DETAILED ACTION
In the preliminary amendment filed 1/2/25, Applicant has cancelled claims 1-14 and added new claims 15-34. Currently, claims 15-34 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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 19 and 27 are objected to because of the following informalities: in claim 19: line 1 should be amended to recite “claim 19” (since claim 10 has been cancelled); and “the material-fitting connection” should be amended to recite “the material and/or form-fitting connection” (which is in agreement with the language in claim 19); in claim 27: “the contour” should be “a contour”. 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.
Claims 26-28 are 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 26 recites the limitation "the region of the at least one cut-out" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the cut-out" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the cut-out" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the outer frame" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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, 23-25 and 27 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]), which 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).
With respect to claim 27, Piferi discloses the device as claimed (see rejection of claim 18) 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).
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, 26, 28-29 and 33 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 discloses the device as claimed (see rejection of claim 15) 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 28, Piferi discloses the device as claimed (see rejection of claim 15) but does not disclose that the cut-out is completely circumferentially surrounded by a material of the drape and/or 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 drape and/or 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 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 drape and/or 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 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 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]).
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]).
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 patch 100 is characterized in that the material-fitting 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 material-fitting 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 material-fitting 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.
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 30-32 and 34 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 34, Piferi in view of O’Neill discloses the device substantially as claimed (see rejection of claim 33) but 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.
Conclusion
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786