DETAILED ACTION
In Applicant’s Response filed 5/5/26, Applicant has amended claims 15, 20, 26-29 and 33; and added new claim 35. Claims 1-14 and 34 have been cancelled. Currently, claims 15-33 and 35 are pending.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/8/26 was filed after the mailing date of the Non-Final Rejection on 1/5/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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) 15, 17-19, and 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piferi et al (US 2009/0177077).
With respect to claim 15, Piferi discloses a device (patch assembly 101 comprising a patch 100) for covering at least one area of the body of a patient during a medical procedure (the patch 100 is shown applied to the head of a user, and thus covering part of the head, for use during a medical procedure in fig 7; see para [0102,0103]), wherein the device comprises a flat, thin, sterile drape (base layer 110; layer 110 is flat as shown in fig 4 and is interpreted as being “thin” since it has a thickness of only about 0.001-0.1 inches – see para [0087]; the assembly 101 is maintained in a package as part of a kit prior to use and thus is interpreted as being maintained in a sterile condition for use – see para [0129]) and a marking grid connected to the drape (top layer 130 which includes MRI-visible fiducial elements 140 arranged in a pattern 163 which is a grid pattern – para [0089-0090;0096]), the marking grid (130) being positioned fully within an outer perimeter of the drape (as shown in figure 3, the outer perimeter edge of layer 130 is spaced inward from the outer perimeter edge of layer 110 with a pull tab 138 attached to and extending outward from layer 130 beyond the perimeter of layer 110 while layer 130 is positioned fully within the perimeter of layer 110), with adhesive free regions of the drape occurring between an outer perimeter of the marking grid and the outer perimeter of the drape (as shown in fig 5, the adhesive layer 122 is the same size as layer 130 and thus does not extend onto the portion of layer 110 that extends beyond the outer perimeter edge of layer 130, thus defining an adhesive free region between the outer perimeter edge of layer 130 and the outer perimeter edge of layer 110), and configured to drape around the patient to provide a physical barrier to protect a surgical field from contamination (the device conformable to the body (para [0082]) and follows the natural anatomical contours of the part of the body that it is attached to such as by extending at least partly around the head as shown in fig 7, and, therefore, is configured to drape “around” the patient; the device covers the part of the body that it is attached to and thus inherently provides a physical barrier to protect that area from contamination) wherein the marking grid (130) has markings for determining a position in CT and/or MRI scans (the grid includes masses 146 of MRI-visible material in a pattern codified by indicia or markings or other indicators – para [0096], the MRI-visible masses 146 serve as MRI-visible landmarks when MR images are obtained– para [0106]), wherein at least a part of the marking grid is attached to the drape via a detachable connection so that it can be removed from the drape during the course of the medical procedure without the need to remove the drape from the patient (as shown in fig 10; the top layer 130 which includes the grid is removed from base layer 110 by an operator by lifting an edge and peeling layer 130 away from layer 110 with layer 110 remaining on the head 12 – para [0120,0121]).
With respect to claim 17, Piferi discloses the device as claimed (see rejection of claim 15) and Piferi also discloses that the device is packaged in a sterile package with the drape and the marking grid attached to the drape (the patch assembly 101 is packaged as a kit – para [0129]).
With respect to claim 18, Piferi discloses the device as claimed (see rejection of claim 15) and Piferi also discloses that the marking grid (130) has an outer frame (outer border area about the perimeter where the letter indicia 164 are provided on one side as shown in figs 3 and 5) and a grid area (central area of layer 130 which includes the tab array 140 in figs 3 and 5) surrounded by the outer frame (the peripheral border surrounds the tab array as shown in figs 3 and 5), which grid area has the markings for determining the position in CT and/or MRI scans (the grid includes masses 146 of MRI-visible material in a pattern codified by indicia or markings or other indicators – para [0096], the MRI-visible masses 146 serve as MRI-visible landmarks when MR images are obtained– para [0106]).
With respect to claim 19, Piferi discloses the device as claimed (see rejection of claim 18) and Piferi also discloses that the grid area is connected to the outer frame in a material and/or form-fitting manner (as shown in figs 3-5, the central portion which includes the tab array is integrally formed with the outer peripheral border region).
With respect to claim 23, Piferi discloses the device as claimed (see rejection of claim 18) and Piferi also discloses that the grid area comprises a material that is visible in a CT scan or an MRI scan (the grid includes masses 146 of MRI-visible material in a pattern codified by indicia or markings or other indicators – para [0096]).
With respect to claim 24, Piferi discloses the device as claimed (see rejection of claim 15) and Piferi also discloses that a handle element is arranged on the marking grid (pull tab 138; fig 3), which is arranged for manually gripping the marking grid for removal from the drape (shown in fig 10), wherein the handle element is not or is less firmly attached to the drape than parts of the marking grid attached to the drape by the detachable connection (tab 138 may be free of adhesive – para [0089]).
With respect to claim 25, Piferi discloses the device as claimed (see rejection of claim 24) and Piferi also discloses that the handle element is arranged in a manner overlapping the outer frame (as shown in fig 3, the tab 138 extends from the central portion where array 140 is located over the area which includes the peripheral border and, thus, is interpreted as overlapping the outer peripheral border).
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.
Claims 16 and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al (US 2009/0177077) in view of O’Neill (WO 2014/032171).
With respect to claim 16, Piferi discloses the device as claimed (see rejection of claim 15) but does not disclose that the drape comprises at least one cut-out at least when at least a part of the marking grid has been removed from the drape.
O’Neill, however, teaches a device for covering an area of the body during a medical procedure (para [0022]) wherein the device comprises a drape (skin template substrate 30; fig 2) and a marking grid (imaging substrate 12; fig 2) connected to the drape (a heat seal creates a low strength, non-permanent bond between substrate 12 and substrate 30 thus connecting them to each other – para [0059]) wherein the drape (30) comprises at least one cut-out (the skin template substrate 30 may have window cutouts or an open frame to allow the practitioner to mark out the site of the procedure or carryout the procedure through the device – para [0061]; fig 2 shows the surface 84 of the patient’s body with a target incision spot 106 exposed at the cut out at the center of substrate 30) at least when at least a part of the marking grid has been removed from the drape (as shown in fig 2 where substate 12 is being removed from substrate 30 to thereby expose the cut out at the center). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Piferi to include at least one cut-out at least when at least a part of the marking grid has been removed from the drape, like the substrate 30 of O’Neill, in order to allow the practitioner to mark out the site of the procedure or carryout the procedure through the device (O’Neill para [0061]).
With respect to claim 26, Piferi in view of O’Neill discloses the device substantially as claimed (see rejection of claim 16) but does not disclose that the device has at least one self-adhesive region at least in the region of the at least one cut-out on a side of the device configured to face the patient.
O’Neill, however, teaches a device for covering an area of the body during a medical procedure (para [0022]) wherein the device comprises a drape (skin template substrate 30; fig 2) and a marking grid (imaging substrate 12; fig 2) connected to the drape (a heat seal creates a low strength, non-permanent bond between substrate 12 and substrate 30 thus connecting them to each other – para [0059]) and further teaches a low strength adhesive coating or layer 20 that is applied to the bottom surface of the imaging substrate 12 wherein the adhesive layer 20 is permanently bonded to the lower surface of imaging substrate 12 over substantially the entire area of the lower surface (para [0051]). Thus, the adhesive 20 on the bottom surface of substrate 12 inherently provides an adhesive region in the area of the cut out at the center of substrate 30 when the layers are attached to one another and faces the patient skin surface 84 through the cut out (see fig 2). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Piferi so that it has at least one self-adhesive region at least in the region of the at least one cut-out on a side of the device configured to face the patient, as taught by O’Neill, in order to provide improved attachment of the device to the user’s body.
With respect to claim 27, Piferi in view of O’Neill discloses the device substantially as claimed (see rejection of claim 16) and Piferi also discloses that the outer edge of the grid area has a square contour with rounded corners (as shown in figs 3 and 5).
With respect to claim 28, Piferi discloses the device as claimed (see rejection of claim 15) and Piferi also discloses that the marking grid (130) has an outer frame (outer border area about the perimeter where the letter indicia 164 are provided on one side as shown in figs 3 and 5) and a grid area (central area of layer 130 which includes the tab array 140 in figs 3 and 5) surrounded by the outer frame (the peripheral border surrounds the tab array as shown in figs 3 and 5) and including markings for determining a position in CT and/or MRI scans (the grid includes masses 146 of MRI-visible material in a pattern codified by indicia or markings or other indicators – para [0096], the MRI-visible masses 146 serve as MRI-visible landmarks when MR images are obtained– para [0106]),
Piferi does not, however, disclose that the drape comprises at least one cut-out at least when at least a part of the marking grid has been removed from the drape through operation of a detachable connection.
O’Neill, however, teaches a device for covering an area of the body during a medical procedure (para [0022]) wherein the device comprises a drape (skin template substrate 30; fig 2) and a marking grid (imaging substrate 12; fig 2) connected to the drape with a detachable connection (a heat seal creates a low strength, non-permanent bond between substrate 12 and substrate 30 thus connecting them to each other – para [0059]) wherein the drape (30) comprises at least one cut-out (the skin template substrate 30 may have window cutouts or an open frame to allow the practitioner to mark out the site of the procedure or carryout the procedure through the device – para [0061]; fig 2 shows the surface 84 of the patient’s body with a target incision spot 106 exposed at the cut out at the center of substrate 30) at least when at least a part of the marking grid has been removed from the drape (as shown in fig 2 where substate 12 is being removed from substrate 30 to thereby expose the cut out at the center). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Piferi to include at least one cut-out at least when at least a part of the marking grid has been removed from the drape through operation of a detachable connection, like the substrate 30 of O’Neill, in order to allow the practitioner to mark out the site of the procedure or carryout the procedure through the device (O’Neill para [0061]).
Piferi also does not disclose that the cut-out is completely circumferentially surrounded by a material of the outer frame.
O’Neill, however, teaches a device for covering an area of the body during a medical procedure (para [0022]) wherein the device comprises a drape (skin template substrate 30; fig 2) and a marking grid (imaging substrate 12; fig 2) connected to the drape (a heat seal creates a low strength, non-permanent bond between substrate 12 and substrate 30 thus connecting them to each other – para [0059]) wherein the drape (30) comprises at least one cut-out (the skin template substrate 30 may have window cutouts or an open frame to allow the practitioner to mark out the site of the procedure or carryout the procedure through the device – para [0061]; fig 2 shows the surface 84 of the patient’s body with a target incision spot 106 exposed at the cut out at the center of substrate 30) wherein the cut-out is completely circumferentially surrounded by a material of the outer frame (as shown in fig 2, substrate 30 is configured as an open frame with a cut out at the center such that the cut out is circumferentially surrounded by material of open frame substrate 30). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Piferi to include at least one cut-out wherein the cut-out is completely circumferentially surrounded by a material of the outer frame, like the substrate 30 of O’Neill, in order to allow the practitioner to mark out the site of the procedure or carryout the procedure through the device (O’Neill para [0061]).
With respect to claim 29, Piferi discloses the device as claimed (see rejection of claim 18) and Piferi also discloses that the grid area is connected to the outer frame (as shown in figs 3-5, the central portion which includes the tab array is integrally formed with the outer peripheral border region) and the outer frame is connected to the drape (via adhesive 122; see fig 4).
Piferi does not, however, disclose that the patch 100 is characterized in that the connection between the grid area and the outer frame has one or a plurality of predetermined breaking points.
Piferi does, however, teach in the embodiment of figure 20 that the patch 100 can be constructed with a layer having a central grid area (shown in fig 20) with an outer frame surrounding the grid (peripheral region that includes indicia in fig 20) wherein the connection between the grid area and the outer frame has one or a plurality of predetermined breaking points (perforations 614 in fig 20; see also para [0132]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the patch 100 of Piferi so that the connection between the grid area and the outer frame has one or a plurality of predetermined breaking points as taught in the embodiment of figure 20 of Piferi in order to permit selective removal of part of the grid to expose underlying material for marking.
Piferi also does not disclose that the drape comprises at least one cut-out at least when at least a part of the marking grid has been removed from the drape.
O’Neill, however, teaches a device for covering an area of the body during a medical procedure (para [0022]) wherein the device comprises a drape (skin template substrate 30; fig 2) and a marking grid (imaging substrate 12; fig 2) connected to the drape (a heat seal creates a low strength, non-permanent bond between substrate 12 and substrate 30 thus connecting them to each other – para [0059]) wherein the drape (30) comprises at least one cut-out (the skin template substrate 30 may have window cutouts or an open frame to allow the practitioner to mark out the site of the procedure or carryout the procedure through the device – para [0061]; fig 2 shows the surface 84 of the patient’s body with a target incision spot 106 exposed at the cut out at the center of substrate 30) at least when at least a part of the marking grid has been removed from the drape (as shown in fig 2 where substate 12 is being removed from substrate 30 to thereby expose the cut out at the center). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Piferi to include at least one cut-out at least when at least a part of the marking grid has been removed from the drape, like the substrate 30 of O’Neill, in order to allow the practitioner to mark out the site of the procedure or carryout the procedure through the device (O’Neill para [0061]).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al (US 2009/0177077).
With respect to claim 20, Piferi discloses the device as claimed (see rejection of claim 19) but does not disclose that the grid area is connected to the outer frame by a form-fitting connection having one or a plurality of predetermined breaking points.
Piferi does, however, teach in the embodiment of figure 20 that the patch 100 can be constructed with a layer having a central grid area (shown in fig 20) with an outer frame surrounding the grid (peripheral region that includes indicia in fig 20) wherein the connection between the grid area and the outer frame is a form-fitting connection (as shown in fig 20, the shape of the grid material matches/conforms to the shape of the frame material at the connection between these two elements) and has one or a plurality of predetermined breaking points (perforations 614 in fig 20; see also para [0132]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the patch 100 of Piferi so that the grid area is connected to the outer frame by a form-fitting connection having one or a plurality of predetermined breaking points as taught in the embodiment of figure 20 of Piferi in order to permit selective removal of part of the grid to expose underlying material for marking.
With respect to claim 21, Piferi discloses the device as claimed (see rejection of claim 18) but does not explicitly disclose that the outer frame is attached to the drape by a non-detachable connection.
Piferi does, however, teach an embodiment in figures 21-22 where the patch 100 can be configured such that tabs in the top layer can be removed individually or in subgroups from the remainder or the top layer so that the operator can remove a selected one or ones of the tabs to reveal the underlying base layer wherein the base layer may also be frangible via perforations around the central grid region (as shown in fig 20) in which case the underlying segment of the base layer may also be selectively removed to expose the patient's scalp for marking (see para [0133]). Therefore, in this embodiment of the patch, the outer frame of the top layer will remain attached to the underlying base layer while only central portions of both layers are removed to provide access to the scalp. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the patch 100 of Piferi so that the outer frame is attached to the drape by a non-detachable connection as taught in the embodiment of figures 21-22 to permit targeted removal of only specific sections of the bandage for access to the scalp without the need to remove the entire layer.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al (US 2009/0177077) in view of Boyde (US 2005/0107732).
With respect to claim 22, Piferi discloses the device as claimed (see rejection of claim 18) but does not disclose that the grid area is connected to the outer frame by a peelable connecting element, wherein the peelable connecting element can be peeled away from the grid area and the outer frame essentially without leaving any residue and without tools.
Boyde, however, teaches a device wherein an outer frame portion 12 is connected to a central area (flap 14) by a peelable connecting element (sealing mechanism 16 which can comprise a pull cord that a user grasps and pulls – para [0019]; the act of pulling the mechanism away from the frame and flap elements 12/14 is interpreted as involving “peeling” of at least part of the mechanism from these surfaces) wherein the peelable connecting element can be peeled away from the grid area and the outer frame essentially without leaving any residue and without tools (a pull string is interpreted as not requiring any tools for a user to grasp and pull the string; additionally, a pull string is interpreted as not leaving residue on the surfaces that it is pulled away from). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Piferi so that the grid area is connected to the outer frame by a peelable connecting element, wherein the peelable connecting element can be peeled away from the grid area and the outer frame essentially without leaving any residue and without tools, as taught by Boyde, in order to provide a user with a fast and easy means to separate the outer frame from the grid area for access to the underlying layers and/or skin surface for marking.
Claims 30-33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al (US 2009/0177077) in view of O’Neill (WO 2014/032171) and further in view of Boyde (US 2005/0107732).
With respect to claim 30, Piferi in view of O’Neill discloses the device substantially as claimed (see rejection of claim 29) but does not disclose that the grid area is connected to the outer frame by a peelable connecting element, wherein the peelable connecting element can be peeled away from the grid area and the outer frame to remove the grid area from the drape.
Boyde, however, teaches a device wherein an outer frame portion 12 is connected to a central area (flap 14) by a peelable connecting element (sealing mechanism 16 which can comprise a pull cord that a user grasps and pulls – para [0019]) wherein the peelable connecting element can be peeled away from the grid area and the outer frame (the act of pulling the mechanism away from the frame and flap elements 12/14 is interpreted as involving “peeling” of at least part of the mechanism from these surfaces) to remove the central area from the frame (as shown in figs 1 and 2 where flap 14 is separated from the frame on three sides and lifted away from underlying portions of the device).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Piferi in view of O’Neill so that the grid area is connected to the outer frame by a peelable connecting element, wherein the peelable connecting element can be peeled away from the grid area and the outer frame to remove the grid area from the drape, as taught by Boyde, in order to provide a user with a fast and easy means to separate the outer frame from the grid area for access to the underlying layers and/or skin surface for marking.
With respect to claim 31, Piferi in view of O’Neill and further in view of Boyde discloses the device substantially as claimed (see rejection of claim 30) and Boyde also teaches that the peelable connecting element is formed integrally with the grid area and the outer frame (sealing mechanism 16 is operated in conjunction with the type of complementary connection or attachment configuration utilized by edges 28a-c and edges 30a-c – para [0019]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the device of Piferi in view of O’Neill and further in view of Boyde so that the peelable connecting element is formed integrally with the grid area and the outer frame as taught by Boyde since forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art.
With respect to claim 32, Piferi in view of O’Neill and further in view of Boyde discloses the device substantially as claimed (see rejection of claim 30) and Boyde also teaches that the peelable connecting element is coupled to a handle element (the pull string structure is interpreted as including a handle portion at the terminal end that a user grasps to pull on the string). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the device of Piferi in view of O’Neill and further in view of Boyde so that the peelable connecting element is coupled to a handle element as taught in Boyde in order to assist a user with grasping the element.
With respect to claim 33, Piferi discloses a device (patch assembly 101 comprising a patch 100) for covering at least one area of the body of a patient during a medical procedure (the patch 100 is shown applied to the head of a user, and thus covering part of the head, for use during a medical procedure in fig 7; see para [0102,0103]), comprising: a sterile drape (base layer 110; the assembly 101 is maintained in a package as part of a kit prior to use and thus is interpreted as being maintained in a sterile condition for use – see para [0129]) and a marking grid connected to the drape (top layer 130 which includes MRI-visible fiducial elements 140 arranged in a pattern 163 which is a grid pattern – para [0089-0090;0096]), wherein the marking grid (130) has an outer frame (outer border area about the perimeter where the letter indicia 164 are provided on one side as shown in figs 3 and 5) and a grid area (central area of layer 130 which includes the tab array 140 in figs 3 and 5) surrounded by the outer frame (the peripheral border surrounds the tab array as shown in figs 3 and 5), wherein the outer frame is connected to the drape (via adhesive 122; see fig 4) and the grid area has markings that are visible in CT and/or MRI scans (the grid includes masses 146 of MRI-visible material in a pattern codified by indicia or markings or other indicators – para [0096], the MRI-visible masses 146 serve as MRI-visible landmarks when MR images are obtained– para [0106]).
Piferi does not, however, disclose the grid area being connected to the outer frame by a detachable connection including one or a plurality of predetermined breaking portions, wherein separation of the grid area from the outer frame via the detachable connection exposes an opening therethrough.
Piferi does, however, teach in the embodiment of figure 20 that the patch 100 can be constructed with a layer having a central grid area (shown in fig 20) with an outer frame surrounding the grid (peripheral region that includes indicia in fig 20) wherein the connection between the grid area and the outer frame has one or a plurality of predetermined breaking points (perforations 614 in fig 20; see also para [0132]) which define an opening at the center through the layer which is exposed when the central grid area is separated from the outer frame (as shown in fig 20). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the patch 100 of Piferi so that the connection between the grid area and the outer frame has one or a plurality of predetermined breaking points wherein separation of the grid area from the outer frame via the detachable connection exposes an opening therethrough as taught in the embodiment of figure 20 of Piferi in order to permit selective removal of part of the grid to expose underlying material for marking.
Piferi also does not disclose that the drape comprises an opening therethrough wherein the marking grid covers the opening.
O’Neill, however, teaches a device for covering an area of the body during a medical procedure (para [0022]) wherein the device comprises a drape (skin template substrate 30; fig 2) and a marking grid (imaging substrate 12; fig 2) connected to the drape (a heat seal creates a low strength, non-permanent bond between substrate 12 and substrate 30 thus connecting them to each other – para [0059]) wherein the drape (30) comprises at least one opening (the skin template substrate 30 may have window cutouts or an open frame to allow the practitioner to mark out the site of the procedure or carryout the procedure through the device – para [0061]; fig 2 shows the surface 84 of the patient’s body with a target incision spot 106 exposed at the cut out at the center of substrate 30) wherein the marking grid covers the opening (as shown in fig 2 the substate 12 selectively covers/uncovers substrate 30 to thereby expose the opening at the center when desired). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Piferi to include an opening therethrough wherein the marking grid covers the opening, like the substrate 30 of O’Neill, in order to allow the practitioner to selectively access the skin to mark out the site of the procedure or carryout the procedure through the device (O’Neill para [0061]).
Piferi also does not disclose that the detachable connection comprises a peelable connecting element connecting the grid area to the outer frame, wherein the peelable connecting element is configured to be peeled away from the grid area and the outer frame to separate the grid area from the drape so as to expose the opening.
Boyde, however, teaches a device wherein an outer frame portion 12 is connected to a central area (flap 14) by a peelable connecting element (sealing mechanism 16 which can comprise a pull cord that a user grasps and pulls – para [0019]) wherein the peelable connecting element can be peeled away from the grid area and the outer frame (the act of pulling the mechanism away from the frame and flap elements 12/14 is interpreted as involving “peeling” of at least part of the mechanism from these surfaces) to remove the central area from the frame and expose an opening through the device (as shown in figs 1 and 2 where flap 14 is separated from the frame on three sides and lifted away from underlying portions of the device to expose an opening at the center of the frame).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Piferi in view of O’Neill so that the detachable connection comprises a peelable connecting element connecting the grid area to the outer frame, wherein the peelable connecting element is configured to be peeled away from the grid area and the outer frame to separate the grid area from the drape so as to expose the opening, as taught by Boyde, in order to provide a user with a fast and easy means to separate the outer frame from the grid area for access to the underlying layers and/or skin surface for marking.
With respect to claim 35, Piferi in view of O’Neill and further in view of Boyde discloses the device substantially as claimed (see rejection of claim 33) and Piferi also discloses that the marking grid (130) being positioned fully within an outer perimeter of the drape (as shown in figure 3, the outer perimeter edge of layer 130 is spaced inward from the outer perimeter edge of layer 110 with a pull tab 138 attached to and extending outward from layer 130 beyond the perimeter of layer 110 while layer 130 is positioned fully within the perimeter of layer 110), with adhesive free regions of the drape occurring between an outer perimeter of the marking grid and the outer perimeter of the drape (as shown in fig 5, the adhesive layer 122 is the same size as layer 130 and thus does not extend onto the portion of layer 110 that extends beyond the outer perimeter edge of layer 130, thus defining an adhesive free region between the outer perimeter edge of layer 130 and the outer perimeter edge of layer 110),
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 5/5/26 have been fully considered as follows:
Regarding the objections to the claims, Applicant’s amendments have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 112, Applicant’s amendments have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 102, Applicant’s arguments on page 6 of the Response have been fully considered but are not persuasive. Specifically, the Office has noted Applicant’s argument that the prior art differs from the claimed invention because layer 110 in Piferi is not taught to be a drape and a person of ordinary skill in the art would not mistake it for a drape. The Office respectfully disagrees because the broadest reasonable interpretation of the term “drape” is a sterile sheet made of a material such as cloth, paper or plastic used during medical procedures to isolate an area from non-sterile areas. Since the layer 110 in Piferi is formed of a flexible polymeric material such as polyvinyl, PET, silicone, polyethylene, polyurethane, and/or polyamide (para [0086]) and it is used during medical procedures (para [0006]) and isolates an area from non-sterile areas (the device covers the part of the body that it is attached to and thus inherently provides a physical barrier to protect that area from contamination), the Office maintains that it is reasonable to interpret layer 110 as being a “drape”. Thus, the Office is not persuaded by this argument. The Office also has noted Applicant’s arguments on page 6 that Piferi does not disclose the new limitations added to amended claim 15 but these arguments are rendered moot in view of the modified grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 6-8 of the response but for at least the same reasons as provided above with respect to the claim rejections under 35 USC 102, the Office is not persuaded by these arguments and therefore maintains that the prior art of record reads on the claims substantially as recited in the present application.
The Office has also noted Applicant’s arguments on pages 8-11 regarding the rejection of claim 34 but these arguments are obviated based on Applicant’s cancellation of claim 34.
Therefore, for at least the reasons outlined above, the Office maintains that the prior art of record reads on the claims substantially as recited in the present application.
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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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