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 Objections
Claim 10 is objected to because of the following informalities: Claim 10 recites “the guide member” in line 10 which should read “the liquid guide member”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Claim 11 recites “the guide member” in line 2 which should read “the liquid guide member”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Claim 16 recites “the expansion portion” in line 3 which should read “the expandable expansion portion” for consistency purposes. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Claim 16 recites “with expandable expansion portion” in lines 10-11 which should read “with the expandable expansion portion”. Appropriate correction is required.
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 17 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 17 recites the limitation "the fluid supply instrument" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the connector" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the expandable expansion portion" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the fluid" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawaura et al. (US 2021/0059686 A1) in view of Carty (US 2015/0284597 A1).
Regarding claim 1, Kawaura discloses a compression device (compression device 1; Fig. 1) comprising: an adhesive sheet (adhesion sheet 2) provided with an adhesive surface (adhesive surface 11) configured to be adhered to a living body surface (11 is adherable to a biological surface e.g., the outer surface of a patient’s body; [0083]); an expansion member (expander 21; Figs. 4A-4B) including an expandable expansion portion (inflator 23); a base member (support portion 25; Figs. 1-4A) fixed to a fixing surface (mounting surface 12) on a side opposite to the adhesive surface (11) of the adhesive sheet (2; Fig. 4A) and configured to press the expansion portion (23) in an expanded state toward the living body surface (Figs. 4A-4B).
Kawaura fails to disclose a liquid guide member into which a release liquid is configured to permeate, the liquid guide member provided with a main body adhered in the adhesive surface of the adhesive sheet; and the main body extending to a position of an outer edge of the adhesive surface.
However, Carty teaches a wound dressing (as the device of Figs. 6B-6C may be a wound dressing; [0177]) with an adhesive sheet (adhesive article 48) provided with an adhesive surface (bottom surface of 48; Figs. 6B-6C) configured to be adhered to a living body surface (as the substrate 49 can include human skin; [0099]; [0177]); and a liquid guide member (fluid conduit member 51; Fig. 6B) into which a release liquid (debonding agent 50) is configured to permeate (via the porous material of the fluid conduit member 51; [0099]), the liquid guide member (51) provided with a main body (conduit) adhered in the adhesive surface of the adhesive sheet (48; Fig. 6B), and the main body extending to a position of an outer edge of the adhesive surface (as the fluid conduit member 51 extends up to and past the outer edge of the adhesive surface and may be utilized along at least a portion of the interface between the adhesive article 48 and the substrate 49; Fig. 6B; [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive surface of Kawaura to include a liquid guide member into which a release liquid is configured to permeate, the liquid guide member provided with a main body adhered in the adhesive surface of the adhesive sheet; and the main body extending to a position of an outer edge of the adhesive surface as taught by Carty in order to apply a debonding agent to the surface of a patient’s skin to reduce pain caused by removal of an adhesive from skin and improve the removal process of the compression device from a patient.
Regarding claim 2, modified Kawaura discloses the invention as claimed above, and Kawaura further discloses wherein the adhesive sheet (2) is not arranged at a position overlapping the expansion portion (23; Figs. 4A-4B) but is located around the expansion portion in plan view as seen in a thickness direction of the adhesive sheet (Figs. 4A-4B).
Modified Kawaura fails to explicitly disclose the main body of the liquid guide member does not extend to a position of an inner edge of the adhesive surface but terminates in the adhesive surface.
However, Carty teaches the main body (conduit) of the liquid guide member (51) may be utilized along at least a portion of the interface between the adhesive surface (bottom surface of 48) and the substrate (skin; [0099]). Thus, the liquid guide member is not required to extend to both edges of the adhesive surface to provide the debonding benefits.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body of the liquid guide member of modified Kawaura to terminate in the adhesive surface and not extend to a position of an inner edge of the adhesive surface in light of the teachings of Carty since shifting the position of the end of the liquid guide member would not have modified the operation of the device and would allow for the benefits of the debonding agent to be applied to the liquid guide member. Thus, the modification would involve a simple rearrangement of parts. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 3, modified Kawaura discloses the invention as claimed above, and Kawaura further discloses wherein the adhesive sheet (2) includes a fixing portion (fixing portion 4) to which the base member (25) is fixed (Fig. 1), and a non-fixing portion (portion of 12 located closer to the outer edge of 2, outside of 25; Fig. 1) located outside the fixing portion (4) in plan view as seen in a thickness direction of the adhesive sheet to which the base member (25) is not fixed (Figs. 1, 4A-4B); the adhesive surface (11) includes a first adhesive portion provided at a position of the fixing portion, and a second adhesive portion including the outer edge of the adhesive surface and is provided at a position of the non-fixing portion (Figs. 4A-4B).
Modified Kawaura fails to explicitly disclose wherein the main body of the liquid guide member is adhered only to the second adhesive portion.
However, Carty teaches the main body (conduit) of the liquid guide member (51) may be utilized along at least a portion of the interface between the adhesive surface (bottom surface of 48) and the substrate (skin; [0099]). Thus, the liquid guide member is not required to extend to both edges of the adhesive surface to provide the debonding benefits.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body of the liquid guide member of modified Kawaura to be adhered only to the second adhesive portion in light of the teachings of Carty since shifting the position of the end of the liquid guide member to end at the end of the non-fixing portion would not have modified the operation of the device and would allow for the benefits of the debonding agent to be applied to the liquid guide member. Thus, the modification would involve a simple rearrangement of parts. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 4, modified Kawaura discloses wherein the liquid guide member (51 of Carty) is provided with an outer extended portion continuous to the main body (conduit of 51 of Carty) and extending outward from the outer edge of the adhesive surface (bottom surface of 48; Fig. 6B of Carty).
Regarding claim 5, modified Kawaura fails to explicitly disclose wherein the outer extended portion is folded back outside the outer edge of the adhesive surface and is fixed to the fixing surface. It would have been an obvious matter of design choice to further extend the liquid guide member up and over the fixing surface, since applicant has not disclosed that the end of the liquid guide member being on top of the fixing surface solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the liquid guide member extending past the adhesive sheet as it would with the liquid guide member extending past the adhesive sheet to the top of the fixing surface.
Regarding claim 6, modified Kawaura discloses the invention as claimed above, and Kawaura further discloses wherein in a case where a direction from the adhesive surface (11) toward the fixing surface (12) in a thickness direction of the adhesive sheet (2) is defined as an upward direction (Fig. 4A); but modified Kawaura fails to explicitly disclose at least a part of the outer extended portion is configured to be able to protrude in the upward direction from the fixing surface. It would have been an obvious matter of design choice to further extend the liquid guide member up and over the fixing surface, since applicant has not disclosed that the end of the liquid guide member being on top of the fixing surface solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the liquid guide member extending past the adhesive sheet as it would with the liquid guide member extending past the adhesive sheet to the top of the fixing surface.
Regarding claim 7, modified Kawaura discloses the release liquid (debonding agent of Carty), the release liquid being a nonalcoholic silicone-based release agent or an alcohol (silicone or silicone oil; [0134] of Carty).
Regarding claim 8, modified Kawaura discloses wherein the liquid guide member includes a plurality of voids into which the release liquid can permeate (as 51 is porous having interior voids, channels, or the like; [0099] of Carty).
Regarding claim 9, modified Kawaura discloses wherein the liquid guide member is a nonwoven fabric, a woven fabric, a knitted fabric, a twisted yarn, or a porous body (as 51 is a porous material; [0099] of Carty).
Regarding claim 10, Kawaura discloses a compression device (compression device 1; Fig. 1) comprising: an adhesive sheet (adhesion sheet 2) provided with an adhesive surface (adhesion surface 11) configured to be adhered to a living body surface (adherable to the outer surface of a patient’s body; [0083]); an expansion member (expander 21) including an expandable expansion portion (inflator 23; Figs. 4A-4B); a base member (support portion 25) fixed to a fixing surface (mounting surface 12) on a side opposite to the adhesive surface (11) of the adhesive sheet (2) and configured to press the expansion portion in an expanded state toward the living body surface (Figs. 4A-4B).
Kawaura fails to disclsoe a liquid guide member into which a release liquid is configured to permeate, the liquid guide member provided with a main body adhered in the adhesive surface of the adhesive sheet, and wherein the main body of the guide member extends outward from an outer edge of the adhesive surface.
However, Carty teaches a wound dressing (as the device of Figs. 6B-6C may be a wound dressing; [0177]) with an adhesive sheet (adhesive article 48) provided with an adhesive surface (bottom surface of 48; Figs. 6B-6C) configured to be adhered to a living body surface (as the substrate 49 can include human skin; [0099]; [0177]); and a liquid guide member (fluid conduit member 51; Fig. 6B) into which a release liquid (debonding agent 50) is configured to permeate (via the porous material of the fluid conduit member 51; [0099]), the liquid guide member (51) provided with a main body (conduit) adhered in the adhesive surface of the adhesive sheet (48; Fig. 6B), and wherein the main body of the liquid guide member extends outward from an outer edge of the adhesion surface (as the fluid conduit member 51 extends up to and past the outer edge of the adhesive surface and may be utilized along at least a portion of the interface between the adhesive article 48 and the substrate 49; Fig. 6B; [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive surface of Kawaura to include a liquid guide member into which a release liquid is configured to permeate, the liquid guide member provided with a main body adhered in the adhesive surface of the adhesive sheet; and wherein the main body of the liquid guide member extends outward from an outer edge of the adhesion surface as taught by Carty in order to apply a debonding agent to the surface of a patient’s skin to reduce pain caused by removal of an adhesive from skin and improve the removal process of the compression device from a patient.
Regarding claim 11, modified Kawaura discloses wherein the main body of the liquid guide member protrudes inward from an inner edge of the adhesive surface (Fig. 6B of Carty).
Regarding claim 12, modified Kawaura discloses the invention as claimed above, and Kawaura further discloses wherein the adhesive sheet (2) is not arranged at a position overlapping the expansion portion (23) but is located around the expansion portion as seen in a thickness direction of the adhesive sheet (Figs. 4A-4B).
Regarding claim 13, modified Kawaura discloses the invention as claimed above, and Kawaura further discloses wherein the adhesive sheet (2) includes: a fixing portion (fixing portion 4) to which the base (25) member is fixed (Fig. 1); and a non-fixing portion (portion of 12 located closer to the outer edge of 2, outside of 25; Fig. 1) located outside the fixing portion (4) as seen in a thickness direction of the adhesive sheet to which the base member (25) is not fixed (Figs. 1, 4A-4B).
Regarding claim 14, modified Kawaura discloses the invention as claimed above, and Kawaura further discloses wherein the adhesive surface (11) includes: a first adhesive portion provided at a position of the fixing portion (4; Figs. 4A-4B); and a second adhesive portion including the outer edge of the adhesive surface and wherein the second adhesive portion is provided at a position of the non-fixing portion (outside of 4 to the outer edge of 2; Figs. 4A-4B).
Regarding claim 15, Kawaura discloses a method for detaching a compression device (compression device 1; [0154]) adhered to a living body surface (adherable to the outer surface of a patient’s body; [0083]), the compression device provided with an adhesive sheet (adhesion sheet 2) provided with an adhesive surface (adhesive surface 11) that can be adhered to the living body surface (adherable to the outer surface of a patient’s body; [0083]), and detaching the compression device from the living body surface by peeling the adhesive surface (11) of the adhesive sheet (2) off from the living body surface (after hemostasis is completed, the adhesion surface 11 of the adhesion sheet 2 is peeled off from the biological surface to remove the compression device 1 from the biological surface; [0154]).
Kawaura fails to disclose a liquid guide member adhered in the adhesive surface into which a release liquid can permeate, the method comprising: impregnating the liquid guide member with the release liquid by allowing the release liquid to permeate from a liquid introduction portion of the release liquid provided at a position of an outer edge of the adhesive surface or a position outside the outer edge of the adhesive surface in the liquid guide member; and detaching the compression device from the living body surface by peeling the adhesive surface of the adhesive sheet off from the living body surface after the liquid guide member is impregnated with the release liquid.
However, Carty teaches a wound dressing (as the device of Figs. 6B-6C may be a wound dressing; [0177]) with an adhesive sheet (adhesive article 48) provided with an adhesive surface (bottom surface of 48; Figs. 6B-6C) configured to be adhered to a living body surface (as the substrate 49 can include human skin; [0099]; [0177]); and a liquid guide member (fluid conduit member 51; Fig. 6B) adhered in the adhesive surface (Fig. 6B) into which a release liquid (debonding agent 50) can permeate (via the porous material of the fluid conduit member 51; [0099]), and a method comprising: impregnating the liquid guide member (51) with the release liquid (50) by allowing the release liquid to permeate from a liquid introduction portion (as the debonding agent inherently comes from a container) of the release liquid provided at a position of an outer edge of the adhesive surface or a position outside the outer edge of the adhesive surface in the liquid guide member (Fig. 6B; [0099]); and detaching the adhesive sheet (48) from the living body surface (skin) by peeling the adhesive surface of the adhesive sheet off from the living body surface after the liquid guide member is impregnated with the release liquid (Figs. 6B-6C; [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive surface of Kawaura to include a liquid guide member into which a release liquid is configured to permeate, and to modify the method of Kawaura by impregnating the liquid guide member with the release liquid by allowing the release liquid to permeate from a liquid introduction portion of the release liquid provided at a position of an outer edge of the adhesive surface or a position outside the outer edge of the adhesive surface in the liquid guide member; and detaching the compression device from the living body surface by peeling the adhesive surface of the adhesive sheet off from the living body surface after the liquid guide member is impregnated with the release liquid as taught by Carty in order to apply a debonding agent to the surface of a patient’s skin to reduce pain caused by removal of an adhesive from skin and improve the removal process of the compression device from a patient.
Regarding claim 16, modified Kawaura discloses the invention as claimed above, and Kawaura further discloses wherein the compression device (1) further includes an expansion member (expander 21) including an expandable expansion portion (inflator 23), the adhesive sheet (2) is not arranged at a position overlapping the expansion portion but is located around the expansion portion in plan view as seen in a thickness direction of the adhesive sheet (Figs. 4A-4B), and the method further comprises: connecting a fluid supply instrument (fluid supply device) to a connector (connection portion 29) in communication with the expandable expansion portion (23; Figs. 2-3; [0126]); and supplying a fluid (fluid) via the connector in communication with expandable expansion portion (23) to expand the expandable expansion portion to compress a vicinity of a wound on the living body surface ([0126]).
Modified Kawaura fails to explicitly disclose the main body of the liquid guide member does not extend to a position of an inner edge of the adhesive surface but terminates in the adhesive surface.
However, Carty teaches the main body (conduit) of the liquid guide member (51) may be utilized along at least a portion of the interface between the adhesive surface (bottom surface of 48) and the substrate (skin; [0099]). Thus, the liquid guide member is not required to extend to both edges of the adhesive surface to provide the debonding benefits.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body of the liquid guide member of modified Kawaura to terminate in the adhesive surface and not extend to a position of an inner edge of the adhesive surface in light of the teachings of Carty since shifting the position of the end of the liquid guide member would not have modified the operation of the device and would allow for the benefits of the debonding agent to be applied to the liquid guide member. Thus, the modification would involve a simple rearrangement of parts. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 17, modified Kawaura discloses the invention as claimed above, and Kawaura further discloses connecting the fluid supply instrument (fluid supply device) to the connector (29) in communication with the expandable expansion portion (23; [0126]); and removing the fluid from the expandable expansion portion (23) to deflate the expandable expansion portion (fluid may be added or removed with the syringe 30; [0151]).
Regarding claim 18, modified Kawaura discloses wherein the liquid guide member (51 of Carty) is provided with an outer extended portion (portion of 51 outside of 48) extending outward from the outer edge of the adhesive surface (Fig. 6B of Carty).
Regarding claim 19, modified Kawaura discloses wherein the release liquid (debonding agent of Carty) is a nonalcoholic silicone-based release agent or an alcohol (silicone or silicone oil; [0134] of Carty).
Regarding claim 20, modified Kawaura discloses permeating the release liquid (50 of Carty) from a plurality of voids in the liquid guide member (porous material having interior voids; [0099] of Carty).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771