulating layer so there would be no motivation to make any changes to add an insulating layer or change a layer to an insulating material. This is not found to be persuasive. Additional insulation would only enhance the cooling in the skin side direction and one having ordinary skill in the art would be motivate to reduce thermal loss in a direction other than desired to allow for increased thermal capacity at the treatment site.
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.
Claim(s) 1, 4, 8, 11-13, 15-18, 31 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5,449,379 to Hadtke (Hadtke) in view of US 3,871,381 to Roslonski (Roslonski)
Regarding claim 1, Hadtke teaches a wearable cooling apparatus (title “Apparatus for Applying Desired Temperature and Pressure to an Injured Area”) comprising a flexible insulating pad (spacer layer 34) having an open-sided channel (channel 30) formed in a surface thereof (spaces between integrally formed projections 35 which may extend from one or both sides of the layer 34), a thermally conductive membrane (bottom layer 36) secured to the surface of the pad (Fig. 3), wherein the membrane covers an open end of the open-sided channel to form a conduit (Fig. 3) through which gas can flow and walls of the conduit are provided by a surface of the open-sided channel formed in the pad and a surface of the membrane covering the open end of the open-sided channel (Fig. 3), an inlet valve (implicit on can 20) in fluid communication with the conduit( Col. 3, lines 33-68, Figs. 2, 3, 4A-4C), an outlet valve (outlet valve 18) in fluid communication with the conduit (Fig. 3) and configured to release the compressed gas coolant from the conduit (abstract which states “a relief valve is coupled to the inflation chamber so that the pressure within the inflation chamber is maintained at a predetermined pressure.”), and that by varying the flow rate and the length of the tortuous path, various combinations of surface temperatures and pressures may be applied to the injured area (Col. 5, lines 7-15).
However, Hadtke does not teach the inlet valve configured to be connected to a cannister of compressed gas coolant such that the cannister can inject the compressed as coolant through the inlet valve into the conduit and flow through the conduit or the outlet valve allowing a substantially continuous flow of the compressed gas coolant through the conduit and preventing backpressure from stopping the injection of additional compressed gas coolant.
Roslonski teaches an analogous device (title “Cold Compress Device”) to that of Hadtke as well as an inlet valve (valve 4) that controls the rate of flow of refrigerant from tank (2) into sleeve (1) and a pressure relief valve (6) connected to the wall of sleeve (1) and communicating between the interior of the sleeve and an ambient atmosphere. Roslonski teaches that by controlling the rate of flow of the refrigerant from the tank (2) to the sleeve (1), inlet valve (4) controls the temperature of the refrigerant within the compress and that since pressure of the refrigerant within the sleeve is maintained at a substantially constant level by valve (6), for a particular flow rate of refrigerant, the rate of volitization and expansion and consequently the temperature of the refrigerant within the bandage also will remain substantially constant (Col. 5, lines 30-56). 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 Hadtke with the valve configuration of Roslonski to allow for a substantially constant temperature within the device.
Regarding claim 4, the combination teaches the apparatus of claim 1 as well as Hadtke teaching wherein a sheet (40) covers the open side of the open-sided recess and is secured between the membrane and the pad.
Regarding claim 8, the combination teaches the apparatus of claim 1 as well as Hadtke teaching wherein the membrane comprises a material which enhances thermal conduction (Col. 3, lines 60-62).
Regarding claim 11, the combination teaches the apparatus of claim 1 as well as Hadtke teaching the apparatus further comprising a canister (20) of compressed gas in fluid communication with the inlet valve and configured to inject compressed gas into the conduit via the inlet valve (Col. 3, lines 46-50).
Regarding claim 12, the combination teaches the apparatus of claim 11 as well as Hadtke teaching wherein the compressed gas is carbon dioxide (Col. 5, lines 15-18).
Regarding claim 13, the combination teaches the apparatus of claim 11 as well as Hadtke teaching wherein the canister is lightweight and portable (Col. 3, lines 46-50).
Regarding claim 15, the combination teaches the apparatus of claim 11 as well as Hadtke teaching wherein the temperature of the gas injected into the conduit is controlled via the flow rate of the gas from the canister (Col. 5, lines 12-15).
Regarding claim 16, the combination teaches the apparatus of claim 11 as well as Hadtke teaching wherein the gas cannister does not require electric power to release compressed gas (Col. 3, lines 46-50).
Regarding claim 17, the combination teaches the apparatus of claim 1, but not wherein the open-sided recess is U-shaped in cross section. 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 Hadtke to have a cross-section of whatever form or shape was desired or expedient. 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.
Regarding claim 18, the combination teaches the apparatus of claim 1, but not specifically wherein the open-sided recess is molded into the surface of the pad or the membrane. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of the product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the product was made by a different process. Here the claimed product is the same as the product of Hadtke and therefore the claim is unpatentable.
Regarding claim 31, the combination teaches the apparatus of claim 1 as well as Hadtke teaching wherein the pad comprises an insulative material (Col. 3, lines 58-60 which states in part “The spacer layer 34 is preferably formed of a flexible material such as PP or PVC…” and PP and PVC are thermal insulators).
Regarding claim 37, the combination teaches the apparatus of claim 1, as well as Hadtke teaching wherein the inlet valve is a 2-way splitter valve (Col. 4, line 56-Col. 5, line 6).
Claim(s) 48, 27 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadtke and Roslonski as applied to claim 1 above, and further in view of US 2017/0246031 A1 to Benyaminpour et al. (Benyaminpour) and US 2018/0055142 A1 to Yu et al. (Yu).
Regarding claims 48 and 27 Hadtke in view of Roslonski teaches the apparatus of claim 1, but not the pad comprising a flexible self-skinning foam that is self-skinning polyurethane.
Benyaminpour teaches an analogous device (title “Portable Therapeutic System Using Hot or Cold Temperature”) to that of Hadtke as well as teaching the inclusion of an outer layer which is positioned away from the skin surface when in use whose material is an insulating material which can prevent, reduce or retard loss of heat or cold from the pad and that one preferred material is a polymeric foam material ([0108]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a polymeric foam material for the outer covering of the pad to prevent, reduce or retard loss of heat or cold from the pad as taught by Benyaminpour.
However, Benyaminpour does not teach that the foam is a flexible self-skinning polyurethane foam.
Yu teaches foams, foamable compositions and methods of making integral skin foams (title) and that integral skin foams are well-known foams, typically polyurethane and/or polyisocyanurate foams which has a specialized structure comprising a relatively low density, cellular portion (sometimes referred to as the “cushion portion”) integrally connoted to a relatively high density, typically microcellular portions located at a surface of the foam (sometimes referred to as the “skin portion”). These foams are used in large part because the skin provides a cosmetically acceptable appearance while also providing enhanced resistance to abrasion and cracking ([0003]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized an integral skin foam to allow for enhanced resistance to abrasion and cracking during use as taught by Yu.
Regarding claim 42, Hadtke in view of Roslonski teaches the apparatus of claim 1, but not the pad comprising a self-skinning foam.
Benyaminpour teaches an analogous device (title “Portable Therapeutic System Using Hot or Cold Temperature”) to that of Hadtke as well as teaching the inclusion of an outer layer which is positioned away from the skin surface when in use whose material is an insulating material which can prevent, reduce or retard loss of heat or cold from the pad and that one preferred material is a polymeric foam material ([0108]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a polymeric foam material for the outer covering of the pad to prevent, reduce or retard loss of heat or cold from the pad as taught by Benyaminpour.
However, Benyaminpour does not teach that the foam is a flexible self-skinning polyurethane foam.
Yu teaches foams, foamable compositions and methods of making integral skin foams (title) and that integral skin foams are well-known foams, typically polyurethane and/or polyisocyanurate foams which has a specialized structure comprising a relatively low density, cellular portion (sometimes referred to as the “cushion portion”) integrally connoted to a relatively high density, typically microcellular portions located at a surface of the foam (sometimes referred to as the “skin portion”). These foams are used in large part because the skin provides a cosmetically acceptable appearance while also providing enhanced resistance to abrasion and cracking ([0003]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized an integral skin foam to allow for enhanced resistance to abrasion and cracking during use as taught by Yu.
Yu, additional teaches a method of manufacturing including forming the pad via a mold ([0004]), the pad comprising a flexible self-skinning foam ([0004, 0473]), and applying a back pressure to the mold to enable the surface of the pad to increase in density ([0475]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have manufactured the pad as taught by Yu to allow a cosmetically acceptable appearance while also providing enhanced resistant to abrasion.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadtke and Roslonski as applied to claim 1 above, and further in view of US 6,113,626 to Clifton et al. (Clifton).
Regarding claim 1, Hadtke in view Roslonski teaches the apparatus of claim 1, but not wherein a plurality of pads are connected such that the pads articulate with respect to each other. Clifton teaches an analogous device (title “Heat Transfer Blanket for Controlling Patient’s Temperature”) which includes multiple pads (111, 141, 171) that articulate with respect to each other (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 Hadtke to include multiple articulatable pads to allow for more coverage as taught by Clifton (Figs. 3 and 4).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadtke and Roslonski as applied to claim 1 above, and further in view of US 8,113,910 B2 Fortner (Fortner).
Regarding claim 28, Hadtke in view Roslonski teaches the apparatus of claim 1, but not specifically wherein the pad is bonded to the membrane via a high strength flexible urethane adhesive. Fortner teaches bonding fabric using an adhesive, especially a urethane adhesive is applied to the pad to adhere the pad to a garment. A urethane adhesive in liquid form is applied to the garment pad and then the garment pad is pressed onto the garment. Once the urethane adhesive cures, the garment pad is thereby permanently adhered to the garment (Col. 6, lines 22-34). 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 utilized urethane adhesive, since it has been held to be within the general skill of a worker int eh art to select a known material on the basis of tis suitability for the intended use as a matter of obvious design choice.
Claim(s) 30 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadtke and Roslonski as applied to claim 1 above, and further in view of US 2017/0189225 A1 to Voorhees et al. (Voorhees).
Regarding claim 30, Hadtke in view of Roslonski teaches the apparatus of claim 1, but not wherein the pad comprises a material that adheres to the skin. Voorhees teaches an analogous device (title “Medical Pad and System for Thermotherapy”) including a material that adheres to the skin ([0013]). 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 adhesive layer as taught by Voorhees to allow for better thermal conductivity.
Regarding claim 32, Hadtke in view of Roslonski teaches the apparatus of claim 1, but not wherein the membrane is a cured sheet of hydrogel. Voorhees teaches an analogous device (title “Medical Pad and System for Thermotherapy”) including a hydrogel layer interconnected to an extending across one side of the fluid circulation layer to define an adhesive surface for adherence to a patient’s skin (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 included the hydrogel layer as taught by Voorhees to allow for better thermal conductivity.
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.
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