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 22 December 2025 have been fully considered but they are not persuasive.
In response to applicant's argument that Hansen is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Hansen is reasonably pertinent to the problem being solved (i.e. discomfort and irritation caused by a pressure from the edges of a material against the skin. Hansen specifically discusses this with respect to guarding against chaffing. Therefore, Hansen is reasonably pertinent to preventing skin irritation and discomfort related to pressure against the skin.
Applicant additionally argues that strip 60 of Hansen does not extend outwardly from an edge of any flexible sheet as required by claim 1. However, as can be seen, for example, in Fig. 4 of Hansen the strip 60 is positioned and secured over edge 31 of the band 10 and therefore as broadly as claimed extends outwardly from edge 31 as it is placed over edge 31.
Applicant additionally argues that it would not have been obvious to one having ordinary skill in the art to have modified Gildersleeve to include the edge guard of Hansen to protect against chaffing and wear and tear of an edge of the device as taught by Hansen since the chaffing and wear and tear is not caused by the device itself. However, this is not found to be persuasive as the fact that Hansen teaches that wear and tear is not with respect to the device itself does not negate protection against chaffing and wear and tear. The strip 60 of Hansen provides protection against chaffing and wear and tear on both sides of the seam as it extends over the top of the seam as shown in Fig. 4. It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets 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) 1-5, 8-16 and 21-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,352,550 B1 to Gildersleeve et al. (Gildersleeve) in view of US 5,329,638 to Hansen et al. (Hansen) and US 2013/0116760 A1 to Carson et al. (Carson).
Regarding claim 1, Gildersleeve teaches a medical pad (10) for exchanging thermal energy with a patient, the medical pad comprising a flexible upper sheet (30) having an edge (36) and a skin-contacting side (Fig. 2) and a flexible base member (32) interconnected to the flexible upper sheet to define a fluid containing layer (Fig. 2) between the flexible base member and the flexible upper sheet (Fig. 2), wherein the fluid contain layer includes a plurality of tortuous fluid flow paths (See for example Fig. 1). However, Gildersleeve is silent with respect to an edge guard comprising a pliant shock-absorbing material surrounding a portion of an edge of the flexible upper sheet, the edge guard configured to distribute pressure from the medical pad across a portion of the patient body in contact with a surface of the edge guard, and an adhesive surface disposed on the skin-contacting side of the flexible upper sheet and adapted for releasable adhesive contact with skin of the patient. Hansen teaches a medical pad (10) including a guard strip (60) comprising a pliant shock-absorbing material (Col. 3, line 67) stitched via stitching to the inner and outer layers (12,13) to guard against chaffing and wear and tear of a rough edge (23). The edge guard material of Hansen is inherently s shock-absorbent material due to its inherent elasticity and ability to absorb shocks and vibrations. 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 Gildersleeve to include the edge guard of Hansen to protect against chaffing and wear and tear of an edge of the device as taught by Hansen (Col. 3, line 67-Col. 4, line 4). Carson teaches an analogous medical pad (title) to that of Gildersleeve including an adhesive surface disposed on a skin-contacting side ([0067] which states in part “Alternatively, a thermally conductive layer may be comprised of a hydrogel material having sufficient adhesive properties so as to integrally provide the adhesive surface.”) where the adhesive surface extends across the entirety of the skin-contact side of the medical pad ([0067]). 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 Gildersleeve to include the hydrogel of Carson so as to allow for sufficient adhesive properties as taught by Carson ([0067]).
Regarding claim 2, the combination teaches the medical pad of claim 1 as well as wherein the edge guard is configured to conduct thermal energy between the fluid containing layer and the patient body (inherent in the combination as the edge guard material of Hansen will conduct some heat through the material).
Regarding claim 3, the combination teaches the medical pad of claim 1, but not wherein the plaint shock-absorbent material comprises silicone. 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 silicone material, 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.
Regarding claim 4, the combination teaches the medical pad of claim 1, but not wherein the edge guard is disposed on the portion of the edge of the flexible upper sheet via an adhesive bond. It would have been obvious matter of engineering design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized an adhesive bond, since Applicant has not disclosed that an adhesive bond solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well as with the stitching in the prior art of Hansen.
Regarding claim 5, the combination teaches the medical pad of claim 1 as well as Hansen teaching wherein the edge guard is locked on the portion of the edge of the flexible upper sheet via an attachment mechanism (stitching 61). 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 Gildersleeve to include the edge guard of Hansen to protect against chaffing and wear and tear of an edge of the device as taught by Hansen (Col. 3, line 67-Col. 4, line 4).
Regarding claim 8, the combination teaches the medical pad of claim 1 as well as Hansen teaching wherein the portion of the edge comprises at least one corner of the edge of the flexible upper sheet (Col. 3, line 67-Col. 4, line 9).
Regarding claim 9, the combination teaches the medical pad of claim 1 as well as Carson teaching the adhesive comprises a conformable, thermally conductive layer of a hydrogel material ([0067] which states in part “Alternatively, a thermally conductive layer may be comprised of a hydrogel material having sufficient adhesive properties so as to integrally provide the adhesive surface.”). 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 Gildersleeve to include the hydrogel of Carson so as to allow for sufficient adhesive properties as taught by Carson ([0067]).
Regarding claim 10, the combination teaches the medical pad of claim 1 as well as wherein the flexible base member includes a plurality of dimples (38) defining a plurality of tortuous fluid flow paths (Col. 8, lines 61-67).
Regarding claim 11, the combination teaches the medical pad of claim 10, as well as wherein the dimples may be of any desired shape, including, if preferred, of shape and orientation appropriate to impart desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium or fluid within the pad in order to regulate heat transfer on a localized basis (Col. 8, line 67- Col. 9, line 14), but not specifically wherein the plurality of dimples are of a predetermined configuration comprising one or more of a truncated cone configuration, a cylindrical configuration, and an elongated truncated pyramid configuration. 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 the shape of the dimples to be of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of skill in the art, absent any showing of unexpected results.
Regarding claim 12, the combination teaches the medical pad of claim 10 as well as Gildersleeve teaching wherein the plurality of dimples are arranged on an upper surface of the flexible base member (Fig. 2), a lower smooth surface of the flexible upper sheet is supported at a plurality of points of contact with the dimples (Fig. 2) where the shape and orientation of the dimples imparts the desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium (Col. 9, lines 1-4). However, Gildersleeve does not teach a predetermined staggered pattern in at least two transverse directions. 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 Gildersleeve with the claimed arrangement of dimples, since it have been held that 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. This is especially true given the teaching of Gildersleeve that the shape and orientation of the dimples imparts the desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium (Col. 9, lines 1-4).
Regarding claim 13, the combination teaches the medical pad of claim 12 as well as Gildersleeve teaching where the shape and orientation of the dimples is appropriate to impart desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium or fluid within the pad in order to regulate heat transfer on a localized basis (Col. 8, line 67- Col. 9, line 14), but not specifically wherein the predetermined staggered pattern comprises offset rows and columns. 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 the pattern of the dimples to be of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of skill in the art, absent any showing of unexpected results. This is especially true given the teaching of Gildersleeve that the shape and orientation of the dimples imparts the desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium (Col. 9, lines 1-4).
Regarding claim 14, the combination taches the medical pad of claim 13 as well as Gildersleeve teaching where the shape and orientation of the dimples is appropriate to impart desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium or fluid within the pad in order to regulate heat transfer on a localized basis (Col. 8, line 67- Col. 9, line 14), but not specifically wherein the plurality of dimples are offset from one another by sixty degrees. It would have been obvious to one having ordinary skill in the art to have offset the dimples from one another by sixty degrees, since it has been held that discovering the optimum or workable value of a results effective variable involves only routine skill in the art. This is especially true given the teaching of Gildersleeve that the shape and orientation of the dimples imparts the desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium (Col. 9, lines 1-4).
Regarding claim 15, the combination teaches the medical pad of claim 12 as well as Gildersleeve teaching where the shape and orientation of the dimples is appropriate to impart desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium or fluid within the pad in order to regulate heat transfer on a localized basis (Col. 8, line 67- Col. 9, line 14), but not specifically wherein the plurality of dimples are arranged in a herringbone pattern. 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 Gildersleeve to arrange the dimples in a herringbone pattern, since it has been held that rearranging parts of an invention involves only routine skill in the art. This is especially true given the teaching of Gildersleeve that the shape and orientation of the dimples imparts the desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium (Col. 9, lines 1-4).
Regarding claim 16, the combination teaches the medical pad of claim 12 as well as Gildersleeve teaching wherein the base member is formed to integrally define the plurality of dimples (Fig. 2).
Regarding claims 21 and 29, Gildersleeve teaches a medical pad (10) for exchanging thermal energy with a patient, the medical pad comprising a flexible upper sheet of foam (30, 33) having a plurality of integrally defines dimples (Fig. 2) and an edge (36) and a skin-contacting side (Fig. 2) and a flexible base member (32) interconnected to the flexible upper sheet to define a fluid containing layer (Fig. 2) between the flexible base member and the flexible upper sheet (Fig. 2), wherein the plurality of dimples defines a tortuous fluid flow paths within the fluid containing layer Col. 8, line 61-Col. 9, line 14). However, Gildersleeve is silent with respect to an edge guard comprising a pliant shock-absorbent material surrounding a portion of an edge of a thermally conductive layer, the edge guard configured to distribute pressure from the medical pad across a portion of the patient body in contact with a surface of the edge guard and a thermally conductive layer laminated to one side of the flexible film that comprises a conformable hydrogel material. Hansen teaches a medical pad (10) including a guard strip (60) comprising a pliant shock-absorbing material (Col. 3, line 67) stitched via stitching to the inner and outer layers (12,13) to guard against chaffing and wear and tear of a rough edge (23). The edge guard material of Hansen is inherently s shock-absorbent material due to its inherent elasticity and ability to absorb shocks and vibrations. 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 Gildersleeve to include the edge guard of Hansen to protect against chaffing and wear and tear of an edge of the device as taught by Hansen (Col. 3, line 67-Col. 4, line 4). Carson teaches an analogous medical pad (title) to that of Gildersleeve including a thermally conductive hydrogel material surface disposed on a skin-contacting side ([0067] which states in part “Alternatively, a thermally conductive layer may be comprised of a hydrogel material having sufficient adhesive properties so as to integrally provide the adhesive surface.”) where the adhesive surface extends across the entirety of the skin-contact side of the medical pad ([0067]). 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 Gildersleeve to include the hydrogel of Carson so as to allow for sufficient adhesive properties as taught by Carson ([0067]).
Regarding claim 22, the combination teaches the medical pad of claim 21 as well as wherein the edge guard is configured to conduct thermal energy between the fluid containing layer and the patient body (inherent in the combination as the edge guard material of Hansen will conduct some heat through the material).
Regarding claim 23, the combination teaches the medical pad of claim 21, but not wherein the plaint shock-absorbent material comprises silicone. 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 silicone material, 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.
Regarding claim 24, the combination teaches the medical pad of claim 21, but not wherein the edge guard is disposed on the portion of the edge of the flexible upper sheet via an adhesive bond. It would have been obvious matter of engineering design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized an adhesive bond, since Applicant has not disclosed that an adhesive bond solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well as with the stitching in the prior art of Hansen.
Regarding claim 25, the combination teaches the medical pad of claim 21 as well as Hansen teaching wherein the edge guard is locked on the portion of the edge of the flexible upper sheet via an attachment mechanism (stitching 61). 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 Gildersleeve to include the edge guard of Hansen to protect against chaffing and wear and tear of an edge of the device as taught by Hansen (Col. 3, line 67-Col. 4, line 4).
Regarding claim 28, the combination teaches the medical pad of claim 1 as well as Hansen teaching wherein the portion of the edge comprises at least one corner of the edge of the thermally conductive layer (Col. 3, line 67-Col. 4, line 9).
Regarding claim 30, the combination teaches the medical pad of claim 21, as well as wherein the dimples may be of any desired shape, including, if preferred, of shape and orientation appropriate to impart desired laminar/turbulent characteristics, flow direction and flow velocity to the thermal medium or fluid within the pad in order to regulate heat transfer on a localized basis (Col. 8, line 67- Col. 9, line 14), but not specifically wherein the plurality of dimples are of a predetermined configuration comprising one or more of a truncated cone configuration, a cylindrical configuration, and an elongated truncated pyramid configuration. 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 the shape of the dimples to be of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of skill in the art, absent any showing of unexpected results.
Claim(s) 17-20 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildersleeve, Hansen and Carson as applied to claims 1 and 21 above, and further in view of US 11,285,039 to Steele et al. (Steele).
Regarding claims 17 and 31, Gildersleeve in view of Hansen and Carson teaches the medical pad of claims 1 and 21, but not a filter disposed in line with a fluid flow path providing a fluid to the medical pad. Steele teaches a thermal management system (Fig. 1) comprising a filter (30) disposed in line with a fluid flow path providing a fluid to the medical pad (Fig. 1). 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 Gildersleeve to include the filter of Steele to allow for the removal of organic compounds from the water that are capable of forming an adherent layer as taught by Steele (abstract).
Regarding claims 18 and 32, the combination teaches the medical pad of claims 17 and 31 as well as Steele teaching wherein the filter comprises a porous wall disposed parallel to a flow direction of the fluid along the fluid flow path (Fig. 3). 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 Gildersleeve to include the filter of Steele to allow for the removal of organic compounds from the water that are capable of forming an adherent layer as taught by Steele (abstract).
Regarding claims 19 and 33, the combination teaches the medical pads of claims 17 and 31 as well as Steele teaching wherein the filter is attached to the medical pad (Figs. 1-3). 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 Gildersleeve to include the filter of Steele to allow for the removal of organic compounds from the water that are capable of forming an adherent layer as taught by Steele (abstract).
Regarding claims 20 and 34, the combination teaches the medical pad of claims 17 and 31, but not wherein the filter is disposed within the fluid containing layer of the medical pad. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have located the filter as claimed, since it has been held that rearranging parts of an invention involves only routine skill in the art.
Allowable Subject Matter
Claims 6, 7, 26 and 27 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.
Conclusion
THIS ACTION IS MADE FINAL. 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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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794