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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “locking portion” in claim 10; “pressing portion” in claim 12.
Para. [0153] of the published application describes the locking portion as a recess. “Locking portion” uses the generic placeholder “portion” coupled with the term “locking”, which is functional in that the limitation alternatively recites a portion for locking, and the term “portion” is not preceded by a structural modifier since the term “locking” does not imply any structure.
Paras. [0087]-[0096] of the published application describe the pressing portion as a body depicted in fig. 5. “Pressing portion” uses the generic placeholder “portion” coupled with the term “pressing”, which is functional in that the limitation alternatively recites a portion for pressing, and the term “portion” is not preceded by a structural modifier since the term “pressing” does not imply any structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-2, 6 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bootman (US 5833665).
Regarding claim 1, Bootman discloses (see abstract; col. 3 line 40-col. 10 line 67; figs. 4-6) an attachment device (figs. 4-6) comprising:
an attachment sheet (10, col. 7 lines 60-64; fig. 4) including an attachment surface (bottom surface of membrane 10) configured to be attached to a living body surface (bottom surface is secured to skin, col. 9 lines 5-15) and a fixing surface (upper surface of 10, col. 8 lines 42-65) that is positioned on a side opposite to the attachment surface (figs. 4-6);
a device body (17) that is fixed to the fixing surface of the attachment sheet (col. 8 lines 42-65);
a plurality of release sheets (includes removable layers 12, 13a and 13b, col. 9 lines 5-15) that are releasably attached to different positions on the attachment surface of the attachment sheet (figs. 4-5);
the attachment sheet includes an outer edge portion (flap 11, fig. 4) to which the device body is not fixed (depicted in fig. 4), the outer edge portion is positioned at an outer periphery of the device body in plan view as viewed in a thickness direction of the attachment sheet (depicted in fig. 4); and
wherein the plurality of release sheets include a first release sheet (includes 13a and 13b) that is attached to a first attachment region (region of membrane 10 that does not include flap 11) including an attachment surface of a part different from the outer edge portion in the attachment surface of the attachment sheet (depicted in fig. 4), and a second release sheet (12) that is attached to a second attachment region (flap 11) including only an attachment surface of the outer edge portion in the attachment surface of the attachment sheet (depicted in fig. 4).
Regarding claim 2, Bootman discloses the attachment device according to claim 1. Bootman further discloses wherein the first release sheet includes a first release layer (first layer of 13a, col. 9 lines 30-35) that is attached to the first attachment region of the attachment surface of the attachment sheet (layer attached to bottom adhesive surface of membrane 10, col. 9 lines 5-15); and a first folding layer (layer of 13a folded onto itself) that is folded and laminated on the first release layer on a side of the attachment surface opposite to a first attachment region side (considered to be folded onto opposite side of removable layer 13a directly attached to membrane 10, note the limitation “laminated on the first release layer” is treated as a product by process limitation, in which determination of patentability is based on the product itself; since Bootman discloses folded layers 13a, the limitation is considered to be met, see MPEP 2113).
Regarding claim 6, Bootman discloses the attachment device according to claim 1. Bootman further discloses wherein the second attachment region is adjacent to the first attachment region (depicted in figs. 4-5).
Regarding claim 12, Bootman discloses (see abstract; col. 3 line 40-col. 10 line 67; figs. 4-6) an attachment device (figs. 4-6) comprising:
an attachment sheet (10, col. 7 lines 60-64; fig. 4) including an attachment surface (bottom surface of membrane 10) configured to be attached to a living body surface (bottom surface is secured to skin, col. 9 lines 5-15) and a fixing surface (upper surface of 10, col. 8 lines 42-65) that is positioned on a side opposite to the attachment surface (figs. 4-6), the fixing surface configured to receive a device body (17) including a pressing portion (body of 17, considered to correspond to the structure disclosed for the pressing portion interpreted under 112(f)) configured to press the living body surface in a central region of the attachment sheet (considered to provide a level of pressing to the skin when catheter is secured to pillow 17 by flap 14, figs. 4-6);
a plurality of release sheets (includes removable layers 12, 13a and 13b, col. 9 lines 5-15) that are releasably attached to different positions on the attachment surface of the attachment sheet (figs. 4-5); and
wherein the plurality of release sheets include a first release sheet (includes 13a and 13b) that is attached to a first attachment region (region of membrane 10 that does not include flap 11) including an attachment surface of a part different from an outer edge portion in the attachment surface of the attachment sheet (depicted in fig. 4), and a second release sheet (12) that is attached to a second attachment region (flap 11) including only an attachment surface of the outer edge portion in the attachment surface of the attachment sheet (depicted in fig. 4).
Regarding claim 13, Bootman discloses the attachment device according to claim 12. Bootman further discloses wherein the outer edge portion corresponds to an outer periphery of the device body (considered to match with an outer periphery of 17 to a degree, fig. 4).
Claim(s) 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haak (US 8425467 B1).
Regarding claim 20, Haak discloses (see abstract; col. 3 line 12-col. 5 line 28; figs. 1-8) an attachment method for attachment to a living body surface by an attachment device (abstract), the attachment device including an attachment sheet (includes first side member 20, second side member 40 and rigid crossmember 60, col. 3 lines 18-27; fig. 1) including an attachment surface (bottom surface of 20, 40 and 60) that is attachable to a living body surface (col. 4 lines 21-26) and a fixing surface (upper surface of 20, 40 and 60) that is positioned on a side opposite to the attachment surface (figs. 1-2), a device body (80, col. 3 lines 35-47) that is fixed to the fixing surface of the attachment sheet (mounted on crossmember 60, col. 3 lines 35-47), and first and second release sheets (parts of 30, col. 4 lines 47-53) that are releasably attached to different positions on the attachment surface of the attachment sheet (col. 4 lines 47-53; fig. 2), the first release sheet (includes 33 and 34) being attached to a first attachment region in the attachment surface of the attachment sheet (fig. 2), and the second release sheet (includes 31 and 32) being attached to a second attachment region in the attachment surface of the attachment sheet (fig. 2), the method comprising:
releasing the first release sheet from the first attachment region (extension piece 35 pulled to remove backing 30, col. 4 line 58-col. 5 line 11; fig. 2), and attaching the first attachment region to the living body surface (secures device to patient); and
releasing the second release sheet from the second attachment region by moving the second release sheet in a direction orthogonal to the first attachment region in a state attached to the living body surface (31 and 32 considered to be released in an orthogonal direction relative to 33 and 34, see fig. 2 depicting release of 31 and 32 orthogonal to L-shaped parts 33 and 34), and attaching the second attachment region to the living body surface (secured to patient, col. 4 line 58-col. 5 line 11).
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) 3-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bootman in view of Aviles (US 2014/0276544 A1).
Regarding claim 3, Bootman discloses the attachment device according to claim 2. Bootman further discloses wherein the second release sheet includes a second release layer (removable layer 12, col. 9 lines 5-15) that is attached to the second attachment region of the attachment surface of the attachment sheet (figs. 4-5).
However, Bootman fails to disclose the second release sheet including a second folding layer that is folded and laminated on the second release layer on a side of the attachment surface opposite to a second attachment region side.
Aviles teaches (paras. [0045]-[0047]; figs. 1-3), in the same field of endeavor, an attachment device (abstract) comprising a release sheet (liner 180) including a release layer (layer of liner 180 covering adhesive lower surface 160, para. [0044]; fig. 1) and a folding layer (folded over portion defining pull tab 190) that is folded and laminated on the release layer (considered to be folded onto opposite side of liner 180 directly attached to lower surface 160, note the limitation “laminated on the second release layer” is treated as a product by process limitation, in which determination of patentability is based on the product itself; since Aviles teaches folded layers of liner 180, the limitation is considered to be met, see MPEP 2113) on a side of an attachment surface opposite to a second attachment region side (considered to be folded on opposite side of layer of liner 180, figs. 1-3), for the purpose of overcoming any requirement for a healthcare provider to pick at a corner edge or other segment of the liner in order to separate the liner from the adhesive layer (para. [0045]).
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 removable layer 12 of Bootman to include a folded over portion such that layer 12 includes a release layer and a folding layer as claimed, in order to overcome any requirement for a healthcare provider to pick at a corner edge or other segment of the removable layer 12 in order to separate the layer from the adhesive of flap 11, based on the teachings of Aviles (para. [0045]).
Regarding claim 4, Bootman (as modified) teaches the attachment device according to claim 3. Bootman (as modified) further teaches wherein a first folding direction of the first release sheet from the first release layer to the first folding layer is different from a second folding direction of the second release sheet from the second release layer to the second folding layer (combination considered to further teach folding directions of layers 12 and 13a/13b different due to extending direction of layers 12 and 13a/13b in Bootman, figs. 4-5).
Regarding claim 5, Bootman (as modified) teaches the attachment device according to claim 4. Bootman (as modified) further teaches wherein the first folding direction and the second folding direction are in mutually opposite directions in an in-plane direction of the attachment surface of the attachment sheet (see annotated figs. 4-5 of Bootman depicting folding directions of layers 12 and 13a being in opposite directions, see also fold of layer 13a depicted in fig. 4 of Bootman).
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Annotated Figures 4 and 5 of Bootman
Regarding claim 14, Bootman discloses the attachment device according to claim 12.
Bootman further discloses wherein the first release sheet includes a first release layer (first layer of 13a, col. 9 lines 30-35) that is attached to the first attachment region of the attachment surface of the attachment sheet (layer attached to bottom adhesive surface of membrane 10, col. 9 lines 5-15); a first folding layer (layer of 13a folded onto itself) that is folded and laminated on the first release layer on a side of the attachment surface opposite to a first attachment region side (considered to be folded onto opposite side of removable layer 13a directly attached to membrane 10, note the limitation “laminated on the first release layer” is treated as a product by process limitation, in which determination of patentability is based on the product itself; since Bootman discloses folded layers 13a, the limitation is considered to be met, see MPEP 2113); the second release sheet includes a second release layer (removable layer 12, col. 9 lines 5-15) that is attached to the second attachment region of the attachment surface of the attachment sheet (figs. 4-5).
However, Bootman fails to disclose a second folding layer that is folded and laminated on the second release layer on a side of the attachment surface opposite to a second attachment region side.
Aviles teaches (paras. [0045]-[0047]; figs. 1-3), in the same field of endeavor, an attachment device (abstract) comprising a release sheet (liner 180) including a release layer (layer of liner 180 covering adhesive lower surface 160, para. [0044]; fig. 1) and a folding layer (folded over portion defining pull tab 190) that is folded and laminated on the release layer (considered to be folded onto opposite side of liner 180 directly attached to lower surface 160, note the limitation “laminated on the second release layer” is treated as a product by process limitation, in which determination of patentability is based on the product itself; since Aviles teaches folded layers of liner 180, the limitation is considered to be met, see MPEP 2113) on a side of an attachment surface opposite to a second attachment region side (considered to be folded on opposite side of layer of liner 180, figs. 1-3), for the purpose of overcoming any requirement for a healthcare provider to pick at a corner edge or other segment of the liner in order to separate the liner from the adhesive layer (para. [0045]).
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 removable layer 12 of Bootman to include a folded over portion such that layer 12 includes a release layer and a folding layer as claimed, in order to overcome any requirement for a healthcare provider to pick at a corner edge or other segment of the removable layer 12 in order to separate the layer from the adhesive of flap 11, based on the teachings of Aviles (para. [0045]).
Regarding claim 15, Bootman (as modified) teaches the attachment device according to claim 14. Bootman (as modified) further teaches wherein a first folding direction of the first release sheet from the first release layer to the first folding layer is different from a second folding direction of the second release sheet from the second release layer to the second folding layer (combination considered to further teach folding directions of layers 12 and 13a/13b different due to extending direction of layers 12 and 13a/13b in Bootman, figs. 4-5); and the first folding direction and the second folding direction are in mutually opposite directions in an in-plane direction of the attachment surface of the attachment sheet (see annotated figs. 4-5 of Bootman depicting folding directions of layers 12 and 13a being in opposite directions, see also fold of layer 13a depicted in fig. 4 of Bootman).
Claim(s) 7-9 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bootman in view of Martz (US 5593395).
Regarding claim 7, Bootman discloses the attachment device according to claim 6.
However, Bootman fails to disclose wherein the first release sheet includes an overlapping portion that covers the second release sheet.
Martz teaches (col. 27 lines 7-30; figs. 12-15), in the same field of endeavor, an attachment device (abstract) comprising a first release sheet (106a) and a second release sheet (106b), wherein the first release sheet includes an overlapping portion that covers the second release sheet (two sections of release sheet overlap), for the purpose of entirely covering the adhesive layer so as to avoid accidental contact by a nurse or physician with the adhesive layer (col. 27 lines 7-30).
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 first release sheet to further extend along the attachment region such that it overlaps with the second release sheet in Bootman, in order to avoid accidental contact by a nurse or physician with the adhesive surface of membrane 10, based on the teachings of Martz (col. 27 lines 7-30).
Regarding claim 8, Bootman (as modified) teaches the attachment device according to claim 7. Bootman (as modified) further teaches wherein a boundary between the first attachment region and the second attachment region is defined by a ridgeline (ridge of flap 11 depicted in fig. 4 of Bootman) formed by bending of the outer edge portion of the attachment sheet toward a fixing surface side (depicted in fig. 4 of Bootman); and the overlapping portion of the first release sheet protrudes in a direction away from the second release sheet along the first attachment region, not along the second attachment region (combination considered to further teach overlapping portion of 13a extending in the same direction as layer 13a, which is considered to extend in a direction away from layer 12, since layers 12 and 13a/13b extend in different directions as depicted in fig. 4).
Regarding claim 9, Bootman (as modified) teaches the attachment device according to claim 7. Bootman (as modified) further teaches wherein a boundary between the first attachment region and the second attachment region is defined by a ridgeline (ridge of flap 11 depicted in fig. 4) formed by bending of the outer edge portion of the attachment sheet toward a fixing surface side (depicted in fig. 4); and the overlapping portion of the first release sheet extends along the second attachment region and covers the second release sheet (combination considered to further teach overlapping portion of layer 13a extending longitudinally past flap 11 and therefore extending along the region of flap 11 at least width-wise and covering layer 12, see fig. 4).
Regarding claim 16, Bootman discloses the attachment device according to claim 12.
Bootman further discloses wherein the second attachment region is adjacent to the first attachment region (figs. 4-5).
However, Bootman fails to disclose the first release sheet includes an overlapping portion that covers the second release sheet.
Martz teaches (col. 27 lines 7-30; figs. 12-15), in the same field of endeavor, an attachment device (abstract) comprising a first release sheet (106a) and a second release sheet (106b), wherein the first release sheet includes an overlapping portion that covers the second release sheet (two sections of release sheet overlap), for the purpose of entirely covering the adhesive layer so as to avoid accidental contact by a nurse or physician with the adhesive layer (col. 27 lines 7-30).
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 first release sheet to further extend along the attachment region such that it overlaps with the second release sheet in Bootman, in order to avoid accidental contact by a nurse or physician with the adhesive surface of membrane 10, based on the teachings of Martz (col. 27 lines 7-30).
Regarding claim 17, Bootman (as modified) teaches the attachment device according to claim 16. Bootman (as modified) further teaches wherein a boundary between the first attachment region and the second attachment region is defined by a ridgeline (ridge of flap 11 depicted in fig. 4 of Bootman) formed by bending of the outer edge portion of the attachment sheet toward a fixing surface side (depicted in fig. 4 of Bootman); and the overlapping portion of the first release sheet protrudes in a direction away from the second release sheet along the first attachment region, not along the second attachment region (combination considered to further teach overlapping portion of 13a extending in the same direction as layer 13a, which is considered to extend in a direction away from layer 12, since layers 12 and 13a/13b extend in different directions as depicted in fig. 4).
Regarding claim 18, Bootman (as modified) teaches the attachment device according to claim 16. Bootman (as modified) further teaches wherein a boundary between the first attachment region and the second attachment region is defined by a ridgeline (ridge of flap 11 depicted in fig. 4 of Bootman) formed by bending of the outer edge portion of the attachment sheet toward a fixing surface side (depicted in fig. 4 of Bootman); and the overlapping portion of the first release sheet extends along the second attachment region and covers the second release sheet (combination considered to further teach overlapping portion of layer 13a extending longitudinally past flap 11 and therefore extending along the region of flap 11 at least width-wise and covering layer 12, see fig. 4).
Claim(s) 10-11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bootman in view of Bendtsen (US 2021/0038249 A1).
Regarding claim 10, Bootman discloses the attachment device according to claim 1.
However, Bootman fails to disclose wherein the device body includes a locking portion that locks the second release sheet in a state in which the outer edge portion of the attachment sheet is bent toward the fixing surface side.
Bendtsen teaches (paras. [0047]-[0080]; figs. 1a-b), in the same field of endeavor, an attachment device (abstract) comprising a device body (1) including a locking portion (9, considered to correspond to the structure disclosed for the locking portion interpreted under 112(f), para. [0051]) that locks a flap (wall 3) in a state in which an outer edge portion of a window (2) is bent toward a fixing surface side (bent towards side opposite of insertion site 20, para. [0047]; figs. 1a-b), for the purpose of maintaining an angled orientation between the wall 3 and window 2 for safe investigation of the tissue adjacent to the insertion site (paras. [0051] and [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify pillow 17 of Bootman to include a stabilizer positioned between pillow 17 and flap 11, in order to maintain flap 11 and layer 12 in an upright position, allowing for safe investigation of the tissue prior to removing layer 12 and securing flap 11 to tissue when desired, based on the suggestions and teachings of Bendtsen (paras. [0051] and [0070]).
Regarding claim 11, Bootman (as modified) teaches the attachment device according to claim 10. Bootman (as modified) further teaches wherein the locking portion is a recess (combination considered to further teach stabilizer 9 including a bend and therefore recessed, fig. 1b of Bendtsen) that an outer edge portion of the second release sheet enters (combination considered to further teach flap 11 and layer 12 of Bootman secured to stabilizer, therefore encompassing an outer edge portion of layer 12 entering stabilizer, figs. 1a-b of Bendtsen).
Regarding claim 19, Bootman discloses the attachment device according to claim 12.
Bootman further discloses the device body (17).
However, Bootman fails to disclose further comprising: wherein the device body includes a locking portion that locks the second release sheet in a state in which the outer edge portion of the attachment sheet is bent toward the fixing surface side, and the locking portion is a recess that an outer edge portion of the second release sheet enters.
Bendtsen teaches (paras. [0047]-[0080]; figs. 1a-b), in the same field of endeavor, an attachment device (abstract) comprising a device body (1) including a locking portion (9, para. [0051]) that locks a flap (wall 3) in a state in which an outer edge portion of a window (2) is bent toward a fixing surface side (bent towards side opposite of insertion site 20, para. [0047]; figs. 1a-b), and the locking portion is a recess (stabilizer 9 includes bend and is therefore recessed, fig. 1b), for the purpose of maintaining an angled orientation between the wall 3 and window 2 for safe investigation of the tissue adjacent to the insertion site (paras. [0051] and [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify pillow 17 of Bootman to include a stabilizer positioned between pillow 17 and flap 11, in order to maintain flap 11 and layer 12 in an upright position, allowing for safe investigation of the tissue prior to removing layer 12 and securing flap 11 to tissue when desired, based on the suggestions and teachings of Bendtsen (paras. [0051] and [0070]).
Bootman (as modified) further teaches the locking portion is a recess that an outer edge portion of the second release sheet enters (combination considered to further teach flap 11 and layer 12 of Bootman secured to stabilizer, therefore encompassing an outer edge portion of layer 12 entering stabilizer, figs. 1a-b of Bendtsen).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2001/0025159 A1 to Fleischer, disclosing a fixation device.
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/BRIGID K BYRD/Examiner, Art Unit 3771